[Federal Register Volume 80, Number 134 (Tuesday, July 14, 2015)]
[Notices]
[Pages 41062-41079]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-17310]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09-62]
Odette L. Campbell, M.D.; Decision and Order
On October 26, 2010, an Agency Administrative Law Judge issued the
attached Recommended Decision.\1\ Therein, the ALJ rejected, as
unsupported by substantial evidence, the Government's allegations that:
(1) Respondent had unlawfully prescribed methadone to a patient for the
purpose of treating the patient's opioid addiction; (2) Respondent had
issued a controlled substance prescription to an employee for the
purpose of obtaining the controlled substance for her own use; and (3)
Respondent could not account for 13 bottles or 390 dosage units of
Suboxone. R.D., at 32-43.
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\1\ All citations to the Recommended Decision are to the slip
opinion as issued by the ALJ.
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However, the ALJ also found that the Government had proved several
allegations. These included that: (1) Respondent possessed controlled
substances at an unregistered location when she moved her office
without obtaining a modification of her registration; (2) Respondent
occasionally allowed patients to return controlled substances to her if
they did not like the medication or had an adverse reaction to it; and
(3) Respondent failed to keep required records (including DEA Form-
222s) for her receipts of Demerol, a schedule II controlled substance,
as well as both inventories and dispensing logs for Ambien (zolpidem)
and Provigil (modafinil), both being schedule IV controlled
substances.\2\ Id. at 30-32; 44; 46-49.
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\2\ The ALJ also noted that ``the evidence indicates that
Respondent did not follow adequate security procedures'' in that the
controlled substance were not stored ``in a securely locked,
substantially constructed cabinet'' and ``Respondent did not
maintain control over the key.'' R.D. at 45. However, the ALJ
declined to consider the evidence on the ground that the Government
did not provide adequate notice in either the Show Cause Order or
its Prehearing Statement, notwithstanding that Respondent did not
object to the testimony. While the record arguably support a finding
that the issue was litigated by consent, see CBS Wholesale
Distributors, 74 FR 36746, 36750 (2009), the Government did not take
exception to the ALJ's ruling. I therefore do not consider the
evidence.
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With respect to the latter finding, the ALJ noted that while
recordkeeping violations alone can support an order of revocation,
Respondent's violations ``occurred over a comparatively short period of
time, with substantially fewer controlled substances [than in those
cases where revocation was ordered], and with no evidence of actual
diversion of any controlled substances.'' Id. at 52. The ALJ thus
concluded that while ``Respondent's errors and conduct clearly were
neglectful and serious during the relevant time period,'' he then
reasoned that they were ``likely due in part to ongoing issues
including eviction from her registered office, employee problems, and
an office break-in and theft'' and that an order of revocation would be
disproportionate to the misconduct which was proved. Id.
[[Page 41063]]
The ALJ did not explain why these issues prevented Respondent from
maintaining proper records for all of the controlled substances she
obtained and dispensed or for ensuring that she obtained a new
registration after she moved into her new office.
The ALJ further found that ``Respondent's testimony as a whole
demonstrates that she has sufficiently accepted responsibility for her
actions and omission with regard to a revocation penalty.'' Id.
However, he then found that her ``explanation of past errors and
demonstrated plan to avoid future violations is insufficient to support
an unconditional registration.'' Id.
The ALJ thus recommended that Respondent's registration not be
revoked and that she be granted a registration subject to the
conditions that she submit, no later than one year after issuance of a
new registration, documentation reflecting that she had successfully
completed ``accredited training . . . in the proper maintenance,
inventory, and recordkeeping requirements for controlled substances.''
Id. at 52-53. The ALJ also recommended that Respondent's registration
be subject to the condition that for one year after the issuance of a
new registration, she submit a log of all controlled substances
``received, maintained and dispensed'' by her each quarter. Id. at 53.
The Government filed an Exception to the ALJ's decision.
Thereafter, the record was forwarded to this Office for final agency
action.
On review, it was noted that Respondent's registration was due to
expire on August 31, 2010, one week after the hearing in this matter
was conducted. GX 1. Moreover, at the hearing, the Government argued
that the proceeding was moot because under an agency regulation,
Respondent was required to file her renewal application at least 45
days before her registration expired in order for her registration to
remain in existence past its expiration date. Tr. 9. The Government
further argued that Respondent had not filed a renewal application for
a Texas Controlled Substances Registration with the Texas Department of
Public Safety (DPS), and thus, even if Respondent prevailed in the DEA
hearing, she would not be entitled to be registered because she lacked
state authority as a result of her failing to file for a renewal of her
DPS registration.\3\ Id. at 9-10. Respondent disputed the Government's
contention, asserting that she had filed an application with DPS six
months earlier as well as the day before the hearing; she also asserted
that she could not obtain a new DPS registration without a DEA
registration. Id. at 10.
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\3\ This proceeding commenced with the issuance of an Order to
Show Cause and Immediate Suspension of Registration. Thereafter,
both the Texas Medical Board and the Texas Department of Public
Safety suspended Respondent's medical license and state controlled
substance registration. Accordingly, the Government moved for
summary disposition on the ground that because she lacked state
authority, she could not be registered with DEA, and thus, her DEA
registration should be revoked. The ALJ granted the Government's
motion, recommended that her DEA registration be revoked, and
thereafter forwarded the then-existing record to this Office for
final agency action.
While the matter was under review, Respondent submitted a
letter to the ALJ (which was then forwarded to this Office)
asserting that the medical board had reinstated her medical license.
The Government argued, however, that Respondent was still without
state authority because her DPS registration had been revoked and
she had not filed a new application. Respondent then submitted a
letter in which her counsel asserted that she could not be
reinstated by the DPS unless DEA reinstated her registration.
While the parties had engaged in an exchange of letters with
each other and the ALJ, neither party filed a motion seeking relief
from this Office notwithstanding that the record had since been
forwarded to it. The Administrator therefore ordered that if the
Government still sought a final order based on Respondent's lack of
state authority, it should file a properly supported motion seeking
such relief and serve it on Respondent.
Thereafter, the Government filed a request for final agency
action, noting that Respondent's DPS registration had not been
reinstated, which it supported with appropriate evidence. In
opposition, Respondent argued that it was fundamentally unfair and a
denial of due process to revoke her DEA registration based on the
DPS's action, because the DPS's action was based on the
unsubstantiated allegations of the DEA Immediate Suspension Order.
On review, the Administrator noted that it appeared that under
Texas law and regulations, Respondent was not entitled to a hearing
before the DPS to challenge either the DPS's suspension or the
denial of her application for a new registration. See Tex. Health &
Safety Code Sec. 481.063(e)(3) & (h); id. Sec. 481.066(g); see
also Tex. Admin Code Sec. 13.272(h). Because, if this was so,
revoking her registration based on her lack of state authority would
preclude her from ever being able to challenge the basis of the
Immediate Suspension Order, the Administrator remanded the case to
the ALJ with the instruction to first determine whether the DPS
would provide her with a hearing on the allegations. The
Administrator further instructed that if the DPS had provided or
would provide a hearing, the Government could renew its motion for
summary disposition; however, in the event DPS would not provide a
hearing, the ALJ was to conduct a hearing on the allegations of the
Order to Show Cause and Immediate Suspension of Registration.
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The Government then noted that Respondent had not even attempted to
submit a renewal application. Id. The Government further argued that
because Respondent would still not possess a state license after the
DEA proceeding was concluded, there were no collateral consequences
which would preclude a finding of mootness. Id. at 11. Respondent then
offered to ``file a DEA application today after the hearing.'' Id. at
12. The ALJ then denied the Government's motion and proceeded to
conduct a hearing.
Several months later, Respondent's counsel faxed to the ALJ a copy
of a printout from the DPS's Web site which showed that on November 15,
2010, Respondent had been granted a new DPS registration. However,
because there was no evidence that Respondent had filed a renewal
application, the Administrator ordered the parties to address whether
the case was moot. Order, at 2. (June 28, 2011).
Also, having taken official notice that on August 27, 2010, the
Texas Medical Board had issued a formal complaint against Respondent
charging her with multiple violations of Texas laws based on her
prescribing of controlled substances to 19 patients,\4\ the
Administrator ordered the parties to address the status of the Board
proceedings. Id. Thereafter, the Government notified this Office that
Respondent had, in fact, finally filed a renewal application on
November 19, 2010, seven days after it filed its Exception and before
the ALJ forwarded the record. Gov. Submission in Response to Order, at
2. The Government further notified this Office that the Medical Board
matter was still pending and had gone to mediation, but that further
mediation had been postponed and that a date had not been set for
further mediation. In her filing, Respondent denied having engaged in
non-therapeutic prescribing and asserted that the State's allegation
were ``unsubstantiated.''
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\4\ While the Medical Board had restored Respondent's medical
license in October 2009, on August 30, 2010, the Board had filed a
formal complaint against her which charged her, inter alia, with
engaging `` `in a pattern of non-therapeutic prescribing of
controlled substances and/or dangerous drugs.' '' Respondent's Resp.
to the Govt's Req. for Status Update, at 6 (quoting Complaint at 2,
In re Campbell, No 10-6060.MD (Tex. Med. Bd., Aug. 27, 2010)). This
proceeding was, however, resolved through mediation and dismissed on
the motion of the Texas Medical Board. See Order No. 3, In re
Campbell (Tex. SOAH. Mar 19, 2012).
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In its filing, the Government further notified this Office that
Respondent had been indicted for health care fraud and was schedule to
go to trial in October 2011. Gov.'s Submission at 2 n.1. This Office
subsequently determined that on August 19, 2010--approximately one week
before the DEA hearing--Respondent was indicted on 30 counts of Health
Care Fraud, as well as five counts of altering records during a federal
investigation. See Docket Sheet at 1, United States v. Campbell, No.
4:10cr182 (E.D. Tx.).\5\
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\5\ This Office has also taken Official Notice of the Docket
Sheet Entries in this proceeding, as well as Document #27, which
sets forth the disposition of an October 6, 2011 hearing conducted
by the district court on Respondent's violation of the conditions of
her pretrial release, wherein the Court modified the conditions of
her release to prohibit her from writing any controlled substance
prescriptions.
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[[Page 41064]]
Under 42 U.S.C. 1320a-7(a)(3), had Respondent been convicted of
even a single count of Health Care Fraud, she would have been subject
to mandatory exclusion ``from participation in any Federal health care
program.'' Moreover, just as a mandatory exclusion is a ground to
suspend or revoke an existing registration, it is also ground to deny
an application. See 21 U.S.C. 824(a)(5) (authorizing suspension or
revocation of a registration ``upon a finding that the registrant . . .
has been excluded (or directed to be excluded) from participation in a
program pursuant to section 1320a-(7)(a) of Title 42''); see also
Pamela Monterosso, 73 FR 11146, 11148 (2008) (noting that ``the various
grounds for revocation or suspension of an existing registration that
Congress enumerated in section 304(a), 21 U.S.C. 824(a), are also
properly considered in deciding whether to grant or deny an application
under section 303'') (citing cases). Accordingly, this case was held in
abeyance pending the final disposition of the Health Care Fraud charges
against Respondent.
On March 27, 2013, the United States Attorney offered Respondent a
pre-trial diversion agreement, pursuant to which prosecution of the
charges would be deferred for a period of 12 months provided she
complied with the agreement. The United States Attorney further agreed
that upon her ``fulfilling all the terms and conditions of the
Agreement'' for the 12-month period, the charges would be dismissed.
The Government does not dispute that Respondent complied with the
agreement and even submitted a copy of the Certification of Completion
of Pretrial Diversion Program, which recommended that the charges
against her be dismissed when the diversion agreement expired on March
26, 2014. However, months later, the case still remained open according
to the district court docket sheet.
Moreover, during the preparation of this decision, this Office
determined that on September 19, 2014, the Texas Medical Board filed a
new formal complaint against Respondent seeking the revocation of her
medical license. The complaint was based in part on the 2010 indictment
for health care fraud and her subsequent entrance into the pre-trial
diversion agreement, as well as the results of a July 2013 Lifeguard
assessment which found that she ``lacked the fitness to safely practice
medicine'' in that she ``displayed a less than adequate knowledge base
with many of the practice-based competencies tested, as well as
deficiencies in prescriptive practices.'' Mediated Agreed Order, at 1 &
4; In re Campbell, (Tx. Med. Bd. Feb. 13, 2015). Because possessing
state authority to dispense controlled substances is a prerequisite for
holding a DEA registration, see 21 U.S.C. 802(21) & 823(f), this
proceeding was again held in abeyance pending the resolution of the
Board proceeding.
Thereafter, the matter was referred to mediation, and on February
13, 2015, the Board and Respondent entered into a Mediated Agreed
Order. Id. Therein, the Board found that Respondent has successfully
completed the pre-trial diversion agreement, that she had ``complied
with all recommendations made as a result of the Lifeguard
assessment,'' and that she had ``produced evidence of her ongoing
efforts to advance her medical knowledge.'' Id. Respondent was thus
allowed to retain her state license.
The Government's Exception
As noted above, the Government filed an Exception to the ALJ's
Recommended Decision. Because Respondent had allowed her registration
to expire and had not filed a renewal application, the Government
argued that the Agency should reject the ALJ's ultimate recommendation
that Respondent's registration should not be revoked and that she
should be granted a restricted registration. Exception, at 2. Noting
that the ALJ cited no precedent for maintaining a DEA registration
beyond its expiration date where the registrant failed to file a timely
renewal application, the Government argued that ``the only possible
recommendation to be made by the ALJ is whether the Deputy
Administrator should affirm the Immediate Suspension Order issued
simultaneously with the Order to Show Cause.'' Id. at 1-2. However, as
found above, Respondent filed an application for a new registration
prior to the ALJ's forwarding of the record to this Office. Thus,
notwithstanding that Respondent's registration expired on August 31,
2010, there is an application to act upon.
The Government further contended that ``the issuance of the
Immediate Suspension Order'' should be affirmed ``for the reasons
discussed in the Government's Post-Hearing Brief.'' Exception, at 2.
While Respondent did not file her application until after she received
the ALJ's largely favorable decision and the Government filed its
Exception, I assume that the Government would likewise seek denial of
the application ``for the reasons discussed in the Government's Post-
Hearing Brief.'' Id.
However, the Agency regulation on Exceptions is quite specific in
requiring that a ``party shall include a statement of supporting
reasons for such exceptions, together with evidence of record
(including specific and complete citations of the pages of the
transcripts and exhibits) and citations of the authorities relied
upon.'' 21 CFR 1316.66(a). The purpose of Exceptions is to allow a
party to identify the specific factual findings and legal conclusions
of the ALJ which it believes to be erroneous. Cf. The Attorney
General's Manual on the Administrative Procedure Act 87 n.5 (1947)
(quoting Final Report of the Attorney General's Committee on
Administrative Procedure, at 52) (``Too often . . . exceptions are
blanket in character, without reference to pages in the record and
without in any way narrowing the issues. They simply seek to impose
upon the agency the burden of complete reexamination. Review of the
hearing commissioner's decision should in general and in the absence of
clear error be limited to grounds specified in the appeal.'').
Here, the ALJ previously considered the Government's post-hearing
brief and found its evidence unpersuasive on several critical issues,
including the allegations that Respondent had issued a prescription to
an employee that was actually for her own use and that Respondent was
prescribing methadone to treat opioid addiction. With respect to each
allegation, the Government relied on unsworn hearsay statements, which
the ALJ found were not sufficiently reliable when weighed against the
testimony of witnesses which he found credible and the documentary
evidence. Because the Government has failed to identify in its
Exception why the ALJ erred in reaching these findings, I adopt the
ALJ's findings.
As noted above, the ALJ also rejected the Government's evidence
regarding the accountability audit. Here again, the Government has
failed to identify in its Exception why the ALJ erred in reaching his
finding. Indeed, the Government did not even submit the audit
computation chart, let alone such documentation as the closing
inventory taken by the Investigator. Thus, I must reject the
Government's contention.
The ALJ did, however, find that Respondent relocated her practice
and possessed and distributed controlled substances at her new location
without
[[Page 41065]]
being registered there. R.D. at 30-32. The ALJ found that this conduct
constituted a violation of 21 U.S.C. 822(e) and 827(g), as well as 21
CFR 1301.51. Id. at 32. The ALJ found, however, that there was evidence
that mitigated the violations as Respondent had notified the Texas DPS
that she had changed her practice location and concluded that her
failure to notify the Agency of her address change was not
``intentionally deceitful'' but the result of an ``omission.'' Id.
