Mark G. Medinnus, D.D.S.; Decision and Order, 62683-62694 [2013-24697]
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Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Notices
revoked in response to DEA’s revocation
and Respondent alleges he cannot
obtain a new state registration without
a DEA COR. However, Respondent’s due
process rights have not been denied
because he previously had an
opportunity to be heard at a state
administrative hearing before the
AMLC. Further, the Respondent is
actively pursuing his state court
appellate right.
I also forward this case to the Deputy
Administrator for final disposition. I
recommend that the Deputy
Administrator deny Respondent’s
pending application for a DEA COR.
Dated: July 9, 2013.
Gail A. Randall,
Administrative Law Judge.
[FR Doc. 2013–24696 Filed 10–21–13; 8:45 am]
BILLING CODE 4410–09–P
C. Material Question of Fact
It is well-settled that when there is no
material question of fact involved, or
when the facts are agreed upon, there is
no need for a plenary, administrative
hearing. See Larry Elbert Perry, M.D., 77
FR 67,671 (DEA 2012); Treasure Coast
Specialty Pharmacy, 76 FR 66,965 (DEA
2011); Jesus R. Juarez, M.D., 62 FR
14,945 (DEA 1997); Dominick A. Ricci,
M.D., 58 FR 51,104 (DEA 1993).
Congress did not intend for
administrative agencies to perform
meaningless tasks. See Puerto Rico
Aqueduct & Sewer Auth. v. EPA, 35
F.3d 600, 604–05 (1st Cir. 1994); NLRB
v. Int’l Assoc. of Bridge, Structural &
Ornamental Ironworks, AFL–CIO, 549
F.2d 634 (9th Cir. 1977); Philip E. Kirk,
M.D., 48 FR 32,887 (1983), aff’d sub
nom. Kirk v. Mullen, 749 F.2d 297 (6th
Cir. 1984).
Here, the parties do not dispute that
the Respondent lacks state authority to
handle controlled substances in
Alabama. Thus, there is no material
question of fact to be adjudicated.
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III. Conclusion, Order, and
Recommendation
DEA is bound by federal statute to
deny applications for a DEA COR,
where an applicant lacks state authority.
21 U.S.C. 823(f), 824(a)(3); see also
Graham Travers Schuler, 65 FR at
50,571; George Thomas, PA–C, 64 FR at
15,812. Here, there is no genuine
dispute of material fact that Respondent
lacks state authority to handle
controlled substances in the state where
he seeks to obtain a DEA registration.
Furthermore, Respondent’s due process
rights are protected, since he had an
opportunity to be heard by the AMLC
regarding his state authority to handle
controlled substances. Therefore,
summary disposition for the
Government is appropriate.7
Accordingly, I hereby
Grant the Government’s motion for
summary disposition.
7 This opinion does not reach the other factual
issues made in the Order to Show Cause. Rather,
this opinion solely addresses the Respondent’s loss
of his ability to handle controlled substances in the
state of Alabama.
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 12–43]
Mark G. Medinnus, D.D.S.; Decision
and Order
On October 17, 2012, Administrative
Law Judge (ALJ) Gail A. Randall issued
the attached Recommended Decision
(hereinafter, cited as R.D.1). The
Government filed Exceptions to the
Recommended Decision.
Having reviewed the record in its
entirety, I reject the Government’s
Exceptions and adopt the ALJ’s findings
of fact and conclusions of law except as
discussed below. I also adopt in part,
and reject in part, the ALJ’s
recommended order. A discussion of the
Government’s Exceptions follows.
The Government’s Exceptions
The Unauthorized Purchase Allegation
The Government first takes exception
to the ALJ’s finding that it failed to
prove that Respondent, while serving as
the dental director of the Round Valley
Indian Health Clinic (RVIHC), made an
unauthorized purchase of two
controlled substances (hydrocodone and
codeine). Exceptions at 2. The
contention is not well taken as either a
factual or legal matter.
The evidence showed that on
November 29, 2010, Respondent
prepared a purchase order for various
dental supplies, including one bottle of
500 tablets of hydrocodone/
acetaminophen and one bottle of 500
tablets of codeine/acetaminophen. GX
10, at 1–3; Tr. 151. The purchase order
comprised all of one page and listed a
total of eleven items; the order was
approved by Jan Scribner, the deputy
director of the RVIHC. Id.; Tr. 158. The
evidence further showed that Ms.
Scribner had authority to approve
purchase orders in the absence of the
RVIHC’s executive director. GX 21.
