George R. Smith, M.D.; Decision and Order, 44972-44980 [2013-17890]
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terminate the investigation in its
entirety based on the consent order
stipulations, proposed consent orders,
and settlement agreements attached to
the motion. In the motion, the parties
stated that there are no other
agreements, written or oral, express or
implied between the parties concerning
the subject matter of the investigation.
On June 14, 2013, the Commission
investigative attorney (‘‘IA’’) filed a
response in conditional support of the
joint motion, provided that the parties
modify the proposed consent orders to
specify the activities authorized by the
settlement agreements between the
parties. On June 21, 2013, complainants
and respondents jointly moved for leave
to file a reply to the IA’s response to the
joint motion. On June 24, 2013, the IA
indicated to the ALJ that given the
changes made to the consent orders
submitted with the parties’ reply, the IA
does not oppose the joint motion to
terminate.
On July 1, 2013, the ALJ issued the
subject ID granting the joint motion. The
ALJ found that there is good cause for
terminating the investigation, and that
he is not aware of any extraordinary
circumstances that would preclude
granting the motion. The ALJ further
found that entry of the proposed
consent orders and termination of the
investigation is in the public interest.
On July 9, 2013, the ALJ issued a
corrected version of the subject ID to
include the revised versions of the
consent orders. No petitions for review
were filed.
The Commission has determined not
to review the ID.
The authority for the Commission’s
determination is contained in section
337 of the Tariff Act of 1930, as
amended (19 U.S.C. 1337), and in
section 210.42 of the Commission’s
Rules of Practice and Procedure (19 CFR
210.42).
District of Colorado in the lawsuit
entitled United States v. Williams Four
Corners LLC, Civil Action No. 13-cv1923. In its Complaint the United States
seeks civil penalties and injunctive
relief against Williams Four Corners,
LLC (‘‘Williams’’) for violations of the
permit issued pursuant to Part C of
Subchapter I of the CAA, 42 U.S.C. 7475
(Prevention of Significant Deterioration
or ‘‘PSD’’) and the regulations
promulgated thereunder at 40 CFR
52.21, and the federal operating permit
program set forth at Title V of the CAA,
42 U.S.C. 7661–7661f (‘‘Title V’’) and
the regulations promulgated thereunder
at 40 CFR part 71, at a facility known
as PLA–9 Central Deliver Point, also
known as PLA–9 CDP (the ‘‘PLA–9
Facility’’). The PLA–9 Facility is located
approximately 18 miles southwest of
Durango, Colorado, and within the
exterior boundaries of the Southern Ute
Indian Reservation. The PLA–9 Facility
is now shut down. The Decree requires
Williams pay a $63,000 civil penalty to
settle the alleged violations. Should
Williams restart any operations at PLA–
9 within the next two years, the Decree
requires Williams comply with the
requirements of the PSD Permit
applicable to any emitting units that
may be restarted or replaced.
The publication of this notice opens
a period for public comment. Comments
should be addressed to the Acting
Assistant Attorney General,
Environment and Natural Resources
Division, and should refer to United
States v. Williams Four Corners, LLC,
D.J. Ref. No. DOJ # 90–5–2–1–10120. All
comments must be submitted no later
than thirty (30) days after the
publication date of this notice.
Comments may be submitted either by
email or by mail:
Send them to:
By e-mail ............
By order of the Commission.
Issued: July 19, 2013.
Lisa R. Barton,
Secretary to the Commission.
To submit
comments:
pubcommentees.enrd@usdoj.gov.
Assistant Attorney General, U.S. DOJ–ENRD,
PO Box 7611, Washington, DC 20044–
7611.
By mail ...............
[FR Doc. 2013–17847 Filed 7–24–13; 8:45 am]
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DEPARTMENT OF JUSTICE
Notice of Lodging of Proposed
Consent Decree Under the Clean Air
Act
On July 18, 2013 the Department of
Justice filed a Complaint and
simultaneously lodged a proposed
Consent Decree (‘‘Decree’’) with the
United States District Court for the
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During the public comment period,
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[FR Doc. 2013–17874 Filed 7–24–13; 8:45 am]
BILLING CODE 4410–15–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 12–52]
George R. Smith, M.D.; Decision and
Order
On February 5, 2013, Administrative
Law Judge (ALJ) Gail A. Randall issued
the attached Recommended Decision.
Therein, the ALJ recommended that I
deny Respondent’s pending application
for a DEA Certificate of Registration as
a practitioner. Respondent did not file
exceptions to the Recommended
Decision.
Having reviewed the entire record, I
have decided to adopt the ALJ’s
Recommended Decision in its entirety.
Accordingly, Respondent’s application
will be denied.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 28 CFR 0.100(b),
I order that the application of George R.
Smith, M.D., for a DEA Certificate of
Registration as a practitioner, be, and it
hereby is, denied. This Order is effective
immediately.
Dated: July 16, 2013.
Michele M. Leonhart,
Administrator.
Krista Tongring, Esq., for the Government
Louis Leichter, Esq. and Andre D’Souza, Esq.,
for the Respondent
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
I. Introduction
Gail A. Randall, Administrative Law
Judge. This proceeding is an
adjudication pursuant to the
Administrative Procedure Act, 5 U.S.C.
551 et seq., to determine whether the
Drug Enforcement Administration
(‘‘DEA’’ or ‘‘Government’’) should deny
a physician’s application for a DEA
Certificate of Registration pursuant to 21
U.S.C. 823(f) (2006). Without such
registration, the physician, George R.
Smith, M.D. (‘‘Respondent’’ or ‘‘Dr.
Smith’’), would be unable to lawfully
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prescribe, dispense or otherwise handle
controlled substances in the course of
his medical practice.
II. Procedural Background
The Deputy Assistant Administrator,
Drug Enforcement Administration,
issued an Order to Show Cause
(‘‘Order’’) dated June 5, 2012, proposing
to deny the application of George R.
Smith, M.D. for a DEA Certificate of
Registration pursuant to 21 U.S.C. 823(f)
(2006), because Respondent’s
registration would be inconsistent with
the public interest, as that term is used
in 21 U.S.C. § 823(f). [Administrative
Law Judge Exhibit (‘‘ALJ Exh.’’) 1 at 1].
The Order stated that on November 18,
2011, Respondent applied for a DEA
registration as a practitioner in
Schedules II–V at 4721 Bob White Road,
Gilmer, Texas 75645. [Id.]. Additionally,
the Order stated that Respondent had
twice previously surrendered his DEA
registrations for cause. [Id.]. Respondent
first voluntarily surrendered his DEA
registration, DEA number BS2388381,
on March 6, 2002. [Id.]. Respondent
then voluntarily surrendered his second
DEA registration, DEA number
FS0339817, on April 27, 2011. [Id.].
The Order alleged that between
November 1998 and June 2001,
Respondent issued prescriptions for
large quantities of hydrocodone, a
Schedule III controlled substance, to his
family members for his own personal
use for other than legitimate medical
purposes. [Id.]. In relation to this
allegation, the Order asserted that
during this time period, Respondent
obtained and filled prescriptions for
hydrocodone from at least ten different
doctors for his own personal use for
other than legitimate medical purposes.
[Id.]. Additionally, the Order asserted
that between June 2001 and August
2001, Respondent issued prescriptions
for hydrocodone and alprazolam to
third-party non-patients in order for
Respondent to obtain these controlled
substances for his own personal use for
other than legitimate medical purposes.
[Id.]. As a result of issuing these
unlawful prescriptions for controlled
substances, Respondent pled guilty to
one count of obtaining controlled
substances by fraud, in violation of 21
U.S.C. § 843(a)(3), a felony, on
November 26, 2001, before the United
States District Court for the Eastern
District of Texas. [Id. at 2].
Lastly, the Order alleged that
Respondent had prescribed Schedule III
and IV controlled substances between
January 2010 and January 2011 in
violation of his medical license, his
Texas controlled substance registration,
and his DEA registration. [Id.]. In
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regards to this allegation, the Order
stated that Respondent only had
authority to prescribe Schedule V
controlled substances because in March
2007 Respondent had applied for a DEA
registration as a practitioner and was
subsequently issued a DEA registration,
DEA number FS0339817, for Schedule
V controlled substances only. [Id.]. The
Deputy Assistant Administrator then
gave Respondent the opportunity to
show cause as to why his registration
application should not be denied on the
basis of those allegations. [Id.].
On July 3, 2012, Respondent, through
counsel, timely filed a request for a
hearing in the above-captioned matter.
[ALJ Exh. 2].
On December 3, 2012, a Protective
Order was issued to protect patient
names and patient files used in this
proceeding. [ALJ Exh. 8].
After authorized delays, a hearing was
held in Austin, Texas on December 12,
2012 through December 13, 2012, with
the Government and Respondent each
represented by counsel. [ALJ Exh. 3–4,
6–7]. At the hearing, counsel for the
Government called one witness to
testify and introduced documentary
evidence. [Transcript (‘‘Tr.’’) Volume I–
II]. Counsel for the Respondent called
two witnesses to testify, including the
Respondent, and introduced
documentary evidence. [Id.].
After the hearing, the Government
and the Respondent submitted Proposed
Findings of Fact, Conclusions of Law
and Argument (‘‘Govt. Brief’’ and ‘‘Resp.
Brief’’).
III. Issue
The issue in this proceeding is
whether or not the record as a whole
establishes by a preponderance of the
evidence that the Drug Enforcement
Administration should deny the
application of George R. Smith, M.D.,
for a DEA Certificate of Registration as
a practitioner, pursuant to 21 U.S.C.
§ 823(f) (2006), because to grant Dr.
Smith’s application would be
inconsistent with the public interest as
that term is defined in 21 U.S.C. 823(f).
[ALJ Exh. 3; Tr. 5].
IV. Findings of Fact
A. Stipulated Facts
The parties have stipulated to the
following facts:
1. Respondent holds Texas Medical
license H–8411 (expiration February 28,
2013),1 and Texas Department of Public
1 On January 31, 2013, the parties filed Joint
Stipulations of Fact No. 2 with the Court. Therein,
the parties stipulated ‘‘[a]fter the conclusion of the
Hearing on the Merits Respondent submitted a
renewal request to the Texas Medical Board
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Safety Controlled Substances
Registration (Texas DPS Registration)
Certificate 60184908 (expiration
November 30, 2012) 2 which allows
Respondent to issue prescriptions for
controlled substances listed in
Schedules II–V.
2. On March 4, 1995, the Texas State
Board of Medical Examiners (Medical
Board) suspended Respondent’s medical
license because Respondent had
developed a drug addiction due to the
self-administration of hydrocodone and
codeine. The suspension was stayed and
Respondent was placed on probation for
five (5) years.
3. Respondent’s probation was
terminated on October 24, 1998.
4. On October 24, 2001, Respondent’s
medical license was temporarily
suspended because his ‘‘continuation in
the practice of medicine would
constitute a continuing threat to public
welfare.’’
5. On November 26, 2001, before the
United States District Court for the
Eastern District of Texas, Respondent
pleaded guilty to one count of obtaining
a controlled substance by fraud, a
felony. Respondent was sentenced to a
three (3) year term of probation on
March 21, 2002.
6. On March 6, 2002, Respondent
voluntarily surrendered his DEA
Certificate of Registration Number
BS2388381 for cause.
7. By order dated May 17, 2002, the
Medical Board revoked Respondent’s
medical license. The revocation was
stayed, Respondent was placed on
probation for ten (10) years, and
Respondent was required to surrender
his DEA (surrendered prior to the order)
and Texas controlled substance
registrations.
8. By Medical Board Order dated June
2, 2006, Respondent was permitted to
apply to the DEA and the Texas DPS for
Certificates of Registration for Schedule
V controlled substances only.
Respondent was further limited to
prescribing Schedule V controlled
substances to hospital admission
patients only.
(‘‘TMB’’) for his Texas Medical License H–8411
which was set to expire at the end of February 2013.
The TMB renewed Respondent’s medical license for
the ordinary term of two years. Respondent’s Texas
Medical License is now current through February
28, 2015.’’
2 On January 31, 2013, the parties filed Joint
Stipulations of Fact No. 2 with the Court. Therein,
the parties stipulated ‘‘[p]rior to the Hearing on the
Merits the Respondent submitted a request to the
Texas Department of Public Safety (‘‘DPS’’) to
renew his Texas Controlled Substances
Registration. The DPS renewed Respondent’s DPS
Controlled Substances Registration for the ordinary
term of one year. Respondent’s DPS Registration is
now current through November 30, 2013.’’
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9. In March 2007, Respondent applied
for a DEA Registration for Schedule V
controlled substances, which was
approved, and DEA Registration
Number FS0339817 was issued.
10. DEA Registration Number
FS0339817 was renewed in February
2010.
11. Respondent applied to the
Medical Board four times for
modification of his Board order to allow
him to apply for unrestricted DEA and
DPS registrations. He made such
applications on August 18, 2007;
November 2, 2008; March 14, 2010; and
November 17, 2010.
12. On April 27, 2011, Respondent
voluntarily surrendered DEA
Registration Number FS0339817 for
cause after it was discovered that he was
issuing prescriptions for Schedule III
and IV controlled substances to nonhospital admission patients.
13. By Medical Board Order dated
August 26, 2011, Respondent was
permitted to apply to the DEA and the
Texas DPS for unrestricted controlled
substance registrations so that he may
prescribe Schedule II, III, IV, and V
controlled substances.
14. Respondent remains under a
Medical Board order that requires
random drug screens, drug screens upon
request of any of Respondent’s
healthcare providers, treatment for
addiction by a physician, and
attendance at AA meetings. Any
positive drug screen or refusal to submit
to testing is grounds for immediate
suspension of Respondent’s medical
license.
15. The August 26, 2010 3 Medical
Order remains in effect until May 17,
2017, and is not eligible for early
termination.
16. In September 2011, the Texas DPS
issued Respondent a Texas Controlled
Substances Registration in all schedules.
17. On November 18, 2011,
Respondent applied for an unrestricted
DEA Certificate of Registration.4
[ALJ Exh. 5; Tr. 6].
B. Respondent’s History
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1. Respondent’s Education and Training
Respondent received a Bachelor of
Science degree from East Texas State
University, majoring in Molecular
Biology. [Tr. 77–78]. Upon graduating
from college, Respondent attended the
University of Texas Southwestern
Medical School, where he later
3 It appears that both counsel are referring to the
August 26, 2011 Medical Order. See Government
Exhibit (‘‘Govt. Exh.’’) 11 and Respondent Exhibit
(‘‘Resp. Exh.’’) 1.
4 The November 18, 2011 application is the
subject of this administrative hearing.
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graduated in the top 10% of his class.
[Tr. 78–79]. After completing medical
school, Respondent completed a four
year post-graduate residency program in
internal medicine at Presbyterian
Hospital of Dallas. [Tr. 79–81]. In his
final year of residency training,
Respondent was elected the Chief
Resident and during his year as Chief
Resident he served as a critical care
medicine trainee. [Tr. 80–82]. After
completing his residency training, the
Respondent was offered a critical care
fellowship at Parkland Hospital in
Dallas, Texas but, the Respondent
declined this opportunity. [Tr. 82–83].