The ALJ further found that Respondent admitted that she
occasionally accepted controlled substances from patients which she
then destroyed, notwithstanding that no provision in the CSA or DEA
regulations permits this. R.D. at 44. However, the ALJ also found that
there was no evidence that this was a frequent occurrence or evidence
that the drugs were diverted; rather, ``the un-rebutted testimony was
that the drugs were destroyed.'' Id. Be that as it may, it is still a
violation of the CSA. See 21 U.S.C. 844(a) (``It shall be unlawful for
any person knowingly or intentionally to possess a controlled substance
unless such substance was obtained directly, or pursuant to a valid
prescription or order, from a practitioner, while acting in the course
of his professional practice, or except as otherwise authorized by this
subchapter or subchapter II of this chapter.'').
Next, the ALJ found that Respondent failed to keep proper
controlled substance records. Specifically, the ALJ credited the
testimony of the Diversion Investigators that Respondent's records
showed that she had dispensed Demerol, a schedule II controlled
substance. R.D. at 47. Because it is a schedule II drug, Respondent was
required to document her purchases and receipts of the drug on DEA Form
222. 21 CFR 1305.04(a); id. Sec. 1305.12; id. Sec. 1305.13(a) & (e).
She was also required to retain a copy of the form for at least two
years from the date of the order. Id. Sec. 1305.17; 21 CFR 1304.04(a).
However, during a search of Respondent's registered and non-registered
locations (as well as her home), no Form 222s were found. R.D. at 47.
Nor were there any invoices for the Demerol.
Moreover, while the Investigators found that Respondent was
dispensing other controlled substances, including Ambien (zolpidem) and
Provigil (modafinil), each of which is a schedule IV drug, see 21 CFR
1308.14 (c) & (e); there were no inventories or dispensing logs for
either drug. R.D. at 47.
In mitigation, the ALJ credited Respondent's testimony that she had
never been the subject of a prior DEA investigation; that she had been
evicted from her office at the time of the events at issue; that she
also had issues with employees, ``to include alleged misuse of
prescription pads, theft, and related financial matters''; and that she
was a workaholic. R.D. at 49. While finding her testimony to be
generally credible, the ALJ concluded that the Government had made out
a prima facie case, noting that ``[o]n balance . . . Respondent's
recordkeeping violations, handling of returned controlled substances
and failure to properly change her registered address weigh
significantly in favor of revocation'' or the denial of her
application. Id. at 50.\6\
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\6\ As explained above, as of the date of the hearing,
Respondent had not filed a timely renewal application and her
registration expired one week after the hearing and before the
record was forwarded.
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Turning to whether Respondent had produced sufficient evidence to
rebut the Government's prima facie case, the ALJ noted that under the
Agency's rule, ``where a registrant has committed acts inconsistent
with the public interest, a registrant must accept responsibility for
his or her actions and demonstrate that he or she will not engage in
future misconduct.'' Patrick W. Stodola, 74 FR 10083, 10094 (2009).
Moreover, in setting the appropriate sanction, the Agency also
considers the egregiousness of the proven misconduct and the need to
deter future violations by both the Applicant and members of the
regulated community. Fred Samimi, 79 FR 18698, 18713 (2014) (citing
Jacobo Dreszer, 76 FR 19386, 19387-88 (2011)).
As for her failure to update her registered address, the ALJ noted
that Respondent had updated her address with the Texas DPS and had
``made various efforts to do so with DEA.'' R.D. at 51. However, the
ALJ found that Respondent's explanation for her recordkeeping
violations was ``less specific.'' Id. Noting her testimony that
Respondent ``believed she `had very effective oversight' of controlled
substances,'' the ALJ found that her ``belief is contradicted by [her]
own testimony.'' Id. Specifically, the ALJ noted that ``Respondent
testified that she relied heavily on her staff with regard to inventory
and maintenance of controlled substances and . . . did very little
herself.'' Id. While the ALJ concluded that her ``testimony as a whole
demonstrated that she understood the seriousness and importance of
recordkeeping requirements,'' id., at no point in her testimony did she
acknowledge that as a DEA registrant, she was the person ultimately
responsible for maintaining the required records.
Noting that Respondent's recordkeeping violations ``occurred over a
comparatively short period of time, with substantially fewer controlled
substances, and with no evidence of actual diversion,'' the ALJ
rejected the Government's contention that revocation was the
appropriate sanction, reasoning that it was disproportionate to her
misconduct. Id. at 52. However, he also found that while ``Respondent's
testimony as a whole demonstrates that she has sufficiently accepted
responsibility for her actions and omissions . . . [her] explanation of
past errors and demonstrated plan to avoid future violations is
insufficient to support an unconditional registration.'' Id.
Indeed, Respondent offered no plan to avoid future recordkeeping
violations. And while I agree that the proven misconduct would not
support a sanction of revocation (in the event she had not allowed her
registration to expire), consistent with other cases it does support a
period of outright suspension. See Kenneth Harold Bull, 78 FR 62666,
62676 (2013) (imposing six-month suspension based on physician's
failure to maintain records where his dispensing activity appeared to
be limited and there was no evidence of diversion); see also Paul Weir
Battershell, 76 FR 44359, 44368-69 (2011). Moreover, while the ALJ
explained that ``[t]he Respondent's errors were neglectful and serious
during the relevant time period, and likely due in part to ongoing
issues including eviction from her registered office, employee
problems, and an office break-in and theft,'' R.D. at 52, none of these
explain why she was missing records documenting her controlled
substance activities even months after her eviction and when she was
continuing to possess and dispense controlled substances.\7\
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\7\ While Respondent maintained that she was locked out of her
first location (4851 I-35 East, Denton, TX.), she also testified
that her staff had packed up the medical records prior to her
eviction. Tr. 200. Moreover, in her testimony, Respondent stated
that the judge in the eviction case granted her ``a brief period of
time'' to retrieve her medications. Id. Unexplained is why she would
not have also retrieved any controlled substance records at this
time.
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The ALJ recommended that Respondent be granted a restricted
registration subject to the conditions that: (1) ``no later than one
(1) year after issuance'' of a registration, she provide documentation
that she has successfully completed a course in controlled substance
recordkeeping, and (2) that she submit to the nearest DEA Field
Division Office, on a quarterly basis, a
[[Page 41066]]
log of all controlled substances received, maintained and dispensed.
I reject these conditions as insufficient to protect the public
interest. As explained above, Respondent offered no plan to address the
recordkeeping violations that were proved on the record. In the absence
of evidence that Respondent has successfully completed a course in
controlled substance recordkeeping, allowing Respondent to possess,
dispense and administer controlled substance would be ``inconsistent
with the public interest.'' 21 U.S.C. 823(f).
Accordingly, while I will grant Respondent's application, upon the
issuance of her registration, it shall be suspended for a period of six
months. I will further order that her registration be restricted to
authorize her to engage in only the prescribing of controlled
substances. Respondent shall not be allowed to possess any controlled
substance unless she obtains it pursuant to the lawful order of a
practitioner to treat a legitimate medical condition. Moreover,
Respondent may not accept any manufacturer's or distributor's sample of
any controlled substance other than those provided to her by a duly
authorized medical professional in the course of treating her for a
legitimate medical condition.\8\
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\8\ In the event Respondent provides evidence that she has
completed a course in controlled substance recordkeeping, these
conditions will be removed from her registration one year from the
effective date of this Order. However, in the event Respondent is
granted authority to possess, administer and dispense controlled
substances, she shall provide, on a quarterly basis, a log of all
controlled substances she receives, possesses, dispenses, or
otherwise disposes of, to the nearest DEA Field Division Office.
Said log shall be submitted no later than ten (10) calendar days
following March 31st, June 30th, September 30th, and December 31st.
This requirement shall remain in effect for the duration of the
initial period of re-registration. However, if Respondent fully
complies with this condition, this requirement shall be removed upon
the renewal of her registration.
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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 Odette L. Campbell, M.D.,
for a DEA Certificate of Registration as a practitioner, be, and it
hereby is, granted subject to the conditions set forth above. I further
order that upon the granting of the application, the registration shall
be suspended for a period of six months. This Order is effective August
13, 2015.
Dated: July 6, 2015.
Chuck Rosenberg,
Acting Administrator.
Larry P. Cote, Esq., for the Government.
Jeffrey C. Grass, Esq., for Respondent.
Recommended Rulings, 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 governed by the Administrative Procedure Act, 5 U.S.C.
551 et seq., to determine whether Respondent's Certificate of
Registration (COR) with the Drug Enforcement Administration (DEA)
should be revoked and any pending applications for renewal or
modification of that registration should be denied. Without this
registration, Respondent, Odette L. Campbell, M.D., of Denton,
Texas, would be unable to lawfully possess, prescribe, dispense or
otherwise handle controlled substances.
On August 4, 2009, the Deputy Administrator of the DEA
immediately suspended Respondent's registration on grounds that
Respondent had failed to comply with a standard referenced in 21
U.S.C. 823(g)(1) and that her continued registration during the
pendency of these proceedings would constitute an immediate danger
to the public health and safety. The Deputy Administrator
simultaneously issued an Order to Show Cause (OSC) why DEA should
not revoke Respondent's DEA COR as a practitioner pursuant to 21
U.S.C. 824(a)(4) because her continued registration would be
inconsistent with the public interest as that term is defined in 21
U.S.C. 823(f) and (g)(2)(E)(i). The OSC further alleged, in
substance, that:
1. Respondent is currently registered with the DEA as a
practitioner in Denton, Texas. Respondent is also authorized to
treat no more than thirty narcotic-dependant patients at any one
time with Schedule III through V narcotic controlled substances that
are approved by the Food and Drug Administration for that
indication. Respondent's current DEA registration was set to expire
by its own terms on August 31, 2010.
2. Respondent moved her practice to another location in Denton
without notifying the DEA and possessed and dispensed controlled
substances at an unregistered location in violation of Federal
law.\1\
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\1\ Citing 21 U.S.C. 841(a)(1), 822(3) and 827(g).
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3. On January 30, 2009, Respondent prescribed the Schedule II
controlled substance methadone to an individual to treat opioid
addiction.\2\
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\2\ Citing 21 U.S.C. 823(g)(1); 21 CFR 1306.04(c).
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4. In March 2009 Respondent prescribed controlled substances to
an employee for other than legitimate medical purposes.\3\ At
Respondent's request a local pharmacy filled the prescription and
the controlled substances were returned to Respondent for her
personal use.\4\
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\3\ Citing 21 CFR 1306.04.
\4\ Citing 21 U.S.C. 843(a)(3).
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5. An accountability audit conducted at Respondent's medical
office in April 2009 revealed an unexplained shortage of
approximately thirteen bottles, or 390 dosage units, of Suboxone.
Respondent's dispensing log indicated that she dispensed other
controlled substances, such as Demerol, but she was unable to
provide investigators with records showing receipt of these
controlled substances.\5\
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\5\ Citing 21 CFR 1304.21.
The Order to Show Cause and Immediate Suspension of Registration
(OSC/IS) advised Respondent of her right to a hearing in this
matter, and further advised that if she requested a hearing, it
would be held on September 21, 2009, at DEA headquarters in
Arlington, Virginia. Respondent timely filed a request for a hearing
on the issues identified in the OSC/IS and referred all future
correspondence to counsel.
On September 8, 2009, counsel for the Government filed a motion
for summary disposition, asserting, in substance, that Respondent
currently lacked authority to handle controlled substances in Texas,
the jurisdiction in which she is licensed to practice medicine and
in which she holds a DEA registration, and that the DEA does not
have statutory authority to maintain a registration if the
registrant does not have state authority to handle controlled
substances in the state in which she conducts business.\6\ Counsel
for the Government further asserted that even if the suspension of
Respondent's Texas medical license is temporary or there is the
potential for Respondent's state controlled substance privileges to
be reinstated, ``summary disposition is warranted because revocation
is also appropriate when a state license has been suspended, but
with the possibility of future reinstatement.'' \7\ Counsel for the
Government attached to his motion a copy of an Order of Temporary
Suspension (Without Notice of Hearing) dated August 19, 2009, in
which a Disciplinary Panel of the Texas Medical Board suspended
Respondent's medical license. (ALJ Ex. 10.)
---------------------------------------------------------------------------
\6\ Citing Roy Chi Lung, M.D., 74 FR 20,346 (DEA 2009); Michael
Chait, 73 FR 40,382 (DEA 2008); Shahi Musud Siddiqui, M.D., 61 FR
14,818 (DEA 1996); Michael D. Lawton, M.D., 59 FR 17,792 (DEA 1994);
and Abraham A. Chaplan, M.D., 57 FR 55,280 (DEA 1992).
\7\ ALJ Ex. 10 at 2 (citing Stuart A. Bergman, M.D., 70 FR
33,193 (DEA 2005); Roger A. Rodriguez, M.D., 70 FR 33,206 (DEA
2005)).
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On September 11, 2009, counsel for Respondent \8\ entered his
appearance in this matter and filed a response to the Government's
motion. Counsel for Respondent asserted that the Texas Medical Board
action required that Respondent's DEA registration be suspended, but
requested a stay in the instant proceedings pending resolution of
the state proceedings.
---------------------------------------------------------------------------
\8\ Richard Alley, Esq.
---------------------------------------------------------------------------
On September 14, 2009, Administrative Law Judge (ALJ) Mary Ellen
Bittner \9\ issued an Opinion and Recommended Ruling, Findings of
Fact, Conclusions of Law and Decision of the Administrative Law
Judge (Recommended Decision), which granted the Government's motion
for summary disposition and recommended that Respondent's DEA
registration be revoked and any pending applications denied on the
basis that Respondent's state medical license had been suspended and
she was therefore
[[Page 41067]]
without state authority to handle controlled substances. (ALJ Ex.
3.)
---------------------------------------------------------------------------
\9\ ALJ Bittner was designated the presiding officer in this
matter from August 28, 2009, until June 8, 2010.
---------------------------------------------------------------------------
On October 29, 2009, Government counsel submitted a letter to
the ALJ noting Respondent's request that the matter be set for
hearing because Respondent's medical license had been restored by
the Texas Medical Board. While the Government conceded the medical
license had been restored, the Government maintained that Respondent
``nonetheless still does not have authority to prescribe controlled
substances in Texas'' because ``Respondent's state controlled
substance registration was revoked by the Texas Department of Public
Safety on August 4, 2009, and that there are no applications
currently pending for Respondent.'' (ALJ Ex. 12.)
On November 3, 2009, Counsel for Respondent again requested a
hearing, noting that ``in speaking with the Texas Department of
Public Safety (DPS) . . . attorneys, they have stated that Dr.
Campbell cannot be reinstated unless DEA reinstates her license . .
. [o]bviously this reasoning is a tautological chicken and the egg
quandary and denies Dr. Campbell her due process rights.'' (ALJ Ex.
13.)
On January 19, 2010, the Deputy Administrator issued an Order
outlining the procedural history of the matter and inviting the
parties to submit a motion, properly supported, that seeks the
particular relief requested. (ALJ Ex. 4.)
On January 29, 2010, Government filed a Request for Final Agency
Action and on February 8, 2010, Respondent filed her Response. (ALJ
Exs. 14, 15.)
On May 11, 2010, the Deputy Administrator remanded the matter to
the ALJ for further proceedings. The Deputy Administrator found that
although Respondent's Texas medical license had been restored,
Respondent's state controlled substance registration was terminated
on August 4, 2009, and Respondent was therefore without state
authority to handle controlled substances. The Deputy Administrator
further found that the applicable Texas statutes and regulations may
not permit Respondent to challenge the termination of her state
controlled substance registration because the termination was based
on the immediate suspension of Respondent's DEA registration. If
that is the case, Respondent will be denied the opportunity to
challenge the revocation of her DEA registration and her state
controlled substance registration, which will effectively deny
Respondent her right to due process. The Remand Order therefore
directed the ALJ to determine what action the Texas Department of
Public Safety (DPS) has taken on Respondent's application for a
state registration and whether the DPS has provided or will provide
Respondent with a hearing; if not, Respondent is entitled to an
expedited hearing on the allegations of the OSC/IS. (ALJ Ex. 5.)
