[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45656-45663]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18750]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 11-45]


Decision and Order; Perry T. Dobyns, M.D.

    On November 2, 2011, Administrative Law Judge (ALJ) Gail A. Randall 
issued the attached recommended decision. Therein, the ALJ found that 
while the Government had established grounds for denying Respondent's 
application, ALJ at 22, Respondent has been sober since December 2008, 
that he has been in compliance with his Indiana Physicians' Assistance 
Program Continuing Care Contract since November 2009, id. at 20, and 
that he ``has consistently taken responsibility for his misconduct.'' 
\1\ Id. at 21. The ALJ thus recommended that Respondent be granted a 
restricted registration subject to multiple conditions. The Government 
did not file exceptions to the ALJ's decision.\2\
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    \1\ No evidence was put forward showing that Respondent diverted 
controlled substances to others.
    \2\ In its post-hearing brief, the Government cites a prior 
decision of this Agency, which after having already ordered that the 
practitioner's application be granted, then noted ``evidence of the 
community's need for a physician of his specialty with prescribing 
capabilities.'' Gov. Br. 11 (quoting David M. Headley, 61 FR 39469, 
39471 (1996)). However, the Agency has since held in multiple cases 
that community impact evidence is not relevant in the public 
interest determination and provided an extensive explanation as to 
why. See Linda Sue Cheek, 76 FR 66972, 66973 (2011); Mark De La 
Lama, 76 FR 20011, 20020 n.20 (2011); Bienvenido Tan, 76 FR 17673, 
17694 n.58 (2011); Gregory D. Owens, 74 FR 36571, 36757 & n.22 
(2009).
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    Having reviewed the record, I have decided to adopt the ALJ's 
findings of fact, conclusions of law, and recommended Order. 
Accordingly, I will order that Respondent be granted a registration 
subject to the following conditions:
    (1) Respondent shall be limited to prescribing controlled 
substances and may not administer or dispense directly any controlled 
substances. In addition, Respondent may not order any controlled 
substances or accept any samples of controlled substances. If 
Respondent is employed at a practice in which controlled substances are 
stored on the premises, Respondent shall not have access to the cabinet 
in which the controlled substances are stored. Respondent shall inform 
any medical practice at which he becomes employed of this restriction 
on his registration.
    (2) Respondent is prohibited from prescribing controlled substances 
to himself or any family member.
    (3) Respondent shall maintain a log of all controlled substance 
prescriptions he authorizes and shall file a report listing in 
chronological order all such prescriptions by date, and including the 
following information: the name and address of the patient, name and 
dosage of the drug, quantity of the drug, and number of refills 
authorized. Each report shall be filed with the local DEA field office 
no later than ten (10) calendar days after the end of the previous 
quarter, e.g., April 10 (for the quarter ending on March 31), July 10

[[Page 45657]]

(for the quarter ending on June 30), October 10 (for the quarter ending 
on September 30), and January 10 (for the quarter ending on December 
31). If Respondent issues no controlled substance prescriptions during 
a quarter, a report indicating that no prescriptions were issued shall 
also be filed no later than ten (10) calendar days following the end of 
the quarter.
    (4) If Respondent opens his own practice, he shall consent to 
unannounced inspections by DEA personnel of any medical office he 
maintains and shall waive his right to require DEA personnel to obtain 
an Administrative Inspection Warrant prior to conducting an inspection.
    (5) Respondent shall enter into an agreement with the Indiana 
Physicians' Assistance Program pursuant to which he agrees that it 
shall disclose any violation of the conditions of his contract 
(including any failed drug screens) to the local DEA field office. In 
the event Respondent tests positive for a drug for which he does not 
hold a valid prescription, or fails to report for drug screening upon 
being ordered to do so, such acts shall constitute grounds for the 
immediate suspension of his registration.
    (6) Respondent shall report to the local DEA field office any 
relapse within forty-eight hours of such occurrence.
    (7) These conditions shall remain in effect for a period of three 
years, except that in the event Respondent successfully completes his 
contract with the Indiana Physicians' Assistance Program, condition 
number five shall terminate upon completion of said contract. However, 
if said contract is renewed, condition number five shall continue in 
effect until three years from the date of issuance of this 
registration.

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 Perry T. Dobyns, M.D., 
for a DEA Certificate of Registration as a practitioner, be, and it 
hereby is, granted, subject to the conditions set forth above. This 
Order is effective immediately.

    Dated: July 24, 2012.
Michele M. Leonhart,
Administrator.
    D. Linden Barber, Esq., and
    Jonathan P. Novak, Esq., for the Government
    Robert E. Saint, Esq., for the Respondent