In 1994, the Respondent entered
private practice after the completion of
his residency training. [Tr. 82, 84]. The
Respondent began practicing with an
internist in Mount Pleasant, Texas. [Id.].
In addition to seeing patients at his own
office, the Respondent served as the
critical care unit director at Titus
Regional Medical Center. [Tr. 84].
Respondent practiced with the internist
and served as the critical care unit
director at Titus Regional Medical
Center for a period of 6–7 years. [Id.].
In 2000, the Respondent became
Board Certified in Internal Medicine.5
[Tr. 89]. Following his time in private
practice and working as the critical care
unit director at Titus Regional Medical
Center, Respondent conducted pilot
exams for American Airlines for a
period of 6–8 months. [Tr. 113]. After
this position was eliminated, the
Respondent began working for a county
hospital in Mineral Wells, Texas as the
hospitalist. [Id.]. Next, the Respondent
conducted routine pre-employment
physicals for a company before
becoming employed at Hugman-Kent
Clinic, in Gladewater, Texas, in 2006.6
[Tr. 113–115]. Respondent continues to
practice at Hugman-Kent Clinic. [Tr.
114–115]. Approximately 85% of the
Respondent’s patients are Medicare
patients. [Tr. 115]. The median age of
the Respondent’s patients is about 60–
65 years old. [Tr. 119]. A significant
number of the Respondent’s patients
have co-morbidities that require
complex medical management. [Tr.
116–117].
5 Respondent is no longer Board Certified in
Internal Medicine because his certification expired
December 31, 2010. He is not permitted to sit for
recertification because he is currently under an
Agreed Order with the Texas Medical Board. [Tr.
111–112, 217; Govt. Exh. 11; Resp. Exh. 1].
6 The reasoning for Respondent’s constant
movement from job to job will be discussed below.
However, such job hopping was due in large part
to his addiction problems and the restrictions
placed on his medical license by the Texas Medical
Board.
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2. Respondent’s Addiction to Controlled
Substances
In 1993, the Respondent developed an
addiction to hydrocodone after he had
injured his back from working on his
car. [Tr. 85, 185; Govt. Exh. 3 at 2].
Respondent began self-administering
hydrocodone after previously obtaining
hydrocodone from physicians and from
samples. [Tr. 86–87; Govt. Exh. 3 at 2].
As a result of his addiction, while
Respondent was working at Presbyterian
Hospital of Dallas in April of 1993, his
clinical privileges were suspended after
Respondent exhibited behavioral
changes and failed to respond to
telephone calls and his beeper. [Tr. 87;
Govt. Exh. 3 at 2]. The Respondent
subsequently entered treatment for his
addiction to hydrocodone and was
placed under the care of Dr. Michael
Healy, an addiction specialist. [Tr. 87–
88].
After practicing medicine for only two
and one half years, the Respondent
entered into an Agreed Order with the
Texas State Board of Medical Examiners
(‘‘the Board’’ or ‘‘the Texas Medical
Board’’) on March 4, 1995, in which his
Texas medical license was suspended as
a result of his addiction to hydrocodone;
however, the Texas Medical Board
stayed the suspension of Respondent’s
medical license and placed him on
probation for a term of five years. [Govt.
Exh. 3; Tr. 85]. As a result of the 1995
Agreed Order, restrictions were placed
on the Respondent’s ability to practice
medicine. [Govt. Exh. 3; Tr. 88–89]. The
Respondent was required to abstain
from the consumption of alcohol and
drugs unless prescribed by another
physician for a legitimate purpose,
submit to drug testing at the request of
the Board, and continue under the care
of Dr. Michael Healy. [Id.].
The Respondent subsequently sought
termination of the March 4, 1995 Agreed
Order. [Tr. 90; Govt. Exh. 4]. However,
on September 20, 1997, the Texas
Medical Board denied Respondent’s
request to terminate the 1995 Agreed
Order due to the nature of the violation
and the fact that less than three of the
five year probation term had been
served. [Id.]. But, on October 24, 1998,
the Texas Medical Board did terminate
the March 4, 1995 Agreed Order. [Govt.
Exh. 5; Tr. 90].
However, the Respondent started
abusing controlled substances again in
1999, approximately one year after the
Texas Medical Board had terminated the
1995 Agreed Order. [Tr. 185]. Around
November of 1999, the Respondent
suffered two compression fractures. [Tr.
92]. The Respondent then began taking
hydrocodone for pain. [Id.]. Respondent
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initially began obtaining hydrocodone
from physicians and then later started
writing prescriptions for it himself. [Id.].
In addition to abusing hydrocodone,
Respondent prescribed hydrocodone to
family members and Respondent would
consume the hydrocodone that he
prescribed to family members a majority
of the time. [Tr. 93, 185; Govt. Exh. 6].
Respondent also approached nurses and
employees of the Titus Regional
Medical Center, where he was working
in 2001, and asked them to fill
controlled substance prescriptions for
him. [Govt. Exh. 6 at 2]. As a result of
his addiction problems, the Titus
Regional Medical Center suspended
Respondent’s hospital privileges. [Tr.
93; Govt. Exh. 6 at 3].
On October 24, 2001, the Texas
Medical Board entered a Temporary
Suspension Order, which temporarily
suspended the Respondent’s Texas
medical license as a result of his return
to addiction. [Govt. Exh. 6]. Following
the 2001 Temporary Suspension, the
Board entered an Agreed Order on May
17, 2002. [Govt. Exh. 7; Resp. Exh. 4].
The Order revoked the Respondent’s
Texas medical license; however, the
Board stayed the revocation and placed
the Respondent on probation for a term
of ten years. [Govt. Exh. 7 at 4; Resp.
Exh. 4 at 4]. The 2002 Agreed Order
required the Respondent to abstain from
the consumption of alcohol and
controlled substances unless prescribed
by a physician for a legitimate purpose,
to report any prescription of controlled
substances to the Board, to give a copy
of the Agreed Order to all treating
physicians, to submit to drug testing at
the request of the Board, to remain
under the care of Dr. Michael Healy,7 to
attend Alcoholics Anonymous (‘‘AA’’)
meetings, to surrender all controlled
substances registrations,8 and to limit
his medical practice to a group or
institutional setting approved by the
Board. [Govt. Exh. 7; Resp. Exh. 4].
Should the Respondent test positive for
drug use, then his medical license could
be automatically revoked without the
need for further hearings. [Tr. 103; Govt.
Exh. 7]. The agreement also prohibited
the Respondent from applying for a
controlled substances registration absent
Board approval. [Govt. Exh. 7]. Further,
the Respondent was only allowed to file
a request to modify this order once a
year thereafter. [Id.].
7 After the retirement of Dr. Michael Healy, the
Respondent has been under the care of Dr. Jonathon
Lockhart and continues to see Dr. Lockhart once a
month per the 2002 Agreed Order. [Tr. 109].
8 Respondent voluntarily surrendered his Texas
DPS and DEA registrations prior to the date of the
2002 Agreed Order. [Tr. 110].
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Respondent subsequently sought
treatment for his relapse in addiction.
[Tr. 94]. Respondent went to Baylor, in
Dallas, where he underwent a threemonth treatment program for his
addiction. [Id.]. Respondent has been
required to submit to over 600 drug tests
as a result of the 2002 Agreed Order and
has never failed to appear for a drug test
nor has the Respondent tested positive.9
[Tr. 103–108]. As a result of the
Respondent’s treatment and willingness
to stay sober, the Respondent reports a
sobriety date of October 22, 2001.10 [Tr.
96; Govt. Exh. 7; Resp. Exh. 4].
Respondent admits that his return to
addiction and his prescribing to family
members, self-administration, and
solicitation of colleagues was an abuse
of the authority of his Texas medical
license, his Texas DPS registration, and
his DEA registration. [Tr. 92]. The 2002
Agreed Order was subsequently
modified on October 10, 2003 and June
2, 2006. [Govt. Exh. 8 and 10; Resp. Exh.
3 and 2].
The October 10, 2003 Modified
Agreed Order permitted the Respondent
to practice in a setting where there is at
least one other physician located in the
place that services are being rendered,
rather than the previous requirement
under the 2002 Order, which restricted
Respondent’s practice to a group or
institutional setting. [Govt. Exh. 8 at 9;
Govt. Exh. 3 at 9]. In addition, the 2003
Modified Agreed Order required the
Respondent to take and pass the Special
Purpose Examination (SPEX). [Id. at 10].
The Respondent again sought
modification of the 2002 Agreed Order;
however, his modification request was
denied by the Board on December 10,
2004. [Govt. Exh. 9]. But, on June 2,
2006, the Board issued an Order
Granting Modification to the 2002
Agreed Order, in which Respondent was
authorized to reapply for a Texas DPS
registration and a DEA registration in
Schedule V controlled substances only.
[Govt. Exh. 10 at 2; Resp. Exh. 2 at 2].
Additionally, the 2006 Order Granting
Modification restricted the
Respondent’s prescribing authority to
hospital admission patients only. [Id.].
9 The drug testing that Respondent must submit
to as a result of his 2002 Agreed Order and
subsequent modifications to this Agreed Order are
intense. Respondent must call an automated
mechanism every morning in order to determine if
he must give a specimen on that particular day. If
Respondent is required to give a specimen on a
particular day, then he must report to give the
specimen before the early afternoon. Respondent
has never failed to call or failed to provide a
specimen over the eleven year period that he has
been required to submit to this drug testing. The
Respondent pays the costs for the drug tests. [Tr.
103–108, 314–316].
10 The Government does not challenge this
sobriety date. [Tr. 313–314].
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After the entry of the Medical Board’s
orders, the Respondent was terminated
from multiple third-party payer
insurance plans. [Tr. 112]. With the loss
of his DEA registration, the Respondent
experienced even more third-party
payer loss, leaving him with mostly
cash-only patients or Medicare patients.
[Id.]. Subsequently, the Respondent
moved from job to job as work became
available. [Tr. 113].
The Respondent continues to see a
psychiatrist once a month. [Tr. 109]. He
currently has no mental health
diagnosis that would impair his abilities
as a physician. [Id.].
C. Respondent Prescribing Controlled
Substances Outside the Scope of His
Registration
Pursuant to the 2002 Agreed Order
and the subsequent 2003 and 2006
modifications to the Agreed Order, the
Respondent re-applied for DPS and DEA
registrations for only Schedule V
controlled substances in March 2007.
[Govt. Exh. 10; Resp. Exh. 2; ALJ Exh.
5]. He obtained these registrations. [Id.].
But, under the June 2, 2006 Order
Granting Modification, the Respondent’s
prescribing authority was restricted to
hospital patients only. [Id.].
In late 2009, Respondent began
prescribing Schedules III and IV
controlled substances to his patients at
the Hugman-Kent Clinic. [Tr. 139].
Respondent continued prescribing
outside the scope of his Texas DPS and
DEA registrations up until he was
visited by Diversion Investigator (‘‘DI’’)
Thomas McLaughlin 11 on April 6, 2011.
[Tr. 23, 139]. Yet, the Respondent
credibly testified that he prescribed
these controlled substances to
adequately treat his patients. [Tr. 130,
135].
DI McLaughlin first began
investigating the Respondent after he
received information from Sandra
Atkins, a DEA registration technician,
that Respondent was writing Schedule
III and IV prescriptions when he was
only authorized to write Schedule V
prescriptions. [Tr. 10–11]. DI
McLaughlin requested information from
the Texas Prescription Monitoring
11 DI McLaughlin is employed by the DEA at the
Tyler Resident Office of the Dallas Field Division.
[Tr. 8]. DI McLaughlin has been a Diversion
Investigator for over 15 years. [Tr. 9]. Prior to being
employed with DEA, DI McLaughlin served as a
Correctional Officer for the Illinois Department of
Corrections, served as an Investigator with the City
of Chicago, and served a total of 21 years in the Air
Force. [Id.]. As part of his training in being a
Diversion Investigator, DI McLaughlin has attended
the basic diversion investigator course in Quantico,
Virginia, and has received continuing training
throughout his tenure as a Diversion Investigator.
[Tr. 9–10].
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Program (‘‘PMP’’) 12 from the time
period of January 2010 through January
2011, and discovered through the report
that Respondent prescribed 1,532
prescriptions in Schedules III, IV, and V
to 335 patients. [Tr. 14–18; Govt. Exh.
2]. These prescriptions were issued to
non-hospital admission patients. [Tr.
22]. Of the 1,532 prescriptions issued
during this time period, over 1,400 were
for Schedule III and IV controlled
substances. [Tr. 18–19; Govt. Exh. 2]. DI
McLaughlin also requested copies of
original prescriptions from the
pharmacies that filled Respondent’s
issued prescriptions. [Tr. 20–22; Govt.
Exh. 2, 12]. He noted that there were no
discrepancies between the Prescription
Monitoring Program Data and the
prescription slips that he received. [Id.].
The Respondent contends that he has
no record of 47 patients named in the
Prescription Monitoring Program Data
Report as being treated by him at the
Hugman-Kent Clinic. [Tr. 173–178;
Resp. Exh. 15]. However, only 41 of
these contested names were listed on
the Prescription Monitoring Program
Data. [Resp. Exh. 15; Govt. Exh. 2; Tr.
59]. These 41 people were prescribed a
total of 155 prescriptions. [Govt. Exh. 2;
Tr. 59]. Therefore, rather than the
Respondent prescribing 1,532 total
prescriptions during the time of January
2010 through January 2011, he issued
1,377 prescriptions. [Govt. Exh. 2].
Although Respondent did not prescribe
to 41 of those listed on the Prescription
Monitoring Program Data Report, the
Respondent did prescribe to the
remaining 294 people and prescribed
1,071 prescriptions for Schedule III and
IV controlled substances. [Id.].
Finding Respondent’s testimony to be
credible, it is probable that someone had
in fact abused Respondent’s DEA
registration because neither the
Respondent nor the Clinic have any
records of these 41 patients being
prescribed controlled substances.13 [Tr.
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12 Under
Texas law all pharmacies must submit
prescription information on controlled substances
to the PMP when the prescriptions are filled. The
information includes the date, the drug, the
practitioner’s name and DPS registration numbers.
[Tr. 12].
13 There was some testimony that implicated an
employee of the Hugman-Kent Clinic, who was
functioning as a nurse, had illegally used
Respondent’s prescriptive authority to help others
obtain controlled substances. [Tr. 174–178]. But,
there is no concrete evidence that this unidentified
nurse had in fact used Respondent’s prescriptive
authority to help 41 people obtain controlled
substances under the guise of Respondent’s Texas
DPS and DEA registrations. [Id.]. However, this
unidentified nurse was later fired from the Clinic
after it had been discovered that she had taken
samples from the Clinic. [Tr. 177].