In challenging this finding, the
Government takes issue with the ALJ’s
1 All citations to the R.D. are to the ALJ’s slip
opinion.
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credibility findings. Citing Ryan v.
CFTC, 145 F.3d 910, 918 (7th Cir. 1998),
it argues that I am ‘‘free to discount the
weight that the ALJ placed on the
testimony when the record would
support an alternative finding.’’
Exceptions at 1 (also citing Universal
Camera Corp. v. NLRB, 340 U.S. 474
(1951)).2
More specifically, the Government
requests that I reject the ALJ’s
credibility findings regarding the
testimony of both Respondent (whom
she found credible on the issue of
whether a dental clinic employee had
told him that the executive director had
approved the purchase order, see R.D. at
12, 27) and the clinic employee (whom
she found not credible when she
testified that the executive director did
not think it was a good idea because of
Respondent’s history of substance
abuse, see id.). See Exceptions at 2–6.
While the Government clearly misreads
Ryan,3 I conclude that it is not
2 In the Show Cause Order, the Government
alleged both that Respondent made an unauthorized
purchase of controlled substances, and that he
stored and dispensed controlled substances at the
RVIHC’s dental clinic in violation of the RVIHC’s
guidelines for storing and dispensing controlled
substances. ALJ Ex. 1, at 2. The ALJ reasoned that
because Respondent ‘‘reasonably believed the
purchase order was duly approved, the
Government’s allegation that he failed to abide by
RVIHC policies regarding the storage and
dispensing of controlled substances, also fails.’’
R.D. at 28. It is, however, far from clear why, even
if Respondent had authority to order controlled
substances, this would necessarily lead to the
conclusion that he also had authority to store and
dispense controlled substances out of the dental
clinic.
In taking exception to the ALJ’s findings
regarding the purchase, the Government also takes
issue with the ALJ’s finding that Respondent
‘‘honestly and reasonably believed he possessed the
necessary authority to store and dispense controlled
substances in [the RVIHC] dental department.’’
Exceptions at 2. To the extent the Government has
even properly put this finding at issue, I reject its
contention, because, by itself, it does not establish
a violation of the CSA or state law, or otherwise
actionable misconduct under the public interest
standard.
3 At issue in Ryan was whether an Agency was
required to defer to an ALJ’s finding that an
applicant for a trader’s license ‘‘was fully
rehabilitated and not a threat to the integrity of the
[commodities] markets,’’ which was based on the
ALJ having found credible the testimony of the
applicant’s character witnesses. See 145 F.3d at
918. The Commission discredited the testimony
because ‘‘almost every one can produce’’ a character
witness who will testify as to his/her ‘‘belief that
the defendant will not repeat his violative
conduct,’’ and because the ‘‘testimony reflected at
most a perfunctory concern with the customers
harmed by Ryan’s wrongdoing.’’ Id. (internal
citation omitted).
The Seventh Circuit held that the Commission
could ‘‘discredit the weight of a witness’s testimony
without impinging on an ALJ’s credibility
determinations.’’ Id. As the court of appeals further
explained:
The Commission must attribute significant weight
to an ALJ’s findings based on a witness’s demeanor
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necessary to either adopt or reject the
ALJ’s credibility findings, because even
were I to reject the findings with respect
to both Respondent and the clinic
employee, the Government cannot
overcome the evidence that the
purchase order was approved by an
official of the clinic, who indisputably
had authority to do so. R.D. at 12, 27;
Tr. 158.
The Government attempts to
overcome this evidence, arguing that in
an affidavit, the deputy director
‘‘unequivocally states that she was not
aware [that] the purchase order, which
contained a number of items, also
contained an order for controlled
substances.’’ Exceptions at 7. The
Government then argues that ‘‘[a] review
of the purchase order shows that . . .
the controlled substances order is
buried in the middle/end of the
purchase order.’’ Id.
The Government’s argument is wholly
unpersuasive. Notably, the purchase
order was but a single page in length
and listed all of eleven items. GX 10, at
1. Moreover, the purchase order clearly
described the respective controlled
substances as ‘‘1 bottle’’ of
‘‘Hydrocodone’’ and ‘‘1 bottle’’ of
‘‘APAP w/codeine.’’ Id. Thus, even a
cursory review of the purchase order by
the deputy director should have
revealed that it contained controlled
substances. I thus give no weight to the
assertion of the deputy director that she
inadvertently approved the order and
reject the Government’s contention that
Respondent’s purchase of controlled
substances was unauthorized.4 Cf.