RECOMMENDED RULINGS, FINDINGS OF FACT, CONCLUSIONS OF LAW, AND DECISION 
OF THE ADMINISTRATIVE LAW JUDGE

I. PROCEDURAL BACKGROUND

    Gail A. Randall, Administrative Law Judge. The Deputy Assistant 
Administrator, Office of Diversion Control, Drug Enforcement 
Administration (``DEA'' or ``Government''), issued an Order to Show 
Cause (``Order'') dated March 7, 2011, proposing to deny the DEA 
Certificate of Registration application of Perry T. Dobyns, M.D., 
(``Respondent''), as a practitioner, pursuant to 21 U.S.C. Sec.  823(f) 
(2006), because to grant the 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 alleged that on June 25, 2010, the Respondent submitted 
an application for a DEA registration as a practitioner with authority 
to handle controlled substances in Schedules II-V. [Id.].
    The Order further alleged that the Respondent had entered into an 
agreement with the North Carolina Medical Board in 2007, because of his 
misuse of drugs, including controlled substances. The Respondent also 
agreed not to use mood-altering drugs that had not been prescribed to 
him by a physician. However, a urine screen submitted on October 31, 
2008, tested positive for tetrahydrocannabinol, indicating that he had 
unlawfully possessed and used a Schedule I controlled substance. 
Further, the Respondent's urine screen submitted on November 22, 2008, 
tested positive for oxycodone and oxymorphone, indicating that he had 
unlawfully possessed and consumed two Schedule II controlled 
substances. [Id.].
    Next, the Order asserted that, on December 2, 2008, the Respondent 
forged a prescription for oxycodone in order to illegally obtain this 
Schedule II controlled substance. He filled this prescription. [ALJ 
Exh. 1 at 2].
    The Order noted that, on August 3, 2010, the Respondent was 
interviewed by DEA personnel, and he admitted that: (a) in 2002 the 
Respondent was admitted to a hospital due to abuse of alcohol and 
narcotics, and he subsequently entered into an agreement with the 
Indiana State Medical Association's Physicians Assistance Program; (b) 
in 2008, the Respondent had used narcotics that had been prescribed to 
one of his family members; (c) in September of 2008, he smoked 
marijuana; and (d) in late 2008, he issued a forged prescription for 
oxycodone to himself. [Id.].
    Lastly, the Order asserts that the Respondent returned to Indiana 
in June of 2010, and began practicing medicine. Although he did not 
possess a DEA registration, on November 15, 2010, the Respondent or his 
medical office staff issued two prescriptions for controlled substances 
using an electronic prescribing program. [Id.].
    The Deputy Assistant Administrator then gave the Respondent the 
opportunity to show cause as to why his application should not be 
denied on the basis of those allegations. [Id. at 2].
    On April 25, 2011, the Respondent \1\ filed a request for a hearing 
in the above-captioned matter. [ALJ Exh. 2].
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    \1\ On May 26, 2011, the Respondent filed his Pre-Hearing 
Statement. Mr. Saint entered his appearance by filing this document.
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    On May 31, 2011, the Government filed Government's Motion to 
Terminate Proceeding Due to Untimely Request for Hearing, [Motion]. 
[ALJ Exh. 3]. On June 17, 2011, I denied the Government's Motion. [ALJ 
Exh. 5].
    On July 20, 2011, Jonathan P. Novak entered his appearance on 
behalf of the Government in the above captioned matter. [ALJ Exh. 6].
    The hearing was conducted on August 23, 2011, in Lafayette, 
Indiana. [ALJ Exh. 7]. At the hearing, counsel for the DEA called one 
witness to testify and introduced documentary evidence. The Respondent 
testified and introduced documentary evidence. [Transcript (``Tr.'') 
Volume I].
    After the hearing, the Government submitted Proposed Findings of 
Fact, Conclusions of Law and Argument (``Govt. Brief''). The Respondent 
also submitted Proposed Findings of Fact, Conclusions of Law and 
Argument (``Resp. Brief'').

II. 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 (``DEA'' or ``Government'') should deny the 
application for a DEA Certificate of Registration, of Perry T. Dobyns, 
M.D., (``Respondent''), as a practitioner, pursuant to 21 U.S.C. Sec.  
823(f) (2006), because to grant his application would be inconsistent 
with the public interest, as that term is defined in 21 U.S.C. Sec.  
823(f). [ALJ Exh. 4; Transcript (``Tr.'') at 8].

[[Page 45658]]

III. FINDINGS OF FACT

A. Stipulated Facts
    The parties have stipulated to the following facts:
    1. Respondent applied for a DEA registration on June 25, 2010. 
[Government Exhibit (``Govt. Exh.'') 1].
    2. Respondent previously held a DEA registration but allowed it to 
expire without renewal in 2009.
    3. Respondent was hospitalized for alcohol and drug abuse in 2002, 
and entered into the Physicians Assistance Program in Indiana because 
of his abuse of alcohol and narcotic controlled substances.
    4. In 2007, Respondent entered an agreement with the North Carolina 
Physicians Health Program that required him to submit to drug testing.
    5. In the fall of 2008, Respondent unlawfully possessed marijuana, 
oxymorphone and oxycodone, and used these drugs.
    6. On October 31, 2008, Respondent tested positive for marijuana in 
a drug test performed under his agreement with the North Carolina 
Physicians Health Program.
    7. On November 22, 2008, Respondent tested positive for oxymorphone 
and oxycodone in a drug test performed under his agreement with the 
North Carolina Physicians Health Program.
    8. On December 2, 2008, Respondent filled a prescription for 
oxycodone which he had forged using the name and DEA number of another 
physician.

