Kimberly Maloney, N.P.; Decision and Order, 60922-60930 [2011-25238]
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substances and maintain her DEA 222
forms. More importantly, however, the
record clearly reflects that the
Respondent created serious risks of
diversion through her practice and
failed to otherwise mitigate those risks.
Thus, I find the Government has met its
burden of proof that the Respondent’s
continued registration would not be in
the public’s interest.
The Respondent, however, has not
accepted responsibility for all of her
wrongdoing, nor has she adequately
assured this tribunal of future
compliance.
In balancing the statutory public
interest factors and the Respondent’s
remedial efforts, I conclude that
revocation of the Respondent’s DEA
Certificate of Registration, and denial of
any pending renewal applications,
would be consistent with the public
interest in this case.
Accordingly, I recommend that the
Respondent’s Certificate of Registration
be revoked and any pending
applications for renewal be denied.
June 17, 2011.
Gail A. Randall,
Administrative Law Judge.
[FR Doc. 2011–25231 Filed 9–29–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10–77]
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Kimberly Maloney, N.P.; Decision and
Order
On February 4, 2011, Administrative
Law Judge Timothy D. Wing issued the
attached recommended decision.
Neither party filed exceptions to the
decision.
Having reviewed the entire record, I
have decided to adopt the ALJ’s ruling,
findings of fact, conclusions of law
(except as explained below), and
recommended order. Accordingly,
Respondent’s application for a
registration will be granted subject to a
condition.
In his discussion of factor three—
Respondent’s ‘‘conviction record under
Federal or State laws relating to the
manufacture, distribution, or dispensing
of controlled substances,’’ 21 U.S.C.
823(f)—the ALJ found that she had pled
guilty to a felony count of obtaining a
narcotic drug by means of a forged
prescription in violation of Cal. Health
& Safety Code § 11368. ALJ at 15–16.1
However, pursuant to Cal. Penal Code
1 All citations to the ALJ’s decision are to the slip
opinion as issued by him.
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§ 1000.1, Respondent was allowed to
participate in the deferred entry of
judgment program, GX 10, and upon her
successful completion of treatment, her
guilty plea was set aside and the charge
was dismissed. GX 11.
Noting that California law provides
that ‘‘[a] defendant’s plea of guilty
pursuant to this chapter shall not
constitute a conviction for any purpose
unless a judgment of guilty is entered
pursuant to’’ Cal Penal Code § 1000.3,
and that Agency precedent holds that a
deferred adjudication is nonetheless a
conviction for purposes of the CSA, the
ALJ explained that ‘‘the fact that a
finding of guilt was specifically not
entered as to Respondent and the
charges dismissed, leaves open the
question as to whether Respondent’s
plea constitutes a conviction under 21
U.S.C. 823(f).’’ ALJ at 17. The ALJ
deemed it unnecessary to reach the
issue, however, reasoning that the
offense committed by Respondent ‘‘does
not ‘relate[] to the manufacture,
distribution, or dispensing of controlled
substances,’ the standard embraced in’’
21 U.S.C. 823(f)(3). Id. (citing Super-Rite
Drugs, 56 FR 46014 (1995)).
Contrary to the ALJ’s understanding,
the Agency has long since resolved both
issues. In Edson W. Redard, 65 FR
30616 (2000), a practitioner, who was
charged with three felony counts of
obtaining and attempting to obtain
hydrocodone by fraud under California
law, pled nolo contendere to a single
count and was allowed to participate in
the State’s deferred entry of judgment
program (the same statutory scheme at
issue here), which he successfully
completed. Id. at 30617–18. Thereupon,
the state court granted deferred entry of
judgment and the charges were
dismissed. Id. at 30618.
Thereafter, the Agency proposed the
revocation of the practitioner’s
registration on the ground that he had
been convicted of a felony offense
relating to controlled substances under
state or Federal law. Id. (citing 21 U.S.C.
824(a)(2)). In opposition, the
practitioner argued that he had not been
‘‘convicted of a felony offense [because]
no judgment was entered against him
and the criminal proceedings were
dismissed.’’ Id.
The Agency rejected the practitioner’s
argument, explaining that ‘‘there is still
a ‘conviction’ within the meaning of the
Controlled Substances Act even if the
proceedings are later dismissed. * * *
[A]ny other interpretation would mean
that the conviction could only be
considered between its date and the
date of its subsequent dismissal.’’ Id.
(int. quotations omitted). The Agency
thus held that the practitioner had
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‘‘been convicted of a felony relating to
controlled substances’’ and that this was
ground to revoke his registration under
21 U.S.C. 824(a)(2). Id.
In Harlan J. Borcherding, 60 FR 28796
(1995), a practitioner who had been
indicted under Texas law on three
counts of prescribing a controlled
substance ‘‘without a valid medical
purpose,’’ was allowed to plead guilty to
a single misdemeanor count and was
placed on probation; following the
practitioner’s completion of his
probation, the proceeding was
dismissed without an adjudication of
guilt. Id. at 28797. While the
practitioner argued ‘‘that he had not
been ‘convicted’ of any offense within
the meaning of 21 U.S.C. 823(f)(3),’’ the
Agency rejected the argument, holding
that ‘‘[t]he law is well settled that a DEA
registrant may be found to have been
‘convicted’ within the meaning of the
Controlled Substances Act, despite a
deferred adjudication of guilt.’’ Id.
(citations omitted).
More recently, in Pamela Monterosso,
73 FR 11146, 11148 (2008), a case in
which an applicant pled guilty to a state
law controlled substance offense but
was granted probation before judgment
and the charge was dismissed, I
explained that ‘‘DEA has long taken the
view that even when a court withholds
adjudication and ultimately dismisses
the charge after the completion of
probation, the proceeding is still a
conviction within the meaning of the
Controlled Substances Act.’’ See also
Thomas G. Easter II, 69 FR 5579, 5580–
81 (2004) (‘‘DEA has consistently held
that a deferred adjudication of guilt
following a guilty plea, is a conviction
within the meaning of the Controlled
Substances Act.’’); Clinton D. Nutt, 55
FR 30992 (1990); Eric A. Baum, 53 FR
47272 (1988); Stanley Granet Rosen, 50
FR 46844 (1985).
Moreover, the Superior Court form
evidencing Respondent’s guilty plea
includes the ‘‘Court’s Finding And
Order.’’ GX 9, at 3. This section of the
form concludes by stating: ‘‘The Court
accepts the defendant’s plea and
admissions, and the defendant is
convicted thereby.’’ Id. For purposes of
the CSA, including whether this action
must be disclosed on an application for
registration and whether it provides
ground to deny an application or revoke
a registration, see 21 U.S.C. 824(a)(1) &
(2), Respondent’s plea and the Superior
Court’s finding constitutes a conviction
notwithstanding that her plea was
eventually set aside and the charge
dismissed.
As discussed above, the ALJ also
concluded that Respondent’s offense of
obtaining a prescription for a controlled
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substance by fraud ‘‘does not relate to
the manufacture, distribution, or
dispensing of controlled substances.’’
ALJ at 17 (quoting 21 U.S.C. 823(f) and
citing Super-Rite Drugs, 56 FR 46014,
46015 (1991)). However, the underlying
offense at issue in Super-Rite Drugs was
a state law offense of possession of
cocaine and not possession with intent
to distribute. See 56 FR at 46014. The
case thus does not stand for the
proposition cited by the ALJ.2
Most significantly, in several cases,
the Agency has held that the offense of
obtaining controlled substances by
using fraudulent prescriptions
constitutes an offense related to the
manufacture, distribution, or dispensing
of controlled substances within the
meaning of factor three. See Redard, 65
FR at 30619 (practitioner obtained
controlled substances by issuing
fraudulent prescriptions); Ronald D.
Springel, 62 FR 67092, 67094 (1997)
(holding that conviction for federal
offense ‘‘of obtaining a controlled
substance by fraud’’ was actionable
under factor three); Rick’s Pharmacy,
Inc., 62 FR 42595, 42597 (1997) (same);
Ronald Phillips, 61 FR 15304, 15305–06
(1996) (same). Forging a prescription to
obtain a controlled substance clearly
relates to the ‘‘distribution[] or
dispensing of controlled substances,’’ 21
U.S.C. 823(f)(3), whether the
practitioner wrote the prescriptions on
her own pad, or, as here, stole
prescriptions from another practitioner’s
pad.
However, aside from the ALJ’s
analysis of factor three, I agree with the
ALJ’s findings as to the remaining
factors. Moreover, I agree with the ALJ
that Respondent has ‘‘credibly’’
accepted responsibility for her
misconduct and that she has put
forward compelling and unrebutted
evidence of her rehabilitation, thus
demonstrating that ‘‘she will not engage
in future misconduct.’’ ALJ at 22.
Because there is no evidence that
Respondent harmed others or diverted
the drugs she illegally obtained, and this
episode is, in essence, a first offense, I
conclude that consideration of the
Agency’s interest in deterrence is not
warranted. Accordingly I will adopt the
ALJ’s recommended order and grant
Respondent’s application for
2 It is acknowledged that there are a number of
older cases which held that convictions for the
offense of simple possession of a controlled
substance could be considered under factor three.
However, in Alvin Darby, 75 FR 26993, 27000
(2009), I explained that a conviction for simple
possession does not fall within factor three.
However, as I also noted in Darby, such a
conviction can be considered under factor five. Id.
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registration subject to the following
condition.
(1) Any violation of either condition
13 or 14 of the California Board of
Registered Nursing’s Order shall be
deemed an act inconsistent with the
public interest and subject her
registration to proceedings under 21
U.S.C. 824(a).
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 Kimberly
Maloney, N.P., for a DEA Certificate of
Registration as a mid-level practitioner
be, and it hereby is, granted. This Order
is effective immediately.
Dated: September 19, 2011.
Michele M. Leonhart,
Administrator.
Paul E. Soeffing, Esq., for the
Government.
Kimberly Maloney, N.P., Pro Se, for the
Respondent.
Recommended Ruling, Findings of Fact,
Conclusions of Law and Decision of the
Administrative Law Judge
Introduction
Timothy D. Wing, Administrative Law
Judge. This proceeding is an
adjudication pursuant to the
Administrative Procedure Act (APA), 5
U.S.C. 551 et seq., to determine whether
the Drug Enforcement Administration
(DEA) should deny a nurse
practitioner’s application for a
Certificate of Registration (COR) as a
mid-level 1 practitioner. Without this
registration the nurse practitioner,
Kimberly Maloney, N.P. (Respondent),
of Chula Vista, California, will be
unable to lawfully handle controlled
substances in the course of her practice.
On September 10, 2010, the DEA
Deputy Assistant Administrator, Office
of Diversion Control, issued an Order to
Show Cause 2 (OSC) to Respondent,
giving Respondent an opportunity to
show cause why the DEA should not
deny her application for a DEA COR,
assigned Control No. W09131151M,
pursuant to 21 U.S.C. 824(a)(4), and
deny any other pending applications for
a DEA COR, alleging that Respondent’s
registration would be inconsistent with
the public interest, as that term is
defined in 21 U.S.C. 823(f).
In substance, the OSC alleges that:
1. On February 18, 2009, Respondent
applied for a DEA COR (Control No.
W09131151M) as a mid-level practitioner in
Schedules II through V with a registered
address of 3855 Health Sciences Drive, La
1 See
2 ALJ
PO 00000
21 CFR 1300.01(b)(28) (2010).
Ex. 1.
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Jolla, CA 92093–9191 and a mailing address
of 1503 Apache Drive, Unit A, Chula Vista,
CA 81910;
2. In a letter dated April 3, 2009,
Respondent requested that the registered
address for her application be changed to
eStudysite, 452 Medical Center Court, Chula
Vista, CA 91911;
3. In 2006, Respondent forged
prescriptions on a doctor’s prescription pad
for Actiq (fentanyl) and OxyContin
(oxycodone), both Schedule II controlled
substances, to support a drug habit for
Respondent. Respondent injected herself
with Actiq after dissolving it in saline.
Respondent used her health insurance to pay
for these forged prescriptions;
4. On January 19, 2007, the San Diego
District Attorney’s Office filed a felony
complaint against Respondent for violations
of Cal. Health & Safety Code § 11173(a)
(obtaining prescriptions by fraud or deceit)
and Cal. Penal Code § 459 (burglary). On
April 17, 2007, Respondent pleaded guilty to
a felony count of obtaining a narcotic drug
(OxyContin) by means of a forged
prescription, in violation of California Health
& Safety Code § 11368. The court deferred
entry of judgment for eighteen months and
ordered Respondent to enroll in and
complete a California Penal Code § 1000 drug
treatment program;
5. On December 21, 2006, Respondent
began the McDonald Center Intensive
Outpatient Alcohol and Drug Rehabilitation
Program a seven-week, three-nights-per-week
program. Respondent completed this
program on February 8, 2007. Subsequently,
Respondent enrolled in Scripps McDonald
Center’s Chemical Dependency Aftercare
program, a one-year, one-night-per-week
program. Respondent completed this
program on February 7, 2008. On October 22,
2008, the court dismissed the felony criminal
complaint against Respondent; and
6. On July 31, 2009, the California Board
of Nursing filed an Accusation against
Respondent alleging unprofessional conduct
for possession of controlled substances
without a prescription and unprofessional
conduct for use of a controlled substance.
The administrative adjudication of the
Accusation is ongoing.3
3 Respondent’s post-hearing brief, filed on
January 25, 2011, indicates that the California Board
of Registered Nursing (BRN) adopted the proposed
decision of the California Administrative Law Judge
(ALJ) on December 28, 2010, and notes that the BRN
took the extraordinary step of reducing
Respondent’s period of probation to one year and
cost recovery to zero. The Government filed with
its post-hearing brief a December 28, 2010 Order of
the BRN entitled ‘‘Decision After Non-Adoption,’’
of which I take official notice. (See Gov’t Br. at
Gov’t Ex. 17.) Under the APA, an agency ‘‘may take
official notice of facts at any stage in a proceeding—
even in the final decision.’’ U.S. Dept. of Justice,
Attorney General’s Manual on the Administrative
Procedure Act 80 (1947) (Wm. W. Gaunt & Sons,
Inc., Reprint 1979). In accordance with the APA
and DEA’s regulations, Respondent is ‘‘entitled on
timely request, to an opportunity to show to the
contrary.’’ 5 U.S.C. 556(e); 21 CFR 1316.59(e)
(2010); see, e.g., R & M Sales Co., 75 FR 78,734,
78,736 n.7 (DEA 2010). Respondent can dispute the
facts of which I take official notice by filing a
properly supported motion for reconsideration
Continued
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Respondent, appearing pro se, timely
requested a hearing on the allegations in
the OSC. Following prehearing
procedures, a hearing was held in San
Diego, California, on December 14,
2010, with the Government represented
by counsel and Respondent appearing
pro se. Both parties called witnesses to
testify and introduced documentary
evidence. After the hearing, both parties
filed proposed findings of fact,
conclusions of law and argument. All of
the evidence and post-hearing
submissions have been considered, and
to the extent the parties’ proposed
findings of fact have been adopted, they
are substantively incorporated into
those set forth below.