Further, the Respondent asserted in his
Prehearing Statement that some of the patients
attributed to him may actually be patients of other
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173–178; Resp. Exh. 15]. However,
Respondent acknowledges that his
actions were still wrong and that he did
prescribe outside the scope of his Texas
DPS and DEA registrations. [Tr. 23, 59,
139, 174]. Regardless of the controversy
concerning the 41 patients, he ceased
prescribing Schedule III and IV
controlled substances after a visit by DI
McLaughlin in April of 2011. [Tr. 139].
Although, Respondent admitted his
fault, he repeatedly gave justifications
for his actions; these included:
prescribing for the patient’s best interest
and patient care; and continuing
prescriptions for patients of a retiring
doctor out of the Hugman-Kent Clinic.14
[Tr. 134–139, 168–172, 204, 206; Resp.
Exh. 13]. The Respondent later admitted
on cross-examination that he would
have had fewer patients if he did not
prescribe Schedule III and IV controlled
substances, and the Clinic could
therefore have lowered his salary. [Tr.
191]. Additionally, the Respondent
admitted that there are hundreds of
physicians located in Longview, Texas,
which is about 20 miles away from the
Respondent’s place of business. [Tr.
202, 39–40]. Finally, there were other
physicians in Gladewater, Texas, who
had unrestricted DEA registrations at
the time the Respondent was
prescribing outside the scope of his
registration. [Tr. 39–40]. Yet the
Respondent credibly testified that other
physicians working at the Hugman-Kent
Clinic were not comfortable writing
controlled substance prescriptions for
the Respondent’s patients because ‘‘they
didn’t know the patients.’’ [Tr. 138].
As a result of the Respondent’s
unauthorized prescribing of Schedule III
and IV controlled substances, he
voluntarily surrendered his DEA
registration on April 27, 2011. [ALJ Exh.
5]. The Respondent also violated his
modified 2002 Agreed Order.15 [Govt.
Dr. George Smiths in Texas. However, this assertion
was not pursued by the Respondent during the
hearing. [But see Tr. 41–44; Govt. Exh. 14–17].
14 Respondent offered justifications as to why he
prescribed Schedules III and IV controlled
substances to five patients under his care. The
Respondent found there was a medical need for
each of the patients to be prescribed controlled
substances. Yet, Respondent did not have the
authority to prescribe these controlled substances to
these patients. However, there is no dispute
concerning the medical necessity for these
prescriptions. [Resp. Exh. 13; Tr. 140–161].
15 The Respondent had been requesting
modification of his 2002 Agreed Order through
letters that he sent to the Texas Medical Board on
four separate occasions. Yet each time that he
requested modification, he was not in compliance
with the 2002 Agreed Order. [Resp. Exh. 7–10; Tr.
188–192]. In fact, at the March 2011 modification
hearing that the Respondent had with the Texas
Medical Board, he represented that he was in
compliance with the 2002 Agreed Order but, he was
not. [Tr. 192].
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Exh. 11 at 4; Resp. Exh. 1 at 4]. Also,
the Respondent had been reporting to
his compliance officer that he was in
full compliance with the 2002 Agreed
Order, when in fact he admitted at the
hearing that he had not been in
compliance. [Resp. Exh. 5–6; Tr. 186–
192].
On August 26, 2011, the Respondent
again entered into an Agreed Order with
the Texas Medical Board. [Govt. Exh.
11; Resp. Exh. 1; Tr. 162–165]. Pursuant
to the 2011 Agreed Order, which was
issued after the Respondent took part in
an Informal Settlement and Show Cause
Proceeding (‘‘ISC’’) 16 on July 28, 2011,
the Respondent is to remain under the
terms of the 2002 Agreed Order, as
modified, without the right to seek an
early termination. [Tr. 308; Govt. Exh.
11 at 5; Resp. Exh. 1 at 5]. The Board
modified the 2002 Agreed Order to
authorize the Respondent to reapply to
the DEA and the Texas DPS to obtain
registrations in Schedule II, III, IV, and
V controlled substances. [Id.]. But, the
decision to grant or deny the
Respondent’s application remains ‘‘a
matter for appropriate determination by
the DEA and DPS.’’ [Govt. Exh. 11 at 5–
6; Resp. Exh. 1 at 5–6]. In addition, the
Respondent was ordered to pay an
administrative penalty of $10,000,
which he has paid. [Tr. 164; Govt. Exh.
11 at 6; Resp. Exh. 1 at 6]. Thus, after
the Respondent had been found to be in
violation of both his Texas DPS and
DEA registrations and his 2002 Agreed
Order, the Respondent was permitted to
reapply for unrestricted registrations,
and he obtained an unrestricted Texas
DPS registration in Schedules II through
V in September 2011. [ALJ Exh. 5].
Now, in spite of his violations, the
Respondent seeks a DEA registration for
Schedules II through V. [ALJ Exh. 5;
Govt. Exh. 1].
D. Respondent’s Felony Convictions
1. 2001 Felony Conviction
As a result of Respondent’s addiction
to hydrocodone and his selfadministration of hydrocodone, he pled
guilty to one count of obtaining a
controlled substance by fraud, a felony,
on November 26, 2001, before the
United States District Court for the
Eastern District of Texas. [ALJ Exh. 5;
Tr. 99]. Respondent was then sentenced
to a three year term of probation on
March 21, 2002. [ALJ Exh. 5].
16 The record contains testimony concerning the
ISC process. [Tr. 308–311]. Since there is no dispute
concerning this due process procedure, I do not
explain this Medical Board process here.
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2. 2012 Felony Conviction
V. Statement of Law and Discussion
As a result of the Respondent’s
admitting that he prescribed Schedule
III and IV controlled substances, when
he was only authorized to prescribe
Schedule V controlled substances, he
pled guilty to violating 21 U.S.C.
842(a)(1) and (c)(2)(B) (2006) for illegal
dispensing before the United States
District Court for the Eastern District of
Texas, Tyler Division on September 5,
2012. [Govt. Exh. 13; Tr. 36–38, 167–
168]. Respondent has not yet been
sentenced for this conviction; however,
the sentencing recommendation is a
probationary term and a fine. [Tr. 38,
168].
A. The Position of the Parties
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E. Respondent’s Remedial Actions
Respondent has taken remedial
actions to help ensure that the terms of
his medical license agreement would
not be violated. [Tr. 178–179]. Because
Respondent claims that there may have
been some instances where his DEA
registration was abused by others,
although he fully admits to prescribing
outside the scope of his registration, he
intends to take the following actions to
ensure others do not abuse his medical
license and/or a future DEA registration:
use the Prescription Access Texas
Program to monitor patients’
prescriptions; implement a better
screening process prior to hiring
employees at the Clinic; use only hard
copy prescriptions, rather than calling
in prescriptions to pharmacies; and
notify local pharmacies regarding his
use of hard copy prescriptions. [Tr. 178–
179]. The Respondent admitted that he
could have implemented these remedial
measures when he first gained
employment at Hugman-Kent Clinic but,
he did not. [Tr. 192–193].
Currently any patient who calls for an
appointment is told that the Respondent
is unable to prescribe controlled
substances. [Tr. 180, 219]. The
Respondent also credibly testified that
he would expect his DEA registration
would contain conditions, such as the
keeping of a log book. [Tr. 205, 214–
215]. The Respondent testified that he
would not violate his DEA registration
again. [Tr. 207–208]. The last time the
Respondent prescribed controlled
substances in Schedules III and IV to a
patient was in the Spring of 2011. [Tr.
219].
The Respondent also provided
testimony as to why having a DEA
registration would be beneficial to his
patients. [Tr. 166, 218]. He would be
able to participate in more third-party
payer plans, and he could take steps to
obtain hospital privileges to better treat
his patients. [Id.].
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1. Government’s Position
The Government asserts that the
Respondent’s application for a DEA
Certificate of Registration should be
denied. [Govt. Brief at 18]. Specifically,
the Government argues that granting the
Respondent’s application is inconsistent
with the public interest, under 21 U.S.C.
823(f) (2006), because the Respondent
has previously failed to be a responsible
registrant, has violated the Controlled
Substances Act, has two felony
convictions, and has failed to take
responsibility for his actions. [Id.].
The Government argues that the
recommendation of the Texas Medical
Board, which allows the Respondent to
reapply for a DEA registration in
Schedule II through V controlled
substances, should be given ‘‘nominal
weight.’’ [Id. at 12–13]. In support of its
argument, the Government contends
that the Respondent has ‘‘been the
subject of Texas Medical Board orders
from 1995 through 1998 and again from
2001 through the present day based on
Respondent’s misconduct involving
controlled substances.’’ [Id. at 12].
In addition, the Government argues
that the Respondent’s experience in
dispensing controlled substances, his
conviction record, and his compliance
with federal and state laws relating to
controlled substances ‘‘all strongly
weigh in favor of the denial of
Respondent’s application’’ for a DEA
Certificate of Registration. [Id. at 13].
The Government argues that
Respondent has had his Texas medical
license revoked (although stayed) twice
due to his addiction to hydrocodone
and his prescribing hydrocodone to his
family members. [Id. at 13–14].
Additionally, the Government argues
that the Respondent has had two felony
convictions related to controlled
substances, one for issuing fraudulent
prescriptions and another for
prescribing controlled substances
outside the scope of his prescriptive
authority. He has twice surrendered his
DEA registrations. [Id.]. The
Government also argues that
Respondent violated federal and local
law on several occasions when he
prescribed Schedule III and IV
controlled substances to his nonhospital patients. [Id. at 14].
Lastly, the Government argues that
the Respondent’s application for a DEA
registration is inconsistent with the
public interest because Respondent has
failed to be a compliant registrant in the
past and will likely fail to be a
compliant registrant in the future. [Id. at
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44977
15]. The Government also argues that
the Respondent has failed to take full
responsibility for his actions. [Id. at 16].
The Government additionally argues
that the Respondent’s excuses for his
failure to be a compliant registrant, i.e.
the need of the community and his
patients, is not a viable argument and
does not support the granting of
Respondent’s application for a DEA
registration. [Id. at 17]. In conclusion,
the Government asserts that
‘‘Respondent failed in his
responsibilities as a DEA registrant, not
once but two times. Both failures
involved Respondent’s knowing and
willful violations of the Controlled
Substances Act and resulted in criminal
convictions.’’ [Id. at 18]. For these
reasons, the Government concludes that
the Respondent’s application should be
denied.
2. Respondent’s Position
The Respondent asserts that his
application for a DEA registration
should be granted because granting his
registration is consistent with the public
interest.17 [Resp. Brief at 13]. First, Dr.
Smith argues that the Texas Medical
Board has recommended that he be able
to apply for an unrestricted DEA
registration, in spite of his past
disciplinary history with the Texas
Medical Board. [Id. at 13–14].
Additionally, the Respondent notes that
he has already obtained an unrestricted
Texas DPS registration for controlled
substances that weighs in favor of the
DEA granting his registration. [Id. at 14].
The Respondent next argues that he
has sufficient knowledge and
experience in dispensing controlled
substances. [Id.]. Respondent claims
that he has ‘‘a good working knowledge
of complex medical management.’’ [Id.].
Although the Respondent
acknowledges that he has had two
felony convictions and has not
complied with state, federal, or local
laws relating to controlled substances,
he asserts that he has rehabilitated
himself and thus, these factors do not
warrant the denial of his DEA
registration application. [Id. at 14–16].
Specifically, the Respondent asserts that
he has been sober since October of 2001,
and has submitted to over 600 drug
tests, in which he has never tested
positive. [Id. at 15]. Additionally, the
Respondent argues that, although he
prescribed outside the scope of his
17 Although the Respondent contends that
granting his application for a DEA registration is in
the public interest, he recognizes that restrictions
could be placed on his registration, such as
maintaining a log book and agreeing to inspections
without the need for an administrative warrant.
[Resp. Brief at 13].
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registration, he did so because it was in
the best interest of his patients and he
never ‘‘non-therapeutically prescribed
drugs since his 2002 arrest.’’ [Id.].
Moreover, Respondent asserts that since
his noncompliance was discovered in
2011, he has been in full compliance
with his Texas Medical Board Orders,
his Texas DPS registration and his DEA
registration. [Id. at 15–16].
Lastly, the Respondent argues that a
DEA registration in Schedules II through
V will not threaten the public health
and safety because he is committed to
remaining sober and complying with all
laws. [Id. at 16–18]. Dr. Smith asserts
that he has taken responsibility for his
past wrongdoing and if he were to
receive a DEA registration, he would
understand and comply with any
stipulations that were included with his
DEA registration. [Id. at 17–18].
Moreover, Dr. Smith argues that
granting his DEA registration
application is in fact in the public’s best
interest because he will be better
equipped to handle his patients and the
community will be effected in a positive
way. [Id. at 17]. Therefore, Dr. Smith
requests that his DEA registration
application be granted with any
provisions the Court deems fit. [Id. at
18].
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B. Statement of Law and Analysis
Pursuant to 21 U.S.C. 823(f) (2006),
the Deputy Administrator may deny an
application for a DEA Certificate of
Registration if he determines that such
registration would be inconsistent with
the public interest.18 In determining the
public interest, the following factors are
considered:
(1) The recommendation of the
appropriate State licensing board or
professional disciplinary authority.
(2) The applicant’s experience in
dispensing, or conducting research with
respect to controlled substances.
(3) The applicant’s conviction record
under Federal or State laws relating to
the manufacture, distribution, or
dispensing of controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to
controlled substances.
(5) Such other conduct which may
threaten the public health and safety. 21
U.S.C. § 823(f) (2006).
These factors are to be considered in
the disjunctive; the Deputy
Administrator may rely on any one or a
combination of factors and may give
each factor the weight he deems
appropriate in determining whether an
18 The Deputy Administrator has the authority to
make such a determination pursuant to 28 C.F.R.
§§ 0.100(b), 0.104 (2012).
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application should be denied. See
Robert A. Leslie, M.D., 68 Fed. Reg.
15,227, 15,230 (DEA 2003). Moreover,
the Deputy Administrator is ‘‘not
required to make findings as to all of the
factors.’’ Hoxie v. DEA, 419 F.3d 477,
482 (6th Cir. 2005); see also Morall v.
DEA, 412 F.3d 165, 173–74 (DC Cir.
2005).
The Government bears the ultimate
burden of proving that the requirements
for registration are not satisfied. 21 CFR
1301.44(d) (2012). However, where the
Government has made out a prima facie
case that Respondent’s application
would be ‘‘inconsistent with the public
interest,’’ the burden of production
shifts to the applicant to ‘‘present[]
sufficient mitigating evidence’’ to show
why he can be trusted with a new
registration. See Medicine Shoppe—
Jonesborough, 73 FR 364, 387 (DEA
2008). To this point, the Agency has
repeatedly held that the ‘‘registrant must
accept responsibility for [his] actions
and demonstrate that [he] will not
engage in future misconduct. Id.; see
also Samuel S. Jackson, D.D.S., 72 FR
23,848, 23,853 (DEA 2007). In short,
after the Government makes its prima
facie case, the Respondent must
produce sufficient evidence that he can
be trusted with the authority that a
registration provides by demonstrating
that he accepts responsibility for his
misconduct and that the misconduct
will not reoccur. Yet, the DEA has
consistently held the view that ‘‘past
performance is the best predictor of
future performance.’’ Alra Laboratories,
59 FR 50,620 (DEA 1994), aff’d Alra
Laboratories, Inc. v. DEA, 54 F.3d 450,
451 (7th Cir 1995).