Consolidated Edison Co. v. United
States, 221 F.3d 364, 371 (2d Cir. 2000)
(‘‘In general, individuals are charged
because it does not have the opportunity to observe
a testifying witness. This recognition, however,
does not preclude the Commission from
discounting the weight that an ALJ places on
witness’s testimony when the Commission
questions the witness’s basis of knowledge.
Id. In short, Ryan provides no support for the
Government’s contention, which ignores that the
ALJ’s finding involves an issue of historical fact and
involves a classic situation in which an assessment
of each witness’s demeanor is essential in making
a factual finding.
4 In her affidavit, the Deputy Director also stated
that ‘‘RVIHC does not order controlled substances
from Henry Schein,’’ that it ‘‘orders all controlled
substances from other government suppliers by
RVIHC contracts with those venders [sic],’’ and that
‘‘[t]his procedure has been long standing and well
known to all relevant staff.’’ GX 21, at 1. The
Government, however, produced no evidence that
these purported procedures have been
memorialized in writing. Nor did the Government
establish that Respondent was aware of any such
policy. Beyond this, the Deputy Director’s assertion
that the procedure is well known undermines any
claim that she is a disinterested witness, which,
given that her testimony constitutes hearsay, is a
relevant consideration in determining the reliability
of her statement.
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with knowledge of the contents of
documents they sign—that is, they have
‘constructive knowledge’ of those
contents.’’).5
Even if the Government’s contention
was supported by substantial evidence,
I would nonetheless reject the
exception. Notably, while the
Government argues—as an
afterthought—that Respondent used the
clinic’s ‘‘DEA registration without
authorization from RVIHC executive
personnel,’’ it does not go so far as to
maintain that this constitutes a violation
of the Controlled Substances Act. See
Exceptions at 10, but see 21 U.S.C.
843(a)(2) (‘‘It shall be unlawful for any
person knowingly or intentionally . . .
to use for the purpose of acquiring or
obtaining a controlled substance, a
registration number which is . . .
issued to another person.’’). Indeed,
notwithstanding that Respondent could
not account for forty tablets of
hydrocodone, the evidence showed that
the drugs were generally dispensed to
patients in the course of providing
dental treatment. Finally, while in its
post-hearing brief, the Government
notes that both factors four (compliance
with applicable controlled substance
laws, 21 U.S.C. 823(f)(4)) and five (such
other conduct which may threaten
public health and safety, id. § 823(f)(5)),
are to be considered in determining the
public interest, it does not cite to any
provision of state law that Respondent
violated in making the purported
unauthorized purchase.6 Nor does it cite
to any Agency decision holding that a
violation of a clinic’s internal operating
policies, which does not otherwise
violate the CSA or state law, constitutes
conduct ‘‘inconsistent with the public
interest.’’ 21 U.S.C. 824(a)(4). Thus,
even if the Government had proved that
Respondent made an unauthorized
purchase of the two drugs, I would
reject the exception because it fails to
establish actionable misconduct under
the public interest standard.
5 Given that the purchase order was but a single
page, listed only eleven items, and clearly listed
hydrocodone and codeine as among the items to be
purchased, see GX 10, it is fair to draw the
inference that the Deputy Director had actual
knowledge that Respondent was seeking controlled
substances.
6 Indeed, in its brief containing its proposed
findings of fact and conclusions of law, the only
provisions of law or regulations cited by the
Government are various recordkeeping
requirements, which it is undisputed that
Respondent violated. Gov’t Prop. Findings of Fact,
Conclusions of Law, and Argument (hereinafter,
Gov’t Post-Hrng. Br.) at 19 (citing 21 U.S.C.
827(a)(3); 21 CFR 1304.22(c)).
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The ALJ’s Finding That Respondent
Has Accepted Responsibility
The ALJ found that Respondent took
responsibility for his actions and
‘‘repeatedly demonstrated remorse for
his conduct at the RVIHC.’’ R.D. at 29.
The Government takes exception to this
finding, arguing that while Respondent
acknowledged the misconduct he
committed prior to 2008, he ‘‘was not
candid and not willing to accept actual
responsibility for his [more recent]
violations,’’ which included his
‘‘inaccurate dispensing records, the
unlawful dispensing to an unknown
patient, and the failure to keep a
dispensing log as required by’’ the
probation imposed by the Dental Board
of California when it issued him a new
license. Exceptions at 8 (emphasis
added).