Issue
Whether the record establishes by
substantial evidence that Respondent’s
application for a DEA COR, Control
Number W09131151M, as a mid-level
practitioner, should be denied pursuant
to 21 U.S.C. 823(f) and 824(a)(4),
because Respondent’s registration
would be inconsistent with the public
interest as that term is used in 21 U.S.C.
823(f).
Evidence and Incorporated Findings of
Fact
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I. Background
The parties stipulated as fact the
allegations contained within the OSC.
(Tr. 17.) Additionally, at hearing the
parties stipulated to the admission and
consideration of Government Exhibits
1–16 and Respondent Exhibits 1–8. (Tr.
16.)
Respondent’s education includes: A
1992 Bachelor of Science degree in
Biology from San Diego State
University, a 1995 Bachelor of Science
degree in nursing from San Diego State
University and a 2000 Masters of
Science/Nurse Practitioner Critical Care
degree from the University of
Pennsylvania. (Resp’t Ex. 2.)
Additionally, Respondent’s professional
experience between August 2000 and
November 2006 includes work as a
nurse practitioner in various medical
settings to include neurosurgical patient
care, neuro-radiology and a trauma
department. (Id.) Respondent’s
professional experience between August
2007 and October 2009 includes work as
a lecturer, bone marrow transplant
patient care, and care of patients
involved in various research studies.
within twenty days of service of this Recommended
Decision, which shall begin on the date it is mailed.
See, e.g., Joseph Gaudio, M.D., 74 FR 10,083, 10,088
(DEA 2009) (granting respondent opportunity to
dispute officially noticed facts within fifteen days
of service).
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(Id.) More recently, Respondent has
stopped seeking employment pending
final resolution of her application for a
DEA COR, explaining that most ‘‘of the
positions I have sought require a DEA
certificate or else eligibility within a
year.’’ (Tr. 54–55.)
II. The Investigation of Respondent
At hearing, the Government presented
the testimony of two witnesses: DEA
Diversion Investigator Lucia Bartolomeo
(DI Bartolomeo) and DEA Diversion
Investigator Ayoma Rudy (DI Rudy). DI
Bartolomeo credibly testified in
substance that she has been a diversion
investigator with DEA for approximately
twenty-two years and has been assigned
during that time to the DEA San Diego
Field Division. (Tr. 21.) DI Bartolomeo’s
education and training includes basic
diversion investigator training along
with a Bachelor of Science degree. (Tr.
21.) DI Bartolomeo began an
investigation of Respondent in 2006
after receiving an investigative lead that
Respondent was in possession of a
prescription pad, not her own, and
possibly forging controlled substance
prescriptions to obtain oxycodone and
fentanyl for herself. (Tr. 22.)
The evidence further included two
California Controlled Substance
Utilization Review and Evaluation
System (CURES) patient activity reports
for Respondent, obtained by DI
Bartolomeo as part of her investigation
of Respondent. (Gov’t Ex. 3; Tr. 22.) The
first CURES report covers the time
period from September 2003 to October
2006 and the second from December
2006 to April 2007. (Gov’t Ex. 3.) The
first report reflects numerous
prescriptions for oxycodone and Actiq,
the brand name for fentanyl; in the
majority of instances the pharmacy
listed is Bonita Pharmacy. (Id.) DI
Bartolomeo further testified to obtaining
prescriptions from Bonita Pharmacy in
Respondent’s name, many of which had
been issued in the name of Dr. [JR]; DI
Bartolomeo noted discrepancies to
include sequential serial numbers and
inconsistent hand writing. (Tr. 24–26.)
DI Bartolomeo also testified to meeting
with Dr. [JR], who confirmed that
‘‘many of the prescriptions were not his
true signature.’’ (Tr. 26.)
DI Bartolomeo testified that she met
with Respondent on December 18, 2006,
and Respondent admitted to forging
prescriptions and identified nine
prescriptions that she forged. (Tr. 27;
see Gov’t Ex. 2 at 9, 14, 16, 18, 20, 22,
24, 26 & 28.) DI Bartolomeo explained
that Respondent admitted ‘‘[t]hat she
had forged those prescriptions in order
to obtain Actiq and some oxycodone,
and she explained that she wasn’t
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getting additional prescriptions from her
physician. So that’s why she had done
this activity.’’ (Tr. 29.)
Documentary evidence submitted by
the Government also included a July 31,
2009 Accusation filed by the California
BRN, alleging four causes of discipline
against Respondent for unprofessional
conduct, specifically: ‘‘Possession of
Controlled Substances Without a
Prescription’’; ‘‘Use of a Controlled
Substance’’; ‘‘Prescription Forgery’’; and
Violation of the Nursing Practice Act.’’
(Gov’t Ex. 13.) The Accusation states in
relevant part that
[o]n or about December 18, 2006, an RxNET
agent interviewed Respondent at the San
Diego Bureau of Narcotics Enforcement
office. Respondent initially denied forging
any prescriptions, but eventually admitted
that she had stolen Dr. [JR]’s prescription pad
from his La Jolla office. Respondent stated
that she forged prescriptions for Oxycontin
and Actiq to administer to herself for
migraine headaches. Respondent further
admitted that she would dissolve the Actiq
in a saline solution and inject herself with it.
(Id. at 6.)
On April 1, 2007, Respondent
voluntarily surrendered her DEA COR
‘‘while in treatment for substance
abuse.’’ (Gov’t Ex. 1 at 3.)
DI Rudy credibly testified in
substance that she has been assigned to
the DEA San Diego Field Division as a
diversion investigator since 2005, and
her education includes a Bachelor’s
degree in criminal justice. (Tr. 35.) DI
Rudy testified that she became involved
in the investigation of Respondent in
February 2009 when Respondent
applied for a DEA registration as a midlevel practitioner. (Tr. 36.) DI Rudy
further testified that at the time of
application, Respondent was exempt
from payment of an application fee
because Respondent’s proposed
registered location at that time was a
state university. (Tr. 37–38, 41; see
Gov’t Ex. 1.) Subsequent to
Respondent’s initial application,
Respondent wrote a letter, dated April
3, 2009, requesting that DEA change the
address of her intended registered
location to a facility that is a nonexempt entity for purposes of
registration fee. (Tr. 38; see Gov’t Ex.
14.) DI Rudy further testified that there
was no indication or implication that
Respondent intended to avoid paying
the application fee. (Tr. 41.)
The Government’s documentary
evidence included a handwritten
confession by Respondent dated
December 18, 2006, describing several
life stresses and admitting to taking ‘‘the
prescription pads because I was scared
that my migraines were out of control,
that I would need more medicine.
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the felony criminal complaint against
Respondent. (Gov’t Exs. 11 & 12.)
* * *’’ (Gov’t Ex. 4.) The Government
also submitted as evidence three
photographs (Gov’t Ex. 5), which
Respondent testified were taken on the
day she met with DI Bartolomeo and
another person (Tr. 60). Respondent
speculated that investigators
photographed her arm because ‘‘they
wanted to prove that I was a drug
addict.’’ (Tr. 61.) Respondent was
candid: ‘‘I’m not here to dispute the fact
that I got addicted to drugs. I mean, I
accept what happened, and I’m here to
tell you what happened after that. So I
don’t dispute that they took pictures of
me on that day.’’ (Tr. 61.) No other
testimony or evidence was offered with
regard to the photographs.
The record also contains a February 8,
2007 letter from the McDonald Center
for Alcoholism and Drug Addiction
Treatment, La Jolla, California
(McDonald Center), certifying that
Respondent successfully completed an
intensive, seven-week outpatient
alcohol and drug rehabilitation program
on February 8, 2007, noting that
Respondent ‘‘showed a high level of
commitment to her sobriety * * * was
a willing participant in all aspects of the
program [and] completed all of her
written assignments on time.’’ (Gov’t Ex.
6.) 4 A February 7, 2008 Chemical
Dependency Aftercare Letter of
Completion from the McDonald Center
confirms that Respondent successfully
completed fifty-two sessions required by
its Nursing Diversion Program. (Gov’t
Ex. 7.) 5 The letter also notes that
Respondent ‘‘met all requirements and
expectations of the aftercare program.
Her positive attitude and adherence to
the Aftercare requirements have shown
a concern and care for her continued
recovery.’’ (Gov’t Ex. 7.)
Finally, the record reveals that on
January 19, 2007, the San Diego District
Attorney’s Office filed a felony
complaint against Respondent for
violations of Cal. Health & Safety Code
§ 11173(a) (obtaining prescriptions by
fraud or deceit) and Cal. Penal Code
§ 459 (burglary). (Gov’t Ex. 8.) On April
17, 2007, Respondent pleaded guilty to
a felony count of obtaining a narcotic
drug (OxyContin) by means of a forged
prescription, in violation of California
Health & Safety Code § 11368. (Gov’t Ex.
9.) The court deferred entry of judgment
for eighteen months and ordered
Respondent to enroll in and complete a
California Penal Code § 1000 drug
treatment program. (Gov’t Ex. 10.) On
October 22, 2008, the court dismissed
Respondent testified at hearing and
also presented testimony from her
father, Mr. William Mayer. Respondent
credibly testified in substance that she
became a registered nurse in 1995 and
candidly admitted to the fact that she
became addicted to prescription
medications and was ‘‘guilty of
egregious behavior when I made
unprofessional choices that led to my
chemical dependence.’’ (Tr. 44.)
Respondent explained that in or about
1990 she began having migraine
headaches ‘‘and saw many health
practitioners for this problem, and tried
every therapy that was recommended.’’
(Tr. 45.) In 2000 her neurologist began
prescribing different narcotic
medications such as OxyContin,
Vicodin, Actiq and Dilaudid for
maintenance and rescue therapy. (Tr.
45.) Respondent stated the medications
helped initially but did not resolve the
migraine headaches, and she was
prescribed more of the same narcotic or
larger doses over time. (Tr. 45–46.)
Respondent also testified that she
experienced a series of very difficult life
events which increased her stress,6 and
the migraine headaches grew worse.
(See, e.g., Tr. 46.)
Respondent next testified that she
attempted to discuss her concern that
she was becoming addicted to narcotics
with her treating physician, but the
physician did not believe that
intervention was warranted. (Tr. 46.)
Responded admitted that she
‘‘eventually betrayed his trust’’ by
forging his name to acquire more
narcotics, but that not ‘‘long after, I
called a therapist I had recently been
seeing, and told him what I had done,
and asked for help.’’ (Tr. 46.)
Respondent testified that she started
an outpatient drug treatment program
on December 21, 2006, and completed
the program on February 8, 2007. (Tr.
46.) Thereafter, Respondent completed a
year-long aftercare program running
between February 8, 2007 and February
2008. (Tr. 46.) From April 2007 to
February 2009, Respondent participated
in the BRN Nursing Diversion Program,
but was dismissed on the grounds that
she ‘‘admitted a patient to the hospital
ward, and the computer admission
orders included orders for
[o]xycodone.’’ (Tr. 46–47.) Respondent
was told that this was equivalent to
4 Government Exhibit 6 duplicates Respondent
Exhibit 7 at 3.
5 Government Exhibit 7 duplicates Respondent
Exhibit 7 at 4.
6 As the BRN succinctly summarized, Respondent
‘‘was going through a tumultuous divorce, a death
in the family, caring for her child, and she was the
victim of criminal voyeurism.’’ (Resp’t Ex. 1 at 3.)
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III. Respondent’s Evidence
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60925
dispensing oxycodone. (Tr. 47.) In
mitigation, Respondent testified that ‘‘I
have not dispensed medications in over
ten years, and the orders were part of a
standardized set for all cancer patients.’’
(Tr. 47.)
With regard to the circumstances of
Respondent’s dismissal from the BRN
Nursing Diversion Program, the
evidence also included the following
factual information:
Respondent successfully participated in
the Nursing Diversion Program for 22 months
when she was asked to leave the program
because of a technical violation of the
Diversion Program’s rules. While in the
Diversion Program, respondent was working
as a Nurse Practitioner in the bone marrow
transplant unit at the University of
California, San Diego (UCSD) Medical Center.
When patients were admitted to the unit,
respondent, using a preprogrammed
computer check sheet, admitted the patients
by checking the appropriate admission box
that appeared on the computer screen. By
checking the box, the computer program
automatically issued a standard set of
admission orders. In some instances, the set
orders included an order for the patient to
receive Oxycodone. Consequently, when the
fact respondent had been ‘‘prescribing’’
Oxycodone came to the attention of the
Diversion Program, respondent was asked to
leave even though she had been in full
compliance with the strict Diversion Program
requirements, including: Calling every
morning between 6 and 7 a.m.; taking
random drug tests several times per month
with no ‘‘dirty’’ tests; turning in monthly
paperwork on time; attending AA and NA
meetings five to seven days per week;
attending weekly nurse-to-nurse meetings;
completing 16 CEU’s on substance abuse;
calling monthly to check in with her case
manager; and always getting permission
before leaving San Diego.
(Resp’t Ex. 1 at 4.)
Respondent’s father, Mr. Mayer,
credibly testified in part and in
substance that he is a retired Certified
Public Accountant, and lives
approximately three miles from
Respondent, seeing her at least weekly.
(Tr. 81.) Mr. Mayer testified to what he
described as a ‘‘double whammy’’
inflicted on Respondent by her treating
physician and two drug companies,
explaining that Respondent’s treating
physician ‘‘prescribed OxyContin and
Actiq for [Respondent’s] migraine
headaches, although her stresses were
far beyond migraine headaches at that
time.’’ (Tr. 70.) Mr. Mayer further
explained that prescribing ‘‘OxyContin,
which was marketed as less addictive
and less subject to abuse, when it was
not, and Actiq, which the FDA had only
approved for cancer patients’’ in
combination to treat Respondent’s
migraine headaches, significantly
contributed to Respondent becoming
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addicted. (Tr. 76–77.) Mr. Mayer also
testified that Respondent has put the
issues that contributed to her addiction
behind her and has been drug free since
her sobriety date of November 29,
2006.7 (Tr. 80.) In terms of Respondent’s
current state of mind regarding use of
medications, Mr. Mayer testified to a
February 2010 emergency room visit by
Respondent for an acute illness causing
pain during which Respondent refused
to accept pain medication such as
morphine or Dilaudid for fear of
becoming addicted again. (Tr. 79.)
Respondent’s documentary evidence
included, inter alia, an April 7, 2010
Proposed Decision (Proposed Decision)
of an ALJ of the California BRN. The
Proposed Decision ordered
Respondent’s Registered Nurse License,
Nurse Practitioner Certificate, Nurse
Practitioner Furnisher Certificate and
Health Nurse Certificate revoked, but
stayed the revocation and placed
Respondent on probation for two (2)
years with specified terms and
conditions. (Resp’t Ex. 1 at 6–7.) The
Proposed Decision followed a March 29,
2010 administrative hearing regarding
the July 31, 2009 Accusation filed by the
BRN, alleging four causes of discipline
against Respondent. (See Gov’t Ex. 13.)