I. Procedural Issue
What action the Texas Department of Public Safety (DPS) has
taken on Respondent's application for state registration to handle
controlled substances and whether the DPS has provided or will
provide Respondent with a hearing; and, if the DPS has determined
that Respondent is not entitled to a hearing, to conduct an
expedited hearing on the allegations of the OSC/IS served on
Respondent on August 4, 2009.
A. The Government's Contentions
The Government first contends that Respondent's alleged due
process violations and the failure of the Texas DPS to provide
Respondent with a hearing regarding the revocation of her state
controlled substance license are beyond the jurisdiction of this
agency to adjudicate and would properly be heard by the Texas courts
and the DPS.
The Government further argues that because Respondent currently
lacks authority to handle controlled substances in Texas, the
jurisdiction in which she is licensed to practice medicine and in
which she holds a DEA registration, ``any fact-finding proceeding
regarding the original basis for the Order to Show Cause [is]
moot.'' \10\ Citing 37 Tex. Admin. Code Sec. 13.274(b), the
Government contends that the DPS will not automatically restore
Respondent's controlled substances registration even if Respondent
prevails in these proceedings because the DPS will not reinstate a
revoked registration sooner than one year from the date of the final
revocation and upon filing of a new application for registration.
According to the Government, these proceedings are therefore moot
because, if Respondent's DEA registration is reinstated, the
Government would have to immediately reinitiate proceedings by
issuing an OSC on the ground that Respondent lacks authority to
handle controlled substances in Texas.
---------------------------------------------------------------------------
\10\ (ALJ Ex. 18 at 3.)
---------------------------------------------------------------------------
The Government also asserts that Texas law does provide
Respondent a mechanism to seek reinstatement of her DPS registration
under Texas Health & Safety Code Sec. 481.066(j) but Respondent has
failed to seek a reinstatement under that authority. Under Texas
Health & Safety Code Sec. 481.066(j), the Governments contends that
Respondent should be able to show good cause for reinstatement of
her DPS registration based on the Texas Medical Board finding that
``rejected the Government's allegations serving as the basis of the
suspension of Respondent's DEA registration.'' (ALJ Ex. 18.)
B. Respondent's Contentions
Respondent first contends that the allegations contained in the
OSC/IS are untrue and, therefore, her DEA registration should not be
``permanently revoked.'' Respondent argues that 37 Tex. Admin. Code
Sec. 13.274(b)(1)(B) provides that within one year after a DPS
revocation becomes final, the DPS will consider a request for
reinstatement if Respondent demonstrates by a preponderance of the
evidence that Respondent's DEA registration has not been permanently
revoked. Respondent further contends, however, that it will be
pointless to request a DPS hearing on the matter until after the DEA
has issued a final order because the sole basis for the DPS
revocation is the fact that the DEA suspended Respondent's DEA
registration.
Respondent similarly contends that the DPS will not provide a
hearing on the matter of reinstatement one year after revocation
under 37 Tex. Admin. Code Sec. 13.274(b)(2)(A) because there is no
question of fact regarding whether DPS has taken adverse action
against Respondent. Again, Respondent argues that such a hearing
request will not be granted because the only issue pertains to the
status of Respondent's DEA registration. Respondent contends that
the restoration of her DEA registration is the only evidence
necessary or sufficient to negate the basis of the revocation of her
DPS registration and, therefore, only a DEA hearing can result in
the resolution of the matter with Texas and with the DEA.
Respondent also argues that Respondent has exhausted her
attempts at reinstatement of her DPS registration under a showing of
good cause. (ALJ Ex. 19.)
C. Discussion and Conclusions
The parties' contentions and the Remand Order essentially
concern two procedural issues: (1) whether Respondent has been
afforded due process under federal law; and (2) whether the fact
that Respondent does not possess state authority to handle
controlled substances renders this proceeding moot.
(1) Federal Due Process and Mootness Doctrine
The Supreme Court of the United States has held that the ``Due
Process Clause of the Fifth Amendment prohibits the United States,
as the Due Process Clause of the Fourteenth Amendment prohibits the
States, from depriving any person of property without `due process
of law.' '' Dusenbery v. United States, 534 U.S. 161, 167 (2002).
``The fundamental requirement of due process is the opportunity to
be heard `at a meaningful time and in a meaningful manner.' ''
Mathews v. Eldridge, 424 U.S 319, 333 (1976) (citations omitted).
In analyzing procedural due process issues, courts have
generally engaged in a ``two-step inquiry: (1) Did the individual
possess a protected interest to which due process protection was
applicable? (2) Was the individual afforded an appropriate level of
process?'' Ward v. Anderson, 494 F.3d 929, 934 (10th Cir. 2007)
(citations omitted).
As to the first step, a license has consistently been held to be
a property interest entitled to due process protection. Barry v.
Barchi, 443 U.S. 55, 64 (1979).
The second step of the analysis in this case rests significantly
on the interrelationship between the DEA-initiated OSC/IS and the
relevant Texas statutes and regulations pertaining to the regulation
of controlled substances by practitioners. The United States Court
of Appeals for the Fifth Circuit has held that the DEA's revocation
of a registration based on a state agency action ``would only be
invalid if the alleged state agency errors rose to the level of a
federal due process violation . . . .'' Maynard v. DEA, 117 Fed.
App'x 941, 945 (5th Cir. 2004). The DEA's revocation of a COR
amounts to the deprivation of a property interest and therefore must
comport with the requirements of federal due process. See Mathews,
424 U.S. at 333. At a minimum,
[[Page 41068]]
federal due process requires that a respondent be afforded adequate
notice and opportunity to be heard ``at a meaningful time and in a
meaningful manner.'' Id.; see also Mullane v. Central Hanover Bank &
Trust Co., 339 U.S. 306, 313 (1950).
Agency precedent has consistently held that where, for example,
a state action precedes a DEA OSC or OSC/IS, the DEA need not
inquire into the validity of a state licensing agency's decision.
George S. Heath, M.D., 51 FR 26,610 (DEA 1986). Similarly, where
there is an independent basis for the state action, the DEA has
relied on the state authority without further inquiry. See Joseph
Baumstarck, M.D., 74 FR 17,525 (DEA 2009); Michael D. Lawton, M.D.,
59 FR 17,792 (DEA 1994); George S. Heath, M.D., 51 FR 26,610 (DEA
1986); Hezekiah K. Heath, M.D., 51 FR 26,612 (DEA 1986). Summary
disposition based on suspension of a respondent's state authority,
of even a temporary nature, has been consistently upheld. E.g.,
Roger A. Rodriquez, M.D., 70 FR 33,206 (DEA 2005). The Controlled
Substances Act (CSA) requires that a practitioner be currently
authorized to handle controlled substances in ``the jurisdiction in
which he practices'' in order to maintain a DEA registration.\11\
Therefore, because ``possessing authority under state law to handle
controlled substances is an essential condition for holding a DEA
registration,'' the DEA has repeatedly held that ``the CSA requires
the revocation of a registration issued to a practitioner whose
State license has been suspended or revoked.'' See Scott Sandarg,
D.M.D., 74 FR 17,528 (DEA 2009) (citing David W. Wang, M.D., 72 FR
54,297 (DEA 2007); Sheran Arden Yeates, M.D., 71 FR 39,130 (DEA
2006); Dominick A. Ricci, M.D., 58 FR 51,104 (DEA 1993); and Bobby
Watts M.D., 53 FR 11,919 (DEA 1988)).
---------------------------------------------------------------------------
\11\ See 21 U.S.C. 802(21).
---------------------------------------------------------------------------
A review of agency precedent, however, reveals no instance where
a respondent's registration has been the subject of a final
revocation by summary disposition where state action was triggered
solely by the DEA suspension process, and the respondent was
afforded no opportunity to be heard ``at a meaningful time and in a
meaningful manner.'' Mathews v. Eldridge, 424 U.S 319, 333 (1976)
(citations omitted). To the contrary, the DEA has recently rejected
a due process argument by a respondent claiming the state action was
based on the DEA's order immediately suspending his registration,
stating: ``Respondent ignores, however, that the State's suspension
order did not rely solely on my Order. Rather, the State Board also
relied on Respondent's indictment by a federal grand jury . . . .
[T]he board clearly conducted its own independent evaluation of the
evidence against him and did not simply piggyback on my Order of
Immediate Suspension.'' Joseph Baumstarck, 74 FR 17,525, 17,527 (DEA
2009) (internal citations omitted); see also Oakland Medical
Pharmacy, 71 FR 50,100, 50,102 (DEA 2006) (rejecting the contention
that it is circular for DEA to rely on a state suspension order to
revoke a registration where the State did not rely solely on the DEA
order in suspending a practitioner's state license).
The Texas authorities in the instant case did ``piggyback''
solely on the OSC/IS to suspend Respondent's state registration on
August 4, 2009, and relied exclusively on the DEA action to suspend
Respondent's state authority.\12\
---------------------------------------------------------------------------
\12\ (See Gov't Ex. 5; Gov't Ex. 6; Gov't Ex. 7; Resp't Ex. 2.)
---------------------------------------------------------------------------
The Government also argues in substance that the ultimate issue
in this case is ``moot'' given Respondent's current lack of state
authority.\13\ Additionally, as of the hearing date, Respondent's
registration was due to expire by its terms on August 31, 2010, and
there is no evidence of record indicating that Respondent has
submitted an application for renewal.\14\ The Government's mootness
argument with regard to Respondent's current application status is
misplaced because this proceeding began as an immediate suspension.
To find otherwise would be contrary to the applicable regulation and
agency precedent.\15\
---------------------------------------------------------------------------
\13\ (ALJ Ex. 18 at 3.)
\14\ At hearing, the Government represented that ``there's no
indication in the DEA system that an attempt was even made to submit
a renewal application.'' The Respondent questioned the requirement
``to do meaningless acts if it's going to be kicked back,'' but
indicated she would file a DEA application immediately. (Tr. 10-12.)
\15\ 21 CFR 1301.36(h) states that ``[a]ny suspension shall
continue in effect until the conclusion of all proceedings upon the
revocation or suspension, unless sooner withdrawn by the
Administrator or dissolved by a court of competent jurisdiction.''
This section is distinguishable from the extension requirements for
an ``applicant . . . who is doing business under a registration . .
. not revoked or suspended . . . .'' 21 CFR 1301.36(i).
---------------------------------------------------------------------------
In William R. Lockridge, M.D., 71 FR 77,791 (DEA 2006), the
agency declined to apply the mootness doctrine to a case in which
the respondent's registration had expired several months before the
hearing and a renewal application had not been timely filed. In that
decision, the Agency concluded that
a case remains a live dispute when `collateral consequences' attach
to a proceeding which otherwise would be moot . . . . As several
courts have noted in cases involving sanctions against licensed
professionals such as attorneys, even a temporary suspension
followed by a reinstatement does not moot a challenge to the initial
suspension because the action `is harmful to a [professional's]
reputation, and `the mere possibility of adverse collateral
consequences is sufficient to preclude a finding of mootness.'
Id. at 77,797 (internal citations and formatting omitted).
Additionally, ``the issuance of an immediate suspension creates
collateral consequences beyond those that are present when the
Government serves a Show Cause Order but allows the registrant to
continue to handle controlled substances throughout the
litigation.'' Id.
Consistent with the rationale set forth in Lockridge, I find
that application of the mootness doctrine to Respondent's case is
unwarranted and would deny both Parties an opportunity to resolve
the evidentiary issues, as well as prejudice the public interest.
Additionally, there is no indication that Respondent intends to
suspend her medical practice or not seek restoration of her
registration. See Meetinghouse Community Pharmacy, Inc., 74 FR
10,073 (DEA 2009). Absent an opportunity to be heard ``at a
meaningful time and in a meaningful manner'' under the Texas
statutory scheme, reliance on agency precedent, including the
mootness doctrine, to support summary disposition in this instance
is entirely misplaced.
(2) The Texas Statutory and Regulatory Scheme
The Texas Controlled Substances Act (Texas CSA), Tex. Health &
Safety Code Sec. 481.001 et. seq., governs the registration of
practitioners to dispense controlled substances in Texas. Pursuant
to Sec. 481.066(b), ``[t]he director may cancel, suspend, or revoke
a registration, place on probation a person whose license has been
suspended, or reprimand a registrant for cause described by Section
481.063(e).'' In addition, Section 481.063(e)(3) authorizes the
denial of an application for a state registration ``to manufacture,
distribute, analyze, [or] dispense . . . controlled substance[s]''
if the applicant's DEA registration has been ``suspended, denied, or
revoked'' under the Federal Controlled Substances Act defined as 21
U.S.C. Section 801 et seq.\16\
---------------------------------------------------------------------------
\16\ See Tex. Health & Safety Code Ann. Sec. 481.002(18)
(identifying the federal Controlled Substances Act).
---------------------------------------------------------------------------
The Texas regulatory structure for practitioners is further
governed by the Texas Administrative Code, Title 37, Part 1, Ch 13.
A ``registration terminates: . . . (3) when a regulatory board or
DEA accepts a voluntary surrender, or denies, suspends, or revokes a
license or a federal controlled substance registration. . . .'' \17\
Of significance, the Texas Administrative Code states that the
``director will revoke a registration if the registrant: (1)
violates a ground of denial described in the Act, Sec.
481.063(e).'' \18\ The Code further provides that upon revocation
under this section, ``the registrant may request a hearing, unless
otherwise stated in the Act.'' \19\ The state due process
requirements for licenses, set forth at Tex. Gov't Code Ann. Sec.
2001.054, do not apply to suspensions and revocations pursuant to
Texas CSA Sec. Sec. 481.063(e)(2)(A) or (B), (e)(3), (e)(4) or
(e)(9). Maynard v. DEA, 117 Fed. App'x 941 (5th Cir. 2004); see Tex.
Health & Safety Code Ann. Sec. 481.063(h).
---------------------------------------------------------------------------
\17\ 37 Tex. Admin. Code Sec. 13.30 (2010).
\18\ Id. Sec. 13.274.
\19\ Id. Sec. 13.274(d) (emphasis added).
---------------------------------------------------------------------------
The applicable Texas statutes and regulations contemplate a
right to a hearing pursuant to the Texas APA in certain enumerated
circumstances, but not where the initial suspension or revocation
was based solely on federal action.\20\ Consistent with the
foregoing, the Respondent has not been afforded a hearing in Texas
nor is one contemplated. The procedural due process available to
Respondent under Texas law
[[Page 41069]]
simply cannot support summary disposition on the facts of this case.
Accordingly, I find that Respondent is entitled to a federal
administrative hearing on the substantive issues alleged in the OSC/
IS.
---------------------------------------------------------------------------
\20\ I have also carefully considered the ``informal hearing''
provisions pursuant to Sec. 13.301, but do not find that provision
adequate to afford Respondent a meaningful right to a hearing,
consistent with due process.
---------------------------------------------------------------------------
II. Substantive Issue
Whether the record establishes that Respondent's DEA COR
BC0181999 as a practitioner should be revoked and any pending
applications for renewal or modification of that registration should
be denied because her continued registration would be inconsistent
with the public interest as that term is used in 21 U.S.C. 824(a)(4)
and 823(f).
III. Findings of Fact
I find, by a preponderance of the evidence, the following facts:
A. Stipulated Facts
Respondent is registered as a practitioner in Schedules II-V
under DEA registration number BC0181999.
B. General Overview
Respondent's State Medical License and Controlled Substance License
The Texas Medical Board issued an Order of Temporary Suspension
(without Notice of Hearing) on August 19, 2008, thereby rendering
Respondent's Texas medical license temporarily suspended. (Gov't Ex.
6; Tr. 33.) On October 16, 2009, the Texas Medical Board issued an
Order Denying Temporary Suspension or Restriction of Texas Medical
License, thereby reinstating Respondent's Texas medical license.
(Gov't Ex. 7; Tr. 33.) The Texas Department of Public Safety revoked
Respondent's Controlled Substances Registration on August 4, 2009,
based solely on the Drug Enforcement Administration's immediate
suspension of Respondent's Controlled Substance Registration.\21\
(Resp't Ex. 2.). Respondent was previously disciplined by the Texas
Medical Board on three separate occasions between December 2000 and
April 2009; each action resulted in a monetary fine.\22\
---------------------------------------------------------------------------
\21\ See Tex. Health & Safety Code Sec. Sec. 481.066(b),
481.063(e)(3); 37 Tex. Admin. Code Sec. 13.274(a).