[ALJ Exh. 4].
B. Respondent's Addiction History
    In late 2001, the Respondent's medical practice in Oklahoma was 
failing. The Respondent's alcohol intake increased at home, and he 
began taking a controlled substance, hydrocodone, ``to help (him) 
during the day.'' [Tr. 44]. The Respondent used hydrocodone samples 
given to the clinic by drug representatives. [Tr. 45]. He failed to 
maintain distribution records for these controlled substances. [Tr. 
88].
    In 2002, the Respondent moved to Indiana. He continued to drink 
during the night and use narcotic prescription medications during the 
day. [Tr. 44-45]. The narcotics were taken from the practice's sample 
cabinet. [Tr. 46]. In November of 2002, the Respondent's ``depression, 
exacerbated by the alcohol and drug dependence, came to an extreme, and 
(he) attempted suicide.'' [Tr. 46]. His employers at the Harrison 
Family Practice referred him to the Indiana Physician Assistance 
Program, (PAP), who recommended that he seek inpatient treatment. [Tr. 
46-47].
    In late 2002, the Respondent was admitted to the Rush Memorial 
Behavioral Health program in Chicago, Illinois, which was a specific 
program for impaired physicians. [Tr. 47]. The Respondent attended this 
in-patient program for 10 weeks. [Tr. 20, 47, 87]. He was initially 
diagnosed as chemically dependent on opiates and alcohol along with a 
diagnosis of depression. [Respondent's Exhibit (``Resp. Exh.'') D].
    The Respondent enrolled in the Indiana PAP and signed a Continuing 
Care Contract (``Contract''). [Tr. 48; Resp. Exh. D]. He was required 
to have regular contact with the PAP through in-person meetings in 
Indianapolis. [Tr. 48]. He was also required to attend regular meetings 
of Alcoholics Anonymous or Narcotics Anonymous three times per week. 
[Id.]. He was also to attend weekly meetings of the Caduceus Group, a 
treatment group for doctors with substance abuse issues, in 
Indianapolis. [Id.]. The Contract also required the Respondent to 
participate in random urine drug screens. [Tr. 48-50]. While in 
Indiana, the Respondent remained in compliance with the Contract. [Tr. 
49].
    In 2007, the Respondent moved to North Carolina, enrolled in the 
North Carolina PAP, and signed a new five-year contract. [Tr. 51; Resp. 
Exh. D]. Similar to the Indiana PAP, this program is intended to 
``help[] physicians overcome an addiction issue.'' [Tr. 19]. As a 
requirement of this program, the Respondent was to refrain from 
consuming any controlled substances that were not legitimately 
prescribed to him or given to him for medical purposes. [Tr. 20]. He 
was also to submit to urine drug screens as dictated to by the program. 
[Id.].
    While in North Carolina, the Respondent worked in Chapel Hill 
during the week and spent his weekends in Fayetteville with his family. 
[Tr. 52-53]. He was also caring for his dying brother. [Tr. 53]. The 
stress of caring for his brother contributed to his relapse. [Tr. 21-
22]. This was his first relapse since beginning the recovery process in 
2002. [Tr. 22, 93]. The Respondent's brother used medical marijuana, 
and the Respondent used it in October of 2008. [Tr. 53-54]. The 
Respondent also consumed oxycodone from his brother's prescription, and 
subsequently he issued a prescription to himself using another doctor's 
DEA number. [Tr. 22]. This doctor did not know of the Respondent's 
conduct until the DEA informed him. [Tr. 22]. The Respondent also wrote 
a prescription for his sister using his DEA registration and consumed 
the controlled substances himself. [Tr. 94].
    The Respondent then had a positive drug screen for marijuana in 
October of 2008, and another positive drug screen for oxycodone and 
oxymorphone in November of 2008. [Tr. 55-56, 88-89]. The North Carolina 
PAP reported these positive test results to the North Carolina Medical 
Board. [Tr. 56]. Ultimately, the Respondent's North Carolina medical 
license was indefinitely suspended. [Tr. 22].
    The DEA did not know about the Respondent's sobriety between 
November of 2008 until November of 2009, when he reentered the Indiana 
Physician Assistance Program. [Tr. 31, 58]. He then applied to renew 
his Indiana medical license. On the application for such renewal, the 
Respondent disclosed the action that had been taken against his North 
Carolina medical license. [Tr. 58-59]. The Indiana Medical Board 
renewed the Respondent's medical license with probationary conditions. 
[Tr. 23]. In August and December of 2009, those terms and conditions 
were altered slightly. [Resp. Exh. A]. The Respondent is to remain 
compliant with the Indiana's Physician Assistance Program (PAP), and he 
is to notify the Indiana Medical Board within twenty-four hours of any 
relapse. [Tr. 23]. The Respondent is only allowed to work a forty hour 
work week, and, prior to the Board's removal of this condition, there 
had to be another physician on-site when the Respondent was working. 
The Respondent has remained compliant with the terms of his probation. 
[Tr. 23, 28].
    On November 23, 2009, the Respondent signed a second Continuing 
Care Contract with the Indiana PAP. [Resp. Exh. D]. This is a five-year 
agreement. [Id.]. The Respondent agreed, among other provisions, to 
participate in supervised urine/hair/blood drug screens, and agreed to 
abstain from mood-changing chemicals except those prescribed by a 
treating physician. [Id.]. In the event of a relapse, the Respondent is 
to notify the PAP. [Id.]. The Respondent also agreed to attend Caduceus 
meetings and to attend ``mutual self-help meetings''such as AA or NA at 
a frequency of three times per week. [Tr. 68; Resp. Exh. D]. The 
Respondent also agreed to attend individual therapy bi-weekly for a 
period of time and to see a psychiatrist for medication management. 
[Resp. Exh. D; Tr. 69-70].