1. Factor One: Recommendation of
Appropriate State Licensing Board
Although the recommendation of the
applicable state licensing board is
probative to this factor, the Agency
possesses ‘‘a separate oversight
responsibility with respect to the
handling of controlled substances’’ and
therefore, must make an ‘‘independent
determination as to whether the
granting of [a registration] would be in
the public interest.’’ Mortimer B. Levin,
D.O., 55 Fed. Reg. 8,209, 8,210 (DEA
1990); see also Jayam Krishna-Iyer,
M.D., 74 Fed. Reg. 459, 461 (DEA 2009).
It is well-established Agency precedent
that a ‘‘state license is a necessary, but
not a sufficient condition for
registration.’’ Leslie, 68 Fed. Reg. at
15,230; John H. Kennedy, M.D., 71 FR
35,705, 35,708 (DEA 2006). Even the
reinstatement of a state medical license
does not affect the DEA’s independent
responsibility to determine whether a
registration is in the public interest.
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Levin, 55 FR at 8,210. The ultimate
responsibility to determine whether a
registration is consistent with the public
interest has been delegated exclusively
to the DEA, not to entities within a state
government. Edmund Chein, M.D., 72
Fed. Reg. 6,580, 6,590 (DEA 2007), aff’d
Chein v. DEA, 533 F.3d 828 (DC Cir.
2008). So while not dispositive, state
board recommendations are relevant to
the issue of granting a DEA registration.
See Gregory D. Owens, D.D.S., 74 FR
36,751, 36,755 (DEA 2009); Martha
Hernandez, M.D., 62 FR 61,145, 61,147
(DEA 1997).
The Respondent has been the subject
of numerous orders from the Texas
Medical Board throughout his medical
career. [Govt. Exh. 3–11; Resp. Exh. 1–
4]. The disciplinary proceedings
regarding the Respondent with the
Texas Medical Board span over a
decade. [Id.]. The Respondent initially
had his Texas medical license
suspended in 1995 after it was
discovered that the Respondent had
become addicted to hydrocodone and
codeine. [Govt. Exh. 3]. Then again, in
October of 2001, the Respondent’s
medical license was suspended after the
Texas Medical Board discovered that
the Respondent had relapsed in his drug
addiction. [Govt. Exh. 6]. Thereafter, on
May 17, 2002, the Texas Medical Board
revoked Respondent’s Texas medical
license in light of his abuse of
controlled substances and his
prescribing controlled substances to his
family members for his own personal
use; however, the revocation was stayed
and the Respondent was placed on a
term of probation for ten years. [Govt.
Exh. 7; Resp. Exh. 4]. In addition to the
stay of revocation and the term of
probation, the Respondent was required
to surrender his DEA Certificate of
Registration and his Texas DPS
controlled substance registration. [Id.].
However, in 2006, the Texas Medical
Board allowed the Respondent to seek a
modification of the May 17, 2002 Order,
and the Respondent was subsequently
permitted to apply to the DEA and the
Texas DPS for controlled substance
registrations in Schedule V only. [Govt.
Exh. 10; Resp. Exh. 2]. Additionally, the
June 2, 2006 Order mandated that, if
Respondent were to receive authority to
prescribe Schedule V controlled
substances, then his prescribing
authority would be restricted to hospital
admission patients only. [Id.].
In spite of the Respondent’s past
history, the most recent Texas Medical
Board Order, dated August 26, 2011,
permits Respondent to reapply to the
DEA and the Texas DPS for controlled
substance registrations in Schedules II
through V. [Govt. Exh. 11; Resp. Exh. 1].
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However, the 2011 Order notes that,
although the Board will allow the
Respondent to reapply for these
registrations, the decision of whether to
grant or deny the Respondent’s
application is reserved for the issuing
agency. [Id.].
Therefore, while the Respondent’s
Texas medical license is not currently
suspended or revoked, the Respondent
is currently the subject of the 2011
Agreed Order, by which the Respondent
must abide. [Id.]. Although the
Respondent’s medical license has been
the subject of numerous disciplinary
actions by the Texas Medical Board, I
find that the current recommendation of
the Texas Medical Board permits the
Respondent to apply for a DEA
registration in Schedules II through V.
[Id.]. However, the Texas Medical Board
did not directly recommend that the
Respondent’s DEA application for
registration should be granted. [Id.]. In
fact, the Texas Medical Board
recognizes that the decision of whether
to grant or deny the Respondent’s DEA
application is entirely reserved to the
DEA. [Id.]. Thus, I find that the decision
of the Texas Medical Board neither
weighs in favor of granting nor denying
the Respondent’s application for a DEA
Certificate of Registration in Schedules
II through V.
2. Factors Two and Four: Applicant’s
Experience With Controlled Substances
and Applicant’s Compliance With
Applicable State, Federal, or Local Laws
Relating to Controlled Substances
Respondent’s experience with
controlled substances and his
compliance with applicable laws related
to the handling of controlled substances
are relevant to determining the public
interest in this case. ‘‘Pursuant to 21
U.S.C. 822(b), ‘[p]ersons registered by
the Attorney General under this
subchapter to . . . dispense controlled
substances . . . are authorized to
possess . . . or dispense such
substances . . . to the extent authorized
by their registration and in conformity
with the other provisions of this
subchapter.’ ’’ Leonard E. Reaves, III,
M.D., 63 FR 44,471, 44,473 (DEA 1998)
(registration revoked after physician was
prescribing outside the scope of his DEA
registration). Additionally, except as
authorized, ‘‘it shall be unlawful for any
person knowingly or intentionally to
. . . dispense, or possess with intent to
. . . dispense a controlled substance.’’
21 U.S.C. 841(a)(1) (2006); see 21 U.S.C.
802(10) (‘‘‘dispense’ means to deliver a
controlled substance to an ultimate user
. . . pursuant to the lawful order of, a
practitioner, including the prescribing
. . . of a controlled substance’’); see
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also 21 CFR 1301.13(a) (providing that
‘‘[n]o person required to be registered
shall engage in any activity for which
registration is required until the
application for registration is granted
and a Certificate of Registration is
issued by the Administrator to such
person.’’).
In this case, the Respondent’s
experience with controlled substances
has been troubled for a majority of his
career. [Govt. Exh. 3–11; Resp. Exh. 1–
4]. Respondent has struggled with
addiction to controlled substances;
although, now the Respondent is sober
and has been sober for eleven years. [Tr.
96, 122]. Additionally, the Respondent
prescribed controlled substances to his
family members without maintaining
proper records and a majority of those
prescriptions Respondent obtained for
his own addiction purposes. [Tr. 93].
Respondent also prescribed Schedule
III and IV controlled substances in
violation of his 2002 Agreed Order,
modified in 2006, and Texas DPS and
DEA registrations. [Govt. Exh. 10; Resp.
Exh. 2]. Specifically, the Respondent
was only authorized by his DEA
registration to prescribe Schedule V
controlled substances, and by his
modified Agreed Order, to prescribe
such substances to hospital admitted
patients. Yet, the Respondent prescribed
1,071 Schedule III and IV controlled
substances to non-hospital admitted
patients over the course of one year.
[Govt. Exh. 2, 10; Resp. Exh. 2]. In fact,
the Respondent had been prescribing
outside the scope of his registration
since 2009 and only stopped doing so in
April of 2011, after DI McLaughlin
visited the Respondent at the Clinic and
informed him that he could not
prescribe Schedule III and IV controlled
substances when his DEA registration
was restricted to Schedule V controlled
substances. [Tr. 23, 139].
The Respondent blatantly disregarded
the restrictions that had been placed on
his authority to prescribe controlled
substances. Although the Respondent
claims that he would not abuse his
registration in the future, in light of his
past behavior his claim cannot be
trusted. His history and experience with
controlled substances throughout his
medical career is not indicative of a
compliant registrant. Thus, I find that
these factors weigh against the granting
of Respondent’s application for a DEA
Certificate of Registration.
3. Factor Three: Applicant’s Conviction
Record Relating to Controlled
Substances
Pursuant to 21 U.S.C. 823(f)(3) (2006),
the Deputy Administrator may deny a
pending application for a DEA
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Sfmt 4703
44979
Certificate of Registration upon a
finding that the applicant has been
convicted of a felony related to
controlled substances under state or
federal law. See Barry H. Brooks, M.D.,
66 FR 18,305, 18,307 (DEA 2001); John
S. Noell, M.D., 56 FR 12,038, 12,039
(DEA 1991); Thomas G. Easter II, M.D.,
69 FR 5,579, 5,580 (DEA 2004).
In this case, the record contains ample
evidence that Respondent has been
convicted of two felony offenses related
to the dispensing of controlled
substances. [ALJ Exh. 5; Govt. Exh. 13].
Respondent has a 2001 felony
conviction for obtaining a controlled
substance by fraud in violation of 21
U.S.C. 843(a)(3). [ALJ Exh. 5]. In
addition, the Respondent has a 2011
felony conviction for issuing
prescriptions for Schedule III and IV
controlled substances in violation of his
restricted Schedule V DEA registration,
thus violating 21 U.S.C. 842(a)(1) and
(c)(2)(B). [Govt. Exh. 13]. Therefore, I
find that this factor weighs against the
granting of Respondent’s application for
a DEA Certificate of Registration.
4. Factor Five: Such Other Conduct
Which May Threaten the Public Health
and Safety
Under Factor Five, the Deputy
Administrator is authorized to consider
‘‘other conduct which may threaten the
public health and safety.’’ 21 U.S.C.
823(f)(5) (2006). This factor
encompasses ‘‘conduct which creates a
probable or possible threat (and not only
an actual [threat]) to public health and
safety.’’ Jacobo Dreszer, M.D., 76 FR
19,386, 19,401 FN2 (DEA 2011). The
Agency has long held that a
practitioner’s self-abuse of controlled
substances constitutes ‘‘conduct which
may threaten public health and safety.’’
21 U.S.C. § 823(f)(5) (2006); see also
Tony T. Bui, M.D., 75 Fed. Reg. 49,979,
49,990 (DEA 2010); Kenneth Wayne
Green, Jr., M.D., 59 FR 51,453 (DEA
1994); David E. Trawick, D.D.S., 53 Fed.
Reg. 5,326 (DEA 1988). Additionally,
the DEA has consistently held that
‘‘[c]andor during DEA investigations,
regardless of the severity of the
violations alleged, is considered by the
DEA to be an important factor when
assessing whether a . . . registration is
consistent with the public interest’’ and
noting that a registrant’s ‘‘lack of candor
and failure to take responsibility for his
past legal troubles . . . provide
substantial evidence that his registration
is inconsistent with the public interest.’’
Jeri Hassman, M.D., 75 FR 8,194, 8,236
(DEA 2010); see also Prince George
Daniels DDS, 60 FR 62,884, 62,887 (DEA
1995); see also Ronald Lynch, M.D., 75
FR 78,745, 78,749 (DEA 2010)
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(Respondent’s attempts to minimize
misconduct held to undermine
acceptance of responsibility).
Furthermore, the Agency is not required
to ‘‘consider community impact
evidence in exercising its
authority.. . .’’ Linda Sue Cheek, M.D.,
76 FR 66,972, 66,973 (DEA 2011); see
also Steven M. Abbadessa, D.O., 74 FR
10,077, 10,078 (DEA 2009) (the hardship
imposed because Respondent lacks a
registration is not a relevant
consideration under the Controlled
Substances Act).
Here, Respondent self-abused and
prescribed significant quantities of
controlled substances to his family
members, from approximately 1993
through October 22, 2001, which he
reports as his sobriety date. [Govt. Exh.
3–10]. Such unlawful ingestion and
prescribing of controlled substances
clearly places the public health and
safety in jeopardy. This unlawful
conduct led to the temporary
suspension of Respondent’s Texas
medical license, a felony conviction, the
surrender of Respondent’s DEA
registration, and revocation of
Respondent’s Texas medical license.19
[Govt. Exh. 3, 6–7; ALJ Exh. 5; Resp.
Exh. 4].
Yet, I find that Respondent has
successfully addressed his addiction
problem and returned to the practice of
medicine by regaining his medical
license in 2002. [Govt. Exh. 7; Resp.
Exh. 4]. At the hearing, Respondent
proffered substantial and detailed
evidence regarding his impressive
recovery program, including numerous
negative drug screens he has taken over
the past eleven years. [Tr. 103–108]. As
the Deputy Administrator has
previously determined, ‘‘[t]he
paramount issue is not how much time
has elapsed since [the Respondent’s]
unlawful conduct, but rather, whether
during that time [the] Respondent has
learned from past mistakes and has
demonstrated that he would handle
controlled substances properly if
entrusted with a DEA registration.’’
Leonardo V. Lopez, M.D., 54 FR 36,915
(DEA 1989). Even though it has been
previously found that time, alone, is not
dispositive in such situations, it is
certainly an appropriate factor to be
considered. See Robert G. Hallermeier,
M.D., 62 FR 26,818 (DEA 1997) (four
years); John Porter Richards, D.O., 61 FR
13,878 (DEA 1996) (ten years); Norman
Alpert, M.D., 58 FR 67,420, 67,421 (DEA
1993) (seven years).
19 Although the Respondent’s medical license
was temporarily suspended and later revoked, both
of these actions were stayed and the Respondent
was placed on probation each time. See Govt. Exh.
3, 6, 7 and Resp. Exh. 4.
VerDate Mar<15>2010
13:49 Jul 24, 2013
Jkt 229001
In Respondent’s case, the fact that he
has been sober for over eleven years and
continues to abide by all terms and
conditions imposed upon him regarding
his sobriety shows that Respondent
intends to remain sober. In addition,
there has been no evidence that the
Respondent has suffered any sort of
relapse to addiction since his reported
sobriety date of October 22, 2001.
Therefore, the public interest is not
being threatened by the Respondent’s
previous addiction to hydrocodone,
because it does not appear that the
Respondent will return to this conduct.
However, although the Respondent
attempted to take responsibility for his
unlawful prescribing of Schedules III
and IV controlled substances by
admitting that his actions were wrong,
he continuously provided justifications
for his actions in an effort to persuade
the Court that his violations of his DEA
registration were justified under the
circumstances. [Tr. 134–139, 168–172,
204, 206; Resp. Exh. 13]. Moreover,
Respondent repeatedly provided the
Court with reasons as to why it was not
feasible for him to refer his patients to
another doctor who could prescribe the
necessary scheduled controlled
substance, or to simply refuse to
prescribe outside of his DEA and Texas
DPS registrations. [Id.]. I find that
Respondent’s misplaced justifications
amount to a failure to take full
responsibility for his actions.
Moreover, although the Respondent
attempts to justify the need for his DEA
registration because it would be in his
patient’s and the community’s best
interest, this reasoning has failed in
determining whether the Respondent’s
application should be granted.