In that proceeding, the BRN had
requested that Respondent be placed on
probation for three years with terms and
conditions; the ALJ, however,
concluded that two years probation was
adequate ‘‘in view of the substantial
evidence of rehabilitation and sobriety
presented by’’ Respondent. (Resp’t Exs.
1 at 6.)
Respondent also submitted a
September 6, 2008 Certificate of
Attendance reflecting successful
completion of eight hours of continuing
education in Pharmacology In
Addiction and eight hours in Relapse
Prevention. (Resp’t Ex. 3.) Respondent
also submitted letters dated September
and August 2009 from two friends and
colleagues, Linda Long, R.N., M.S.N.,
F.N.P., and Linnea Trageser, N.P., both
attesting to Respondent’s
professionalism and qualifications to
practice. (Respt’ Ex. 4 at 1–4.) A
September 2009 letter from
Respondent’s parents thoughtfully
describes Respondent’s addiction to
prescription medications, including the
causes, as well as her successful efforts
at rehabilitation and continued
abstinence. (Resp’t Ex. 4 at 5.) A March
7 Although I find Mr. Mayer’s testimony credible,
I do note a disparity between the November 29,
2006 sobriety date he and others identified (see Tr.
80; see also Resp’t Ex. 8 at 1), and DI Bartolomeo’s
testimony suggesting that Respondent forged a
prescription as late as December 6, 2006 (Tr. 27; see
Gov’t Ex. 2 at 28).
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11, 2010 letter of personal reference
from Alison McManus, Family Nurse
Practitioner, a friend of Respondent and
her co-worker from April to November
2009, describes Respondent as ‘‘always
professional’’ and ‘‘punctual and
reliable, organized, efficient, and
competent.’’ (Resp’t Ex. 5 at 1.) Three
other letters dating from February 2008
to February 2009, written by a former
student, supervisor and co-worker,
respectively, refer to Respondent as a
dedicated professional and
‘‘inspirational role model.’’ (Id. at 2–4.)
A September 1, 2009 letter from a friend
and ‘‘sponcee’’ at Alcoholics
Anonymous (AA) credibly describes
Respondent’s acceptance of
responsibility for her actions as well as
Respondent’s demonstrated willingness
to change her behavior. (Resp’t Ex 8 at
2.)
The record reflects that on September
10, 2007, Respondent was recertified as
an Acute Care Nurse Practitioner,
effective September 1, 2007, to August
31, 2012. (Resp’t Ex. 6.)
Letters dated March 25, 2008, and
September 9, 2009, from Steven F.
Bucky, PhD, Clinical Psychologist,
report in relevant part that Respondent
has been seen in psychotherapy for
approximately two years and ‘‘is
progressing well with no evidence of
drug, alcohol, or prescription drug use.’’
(Resp’t Ex. 7 at 1–2.)
A July 5, 2007 letter by Dr. Marina
Katz, M.D., documents a June 18, 2007
psychiatric evaluation of Respondent.
The report assesses Respondent’s opiate
dependence and finds that it is in
remission, noting that Respondent is
active in Narcotics Anonymous (NA),
and cautiously gives Respondent a
favorable prognosis. (Resp’t Ex. 7 at 5–
6.)
A September 4, 2008 letter from
Kristine M. Vickery, R.N., Facilitator of
the San Diego Nurse to Nurse peer
support group, notes Respondent’s
weekly attendance at the support group
since April 2007, describing Respondent
as a ‘‘determined, motivated individual
who is genuinely committed to recovery
from chemical dependency.’’ (Resp’t Ex.
8 at 1.) The letter further notes
Respondent’s ‘‘sobriety date is
November 29, 2006 and she maintained
negative drug/ETG tests since her
entrance into the [Nursing] Diversion
Program. Additionally, a hair follicle
test was performed in June 2007, and it
was negative, as well.’’ (Id.)
I. The Applicable Statutory Provisions
The Controlled Substances Act (CSA)
provides that any person who dispenses
Frm 00128
A. The Public Interest Standard
Pursuant to 21 U.S.C. 823(f), the
Deputy Administrator may deny an
application for a DEA COR if she
determines that such registration would
be inconsistent with the public interest.
In determining the public interest, the
Deputy Administrator is required to
consider the following factors:
(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.
As a threshold matter, the factors
specified in Section 823(f) are to be
considered in the disjunctive: The
Deputy Administrator may properly rely
on any one or a combination of those
factors, and give each factor the weight
she deems appropriate, in determining
whether a registration should be
revoked or an application for
registration denied.13
8 21
U.S.C. 822(a)(2).
U.S.C. 843(a)(3).
10 21 U.S.C. 822(e).
11 See 21 CFR 1301.51 (2010)
12 21 U.S.C. 844(a).
13 See Henry J. Schwarz, Jr., M.D., 54 FR 16,424
(DEA 1989).
9 21
Discussion
PO 00000
(including prescribing) a controlled
substance must obtain a registration
issued by the DEA in accordance with
applicable rules and regulations.8 ‘‘It
shall be unlawful for any person
knowingly or intentionally to acquire or
obtain possession of a controlled
substance by misrepresentation, fraud,
forgery, deception, or subterfuge.’’ 9 ‘‘A
separate registration shall be required at
each principal place of business or
professional practice where the
applicant * * * dispenses controlled
substances.’’ 10 DEA regulations provide
that any registrant may apply to modify
her registration to change her address
but such modification shall be handled
in the same manner as an application
for registration.11
It is unlawful for any person to
possess a controlled substance unless
that substance was obtained pursuant to
a valid prescription from a practitioner
acting in the course of professional
practice.12
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B. Other Factors
In addition to the public interest
factors discussed above, 21 U.S.C.
824(a) provides four other factors that
the Deputy Administrator may consider
in a proceeding to suspend or revoke a
DEA COR.14 Despite the lack of an
explicit provision applying these factors
to a denial of an application [t]he
agency has consistently held that the
Administrator may also apply these
bases to the denial of a registration,
since the law would not require an
agency to indulge in the useless act of
granting a license on one day only to
withdraw it on the next.15 In addition,
I conclude that the reference in
§ 823(f)(5) to ‘‘other conduct which may
threaten the public health and safety’’
would as a matter of statutory
interpretation logically encompass the
factors listed in § 824(a).16
II. The Factors To Be Considered
Factor 1: The Recommendation of the
Appropriate State Licensing Board
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As described in the Evidence and
Incorporated Findings of Fact Section of
this Recommended Decision,
Respondent holds active state
authority 17 in California as a mid-level
practitioner, which has been the subject
of prior disciplinary action. (See, e.g.,
Gov’t Ex. 13.) The gravamen of the
misconduct which formed the basis of
the California BRN Accusation filed on
July 31, 2009, related solely to
Respondent’s actions between June 2006
and December 2006, which were
attributable to an addiction to
prescription pain medications. (See
Gov’t Ex. 13 at 6–7.)
The evidence at hearing reflects that
the BRN complaint against Respondent
was the subject of a March 29, 2010
California administrative hearing,
14 That subsection provides that a DEA COR may
be revoked upon a finding that the registrant: (1)
Has materially falsified an application; (2) has been
convicted of a felony under the CSA or any other
federal or state law relating to any controlled
substance; (3) has had a state license or registration
suspended, revoked or denied and is no longer
authorized by state law to handle controlled
substances; (4) has committed such acts as would
render his registration under 21 U.S.C. 823
inconsistent with the public interest; or (5) has been
excluded from participation in incorporating the
public interest factors from § 823(f). See 21 U.S.C.
824(a)(4).
15 Kuen H. Chen, M.D., 58 FR 65,401, 65, 402
(DEA 1993) (citing Serling Drug co. & Detroit
Prescription Wholesaler, Inc., 40 FR 11,918, 11,919
(DEA 1975)); accord Scott J. Loman, D.D.S., 50 FR
18,941 (DEA 1985); Roger Lee Palmer, D.M.D., 49
FR 950 (DEA 1984).
16 See Chen, 58 FR at 65,402.
17 Registered Nurse Licdense No. 513926; Nurse
Practitioner Certificate No. 12026; Nurse
Practitioner Furnisher Certificate No. 12026; Public
Health Nurse Certificate No. 55127.
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during which the BRN recommended
that Respondent be placed on a threeyear period of probation, with specified
terms and conditions. (See Resp’t Ex. 1
at 6.) The April 7, 2010 Proposed
Decision of the state ALJ concluded that
cause for discipline exists under
applicable California law, finding that
Respondent committed acts of
unprofessional conduct by possession
and use of Schedule II controlled
substances without valid prescriptions;
and that Respondent forged
prescriptions for controlled substances
using a prescription pad stolen from a
physician. (Resp’t Ex. 1 at 5–6.)
In mitigation, the Proposed Decision
ordered revocation of Respondent’s state
nursing licenses, but stayed the
revocation and placed Respondent on
probation for two years, with specified
terms and conditions. (Resp’t Ex. 1 at 6–
7.) Of note, the state ALJ found
substantial evidence of Respondent’s
rehabilitation and sobriety, concluding
that two rather than three years of
probation would be ‘‘adequate for the
board to monitor respondent to ensure
public protection.’’ (Resp’t Ex. 1 at 6.)
On December 28, 2010, the BRN issued
a Decision After Non-Adoption, which
was consistent with the Proposed
Decision, except it further reduced the
period of probation to one year and
reduced Respondent’s costs to zero.
(Gov’t Br. at Gov’t Ex. 17.) 18
The most recent action by the
California BRN reflects a determination
that notwithstanding findings of
unprofessional conduct, Respondent
can be entrusted with an active license
subject to probationary terms and
conditions. While not dispositive,19 I
find the careful deliberations and action
by the state licensing authorities weigh
in favor of a finding that Respondent’s
registration would be consistent with
the public interest under 21 U.S.C.
823(f).
Factor 3: Respondent’s Conviction
Record
As noted above, one of the factors in
determining whether Respondent’s
registration would be inconsistent with
the public interest is ‘‘[t]he applicant’s
conviction record under Federal or state
laws relating to the manufacture,
distribution, or dispensing of controlled
substances.’’ 21 U.S.C. 823(f)(3).20 The
supra note 3.
B. Levin, D.O., 55 FR 8209, 8210
(DEA 1990) (finding DEA maintains separate
oversight responsibility and statutory obligation to
make independent determination whether to grant
registration).
20 I note that 21 U.S.C. 824(a)(2) (factor
considering whether registrant ‘‘has been convicted
of a felony under the Controlled Substances Act or
60927
OSC alleges that Respondent pled
‘‘guilty to a felony count of obtaining a
narcotic drug (OxyContin) by means of
a forged prescription, in violation of
California Health & Safety Code
§ 11368.’’ (ALJ Ex. 1 at 2.) Pursuant to
applicable state law,21 the entry of
judgment was deferred and upon
successful completion of a treatment
program, the charges were dismissed.
(Gov’t Ex. 11.) The California statute
provides in pertinent part that a
‘‘defendant’s plea of guilty pursuant to
this chapter shall not constitute a
conviction for any purpose,’’ unless
judgment of guilt is entered.22 But even
the clearest statement of state law is not
controlling on the question of what
constitutes a ‘‘conviction’’ pursuant to
the federal CSA. The question therefore
remains whether Respondent’s plea of
guilty, which was ultimately dismissed,
constitutes a ‘‘conviction’’ on the facts
of this case.
Federal case law has established that
‘‘[a] conviction alone is sufficient to
allow the Attorney General (through the
DEA Administrator) to revoke or
suspend a DEA registration.’’ Pearce v.
DEA, 867 F.2d 253, 255 (6th Cir. 1988)
(citing Fitzhugh v. DEA, 813 F.2d 1248,
1253 (DC Cir. 1987)). Agency precedent
takes an expansive view of what
constitutes a ‘‘conviction.’’ ‘‘The law is
well settled that a DEA registrant may
be found to have been ‘convicted’
within the meaning of the Controlled
Substances Act, despite a deferred
adjudication of guilt.’’ Harlan J.
Borcherding, D.O., 60 FR 28796–01,
28798 (DEA 1995) (citing Mukand Lal
Arora, M.D., 60 FR 4447, 4448 (DEA
1995) (fine, two years of probation and
deferred adjudication deemed
sufficient), Clinton D. Nutt, D.O., 55 FR
30,992, 30,992 (DEA 1990) (nolo
contendere plea and deferred
adjudication of guilt deemed sufficient)
and Eric A. Baum, M.D., 53 FR 47,272,
47,272 (DEA 1988) (‘‘best interest’’ plea,
probation, drug counseling and
withholding of adjudication deemed
sufficient)).
The policy underlying this precedent
is founded in the doctrine of claim
preclusion. ‘‘When the judge decided to
withhold adjudication and sentence and
instead placed the defendant on
probation * * * it is clear that the
defendant could no longer be tried on
the information.’’ United States v. Cook,
18 See
19 Mortimer
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any other federal or state law relating to any
controlled substance’’) was not cited in either the
OSC or otherwise noticed prior to hearing, and
therefore is not applicable to this Recommended
Decision. See CBS Wholesale Distribs., 74 FR
36,746, 36,749 (DEA 2009).
21 Cal. Penal Code 1000.1.
22 Id. § 1000.1(d).
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10 M.J. 138, 139 (U.S. Ct. Mil. App.
1981) (cited, but not quoted, in Eric A.
Baum, M.D., 53 FR 47,272 (DEA 1988)).
Accordingly, a registrant whose
criminal adjudication has been deferred
is nevertheless considered to have been
‘‘convicted’’ under DEA precedent.
In this case, the fact that a finding of
guilt was specifically not entered as to
Respondent and the charges dismissed,
leaves open the question as to whether
the foregoing Agency precedent is
controlling on the issue of whether
Respondent’s plea constitutes a
conviction under 21 U.S.C. 823(f).23 It is
unnecessary to reach that issue,
however, because the underlying
offense to which Respondent pled guilty
does not ‘‘relate[ ] to the manufacture,
distribution, or dispensing of controlled
substances,’’ the standard embraced in
§ 823(f). See Super-Rite Drugs, 56 FR
46,014, 46,015 (DEA 1991) (‘‘Although
[applicant] entered a guilty plea to a
drug-related felony, his actions did not
relate to the manufacture, distribution,
or dispensing of controlled
substances.’’).
Accordingly, I find that Respondent
has not been convicted of any laws
relating to the manufacture, distribution
or dispensing of controlled substances.
I therefore find that Factor Three under
Section 823(f), while not dispositive,
does weigh in favor of a finding that
Respondent’s registration would be
consistent with the public interest.
Factors 2, 4 and 5: Respondent’s
Experience in Dispensing Controlled
Substances; Compliance With
Applicable State, Federal or Local Laws
Relating to Controlled Substances; and
Such Other Conduct Which May
Threaten the Public Health and Safety
The central issue in this case centers
on Respondent’s addiction to
prescription pain medications, which
began in or about 2006 while under
medical care for chronic migraine
headaches. (See Tr. 45–46.)