[[Page 45659]]

    In August of 2010, Diversion Investigator (DI) Gary L. Whisenand 
\2\ interviewed the Respondent. [Tr. 19]. I find DI Whisenand's 
testimony consistent with the documentary exhibits and credible. DI 
Whisenand credibly testified that Indiana's Physician Assistance 
Program was a reliable program that cooperated with the DEA. [Tr. 30]. 
During the interview with DI Whisenand, the Respondent admitted to 
smoking marijuana and consuming oxycodone. [Tr. 21, 84]. The Respondent 
had explained that he had moved to North Carolina to care for an ailing 
brother, who had Stage IV lung cancer, and the stress of tending to his 
brother had caused the Respondent to relapse. [Tr. 21-22]. This was his 
first relapse since beginning the recovery process in 2002. [Tr. 22, 
93].
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    \2\ DI Whisenand has been a DEA diversion investigator for just 
over six years. [Tr. 15].
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    Dr. Fred W. Frick submitted an affidavit in this proceeding. [Resp. 
Exh. D]. Dr. Frick is board certified in internal medicine with an 
extensive record as an addictionologist. [Id.]. Since 2004, he has been 
the contract Medical Consultant and Director of the Indiana State 
Medical Association's Physicians Assistance Program. [Id.]. He 
explained that the PAP ``is currently recognized as an acceptable 
monitoring and advocacy program by the Indiana Medical Licensing 
Board.'' [Id.]. Dr. Frick oversees the program, ``which directs the 
monitoring and advocacy for chemically dependent physicians in the 
State of Indiana.'' [Id.]. Dr. Frick was familiar with the Respondent's 
history of drug use and addiction. [Id.].
    Dr. Frick wrote that each of the Respondent's drug screens have 
been negative since November 23, 2009, except for the presence of 
Ultram, ``which was prescribed for Dr. Dobyns by a treating 
physician.'' [Id.]. Lastly, Dr. Frick wrote that to the best of his 
knowledge, the Respondent ``has been compliant with all other aspects 
of his Continuing Care Contract since November 23, 2009.'' [Id.].
C. Respondent's DEA Application
    In his DEA application, the Respondent disclosed that his North 
Carolina medical license had been placed on indefinite suspension. [Tr. 
18; Govt. Exh. 1]. No charges are pending before the North Carolina 
medical board. [Govt. Exh. 1]. The Respondent also disclosed that he 
had had a positive drug test in 2008. [Id.].
    The Respondent also disclosed that he had applied to renew his 
medical license in Indiana, and that the Indiana Medical Board agreed 
to do so on a probationary basis. [Id.]. The Respondent agreed to 
participate in the Indiana State Medical Association's Physician 
Assistance Program (PAP). [Id.]. The Respondent also wrote that his 
participation in Indiana has continued to the date of his application 
without incident. [Id.].
D. Electronic Prescriptions
    In June of 2010, the Respondent accepted a position at the Madison 
County Health Center (``Center'') as a staff physician. [Tr. 75]. He 
made a full disclosure to that employer about his drug use history. 
[Tr. 62]. There, if a patient needed controlled substances, the 
Respondent would take a medical history, perform a physical 
examination, and determine whether the prescription was appropriate for 
the patient. [Tr. 64]. At that point, the Respondent would refer the 
patient to the Center's medical director for issuance of the controlled 
substance prescription. [Id.].
    The DEA received two electronic prescriptions for controlled 
substances written under the Respondent's name and dated in November of 
2010. [Tr. 26-28; Govt. Exh. 2]. These prescriptions contained the 
Respondent's electronic signature. [Tr. 31]. These two prescriptions 