\22\ In December 2000, Respondent was cited for substandard
chart documentation resulting in a monetary fine, chart monitoring
and eight hours of continuing education in medical recordkeeping;
Respondent received a monetary fine for failure to timely notify the
Texas Medical Board of the relocation of her practice from Corinth
to Denton (date not reflected in record but assumed to be prior to
April 2009); and in March or April 2009, Respondent received a
monetary fine in relation to missing fentanyl. (Tr. 185.)
---------------------------------------------------------------------------
Dr. Odette Louise Campbell (Respondent)
Respondent attended the College of William & Mary in
Williamsburg, Virginia. She received a master's degree in psychology
from Virginia Commonwealth University and attended medical school in
Virginia. Respondent completed internal medicine and oncology
residency programs in Philadelphia and remained at the hospital as
an attending physician. She relocated to Galveston, Texas, and then
to Dallas, Texas, where she has practiced medicine since
approximately 1991. (Tr. 110.) Between 1999 and 2002, Respondent
built four cancer centers. She built a fifth cancer center in 2005
at 4851 South I-35 East, Corinth, Texas. (Tr. 112.) She has been
involved in multiple research projects regarding lymphoma, central
nervous system lymphoma and the method of delivery of fentanyl to
cancer patients. (Tr. 114.)
Dr. Robert James Babuji (Dr. Babuji)
Dr. Babuji is a practicing physician. He completed his basic
medical degree at Stanley Medical College in Madras, India in 1986;
he completed general internal medicine training in the United
Kingdom from 1987 until 1991; from 1991 until 1992, Dr. Babuji
conducted basic research in cardiology; in 1994, he relocated to the
United States and completed residency training at the University of
Utah in Salt Lake City, Utah; he completed an advanced heart failure
and transplantation fellowship in Salt Lake City, a cardiology
fellowship at the University of Virginia in Charlottesville and
Salem, Virginia, and then a cardiology fellowship in San Francisco,
California; in 1999, Dr. Babuji returned to the United Kingdom where
he practiced cardiology and internal medicine; in 2002, he returned
to the U.S. to start in private practice in Florida and then later
in Dallas, Texas, where he has practiced in cardiology, internal
medicine, and primary care for the last three years. (Tr. 265.) Dr.
Babuji is not certified in pain management but based on his training
and experience is familiar with the procedures involved in pain
management, based in part on his treatment of patients with numerous
pain conditions. Dr. Babuji further testified that he is familiar
with the standard of care required to treat patients with chronic
pain syndrome. (Tr. 266.)
C. DEA Investigations
(a) DEA Diversion Investigator Joel Lynn Dunn (DI Dunn)
DI Dunn has been a DEA Diversion Investigator for six years. He
is assigned to the Dallas Field Division. DI Dunn received training
as a diversion investigator at the DEA training academy. (Tr. 15.)
(b) DEA Diversion Investigator Anita Chalmers (DI Chalmers)
DI Chalmers has been a DEA Diversion Investigator for ten years.
She is assigned to the Dallas Field Division, where she has been
employed for twenty years. (Tr. 91.)
(c) DEA Diversion Investigator Richard Leakey (DI Leakey)
DI Leakey has been a DEA Diversion Investigator for
approximately seven years. He is assigned to the Dallas Field
Division. (Tr. 98.)
(d) Respondent's Registered Location
Respondent's DEA-registered location is the Corinth Medical
Group, 4851 I-35 East, Denton, Texas. Respondent was evicted from
that location in late 2008 and moved to a temporary location
(Collier Street) for an unknown length of time and then to a
permanent location at 431 Mesa Drive on or about February 1, 2009.
(Tr. 160.) Respondent did not move any controlled substances from
the Denton location and the medications were destroyed prior to
Respondent's eviction. (Tr. 197-98.) DI Dunn testified that
Respondent was practicing at 431 Mesa Drive in April 2009, when the
FBI executed a search warrant of that location; that Respondent was
not authorized to possess controlled substances at that location;
and that controlled substances were found there. (Tr. 52, 53.) DI
Dunn further testified he was unaware of any requests from or
attempts made by Respondent to modify the address of her registered
location but that Respondent has updated her registered location in
the past and Respondent did not have a practice at 4851 I-35 East.
(Tr. 85, 87.)
Respondent did update her new Mesa Drive registered address with
the Texas Department of Public Safety and the Texas Medical Board.
(Tr. 85, 160.) Respondent testified that she contacted the DEA
seeking copies of records and provided her new address at that time.
Respondent further stated that she believed she had fulfilled her
requirement to change her registered address because she received
documents from the DEA at 431 Mesa Drive. (Tr. 160.)
Respondent stated in a written request for hearing dated August
27, 2009, that
[m]y office administrator notified the Dallas office of the DEA in
the third week of February 2009 informing them of my new office
address. At the time of the notification, my office had requested a
copy of a prior report of a theft which occurred in January 2009 be
sent to our new office address. In addition, my new office address
had been sent to the Texas Medical Board and the Texas DPS office in
Austin, Texas. My Duplicate prescriptions reflected my new office
address which led me to believe that I had fulfilled the Federal law
requirements. I did not also send my new address to the Arlington,
Virginia office. I did not know that this additional notification
was required until August 4, 2009. I have been unable to complete my
change of address successfully on the DEA internet site after
multiple attempts prior hereto . . . .
(ALJ Ex. 2.)
(e) Respondent's Issuance of Methadone to Opioid-Addicted Patients
(i) [JF]
DI Dunn testified that a physician must be registered with the
DEA as a narcotic treatment program to prescribe methadone;
Respondent is not registered with the DEA as a narcotic treatment
program. (Tr. 21.) DI Dunn further testified that he did not consult
with a physician regarding the standard of care applied when a
physician treats a methadone patient with Suboxone but that he does
consult the Code of Federal Regulations (CFR) which allows a
physician to prescribe Suboxone. (Tr. 70.)
DI Dunn further explained that he was contacted by Lori Price,
Director of the Denton Treatment Program, a narcotic treatment
program that is registered by the DEA to administer methadone to
narcotic addicts; that Ms. Price was concerned because she was aware
of a number of
[[Page 41070]]
patients who left the clinic to be treated by Respondent; and that
he asked Ms. Price to speak with the patients to ask them to contact
him to discuss their treatment. (Tr. 21.)
DI Dunn related that [JF] contacted him and they spoke on
several occasions; that [JF] went to Respondent for only one reason:
to get off methadone and start taking Suboxone, a Schedule III
controlled substance (Tr. 22); and that Respondent never prescribed
Suboxone to [JF]. DI Dunn stated that he had not seen [JF]'s medical
chart as of the time of Respondent's suspension. (Tr. 67.)
The Government introduced at hearing an unsworn but witnessed
statement signed ``[JF],'' \23\ indicating that [JF] received from
Respondent prescriptions for Valium and methadone and that ``[a]s a
result of taking these prescription [sic] I ended up on life sapport
[sic] for 30 days. I could not walk or move any part of my body.''
(Gov't Ex. 12.)
---------------------------------------------------------------------------
\23\ [JF] was not called by either party, nor is there any
evidence of record to indicate that [JF] was not otherwise available
as a witness.
---------------------------------------------------------------------------
Respondent testified that the Denton Treatment Center provides
methadone treatment for patients that have methadone addiction
issues and that she spoke with Lori Price when she contacted the
Center to request [JF]'s records. (Tr. 130.) Respondent further
testified that she did prescribe to [JF] 10 mg methadone quantity
120 with instructions to take two tablets two times per day, a
thirty-day supply, pursuant to Respondent's instructions, and 10 mg
diazepam quantity 90 with instructions to take one tablet every
eight hours. (Gov't Ex. 13 & 14.) The medical record for [JF]
indicates that [JF] initially began taking methadone to treat
chronic pain from ``chronic arthritics pain in [the] neck, lumbar
spine and left knee.'' (Resp't Ex. 6, at 8.)
Respondent testified that [JF] was self-referred to Respondent,
whose name she said she received from Lori Price, and that [JF]
wanted to stop taking methadone and start taking Suboxone in order
to save money because she did not have a lot of money to receive
treatment from the methadone clinic. (Tr. 132, 141, & 220.)
Respondent explained that in order to change a patient's medication
from methadone to Suboxone, the physician must first counsel the
patient regarding potential side effects and then the patient must
detoxify from methadone before taking Suboxone. (Tr. 141.)
Respondent further explained that Suboxone was a superior medication
for [JF] because it has less of a respiratory depressant effect and
[JF] was on oxygen twenty four-hours per day; the Suboxone for [JF]
would be used for pain management and [JF] signed a pain management
agreement; [JF] had to first detoxify from the methadone and then
Respondent would prescribe Suboxone; and [JF] did detoxify from
methadone. (Tr. 141; Resp't Ex. 6; Tr. 143.)
Respondent also testified that, during an office visit, she did
not prescribe Suboxone because [JF] determined that she was unable
to afford the Suboxone; Respondent could not send [JF] back to the
treatment center to resume methadone because the center had stopped
seeing patients for the day; Respondent provided [JF] with a very
low pain management dose of methadone: 20 mg with instructions to
take one two times per day; Respondent previously took 120 mg of
methadone per day; and if the methadone clinic had been open that
day, Respondent would have sent [JF] back. (Tr. 143, 220.)
Respondent agreed to place [JF] on a list to receive free Suboxone
because Respondent can sponsor two Suboxone patients per year and
agreed that Respondent would maintain [JF] on methadone in the
interim. (Tr. 144.)
Respondent testified that [JF] was hospitalized four days after
[JF]'s visit with Respondent because [JF] had aspiration pneumonia
and an upper GI bleed; that no drug screen was performed at the
hospital; and it was impossible for [JF] to overdose from
Respondent's prescriptions as written. (Tr. 145.)
Dr. Babuji testified the normal course of treatment when
starting a patient on Suboxone is to wean the patient off methadone
first and then start prescribing Suboxone. (Tr. 267.) Dr. Babuji
explained that Suboxone is used to treat opioid addiction and as a
pain management tool and that Suboxone would be an appropriate
treatment for [JF]. (Tr. 291.) Dr. Babuji further testified that,
because [JF] was unable to afford the Suboxone, [JF] was maintained
on a smaller dose of methadone to stop further withdrawal and allow
a slow withdrawal of the methadone, which would be helpful for
chronic pain syndrome, and that there was no reason for [JF] to
return to the Denton Treatment Center because [JF] was already on
methadone and being weaned off with the intent of starting on
Suboxone. (Tr. 268.)
Based on his review of [JF]'s medical records, Dr. Babuji found
that [JF] presented to Respondent with pain in the right foot, left
knee, the lumbar region and the neck area. (Tr. 267.) Dr. Babuji
testified that he reviewed the discharge summary from [JF]'s
hospital visit; that the visit was the result of the exacerbation of
chronic obstructive pulmonary disease which led to pneumonia; and
that there was no evidence of a drug overdose. (Tr. 269, 290.)
(ii) [MM]
DI Dunn testified that he received [MM]'s patient file pursuant
to a search warrant executed on the premises of Respondent's
practice. (Tr. 43.) A review of the patient file indicated that [MM]
was receiving methadone and that [MM]'s previous physician was a
narcotic treatment program. (Tr. 41.)
DI Dunn further testified that he spoke with [MM], who told him
that [MM] was a lifelong heroin addict; [MM] was seeing Respondent
for narcotic treatment because the methadone from Respondent was
less expensive than what [MM] received through the narcotic
treatment program; and that although [MM] did sign a pain management
agreement with Respondent, [MM] was not seeing Respondent for pain
management. (Tr. 41.)
[MM] signed an unsworn, but witnessed statement indicating that
[MM] was a recovering alcoholic and used heroin; [MM] relapsed and
went to the methadone clinic ten years ago; in or around April 2009,
after [MM] started receiving Medicaid and Social Security
disability, [MM] heard that Respondent would accept Medicaid and
prescribe methadone; and [MM] saw Respondent for addiction
treatment, not pain treatment. (Gov't Ex. 18.)
[MM]'s patient file indicates [MM] signed a pain management
agreement on April 15, 2009; [MM] wrote that [MM]'s reason for
visiting Respondent's office was ``methadone, osteoporosis, ativane,
and smoking patch''; that [MM]'s previous physician was the
Brentwood clinic where [MM] received methadone; and [MM] had
complaints and history of back pain and leg pain. [MM]'s patient
file also reflects that Respondent noted that [MM] suffered from
shoulder and leg pain, opioid addiction, anxiety, depression,
chronic back pain and arthritis. (Gov't Ex. 16.)
Respondent testified that [MM] told her that she had been
diagnosed with osteoporosis; that she explained to [MM] that she
helps patients get off methadone and that she doesn't do methadone
maintenance for patients with only addiction problems but she may
use methadone to treat chronic pain; that [MM] said [MM] did have
chronic pain; that Respondent reviewed the pain management contract
with [MM]; and that [MM] presented as a dual-diagnosis patient
suffering from both chronic pain and addiction. (Tr. 172.)
(iii) [TR]
DI Dunn testified that [TR]'s patient file was seized pursuant
to a search warrant executed at Respondent's practice. DI Dunn has
not spoken with [TR]. (Tr. 46.)
Respondent testified that [TR] described [TR]'s condition as
back pain, sciatica and severe pain; that [TR] had been on methadone
for pain; and that Respondent reviewed the pain management agreement
with [TR] and subsequently placed [TR] on methadone with good
results. (Tr. 171.)
The patient file for [TR] indicates that [TR] signed a pain
management agreement on June 10, 2009; that [TR] stated the reason
for [TR]'s visits to Respondent was a need for a new doctor, to
resolve ``a lot of female problems and back problems'' and for pain
management of severe back and leg pain; that [TR] had a history of
or complaints of back pain and arthritis; and that [TR] had received
120 mg of methadone daily from a clinic. (Gov't Ex. 17.)
(f) Respondent's Possession of a Prescription Written in the Name
of an Employee
DI Dunn testified that [HM] was an employee of Respondent; that
diazepam, written in [HM]'s name, was recovered when a search
warrant was executed at Respondent's home. (Tr. 29.) DI Dunn related
that he spoke with [HM] regarding the diazepam found in Respondent's
home and that [HM] stated that Respondent asked if she could write a
prescription in [HM]'s name and then take the medication back from
[HM] because Respondent could not write prescriptions in her own
name. (Tr. 29.)
DI Dunn conceded that the sole basis for his conclusion that
Respondent received a prescription written in [HM]'s name is [HM]'s
statement and the recovery of the medication from Respondent's home.
(Tr. 83.)
[[Page 41071]]
DI Leakey testified to assisting in the execution of the search
warrant at Respondent's residence; that a bottle containing
approximately fifty tablets of diazepam was found in the master
bedroom's bathroom medicine cabinet; and that DI Leakey participated
in DI Dunn's interview of [HM]. (Tr. 99, 100, 105-06.) [HM] signed
an unsworn, but witnessed statement indicating that [HM] became a
patient of Respondent in November 2008; that [HM]worked for
Respondent until April 2009; that in early March Respondent asked
[HM] to fill a prescription for her for diazepam and for hormones
because Respondent did not have time to see her own doctor; that
[HM] filled at CVS the prescription written by Respondent and then
provided the medication to Respondent. [HM]'s statement said ``I
have never taken Valium ever . . . .'' (Gov't Ex. 11) (emphasis in
original). [HM] concluded by stating, ``[a]fter the FBI did the
search of [Respondent's] house she called me to tell me they found
the Valium RX in my name & she told them that I kept it at work & it
must have fallen in a box of files she brought home. She asked me to
tell everyone that story.'' (Gov't Ex. 11 at 2.)
A CVS pharmacy patient prescription record introduced in
evidence by Respondent for [HM] indicates that [HM] received 10 mg
diazepam quantity 10 on February 27, 2001, from Dr. [VS]. (Resp't
Ex. 13.)
Respondent testified that [HM] was initially a patient who had
depression, generalized anxiety disorder, morbid obesity, severe
rheumatoid arthritis and multiple back surgeries; and that [HM] was
taking Xanax and Effexor for anxiety disorder. (Tr. 149; Resp't Ex.
8.) Respondent also testified that [HM] was scheduled for back
surgery, in preparation for which Respondent was transitioning [HM]
from Xanax to Valium, which she considered to be a safer medication
and which was the reason Respondent wrote [HM] the prescription for
Valium. (Tr. 150.)