Respondent’s use of prescription pain
medications eventually culminated in a
course of conduct between June 2006 to
December 2006, where she forged
approximately nine prescriptions for
Schedule II controlled substances for
herself using a stolen prescription pad
(see, e.g., Tr. 24–26, 46), and wrongfully
used and possessed Schedule II
controlled substances (e.g., Gov’t Ex. 13
23 Agency precedent as embodied in Baum and
other cases, carried to its logical conclusion, could
arguably deem a plea that was later withdrawn, and
a defendant found not guilty after trial, to be a
conviction, on the claim preclusion grounds
discussed in United States v. Cook, 10 M.J. 138, 139
(U.S. Ct. Mil. App. 1981), a case cited favorably in
Baum. Cf. Baum, 53 FR at 47,274.
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at 6). Other than the time period from
June to December 2006, with a single
exception noted below, there is no
evidence that Respondent has failed to
comply with all applicable laws and
regulations relating to controlled
substances during her professional
career.
As to the single instance of
Respondent’s noncompliance with
controlled substance laws following her
sobriety date, there is evidence of record
that Respondent was dismissed in
February 2009 from a Nursing Diversion
Program, during her employment as a
nurse practitioner in a bone marrow
transplant unit, on the grounds that a
computer-generated admission order for
a patient automatically included an
order for oxycodone. (E.g., Resp’t Ex. 1
at 4.) Respondent was informed that she
was being dismissed because this
admission order, which included an
order for oxycodone, was considered the
equivalent to dispensing oxycodone.
(Tr. 47.) Respondent credibly testified
that she had ‘‘not dispensed
medications in over ten years, and the
orders were part of a standardized set
for all cancer patients.’’ (Tr. 47.)
Additionally, the evidence reflects that
as of February 2009, Respondent had
successfully participated in the Nursing
Diversion Program for approximately
twenty-two months and had been in full
compliance with other strict
requirements to include random drug
tests, all of which were negative. (Resp’t
Ex. 1 at 4.)
As an initial matter, the issue of
Respondent’s dismissal from the
Nursing Diversion Program due to
improper dispensing of oxycodone was
not specifically noticed by the
Government in the OSC or prehearing
statement, nor was it referenced in any
Government exhibits prior to hearing.
The issue was introduced by
Respondent at hearing during her direct
testimony as well as in documentary
evidence. (Tr. 47; Resp’t Ex. 1 at 4.)
To comport with due process
requirements, the DEA must ‘‘provide a
Respondent with notice of those acts
which the Agency intends to rely on in
seeking the revocation of [her]
registration so as to provide a full and
fair opportunity to challenge the factual
and legal basis for the Agency’s action.’’
CBS Wholesale Distribs., 74 FR 36,746,
36,749 (DEA 2009) (citing NLRB v.
I.W.G., Inc., 144 F.3d 685, 688–89 (10th
Cir. 1998) and Pergament United Sales,
Inc., v. NLRB, 920 F.2d 130, 134 (2d Cir.
1990)). An issue cannot be the basis for
a sanction when the Government has
failed to ‘‘disclose ‘in its prehearing
statements or indicate at any time prior
to the hearing’ that an issue will be
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Sfmt 4703
litigated.’’ Id. at 36,750 (citing Darrell
Risner, D.M.D., 61 FR 728, 730 (DEA
1996)). The DEA has also previously
found, however, that a respondent may
waive objection to the admission of
evidence not noticed by the Government
prior to the hearing when the
respondent does not timely object and
when the respondent also raises the
issue. Gregory D. Owens, D.D.S., 74 FR
36,751, 36,755 (DEA 2009).
In accordance with agency precedent,
I find in this case that the issue of
Respondent’s February 2009 dispensing
of oxycodone may properly be
considered in evaluating Respondent’s
application, as well as on the issue of
sanction. I also find that Respondent’s
conduct culminating in the single
instance of dispensing oxycodone in
February 2009 was inadvertent. The
record reveals that
[w]hen patients were admitted to the unit,
respondent, using a preprogrammed
computer check sheet, admitted the patients
by checking the appropriate admission box
that appeared on the computer screen. By
checking the box, the computer program
automatically issued a standard set of
admission orders. In some instances, the set
orders included an order for the patient to
receive [o]xycodone.
(Resp’t Ex. 1 at 4.) The circumstances
of this single incident and Respondent’s
early termination from the Nursing
Diversion Program after approximately
twenty-two fully successful months
does not weigh against Respondent’s
application for DEA registration. I also
note that as with all other aspects of
Respondent’s testimony, Respondent
was fully credible and candid in her
explanation of this incident.
The Government maintains that
Factors Four and Five are relevant to the
public interest inquiry, relying in part
on the undisputed evidence of
Respondent’s history of self-abuse of
controlled substances, and citing Gary
E. Stanford, M.D., 58 FR 14,430 (DEA
1993) and William L. Pigg, M.D., 55 FR
3120 (DEA 1990), cases finding a
registrant’s abuse of controlled
substances and alcohol relevant to the
public interest inquiry.
In Stanford, the evidence of abuse
included ‘‘a history of abuse of alcohol,
recreational use of cocaine, and other
controlled substances for other than a
legitimate medical purpose over several
years’’ and concerned a registrant in the
‘‘early months of recovery.’’ Stanford,
58 FR at 14,432. Of note, the ALJ’s
recommended decision in Stanford,
which the Agency adopted in its
entirety, ‘‘recommended that if after the
passage of one year from the final
disposition of the case, [r]espondent
files a new application for registration,
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and if his rehabilitation efforts have
continued successfully, investigation of
that application should be expedited,
and favorable consideration should be
given to the application.’’ Id. In Pigg, a
case in which the respondent waived
hearing and the Agency issued a final
decision on grounds of lack of state
authority, as well as drug abuse, the
facts relating to substance abuse
included abuse of cocaine and alcohol
over at least a two-year period, along
with a subsequent abuse of alcohol and
controlled substances following entry to
an Impaired Physicians Program. Pigg,
55 FR at 3120.
Other cases reflect long-held
‘‘precedent that a practitioner’s selfabuse of controlled substances
constitutes ‘conduct which may
threaten public health and safety.’’’
Steven B. Brown, M.D., 75 FR 65,660,
65,662 (DEA2010) (citing Tony T. Bui,
M.D., 75 FR 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 FR 5326 (DEA 1988). In
Brown, the evidence of self-abuse
spanned approximately a two year
period during which the registrant
prescribed 160–180 tablets of
oxycodone 30 mg monthly to a patient
in exchange for return of half of the
controlled substances. Brown, 75 FR at
65,661. Additional evidence included a
finding that the registrant was a drug
abuser and a threat to public health and
safety, when he offered the patient ‘‘a
hit of liquid oxycodone.’’ Id. at 65,662.
In the instant case, the evidence is
undisputed that Respondent’s conduct
between approximately June and
December 2006 violated federal and
state law and reflected a serious drug
addiction by Respondent during that
time period of approximately six
months.24 The evidence includes
approximately nine instances of
Respondent forging prescriptions using
a stolen prescription pad, resulting in
the acquisition of approximately 115
tablets of fentanyl and 120 tablets of
oxycontin. (Gov’t Exs. 2 & 3.) The
evidence further reflects that
Respondent’s addiction had progressed
to the point where she would dissolve
‘‘the Actiq [fentanyl] in a saline solution
and inject herself with it.’’ (Gov’t Ex. 13
at 6.)
Additionally, the evidence regarding
Respondent’s acknowledgement of her
addiction includes a December 18, 2006
interview at the San Diego Bureau of
Narcotics Enforcement office, where
24 Compare Tr. 46, with Tr. 27, and Gov’t Ex. 2
at 9, 14, 16, 18, 20, 22, 24, 26, & 28 (forged
prescriptions ranging between August 9, 2006, and
December 6, 2006).
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Respondent initially denied forging any
prescriptions, but eventually admitted
that she had stolen the prescription pad
and forged prescriptions for OxyContin
and Actiq.25 (Gov’t Ex. 4; Gov’t Ex. 13
at 6.) There is other evidence suggesting
Respondent was already attempting to
seek help on her own, including
Respondent’s testimony that not long
after forging prescriptions ‘‘I called a
therapist I had recently been seeing, and
told him what I had done, and asked for
help.’’ (Tr. 46.)
To summarize, Respondent’s admitted
misconduct and substance abuse
between June and December 2006, if
viewed standing alone, does weigh
against a finding that Respondent’s
unconditional registration would be
consistent with the public interest
under Factors Four and Five.
Conclusion and Recommendation
After balancing the foregoing public
interest factors, I find the Government
has established by substantial evidence
a prima facie case in support of denial
of Respondent’s application for
registration, based on Respondent’s
unlawful possession, use and fraudulent
acquisition of controlled substances
between June and December 2006. Once
DEA has made its prima facie case for
revocation, the burden then shifts to the
respondent to show that, given the
totality of the facts and circumstances in
the record, denial of the application
would not be appropriate. See Morall v.
DEA, 412 F.3d 165, 174 (DC Cir. 2005);
Humphreys v. DEA, 96 F.3d 658, 661
(3d Cir. 1996); Shatz v. United States
Dep’t of Justice, 873 F.2d 1089, 1091
(8th Cir. 1989); Thomas E. Johnston, 45
FR 72, 311 (DEA 1980).
Additionally, where a registrant has
committed acts inconsistent with the
public interest, the registrant must
accept responsibility for his or her
actions and demonstrate that he or she
will not engage in future misconduct.
Patrick W. Stodola, M.D., 74 FR 20,727
(DEA 2009). Also, ‘‘[c]onsideration of
the deterrent effect of a potential
sanction is supported by the CSA’s
purpose of protecting the public
interest.’’ Joseph Gaudio, M.D., 74 FR
10,083, 10,094 (DEA 2009).
25 This evidence is somewhat consistent with
testimony of DI Bartolomeo with regard to
Respondent’s confession on December 18, 2006,
although DI Bartolomeo did not reference
Respondent’s initial denial. (See, e.g., Tr. 29.) For
instance, the record was unclear whether
Respondent made two separate admissions on
December 18, 2006. Notwithstanding the ambiguity
and intial denial, I find that Respondent’s
admission of misconduct and cooperation with law
enforcement authorities was timely and is to her
credit.
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60929
In the instant case, Respondent’s
testimony at hearing with regard to her
past misconduct, and demonstrated
efforts to avoid a repeat of those
mistakes, was fully credible.
Respondent’s testimony was consistent
and candid throughout her direct and
cross examination. With regard to the
facts surrounding her misconduct,
Respondent credibly assumed full
responsibility for her actions, stating at
the outset of her testimony that ‘‘I was
guilty of egregious behavior when I
made unprofessional choices that led to
my chemical dependence.’’ (Tr. 44.) The
Government argues that Respondent
‘‘appeared to accept responsibility,’’ but
that ‘‘her father attempted to shift the
blame for Respondent’s addiction to her
physician and two drug manufacturers.’’
(Gov’t Br. at 5.) The relevant inquiry,
however, is Respondent’s own
acceptance of responsibility, not that of
a third party.26
The evidence and testimony
demonstrating Respondent’s efforts to
ensure that she will not engage in future
misconduct relating to drug addiction is
substantial and compelling. The
Government ‘‘contends that Respondent
needs additional time to demonstrate
she can remain free from drug abuse and
to solidify her recovery.’’ 27 The facts
reflect that Respondent has been free
from drug abuse for over four years
(compare Gov’t Exs. 6 & 7, with Tr. 44–
46, Tr. 80, and Resp’t Ex. 1 at 4) and the
time period of her abuse covered a
relatively short time of approximately
six months.28 The passage of time and
significant efforts at rehabilitation are
relevant and weighty considerations.
See Sokoloff v. Saxbe, 501 F.2d 571 (2d
Cir. 1974) (passage of time requires
careful consideration of new
application); see also Azen v. DEA, 1996
WL 56114 at *2 (9th Cir. Feb. 9, 1996)
(impressive evidence of rehabilitation
and continued abstinence important
consideration). The evidence also
reflects that Respondent admitted her
addiction to a therapist in late 2006 (Tr.
46) and timely cooperated with
authorities in December 2006 when
26 Even assuming the testimony of a third party
might be relevant in some circumstances to whether
a respondent has accepted responsibility, such as,
for example, to impeach a respondent’s credibility,
I find Respondent’s father’s testimony in this case
to be fully consistent with Respondent’s acceptance
of responsibility. In explaining the circumstances
and context of Respondent’s addiction,
Respondent’s father concluded by stating ‘‘I believe
* * * that forging prescriptions is a serious offense,
especially by someone who has been granted a DEA
certificate. But the circumstances which caused
* * * this are far behind her,’’ credibly
enumerating the specific positive changes in his
daughter’s life. (Tr. 77.)
27 Gov’t Br. at 6.
28 Supra note 24.
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confronted with allegations of
misconduct (Gov’t Ex. 13 at 6), behavior
which weighs in Respondent’s favor.
See Karen A. Kruger, M.D., 69 FR 7016,
7017–18 (DEA 2004) (timely
cooperation with investigators when
questioned on past misconduct held a
significant consideration in granting
subsequent application for registration).
Respondent’s abstinence from drug
abuse since 2006, and her efforts at
rehabilitation have been consistent,
substantial, and successful. The
uncontroverted evidence of
rehabilitation shows that Respondent:
successfully completed a seven-week
outpatient alcohol and drug treatment
program (Gov’t Ex. 6); successfully
completed a one-year dependency
aftercare program (Gov’t Ex. 7);
successfully participated in a Nursing
Diversion Program for twenty-two
months (Resp’t Ex. 1 at 4); regularly
attended AA and NA meetings (Resp’t
Ex. 7 at 5–6; Resp’t Ex. 8 at 2); regularly
attended nurse-to-nurse meetings
(Resp’t Ex. 1 at 4); and has had
sustained sobriety since December 2006,
as evidenced by repeated negative
random drug tests (see Resp’t Ex. 1 at 4),
inter alia. Credible and unrebutted
testimony even reveals that Respondent
went as far as avoiding medically
indicated pain medication in 2010, just
to avoid any potential for relapse. (Tr.
79.) In addition to the foregoing, the
record is replete with credible evidence
from family, friends, colleagues,
students, treating sources and mentors,
all consistently attesting to
Respondent’s sustained recovery and
abstinence from prescription drug
abuse. In light of the significant
evidence of rehabilitation and ongoing
monitoring by the California BRN, I find
Respondent has sustained her burden in
accepting responsibility and
demonstrated that she has taken the
necessary steps to avoid a repeat of her
mistakes. Granting Respondent’s
application for a COR, subject to
conditions, is fully consistent with the
public interest.