Respondent is, however, only
required to accept responsibility for the
misconduct which the Government has
proven on the record. See Jeffrey P.
Gunderson, 61 FR 26208, 26211 (1996)
(a respondent must ‘‘admit to the full
extent of his involvement in
documented misconduct’’). With respect
to the alleged ‘‘unlawful dispensing to
an unknown patient,’’ Exceptions at 8,
the Government points to evidence that
Respondent ‘‘dispensed hydrocodone to
a transient without eve [sic]
documenting that he ever saw this
person as a patient at the time he
dispensed the Vicodin.’’ Gov’t PostHrng. Br. at 23. The Government argues
that ‘‘[t]his incident is not just a
‘documentation’ error but is tantamount
to outright diversion.’’ Id. Yet, the ALJ
found that Respondent ‘‘credibly
testified that he had examined the
patient on January 20, 2011, and
observed that he needed a surgical
extraction,’’ that ‘‘[w]hen the patient
returned to [the clinic] on January 24,
2011, [Respondent] could not perform
the extraction because of his busy
schedule,’’ and that ‘‘[w]hen the patient
reported experiencing pain symptoms,
[he] agreed to provide him with
hydrocodone to temporarily alleviate
his symptoms.’’ R.D. at 14.
The Government did not, however,
take exception to these findings.7 Thus,
while in its post-hearing brief, the
Government argued that Respondent
engaged in ‘‘outright diversion’’ when
he provided hydrocodone to this
patient, and in its Exceptions, it argues
that he has failed to accept
7 Nor did the Government offer any evidence at
the hearing as to the standards of dental practice
and establishing that Respondent acted outside of
the usual course of professional practice when he
dispensed hydrocodone to this patient. See 21 CFR
1306.04(a).
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responsibility for the ‘‘unlawful
dispensing,’’ I conclude that
Government has offered no reason to
reject the ALJ’s findings. Moreover,
Respondent acknowledged that he failed
to properly document the dispensing.
Tr. 523. Because Respondent accepted
responsibility with respect to the only
misconduct the Government proved
with respect to this patient, I reject the
Government’s contention to the extent it
relies on Respondent’s act of dispensing
a controlled substance to this patient.
The record, however, does establish
that Respondent failed to maintain
accurate dispensing records, as well as
a dispensing log, which was required
under the terms of the Dental Board’s
order, which restored his dental license.
While there is some evidence to support
the Government’s contention that
Respondent did not accept
responsibility for his failure to maintain
accurate records, I conclude that the
ALJ’s finding is supported by the record
as a whole.
At the hearing, Government counsel
asked Respondent whether it was
correct that he did not keep ‘‘a separate
dispensing record when [he] started to
use the Vicodin . . . that [he] had
ordered.’’ Tr. 491. Respondent answered
that this was ‘‘[a]bsolutely correct.’’ Id.
When asked by the Government
whether he had ‘‘the legal duty to keep
accurate records of th[e] Vicodin
supply,’’ Respondent answered: ‘‘I do.’’
Id. at 498. And when asked whether it
was correct that because he ‘‘had the
supply, . . . did the dispensing directly
to the patients, . . . [he] had the
obligations to keep an accurate patient
chart as well as a log,’’ Respondent
answered: ‘‘Absolutely. That’s why I say
I didn’t do it right.’’ Id. at 499.
Subsequently, the Government asked
Respondent whether ‘‘hav[ing] shortages
and . . . overages’’ is ‘‘a violation of
DEA law?’’ Id. at 509. Respondent
answered that he knew that he had
violated the State Board’s order but that
he did not know if this was a violation
of federal law. Id. The Government then
asked Respondent if it was ‘‘a violation
of DEA law not to keep a separate
dispensing log for narcotic controlled
substances?’’ Id. at 509–10. Respondent
answered:
I don’t know, but I do know that I violated
[the State] order. I’m willing to stipulate that
I violated that too. However you want to
characterize it, they wouldn’t have happened
if I hadn’t made my mistakes. There would
be no three separate logs. So if you want to
say that I violated a couple of steps, of
course, I’m willing to stipulate that there was
a tough time in my life. I’m sorry. I don’t
mean, if I get argumentative, I ask the Court’s
forgiveness.
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Id.
Respondent also testified that he had
abused the public trust in his handling
of Vicodin while at the RVIHC. Tr. 539–
40. While Respondent subsequently
testified that there was a difference in
degree between his previous violations
and the violations he committed at
RVIHC, he testified that ‘‘I abused the
public trust here’’ and ‘‘I screwed up.’’