Respondent further testified that [HM] brought into the office
the Valium written to [HM] by Respondent and left the bottle sitting
on a desk in a room that was being painted; that Respondent, upon
seeing a painter in the room with the unsecured medication, feared
the medication would be stolen and placed the bottle in her lab coat
pocket; Respondent then took her lab coat home and likely placed it
in the laundry, as she typically does; Respondent has no further
recollection regarding the whereabouts of the medication. (Tr. 153.)
Respondent explained that her relationship with [HM]
deteriorated because [HM] intended to sue Respondent over a medical
procedure performed by another doctor in Respondent's office. (Tr.
154.)
Debra Allinger testified that she worked in Respondent's office
from March until August 2009; that on her second day of work she was
asked to clean out [HM]'s belongings from an office that was to be
painted; and that upon seeing a prescription bottle in the office,
she told Respondent, who then put the bottle in her lab coat. (Tr.
297.)
Shelley Franks-Chapa testified that she was employed by
Respondent from February 2009 to about June 2009, and began
employment before February 14, 2009. (Tr. 310, 319.) Ms. Franks-
Chapa further testified that she was familiar with an employee named
[HM], also known as [GM]. (Tr. 312.) Ms. Franks-Chapa recalled being
present in Respondent's office on an unknown date but during her
period of employment, and overheard [HM] ask that her prescription
of Valium be faxed out. (Tr. 312.) Ms. Franks-Chapa further recalled
on cross-examination that the conversation took place in an end
office which was about to be painted within a few days and that [HM]
was present in the office working. (Tr. 316-17.)
(g) The DEA's Accountability Audit of Respondent's Practice and
Respondent's Handling of Controlled Substances
DI Dunn testified that in May 2008, he launched an investigation
of Respondent based on theft and loss reports related to the theft
or loss of experimental fentanyl; the investigation revealed reports
had not been completed properly, DI Dunn instructed Respondent as to
the proper filing of the report form and no further action was taken
and that investigation was unrelated to the instant matter. (Tr. 17,
55.) DI Dunn has been trained in how to conduct an audit at a
registered location. (Tr. 16.) DI Dunn testified that he obtained
Respondent's Demerol log from the FBI, who seized the log pursuant
to an April 2009 search warrant. (Tr. 48.)
Respondent testified she believed that an employee, Marie Lopez,
was stealing or forging prescriptions so she eventually fired Ms.
Lopez. (Tr. 115, 116.) Respondent further testified that she
believes that Ms. Lopez stole the fentanyl that was reported to the
DEA as lost. (Tr. 196.)
Respondent described how, after the first theft from her office,
she acquired two safes for the Mesa Drive location and placed one
under the sink in the triage room and one in Respondent's office.
(Tr. 119.) Respondent explained that some Schedule IV controlled
substances were stored in cabinets in the triage room and that
Suboxone, Demerol, probably Ambien, and sometimes Provigil, were
stored in a safe under the sink, but that some Provigil was in the
cabinet. (Tr. 192.) Respondent further testified that she believed
that the safe in the triage room was opened with both a combination
and a key and that Respondent did not have a key to the safe but a
member of her clinical staff would keep the key during the day, and
lock the key in the triage room at night. Respondent maintained the
key to the triage room and was always the last person out of the
office at night. (Tr. 193.) Respondent further explained that in
late 2008, her office was broken into and a safe containing
triplicate prescriptions and possibly two bottles of Suboxone was
stolen; and Respondent reported the theft to the local police and
the DEA. (Tr. 119, 196 & 199.)
Respondent testified her office procedure for documenting the
receipt of controlled substances was as follows: certain employees
were authorized to receive delivery of medications or office
supplies; all medications were taken to the triage room, where there
was a safe for storing controlled substances, and the delivery
receipt was placed in the appropriate manual for the particular
medication. (Tr. 120, 205.) Respondent further testified that
because fentanyl was part of an investigational study, the
medication was signed into a book upon receipt; each pill was
counted by an independent person who was part of the investigational
study. (Tr. 120.)
Respondent further testified that when her safe was stolen in
late 2008, the Suboxone manual was damaged and Respondent later
requested that Dendrite (a pharmaceutical supply company), send
copies of receipts of all deliveries of Suboxone to her office. (Tr.
121, 123; Resp't Ex. 11.) Respondent then obtained from Community
Pharmacy copies of receipts of medical supplies ordered by her
office. (Resp't Ex. 9.)
Respondent testified that she typically purchased Demerol
through Community Pharmacy and she requested copies of receipts from
Community Pharmacy in an effort to account for the Demerol in her
office. (Tr. 125.) Respondent testified that when she moved her
practice from 7851 South I-35 East to 431 Mesa Drive, scheduled
medications were destroyed, not moved. (Tr. 200.)
DI Dunn testified that an audit occurred after search warrants
were executed on Respondent's registered and unregistered locations
and home in April 2009, and that he did not participate in the
execution of the search warrants. (Tr. 20, 33.) DI Dunn further
testified that at a later time, he conducted an audit of
Respondent's Suboxone 8 mg for the period beginning July 18, 2008,
and ending April 9, 2009; the audit was conducted from materials
located at DEA and FBI offices, based on Respondent's inventory
records and dispensing logs that were seized pursuant to the
execution of search warrants at Respondent's office; as well as from
distributor records, ARCOS records, and a count of drugs that were
identified during the execution of the search warrants; and
approximately fifteen bottles of Suboxone were found to be missing.
(Tr. 36; see Gov't Ex. 4.) DI Dunn testified that he had no
recollection of seeing a report regarding, or being informed of, a
break-in at Respondent's office. (Tr. 64.)
DI Dunn testified that Respondent had records indicating the
dispensing of Demerol but not the receipt; because Demerol is a
Schedule II controlled substance, it can only be transferred between
registrants pursuant to a DEA Form 222, which Respondent did not
have; and that DI Dunn did not request Respondent's DEA Form 222
because he was not present when the search warrant was executed.
(Tr. 35, 65.)
DI Chalmers testified that she was present at the execution of
the search warrant at Respondent's practice location; she conducted
a search in the medication room and a location in the back of that
room that may have been Respondent's office; DI Chalmers found
controlled substances (Suboxone, Provigil, and possibly Ambien) in
an unlocked cabinet; she inventoried but did not seize the
controlled substances that she found; and that drug logs were among
the documents seized from the medication room. (Tr. 92-93.)
Respondent further testified she did not recall having copies of
DEA Form 222 for Demerol at the time of the April 2009 search,
[[Page 41072]]
stating ``I would guess that we did, but I'm not going to . . . .''
\24\ (Tr. 126-27.) Respondent explained that during the relocation
from the Corinth office to the temporary Denton office, medications
were not transferred, so she ``didn't have those little DEA 222s, so
I really didn't purchase any scheduled medications during that brief
period of time.'' After moving to the permanent office ``on Mesa, we
had to get those little 222s, because we . . . had to order them.''
(Tr. 197.)
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\24\ Respondent's answer on direct examination was interrupted
by Respondent's counsel, with a question on a different topic.
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IV. The Parties' Contentions
A. The Government
The Government first contends that there is ``no viable DEA
registration to revoke in the matter'' because Respondent failed to
file a renewal application and her registration expired by its terms
on August 31, 2010. The Government argues that any discussion
regarding revocation of Respondent's DEA registration is moot
because Respondent does not currently possess a valid DEA
registration. In the alternative, the Government argues that if the
Deputy Administrator finds that collateral consequences require the
issuance of a Final Order, then the Deputy Administrator should
affirm the immediate suspension order on the grounds that
Respondent's continued registration is inconsistent with the public
interest.
The Government argues, in substance, that Respondent's
``experience in dispensing controlled substances and record of
compliance with applicable controlled substances laws is abysmal.''
(ALJ Ex. 16, 10.) The Government supports its position with
allegations that Respondent dispensed a controlled substance
prescription for other than a legitimate medical purpose; Respondent
prescribed a Schedule II controlled substance for the purpose of
opioid addiction treatment; Respondent acted as a reverse
distributor without proper authorization by accepting from patients
and destroying controlled substances; Respondent illegally possessed
controlled substances at an unregistered location; an accountability
audit revealed that approximately fifteen bottles of Suboxone were
missing from Respondent's office; and Respondent's substandard
record-keeping prevented the DEA from performing audits of
additional controlled substances.
B. Respondent
Respondent argues, in substance, that she has never previously
been the subject of ``an allegation related to the manufacture,
distribution or dispensing of controlled substances'' and Respondent
has no conviction record under State or Federal law. Respondent
further contends that although the DEA has suggested that
Respondent's arrest in Denton County, Texas, should be considered in
determining whether Respondent's DEA COR should be revoked, this
fact should not be considered because it did not result in an
indictment or conviction and because 21 U.S.C. 824(a) was never
meant to apply to physicians in this circumstance.\25\ (ALJ Ex. 17,
12.)
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\25\ I have specifically given no weight and find no relevance
to any references or suggestions about ``arrests,'' ``criminal
search warrants'' or similar statements appearing in this record.
---------------------------------------------------------------------------
Respondent next contends that Respondent did notify the local
DEA of her change of address and was unable to complete an attempt
to ``change the national registration database,'' and Respondent
reasonably believed that she had complied with the DEA regulations
regarding address changes. (ALJ Ex. 17, 14.)
With regard to the unauthorized prescribing of a Schedule II
controlled substance for the purpose of treating opioid addiction,
Respondent contends that the allegation applies to only one
prescription and that Respondent was within the standard of care for
prescribing such medication and did not violate any laws because
Respondent provided the methadone prescription for pain management,
which Respondent documented.
Respondent also contends that she did not take a patient or
employee's Valium for her own use. Respondent asserts that she came
into possession of the medication because she found the medication
in the open and attempted to secure it; and that she subsequently
forgot about the medication, which eventually ended up in her home,
in her laundry pile.
Respondent argues that although the DEA contends that Respondent
failed to properly maintain logs and receipts for controlled
substances, the DEA never asked to review her controlled substances
logs and never asked Respondent to provide receipts.
Respondent finally contends that a finding that Respondent's
continued registration would be inconsistent with the public
interest, would not be consistent with the finding of the state
licensing authority, which refused to suspend or revoke Respondent's
medical license, and that Respondent has at all times ``remained
compliant with State and Federal law in her practice of medicine and
prescribing controlled substances.'' (ALJ Ex. 17, 16.)
V. Discussion and Conclusions
A. The Applicable Statutory and Regulatory Provisions
The Controlled Substances Act 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.\26\ ``A separate registration shall be required at
each principal place of business or professional practice where the
applicant . . . dispenses controlled substances.'' \27\ DEA
regulations provide that any registrant may apply to modify his
registration to change his address but such modification shall be
handled in the same manner as an application for registration.\28\
---------------------------------------------------------------------------
\26\ 21 U.S.C. 822(a)(2).
\27\ 21 U.S.C. 822(e).
\28\ 21 CFR 1301.51.
---------------------------------------------------------------------------
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 his professional
practice.\29\ A registered individual practitioner is required to
maintain records of controlled substances in Schedules II through V
that are dispensed and received, including the number of dosage
units, the date of receipt or disposal, and the name, address and
registration number of the distributor.\30\
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\29\ 21 U.S.C. 844(a).
\30\ 21 CFR 1304.03(b), 1304.22(a)(2)(ix), 1304.21(a),
1304.22(c) & 1304.22(a)(2)(iv).
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B. Statement of Law and Discussion
The Controlled Substances Act, at 21 U.S.C. 824(a)(4), provides,
insofar as pertinent to this proceeding, that the Deputy
Administrator may revoke a COR if she finds that the continued
registration would be inconsistent with the public interest as that
term is used in 21 U.S.C. 823(f).\31\
---------------------------------------------------------------------------
\31\ 21 U.S.C. 824(a)(4).
---------------------------------------------------------------------------
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. See David H. Gillis, M.D., 58 FR 37,507, 37,508
(DEA 1993); see also D & S Sales, 71 FR 37,607, 37,610 (DEA 2006);
Joy's Ideas, 70 FR 33,195, 33,197 (DEA 2005); Henry J. Schwarz, Jr.,
M.D., 54 FR 16,422, 16,424 (DEA 1989).
Additionally, in an action to revoke a registrant's COR, the DEA
has the burden of proving that the requirements for revocation are
satisfied.\32\ The burden of proof shifts to Respondent once the
Government has made its prima facie case. Medicine Shoppe--
Jonesborough, 73 FR 364 (DEA 2008); see also Thomas Johnston, 45 FR
72,311 (DEA 1980).
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\32\ 21 CFR 1301.44(e) (2010).
---------------------------------------------------------------------------
C. The Factors To Be Considered
Factor 1: The Recommendation of the Appropriate State Licensing Board
As described in the Procedural Section of these Recommended
Rulings, Respondent does hold a valid state medical license but
Respondent's state controlled substances
[[Page 41073]]
registration has been suspended. Respondent, therefore, does not
possess valid authority to handle controlled substances in the
jurisdiction in which she is registered. Given that the Texas
authorities relied exclusively on the DEA action to suspend
Respondent's state authority, however, Respondent's lack of such
authority is not dispositive and has no relevance in determining
whether Respondent's continued registration would be inconsistent
with the public interest.
There is evidence, however, that the Texas Medical Board has
taken prior action against Respondent's medical license. Although
the Government presented no evidence regarding the matter,
Respondent did testify that she has been disciplined by the Texas
Medical Board on three prior occasions: 1) in December 2000,
Respondent was cited for substandard chart documentation resulting
in a monetary fine, chart monitoring, and eight hours of continuing
education in medical recordkeeping; 2) Respondent received a
monetary fine for failure to timely notify the Texas Medical Board
of the relocation of her practice from the City of Corinth to the
City of Denton; and 3) in March or April 2009, Respondent received a
monetary fine in relation to missing fentanyl. (Tr. 186-87.)
Although no additional detail is available, the Texas Medical
Board action taken against Respondent with regard to Respondent's
failure to timely notify the Texas Medical Board of the relocation
of her practice appears to be similar to Respondent's failure to
notify the DEA of a subsequent change of practice location.
Accordingly, the fact that Respondent was previously disciplined by
the Texas Medical Board does weigh in favor of revocation.
It is important to also note that the Texas Medical Board did
temporarily suspend Respondent's medical license on August 19, 2009,
and reinstate Respondent's medical license on October 16, 2009; the
evidence indicates that Respondent's Texas medical license is
currently active. The August 19, 2009, suspension order referenced
the suspension action taken by the DEA; however, the order also
referenced numerous other grounds which were apparently unrelated to
the grounds upon which the DEA issued the OSC/IS; specifically, the
Texas order addressed issues related to the issuance of
prescriptions to Respondent's patients by another physician. (Gov't
Ex. 6, 7.)
These issues were not raised in the OSC/IS but were addressed in
the Government's Prehearing Statement. At hearing, however, the
Government did not elicit testimony regarding the issues related to
prescriptions written by another physician but did submit some
limited documentary evidence on the matter. (See Gov't Ex. 3, 6 &
7.) The documentary evidence provided is not sufficient to warrant a
review of an issue which the Government has failed to adequately
pursue in the proceeding and the issue, therefore, will not be
considered further.
The Texas Medical Board's October 16, 2009 Order reinstating
Respondent's Texas medical license offers little substantive insight
with regard to its own factual findings, which were found to be
inconclusive. ``The Panel is unable to determine from the evidence
presented that Respondent is a continuing threat to the health of
Respondent's patients or a continuing threat to the public. . . .''
(Gov't Ex. 7.) Accordingly, the action and findings of the Texas
Medical Board do not significantly weigh for or against Respondent
with regard to the temporary suspension and later reinstatement. The
current active status of Respondent's Texas medical license does, on
balance, weigh against a finding that Respondent's continued
registration would be inconsistent with the public interest.
Factor 3: Respondent's Conviction Record
There is no evidence that Respondent has ever been convicted
under any federal or state laws relating to the manufacture,
distribution or dispensing of controlled substances. I therefore
find that this factor, although not dispositive, weighs against a
finding that Respondent's continued registration would be
inconsistent with the public interest.