were for a patient who had seen the Respondent's supervisory physician 
previously, and she was issued these two prescriptions for ongoing 
treatment of chronic pain and anxiety. [Tr. 78].
    At the time of these prescriptions, the Respondent was working at 
the Center. [Tr. 75]. The Center had an electronic medical records 
system. [Tr. 31, 65]. The default for the Respondent was for the system 
to send prescriptions to the printer for the Respondent to then take to 
the medical director to issue. [Tr. 65].
    The two electronic prescriptions for controlled substances were 
inadvertently sent by the system to the facsimile machine rather than 
to the printer. As soon as the Respondent became aware of the computer 
error, he took corrective action. He credibly testified that ``the 
measure that we took was to disconnect the fax function from the 
computer entirely so that the computer could no longer physically 
access the fax line.'' [Tr. 67]. It was DI Whisenand's assumption that 
the Respondent's electronic signature was affixed by that system. [Tr. 
32]. The prescriptions were then faxed to a pharmacy by the electronic 
medical records system without the Respondent's knowledge. [Tr. 33]. DI 
Whisenand credibly testified that he did not have any evidence that the 
Respondent knowingly transmitted controlled substance prescriptions via 
facisimile to a pharmacy. [Tr. 35]. After this time, DI Whisenand never 
received any complaints from a pharmacy or a pharmacy worker regarding 
the Respondent. [Tr. 34].
E. Respondent's Current Situation
    The Respondent received his medical degree with honors in 1995 from 
the University of Tennessee at Memphis, Tennessee. [Tr. 42]. The 
Respondent completed a residency in family medicine in 1997, and he 
became board certified by the American Board of Family Practice the 
same year. [Tr. 43]. In 2005, the Respondent recertified for a ten-year 
period. [Id.]. However, due to the North Carolina action against his 
medical license, his certification was invalidated. [Id.].
    The Respondent has been clean and sober since December 20, 2008. 
[Tr. 98]. The Respondent is unemployed, and he does not have a DEA 
registration number. [Tr. 24-25]. The Respondent is currently active in 
AA and has a sponsor. [Tr. 70-71]. He attends at least two meetings a 
week with his sponsor and engages in one or two phone calls during the 
week. [Tr. 71].
    The Respondent currently has an active, in all substances, 
controlled substances registration with Indiana. [Tr. 40, 61-62]. He 
also has an active Indiana medical license which is on probation. [Tr. 
40-41; Resp. Exh. A]. In July of 2011, the Indiana Medical Board 
modified the Respondent's probationary conditions of December 2009. 
[Resp. Exh. C]. Currently the Respondent's probationary conditions 
include: (a) the Respondent must maintain and remain in compliance with 
a contract from the Indiana PAP; (b) the Respondent shall report any 
relapse regarding chemical dependency to the Board within twenty-four 
hours; (c) the Respondent shall not work more than forty hours a week 
and for the next year shall submit quarterly written reports to the 
Board from his employer concerning his employment, and from the 
Respondent concerning his DEA status; and (d) the Respondent shall 
comply with the statutes and rules governing the practice of medicine. 
[Resp. Exh. B; Resp. Exh. C].
    In April of 2011, the Respondent was discharged from the Center. 
The primary reason for that action was the difficulties experienced by 
the Center in handling the Respondent's lack of a DEA registration. 
[Tr. 67].
    The Respondent credibly testified that he has never had a medical 
malpractice judgment entered against him, he has never settled a 
medical malpractice claim, and that the disclosed adverse actions taken 
against his medical license