Accordingly, I recommend that
Respondent’s application for DEA COR
be granted, subject to the following
conditions: (1) Respondent shall comply
with all of the terms and conditions
specified in the December 28, 2010
Order of the California BRN (see Gov’t
Br. at Gov’t Ex. 17); and (2) for one (1)
year following the issuance of a final
order in this proceeding, Respondent
shall upon request, submit to the nearest
Field Division Office of DEA, copies of
the results of any random or directed
drug screening tests involving
Respondent.
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Dated: February 4, 2011.
Timothy D. Wing,
Administrative Law Judege.
[FR Doc. 2011–25238 Filed 9–29–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF LABOR
Bureau of Labor Statistics
Proposed Collection, Comment
Request
ACTION:
Notice.
The Department of Labor, as
part of its continuing effort to reduce
paperwork and respondent burden,
conducts a pre-clearance consultation
program to provide the general public
and Federal agencies with an
opportunity to comment on proposed
and/or continuing collections of
information in accordance with the
Paperwork Reduction Act of 1995
(PRA95) [44 U.S.C. 3506(c)(2)(A)]. This
program helps to ensure that requested
data can be provided in the desired
format, reporting burden (time and
financial resources) is minimized,
collection instruments are clearly
understood, and the impact of collection
requirements on respondents can be
properly assessed. The Bureau of Labor
Statistics (BLS) is soliciting comments
concerning the proposed extension of
the ‘‘Mass Layoff Statistics Program.’’ A
copy of the proposed information
collection request (ICR) can be obtained
by contacting the individual listed
below in the ADDRESSES section of this
notice.
DATES: Written comments must be
submitted to the office listed in the
ADDRESSES section of this notice on or
before November 29, 2011.
ADDRESSES: Send comments to Carol
Rowan, BLS Clearance Officer, Division
of Management Systems, Bureau of
Labor Statistics, Room 4080, 2
Massachusetts Avenue, NE.,
Washington, DC 20212. Written
comments also may be transmitted by
fax to 202–691–5111 (this is not a toll
free number).
FOR FURTHER INFORMATION CONTACT:
Carol Rowan, BLS Clearance Officer, at
202–691–7628 (this is not a toll free
number). (See ADDRESSES section.)
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 309(2)(15)(a)(1)(A)(iii) of the
Workforce Investment Act (WIA) states
that the Secretary of Labor shall oversee
development, maintenance, and
continuous improvements of the
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program to measure the incidence of,
industrial and geographical location of,
and number of workers displaced by,
permanent layoffs and plant closings.
Prior to the WIA, Section 462(e) of
Public Law 97–300, the Job Training
Partnership Act (JTPA), provided that
the Secretary of Labor develop and
maintain statistical data relating to
permanent mass layoffs and plant
closings and issue an annual report. The
report includes, at a minimum, the
number of plant closings and mass
layoffs, and the number of workers
affected. The data are summarized by
geographic area and industry.
The Mass Layoff Statistics (MLS)
program uses a standardized, automated
approach to identify, describe, and track
the impact of major job cutbacks. The
program utilizes, to the greatest degree
possible, existing Unemployment
Insurance (UI) records and
computerized data files, supplemented
by direct employer contact. Its major
features include:
• The identification of major layoffs
and closings through initial UI claims
filed against the identified employer;
• The use of existing files on
claimants to obtain basic demographic
and economic characteristics on the
individual;
• The telephone contact of those
employers meeting mass layoff criteria
to obtain specific information on the
nature of the layoff and characteristics
of the establishment;
• The identification of the continuing
impact of the mass layoff on individuals
by matching affected initial claimants
with persons in claims status;
• The measurement of the incidence
of the exhaustion of regular state UI
benefits by affected workers;
• The identification and quantifying
the effects that extended mass layoffs
have on the movement of work; and,
• The identification of business
functions within establishments which
are affected by mass layoffs.
In the program, State Workforce
Agencies (SWAs) submit one report
each quarter and a preliminary,
summary report each month. These
computerized reports contain
information from State administrative
files and information obtained from
those employers meeting the program
criteria of a mass layoff.
Congress provided for the
implementation of the MLS program by
the Bureau of Labor Statistics (BLS)
through the Fiscal Years 1984–1992
appropriations for the Departments of
Labor, Health and Human Services,
Education, and related agencies. The
program was not operational in Fiscal
Years 1993 and 1994. Program operation
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[Federal Register Volume 76, Number 190 (Friday, September 30, 2011)]
[Notices]
[Pages 60922-60930]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25238]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-77]
Kimberly Maloney, N.P.; Decision and Order
On February 4, 2011, Administrative Law Judge Timothy D. Wing
issued the attached recommended decision. Neither party filed
exceptions to the decision.
Having reviewed the entire record, I have decided to adopt the
ALJ's ruling, findings of fact, conclusions of law (except as explained
below), and recommended order. Accordingly, Respondent's application
for a registration will be granted subject to a condition.
In his discussion of factor three--Respondent's ``conviction record
under Federal or State laws relating to the manufacture, distribution,
or dispensing of controlled substances,'' 21 U.S.C. 823(f)--the ALJ
found that she had pled guilty to a felony count of obtaining a
narcotic drug by means of a forged prescription in violation of Cal.
Health & Safety Code Sec. 11368. ALJ at 15-16.\1\ However, pursuant to
Cal. Penal Code Sec. 1000.1, Respondent was allowed to participate in
the deferred entry of judgment program, GX 10, and upon her successful
completion of treatment, her guilty plea was set aside and the charge
was dismissed. GX 11.
---------------------------------------------------------------------------
\1\ All citations to the ALJ's decision are to the slip opinion
as issued by him.
---------------------------------------------------------------------------
Noting that California law provides that ``[a] defendant's plea of
guilty pursuant to this chapter shall not constitute a conviction for
any purpose unless a judgment of guilty is entered pursuant to'' Cal
Penal Code Sec. 1000.3, and that Agency precedent holds that a
deferred adjudication is nonetheless a conviction for purposes of the
CSA, the ALJ explained that ``the fact that a finding of guilt was
specifically not entered as to Respondent and the charges dismissed,
leaves open the question as to whether Respondent's plea constitutes a
conviction under 21 U.S.C. 823(f).'' ALJ at 17. The ALJ deemed it
unnecessary to reach the issue, however, reasoning that the offense
committed by Respondent ``does not `relate[] to the manufacture,
distribution, or dispensing of controlled substances,' the standard
embraced in'' 21 U.S.C. 823(f)(3). Id. (citing Super-Rite Drugs, 56 FR
46014 (1995)).
Contrary to the ALJ's understanding, the Agency has long since
resolved both issues. In Edson W. Redard, 65 FR 30616 (2000), a
practitioner, who was charged with three felony counts of obtaining and
attempting to obtain hydrocodone by fraud under California law, pled
nolo contendere to a single count and was allowed to participate in the
State's deferred entry of judgment program (the same statutory scheme
at issue here), which he successfully completed. Id. at 30617-18.
Thereupon, the state court granted deferred entry of judgment and the
charges were dismissed. Id. at 30618.
Thereafter, the Agency proposed the revocation of the
practitioner's registration on the ground that he had been convicted of
a felony offense relating to controlled substances under state or
Federal law. Id. (citing 21 U.S.C. 824(a)(2)). In opposition, the
practitioner argued that he had not been ``convicted of a felony
offense [because] no judgment was entered against him and the criminal
proceedings were dismissed.'' Id.
The Agency rejected the practitioner's argument, explaining that
``there is still a `conviction' within the meaning of the Controlled
Substances Act even if the proceedings are later dismissed. * * * [A]ny
other interpretation would mean that the conviction could only be
considered between its date and the date of its subsequent dismissal.''
Id. (int. quotations omitted). The Agency thus held that the
practitioner had ``been convicted of a felony relating to controlled
substances'' and that this was ground to revoke his registration under
21 U.S.C. 824(a)(2). Id.
In Harlan J. Borcherding, 60 FR 28796 (1995), a practitioner who
had been indicted under Texas law on three counts of prescribing a
controlled substance ``without a valid medical purpose,'' was allowed
to plead guilty to a single misdemeanor count and was placed on
probation; following the practitioner's completion of his probation,
the proceeding was dismissed without an adjudication of guilt. Id. at
28797. While the practitioner argued ``that he had not been `convicted'
of any offense within the meaning of 21 U.S.C. 823(f)(3),'' the Agency
rejected the argument, holding that ``[t]he law is well settled that a
DEA registrant may be found to have been `convicted' within the meaning
of the Controlled Substances Act, despite a deferred adjudication of
guilt.'' Id. (citations omitted).
More recently, in Pamela Monterosso, 73 FR 11146, 11148 (2008), a
case in which an applicant pled guilty to a state law controlled
substance offense but was granted probation before judgment and the
charge was dismissed, I explained that ``DEA has long taken the view
that even when a court withholds adjudication and ultimately dismisses
the charge after the completion of probation, the proceeding is still a
conviction within the meaning of the Controlled Substances Act.'' See
also Thomas G. Easter II, 69 FR 5579, 5580-81 (2004) (``DEA has
consistently held that a deferred adjudication of guilt following a
guilty plea, is a conviction within the meaning of the Controlled
Substances Act.''); Clinton D. Nutt, 55 FR 30992 (1990); Eric A. Baum,
53 FR 47272 (1988); Stanley Granet Rosen, 50 FR 46844 (1985).
Moreover, the Superior Court form evidencing Respondent's guilty
plea includes the ``Court's Finding And Order.'' GX 9, at 3. This
section of the form concludes by stating: ``The Court accepts the
defendant's plea and admissions, and the defendant is convicted
thereby.'' Id. For purposes of the CSA, including whether this action
must be disclosed on an application for registration and whether it
provides ground to deny an application or revoke a registration, see 21
U.S.C. 824(a)(1) & (2), Respondent's plea and the Superior Court's
finding constitutes a conviction notwithstanding that her plea was
eventually set aside and the charge dismissed.
As discussed above, the ALJ also concluded that Respondent's
offense of obtaining a prescription for a controlled
[[Page 60923]]
substance by fraud ``does not relate to the manufacture, distribution,
or dispensing of controlled substances.'' ALJ at 17 (quoting 21 U.S.C.
823(f) and citing Super-Rite Drugs, 56 FR 46014, 46015 (1991)).
However, the underlying offense at issue in Super-Rite Drugs was a
state law offense of possession of cocaine and not possession with
intent to distribute. See 56 FR at 46014. The case thus does not stand
for the proposition cited by the ALJ.\2\
---------------------------------------------------------------------------
\2\ It is acknowledged that there are a number of older cases
which held that convictions for the offense of simple possession of
a controlled substance could be considered under factor three.
However, in Alvin Darby, 75 FR 26993, 27000 (2009), I explained that
a conviction for simple possession does not fall within factor
three. However, as I also noted in Darby, such a conviction can be
considered under factor five. Id.
---------------------------------------------------------------------------
Most significantly, in several cases, the Agency has held that the
offense of obtaining controlled substances by using fraudulent
prescriptions constitutes an offense related to the manufacture,
distribution, or dispensing of controlled substances within the meaning
of factor three. See Redard, 65 FR at 30619 (practitioner obtained
controlled substances by issuing fraudulent prescriptions); Ronald D.
Springel, 62 FR 67092, 67094 (1997) (holding that conviction for
federal offense ``of obtaining a controlled substance by fraud'' was
actionable under factor three); Rick's Pharmacy, Inc., 62 FR 42595,
42597 (1997) (same); Ronald Phillips, 61 FR 15304, 15305-06 (1996)
(same). Forging a prescription to obtain a controlled substance clearly
relates to the ``distribution[] or dispensing of controlled
substances,'' 21 U.S.C. 823(f)(3), whether the practitioner wrote the
prescriptions on her own pad, or, as here, stole prescriptions from
another practitioner's pad.
However, aside from the ALJ's analysis of factor three, I agree
with the ALJ's findings as to the remaining factors. Moreover, I agree
with the ALJ that Respondent has ``credibly'' accepted responsibility
for her misconduct and that she has put forward compelling and
unrebutted evidence of her rehabilitation, thus demonstrating that
``she will not engage in future misconduct.'' ALJ at 22. Because there
is no evidence that Respondent harmed others or diverted the drugs she
illegally obtained, and this episode is, in essence, a first offense, I
conclude that consideration of the Agency's interest in deterrence is
not warranted. Accordingly I will adopt the ALJ's recommended order and
grant Respondent's application for registration subject to the
following condition.
(1) Any violation of either condition 13 or 14 of the California
Board of Registered Nursing's Order shall be deemed an act inconsistent
with the public interest and subject her registration to proceedings
under 21 U.S.C. 824(a).
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 Kimberly Maloney, N.P.,
for a DEA Certificate of Registration as a mid-level practitioner be,
and it hereby is, granted. This Order is effective immediately.
Dated: September 19, 2011.
Michele M. Leonhart,
Administrator.
Paul E. Soeffing, Esq., for the Government.
Kimberly Maloney, N.P., Pro Se, for the Respondent.
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge
Introduction
Timothy D. Wing, Administrative Law Judge. This proceeding is an
adjudication pursuant to the Administrative Procedure Act (APA), 5
U.S.C. 551 et seq., to determine whether the Drug Enforcement
Administration (DEA) should deny a nurse practitioner's application for
a Certificate of Registration (COR) as a mid-level \1\ practitioner.
Without this registration the nurse practitioner, Kimberly Maloney,
N.P. (Respondent), of Chula Vista, California, will be unable to
lawfully handle controlled substances in the course of her practice.
---------------------------------------------------------------------------
\1\ See 21 CFR 1300.01(b)(28) (2010).
---------------------------------------------------------------------------
On September 10, 2010, the DEA Deputy Assistant Administrator,
Office of Diversion Control, issued an Order to Show Cause \2\ (OSC) to
Respondent, giving Respondent an opportunity to show cause why the DEA
should not deny her application for a DEA COR, assigned Control No.
W09131151M, pursuant to 21 U.S.C. 824(a)(4), and deny any other pending
applications for a DEA COR, alleging that Respondent's registration
would be inconsistent with the public interest, as that term is defined
in 21 U.S.C. 823(f).
---------------------------------------------------------------------------
\2\ ALJ Ex. 1.
---------------------------------------------------------------------------
In substance, the OSC alleges that:
1. On February 18, 2009, Respondent applied for a DEA COR
(Control No. W09131151M) as a mid-level practitioner in Schedules II
through V with a registered address of 3855 Health Sciences Drive,
La Jolla, CA 92093-9191 and a mailing address of 1503 Apache Drive,
Unit A, Chula Vista, CA 81910;
2. In a letter dated April 3, 2009, Respondent requested that
the registered address for her application be changed to eStudysite,
452 Medical Center Court, Chula Vista, CA 91911;
3. In 2006, Respondent forged prescriptions on a doctor's
prescription pad for Actiq (fentanyl) and OxyContin (oxycodone),
both Schedule II controlled substances, to support a drug habit for
Respondent. Respondent injected herself with Actiq after dissolving
it in saline. Respondent used her health insurance to pay for these
forged prescriptions;
4. On January 19, 2007, the San Diego District Attorney's Office
filed a felony complaint against Respondent for violations of Cal.