Id. And while his closing statement is
not technically evidence, therein,
Respondent stated: ‘‘I’m sorry that I
made the mistakes in the past and then
more recently.’’ Id. at 554.
Ignoring nearly all of the evidence
which supports the ALJ’s finding, the
Government argues that ‘‘Respondent
repeatedly minimized the significance
of his dispensing-record violations.’’
Exceptions at 10. As support for this
contention, it quotes Respondent’s
testimony that ‘‘we’re talking about 40
tabs. . . . so I’m going to jeopardize my
licenses for 40 Vicodin tabs . . . [f]or
forty tabs?’’ 8 Respondent did not,
8 The Government points to several other portions
of Respondent’s testimony which it asserts provide
evidence that he has not admitted to his
misconduct. See Exceptions at 8–9. As support for
these assertions, the Government did not cite to the
specific pages of the transcript or exhibits, as is
required by DEA’s regulation, see 21 CFR
1316.66(a), but to a document which is abbreviated
as ‘‘FCA.’’ Id. Nowhere in its Exceptions does the
Government identify what this term means, and
while it may be a reference to the Government’s
proposed findings of fact, conclusion of law, and
argument, the Agency has previously held that
citation to a post-hearing brief does not comply
with the regulation and is ground to reject an
exception. See Carlos Gonzales, 76 FR 63118, 63119
(2011).
In any event, I have considered the entirety of
Respondent’s testimony in reviewing the ALJ’s
finding and conclude that much of the testimony
cited by the Government is not probative of whether
he has accepted responsibility for his failure to
maintain accurate records. For example, the
Government contends that ‘‘Respondent did not
admit to wrongdoing when he was asked during
cross-examination whether the audit shortages
could be partially attributable to the hydrocodone
he gave to the transient patient.’’ Exceptions at 9.
A review of what appears to be the relevant portion
of the transcript shows that the Government asked
Respondent whether the forty dosage unit shortage
‘‘could be accounted for, if not in total, at least in
part based on the amount of Vicodin that [he]
dispensed to [the] transient that did not get
charted.’’ Tr. 528. Respondent answered: ‘‘I suppose
some of the Vicodin, some of those 40 tabs could
have been it. I don’t know. I’m confused. Do you
want me to confess to something?’’ Id. The
Government offers no further explanation as to why
this testimony supports rejection of the ALJ’s
finding.
The Government also points to a question it asked
Respondent about an email to the RVIHC Executive
Director, in which he wrote that he ‘‘desperately
wanted to be liked by the natives so I prescribed
Vicodin too liberally.’’ Exceptions at 9; see also Tr.
506. When asked whether this was ‘‘a true
statement,’’ Respondent answered: ‘‘No, I was being
disingenuous.’’ Tr. 506. While this answer does not
inspire confidence in Respondent’s credibility, the
Government neither alleged, nor established that he
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62685
however, offer this testimony to
downplay the dispensing record
violations but rather to respond to the
insinuation (which permeates the
proceeding but which is unproven on
the record) that he had resumed selfabusing controlled substances.
Accordingly, I reject the Government’s
contention that Respondent has failed to
accept responsibility for his
misconduct.
However, while I adopt the ALJ’s
finding that Respondent has accepted
responsibility for his misconduct, I
nonetheless conclude that the ALJ’s
proposed sanction does not adequately
protect the public interest. As noted
above, pursuant to the Dental Board’s
order which restored his dental license,
Respondent was required to ‘‘maintain a
record of all controlled substances
prescribed, dispensed or administered
by [him] during probation.’’ GX 7, at 7.
This record was required to be
maintained ‘‘in a separate file or
ledger,’’ and to include, ‘‘in
chronological order,’’ each patient’s
name and address, the date, the
controlled substances and quantity, and
‘‘the pathology and purpose for which
the controlled substance was
furnished.’’ Id. Moreover, under federal
law, Respondent was required to
maintain a complete and accurate
record of all controlled substances he
dispensed. 21 U.S.C. 827(a)(3); 21 CFR
1304.22(c).
Notwithstanding the egregiousness of
his prior misconduct, Respondent did
not appreciate the forbearance shown by
the Board 9 and this Agency in granting
him a second chance. Accordingly,
while Respondent’s application will be
granted, his registration will be subject
to the following conditions:
1. Upon the granting of Respondent’s
application, his registration will be
suspended outright for a period of six
months. Thereafter, Respondent’s
acted outside of the usual course of professional
practice and lacked a legitimate medical purpose
with respect to any of the dispensings he made to
the clinic’s patients, and by itself, the testimony is
insufficient to support rejection of the ALJ’s
credibility findings.