Community impact evidence has been
found irrelevant in DEA precedent.
Linda Sue Cheek, M.D., 76 FR at 66,973;
see also Steven M. Abbadessa, D.O., 74
FR at 10,078.
As to candor, the record demonstrates
that the Respondent falsely reported his
compliance with the Agreed Order
when he was in fact noncompliant.
Specifically, the Respondent reported
that he was abiding by his restricted
prescribing authority, when he was
actually prescribing outside the scope of
that authority. Such lack of candor to
government officials weighs against the
Respondent’s application being granted.
[Resp. Exh. 5, 6].
In sum, Respondent has conclusively
demonstrated his strong recovery from
his previous addiction and his
successful maintenance of his sobriety
for the past eleven years. Therefore, I
find that Respondent’s history of
substance abuse does not weigh against
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Fmt 4703
Sfmt 9990
the granting of Respondent’s application
for a DEA Certificate of Registration.
The Respondent has admitted his
wrongdoing in prescribing outside his
authority. However, each time
Respondent admitted that his past
conduct was a violation, he attempted to
offer justifications for his conduct in an
effort to minimize his wrongdoing.
Therefore, I find that Respondent’s halfhearted attempt to take responsibility
for these actions weighs against the
granting of Respondent’s application for
a DEA Certificate of Registration.
C. Conclusion and Recommendation
I conclude that the Government has
proven, by a preponderance of the
evidence, that Respondent’s application
for a DEA registration in Schedules II
through V should be denied.
Respondent has previously been granted
numerous opportunities to act as a
responsible DEA registrant and has
failed each time. I do not see any
conditions that could be placed on
Respondent’s registration now that
would ensure that Respondent would be
a responsible DEA registrant, especially
considering that Respondent was
afforded the opportunity to hold a DEA
registration for Schedule V controlled
substances after his substance abuse and
felony conviction, and yet, Respondent
violated his registration.
Moreover, had the Respondent not
been caught violating his prescriptive
authority, it is likely that Respondent
would have continued prescribing
outside the scope of his registration.
Although Respondent now claims that
he would be a compliant registrant, if he
were to receive a DEA registration, I find
reason to doubt this claim. Respondent
has been noncompliant, yet has
represented himself as compliant on
several occasions to Board
representatives.
In this case, the Respondent has
shown that his ability to properly
handle controlled substances and abide
by the law has been tainted. I find that
Respondent has not taken full
responsibility for his mistakes.
Therefore, I find that granting
Respondent’s application for a DEA
Certificate of Registration is against the
public interest, and I recommend that
his application be denied.
Date: February 5, 2013.
Gail A. Randall,
Administrative Law Judge.
[FR Doc. 2013–17890 Filed 7–24–13; 8:45 am]
BILLING CODE 4410–09–P
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Agencies
[Federal Register Volume 78, Number 143 (Thursday, July 25, 2013)]
[Notices]
[Pages 44972-44980]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-17890]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 12-52]
George R. Smith, M.D.; Decision and Order
On February 5, 2013, Administrative Law Judge (ALJ) Gail A. Randall
issued the attached Recommended Decision. Therein, the ALJ recommended
that I deny Respondent's pending application for a DEA Certificate of
Registration as a practitioner. Respondent did not file exceptions to
the Recommended Decision.
Having reviewed the entire record, I have decided to adopt the
ALJ's Recommended Decision in its entirety. Accordingly, Respondent's
application will be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28
CFR 0.100(b), I order that the application of George R. Smith, M.D.,
for a DEA Certificate of Registration as a practitioner, be, and it
hereby is, denied. This Order is effective immediately.
Dated: July 16, 2013.
Michele M. Leonhart,
Administrator.
Krista Tongring, Esq., for the Government
Louis Leichter, Esq. and Andre D'Souza, Esq., for the Respondent
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
I. Introduction
Gail A. Randall, Administrative Law Judge. This proceeding is an
adjudication pursuant to the Administrative Procedure Act, 5 U.S.C. 551
et seq., to determine whether the Drug Enforcement Administration
(``DEA'' or ``Government'') should deny a physician's application for a
DEA Certificate of Registration pursuant to 21 U.S.C. 823(f) (2006).
Without such registration, the physician, George R. Smith, M.D.
(``Respondent'' or ``Dr. Smith''), would be unable to lawfully
[[Page 44973]]
prescribe, dispense or otherwise handle controlled substances in the
course of his medical practice.
II. Procedural Background
The Deputy Assistant Administrator, Drug Enforcement
Administration, issued an Order to Show Cause (``Order'') dated June 5,
2012, proposing to deny the application of George R. Smith, M.D. for a
DEA Certificate of Registration pursuant to 21 U.S.C. 823(f) (2006),
because Respondent's registration would be inconsistent with the public
interest, as that term is used in 21 U.S.C. Sec. 823(f).
[Administrative Law Judge Exhibit (``ALJ Exh.'') 1 at 1]. The Order
stated that on November 18, 2011, Respondent applied for a DEA
registration as a practitioner in Schedules II-V at 4721 Bob White
Road, Gilmer, Texas 75645. [Id.]. Additionally, the Order stated that
Respondent had twice previously surrendered his DEA registrations for
cause. [Id.]. Respondent first voluntarily surrendered his DEA
registration, DEA number BS2388381, on March 6, 2002. [Id.]. Respondent
then voluntarily surrendered his second DEA registration, DEA number
FS0339817, on April 27, 2011. [Id.].
The Order alleged that between November 1998 and June 2001,
Respondent issued prescriptions for large quantities of hydrocodone, a
Schedule III controlled substance, to his family members for his own
personal use for other than legitimate medical purposes. [Id.]. In
relation to this allegation, the Order asserted that during this time
period, Respondent obtained and filled prescriptions for hydrocodone
from at least ten different doctors for his own personal use for other
than legitimate medical purposes. [Id.]. Additionally, the Order
asserted that between June 2001 and August 2001, Respondent issued
prescriptions for hydrocodone and alprazolam to third-party non-
patients in order for Respondent to obtain these controlled substances
for his own personal use for other than legitimate medical purposes.
[Id.]. As a result of issuing these unlawful prescriptions for
controlled substances, Respondent pled guilty to one count of obtaining
controlled substances by fraud, in violation of 21 U.S.C. Sec.
843(a)(3), a felony, on November 26, 2001, before the United States
District Court for the Eastern District of Texas. [Id. at 2].
Lastly, the Order alleged that Respondent had prescribed Schedule
III and IV controlled substances between January 2010 and January 2011
in violation of his medical license, his Texas controlled substance
registration, and his DEA registration. [Id.]. In regards to this
allegation, the Order stated that Respondent only had authority to
prescribe Schedule V controlled substances because in March 2007
Respondent had applied for a DEA registration as a practitioner and was
subsequently issued a DEA registration, DEA number FS0339817, for
Schedule V controlled substances only. [Id.]. The Deputy Assistant
Administrator then gave Respondent the opportunity to show cause as to
why his registration application should not be denied on the basis of
those allegations. [Id.].
On July 3, 2012, Respondent, through counsel, timely filed a
request for a hearing in the above-captioned matter. [ALJ Exh. 2].
On December 3, 2012, a Protective Order was issued to protect
patient names and patient files used in this proceeding. [ALJ Exh. 8].
After authorized delays, a hearing was held in Austin, Texas on
December 12, 2012 through December 13, 2012, with the Government and
Respondent each represented by counsel. [ALJ Exh. 3-4, 6-7]. At the
hearing, counsel for the Government called one witness to testify and
introduced documentary evidence. [Transcript (``Tr.'') Volume I-II].
Counsel for the Respondent called two witnesses to testify, including
the Respondent, and introduced documentary evidence. [Id.].
After the hearing, the Government and the Respondent submitted
Proposed Findings of Fact, Conclusions of Law and Argument (``Govt.
Brief'' and ``Resp. Brief'').
III. Issue
The issue in this proceeding is whether or not the record as a
whole establishes by a preponderance of the evidence that the Drug
Enforcement Administration should deny the application of George R.
Smith, M.D., for a DEA Certificate of Registration as a practitioner,
pursuant to 21 U.S.C. Sec. 823(f) (2006), because to grant Dr. Smith's
application would be inconsistent with the public interest as that term
is defined in 21 U.S.C. 823(f). [ALJ Exh. 3; Tr. 5].
IV. Findings of Fact
A. Stipulated Facts
The parties have stipulated to the following facts:
1. Respondent holds Texas Medical license H-8411 (expiration
February 28, 2013),\1\ and Texas Department of Public Safety Controlled
Substances Registration (Texas DPS Registration) Certificate 60184908
(expiration November 30, 2012) \2\ which allows Respondent to issue
prescriptions for controlled substances listed in Schedules II-V.
---------------------------------------------------------------------------
\1\ On January 31, 2013, the parties filed Joint Stipulations of
Fact No. 2 with the Court. Therein, the parties stipulated ``[a]fter
the conclusion of the Hearing on the Merits Respondent submitted a
renewal request to the Texas Medical Board (``TMB'') for his Texas
Medical License H-8411 which was set to expire at the end of
February 2013. The TMB renewed Respondent's medical license for the
ordinary term of two years. Respondent's Texas Medical License is
now current through February 28, 2015.''
\2\ On January 31, 2013, the parties filed Joint Stipulations of
Fact No. 2 with the Court. Therein, the parties stipulated ``[p]rior
to the Hearing on the Merits the Respondent submitted a request to
the Texas Department of Public Safety (``DPS'') to renew his Texas
Controlled Substances Registration. The DPS renewed Respondent's DPS
Controlled Substances Registration for the ordinary term of one
year. Respondent's DPS Registration is now current through November
30, 2013.''
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2. On March 4, 1995, the Texas State Board of Medical Examiners
(Medical Board) suspended Respondent's medical license because
Respondent had developed a drug addiction due to the self-
administration of hydrocodone and codeine. The suspension was stayed
and Respondent was placed on probation for five (5) years.
3. Respondent's probation was terminated on October 24, 1998.
4. On October 24, 2001, Respondent's medical license was
temporarily suspended because his ``continuation in the practice of
medicine would constitute a continuing threat to public welfare.''
5. On November 26, 2001, before the United States District Court
for the Eastern District of Texas, Respondent pleaded guilty to one
count of obtaining a controlled substance by fraud, a felony.
Respondent was sentenced to a three (3) year term of probation on March
21, 2002.
6. On March 6, 2002, Respondent voluntarily surrendered his DEA
Certificate of Registration Number BS2388381 for cause.
7. By order dated May 17, 2002, the Medical Board revoked
Respondent's medical license. The revocation was stayed, Respondent was
placed on probation for ten (10) years, and Respondent was required to
surrender his DEA (surrendered prior to the order) and Texas controlled
substance registrations.
8. By Medical Board Order dated June 2, 2006, Respondent was
permitted to apply to the DEA and the Texas DPS for Certificates of
Registration for Schedule V controlled substances only. Respondent was
further limited to prescribing Schedule V controlled substances to
hospital admission patients only.
[[Page 44974]]
9. In March 2007, Respondent applied for a DEA Registration for
Schedule V controlled substances, which was approved, and DEA
Registration Number FS0339817 was issued.
10. DEA Registration Number FS0339817 was renewed in February 2010.
11. Respondent applied to the Medical Board four times for
modification of his Board order to allow him to apply for unrestricted
DEA and DPS registrations. He made such applications on August 18,
2007; November 2, 2008; March 14, 2010; and November 17, 2010.
12. On April 27, 2011, Respondent voluntarily surrendered DEA
Registration Number FS0339817 for cause after it was discovered that he
was issuing prescriptions for Schedule III and IV controlled substances
to non-hospital admission patients.
13. By Medical Board Order dated August 26, 2011, Respondent was
permitted to apply to the DEA and the Texas DPS for unrestricted
controlled substance registrations so that he may prescribe Schedule
II, III, IV, and V controlled substances.
14. Respondent remains under a Medical Board order that requires
random drug screens, drug screens upon request of any of Respondent's
healthcare providers, treatment for addiction by a physician, and
attendance at AA meetings. Any positive drug screen or refusal to
submit to testing is grounds for immediate suspension of Respondent's
medical license.
15. The August 26, 2010 \3\ Medical Order remains in effect until
May 17, 2017, and is not eligible for early termination.
---------------------------------------------------------------------------
\3\ It appears that both counsel are referring to the August 26,
2011 Medical Order. See Government Exhibit (``Govt. Exh.'') 11 and
Respondent Exhibit (``Resp. Exh.'') 1.
---------------------------------------------------------------------------
16. In September 2011, the Texas DPS issued Respondent a Texas
Controlled Substances Registration in all schedules.
17. On November 18, 2011, Respondent applied for an unrestricted
DEA Certificate of Registration.\4\
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\4\ The November 18, 2011 application is the subject of this
administrative hearing.
---------------------------------------------------------------------------
[ALJ Exh. 5; Tr. 6].
B. Respondent's History
1. Respondent's Education and Training
Respondent received a Bachelor of Science degree from East Texas
State University, majoring in Molecular Biology. [Tr. 77-78]. Upon
graduating from college, Respondent attended the University of Texas
Southwestern Medical School, where he later graduated in the top 10% of
his class. [Tr. 78-79]. After completing medical school, Respondent
completed a four year post-graduate residency program in internal
medicine at Presbyterian Hospital of Dallas. [Tr. 79-81]. In his final
year of residency training, Respondent was elected the Chief Resident
and during his year as Chief Resident he served as a critical care
medicine trainee. [Tr. 80-82]. After completing his residency training,
the Respondent was offered a critical care fellowship at Parkland
Hospital in Dallas, Texas but, the Respondent declined this
opportunity. [Tr. 82-83].
In 1994, the Respondent entered private practice after the
completion of his residency training. [Tr. 82, 84]. The Respondent
began practicing with an internist in Mount Pleasant, Texas. [Id.]. In
addition to seeing patients at his own office, the Respondent served as
the critical care unit director at Titus Regional Medical Center. [Tr.
84]. Respondent practiced with the internist and served as the critical
care unit director at Titus Regional Medical Center for a period of 6-7
years. [Id.].
In 2000, the Respondent became Board Certified in Internal
Medicine.\5\ [Tr. 89]. Following his time in private practice and
working as the critical care unit director at Titus Regional Medical
Center, Respondent conducted pilot exams for American Airlines for a
period of 6-8 months. [Tr. 113]. After this position was eliminated,
the Respondent began working for a county hospital in Mineral Wells,
Texas as the hospitalist. [Id.]. Next, the Respondent conducted routine
pre-employment physicals for a company before becoming employed at
Hugman-Kent Clinic, in Gladewater, Texas, in 2006.\6\ [Tr. 113-115].
Respondent continues to practice at Hugman-Kent Clinic. [Tr. 114-115].
Approximately 85% of the Respondent's patients are Medicare patients.
[Tr. 115]. The median age of the Respondent's patients is about 60-65
years old. [Tr. 119]. A significant number of the Respondent's patients
have co-morbidities that require complex medical management. [Tr. 116-
117].