Health & Safety Code Sec. 11173(a) (obtaining prescriptions by
fraud or deceit) and Cal. Penal Code Sec. 459 (burglary). On April
17, 2007, Respondent pleaded guilty to a felony count of obtaining a
narcotic drug (OxyContin) by means of a forged prescription, in
violation of California Health & Safety Code Sec. 11368. The court
deferred entry of judgment for eighteen months and ordered
Respondent to enroll in and complete a California Penal Code Sec.
1000 drug treatment program;
5. On December 21, 2006, Respondent began the McDonald Center
Intensive Outpatient Alcohol and Drug Rehabilitation Program a
seven-week, three-nights-per-week program. Respondent completed this
program on February 8, 2007. Subsequently, Respondent enrolled in
Scripps McDonald Center's Chemical Dependency Aftercare program, a
one-year, one-night-per-week program. Respondent completed this
program on February 7, 2008. On October 22, 2008, the court
dismissed the felony criminal complaint against Respondent; and
6. On July 31, 2009, the California Board of Nursing filed an
Accusation against Respondent alleging unprofessional conduct for
possession of controlled substances without a prescription and
unprofessional conduct for use of a controlled substance. The
administrative adjudication of the Accusation is ongoing.\3\
\3\ Respondent's post-hearing brief, filed on January 25, 2011,
indicates that the California Board of Registered Nursing (BRN)
adopted the proposed decision of the California Administrative Law
Judge (ALJ) on December 28, 2010, and notes that the BRN took the
extraordinary step of reducing Respondent's period of probation to
one year and cost recovery to zero. The Government filed with its
post-hearing brief a December 28, 2010 Order of the BRN entitled
``Decision After Non-Adoption,'' of which I take official notice.
(See Gov't Br. at Gov't Ex. 17.) Under the APA, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' U.S. Dept. of Justice, Attorney General's Manual
on the Administrative Procedure Act 80 (1947) (Wm. W. Gaunt & Sons,
Inc., Reprint 1979). In accordance with the APA and DEA's
regulations, Respondent is ``entitled on timely request, to an
opportunity to show to the contrary.'' 5 U.S.C. 556(e); 21 CFR
1316.59(e) (2010); see, e.g., R & M Sales Co., 75 FR 78,734, 78,736
n.7 (DEA 2010). Respondent can dispute the facts of which I take
official notice by filing a properly supported motion for
reconsideration within twenty days of service of this Recommended
Decision, which shall begin on the date it is mailed. See, e.g.,
Joseph Gaudio, M.D., 74 FR 10,083, 10,088 (DEA 2009) (granting
respondent opportunity to dispute officially noticed facts within
fifteen days of service).
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[[Page 60924]]
Respondent, appearing pro se, timely requested a hearing on the
allegations in the OSC. Following prehearing procedures, a hearing was
held in San Diego, California, on December 14, 2010, with the
Government represented by counsel and Respondent appearing pro se. Both
parties called witnesses to testify and introduced documentary
evidence. After the hearing, both parties filed proposed findings of
fact, conclusions of law and argument. All of the evidence and post-
hearing submissions have been considered, and to the extent the
parties' proposed findings of fact have been adopted, they are
substantively incorporated into those set forth below.
Issue
Whether the record establishes by substantial evidence that
Respondent's application for a DEA COR, Control Number W09131151M, as a
mid-level practitioner, should be denied pursuant to 21 U.S.C. 823(f)
and 824(a)(4), because Respondent's registration would be inconsistent
with the public interest as that term is used in 21 U.S.C. 823(f).
Evidence and Incorporated Findings of Fact
I. Background
The parties stipulated as fact the allegations contained within the
OSC. (Tr. 17.) Additionally, at hearing the parties stipulated to the
admission and consideration of Government Exhibits 1-16 and Respondent
Exhibits 1-8. (Tr. 16.)
Respondent's education includes: A 1992 Bachelor of Science degree
in Biology from San Diego State University, a 1995 Bachelor of Science
degree in nursing from San Diego State University and a 2000 Masters of
Science/Nurse Practitioner Critical Care degree from the University of
Pennsylvania. (Resp't Ex. 2.) Additionally, Respondent's professional
experience between August 2000 and November 2006 includes work as a
nurse practitioner in various medical settings to include neurosurgical
patient care, neuro-radiology and a trauma department. (Id.)
Respondent's professional experience between August 2007 and October
2009 includes work as a lecturer, bone marrow transplant patient care,
and care of patients involved in various research studies. (Id.) More
recently, Respondent has stopped seeking employment pending final
resolution of her application for a DEA COR, explaining that most ``of
the positions I have sought require a DEA certificate or else
eligibility within a year.'' (Tr. 54-55.)
II. The Investigation of Respondent
At hearing, the Government presented the testimony of two
witnesses: DEA Diversion Investigator Lucia Bartolomeo (DI Bartolomeo)
and DEA Diversion Investigator Ayoma Rudy (DI Rudy). DI Bartolomeo
credibly testified in substance that she has been a diversion
investigator with DEA for approximately twenty-two years and has been
assigned during that time to the DEA San Diego Field Division. (Tr.
21.) DI Bartolomeo's education and training includes basic diversion
investigator training along with a Bachelor of Science degree. (Tr.
21.) DI Bartolomeo began an investigation of Respondent in 2006 after
receiving an investigative lead that Respondent was in possession of a
prescription pad, not her own, and possibly forging controlled
substance prescriptions to obtain oxycodone and fentanyl for herself.
(Tr. 22.)
The evidence further included two California Controlled Substance
Utilization Review and Evaluation System (CURES) patient activity
reports for Respondent, obtained by DI Bartolomeo as part of her
investigation of Respondent. (Gov't Ex. 3; Tr. 22.) The first CURES
report covers the time period from September 2003 to October 2006 and
the second from December 2006 to April 2007. (Gov't Ex. 3.) The first
report reflects numerous prescriptions for oxycodone and Actiq, the
brand name for fentanyl; in the majority of instances the pharmacy
listed is Bonita Pharmacy. (Id.) DI Bartolomeo further testified to
obtaining prescriptions from Bonita Pharmacy in Respondent's name, many
of which had been issued in the name of Dr. [JR]; DI Bartolomeo noted
discrepancies to include sequential serial numbers and inconsistent
hand writing. (Tr. 24-26.) DI Bartolomeo also testified to meeting with
Dr. [JR], who confirmed that ``many of the prescriptions were not his
true signature.'' (Tr. 26.)
DI Bartolomeo testified that she met with Respondent on December
18, 2006, and Respondent admitted to forging prescriptions and
identified nine prescriptions that she forged. (Tr. 27; see Gov't Ex. 2
at 9, 14, 16, 18, 20, 22, 24, 26 & 28.) DI Bartolomeo explained that
Respondent admitted ``[t]hat she had forged those prescriptions in
order to obtain Actiq and some oxycodone, and she explained that she
wasn't getting additional prescriptions from her physician. So that's
why she had done this activity.'' (Tr. 29.)
Documentary evidence submitted by the Government also included a
July 31, 2009 Accusation filed by the California BRN, alleging four
causes of discipline against Respondent for unprofessional conduct,
specifically: ``Possession of Controlled Substances Without a
Prescription''; ``Use of a Controlled Substance''; ``Prescription
Forgery''; and Violation of the Nursing Practice Act.'' (Gov't Ex. 13.)
The Accusation states in relevant part that
[o]n or about December 18, 2006, an RxNET agent interviewed
Respondent at the San Diego Bureau of Narcotics Enforcement office.
Respondent initially denied forging any prescriptions, but
eventually admitted that she had stolen Dr. [JR]'s prescription pad
from his La Jolla office. Respondent stated that she forged
prescriptions for Oxycontin and Actiq to administer to herself for
migraine headaches. Respondent further admitted that she would
dissolve the Actiq in a saline solution and inject herself with it.
(Id. at 6.)
On April 1, 2007, Respondent voluntarily surrendered her DEA COR
``while in treatment for substance abuse.'' (Gov't Ex. 1 at 3.)
DI Rudy credibly testified in substance that she has been assigned
to the DEA San Diego Field Division as a diversion investigator since
2005, and her education includes a Bachelor's degree in criminal
justice. (Tr. 35.) DI Rudy testified that she became involved in the
investigation of Respondent in February 2009 when Respondent applied
for a DEA registration as a mid-level practitioner. (Tr. 36.) DI Rudy
further testified that at the time of application, Respondent was
exempt from payment of an application fee because Respondent's proposed
registered location at that time was a state university. (Tr. 37-38,
41; see Gov't Ex. 1.) Subsequent to Respondent's initial application,
Respondent wrote a letter, dated April 3, 2009, requesting that DEA
change the address of her intended registered location to a facility
that is a non-exempt entity for purposes of registration fee. (Tr. 38;
see Gov't Ex. 14.) DI Rudy further testified that there was no
indication or implication that Respondent intended to avoid paying the
application fee. (Tr. 41.)
The Government's documentary evidence included a handwritten
confession by Respondent dated December 18, 2006, describing several
life stresses and admitting to taking ``the prescription pads because I
was scared that my migraines were out of control, that I would need
more medicine.
[[Page 60925]]
* * *'' (Gov't Ex. 4.) The Government also submitted as evidence three
photographs (Gov't Ex. 5), which Respondent testified were taken on the
day she met with DI Bartolomeo and another person (Tr. 60). Respondent
speculated that investigators photographed her arm because ``they
wanted to prove that I was a drug addict.'' (Tr. 61.) Respondent was
candid: ``I'm not here to dispute the fact that I got addicted to
drugs. I mean, I accept what happened, and I'm here to tell you what
happened after that. So I don't dispute that they took pictures of me
on that day.'' (Tr. 61.) No other testimony or evidence was offered
with regard to the photographs.
The record also contains a February 8, 2007 letter from the
McDonald Center for Alcoholism and Drug Addiction Treatment, La Jolla,
California (McDonald Center), certifying that Respondent successfully
completed an intensive, seven-week outpatient alcohol and drug
rehabilitation program on February 8, 2007, noting that Respondent
``showed a high level of commitment to her sobriety * * * was a willing
participant in all aspects of the program [and] completed all of her
written assignments on time.'' (Gov't Ex. 6.) \4\ A February 7, 2008
Chemical Dependency Aftercare Letter of Completion from the McDonald
Center confirms that Respondent successfully completed fifty-two
sessions required by its Nursing Diversion Program. (Gov't Ex. 7.) \5\
The letter also notes that Respondent ``met all requirements and
expectations of the aftercare program. Her positive attitude and
adherence to the Aftercare requirements have shown a concern and care
for her continued recovery.'' (Gov't Ex. 7.)
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\4\ Government Exhibit 6 duplicates Respondent Exhibit 7 at 3.
\5\ Government Exhibit 7 duplicates Respondent Exhibit 7 at 4.
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Finally, the record reveals that on January 19, 2007, the San Diego
District Attorney's Office filed a felony complaint against Respondent
for violations of Cal. Health & Safety Code Sec. 11173(a) (obtaining
prescriptions by fraud or deceit) and Cal. Penal Code Sec. 459
(burglary). (Gov't Ex. 8.) On April 17, 2007, Respondent pleaded guilty
to a felony count of obtaining a narcotic drug (OxyContin) by means of
a forged prescription, in violation of California Health & Safety Code
Sec. 11368. (Gov't Ex. 9.) The court deferred entry of judgment for
eighteen months and ordered Respondent to enroll in and complete a
California Penal Code Sec. 1000 drug treatment program. (Gov't Ex.
10.) On October 22, 2008, the court dismissed the felony criminal
complaint against Respondent. (Gov't Exs. 11 & 12.)
III. Respondent's Evidence
Respondent testified at hearing and also presented testimony from
her father, Mr. William Mayer. Respondent credibly testified in
substance that she became a registered nurse in 1995 and candidly
admitted to the fact that she became addicted to prescription
medications and was ``guilty of egregious behavior when I made
unprofessional choices that led to my chemical dependence.'' (Tr. 44.)
Respondent explained that in or about 1990 she began having
migraine headaches ``and saw many health practitioners for this
problem, and tried every therapy that was recommended.'' (Tr. 45.) In
2000 her neurologist began prescribing different narcotic medications
such as OxyContin, Vicodin, Actiq and Dilaudid for maintenance and
rescue therapy. (Tr. 45.) Respondent stated the medications helped
initially but did not resolve the migraine headaches, and she was
prescribed more of the same narcotic or larger doses over time. (Tr.
45-46.) Respondent also testified that she experienced a series of very
difficult life events which increased her stress,\6\ and the migraine
headaches grew worse. (See, e.g., Tr. 46.)
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\6\ As the BRN succinctly summarized, Respondent ``was going
through a tumultuous divorce, a death in the family, caring for her
child, and she was the victim of criminal voyeurism.'' (Resp't Ex. 1
at 3.)
---------------------------------------------------------------------------
Respondent next testified that she attempted to discuss her concern
that she was becoming addicted to narcotics with her treating
physician, but the physician did not believe that intervention was
warranted. (Tr. 46.) Responded admitted that she ``eventually betrayed
his trust'' by forging his name to acquire more narcotics, but that not
``long after, I called a therapist I had recently been seeing, and told
him what I had done, and asked for help.'' (Tr. 46.)
Respondent testified that she started an outpatient drug treatment
program on December 21, 2006, and completed the program on February 8,
2007. (Tr. 46.) Thereafter, Respondent completed a year-long aftercare
program running between February 8, 2007 and February 2008. (Tr. 46.)
From April 2007 to February 2009, Respondent participated in the BRN
Nursing Diversion Program, but was dismissed on the grounds that she
``admitted a patient to the hospital ward, and the computer admission
orders included orders for [o]xycodone.'' (Tr. 46-47.) Respondent was
told that this was equivalent to dispensing oxycodone. (Tr. 47.) In
mitigation, Respondent testified that ``I have not dispensed
medications in over ten years, and the orders were part of a
standardized set for all cancer patients.'' (Tr. 47.)
With regard to the circumstances of Respondent's dismissal from the
BRN Nursing Diversion Program, the evidence also included the following
factual information:
Respondent successfully participated in the Nursing Diversion
Program for 22 months when she was asked to leave the program
because of a technical violation of the Diversion Program's rules.
While in the Diversion Program, respondent was working as a Nurse
Practitioner in the bone marrow transplant unit at the University of
California, San Diego (UCSD) Medical Center. When patients were
admitted to the unit, respondent, using a preprogrammed computer
check sheet, admitted the patients by checking the appropriate
admission box that appeared on the computer screen. By checking the
box, the computer program automatically issued a standard set of
admission orders. In some instances, the set orders included an
order for the patient to receive Oxycodone. Consequently, when the
fact respondent had been ``prescribing'' Oxycodone came to the
attention of the Diversion Program, respondent was asked to leave
even though she had been in full compliance with the strict
Diversion Program requirements, including: Calling every morning
between 6 and 7 a.m.; taking random drug tests several times per
month with no ``dirty'' tests; turning in monthly paperwork on time;
attending AA and NA meetings five to seven days per week; attending
weekly nurse-to-nurse meetings; completing 16 CEU's on substance
abuse; calling monthly to check in with her case manager; and always
getting permission before leaving San Diego.