[[Page 45660]]

were the only such actions taken. [Tr. 67-68].
    Today, the Respondent's North Carolina medical license is 
indefinitely suspended. [Tr. 56]. The Respondent does not plan to 
return to North Carolina. [Tr. 56]. The Respondent intends to become 
gainfully employed as a physician in Indiana. [Tr. 71]. Without a DEA 
registration, the Respondent is not able to have a meaningful medical 
practice. [Tr. 72]. The Respondent is not seeking any employment where 
he would have access to mood altering substances on the worksite. [Tr. 
96].

IV. STATEMENT OF LAW AND DISCUSSION

A. Position of the Parties
1. Government's Position
    The Government asserts that the appropriate remedy in this matter 
is denial of the Respondent's application. [Govt. Brief at 12]. Looking 
to the factors defining the public interest, the Government first 
proposes that factor one is applicable, for the North Carolina 
licensing board has indefinitely suspended the Respondent's medical 
license. [Govt. Brief at 6]. Further, the State of Indiana only granted 
the Respondent a medical license with restrictions and monitoring 
requirements. [Id.]. The Government argues that such conditions reflect 
``a systematic concern for Respondent's professional and personal well-
being. As such, this factor weighs in favor of denying Respondent's 
application for a DEA Certificate of Registration.'' [Id.].
    As to factor two, the Government asserts that the Respondent 
admitted to a lengthy history of using illicit drugs for recreational 
purposes, and to obtaining controlled substances for personal use 
through illicit means. [Govt. Brief at 7]. Under this factor, the 
Government concludes that the ``Respondent has shown a callous and 
cavalier attitude towards both using and prescribing controlled 
substances.'' [Govt. Brief at 8].
    Under factor four, the Government asserts that the Respondent 
violated federal law when he fraudulently used a prescription pad 
belonging to another doctor to write a prescription for a controlled 
substance for himself. [Id.]. Also, the Respondent admitted to 
possessing and using marijuana that he obtained illicitly. [Id.]. 
Because of this conduct, the Government argues that factor four weighs 
heavily in favor of denying the Respondent's application. [Govt. Brief 
at 8-9].
    Lastly, under factor five, the Government argues that the 
Respondent has only been in monitored recovery for two years. [Govt. 
Brief at 10]. The Government notes that prior DEA precedent takes into 
account the length of time the Respondent has been in recovery. [Govt. 
Brief at 9]. Here, the Respondent had been clean and sober for six 
years before his relapse. In the context of this behavior, the 
Government argues that the Respondent's ``risk of relapse should be 
considered high until such time (as) Respondent has shown a longer 
period of compliance with the restrictions of his substance abuse 
treatment by remaining sober, as well as a better understanding of the 
seriousness of his addiction and the danger it presents to himself and 
to others.'' [Govt. Brief at 10].
    The Government also finds it significant that the Respondent failed 
to show any remorse or ``even [an] understanding for the danger he 
presented to his patients by practicing under the influence of Schedule 
II narcotics.'' [Id.]. Therefore, the Government concludes, the 
Respondent's application should be denied. [Govt. Brief at 11-12].
    In the alternative, the Government asserts, if the Respondent 
should be granted a restricted registration, the Government requests 
that (a) the Respondent's registration be limited to Schedule IV and V 
controlled substances only; (b) the Respondent be limited to 
prescribing controlled substances only, and not be authorized to 
prescribe to himself or any family members; (c) the Respondent shall 
only be authorized to obtain controlled substances from a treating 
practitioner who prescribes controlled substances to the Respondent for 
a legitimate medical purpose; (d) the Respondent maintain a 
prescription log which he would submit quarterly to the DEA; (e) 
Respondent shall consent to unannounced inspections without the need of 
an Administrative Inspection Warrant; and (f) the Respondent continue 
in his agreement with the Indiana PAP. [Govt. Brief at 12-13].
2. Respondent's Position
    The Respondent asserts that granting his application would be in 
the public interest. [Resp. Brief at 11]. The Respondent argues that he 
has been in substantial compliance with his treatment for eight years 
except for a relapse during two months in 2008. [Resp. Brief at 10]. He 
notes that he has maintained an active probationary medical license in 
Indiana, and he has complied with the terms of that probation. [Id.]. 
The Respondent also has an active Indiana Controlled Substance 
Registration. [Id.].
    The Respondent next asserts that no evidence exists that the 
Respondent's medical care endangered patients or that his care deviated 
from any standard of care. [Resp. Brief at 11]. Instead, Respondent 
argues that his violations stemmed from his chemical dependency, which 
was exacerbated by unusual family circumstances, namely the terminal 
illness of his brother. [Id.]. Therefore, the Respondent proffers that 
the ``issuance of a restricted registration'' would resolve ``[a]ny 
concern for the public health and safety'' posed by the Respondent's 
violations. Lastly, the Respondent concludes that he should be granted 
a registration restricted as follows: (1) the Respondent must remain in 
compliance with the Indiana Continuing Care Contract; (2) and also with 
his probationary medical license; (3) and that the Respondent be 
required to immediately disclose any non-compliance with either of 
these two monitoring agreements. [Id.].
B. Statement of Law and Analysis
    Pursuant to 21 U.S.C. Sec.  823(f) (2006),\3\ the Deputy 
Administrator may deny an application for a DEA Certificate of 
Registration if she determines that such registration would be 
inconsistent with the public interest. In determining the public 
interest, the following factors are considered:
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    \3\ The Deputy Administrator has the authority to make such a 
determination pursuant to 28 C.F.R. Sec. Sec.  0.100(b) and 0.104 
(2011).
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    (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.
    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 she deems appropriate in determining 
whether a registration should be revoked or an application for 
registration be denied. See Robert A. Leslie, M.D., 68 Fed. Reg. 
15,227, 15,230 (DEA 2003); Henry J. Schwarz, Jr., M.D., 54 Fed. Reg. 
16,422 (DEA 1989). Moreover, the Deputy