---------------------------------------------------------------------------
\5\ Respondent is no longer Board Certified in Internal Medicine
because his certification expired December 31, 2010. He is not
permitted to sit for recertification because he is currently under
an Agreed Order with the Texas Medical Board. [Tr. 111-112, 217;
Govt. Exh. 11; Resp. Exh. 1].
\6\ The reasoning for Respondent's constant movement from job to
job will be discussed below. However, such job hopping was due in
large part to his addiction problems and the restrictions placed on
his medical license by the Texas Medical Board.
---------------------------------------------------------------------------
2. Respondent's Addiction to Controlled Substances
In 1993, the Respondent developed an addiction to hydrocodone after
he had injured his back from working on his car. [Tr. 85, 185; Govt.
Exh. 3 at 2]. Respondent began self-administering hydrocodone after
previously obtaining hydrocodone from physicians and from samples. [Tr.
86-87; Govt. Exh. 3 at 2]. As a result of his addiction, while
Respondent was working at Presbyterian Hospital of Dallas in April of
1993, his clinical privileges were suspended after Respondent exhibited
behavioral changes and failed to respond to telephone calls and his
beeper. [Tr. 87; Govt. Exh. 3 at 2]. The Respondent subsequently
entered treatment for his addiction to hydrocodone and was placed under
the care of Dr. Michael Healy, an addiction specialist. [Tr. 87-88].
After practicing medicine for only two and one half years, the
Respondent entered into an Agreed Order with the Texas State Board of
Medical Examiners (``the Board'' or ``the Texas Medical Board'') on
March 4, 1995, in which his Texas medical license was suspended as a
result of his addiction to hydrocodone; however, the Texas Medical
Board stayed the suspension of Respondent's medical license and placed
him on probation for a term of five years. [Govt. Exh. 3; Tr. 85]. As a
result of the 1995 Agreed Order, restrictions were placed on the
Respondent's ability to practice medicine. [Govt. Exh. 3; Tr. 88-89].
The Respondent was required to abstain from the consumption of alcohol
and drugs unless prescribed by another physician for a legitimate
purpose, submit to drug testing at the request of the Board, and
continue under the care of Dr. Michael Healy. [Id.].
The Respondent subsequently sought termination of the March 4, 1995
Agreed Order. [Tr. 90; Govt. Exh. 4]. However, on September 20, 1997,
the Texas Medical Board denied Respondent's request to terminate the
1995 Agreed Order due to the nature of the violation and the fact that
less than three of the five year probation term had been served. [Id.].
But, on October 24, 1998, the Texas Medical Board did terminate the
March 4, 1995 Agreed Order. [Govt. Exh. 5; Tr. 90].
However, the Respondent started abusing controlled substances again
in 1999, approximately one year after the Texas Medical Board had
terminated the 1995 Agreed Order. [Tr. 185]. Around November of 1999,
the Respondent suffered two compression fractures. [Tr. 92]. The
Respondent then began taking hydrocodone for pain. [Id.]. Respondent
[[Page 44975]]
initially began obtaining hydrocodone from physicians and then later
started writing prescriptions for it himself. [Id.]. In addition to
abusing hydrocodone, Respondent prescribed hydrocodone to family
members and Respondent would consume the hydrocodone that he prescribed
to family members a majority of the time. [Tr. 93, 185; Govt. Exh. 6].
Respondent also approached nurses and employees of the Titus Regional
Medical Center, where he was working in 2001, and asked them to fill
controlled substance prescriptions for him. [Govt. Exh. 6 at 2]. As a
result of his addiction problems, the Titus Regional Medical Center
suspended Respondent's hospital privileges. [Tr. 93; Govt. Exh. 6 at
3].
On October 24, 2001, the Texas Medical Board entered a Temporary
Suspension Order, which temporarily suspended the Respondent's Texas
medical license as a result of his return to addiction. [Govt. Exh. 6].
Following the 2001 Temporary Suspension, the Board entered an Agreed
Order on May 17, 2002. [Govt. Exh. 7; Resp. Exh. 4]. The Order revoked
the Respondent's Texas medical license; however, the Board stayed the
revocation and placed the Respondent on probation for a term of ten
years. [Govt. Exh. 7 at 4; Resp. Exh. 4 at 4]. The 2002 Agreed Order
required the Respondent to abstain from the consumption of alcohol and
controlled substances unless prescribed by a physician for a legitimate
purpose, to report any prescription of controlled substances to the
Board, to give a copy of the Agreed Order to all treating physicians,
to submit to drug testing at the request of the Board, to remain under
the care of Dr. Michael Healy,\7\ to attend Alcoholics Anonymous
(``AA'') meetings, to surrender all controlled substances
registrations,\8\ and to limit his medical practice to a group or
institutional setting approved by the Board. [Govt. Exh. 7; Resp. Exh.
4]. Should the Respondent test positive for drug use, then his medical
license could be automatically revoked without the need for further
hearings. [Tr. 103; Govt. Exh. 7]. The agreement also prohibited the
Respondent from applying for a controlled substances registration
absent Board approval. [Govt. Exh. 7]. Further, the Respondent was only
allowed to file a request to modify this order once a year thereafter.
[Id.].
---------------------------------------------------------------------------
\7\ After the retirement of Dr. Michael Healy, the Respondent
has been under the care of Dr. Jonathon Lockhart and continues to
see Dr. Lockhart once a month per the 2002 Agreed Order. [Tr. 109].
\8\ Respondent voluntarily surrendered his Texas DPS and DEA
registrations prior to the date of the 2002 Agreed Order. [Tr. 110].
---------------------------------------------------------------------------
Respondent subsequently sought treatment for his relapse in
addiction. [Tr. 94]. Respondent went to Baylor, in Dallas, where he
underwent a three-month treatment program for his addiction. [Id.].
Respondent has been required to submit to over 600 drug tests as a
result of the 2002 Agreed Order and has never failed to appear for a
drug test nor has the Respondent tested positive.\9\ [Tr. 103-108]. As
a result of the Respondent's treatment and willingness to stay sober,
the Respondent reports a sobriety date of October 22, 2001.\10\ [Tr.
96; Govt. Exh. 7; Resp. Exh. 4]. Respondent admits that his return to
addiction and his prescribing to family members, self-administration,
and solicitation of colleagues was an abuse of the authority of his
Texas medical license, his Texas DPS registration, and his DEA
registration. [Tr. 92]. The 2002 Agreed Order was subsequently modified
on October 10, 2003 and June 2, 2006. [Govt. Exh. 8 and 10; Resp. Exh.
3 and 2].
---------------------------------------------------------------------------
\9\ The drug testing that Respondent must submit to as a result
of his 2002 Agreed Order and subsequent modifications to this Agreed
Order are intense. Respondent must call an automated mechanism every
morning in order to determine if he must give a specimen on that
particular day. If Respondent is required to give a specimen on a
particular day, then he must report to give the specimen before the
early afternoon. Respondent has never failed to call or failed to
provide a specimen over the eleven year period that he has been
required to submit to this drug testing. The Respondent pays the
costs for the drug tests. [Tr. 103-108, 314-316].
\10\ The Government does not challenge this sobriety date. [Tr.
313-314].
---------------------------------------------------------------------------
The October 10, 2003 Modified Agreed Order permitted the Respondent
to practice in a setting where there is at least one other physician
located in the place that services are being rendered, rather than the
previous requirement under the 2002 Order, which restricted
Respondent's practice to a group or institutional setting. [Govt. Exh.
8 at 9; Govt. Exh. 3 at 9]. In addition, the 2003 Modified Agreed Order
required the Respondent to take and pass the Special Purpose
Examination (SPEX). [Id. at 10]. The Respondent again sought
modification of the 2002 Agreed Order; however, his modification
request was denied by the Board on December 10, 2004. [Govt. Exh. 9].
But, on June 2, 2006, the Board issued an Order Granting Modification
to the 2002 Agreed Order, in which Respondent was authorized to reapply
for a Texas DPS registration and a DEA registration in Schedule V
controlled substances only. [Govt. Exh. 10 at 2; Resp. Exh. 2 at 2].
Additionally, the 2006 Order Granting Modification restricted the
Respondent's prescribing authority to hospital admission patients only.
[Id.].
After the entry of the Medical Board's orders, the Respondent was
terminated from multiple third-party payer insurance plans. [Tr. 112].
With the loss of his DEA registration, the Respondent experienced even
more third-party payer loss, leaving him with mostly cash-only patients
or Medicare patients. [Id.]. Subsequently, the Respondent moved from
job to job as work became available. [Tr. 113].
The Respondent continues to see a psychiatrist once a month. [Tr.
109]. He currently has no mental health diagnosis that would impair his
abilities as a physician. [Id.].
C. Respondent Prescribing Controlled Substances Outside the Scope of
His Registration
Pursuant to the 2002 Agreed Order and the subsequent 2003 and 2006
modifications to the Agreed Order, the Respondent re-applied for DPS
and DEA registrations for only Schedule V controlled substances in
March 2007. [Govt. Exh. 10; Resp. Exh. 2; ALJ Exh. 5]. He obtained
these registrations. [Id.]. But, under the June 2, 2006 Order Granting
Modification, the Respondent's prescribing authority was restricted to
hospital patients only. [Id.].
In late 2009, Respondent began prescribing Schedules III and IV
controlled substances to his patients at the Hugman-Kent Clinic. [Tr.
139]. Respondent continued prescribing outside the scope of his Texas
DPS and DEA registrations up until he was visited by Diversion
Investigator (``DI'') Thomas McLaughlin \11\ on April 6, 2011. [Tr. 23,
139]. Yet, the Respondent credibly testified that he prescribed these
controlled substances to adequately treat his patients. [Tr. 130, 135].
---------------------------------------------------------------------------
\11\ DI McLaughlin is employed by the DEA at the Tyler Resident
Office of the Dallas Field Division. [Tr. 8]. DI McLaughlin has been
a Diversion Investigator for over 15 years. [Tr. 9]. Prior to being
employed with DEA, DI McLaughlin served as a Correctional Officer
for the Illinois Department of Corrections, served as an
Investigator with the City of Chicago, and served a total of 21
years in the Air Force. [Id.]. As part of his training in being a
Diversion Investigator, DI McLaughlin has attended the basic
diversion investigator course in Quantico, Virginia, and has
received continuing training throughout his tenure as a Diversion
Investigator. [Tr. 9-10].
---------------------------------------------------------------------------
DI McLaughlin first began investigating the Respondent after he
received information from Sandra Atkins, a DEA registration technician,
that Respondent was writing Schedule III and IV prescriptions when he
was only authorized to write Schedule V prescriptions. [Tr. 10-11]. DI
McLaughlin requested information from the Texas Prescription Monitoring
[[Page 44976]]
Program (``PMP'') \12\ from the time period of January 2010 through
January 2011, and discovered through the report that Respondent
prescribed 1,532 prescriptions in Schedules III, IV, and V to 335
patients. [Tr. 14-18; Govt. Exh. 2]. These prescriptions were issued to
non-hospital admission patients. [Tr. 22]. Of the 1,532 prescriptions
issued during this time period, over 1,400 were for Schedule III and IV
controlled substances. [Tr. 18-19; Govt. Exh. 2]. DI McLaughlin also
requested copies of original prescriptions from the pharmacies that
filled Respondent's issued prescriptions. [Tr. 20-22; Govt. Exh. 2,
12]. He noted that there were no discrepancies between the Prescription
Monitoring Program Data and the prescription slips that he received.
[Id.].
---------------------------------------------------------------------------
\12\ Under Texas law all pharmacies must submit prescription
information on controlled substances to the PMP when the
prescriptions are filled. The information includes the date, the
drug, the practitioner's name and DPS registration numbers. [Tr.
12].
---------------------------------------------------------------------------
The Respondent contends that he has no record of 47 patients named
in the Prescription Monitoring Program Data Report as being treated by
him at the Hugman-Kent Clinic. [Tr. 173-178; Resp. Exh. 15]. However,
only 41 of these contested names were listed on the Prescription
Monitoring Program Data. [Resp. Exh. 15; Govt. Exh. 2; Tr. 59]. These
41 people were prescribed a total of 155 prescriptions. [Govt. Exh. 2;
Tr. 59]. Therefore, rather than the Respondent prescribing 1,532 total
prescriptions during the time of January 2010 through January 2011, he
issued 1,377 prescriptions. [Govt. Exh. 2]. Although Respondent did not
prescribe to 41 of those listed on the Prescription Monitoring Program
Data Report, the Respondent did prescribe to the remaining 294 people
and prescribed 1,071 prescriptions for Schedule III and IV controlled
substances. [Id.].
Finding Respondent's testimony to be credible, it is probable that
someone had in fact abused Respondent's DEA registration because
neither the Respondent nor the Clinic have any records of these 41
patients being prescribed controlled substances.\13\ [Tr. 173-178;
Resp. Exh. 15]. However, Respondent acknowledges that his actions were
still wrong and that he did prescribe outside the scope of his Texas
DPS and DEA registrations. [Tr. 23, 59, 139, 174]. Regardless of the
controversy concerning the 41 patients, he ceased prescribing Schedule
III and IV controlled substances after a visit by DI McLaughlin in
April of 2011. [Tr. 139].
---------------------------------------------------------------------------
\13\ There was some testimony that implicated an employee of the
Hugman-Kent Clinic, who was functioning as a nurse, had illegally
used Respondent's prescriptive authority to help others obtain
controlled substances. [Tr. 174-178]. But, there is no concrete
evidence that this unidentified nurse had in fact used Respondent's
prescriptive authority to help 41 people obtain controlled
substances under the guise of Respondent's Texas DPS and DEA
registrations. [Id.]. However, this unidentified nurse was later
fired from the Clinic after it had been discovered that she had
taken samples from the Clinic. [Tr. 177].
Further, the Respondent asserted in his Prehearing Statement
that some of the patients attributed to him may actually be patients
of other Dr. George Smiths in Texas. However, this assertion was not
pursued by the Respondent during the hearing. [But see Tr. 41-44;
Govt. Exh. 14-17].
---------------------------------------------------------------------------
Although, Respondent admitted his fault, he repeatedly gave
justifications for his actions; these included: prescribing for the
patient's best interest and patient care; and continuing prescriptions
for patients of a retiring doctor out of the Hugman-Kent Clinic.\14\
[Tr. 134-139, 168-172, 204, 206; Resp. Exh. 13]. The Respondent later
admitted on cross-examination that he would have had fewer patients if
he did not prescribe Schedule III and IV controlled substances, and the
Clinic could therefore have lowered his salary. [Tr. 191].
Additionally, the Respondent admitted that there are hundreds of
physicians located in Longview, Texas, which is about 20 miles away
from the Respondent's place of business. [Tr. 202, 39-40]. Finally,
there were other physicians in Gladewater, Texas, who had unrestricted
DEA registrations at the time the Respondent was prescribing outside
the scope of his registration. [Tr. 39-40]. Yet the Respondent credibly
testified that other physicians working at the Hugman-Kent Clinic were
not comfortable writing controlled substance prescriptions for the
Respondent's patients because ``they didn't know the patients.'' [Tr.