(Resp't Ex. 1 at 4.)
Respondent's father, Mr. Mayer, credibly testified in part and in
substance that he is a retired Certified Public Accountant, and lives
approximately three miles from Respondent, seeing her at least weekly.
(Tr. 81.) Mr. Mayer testified to what he described as a ``double
whammy'' inflicted on Respondent by her treating physician and two drug
companies, explaining that Respondent's treating physician ``prescribed
OxyContin and Actiq for [Respondent's] migraine headaches, although her
stresses were far beyond migraine headaches at that time.'' (Tr. 70.)
Mr. Mayer further explained that prescribing ``OxyContin, which was
marketed as less addictive and less subject to abuse, when it was not,
and Actiq, which the FDA had only approved for cancer patients'' in
combination to treat Respondent's migraine headaches, significantly
contributed to Respondent becoming
[[Page 60926]]
addicted. (Tr. 76-77.) Mr. Mayer also testified that Respondent has put
the issues that contributed to her addiction behind her and has been
drug free since her sobriety date of November 29, 2006.\7\ (Tr. 80.) In
terms of Respondent's current state of mind regarding use of
medications, Mr. Mayer testified to a February 2010 emergency room
visit by Respondent for an acute illness causing pain during which
Respondent refused to accept pain medication such as morphine or
Dilaudid for fear of becoming addicted again. (Tr. 79.)
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\7\ Although I find Mr. Mayer's testimony credible, I do note a
disparity between the November 29, 2006 sobriety date he and others
identified (see Tr. 80; see also Resp't Ex. 8 at 1), and DI
Bartolomeo's testimony suggesting that Respondent forged a
prescription as late as December 6, 2006 (Tr. 27; see Gov't Ex. 2 at
28).
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Respondent's documentary evidence included, inter alia, an April 7,
2010 Proposed Decision (Proposed Decision) of an ALJ of the California
BRN. The Proposed Decision ordered Respondent's Registered Nurse
License, Nurse Practitioner Certificate, Nurse Practitioner Furnisher
Certificate and Health Nurse Certificate revoked, but stayed the
revocation and placed Respondent on probation for two (2) years with
specified terms and conditions. (Resp't Ex. 1 at 6-7.) The Proposed
Decision followed a March 29, 2010 administrative hearing regarding the
July 31, 2009 Accusation filed by the BRN, alleging four causes of
discipline against Respondent. (See Gov't Ex. 13.) In that proceeding,
the BRN had requested that Respondent be placed on probation for three
years with terms and conditions; the ALJ, however, concluded that two
years probation was adequate ``in view of the substantial evidence of
rehabilitation and sobriety presented by'' Respondent. (Resp't Exs. 1
at 6.)
Respondent also submitted a September 6, 2008 Certificate of
Attendance reflecting successful completion of eight hours of
continuing education in Pharmacology In Addiction and eight hours in
Relapse Prevention. (Resp't Ex. 3.) Respondent also submitted letters
dated September and August 2009 from two friends and colleagues, Linda
Long, R.N., M.S.N., F.N.P., and Linnea Trageser, N.P., both attesting
to Respondent's professionalism and qualifications to practice. (Respt'
Ex. 4 at 1-4.) A September 2009 letter from Respondent's parents
thoughtfully describes Respondent's addiction to prescription
medications, including the causes, as well as her successful efforts at
rehabilitation and continued abstinence. (Resp't Ex. 4 at 5.) A March
11, 2010 letter of personal reference from Alison McManus, Family Nurse
Practitioner, a friend of Respondent and her co-worker from April to
November 2009, describes Respondent as ``always professional'' and
``punctual and reliable, organized, efficient, and competent.'' (Resp't
Ex. 5 at 1.) Three other letters dating from February 2008 to February
2009, written by a former student, supervisor and co-worker,
respectively, refer to Respondent as a dedicated professional and
``inspirational role model.'' (Id. at 2-4.) A September 1, 2009 letter
from a friend and ``sponcee'' at Alcoholics Anonymous (AA) credibly
describes Respondent's acceptance of responsibility for her actions as
well as Respondent's demonstrated willingness to change her behavior.
(Resp't Ex 8 at 2.)
The record reflects that on September 10, 2007, Respondent was
recertified as an Acute Care Nurse Practitioner, effective September 1,
2007, to August 31, 2012. (Resp't Ex. 6.)
Letters dated March 25, 2008, and September 9, 2009, from Steven F.
Bucky, PhD, Clinical Psychologist, report in relevant part that
Respondent has been seen in psychotherapy for approximately two years
and ``is progressing well with no evidence of drug, alcohol, or
prescription drug use.'' (Resp't Ex. 7 at 1-2.)
A July 5, 2007 letter by Dr. Marina Katz, M.D., documents a June
18, 2007 psychiatric evaluation of Respondent. The report assesses
Respondent's opiate dependence and finds that it is in remission,
noting that Respondent is active in Narcotics Anonymous (NA), and
cautiously gives Respondent a favorable prognosis. (Resp't Ex. 7 at 5-
6.)
A September 4, 2008 letter from Kristine M. Vickery, R.N.,
Facilitator of the San Diego Nurse to Nurse peer support group, notes
Respondent's weekly attendance at the support group since April 2007,
describing Respondent as a ``determined, motivated individual who is
genuinely committed to recovery from chemical dependency.'' (Resp't Ex.
8 at 1.) The letter further notes Respondent's ``sobriety date is
November 29, 2006 and she maintained negative drug/ETG tests since her
entrance into the [Nursing] Diversion Program. Additionally, a hair
follicle test was performed in June 2007, and it was negative, as
well.'' (Id.)
Discussion
I. The Applicable Statutory Provisions
The Controlled Substances Act (CSA) provides that any person who
dispenses (including prescribing) a controlled substance must obtain a
registration issued by the DEA in accordance with applicable rules and
regulations.\8\ ``It shall be unlawful for any person knowingly or
intentionally to acquire or obtain possession of a controlled substance
by misrepresentation, fraud, forgery, deception, or subterfuge.'' \9\
``A separate registration shall be required at each principal place of
business or professional practice where the applicant * * * dispenses
controlled substances.'' \10\ DEA regulations provide that any
registrant may apply to modify her registration to change her address
but such modification shall be handled in the same manner as an
application for registration.\11\
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\8\ 21 U.S.C. 822(a)(2).
\9\ 21 U.S.C. 843(a)(3).
\10\ 21 U.S.C. 822(e).
\11\ See 21 CFR 1301.51 (2010)
---------------------------------------------------------------------------
It is unlawful for any person to possess a controlled substance
unless that substance was obtained pursuant to a valid prescription
from a practitioner acting in the course of professional practice.\12\
---------------------------------------------------------------------------
\12\ 21 U.S.C. 844(a).
---------------------------------------------------------------------------
A. The Public Interest Standard
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an
application for a DEA COR if she determines that such registration
would be inconsistent with the public interest. In determining the
public interest, the Deputy Administrator is required to consider the
following factors:
(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.
As a threshold matter, the factors specified in Section 823(f) are
to be considered in the disjunctive: The Deputy Administrator may
properly rely on any one or a combination of those factors, and give
each factor the weight she deems appropriate, in determining whether a
registration should be revoked or an application for registration
denied.\13\
---------------------------------------------------------------------------
\13\ See Henry J. Schwarz, Jr., M.D., 54 FR 16,424 (DEA 1989).
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[[Page 60927]]
B. Other Factors
In addition to the public interest factors discussed above, 21
U.S.C. 824(a) provides four other factors that the Deputy Administrator
may consider in a proceeding to suspend or revoke a DEA COR.\14\
Despite the lack of an explicit provision applying these factors to a
denial of an application [t]he agency has consistently held that the
Administrator may also apply these bases to the denial of a
registration, since the law would not require an agency to indulge in
the useless act of granting a license on one day only to withdraw it on
the next.\15\ In addition, I conclude that the reference in Sec.
823(f)(5) to ``other conduct which may threaten the public health and
safety'' would as a matter of statutory interpretation logically
encompass the factors listed in Sec. 824(a).\16\
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\14\ That subsection provides that a DEA COR may be revoked upon
a finding that the registrant: (1) Has materially falsified an
application; (2) has been convicted of a felony under the CSA or any
other federal or state law relating to any controlled substance; (3)
has had a state license or registration suspended, revoked or denied
and is no longer authorized by state law to handle controlled
substances; (4) has committed such acts as would render his
registration under 21 U.S.C. 823 inconsistent with the public
interest; or (5) has been excluded from participation in
incorporating the public interest factors from Sec. 823(f). See 21
U.S.C. 824(a)(4).
\15\ Kuen H. Chen, M.D., 58 FR 65,401, 65, 402 (DEA 1993)
(citing Serling Drug co. & Detroit Prescription Wholesaler, Inc., 40
FR 11,918, 11,919 (DEA 1975)); accord Scott J. Loman, D.D.S., 50 FR
18,941 (DEA 1985); Roger Lee Palmer, D.M.D., 49 FR 950 (DEA 1984).
\16\ See Chen, 58 FR at 65,402.
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II. The Factors To Be Considered
Factor 1: The Recommendation of the Appropriate State Licensing Board
As described in the Evidence and Incorporated Findings of Fact
Section of this Recommended Decision, Respondent holds active state
authority \17\ in California as a mid-level practitioner, which has
been the subject of prior disciplinary action. (See, e.g., Gov't Ex.
13.) The gravamen of the misconduct which formed the basis of the
California BRN Accusation filed on July 31, 2009, related solely to
Respondent's actions between June 2006 and December 2006, which were
attributable to an addiction to prescription pain medications. (See
Gov't Ex. 13 at 6-7.)
---------------------------------------------------------------------------
\17\ Registered Nurse Licdense No. 513926; Nurse Practitioner
Certificate No. 12026; Nurse Practitioner Furnisher Certificate No.
12026; Public Health Nurse Certificate No. 55127.
---------------------------------------------------------------------------
The evidence at hearing reflects that the BRN complaint against
Respondent was the subject of a March 29, 2010 California
administrative hearing, during which the BRN recommended that
Respondent be placed on a three-year period of probation, with
specified terms and conditions. (See Resp't Ex. 1 at 6.) The April 7,
2010 Proposed Decision of the state ALJ concluded that cause for
discipline exists under applicable California law, finding that
Respondent committed acts of unprofessional conduct by possession and
use of Schedule II controlled substances without valid prescriptions;
and that Respondent forged prescriptions for controlled substances
using a prescription pad stolen from a physician. (Resp't Ex. 1 at 5-
6.)
In mitigation, the Proposed Decision ordered revocation of
Respondent's state nursing licenses, but stayed the revocation and
placed Respondent on probation for two years, with specified terms and
conditions. (Resp't Ex. 1 at 6-7.) Of note, the state ALJ found
substantial evidence of Respondent's rehabilitation and sobriety,
concluding that two rather than three years of probation would be
``adequate for the board to monitor respondent to ensure public
protection.'' (Resp't Ex. 1 at 6.) On December 28, 2010, the BRN issued
a Decision After Non-Adoption, which was consistent with the Proposed
Decision, except it further reduced the period of probation to one year
and reduced Respondent's costs to zero. (Gov't Br. at Gov't Ex. 17.)
\18\
---------------------------------------------------------------------------
\18\ See supra note 3.
---------------------------------------------------------------------------
The most recent action by the California BRN reflects a
determination that notwithstanding findings of unprofessional conduct,
Respondent can be entrusted with an active license subject to
probationary terms and conditions. While not dispositive,\19\ I find
the careful deliberations and action by the state licensing authorities
weigh in favor of a finding that Respondent's registration would be
consistent with the public interest under 21 U.S.C. 823(f).
---------------------------------------------------------------------------
\19\ Mortimer B. Levin, D.O., 55 FR 8209, 8210 (DEA 1990)
(finding DEA maintains separate oversight responsibility and
statutory obligation to make independent determination whether to
grant registration).
---------------------------------------------------------------------------
Factor 3: Respondent's Conviction Record
As noted above, one of the factors in determining whether
Respondent's registration would be inconsistent with the public
interest is ``[t]he applicant's conviction record under Federal or
state laws relating to the manufacture, distribution, or dispensing of
controlled substances.'' 21 U.S.C. 823(f)(3).\20\ The OSC alleges that
Respondent pled ``guilty to a felony count of obtaining a narcotic drug
(OxyContin) by means of a forged prescription, in violation of
California Health & Safety Code Sec. 11368.'' (ALJ Ex. 1 at 2.)
Pursuant to applicable state law,\21\ the entry of judgment was
deferred and upon successful completion of a treatment program, the
charges were dismissed. (Gov't Ex. 11.) The California statute provides
in pertinent part that a ``defendant's plea of guilty pursuant to this
chapter shall not constitute a conviction for any purpose,'' unless
judgment of guilt is entered.\22\ But even the clearest statement of
state law is not controlling on the question of what constitutes a
``conviction'' pursuant to the federal CSA. The question therefore
remains whether Respondent's plea of guilty, which was ultimately
dismissed, constitutes a ``conviction'' on the facts of this case.
---------------------------------------------------------------------------
\20\ I note that 21 U.S.C. 824(a)(2) (factor considering whether
registrant ``has been convicted of a felony under the Controlled
Substances Act or any other federal or state law relating to any
controlled substance'') was not cited in either the OSC or otherwise
noticed prior to hearing, and therefore is not applicable to this
Recommended Decision. See CBS Wholesale Distribs., 74 FR 36,746,
36,749 (DEA 2009).
\21\ Cal. Penal Code 1000.1.
\22\ Id. Sec. 1000.1(d).
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Federal case law has established that ``[a] conviction alone is
sufficient to allow the Attorney General (through the DEA
Administrator) to revoke or suspend a DEA registration.'' Pearce v.
DEA, 867 F.2d 253, 255 (6th Cir. 1988) (citing Fitzhugh v. DEA, 813
F.2d 1248, 1253 (DC Cir. 1987)). Agency precedent takes an expansive
view of what constitutes a ``conviction.'' ``The law is well settled
that a DEA registrant may be found to have been `convicted' within the
meaning of the Controlled Substances Act, despite a deferred
adjudication of guilt.'' Harlan J. Borcherding, D.O., 60 FR 28796-01,
28798 (DEA 1995) (citing Mukand Lal Arora, M.D., 60 FR 4447, 4448 (DEA
1995) (fine, two years of probation and deferred adjudication deemed
sufficient), Clinton D. Nutt, D.O., 55 FR 30,992, 30,992 (DEA 1990)
(nolo contendere plea and deferred adjudication of guilt deemed
sufficient) and Eric A. Baum, M.D., 53 FR 47,272, 47,272 (DEA 1988)
(``best interest'' plea, probation, drug counseling and withholding of
adjudication deemed sufficient)).