9 As the ALJ found, Respondent has a history of
substance abuse and in February 2003, pled guilty
to one felony count of obtaining controlled
substances by fraud in violation of Cal. Health &
Safety Code § 11173(a). R.D. at 8. While upon
Respondent’s successful completion of his
probation, the conviction was reduced to a
misdemeanor and then dismissed entirely, the
record shows that Respondent unlawfully obtained
approximately 30,000 dosage units of controlled
substances. GX 3; GX 4, at 4–5; GX 5, at 2.
Based on this misconduct, in September 2002, the
Dental Board of California (DBC) filed an accusation
against Respondent and he surrendered his state
dental license. GX 5. On May 26, 2006, Respondent
filed a petition to reinstate his dental license; on
June 12, 2007, the DBC granted the petition. GX 7.
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registration will be suspended through
the expiration of his registration;
however, this portion of the suspension
shall be stayed provided Respondent
fully complies with the conditions
imposed on his registration, the
conditions of any existing or future
Dental Board order which relate to the
use or handling of controlled
substances, as well as all federal and
state controlled-substance laws and
regulations.
2. Respondent is prohibited from
administering or dispensing directly
controlled substances. Respondent is
authorized only to prescribe controlled
substances.
3. Respondent is required to maintain
a log, in chronological order, of all
controlled-substance prescriptions he
issues. The log must include the
following information: (1) the date; (2)
the patient’s name and address; (3) the
drug name, its strength, and quantity;
and (4) the pathology and purpose of the
prescription. Respondent shall maintain
the log at his registered address. In
addition, Respondent must provide a
copy of the log to the nearest DEA field
division office, on a quarterly basis,
within seven calendar days of the last
day of each quarter ending on March
31st, June 30th, September 30th, and
December 31st.
4. Respondent shall not prescribe any
controlled substance to himself or a
family member.
5. Respondent is required to notify the
nearest DEA field division office within
72 hours of any violation of this Order,
any Dental Board Order, or any
provision of federal or state law related
to controlled substances.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f), as well as 28 CFR
0.100(b), I order that the application of
Mark G. Medinnus, D.D.S., for a DEA
Certificate of Registration as a
practitioner, be, and it hereby is,
granted, subject to the conditions set
forth above. This Order is effective
November 21, 2013.
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Dated: September 22, 2013.
Michele M. Leonhart,
Administrator.
Brian Bayly, Esq., for the Government
Mark Medinnus, D.D.S., pro se, for the
Respondent
Recommended Rulings, Findings of
Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
I. Procedural Background
Gail A. Randall, Administrative Law
Judge. The Deputy Assistant
Administrator, Office of Diversion
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Control, Drug Enforcement
Administration (‘‘DEA’’ or
‘‘Government’’), issued an Order to
Show Cause (‘‘Order’’ or ‘‘OSC’’) dated
March 22, 2012, proposing to deny the
application of Mark G. Medinnus,
D.D.S. (‘‘Respondent’’ or ‘‘Dr.
Medinnus’’) for a DEA Certificate of
Registration pursuant to 21 U.S.C.
824(a)(2)–(4) and § 823(f)(2)–(5), because
the registration of the Respondent
would be inconsistent with the public
interest, as that term is used in 21 U.S.C.
823(f). [Administrative Law Judge
Exhibit (‘‘ALJ Exh.’’) 1 at 1].
The Order stated that Respondent had
been previously registered with the DEA
as a practitioner with authority to
handle controlled substances in
Schedules II–IV under DEA Certificate
of Registration BM0207678. [Id.]. The
Order stated that Respondent had
voluntarily surrendered this registration
on January 16, 2002. [Id.].
The Order further stated that on July
30, 2008, Respondent had been granted
a DEA Certificate of Registration
FM0982808 as a practitioner with
authority to handle controlled
substances in Schedules II–IV. [Id.]. The
Order stated that this registration
expired without a timely renewal on
January 31, 2011. [Id.].
The Order also stated that on
December 18, 2002, Respondent entered
into a Stipulated Surrender of License
and Order with the Dental Board of
California wherein Dr. Medinnus
surrendered his rights and privileges as
a dentist in the state of California. [Id.].