Factors 2 and 4: Respondent's Experience in Handling Controlled
Substances; and Compliance with Applicable State, Federal, or Local
Laws Relating to Controlled Substances
In this case, there is no evidence that, prior to any action
related to this matter, Respondent has failed to remain in
compliance with applicable federal laws relating to controlled
substances. The testimony and evidence does reveal, however, that
Respondent failed to properly notify the DEA that she relocated her
practice from her registered location to a new unregistered
location, in violation of both state and federal law.\33\ There is
no evidence that, prior to the current circumstances, Respondent has
failed to comply with the Controlled Substances Act. The Respondent
has admitted to a March or April 2009, Texas Medical Board monetary
fine in relation to missing fentanyl. There is no other independent
evidence of record relating to the circumstances surrounding that
issue.
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\33\ Any registrant may apply to modify his or her registration
to change his or her name or address, by submitting a letter of
request to the Registration Unit, Drug Enforcement Administration,
Department of Justice, Post Office Box 28083, Central Station,
Washington, DC 20005. Cf. 21 CFR 1301.14 (2010). The request for
modification shall be handled in the same manner as an application
for registration. 21 CFR 1301.12 et. seq.; see also 37 Tex. Admin.
Code Sec. 13.23 (2010).
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(a) Respondent's Registered Location
It is undisputed that Respondent relocated her practice from her
registered location, 4851 I-35 East, Suite 101, Denton, Texas 76210
(I-35 office), to a new location, 4310 Mesa Drive, Denton, Texas
76207 (Mesa office), on or around February 1, 2009. Respondent
testified that she relocated her practice to the Mesa office because
she was evicted from the I-35 office in late 2008.\34\ Respondent
maintains that she did not move controlled substances or acquire
controlled substances for use at her temporary Collier street
location. (Tr. 197-98.) The evidence does indicate, however, that
Respondent did possess and distribute controlled substances from the
unregistered Mesa office during the period beginning approximately
February 1, 2009, and ending with the issuance of the OSC/IS on
August 4, 2009.
---------------------------------------------------------------------------
\34\ Respondent testified that all controlled substances that
remained at the I-35 location were destroyed, not relocated.
---------------------------------------------------------------------------
Federal law requires every person who dispenses any controlled
substance to obtain a registration from the Attorney General.\35\
Additionally, a separate registration must be obtained for each
principal place of practice where an applicant dispenses controlled
substances and a registrant must report any change of address by
applying to modify his or her registration to change his/her
address, which shall be treated as an application for
registration.\36\ The CFR clearly states the procedures a registrant
must follow to request a change in the registered address.\37\
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\35\ 21 U.S.C. 822(a)(2).
\36\ 21 U.S.C. 822(e), 827(g); 21 CFR 1301.51 (2010).
\37\ See 21 CFR 1301.51 (2010).
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In this case, the evidence indicates that Respondent failed to
modify her registration to update her Mesa office practice address.
Respondent testified she believed that she properly notified the DEA
of her new address when she requested certain documents be sent to
her new location. The evidence of record reflects that Respondent
has previously successfully modified the address of her registered
location at least three times \38\ and therefore Respondent was
fully aware of the proper procedure for requesting an address
change. (Gov't Ex. 2.) Additionally, there was no evidence presented
at hearing confirming that Respondent has even yet successfully
updated the address of her practice location.
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\38\ August 21, 2001; March 11, 2003; and September 16, 2004.
---------------------------------------------------------------------------
The search warrant executed by the FBI and the DEA in April 2009
reflected the presence of controlled substances from Respondent's
unregistered Mesa Drive location. I therefore find that Respondent
failed to properly notify the DEA of the change in address of her
registered location and Respondent possessed and dispensed
controlled substances from an unregistered location, in violation of
21 U.S.C. 822(e) and 827(g) and 21 CFR 1301.51.
In mitigation, the Respondent's actions with regard to notifying
DEA do not appear to be intentionally deceitful, because the
Respondent credibly testified that she notified the Texas DPS of her
new Mesa office address, and no other evidence of record was offered
by either party at hearing to the contrary. (Tr. 161-64.) Respondent
also introduced as evidence prescription pads which reflected the
address of 4310 Mesa Drive, Denton, Texas. (Resp't Ex. 5.) Clearly
the evidence as a whole is consistent with Respondent's testimony
that the failure to update her new address was due to an omission,
notwithstanding the evidence of neglect by Respondent to ensure it
had been properly done.
(b) Respondent's Issuance of Methadone to Opioid-Addicted Patients
The Government provided evidence, which Respondent corroborated,
that Respondent
[[Page 41074]]
prescribed methadone to three (3) opioid-addicted patients \39\ who
were previously treated at an addiction treatment center. The
Government, however, further alleged that Respondent's treatment of
these patients amounted to the unauthorized treatment of narcotic-
dependent patients by prescribing Schedule II controlled substances
for the purpose of treating opioid addiction, which is inconsistent
with 21 U.S.C. 823(g)(1) and 21 CFR 1306.04(c).
---------------------------------------------------------------------------
\39\ Referred to herein as [JF], [MM] and [TR].
---------------------------------------------------------------------------
Federal law requires a separate registration for
``[p]ractitioners who dispense narcotic drugs to individuals for
maintenance treatment or detoxification treatment . . . .'' \40\ A
practitioner may, however, ``lawfully prescribe methadone to a
patient for pain management purposes under his practitioner's
registration.'' Tony T. Bui, M.D., 75 FR 49,979 (DEA 2010) (citing
21 U.S.C. 823(f)). The Government presented evidence indicating that
Respondent prescribed methadone to three patients who were
previously treated with methadone at an addiction treatment center.
(Gov't Exs. 12-14, 16-18.) The Government contends in part that
Respondent was providing opioid addiction treatment because each of
the three patients were already taking methadone when they first
became patients of Respondent, and that each patient previously
received methadone from a methadone clinic. This alone does not
amount to substantial evidence indicating that Respondent was
improperly prescribing a Schedule II controlled substance for the
purpose of opioid addiction treatment.
---------------------------------------------------------------------------
\40\ 21 U.S.C. 823(g) (2006).
---------------------------------------------------------------------------
Although the documentary evidence does indicate an opioid
addiction in each of the three patients, this evidence consists of
unsworn statements from patients [JF] and [MM], along with medical
records relating to the three patients, which must be weighted
accordingly. The allegation of improper prescribing of methadone is
unsubstantiated by the documentary evidence and was, in fact,
refuted by Respondent's expert witness; and, in each instance,
Respondent has established an underlying purpose of pain management.
``While methadone is approved by the FDA, and has long been used,
for the treatment of opioid addiction . . . the drug is also
approved for the treatment of pain.'' Bui, 75 FR at 49,988.
Moreover, the record contains no expert evidence showing that
Respondent's prescribing of methadone was inconsistent with accepted
medical practice for prescribing the drug for pain management.
The Government bears the burden on the issue of whether
Respondent's prescribing of methadone ``was for the purpose of
treating opioid addiction'' and not as part of an accepted medical
practice for pain management. Similar to Bui, the Government has
presented no expert evidence indicating such and relies solely on
hearsay and unsworn statements. Respondent has testified that the
treatment of the three patients in question was for pain management
related to a number of underlying medical conditions, which are
objectively documented in the medical records introduced at hearing
by both parties. Additionally, the Respondent presented expert
testimony from a medical doctor with experience treating chronic
pain, even though not formally certified in pain management.
In Calhoun v. Bailar, 626 F.2d 145 (9th Cir. 1980), the court
found that to constitute substantial evidence the probative value
and reliability of hearsay evidence may be analyzed using many
factors, such as: a consideration regarding the independence or
possible bias of the declarant; the type of hearsay material
presented; whether the statements are signed and sworn or anonymous,
oral or unsworn; whether the statements are contradicted by direct
testimony; whether the declarant is available to testify and, if so,
whether the objecting party subpoenas the declarant or whether the
declarant is unavailable and no other evidence is available; the
credibility of the witness testifying to the hearsay; and whether or
not the hearsay is corroborated. Id. at 149; see also Richardson v.
Perales, 402 U.S. 389, 402-06 (1971).
DI Dunn credibly testified at hearing that his investigation
revealed that Respondent treated several patients who previously had
been treated for narcotic addiction at the Denton Treatment Center.
DI Dunn obtained unsworn statements from two of those patients, [JF]
and [MM], both indicating in substance that they did not consult
Respondent for the purpose of pain management. That testimony and
evidence, however, does not carry much weight based on the factors
set forth in Calhoun.
The written patient statements presented by the Government were
unsworn; there is no evidence that an attempt was made to subpoena
the witnesses, and the Government provided no indication that the
witnesses were unavailable to testify; no evidence was offered to
explain why the statements were unsworn; there was no evidence
presented to indicate whether the declarant witnesses are credible;
and the statements provided are not corroborated by other record
evidence.
For example, the patient files specifically refer to a number of
objective medical findings and diagnoses that are inconsistent with
the unsworn statements. In the case of [MM], the medical file
reflects entries from April to August 2009, including patient
complaints of osteoporosis left shoulder and leg; back, shoulder and
leg pain at level seven, among other complaints; and diagnoses of
chronic back pain; arthritis; opioid addiction; anxiety; depression;
and weight management, among others; as well as positive physical
findings on examination to include lumbosacral back pain. (Gov't Ex.
16.) In the case of [TR], the medical file reflects entries from
June to August 2009, including patient complaints of back and left
knee pain; ``lumbosacral back pain from scoliosis for several years.
Pain 10/10 without meds.'' (Gov't Ex. 17, at 35.) The file reflects
diagnoses of chronic back pain; left knee arthritis; anxiety; and
depression, among others; as well as positive physical findings on
examination to include positive lumbosacral back pain and bilateral
hip pain, among other findings. (Gov't Ex. 17.) In the case of [JF],
the medical file reflects entries from January to February 2009,
including patient complaints of chronic pain complicated by history
of opioid dependence resulting from chronic arthritic pain in the
neck, back and left knee. Diagnoses included arthritis in the
cervical and lumbar spine, chronic pain syndrome, and opioid
dependence, among other findings.
In addition to the patient files, the unrebutted testimony and
expert opinion of Dr. Babuji support a finding that the methadone
was prescribed for pain management, not for opioid addiction.
Although the Government did object to the testimony of Dr. Babuji at
hearing on the grounds that he was not ``proffered as an expert,''
\41\ that objection is misplaced.\42\ The Government further argues
in its post-hearing brief that Dr. Babuji's testimony be given no
weight because he ``was not tendered and/or accepted as an expert
witness . . . [and] [t]here is no indication from his testimony that
[he] has any experience in pain management or addiction treatment.''
(ALJ Ex. 16, 6.) To the contrary, Respondent indicated in her
Prehearing Statements that she was offering the witness as an
expert, and I so find. Additionally, Dr. Babuji's testimony
specifically included an admission that he was not certified in pain
management, but he based his testimony in part on his experience
treating his own patients with conditions of pain.
---------------------------------------------------------------------------
\41\ (Tr. 288.)
\42\ The Government offers no authority in support this
argument. While Respondent did offer Dr. Babuji as an expert
witness, there is no formal requirement to either ``offer'' or
``accept'' an expert witness during hearing. See United States v.
Johnson, 488 F.3d 690, 697-98 (6th Cir. 2007) (frowning on the
practice of labeling the witness as an ``expert'' in the presence of
the fact finder); see also United States v. Rice, No. ACM 30231,
1994 WL 164477 at *1 (AFCMR Apr. 22, 1994) (noting ``no requirement
in either military or federal practice mandating that an expert
witness be tendered (offered) and accepted before providing expert
testimony.'')
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I find that Dr. Babuji was adequately proffered as an expert and
I have evaluated his testimony as an expert witness with regard to
the standard of care in treating patients with pain management
conditions. Dr. Babuji is clearly qualified to testify regarding the
general standard of care and treatment of patients with pain
management issues, based on his education, training, and experience
over twenty years, including practicing cardiology, internal
medicine and primary care for the last three years in Dallas, Texas.
(Tr. 265.)
Dr. Babuji's demeanor was serious and forthright throughout his
testimony. The evidence reflected that Dr. Babuji has known the
Respondent for between two and three years, having done cardiology
consults in her Denton, Texas office approximately once per week.
(Tr. 270.) Dr. Babuji's appearance and testimony at hearing was
without benefit of financial compensation. On cross-examination the
Government challenged the witness with regard to whether he had
reviewed the entire [JF] file, suggesting that he had not, because
the ``complete file . . . is approximately 700 to a thousand
pages.'' \43\
[[Page 41075]]
While there may be some doubt as to the exact number of pages
reviewed by Dr. Babuji with regard to the [JF] medical file, he
credibly maintained that he had sufficient information available to
support his conclusion, noting his review of hundreds of pages of
the medical file including the discharge summary. There is no other
evidence to suggest the witness had a bias or interest in the
outcome of the case.
---------------------------------------------------------------------------
\43\ Government counsel asked the witness: ``Would it surprise
you to learn that the complete file regarding [JF]'s hospital visit
is approximately 700 to a thousand pages?'' (Tr. 287.) The factual
basis for this question remains a mystery, since no other medical
records relating to [JF] were received in evidence other than
Respondent's exhibit six. Respondent's exhibit seven relating to
[JF] was withdrawn and the Government presented no case in rebuttal.
---------------------------------------------------------------------------
I find that Dr. Babuji presented fully credible competent
evidence within his stated area of expertise. The testimony is
consistent with that presented by the Respondent, who credibly
testified at hearing in detail as to the standard of care she used
in treating the three patients at issue in this matter. The
testimony of Dr. Babuji and the Respondent is also consistent with
other documentary evidence of record including the relevant
treatment records. Accordingly, I find that the Government has not
established by a preponderance of the evidence that Respondent
prescribed Schedule II controlled substances to patients for the
purpose of treating opioid addiction in violation of 21 U.S.C.
823(a)(1) and 21 CFR 1306.04(c).
(c) Respondent's Possession of a Prescription Written in the Name
of an Employee
The Government alleges that Respondent prescribed controlled
substances for other than a legitimate medical purpose when she
issued a prescription to a then-current employee and the controlled
substance was later found in Respondent's home. Under DEA's
regulations, a prescription for a controlled substance is unlawful
unless it is ``issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his
professional practice.'' \44\
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\44\ 21 CFR 1306.04 (2010).
---------------------------------------------------------------------------
At the hearing in this matter, the Government presented evidence
consisting of photographs of a prescription bottle for diazepam 10
mg, quantity 90, issued in the name of [HM], which DI Dunn testified
was found in Respondent's bathroom medicine cabinet and which the
DEA had tested; photographs of tablets; an unsworn statement by
[HM]; and the testimony of DI Leakey, who assisted in the search of
Respondent's residence and seizure of the [HM] prescription
containing an estimated fifty (50) pills.\45\ Respondent provided
evidence consisting of Respondent's medical records for [HM] and CVS
pharmacy records for [HM] along with the testimony of Respondent,
Debra Allinger and Shelley Franks-Chapa.
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\45\ (Gov't Ex. 11, 15; Tr. 29-31, 37-38, 99 & 105.)
---------------------------------------------------------------------------
DI Dunn testified that [HM] was a patient and employee of
Respondent and that the DEA found, in Respondent's home, a
prescription bottle for diazepam issued in the name [HM]. (Tr. 29.)
DI Dunn's testimony is supported by photographs of the prescription
bottle and several loose pills along with the testimony of DI
Leakey, and an unsworn statement from [HM].
Respondent has not argued that the diazepam was not found in her
home, although there may be some discrepancy regarding the last
location where Respondent recalls seeing it; that the medication
found was not actually diazepam; or that she did not authorize the
prescription for [HM]. There is no dispute that the DEA did find in
Respondent's home a prescription bottle containing diazepam issued
in the name of [HM]. I therefore find no reason to provide less than
full weight to the testimony of DI Dunn or DI Leakey that the
prescription bottle of diazepam was found in a medicine cabinet in
Respondent's home containing approximately fifty (50) pills. I do
find reason, however, to provide less weight to the unsworn written
statement of [HM] given the sworn testimony of Respondent, Debra
Allinger and Shelley Franks-Chapa regarding the origin of the single
Valium prescription at issue in this case.
DI Dunn testified that he spoke with [HM] and that the statement
[HM] gave him was consistent with the written statement provided by
the Government. (Tr. 29; Gov't Ex. 11.) DI Dunn testified that [HM]
told him that Respondent asked if [HM] could write a prescription in
[HM]'s name and then get the medication back from [HM] because
Respondent could not write a prescription to herself. (Tr. 29-30.) I
find no reason to doubt the testimony of DI Dunn with regard to his
interaction with [HM]. I do, however, find that, consistent with the
factors set forth in Calhoun, [HM]'s statements are not reliable.