138].
---------------------------------------------------------------------------
\14\ Respondent offered justifications as to why he prescribed
Schedules III and IV controlled substances to five patients under
his care. The Respondent found there was a medical need for each of
the patients to be prescribed controlled substances. Yet, Respondent
did not have the authority to prescribe these controlled substances
to these patients. However, there is no dispute concerning the
medical necessity for these prescriptions. [Resp. Exh. 13; Tr. 140-
161].
---------------------------------------------------------------------------
As a result of the Respondent's unauthorized prescribing of
Schedule III and IV controlled substances, he voluntarily surrendered
his DEA registration on April 27, 2011. [ALJ Exh. 5]. The Respondent
also violated his modified 2002 Agreed Order.\15\ [Govt. Exh. 11 at 4;
Resp. Exh. 1 at 4]. Also, the Respondent had been reporting to his
compliance officer that he was in full compliance with the 2002 Agreed
Order, when in fact he admitted at the hearing that he had not been in
compliance. [Resp. Exh. 5-6; Tr. 186-192].
---------------------------------------------------------------------------
\15\ The Respondent had been requesting modification of his 2002
Agreed Order through letters that he sent to the Texas Medical Board
on four separate occasions. Yet each time that he requested
modification, he was not in compliance with the 2002 Agreed Order.
[Resp. Exh. 7-10; Tr. 188-192]. In fact, at the March 2011
modification hearing that the Respondent had with the Texas Medical
Board, he represented that he was in compliance with the 2002 Agreed
Order but, he was not. [Tr. 192].
---------------------------------------------------------------------------
On August 26, 2011, the Respondent again entered into an Agreed
Order with the Texas Medical Board. [Govt. Exh. 11; Resp. Exh. 1; Tr.
162-165]. Pursuant to the 2011 Agreed Order, which was issued after the
Respondent took part in an Informal Settlement and Show Cause
Proceeding (``ISC'') \16\ on July 28, 2011, the Respondent is to remain
under the terms of the 2002 Agreed Order, as modified, without the
right to seek an early termination. [Tr. 308; Govt. Exh. 11 at 5; Resp.
Exh. 1 at 5]. The Board modified the 2002 Agreed Order to authorize the
Respondent to reapply to the DEA and the Texas DPS to obtain
registrations in Schedule II, III, IV, and V controlled substances.
[Id.]. But, the decision to grant or deny the Respondent's application
remains ``a matter for appropriate determination by the DEA and DPS.''
[Govt. Exh. 11 at 5-6; Resp. Exh. 1 at 5-6]. In addition, the
Respondent was ordered to pay an administrative penalty of $10,000,
which he has paid. [Tr. 164; Govt. Exh. 11 at 6; Resp. Exh. 1 at 6].
Thus, after the Respondent had been found to be in violation of both
his Texas DPS and DEA registrations and his 2002 Agreed Order, the
Respondent was permitted to reapply for unrestricted registrations, and
he obtained an unrestricted Texas DPS registration in Schedules II
through V in September 2011. [ALJ Exh. 5]. Now, in spite of his
violations, the Respondent seeks a DEA registration for Schedules II
through V. [ALJ Exh. 5; Govt. Exh. 1].
---------------------------------------------------------------------------
\16\ The record contains testimony concerning the ISC process.
[Tr. 308-311]. Since there is no dispute concerning this due process
procedure, I do not explain this Medical Board process here.
---------------------------------------------------------------------------
D. Respondent's Felony Convictions
1. 2001 Felony Conviction
As a result of Respondent's addiction to hydrocodone and his self-
administration of hydrocodone, he pled guilty to one count of obtaining
a controlled substance by fraud, a felony, on November 26, 2001, before
the United States District Court for the Eastern District of Texas.
[ALJ Exh. 5; Tr. 99]. Respondent was then sentenced to a three year
term of probation on March 21, 2002. [ALJ Exh. 5].
[[Page 44977]]
2. 2012 Felony Conviction
As a result of the Respondent's admitting that he prescribed
Schedule III and IV controlled substances, when he was only authorized
to prescribe Schedule V controlled substances, he pled guilty to
violating 21 U.S.C. 842(a)(1) and (c)(2)(B) (2006) for illegal
dispensing before the United States District Court for the Eastern
District of Texas, Tyler Division on September 5, 2012. [Govt. Exh. 13;
Tr. 36-38, 167-168]. Respondent has not yet been sentenced for this
conviction; however, the sentencing recommendation is a probationary
term and a fine. [Tr. 38, 168].
E. Respondent's Remedial Actions
Respondent has taken remedial actions to help ensure that the terms
of his medical license agreement would not be violated. [Tr. 178-179].
Because Respondent claims that there may have been some instances where
his DEA registration was abused by others, although he fully admits to
prescribing outside the scope of his registration, he intends to take
the following actions to ensure others do not abuse his medical license
and/or a future DEA registration: use the Prescription Access Texas
Program to monitor patients' prescriptions; implement a better
screening process prior to hiring employees at the Clinic; use only
hard copy prescriptions, rather than calling in prescriptions to
pharmacies; and notify local pharmacies regarding his use of hard copy
prescriptions. [Tr. 178-179]. The Respondent admitted that he could
have implemented these remedial measures when he first gained
employment at Hugman-Kent Clinic but, he did not. [Tr. 192-193].
Currently any patient who calls for an appointment is told that the
Respondent is unable to prescribe controlled substances. [Tr. 180,
219]. The Respondent also credibly testified that he would expect his
DEA registration would contain conditions, such as the keeping of a log
book. [Tr. 205, 214-215]. The Respondent testified that he would not
violate his DEA registration again. [Tr. 207-208]. The last time the
Respondent prescribed controlled substances in Schedules III and IV to
a patient was in the Spring of 2011. [Tr. 219].
The Respondent also provided testimony as to why having a DEA
registration would be beneficial to his patients. [Tr. 166, 218]. He
would be able to participate in more third-party payer plans, and he
could take steps to obtain hospital privileges to better treat his
patients. [Id.].
V. Statement of Law and Discussion
A. The Position of the Parties
1. Government's Position
The Government asserts that the Respondent's application for a DEA
Certificate of Registration should be denied. [Govt. Brief at 18].
Specifically, the Government argues that granting the Respondent's
application is inconsistent with the public interest, under 21 U.S.C.
823(f) (2006), because the Respondent has previously failed to be a
responsible registrant, has violated the Controlled Substances Act, has
two felony convictions, and has failed to take responsibility for his
actions. [Id.].
The Government argues that the recommendation of the Texas Medical
Board, which allows the Respondent to reapply for a DEA registration in
Schedule II through V controlled substances, should be given ``nominal
weight.'' [Id. at 12-13]. In support of its argument, the Government
contends that the Respondent has ``been the subject of Texas Medical
Board orders from 1995 through 1998 and again from 2001 through the
present day based on Respondent's misconduct involving controlled
substances.'' [Id. at 12].
In addition, the Government argues that the Respondent's experience
in dispensing controlled substances, his conviction record, and his
compliance with federal and state laws relating to controlled
substances ``all strongly weigh in favor of the denial of Respondent's
application'' for a DEA Certificate of Registration. [Id. at 13]. The
Government argues that Respondent has had his Texas medical license
revoked (although stayed) twice due to his addiction to hydrocodone and
his prescribing hydrocodone to his family members. [Id. at 13-14].
Additionally, the Government argues that the Respondent has had two
felony convictions related to controlled substances, one for issuing
fraudulent prescriptions and another for prescribing controlled
substances outside the scope of his prescriptive authority. He has
twice surrendered his DEA registrations. [Id.]. The Government also
argues that Respondent violated federal and local law on several
occasions when he prescribed Schedule III and IV controlled substances
to his non-hospital patients. [Id. at 14].
Lastly, the Government argues that the Respondent's application for
a DEA registration is inconsistent with the public interest because
Respondent has failed to be a compliant registrant in the past and will
likely fail to be a compliant registrant in the future. [Id. at 15].
The Government also argues that the Respondent has failed to take full
responsibility for his actions. [Id. at 16]. The Government
additionally argues that the Respondent's excuses for his failure to be
a compliant registrant, i.e. the need of the community and his
patients, is not a viable argument and does not support the granting of
Respondent's application for a DEA registration. [Id. at 17]. In
conclusion, the Government asserts that ``Respondent failed in his
responsibilities as a DEA registrant, not once but two times. Both
failures involved Respondent's knowing and willful violations of the
Controlled Substances Act and resulted in criminal convictions.'' [Id.
at 18]. For these reasons, the Government concludes that the
Respondent's application should be denied.
2. Respondent's Position
The Respondent asserts that his application for a DEA registration
should be granted because granting his registration is consistent with
the public interest.\17\ [Resp. Brief at 13]. First, Dr. Smith argues
that the Texas Medical Board has recommended that he be able to apply
for an unrestricted DEA registration, in spite of his past disciplinary
history with the Texas Medical Board. [Id. at 13-14]. Additionally, the
Respondent notes that he has already obtained an unrestricted Texas DPS
registration for controlled substances that weighs in favor of the DEA
granting his registration. [Id. at 14].
---------------------------------------------------------------------------
\17\ Although the Respondent contends that granting his
application for a DEA registration is in the public interest, he
recognizes that restrictions could be placed on his registration,
such as maintaining a log book and agreeing to inspections without
the need for an administrative warrant. [Resp. Brief at 13].
---------------------------------------------------------------------------
The Respondent next argues that he has sufficient knowledge and
experience in dispensing controlled substances. [Id.]. Respondent
claims that he has ``a good working knowledge of complex medical
management.'' [Id.].
Although the Respondent acknowledges that he has had two felony
convictions and has not complied with state, federal, or local laws
relating to controlled substances, he asserts that he has rehabilitated
himself and thus, these factors do not warrant the denial of his DEA
registration application. [Id. at 14-16]. Specifically, the Respondent
asserts that he has been sober since October of 2001, and has submitted
to over 600 drug tests, in which he has never tested positive. [Id. at
15]. Additionally, the Respondent argues that, although he prescribed
outside the scope of his
[[Page 44978]]
registration, he did so because it was in the best interest of his
patients and he never ``non-therapeutically prescribed drugs since his
2002 arrest.'' [Id.]. Moreover, Respondent asserts that since his
noncompliance was discovered in 2011, he has been in full compliance
with his Texas Medical Board Orders, his Texas DPS registration and his
DEA registration. [Id. at 15-16].
Lastly, the Respondent argues that a DEA registration in Schedules
II through V will not threaten the public health and safety because he
is committed to remaining sober and complying with all laws. [Id. at
16-18]. Dr. Smith asserts that he has taken responsibility for his past
wrongdoing and if he were to receive a DEA registration, he would
understand and comply with any stipulations that were included with his
DEA registration. [Id. at 17-18]. Moreover, Dr. Smith argues that
granting his DEA registration application is in fact in the public's
best interest because he will be better equipped to handle his patients
and the community will be effected in a positive way. [Id. at 17].
Therefore, Dr. Smith requests that his DEA registration application be
granted with any provisions the Court deems fit. [Id. at 18].
B. Statement of Law and Analysis
Pursuant to 21 U.S.C. 823(f) (2006), the Deputy Administrator may
deny an application for a DEA Certificate of Registration if he
determines that such registration would be inconsistent with the public
interest.\18\ In determining the public interest, the following factors
are considered:
---------------------------------------------------------------------------
\18\ The Deputy Administrator has the authority to make such a
determination pursuant to 28 C.F.R. Sec. Sec. 0.100(b), 0.104
(2012).
---------------------------------------------------------------------------
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety. 21 U.S.C. Sec. 823(f) (2006).
These factors are to be considered in the disjunctive; the Deputy
Administrator may rely on any one or a combination of factors and may
give each factor the weight he deems appropriate in determining whether
an application should be denied. See Robert A. Leslie, M.D., 68 Fed.
Reg. 15,227, 15,230 (DEA 2003). Moreover, the Deputy Administrator is
``not required to make findings as to all of the factors.'' Hoxie v.
DEA, 419 F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412
F.3d 165, 173-74 (DC Cir. 2005).
The Government bears the ultimate burden of proving that the
requirements for registration are not satisfied. 21 CFR 1301.44(d)
(2012). However, where the Government has made out a prima facie case
that Respondent's application would be ``inconsistent with the public
interest,'' the burden of production shifts to the applicant to
``present[] sufficient mitigating evidence'' to show why he can be
trusted with a new registration. See Medicine Shoppe--Jonesborough, 73
FR 364, 387 (DEA 2008). To this point, the Agency has repeatedly held
that the ``registrant must accept responsibility for [his] actions and
demonstrate that [he] will not engage in future misconduct. Id.; see
also Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (DEA 2007). In
short, after the Government makes its prima facie case, the Respondent
must produce sufficient evidence that he can be trusted with the
authority that a registration provides by demonstrating that he accepts
responsibility for his misconduct and that the misconduct will not
reoccur. Yet, the DEA has consistently held the view that ``past
performance is the best predictor of future performance.'' Alra
Laboratories, 59 FR 50,620 (DEA 1994), aff'd Alra Laboratories, Inc. v.
DEA, 54 F.3d 450, 451 (7th Cir 1995).
1. Factor One: Recommendation of Appropriate State Licensing Board
Although the recommendation of the applicable state licensing board
is probative to this factor, the Agency possesses ``a separate
oversight responsibility with respect to the handling of controlled
substances'' and therefore, must make an ``independent determination as
to whether the granting of [a registration] would be in the public
interest.'' Mortimer B. Levin, D.O., 55 Fed. Reg. 8,209, 8,210 (DEA
1990); see also Jayam Krishna-Iyer, M.D., 74 Fed. Reg. 459, 461 (DEA
2009). It is well-established Agency precedent that a ``state license
is a necessary, but not a sufficient condition for registration.''
Leslie, 68 Fed. Reg. at 15,230; John H. Kennedy, M.D., 71 FR 35,705,
35,708 (DEA 2006). Even the reinstatement of a state medical license
does not affect the DEA's independent responsibility to determine
whether a registration is in the public interest. Levin, 55 FR at
8,210. The ultimate responsibility to determine whether a registration
is consistent with the public interest has been delegated exclusively
to the DEA, not to entities within a state government. Edmund Chein,
M.D., 72 Fed. Reg. 6,580, 6,590 (DEA 2007), aff'd Chein v. DEA, 533
F.3d 828 (DC Cir. 2008). So while not dispositive, state board
recommendations are relevant to the issue of granting a DEA
registration. See Gregory D. Owens, D.D.S., 74 FR 36,751, 36,755 (DEA
2009); Martha Hernandez, M.D., 62 FR 61,145, 61,147 (DEA 1997).