The Order went on to state that on June
12, 2007, Respondent’s dental license
was reinstated subject to probationary
conditions for a period of five years,
including that he maintain a controlled
substance dispensing log in
chronological order. [Id. at 2]. The Order
alleged that Respondent failed to
maintain this required dispensing log.
[Id.].
The Order also stated that on
February 23, 2003, Respondent pled
guilty to a felony violation of Cal.
Health & Safety Code § 11173(a) (West
2012) for obtaining controlled
substances by fraud. [Id.]. The Order
stated that the basis of this conviction
was Respondent’s use of DEA Certificate
of Registration BM0207678 to divert
more than 30,000 dosage units of
hydrocodone, lorazepam, and diazepam
for his personal use from approximately
January 2000 through November 2001.
[Id.].
Lastly, the Order alleged that in
December 2010, while Respondent was
an employee of the Round Valley Indian
Health Center (‘‘RVIHC’’), Dr. Medinnus
made an unauthorized purchase of
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bottles of hydrocodone and codeine
using RVIHC’s DEA registration. [Id.]. In
addition, the Order alleged that in
January 2011, Respondent failed to
comply with RVIHC’s guidelines
regarding the storage and dispensing of
controlled substances and that
Respondent could not account for
approximately sixty-eight tablets of
hydrocodone/apap which he allegedly
dispensed. [Id.]. The Deputy Assistant
Administrator then gave the Respondent
the opportunity to show cause as to why
his application should not be denied on
the basis of these allegations. [Id.].
On April 5, 2012, Respondent timely
filed a request for a hearing in the
above-captioned matter. [ALJ Exh. 2].
After authorized delays, the hearing
was conducted on July 10–11, 2012, in
Sacramento, California. [ALJ Exh. 5]. At
the hearing, counsel for the DEA called
four witnesses to testify and introduced
documentary evidence. [Transcript
(‘‘Tr.’’) Volume I–II]. The Respondent
called two witnesses to testify,
including himself, and introduced
documentary evidence. [Id.].
After the hearing, the Government
and the Respondent submitted Proposed
Findings of Fact, Conclusions of Law
and Argument (‘‘Govt. Brief’’ and ‘‘Resp.
Brief’’).
II. Issue
The issue in this proceeding is
whether or not the record as a whole
establishes by a preponderance of the
evidence that the Drug Enforcement
Administration should deny the
application for a DEA Certificate of
Registration of Mark G. Medinnus,
D.D.S. as a practitioner, pursuant to 21
U.S.C. 824(a)(2)–(4) (2006), and
pursuant to 21 U.S.C. 823(f)(2)–(5),
because the Respondent’s registration
would be inconsistent with the public
interest, as that term is used in 21 U.S.C.
823(f). [ALJ Exh. 4; Tr. 7].
III. Findings of Fact
A. Stipulated Facts
1. On September 19, 2011, Dr.
Medinnus applied for registration with
DEA as a practitioner in Schedules II
through V at 9024 Sniktaw Lane, Fort
Jones, CA 96032.
2. Dr. Medinnus was previously
registered with DEA as a practitioner in
Schedules II through IV under DEA
Certificate of Registration BM0207678 at
1680 Westwood Drive, Suite C, San Jose,
CA 95125. Dr. Medinnus voluntarily
surrendered this registration on January
16, 2002.
3. On July 30, 2008, Dr. Medinnus
was granted DEA Certificate of
Registration FM0982808 as a
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practitioner, in Schedules II through IV,
at P.O. Box 459, Lewiston, CA 96052.
This registration expired without a
timely renewal on January 31, 2011.
4. On September 3, 2002, the Dental
Board of California, Department of
Consumer Affairs, (hereinafter ‘‘Dental
Board’’) issued an ‘‘Accusation’’ which
sought to revoke or suspend Dr.
Medinnus’ dental license. The
‘‘Accusation’’ alleged that Dr. Medinnus
ordered controlled substances in order
for his own and others illegal use and
not in the course of his dental practice.
5. On September 20, 2002, Dr.
Medinnus entered into a ‘‘Stipulated
Surrender of License and Order’’ with
the Dental Board as a result of the
September 3, 2002, Dental Board
‘‘Accusation.’’ In the September 20,
2002, ‘‘Stipulated Surrender of License
and Order,’’ Dr. Medinnus agreed to
surrender his California dental license.
6. Effective December 18, 2002, the
Dental Board adopted the September 20,
2002, ‘‘Stipulated Surrender of License
and Order.’’