Respondent's testimony indicated a possibility of bias of [HM]
in that [HM] is a former patient and employee and the relationship
between Respondent and [HM] ended badly. (Tr. 154.) Respondent
testified that [HM] intended to initiate a lawsuit against her
because of poor results from a medical procedure performed by
another physician in Respondent's office. The accuracy of this
testimony was uncontested and I find it otherwise credible. As a
result of this prior dispute, [HM] would certainly have some
interest or bias in the outcome of any proceeding related to
Respondent's practice of medicine.
[HM]'s statement is contradicted by objective evidence of
record. [HM]'s statement asserts that [HM] has ``never taken Valium
ever . . . .'' (Gov't Ex. 11) (emphasis in original). Respondent,
however, submitted CVS pharmacy records for [HM] indicating that
[HM] did fill a prescription on February 27, 2001, for 10 diazepam
10 mg, written by Dr. [VS]. [HM] has, therefore, at least received a
prescription for diazepam in the distant past thereby contradicting
her statement that she has never taken Valium.\46\ The Government
also implied that the Valium prescription for [HM] was written
``before [Respondent] even had a patient consult with [GM].'' (Tr.
320.) While Respondent's medical records for [HM] appear to support
that implication, (see Resp't Ex. 8), a review of the record as a
whole indicates otherwise.
---------------------------------------------------------------------------
\46\ I take official notice from the 2007 edition of the
Physicians' Desk Reference that Valium is a brand name product
containing the Schedule IV controlled substance diazepam, a
benzodiazepine derivative.
---------------------------------------------------------------------------
Respondent's medical records for [HM] include a report of a
consultation on February 6, 2009, which indicates that Respondent
prescribed diazepam (Resp't Ex. 8.); [HM]'s prescription records, as
provided by Respondent, indicate that the diazepam prescription was
filled on February 8, 2009. (Resp't Ex. 13, at 3.) The Government
has provided no evidence indicating the actual date that the
prescription was written and is presumably relying on Respondent's
testimony that the prescription was written on February 3, 2009.
(See Tr. 221.) I find no need to determine the precise date upon
which the diazepam prescription was actually written because there
is evidence that Respondent had written prescriptions for [HM] as
early as September 26, 2008, as evidenced by [HM]'s prescription
records. (Resp't Ex. 13.) Given the fact that [HM] worked in
Respondent's office and presumably had a patient-physician
relationship with Respondent, the actual date upon which the
prescription was written provides little or no value to the evidence
regarding whether Respondent prescribed controlled substances for
other than a legitimate medical purpose.
[HM]'s statement is also contradicted by the testimony of
Respondent, Debra Allinger and Shelley Franks-Chapa. [HM] stated
that Respondent called her after the FBI searched her home and asked
her to tell people that Respondent came into possession of the
diazepam because [HM] kept the medication at work (presumably at
Respondent's practice) and ``it must have fallen in a box of files
she brought home.'' (Gov't Ex. 11.) Respondent and Ms. Allinger both
credibly testified that [HM] left the medication sitting on top of a
desk in a room that was being painted and that Respondent, after
seeing the medication, retrieved it from the desk and placed it in
the pocket of her lab coat. (Tr. 153, 297.) Additionally, Ms.
Franks-Chapa testified that she witnessed [HM] requesting
prescriptions for Valium.\47\ (Tr. 313.)
---------------------------------------------------------------------------
\47\ It is unclear whether [HM] requested the prescription from
Respondent or her nurse but the incident apparently occurred in
Respondent's office. (Tr. 317.)
---------------------------------------------------------------------------
Respondent objected at hearing to the admission of [HM]'s
statement on the grounds that the statement was unsworn, constituted
hearsay, and was unduly prejudicial because Respondent was not able
to cross-examine the declarant. (Tr. 31.) Neither party has shown
that [HM] was unavailable to testify and the Government has provided
no explanation as to why [HM] was not made available as a witness.
Neither party attempted to subpoena the witness. As the court
recognized in Calhoun, however, a respondent cannot complain of an
inability to cross-examine a witness with regard to a written report
when the respondent has failed to exercise her right to subpoena the
witness. That said, the absence of sworn testimony by [HM] at
hearing, weighed against other credible sworn testimony and credible
documentary evidence, significantly discredits the reliability and
probative value of [HM]'s statement.
[[Page 41076]]
I find [HM]'s unequivocal statements that [HM] had ``never''
taken Valium, ``ever,'' and that it was ``prescribed only this one
time for her,'' were directly contradicted by objective uncontested
evidence of a past prescription for Valium issued to [HM] and
testimony by Ms. Franks-Chapa that she witnessed [HM] requesting a
prescription for Valium. [HM]'s past adverse patient and employment
history with Respondent also indicates [HM] had a reason to be
biased against Respondent. In light of the foregoing, the unsworn
statement of [HM], corroborated only by the prescription found at
Respondent's home, is entirely discredited by the objective and
sworn testimony to the contrary.
Accordingly, I find that the Government has not established by a
preponderance of the evidence that Respondent prescribed controlled
substances for other than a legitimate medical purpose to a then-
current employee.
(d) The DEA's Accountability Audit of Respondent's Practice
The Government alleges in the OSC/IS that an accountability
audit ``performed at your office in April 2009, revealed . . . an
unexplained shortage of approximately 13 bottles of Suboxone, or 390
dosage units.'' The Government's Prehearing Statement filed on June
15, 2010, further states that an
``accountability audit was conducted on the Suboxone 8mg for the
period of July 1, 2008, through April 9, 2009. Respondent's records
show dispensation of 38 bottles (1,140 dosage units) of Suboxone.
There were 11 bottles present on-hand on the day of the search
warrant. Therefore, Respondent could only account for 49 bottles
(1,470 dosage units) of Suboxone, leaving a shortage of 13 bottles
(390 dosage units unaccounted for based on the records.''
The Government's Prehearing Statement further stated in part that DI
Chalmers would testify about the ``accountability audit conducted on
the Suboxone . . . .''
The Government's evidence at hearing with regard to the Suboxone
audit consisted of a two page ARCOS \48\ Transaction History Report
and the testimony of DI Dunn, reflecting an audit period of July 18,
2008 to April 9, 2009. (Tr. 34-35.) DI Dunn's direct testimony
regarding the audit is reflected in the following testimony:
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\48\ While neither party offered background information
regarding ARCOS during hearing, it is noted that ``Registrants are
also required to report records of sales or acquisitions of
controlled substances in Schedules I and II, of narcotic controlled
substances listed in Schedules III, IV and V, and of psychotropic
controlled substances listed in Schedules III and IV with the DEA's
Automation of Reports and Consolidated Orders System (ARCOS). 21 CFR
1304.33(c); 21 U.S.C. 827(d). These reports must be filed every
quarter not later than the 15th day of the month succeeding the
quarter for which it is submitted. 21 CFR 1304.33(b).'' Easy Returns
Worldwide, Inc. v. United States, 266 F. Supp. 2d 1014, 1016 (E.D.
Mo. 2003).
Q: Now how did you conduct your audit of Suboxone?
A: With the Suboxone, she did have some records there that
showed an inventory date. I used that date as a starting point from
her own records. She had a log of dispensing of Suboxone, so I was
able to utilize that as well. I then turned to ARCOS's subpoena and
found out who the provider for the Suboxone was, the distributor,
subpoenaed their records, used the ARCOS records, and then from
account of the drugs that were on hand on the date of the search
warrant, we were able to do an audit with those numbers on that one
drug.
(Tr. 36.) DI Dunn testified that from the foregoing audit fifteen
(15) bottles of Suboxone were missing, each containing thirty (30)
pills, for a total loss of 450 pills. (Tr. 36.)
DI Chalmers testified on direct examination that she
participated in the FBI search of Respondent's practice location on
Mesa Drive in April 2009, as DI Dunn was out of town and could not
participate. DI Chalmers further testified that her responsibilities
during the search were to speak with the Respondent and assist with
the search warrant. DI Chalmers searched the ``medication room at
the clinic and another location at the back of the room believed to
be Respondent's office setting.'' (Tr. 92.) DI Chalmers testified
that she did not conduct an audit on the Suboxone or other drugs
found in the specific location that she searched, nor did she seize
any of the controlled substances at that time. (Tr. 93.) DI Chalmers
also testified that rather than conduct an audit, she did an
inventory of the controlled substances ``that she encountered'' and
also seized documents from the medication room, to include a drug
log. While the evidence is clear that DI Chalmers did not seize any
drugs, there is no evidence of record reflecting whether any drugs
were seized from the premises or if all drugs present were
inventoried, since DI Chalmers's role in the search was limited to a
narrow location and purpose.
The evidence of an audit in this case simply cannot support any
credible findings of a shortage of Suboxone during the alleged time
period. DI Dunn's testimony of a shortage of fifteen bottles of
Suboxone as of the date of the April search appears to rest on the
``account of the drugs that were on hand on the date of the search
warrant'' compared with the data obtained from the ``ARCOS
records,'' and records from the distributor.\49\ There was no
documentary or testimonial evidence offered to indicate the search
established an accurate count of the number of bottles of Suboxone
present in Respondent's office, which is an essential component of
the audit.\50\ The testimony by DI Chalmers clearly indicates that
she only inventoried the controlled substances that she encountered
and there is no evidence whatsoever as to the number of other agents
participating in the search, what other agents encountered, the
scope of the search or the identity and total inventory of
controlled substances found during the search.\51\ There is no
evidence of record to support the conclusions reached by DI Dunn
regarding the audit, to include the details related to the search of
Respondent's office, specific items seized or inventoried, the
location of the items and related information as may be found in a
search inventory.
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\49\ DI Dunn testified that he ``subpoenaed their records,''
meaning the distributor of the Suboxone. Government exhibit four
indicates the source of the data is ARCOS rather than distributor
records. DI Dunn was asked whether the subpoenaed distributor
records ``matched up'' with the ARCOS report, and DI Dunn stated he
``believed so.'' (Tr. 36-37.) Remarkably, the Government submitted
no audit report or any other supporting documentation with regard to
distributor records, drug inventory reports compiled at the time of
the April 2009 search of Respondent's office, or any other related
documentation to factually support the audit results. The only
distributor evidence with regard to the Suboxone shipments was
offered by the Respondent. Additionally, no testimonial or other
evidence was offered with regard to the definition, source, or
reliability of ARCOS data.
\50\ It is noteworthy that the OSC/IS and Government's
Prehearing Statement recited specifically that thirteen bottles of
Suboxone were missing for a total dosage count of 390, differing
from the testimony at hearing that fifteen bottles of Suboxone were
missing for a total dosage count of 450.
\51\ The evidence at hearing suggested that the scope of the
April 9, 2009 search warrant did not specifically relate to the
search and seizure of controlled substances from any of the
premises, but rather involved the search and seizure of records.
(Tr. 93, 105.)
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Additionally, the reliability of the audit results is further
undermined by the distributer records. (See Resp't Ex. 11.) As an
example, the ARCOS data reflected in Government exhibit four
reflects a transaction date of October 28, 2008, for the shipment of
three (3) bottles of Suboxone, thirty (30) dosage units each, for a
total of ninety (90) dosage units, from the supplier Dendrite. An
invoice from Dendrite with a process date of October 28, 2008,
reflects a shipment of ``6 SUBOXONE SUBLINGUAL 8MG CIII TABLETS-30
TABLETS PER BOTTLE.'' (Resp't Ex. 11, at 3 & 9.) While there may be
an explanation for the discrepancy, none was offered at hearing nor
is an explanation readily apparent from the limited evidence offered
with regard to the audit. Evidence submitted by Respondent also
indicates that some of the Suboxone shipments were returned during
the relevant time period. (Resp't Ex. 11, at 4.)
Other discrepancies exist but it is unnecessary to elaborate
further. While I find the testimony of DI Dunn and DI Chalmers
generally credible, the limited evidence offered by the Government
at hearing related to the audit of Respondent's handling of Suboxone
for the time period of July 18, 2008 to April 9, 2009, is so lacking
in specificity and reliability that it cannot support any credible
findings or constitute substantial evidence.\52\
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\52\ The Government's post-hearing brief (ALJ Ex. 16) states
``DI Dunn's accountability audit of Suboxone is also uncontested.''
This ignores the fact that Respondent alleged in her Prehearing
Statement discrepancies with the Suboxone audit. At hearing,
Respondent further offered Respondent's exhibit eleven to rebut the
audit results, which was admitted without objection. (Tr. 123.)
---------------------------------------------------------------------------
Accordingly, I find that the Government has not established by a
preponderance of the evidence that Respondent cannot account for
``approximately 13 bottles of Suboxone or 390 dosage units.''
[[Page 41077]]
(e) DEA 222 Forms, Effective Controls and Disposal of Controlled
Substances
The Government alleges in the OSC/IS that Respondent's
``dispensing log indicates that you dispensed other controlled
substances, such as Demerol; however, you were unable to provide
investigators with any records showing receipt of those controlled
substances'' as required by 21 CFR 1304.21. The Government's
Prehearing Statement further noticed: the absence of DEA 222
Official Order Forms accounting for Demerol purchases, and no
receiving or distribution records for Provigil; and the ``Narcotic
Logbook also showed receipt of controlled substances returned to
Respondent by patients that did not want the medication. This
activity is not specifically authorized by Respondent's
registration.'' \53\
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\53\ Gov't PHS, at 4.
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The DEA regulations require all applicants and registrants to
provide ``effective controls and procedures to guard against theft
and diversion of controlled substances.'' \54\ In determining
whether there has been substantial compliance with the required
security standards, the Deputy Administrator may consider a number
of factors, including, but not limited to: the type and form of
activity conducted; the quantity of controlled substances handled;
the type of storage system used; the adequacy of key control
systems; the adequacy of supervision over employees with access to
storage areas; and the adequacy of the registrant's system for
monitoring the receipt, distribution and disposition of controlled
substances.\55\ A practitioner must store controlled substances
listed in Schedules II-V in a ``securely locked, substantially
constructed cabinet.'' \56\ Additionally, a registrant must ``notify
the Field Division Office of the Administration in his area, in
writing, of the theft or significant loss of any controlled
substances within one business day of discovery of such loss or
theft'' and complete a DEA Form 106 regarding the theft or loss.\57\
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\54\ 21 CFR 1301.71 (2010).
\55\ Id. 1301.71(b).
\56\ Id. 1301.75(b).
\57\ Id. 1301.76(b).
---------------------------------------------------------------------------
DEA regulations require a registrant to dispose of controlled
substances consistent with procedures outlined in 21 CFR Sec.
1307.21. There are no provisions in the regulations to allow a non-
registrant to return a controlled substance to a registrant. There
is no factual dispute in this case, and the Respondent readily
admitted in testimony, that on occasion controlled substances were
returned and destroyed. An undated ``narcotic log'' introduced at
hearing reflects the return of ``various'' medications during the
month of December, although no year is indicated. (Gov't Ex. 10, at
1.)
The Respondent testified in substance that her office policy was
that if a patient did not like the medication, or had a bad reaction
to the medication, the patient could return it; ``we would count it,
document it, destroy it'' and it ``didn't happen very often.'' (Tr.
248.) There is no indication that this practice as described by
Respondent was a frequent occurrence, and there is no evidence of
any diversion of the controlled substances returned. In fact, the
un-rebutted testimony of the Respondent is that they were destroyed.
The testimony of Respondent and DI Chalmers provides evidence
that Respondent did not properly secure all Schedule II-V controlled
substances in a securely locked, substantially constructed cabinet.
Although there is no evidence regarding the exact quantities of
controlled substances maintained at Respondent's Mesa office, there
is sufficient evidence in the form of Respondent's testimony, and
that of DI Chalmers, to determine that Respondent did maintain
possession of some controlled substances, including at least
fentanyl and Suboxone. Additionally, given the credible testimony of
both Respondent and DI Chalmers that some controlled substances were
found in unlocked cabinets, it is apparent that Respondent did not
store all Schedule II-V controlled substances in a securely locked,
substantially constructed cabinet as required by applicable
regulations. The fact that Respondent did not maintain control over
the key to access her medication safe and was unfamiliar with the
necessary procedure for opening the safe further indicates that
Respondent also did not maintain an adequate key control system.