The policy underlying this precedent is founded in the doctrine of
claim preclusion. ``When the judge decided to withhold adjudication and
sentence and instead placed the defendant on probation * * * it is
clear that the defendant could no longer be tried on the information.''
United States v. Cook,
[[Page 60928]]
10 M.J. 138, 139 (U.S. Ct. Mil. App. 1981) (cited, but not quoted, in
Eric A. Baum, M.D., 53 FR 47,272 (DEA 1988)). Accordingly, a registrant
whose criminal adjudication has been deferred is nevertheless
considered to have been ``convicted'' under DEA precedent.
In this case, the fact that a finding of guilt was specifically not
entered as to Respondent and the charges dismissed, leaves open the
question as to whether the foregoing Agency precedent is controlling on
the issue of whether Respondent's plea constitutes a conviction under
21 U.S.C. 823(f).\23\ It is unnecessary to reach that issue, however,
because the underlying offense to which Respondent pled guilty does not
``relate[ ] to the manufacture, distribution, or dispensing of
controlled substances,'' the standard embraced in Sec. 823(f). See
Super-Rite Drugs, 56 FR 46,014, 46,015 (DEA 1991) (``Although
[applicant] entered a guilty plea to a drug-related felony, his actions
did not relate to the manufacture, distribution, or dispensing of
controlled substances.'').
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\23\ Agency precedent as embodied in Baum and other cases,
carried to its logical conclusion, could arguably deem a plea that
was later withdrawn, and a defendant found not guilty after trial,
to be a conviction, on the claim preclusion grounds discussed in
United States v. Cook, 10 M.J. 138, 139 (U.S. Ct. Mil. App. 1981), a
case cited favorably in Baum. Cf. Baum, 53 FR at 47,274.
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Accordingly, I find that Respondent has not been convicted of any
laws relating to the manufacture, distribution or dispensing of
controlled substances. I therefore find that Factor Three under Section
823(f), while not dispositive, does weigh in favor of a finding that
Respondent's registration would be consistent with the public interest.
Factors 2, 4 and 5: Respondent's Experience in Dispensing Controlled
Substances; Compliance With Applicable State, Federal or Local Laws
Relating to Controlled Substances; and Such Other Conduct Which May
Threaten the Public Health and Safety
The central issue in this case centers on Respondent's addiction to
prescription pain medications, which began in or about 2006 while under
medical care for chronic migraine headaches. (See Tr. 45-46.)
Respondent's use of prescription pain medications eventually culminated
in a course of conduct between June 2006 to December 2006, where she
forged approximately nine prescriptions for Schedule II controlled
substances for herself using a stolen prescription pad (see, e.g., Tr.
24-26, 46), and wrongfully used and possessed Schedule II controlled
substances (e.g., Gov't Ex. 13 at 6). Other than the time period from
June to December 2006, with a single exception noted below, there is no
evidence that Respondent has failed to comply with all applicable laws
and regulations relating to controlled substances during her
professional career.
As to the single instance of Respondent's noncompliance with
controlled substance laws following her sobriety date, there is
evidence of record that Respondent was dismissed in February 2009 from
a Nursing Diversion Program, during her employment as a nurse
practitioner in a bone marrow transplant unit, on the grounds that a
computer-generated admission order for a patient automatically included
an order for oxycodone. (E.g., Resp't Ex. 1 at 4.) Respondent was
informed that she was being dismissed because this admission order,
which included an order for oxycodone, was considered the equivalent to
dispensing oxycodone. (Tr. 47.) Respondent credibly testified that she
had ``not dispensed medications in over ten years, and the orders were
part of a standardized set for all cancer patients.'' (Tr. 47.)
Additionally, the evidence reflects that as of February 2009,
Respondent had successfully participated in the Nursing Diversion
Program for approximately twenty-two months and had been in full
compliance with other strict requirements to include random drug tests,
all of which were negative. (Resp't Ex. 1 at 4.)
As an initial matter, the issue of Respondent's dismissal from the
Nursing Diversion Program due to improper dispensing of oxycodone was
not specifically noticed by the Government in the OSC or prehearing
statement, nor was it referenced in any Government exhibits prior to
hearing. The issue was introduced by Respondent at hearing during her
direct testimony as well as in documentary evidence. (Tr. 47; Resp't
Ex. 1 at 4.)
To comport with due process requirements, the DEA must ``provide a
Respondent with notice of those acts which the Agency intends to rely
on in seeking the revocation of [her] registration so as to provide a
full and fair opportunity to challenge the factual and legal basis for
the Agency's action.'' CBS Wholesale Distribs., 74 FR 36,746, 36,749
(DEA 2009) (citing NLRB v. I.W.G., Inc., 144 F.3d 685, 688-89 (10th
Cir. 1998) and Pergament United Sales, Inc., v. NLRB, 920 F.2d 130, 134
(2d Cir. 1990)). An issue cannot be the basis for a sanction when the
Government has failed to ``disclose `in its prehearing statements or
indicate at any time prior to the hearing' that an issue will be
litigated.'' Id. at 36,750 (citing Darrell Risner, D.M.D., 61 FR 728,
730 (DEA 1996)). The DEA has also previously found, however, that a
respondent may waive objection to the admission of evidence not noticed
by the Government prior to the hearing when the respondent does not
timely object and when the respondent also raises the issue. Gregory D.
Owens, D.D.S., 74 FR 36,751, 36,755 (DEA 2009).
In accordance with agency precedent, I find in this case that the
issue of Respondent's February 2009 dispensing of oxycodone may
properly be considered in evaluating Respondent's application, as well
as on the issue of sanction. I also find that Respondent's conduct
culminating in the single instance of dispensing oxycodone in February
2009 was inadvertent. The record reveals that
[w]hen patients were admitted to the unit, respondent, using a
preprogrammed computer check sheet, admitted the patients by
checking the appropriate admission box that appeared on the computer
screen. By checking the box, the computer program automatically
issued a standard set of admission orders. In some instances, the
set orders included an order for the patient to receive [o]xycodone.
(Resp't Ex. 1 at 4.) The circumstances of this single incident and
Respondent's early termination from the Nursing Diversion Program after
approximately twenty-two fully successful months does not weigh against
Respondent's application for DEA registration. I also note that as with
all other aspects of Respondent's testimony, Respondent was fully
credible and candid in her explanation of this incident.
The Government maintains that Factors Four and Five are relevant to
the public interest inquiry, relying in part on the undisputed evidence
of Respondent's history of self-abuse of controlled substances, and
citing Gary E. Stanford, M.D., 58 FR 14,430 (DEA 1993) and William L.
Pigg, M.D., 55 FR 3120 (DEA 1990), cases finding a registrant's abuse
of controlled substances and alcohol relevant to the public interest
inquiry.
In Stanford, the evidence of abuse included ``a history of abuse of
alcohol, recreational use of cocaine, and other controlled substances
for other than a legitimate medical purpose over several years'' and
concerned a registrant in the ``early months of recovery.'' Stanford,
58 FR at 14,432. Of note, the ALJ's recommended decision in Stanford,
which the Agency adopted in its entirety, ``recommended that if after
the passage of one year from the final disposition of the case,
[r]espondent files a new application for registration,
[[Page 60929]]
and if his rehabilitation efforts have continued successfully,
investigation of that application should be expedited, and favorable
consideration should be given to the application.'' Id. In Pigg, a case
in which the respondent waived hearing and the Agency issued a final
decision on grounds of lack of state authority, as well as drug abuse,
the facts relating to substance abuse included abuse of cocaine and
alcohol over at least a two-year period, along with a subsequent abuse
of alcohol and controlled substances following entry to an Impaired
Physicians Program. Pigg, 55 FR at 3120.
Other cases reflect long-held ``precedent that a practitioner's
self-abuse of controlled substances constitutes `conduct which may
threaten public health and safety.''' Steven B. Brown, M.D., 75 FR
65,660, 65,662 (DEA2010) (citing Tony T. Bui, M.D., 75 FR 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 FR 5326 (DEA 1988). In Brown, the
evidence of self-abuse spanned approximately a two year period during
which the registrant prescribed 160-180 tablets of oxycodone 30 mg
monthly to a patient in exchange for return of half of the controlled
substances. Brown, 75 FR at 65,661. Additional evidence included a
finding that the registrant was a drug abuser and a threat to public
health and safety, when he offered the patient ``a hit of liquid
oxycodone.'' Id. at 65,662.
In the instant case, the evidence is undisputed that Respondent's
conduct between approximately June and December 2006 violated federal
and state law and reflected a serious drug addiction by Respondent
during that time period of approximately six months.\24\ The evidence
includes approximately nine instances of Respondent forging
prescriptions using a stolen prescription pad, resulting in the
acquisition of approximately 115 tablets of fentanyl and 120 tablets of
oxycontin. (Gov't Exs. 2 & 3.) The evidence further reflects that
Respondent's addiction had progressed to the point where she would
dissolve ``the Actiq [fentanyl] in a saline solution and inject herself
with it.'' (Gov't Ex. 13 at 6.)
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\24\ Compare Tr. 46, with Tr. 27, and Gov't Ex. 2 at 9, 14, 16,
18, 20, 22, 24, 26, & 28 (forged prescriptions ranging between
August 9, 2006, and December 6, 2006).
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Additionally, the evidence regarding Respondent's acknowledgement
of her addiction includes a December 18, 2006 interview at the San
Diego Bureau of Narcotics Enforcement office, where Respondent
initially denied forging any prescriptions, but eventually admitted
that she had stolen the prescription pad and forged prescriptions for
OxyContin and Actiq.\25\ (Gov't Ex. 4; Gov't Ex. 13 at 6.) There is
other evidence suggesting Respondent was already attempting to seek
help on her own, including Respondent's testimony that not long after
forging prescriptions ``I called a therapist I had recently been
seeing, and told him what I had done, and asked for help.'' (Tr. 46.)
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\25\ This evidence is somewhat consistent with testimony of DI
Bartolomeo with regard to Respondent's confession on December 18,
2006, although DI Bartolomeo did not reference Respondent's initial
denial. (See, e.g., Tr. 29.) For instance, the record was unclear
whether Respondent made two separate admissions on December 18,
2006. Notwithstanding the ambiguity and intial denial, I find that
Respondent's admission of misconduct and cooperation with law
enforcement authorities was timely and is to her credit.
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To summarize, Respondent's admitted misconduct and substance abuse
between June and December 2006, if viewed standing alone, does weigh
against a finding that Respondent's unconditional registration would be
consistent with the public interest under Factors Four and Five.
Conclusion and Recommendation
After balancing the foregoing public interest factors, I find the
Government has established by substantial evidence a prima facie case
in support of denial of Respondent's application for registration,
based on Respondent's unlawful possession, use and fraudulent
acquisition of controlled substances between June and December 2006.
Once DEA has made its prima facie case for revocation, the burden then
shifts to the respondent to show that, given the totality of the facts
and circumstances in the record, denial of the application would not be
appropriate. See Morall v. DEA, 412 F.3d 165, 174 (DC Cir. 2005);
Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v. United
States Dep't of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989); Thomas E.
Johnston, 45 FR 72, 311 (DEA 1980).
Additionally, where a registrant has committed acts inconsistent
with the public interest, the registrant must accept responsibility for
his or her actions and demonstrate that he or she will not engage in
future misconduct. Patrick W. Stodola, M.D., 74 FR 20,727 (DEA 2009).
Also, ``[c]onsideration of the deterrent effect of a potential sanction
is supported by the CSA's purpose of protecting the public interest.''
Joseph Gaudio, M.D., 74 FR 10,083, 10,094 (DEA 2009).
In the instant case, Respondent's testimony at hearing with regard
to her past misconduct, and demonstrated efforts to avoid a repeat of
those mistakes, was fully credible. Respondent's testimony was
consistent and candid throughout her direct and cross examination. With
regard to the facts surrounding her misconduct, Respondent credibly
assumed full responsibility for her actions, stating at the outset of
her testimony that ``I was guilty of egregious behavior when I made
unprofessional choices that led to my chemical dependence.'' (Tr. 44.)
The Government argues that Respondent ``appeared to accept
responsibility,'' but that ``her father attempted to shift the blame
for Respondent's addiction to her physician and two drug
manufacturers.'' (Gov't Br. at 5.) The relevant inquiry, however, is
Respondent's own acceptance of responsibility, not that of a third
party.\26\
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\26\ Even assuming the testimony of a third party might be
relevant in some circumstances to whether a respondent has accepted
responsibility, such as, for example, to impeach a respondent's
credibility, I find Respondent's father's testimony in this case to
be fully consistent with Respondent's acceptance of responsibility.
In explaining the circumstances and context of Respondent's
addiction, Respondent's father concluded by stating ``I believe * *
* that forging prescriptions is a serious offense, especially by
someone who has been granted a DEA certificate. But the
circumstances which caused * * * this are far behind her,'' credibly
enumerating the specific positive changes in his daughter's life.
(Tr. 77.)
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The evidence and testimony demonstrating Respondent's efforts to
ensure that she will not engage in future misconduct relating to drug
addiction is substantial and compelling. The Government ``contends that
Respondent needs additional time to demonstrate she can remain free
from drug abuse and to solidify her recovery.'' \27\ The facts reflect
that Respondent has been free from drug abuse for over four years
(compare Gov't Exs. 6 & 7, with Tr. 44-46, Tr. 80, and Resp't Ex. 1 at
4) and the time period of her abuse covered a relatively short time of
approximately six months.\28\ The passage of time and significant
efforts at rehabilitation are relevant and weighty considerations. See
Sokoloff v. Saxbe, 501 F.2d 571 (2d Cir. 1974) (passage of time
requires careful consideration of new application); see also Azen v.
DEA, 1996 WL 56114 at *2 (9th Cir. Feb. 9, 1996) (impressive evidence
of rehabilitation and continued abstinence important consideration).
The evidence also reflects that Respondent admitted her addiction to a
therapist in late 2006 (Tr. 46) and timely cooperated with authorities
in December 2006 when
[[Page 60930]]
confronted with allegations of misconduct (Gov't Ex. 13 at 6), behavior
which weighs in Respondent's favor. See Karen A. Kruger, M.D., 69 FR
7016, 7017-18 (DEA 2004) (timely cooperation with investigators when
questioned on past misconduct held a significant consideration in
granting subsequent application for registration).
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\27\ Gov't Br. at 6.
\28\ Supra note 24.
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Respondent's abstinence from drug abuse since 2006, and her efforts
at rehabilitation have been consistent, substantial, and successful.
The uncontroverted evidence of rehabilitation shows that Respondent:
successfully completed a seven-week outpatient alcohol and drug
treatment program (Gov't Ex. 6); successfully completed a one-year
dependency aftercare program (Gov't Ex. 7); successfully participated
in a Nursing Diversion Program for twenty-two months (Resp't Ex. 1 at
4); regularly attended AA