[[Page 45661]]

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 burden of proving that the requirements 
for registration are not satisfied. 21 C.F.R. Sec.  1301.44(d) (2011). 
The burden of proof shifts to the Respondent once the Government has 
made its prima facie case. See Medicine Shoppe--Jonesborough, 73 Fed. 
Reg. 364, 380 (DEA 2008); see also Thomas E. Johnston, 45 Fed. Reg. 
72,311 (DEA 1980).
    DEA precedent has also held that ``past performance is the best 
predictor of future performance.'' Alra Labs., Inc. v. DEA, 54 F.3d 
450, 452 (7th Cir. 1995). Further, DEA has repeatedly held that ``where 
a registrant has committed acts inconsistent with the public interest, 
the registrant must accept responsibility for [his] actions and 
demonstrate that [he] will not engage in future misconduct.'' Medicine 
Shoppe--Jonesborough, 73 Fed. Reg. at 387; see also Samuel S. Jackson, 
D.D.S., 72 Fed. Reg. 23,848, 23,853 (DEA 2007). In short, after the 
Government makes its prima facie case, the Respondent must prove by a 
preponderance of the evidence that he can be entrusted with the 
authority that a registration provides by demonstrating that he accepts 
responsibility for his misconduct and that the misconduct will not re-
occur.
1. Recommendation of Appropriate State Licensing Board.
    The DEA has long held that a practitioner's reinstatement by a 
State board ``is not dispositive,'' because ``DEA maintains a separate 
oversight responsibility with respect to the handling of controlled 
substances and has a statutory obligation to make its 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). 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 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). Although not dispositive, state board 
decisions are relevant on the issue of granting or denying a DEA 
application. See Gregory D. Owens, D.D.S., 74 Fed. Reg. 36,751, 36,755 
(DEA 2009); Martha Hernandez, M.D., 62 Fed. Reg. 61,145, 61,147 (DEA 
1997).
    Here, the Indiana State Medical Board has not made a recommendation 
concerning the Respondent's DEA application. The Respondent currently 
has an active, in all substances, controlled substances registration 
with Indiana. He also has an active Indiana medical license which is on 
probation. Nevertheless, the DEA has consistently held that a 
practitioner's possession of State authority, while a prerequisite to 
registration, is not dispositive of the public interest determination. 
Mark De La Lama, P.A., 76 Fed. Reg. 20,011, 20,018 (DEA 2011).
2. Applicant's Conviction Record Relating to Controlled Substances, 
Experience With Controlled Substances And Compliance With Applicable 
State, Federal, Or Local Laws Relating To Controlled Substances.
    The critical consideration in this proceeding is whether the 
circumstances that existed in 2008, have changed sufficiently to 
support a conclusion that Respondent's registration would be in the 
public interest. See Ellis Turk, M.D., 62 Fed. Reg. 19,603, 19,604 (DEA 
1997). As this Agency has repeatedly held, a proceeding under the 
Controlled Substances Act ```is a remedial measure, based upon the 
public interest and the necessity to protect the public from those 
individuals who have misused * * * their DEA Certificate of 
Registration, and who have not presented sufficient mitigating evidence 
to assure the Administrator that they can be entrusted with the 
responsibility carried by such a registration.''' Jon Karl Dively, 
D.D.S., 72 Fed. Reg. 74,332, 74,334 (DEA 2007) (quoting Samuel S. 
Jackson, D.D.S., 72 Fed. Reg. 23,848, 23,853 (DEA 2007)).
    As for Factor 3, the parties do not dispute that the Respondent has 
not been convicted of any offense relating to controlled substances. 
The Respondent also previously held a DEA registration but allowed it 
to expire without renewal in 2009.
    In late 2001, the Respondent illegally used hydrocodone samples 
given to the clinic by drug representatives. He failed to maintain 
distribution records for these controlled substances. The Respondent 
continued this behavior of unlawful consumption of controlled 
substances through 2002.
    In late 2002, the Respondent was hospitalized for alcohol and drug 
abuse. He was diagnosed as chemically dependent on opiates and alcohol. 
In March of 2003, when he completed the inpatient treatment, he entered 
the Physicians Assistance Program in Indiana. He remained in compliance 
with his Contract during this time.
    Under the Controlled Substances Act, it is ``unlawful for any 
person knowingly or intentionally * * * to acquire or obtain possession 
of a controlled substance by misrepresentation, fraud, forgery, 
deception, or subterfuge.'' 21 U.S.C. Sec.  843(a)(3) (2006). In 2008, 
the Respondent began smoking marijuana and consuming other controlled 
substances unlawfully. The Respondent wrote a prescription for his 
sister, filled it, and consumed the controlled substances himself. He 
also wrote a prescription for controlled substances on another 
physician's prescription pad, filled that prescription, and consumed 
those controlled substances. Subsequently the Respondent tested 
positive for marijuana use in October of 2008, and for oxycodone and 
oxymorphone in November of 2008. Such unlawful consumption of 
controlled substances weighs against the Respondent's being granted a 
DEA registration.
    Further, the Respondent's use of another's DEA registration to 
prescribe himself controlled substances is, itself, a violation of the 
Controlled Substances Act. See 21 U.S.C. Sec.  843(a)(2) (2006) (``It 
shall be unlawful for any person knowingly or intentionally to use in 
the course of the * * * dispensing of a controlled substance * * * a 
registration number which is * * * issued to another person.''); see 
also Patrick W. Stodola, M.D., 74 Fed. Reg. 20,727, 20,735-36 (DEA 
2009); Harrell E. Robinson, M.D., 74 Fed. Reg. 61,370, 61,376 (DEA 
2009). This violation also weighs against the granting of the 
Respondent's application for a DEA registration.
    In June of 2010, a pharmacy received two electronic prescriptions 
for controlled substances electronically signed by the Respondent. The 
Respondent did not have a DEA registration. Such conduct also violates 
the Controlled Substances Act and its implementing regulations. See 21 
U.S.C. Sec.  841(a)(1) (2006) (``Except as authorized by this title, it 
shall be unlawful for any person knowingly or intentionally to * * * 
dispense * * * a controlled substance.''); see also 21 C.F.R. Sec.  
1301.11 (2011) (requiring any person who dispenses a controlled 
substance to be registered unless exempted by law). However, I also 
note the nature of the offense, for the computer-generated 
prescriptions were sent to the facsimile machine in error. I also note 
that the Respondent took remedial actions to ensure such an error does 
not happen again. Further, although not an excuse

[[Page 45662]]