Although the evidence indicates that Respondent did not follow
adequate security procedures, the question remains as to whether
that information can be considered in determining if Respondent's
continued registration is consistent with the public interest. In
order 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 its registration so
as to provide a full and fair opportunity to challenge the factual
and legal basis for the Agency's action.'' CBS Wholesale
Distributors, 74 FR 36,746 (DEA 2009) (citing NLRB v. I.W.G., Inc.,
144 F.3d 685, 688-89 (10th Cir. 1998); Pergament United Sales, Inc.,
v. NLRB, 920 F.2d 130, 134 (2d Cir. 1990)). The DEA has previously
held that 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
(DEA 1996)). The DEA has also previously found, however, that a
respondent may waive his objection to admission of evidence not
noticed by the Government prior to the hearing when a respondent
does not timely object and when the respondent also raises the issue
himself. Gregory D. Owens, D.D.S., 74 FR 36,751, 36,755 (DEA 2009).
In the instant matter, the Government did not raise the issue of
security controls in the OSC or in its Prehearing Statement. In
fact, the Government first raised the issue of Respondent's security
controls during the direct examination of DI Chalmers. The
Government asked DI Chalmers whether Respondent's storage cabinets
were locked and if they were capable of being locked. (Tr. 94.)
While it is true that Respondent did not object to the line of
questioning, and offered some testimony on direct examination with
regard to controlled substances kept locked in safes, Respondent's
primary testimony regarding the issue was raised during the
Government's cross-examination of Respondent.
I therefore find that the Government did not provide Respondent
with adequate notice regarding Respondent's security control
measures and that the issue cannot serve as a basis for determining
whether Respondent's continued registration would be inconsistent
with the public interest.\58\
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\58\ In this case, even assuming, arguendo, that I were to
consider this additional evidence of security control measures with
regard to an appropriate sanction, I would not find the additional
facts to warrant revocation.
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The Government also alleges that Respondent failed to
effectively monitor the receipt and distribution of controlled
substances because Respondent did not maintain an effective
recordkeeping system in accordance with 21 CFR Sec. Sec.
1304.03(b), 1304.04, 1304.11, 1304.21 and 1304.22(c). This
substantive issue was noticed in the OSC/IS and in subsequent
Prehearing Statements.
Pursuant to 21 CFR Sec. Sec. 1304.03(b), 1304.22(a)(2)(ix),
1304.21(a), 1304.22(c) and 1304.22(a)(2)(iv), a registered
individual practitioner is required to maintain records of
controlled substances in Schedules II-V that are dispensed and
received, including the number of dosage units, the date of receipt
or disposal, and the name, address and registration number of the
distributor. It is unlawful to fail to make, keep or furnish
required records.\59\
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\59\ 21 U.S.C. 842(a)(5).
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One mandatory recordkeeping vehicle is DEA Form 222, the
``official triplicate order form[] used by physicians to order
scheduled narcotics'' and other controlled substances.\60\ A menu of
federal regulations specifies procedures relating to DEA Form 222,
such as obtaining, 21 CFR Sec. 1305.11, executing, Sec. 1305.12,
filling Sec. 1305.13, and endorsing DEA Form 222, Sec. 1305.14,
among other procedures.\61\ In addition, 21 CFR Sec. 1305.03
requires that a DEA Form 222 be used for each distribution of a
controlled substance listed in Schedule I or II, and Section Sec.
1305.13 provides that these order forms must be maintained
separately from all other records and that they ``are required to be
kept available for inspection for a period of 2 years.''
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\60\ Robert L. Dougherty, Jr., M.D., 60 FR 55,047, 55,048 (DEA
1995).
\61\ See, e.g., 21 CFR 1305.15-.19.
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Failing to comply with recordkeeping laws and regulations
relating to controlled substances can justify revocation. ``[A]
blatant disregard for statutory provisions implemented to maintain a
record of the flow of controlled substances and to prevent the
diversion of controlled substances to unauthorized individuals[]
would justify revocation'' of a certificate of registration.'' \62\
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\62\ Robert L. Dougherty, Jr., M.D., 60 FR 55,047, 55,050 (DEA
1995) (citing George D. Osafo, M.D., 58 Fed. Reg 37,508, 37,509
(1993) (revoking practitioner's registration where ``[r]espondent
failed to comply with numerous recordkeeping requirements[,
explaining that] . . . it is a registrant's responsibility to be
familiar with the Federal regulations applicable to controlled
substances''); see also Hugh I. Schade, M.D., 60 FR 56,354, 56,356
(DEA 1995) (noting the inventory procedures required by Sections
Sec. Sec. 1304.11 to 1304.13, and 1305.06).
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[[Page 41078]]
DEA regulations state that a registered individual practitioner
is required to keep records of controlled substances in Schedules
II, III, IV and V which are dispensed.\63\ As a general matter,
records are required to be kept by the registrant and must be
available for at least two years.\64\
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\63\ 21 CFR 1304.03(b) (2010).
\64\ Id. Sec. 1304.04
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The evidence at hearing on this issue included the testimony of
DI Dunn and DI Chalmers. DI Dunn testified that he reviewed the
records seized by the FBI during search warrants executed at the
Respondent's registered and unregistered office locations, as well
as her home. DI Chalmers testified that she was present at the
search of Respondent's unregistered office on Mesa Drive in April
2009, participating in a search of the medication room and a
location at the back of the medication room that may have been the
Respondent's office. DI Chalmers further testified that drug logs
were among the items seized. (Tr. 92.) DI Dunn explained that from
his review of the records seized he found records for the dispensing
of Demerol, but not the receipt of that drug. He further explained
that because Demerol is a Schedule II controlled substance, it can
only be transferred between registrants pursuant to a DEA Form 222.
A review of the seized documents by DI Dunn revealed no copies of
DEA Form 222.
DI Dunn further testified that ``there were other drugs there or
an indication of other drugs there'' to include the controlled
substances Demerol, Ambien, Balacet and Provigil. (Tr. 34, 36.) DI
Dunn indicated that dispensing logs existed for Demerol but no
invoices were found reflecting purchases of Demerol. DI Dunn also
found no dispensing logs or inventories for Provigil and Ambien.
The evidence at hearing further included a narcotic log seized
from Respondent during the April 2009 FBI search, reflecting the
administration of Demerol on numerous occasions from August 26,
2008, to March 25, 2009. (Gov't Exs. 9, 10 at 2.)
The Respondent testified that she was never asked for any copies
of DEA Form 222 and was unaware of any of the audits. With regard to
whether she possessed copies of DEA Form 222, as required, her
testimony was equivocal. The Respondent testified on direct
examination that she ``did not recall having DEA Form 222's for
Demerol at the time of the April 2009 search'' but ``guessed'' that
``we did.'' The Respondent was less equivocal in her testimony
regarding having copies of DEA Form 222 at the Collier street
temporary office, stating ``I didn't have those little DEA 222s, so
I really didn't purchase any scheduled medications during that brief
period of time.'' (Tr. 197.) Respondent also introduced records that
Respondent obtained from a pharmacy supplier that include three
references to Demerol purchases by Respondent. The shipping dates
were August 26, September 24, and October 30, 2008. (Resp't Ex. 9,
at 5-7.) None of the documents appear relevant to the presence of
copies of DEA Form 222 at Respondent's unregistered Mesa office as
of April 2009, because Respondent testified that no controlled
substances were moved from her registered office in Denton, Texas to
the temporary Collier Street office, as they were destroyed prior to
Respondent's being evicted. (Tr. 197-98.)
The absence of any copies of DEA Form 222 found by DI Dunn
during his review of the seized documents related to the search of
Respondent's office, along with Respondent's lack of certainty that
any were present, supports a finding that Respondent did not keep
proper records for controlled substances that were ordered and
maintained under her registration. DI Dunn's testimony is consistent
with the testimony of DI Chalmers regarding the seizure of documents
during the April 2009 search warrant, including the seizure of
Government exhibits nine and ten. While the testimony offered with
regard to the specifics of the FBI search was limited, the evidence
as a whole reflects that a considerable quantity of documents was
seized from Respondent's office. The fact that no copies of DEA Form
222 were found, independent of whether Respondent was asked to
produce them, is persuasive proof of non-compliance.
The Respondent's testimony on the topic is equivocal at best,
and is fully consistent with a finding that few if any copies of DEA
Form 222 were maintained at the Respondent's unregistered Mesa
office during 2009. ``Recordkeeping is one of the CSA's central
features; a registrant's accurate and diligent adherence to this
obligation is absolutely essential to protect against diversion of
controlled substances.'' Paul H. Volkman, M.D., 73 FR 30,630, 30,643
(DEA 2008). The evidence of record, including the Respondent's own
testimony, reflects that at least during the time period from in or
about November or December 2008 until April 2009, Respondent did not
properly maintain copies of DEA Form 222 for Demerol, a Schedule II
controlled substance. Similarly, the Respondent's acceptance and
documentation of returned controlled substances was not in
compliance with applicable regulations. Nor did the Respondent
maintain other documentation related to the controlled substances
Ambien Balacet and Provigil.
(f) Respondent's Testimony
In mitigation, the Respondent testified that she had never had a
prior DEA complaint or investigation, and has been in medical
practice for twenty-five years, practicing in Texas since 1991. (Tr.
110, 113 & 225.) Respondent further testified that in January 2008
she became aware of a theft of fentanyl and reported the theft to
DEA and other law enforcement agencies. DI Dunn also testified that
he investigated the reported theft issues in May 2008, and found
Respondent's reporting of theft to be proper but the theft and loss
reports submitted by Respondent were incomplete. (Tr. 55.)
Respondent also testified at hearing to the theft of a safe from her
office in late 2008, which possibly included Suboxone and other
scheduled medications, as well as ``all my triplicates.'' (Tr. 119,
196.) The Respondent also testified that in late 2008 she was
evicted from her then-registered location and had to move to a
temporary office (Collier office) for a short period of time, before
moving to her permanent office location (Mesa office). During late
2008 and 2009, Respondent also experienced employee issues, to
include alleged misuse of prescription pads, theft and related
financial matters. (Tr. 209-10.) At Respondent's Mesa office she has
five active examination rooms, and relies on her staff to maintain
logs and inventory. (Tr. 205.) Respondent has approximately thirty
(30) patient visits per day and described herself as a
``workaholic'' working non-stop without a lunch break. (Tr. 116.)
I find the Respondent's testimony at hearing to be generally
credible. The Respondent's manner throughout her testimony was
serious and deliberate. Respondent's education, experience and
training, which included regular continuing medical education in
pain management, reasonably supported her opinion testimony with
regard to patients [JF], [HM], [TR] and [MM]. This opinion testimony
was also fully consistent with Dr. Babuji's testimony. The
Respondent testified throughout a four hour period without reference
to notes or other written material, unless specifically directed by
counsel, and was accurately able to recall events with a reasonable
level of certainty. The Respondent did not display hostility during
testimony or other visible mannerisms that adversely impacted her
credibility.
On balance, however, the Respondent's record-keeping violations,
handling of returned controlled substances and failure to properly
change her registered address weigh significantly in favor of
revocation.
Factor 5: Such Other Conduct Which May Threaten the Public Health and
Safety
As to factor five, there is no other substantial evidence of
record demonstrating conduct by Respondent which may threaten the
public health or safety, other than the risk of diversion inherent
in the failure to maintain effective controls and procedures to
guard against theft and diversion of controlled substances, which
has been evaluated under factors two and four.
VI. CONCLUSION AND RECOMMENDATION
I find that a balancing of the foregoing public interest factors
supports a finding that the Government has established a prima facie
case in support of revocation of Respondent's registration, or
denial of an application for registration. 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, revoking the registrant's registration
would not be appropriate. Morall v. DEA, 412 F.3d 165, 174 (D.C.
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).
A ``Respondent's failure to maintain accurate records . . . is
sufficient by itself. . .'' in some cases, to conclude that granting
a registration would be inconsistent with the public interest.
Volkman, 73 FR at 30644.
[[Page 41079]]
The facts in Volkman pertaining to record keeping violations
involved a doctor who ``rapidly became the largest practitioner-
purchaser in the nation of oxycodone'' which included ordering
``hundreds of thousands of dosage units of these drugs'' over time
periods as short as several months. Id. at 30,643. The facts in
Volkman further reflected that no dispensing logs were maintained,
at times exceeding an entire year. Id. at 30,645.
Additionally, where a registrant has committed acts inconsistent
with the public interest, a registrant must accept responsibility
for his or her actions and demonstrate that he or she will not
engage in future misconduct. Patrick W. Stodola, 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, 74 FR 10,083, 10,094 (DEA
2009).
The Respondent testified in substance that she updated her new
registration address with Texas authorities, made various efforts to
do so with DEA including receiving correspondence, and therefore
thought she had satisfied her obligation. (Tr. 161-63; ALJ Ex. 2.)
Respondent's explanation for record keeping violations is less
specific. The Respondent's testimony as a whole demonstrated that
she understood the seriousness and importance of record keeping
requirements, and testified that while at the temporary Collier
street location ``I didn't have those little DEA 222s, so I really
didn't purchase any scheduled medications during that brief period
of time.'' (Tr. 197.) The Respondent also testified that she
believed she ``had very effective oversight'' of controlled
substances.'' (Tr. 248.) This belief is contradicted by Respondent's
own testimony. Respondent also testified that she relied heavily on
her staff with regard to inventory and maintenance of controlled
substances, and that Respondent did very little herself. (Tr. 205.)
The evidence of record does demonstrate, however, that Respondent's
errors were often due to lack of knowledge, omission or neglect,
rather than a deliberate violation of the record keeping
requirements.
The alleged conduct supported by substantial evidence in this
case centers on Respondent's record keeping violations, which have
been documented to be deficient over a relatively short period of
time, as well as a failure to update her registered address, and
improper acceptance and disposal of returned controlled substances
from patients. The Government argues in its post-hearing brief that
revocation is the appropriate remedy in this case. An agency's
choice of sanction will be upheld unless unwarranted in law or
without justification in fact. A sanction must be rationally related
to the evidence of record and proportionate to the error committed.
See Morall v. DEA, 412 F.3d 165, 181 (D.C. Cir. 2005) (sanction will
be upheld unless unwarranted in law or without justification in
fact).
In support of its recommendation for revocation, the Government
cites Paul H. Volkman, 73 FR 30,630, 30,644 (DEA 2008), which is
significantly distinguishable from the facts of this case.
Respondent's conduct in this case occurred over a comparatively
short period of time, with substantially fewer controlled
substances, and with no evidence of actual diversion of any
controlled substances. The Government cites no other precedent to
support a revocation sanction on facts similar to Respondent's, nor
does there appear to be any. The Respondent's errors and conduct
clearly were neglectful and serious during the relevant time period,
and likely due in part to ongoing issues including eviction from her
registered office, employee problems, and an office break-in and
theft, among other factors. That said, a revocation penalty is
simply not rationally related to the evidence of record established
by substantial evidence or proportionate to Respondent's misconduct.
I find that Respondent's testimony as a whole demonstrates that
she has sufficiently accepted responsibility for her actions and
omissions with regard to a revocation penalty, but Respondent's
explanation of past errors and demonstrated plan to avoid future
violations is insufficient to support an unconditional registration.
Accordingly, I recommend that Respondent's COR BC0181999 as a
practitioner not be revoked or a pending application denied, on the
condition that Respondent: a) within a reasonable period of time as
set forth in the agency's final order in this matter, satisfy the
appropriate DEA designee that Respondent has state authority to
handle controlled substances in Texas, the state in which she is
registered with DEA; \65\ b) submit to the nearest Field Division
Office of DEA no later than one (1) year after issuance of a DEA
COR, documentation reflecting successful completion of accredited
training at Respondent's expense, in the proper maintenance,
inventory, and record-keeping requirements for controlled
substances, with such training to take place after the Agency issues
a final order in this matter; and c) for one (1) year after the
issuance of a COR, Respondent shall submit to the nearest Field
Division Office of DEA, on a quarterly basis, a log of all
controlled substances in Schedules II, III, IV and V received,
maintained and dispensed by Respondent.
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\65\ 21 U.S.C. 824(a)(3).
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Dated: October 26, 2010
s/ Timothy D. Wing,
Administrative Law Judge
[FR Doc. 2015-17310 Filed 7-13-15; 8:45 am]
BILLING CODE 4410-09-P