The Respondent has been the subject of numerous orders from the
Texas Medical Board throughout his medical career. [Govt. Exh. 3-11;
Resp. Exh. 1-4]. The disciplinary proceedings regarding the Respondent
with the Texas Medical Board span over a decade. [Id.]. The Respondent
initially had his Texas medical license suspended in 1995 after it was
discovered that the Respondent had become addicted to hydrocodone and
codeine. [Govt. Exh. 3]. Then again, in October of 2001, the
Respondent's medical license was suspended after the Texas Medical
Board discovered that the Respondent had relapsed in his drug
addiction. [Govt. Exh. 6]. Thereafter, on May 17, 2002, the Texas
Medical Board revoked Respondent's Texas medical license in light of
his abuse of controlled substances and his prescribing controlled
substances to his family members for his own personal use; however, the
revocation was stayed and the Respondent was placed on a term of
probation for ten years. [Govt. Exh. 7; Resp. Exh. 4]. In addition to
the stay of revocation and the term of probation, the Respondent was
required to surrender his DEA Certificate of Registration and his Texas
DPS controlled substance registration. [Id.].
However, in 2006, the Texas Medical Board allowed the Respondent to
seek a modification of the May 17, 2002 Order, and the Respondent was
subsequently permitted to apply to the DEA and the Texas DPS for
controlled substance registrations in Schedule V only. [Govt. Exh. 10;
Resp. Exh. 2]. Additionally, the June 2, 2006 Order mandated that, if
Respondent were to receive authority to prescribe Schedule V controlled
substances, then his prescribing authority would be restricted to
hospital admission patients only. [Id.].
In spite of the Respondent's past history, the most recent Texas
Medical Board Order, dated August 26, 2011, permits Respondent to
reapply to the DEA and the Texas DPS for controlled substance
registrations in Schedules II through V. [Govt. Exh. 11; Resp. Exh. 1].
[[Page 44979]]
However, the 2011 Order notes that, although the Board will allow the
Respondent to reapply for these registrations, the decision of whether
to grant or deny the Respondent's application is reserved for the
issuing agency. [Id.].
Therefore, while the Respondent's Texas medical license is not
currently suspended or revoked, the Respondent is currently the subject
of the 2011 Agreed Order, by which the Respondent must abide. [Id.].
Although the Respondent's medical license has been the subject of
numerous disciplinary actions by the Texas Medical Board, I find that
the current recommendation of the Texas Medical Board permits the
Respondent to apply for a DEA registration in Schedules II through V.
[Id.]. However, the Texas Medical Board did not directly recommend that
the Respondent's DEA application for registration should be granted.
[Id.]. In fact, the Texas Medical Board recognizes that the decision of
whether to grant or deny the Respondent's DEA application is entirely
reserved to the DEA. [Id.]. Thus, I find that the decision of the Texas
Medical Board neither weighs in favor of granting nor denying the
Respondent's application for a DEA Certificate of Registration in
Schedules II through V.
2. Factors Two and Four: Applicant's Experience With Controlled
Substances and Applicant's Compliance With Applicable State, Federal,
or Local Laws Relating to Controlled Substances
Respondent's experience with controlled substances and his
compliance with applicable laws related to the handling of controlled
substances are relevant to determining the public interest in this
case. ``Pursuant to 21 U.S.C. 822(b), `[p]ersons registered by the
Attorney General under this subchapter to . . . dispense controlled
substances . . . are authorized to possess . . . or dispense such
substances . . . to the extent authorized by their registration and in
conformity with the other provisions of this subchapter.' '' Leonard E.
Reaves, III, M.D., 63 FR 44,471, 44,473 (DEA 1998) (registration
revoked after physician was prescribing outside the scope of his DEA
registration). Additionally, except as authorized, ``it shall be
unlawful for any person knowingly or intentionally to . . . dispense,
or possess with intent to . . . dispense a controlled substance.'' 21
U.S.C. 841(a)(1) (2006); see 21 U.S.C. 802(10) (```dispense' means to
deliver a controlled substance to an ultimate user . . . pursuant to
the lawful order of, a practitioner, including the prescribing . . . of
a controlled substance''); see also 21 CFR 1301.13(a) (providing that
``[n]o person required to be registered shall engage in any activity
for which registration is required until the application for
registration is granted and a Certificate of Registration is issued by
the Administrator to such person.'').
In this case, the Respondent's experience with controlled
substances has been troubled for a majority of his career. [Govt. Exh.
3-11; Resp. Exh. 1-4]. Respondent has struggled with addiction to
controlled substances; although, now the Respondent is sober and has
been sober for eleven years. [Tr. 96, 122]. Additionally, the
Respondent prescribed controlled substances to his family members
without maintaining proper records and a majority of those
prescriptions Respondent obtained for his own addiction purposes. [Tr.
93].
Respondent also prescribed Schedule III and IV controlled
substances in violation of his 2002 Agreed Order, modified in 2006, and
Texas DPS and DEA registrations. [Govt. Exh. 10; Resp. Exh. 2].
Specifically, the Respondent was only authorized by his DEA
registration to prescribe Schedule V controlled substances, and by his
modified Agreed Order, to prescribe such substances to hospital
admitted patients. Yet, the Respondent prescribed 1,071 Schedule III
and IV controlled substances to non-hospital admitted patients over the
course of one year. [Govt. Exh. 2, 10; Resp. Exh. 2]. In fact, the
Respondent had been prescribing outside the scope of his registration
since 2009 and only stopped doing so in April of 2011, after DI
McLaughlin visited the Respondent at the Clinic and informed him that
he could not prescribe Schedule III and IV controlled substances when
his DEA registration was restricted to Schedule V controlled
substances. [Tr. 23, 139].
The Respondent blatantly disregarded the restrictions that had been
placed on his authority to prescribe controlled substances. Although
the Respondent claims that he would not abuse his registration in the
future, in light of his past behavior his claim cannot be trusted. His
history and experience with controlled substances throughout his
medical career is not indicative of a compliant registrant. Thus, I
find that these factors weigh against the granting of Respondent's
application for a DEA Certificate of Registration.
3. Factor Three: Applicant's Conviction Record Relating to Controlled
Substances
Pursuant to 21 U.S.C. 823(f)(3) (2006), the Deputy Administrator
may deny a pending application for a DEA Certificate of Registration
upon a finding that the applicant has been convicted of a felony
related to controlled substances under state or federal law. See Barry
H. Brooks, M.D., 66 FR 18,305, 18,307 (DEA 2001); John S. Noell, M.D.,
56 FR 12,038, 12,039 (DEA 1991); Thomas G. Easter II, M.D., 69 FR
5,579, 5,580 (DEA 2004).
In this case, the record contains ample evidence that Respondent
has been convicted of two felony offenses related to the dispensing of
controlled substances. [ALJ Exh. 5; Govt. Exh. 13]. Respondent has a
2001 felony conviction for obtaining a controlled substance by fraud in
violation of 21 U.S.C. 843(a)(3). [ALJ Exh. 5]. In addition, the
Respondent has a 2011 felony conviction for issuing prescriptions for
Schedule III and IV controlled substances in violation of his
restricted Schedule V DEA registration, thus violating 21 U.S.C.
842(a)(1) and (c)(2)(B). [Govt. Exh. 13]. Therefore, I find that this
factor weighs against the granting of Respondent's application for a
DEA Certificate of Registration.
4. Factor Five: Such Other Conduct Which May Threaten the Public Health
and Safety
Under Factor Five, the Deputy Administrator is authorized to
consider ``other conduct which may threaten the public health and
safety.'' 21 U.S.C. 823(f)(5) (2006). This factor encompasses ``conduct
which creates a probable or possible threat (and not only an actual
[threat]) to public health and safety.'' Jacobo Dreszer, M.D., 76 FR
19,386, 19,401 FN2 (DEA 2011). The Agency has long held that a
practitioner's self-abuse of controlled substances constitutes
``conduct which may threaten public health and safety.'' 21 U.S.C.
Sec. 823(f)(5) (2006); see also Tony T. Bui, M.D., 75 Fed. Reg.
49,979, 49,990 (DEA 2010); Kenneth Wayne Green, Jr., M.D., 59 FR 51,453
(DEA 1994); David E. Trawick, D.D.S., 53 Fed. Reg. 5,326 (DEA 1988).
Additionally, the DEA has consistently held that ``[c]andor during DEA
investigations, regardless of the severity of the violations alleged,
is considered by the DEA to be an important factor when assessing
whether a . . . registration is consistent with the public interest''
and noting that a registrant's ``lack of candor and failure to take
responsibility for his past legal troubles . . . provide substantial
evidence that his registration is inconsistent with the public
interest.'' Jeri Hassman, M.D., 75 FR 8,194, 8,236 (DEA 2010); see also
Prince George Daniels DDS, 60 FR 62,884, 62,887 (DEA 1995); see also
Ronald Lynch, M.D., 75 FR 78,745, 78,749 (DEA 2010)
[[Page 44980]]
(Respondent's attempts to minimize misconduct held to undermine
acceptance of responsibility). Furthermore, the Agency is not required
to ``consider community impact evidence in exercising its authority.. .
.'' Linda Sue Cheek, M.D., 76 FR 66,972, 66,973 (DEA 2011); see also
Steven M. Abbadessa, D.O., 74 FR 10,077, 10,078 (DEA 2009) (the
hardship imposed because Respondent lacks a registration is not a
relevant consideration under the Controlled Substances Act).
Here, Respondent self-abused and prescribed significant quantities
of controlled substances to his family members, from approximately 1993
through October 22, 2001, which he reports as his sobriety date. [Govt.
Exh. 3-10]. Such unlawful ingestion and prescribing of controlled
substances clearly places the public health and safety in jeopardy.
This unlawful conduct led to the temporary suspension of Respondent's
Texas medical license, a felony conviction, the surrender of
Respondent's DEA registration, and revocation of Respondent's Texas
medical license.\19\ [Govt. Exh. 3, 6-7; ALJ Exh. 5; Resp. Exh. 4].
---------------------------------------------------------------------------
\19\ Although the Respondent's medical license was temporarily
suspended and later revoked, both of these actions were stayed and
the Respondent was placed on probation each time. See Govt. Exh. 3,
6, 7 and Resp. Exh. 4.
---------------------------------------------------------------------------
Yet, I find that Respondent has successfully addressed his
addiction problem and returned to the practice of medicine by regaining
his medical license in 2002. [Govt. Exh. 7; Resp. Exh. 4]. At the
hearing, Respondent proffered substantial and detailed evidence
regarding his impressive recovery program, including numerous negative
drug screens he has taken over the past eleven years. [Tr. 103-108]. As
the Deputy Administrator has previously determined, ``[t]he paramount
issue is not how much time has elapsed since [the Respondent's]
unlawful conduct, but rather, whether during that time [the] Respondent
has learned from past mistakes and has demonstrated that he would
handle controlled substances properly if entrusted with a DEA
registration.'' Leonardo V. Lopez, M.D., 54 FR 36,915 (DEA 1989). Even
though it has been previously found that time, alone, is not
dispositive in such situations, it is certainly an appropriate factor
to be considered. See Robert G. Hallermeier, M.D., 62 FR 26,818 (DEA
1997) (four years); John Porter Richards, D.O., 61 FR 13,878 (DEA 1996)
(ten years); Norman Alpert, M.D., 58 FR 67,420, 67,421 (DEA 1993)
(seven years).
In Respondent's case, the fact that he has been sober for over
eleven years and continues to abide by all terms and conditions imposed
upon him regarding his sobriety shows that Respondent intends to remain
sober. In addition, there has been no evidence that the Respondent has
suffered any sort of relapse to addiction since his reported sobriety
date of October 22, 2001. Therefore, the public interest is not being
threatened by the Respondent's previous addiction to hydrocodone,
because it does not appear that the Respondent will return to this
conduct.
However, although the Respondent attempted to take responsibility
for his unlawful prescribing of Schedules III and IV controlled
substances by admitting that his actions were wrong, he continuously
provided justifications for his actions in an effort to persuade the
Court that his violations of his DEA registration were justified under
the circumstances. [Tr. 134-139, 168-172, 204, 206; Resp. Exh. 13].
Moreover, Respondent repeatedly provided the Court with reasons as to
why it was not feasible for him to refer his patients to another doctor
who could prescribe the necessary scheduled controlled substance, or to
simply refuse to prescribe outside of his DEA and Texas DPS
registrations. [Id.]. I find that Respondent's misplaced justifications
amount to a failure to take full responsibility for his actions.
Moreover, although the Respondent attempts to justify the need for
his DEA registration because it would be in his patient's and the
community's best interest, this reasoning has failed in determining
whether the Respondent's application should be granted. Community
impact evidence has been found irrelevant in DEA precedent. Linda Sue
Cheek, M.D., 76 FR at 66,973; see also Steven M. Abbadessa, D.O., 74 FR
at 10,078.
As to candor, the record demonstrates that the Respondent falsely
reported his compliance with the Agreed Order when he was in fact
noncompliant. Specifically, the Respondent reported that he was abiding
by his restricted prescribing authority, when he was actually
prescribing outside the scope of that authority. Such lack of candor to
government officials weighs against the Respondent's application being
granted. [Resp. Exh. 5, 6].
In sum, Respondent has conclusively demonstrated his strong
recovery from his previous addiction and his successful maintenance of
his sobriety for the past eleven years. Therefore, I find that
Respondent's history of substance abuse does not weigh against the
granting of Respondent's application for a DEA Certificate of
Registration.
The Respondent has admitted his wrongdoing in prescribing outside
his authority. However, each time Respondent admitted that his past
conduct was a violation, he attempted to offer justifications for his
conduct in an effort to minimize his wrongdoing. Therefore, I find that
Respondent's half-hearted attempt to take responsibility for these
actions weighs against the granting of Respondent's application for a
DEA Certificate of Registration.
C. Conclusion and Recommendation
I conclude that the Government has proven, by a preponderance of
the evidence, that Respondent's application for a DEA registration in
Schedules II through V should be denied. Respondent has previously been
granted numerous opportunities to act as a responsible DEA registrant
and has failed each time. I do not see any conditions that could be
placed on Respondent's registration now that would ensure that
Respondent would be a responsible DEA registrant, especially
considering that Respondent was afforded the opportunity to hold a DEA
registration for Schedule V controlled substances after his substance
abuse and felony conviction, and yet, Respondent violated his
registration.
Moreover, had the Respondent not been caught violating his
prescriptive authority, it is likely that Respondent would have
continued prescribing outside the scope of his registration. Although
Respondent now claims that he would be a compliant registrant, if he
were to receive a DEA registration, I find reason to doubt this claim.
Respondent has been noncompliant, yet has represented himself as
compliant on several occasions to Board representatives.
In this case, the Respondent has shown that his ability to properly
handle controlled substances and abide by the law has been tainted. I
find that Respondent has not taken full responsibility for his
mistakes. Therefore, I find that granting Respondent's application for
a DEA Certificate of Registration is against the public interest, and I
recommend that his application be denied.
Date: February 5, 2013.
Gail A. Randall,
Administrative Law Judge.
[FR Doc. 2013-17890 Filed 7-24-13; 8:45 am]
BILLING CODE 4410-09-P