for this incident, I also note that the recipient of this prescription 
was being treated by the Respondent, who credibly testified that the 
prescriptions were issued for a legitimate medical purpose.
3. Other Factors Affecting the Public Interest
    Another factor in this case is the fact that the Respondent 
unlawfully consumed controlled substances while caring for patients. 
Although this record contains no evidence of any harm coming to his 
patients, the fact that he was willing to risk such harm is 
inconsistent with the requirements of a DEA registrant.
    Further, the DEA 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 Fed. Reg. 51,453 (DEA 1994); David E. Trawick, D.D.S., 53 
Fed. Reg. 5,326 (DEA 1988). Here, the Respondent self-abused 
hydrocodone products in 2001 and oxycodone products in 2008. Such 
unlawful ingestion of controlled substances, especially when a 
physician is caring for patients while under the influence of these 
drugs, places the public health and safety in jeopardy.
    Yet, I found the Respondent credible when he testified that he has 
been drug free since December of 2008. He has remained active in his 
recovery, and his drug screens have been negative. 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 Fed. Reg. 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 Fed. Reg. 26,818 (DEA 1997) (four 
years); John Porter Richards, D.O., 61 Fed. Reg. 13,878 (DEA 1996) (ten 
years); Norman Alpert, M.D., 58 Fed. Reg. 67,420, 67,421 (DEA 1993) 
(seven years).
    Here, the Respondent's Indiana medical license requires him to 
remain compliant with the Indiana's Physician Assistance Programs' 
Continuing Care Contract. The Respondent signed that five-year contract 
in November of 2009. The contract provides for supervised drug screens, 
and in the event of a relapse, the Respondent is to notify the Indiana 
PAP. The Respondent agreed to attend Caduceus meetings, AA or NA 
meetings, to receive counseling, to abstain from consuming 
nonprescribed mood-changing chemicals, and to see a psychiatrist for 
medication management. The Medical Director, Dr. Frick, affirmed that 
the Respondent has been compliant with these requirements, and that his 
drug screens have been negative since November 23, 2009. The Respondent 
credibly testified that he has been clean and sober since December 20, 
2008. This past conduct demonstrates the Respondent's ability to comply 
with his PAP contract and to continue to perform his daily functions 
drug-free.
    After the Government ``has proved that a registrant has committed 
acts inconsistent with the public interest, a registrant must `present 
sufficient mitigating evidence to assure the Administrator that [he] 
can be entrusted with the responsibility carried by such a 
registration.' '' Medicine Shoppe--Jonesborough, 73 Fed. Reg. 364, 387 
(DEA 2008) (quoting Samuel S. Jackson, D.D.S., 72 Fed. Reg. 23,848, 
23,853 (DEA 2007). ``Moreover, because `past performance is the best 
predictor of future performance,' Alra Labs., Inc. v. DEA, 54 F.3d 450, 
452 (7th Cir. 1995), [DEA] has repeatedly held that where a registrant 
has committed acts inconsistent with the public interest, the 
registrant must accept responsibility for [his] actions and demonstrate 
that [he] will not engage in future misconduct.'' Medicine Shoppe--
Jonesborough, 73 Fed. Reg. at 387; see also Samuel S. Jackson, D.D.S., 
72 Fed. Reg. 23, 848, 23,853 (DEA 2007); John H. Kennedy, M.D., 71 Fed. 
Reg. 35,705, 35,709 (DEA 2006); Prince George Daniels, D.D.S., 60 Fed. 
Reg. 62,884, 62,887 (DEA 1995). See also Hoxie v. DEA, 419 F.3d 477, 
483 (6th Cir. 2005) (``admitting fault'' is ``properly consider[ed]'' 
by DEA to be an ``important factor[]'' in the public interest 
determination).
    Here, the Respondent has consistently taken responsibility for his 
misconduct. He disclosed his misconduct to the Indiana medical board 
and to the DEA in his applications and in his testimony at this 
proceeding. Further, requirements are in place to ensure the public 
interest is protected from the possibility of relapse by the 
Respondent. First, early detection will take place because of the urine 
screens and the requirement for the Respondent to disclose any 
violations of his Continuing Care Contract. Second, the DEA can 
restrict his registration to the prescribing of controlled substances 
only, and to prohibit his prescribing to himself or to any other family 
member. Lastly, the situation that led to his relapse in 2008 no longer 
exists. The Respondent is no longer caring for his brother. These 
factors are also appropriate to consider when determining the 
appropriate use of the Deputy Administrator's discretion in this 
matter. See Martha Hernandez, M.D., 62 Fed. Reg. 61,145 (DEA 1997) 
(holding that, in exercising his discretion in determining the 
appropriate remedy, the Deputy Administrator should consider all of the 
facts and circumstances of a particular case).

V. CONCLUSION AND RECOMMENDATION

    Therefore, I conclude that the DEA has met its burden of proof and 
has established that grounds exist for denying the Respondent's DEA 
application for registration.
    I do not condone nor minimize the seriousness of the Respondent's 
prior misconduct in 2001-2002, and again in 2008. However, based on 
this record, I recommend that the Respondent be afforded an opportunity 
to demonstrate that he can responsibly handle controlled substance 
prescriptions by the granting of a restricted registration. See Cecil 
E. Oakes, Jr., M.D., 63 Fed. Reg. 11,907, 11,910 (DEA 1998) (``Such a 
resolution will provide Respondent with the opportunity to demonstrate 
that he can responsibly handle controlled substances, while at the same 
time protect the public health and safety, by providing a mechanism for 
rapid detection of any improper activity.'').
    Based on this record and the Respondent's actions since December of 
2008, I recommend to the Deputy Administrator \4\ that the Respondent 
be granted a conditional DEA registration. I suggest that the 
conditions include: that the registration restricts his handling of 
controlled substances to merely prescribing and not storing or 
dispensing such drugs and that he be prohibited from prescribing 
controlled substances to himself or any family member. Further, I 
recommend the Respondent be subject to quarterly reporting of his 
prescribing of controlled substances to his local DEA office. I also 
recommend that the Respondent be ordered to consent to unannounced 
inspections by DEA personnel without requiring an administrative 
inspection warrant. Lastly, I recommend that the Respondent be ordered 
to continue with

[[Page 45663]]

his agreement with the Indiana PAP and to notify the DEA should a 
relapse occur. I recommend these restrictions apply for three years 
from the date of the final order so directing this result. In this way, 
the Respondent may return to the full practice of medicine, and the DEA 
can assure itself of the Respondent's compliance with DEA regulations 
and of the protection of the public interest.

    \4\ The Deputy Administrator has the authority to make such a 
determination pursuant to 28 C.F.R. Sec. Sec.  0.100(b) and 0.104 
(2011).
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Date: November 2, 2011
/s/Gail A. Randall
Administrative Law Judge

[FR Doc. 2012-18750 Filed 7-31-12; 8:45 am]
BILLING CODE 4410-09-P