7. On February 27, 2003, Dr.
Medinnus pled guilty in Santa Clara
County to one felony count of a
violation of California Health & Safety
Code 11173, obtaining controlled
substances by fraud. Dr. Medinnus was
sentenced to probation.
8. On April 27, 2006, Dr. Medinnus’
felony conviction of California Health &
Safety Code 11173 was reduced to a
misdemeanor conviction under
California Penal Code, Section 17, and
then the conviction was dismissed
under California Penal Code, Section
1203.4.
9. On or about May 26, 2006, Dr.
Medinnus petitioned the Dental Board
to re-instate his license. On March 15,
2007, a Dental Board Administrative
Law Judge submitted a ‘‘Proposed
Decision’’ to grant Dr. Medinnus’
petition to re-instate his dental license
subject to probation for five years. The
‘‘Proposed Decision’’ was adopted by
the Dental Board in a ‘‘Decision’’ on
May 10, 2007. The ‘‘Decision’’ became
effective on June 12, 2007.
10. Hydrocodone, in combination
dosage unit form, is a Schedule III
narcotic controlled substance. Its
brands, inter alia, include Lortab, Lorcet
and Vicodin.
11. Codeine with apap, in dosage unit
form, is a Schedule III narcotic
controlled substance.
12. Lorazepam and diazepam are both
Schedule IV depressant controlled
substances.
13. The Respondent stipulates that the
Government can establish a prima facie
case supporting the denial of his
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21:08 Oct 21, 2013
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62687
pending DEA Certificate of Registration
application. [ALJ Exh. 6].
January 18, 2002 by signing a DEA Form
104. [Tr. 323].
B. Respondent’s Registration History
The Respondent was first licensed to
practice dentistry in 1985. [Govt. Exh.
5]. On November 25, 1985, the Agency
issued a Certificate of Registration
Number BM0207678 to Respondent as a
practitioner with authority to handle
controlled substances in schedules II–
IV. [Govt. Exh. 2; Tr. 323]. Respondent
voluntarily surrendered this registration
for cause on January 18, 2002. [Govt.
Exh. 2; Tr. 323–24].
On July 23, 2008, Respondent applied
for a new DEA Certificate of
Registration. [Tr. 326]. This application
was granted and the Agency issued
Certificate of Registration Number
FM0982808 to Respondent as a
practitioner with authority to handle
controlled substances in schedules II–
IV. [Govt. Exh. 3; Resp. Exh. A74; Tr.
325–326]. This registration expired on
January 31, 2011 and was retired from
the DEA computer system on December
5, 2011. [Govt. Exh. 3].
On September 19, 2011, Respondent
submitted a new application for
registration under DEA control number
W11065544C. [Govt. Exh. 1; Tr. 321].
This application is the subject of these
proceedings. [Id.].
D. 2002 DBC Action Against Respondent
C. Respondent’s Addiction History
Respondent began experiencing
headaches and tinnitus in
approximately 1996 while he was
working in a private family dentistry
practice in San Jose, California. [Govt.
Exh. 7 at 2]. To treat these conditions,
Dr. Medinnus began to take Vicodin
tablets from his office. [Id.]. By 1999,
Respondent was addicted to Vicodin
and he had begun to supply his family
members with Vicodin for non-dental
medical conditions. [Id.]. Respondent’s
headaches were eventually diagnosed as
resulting from cataracts, and he
underwent surgery. [Id.]. During his
recovery from surgery and while
suffering from depression, Respondent
closed his dental practice in June 2000.
[Id.]. Despite the closure of his practice,
Dr. Medinnus continued to order large
quantities of controlled substances to
support his addiction and provide pills
for his family members from
approximately 2000 to 2001. [Id.; Tr.
426–427]. When confronted by a Dental
Board of California (‘‘DBC’’ or ‘‘the
Board’’) investigator in January 2002
regarding these orders, Respondent
admitted to illegally obtaining these
controlled substances and using them to
support his addiction. [Govt. Exh. 7 at
2]. Dr. Medinnus voluntarily
surrendered his DEA registration on
On February 27, 2003, Dr. Medinnus
pled guilty in Santa Clara County,
California to one felony count of a
violation of Cal. Health & Safety Code
§ 11173(a) (West 2012) for obtaining
controlled substances by fraud. [Resp.
Exh. 3]. Dr. Medinnus was sentenced to
three years’ probation. [Govt. Exh. 7 at
2]. Respondent successfully complied
with all his probationary conditions and
on April 27, 2006, Dr. Medinnus
successfully petitioned to reduce his
felony conviction to a misdemeanor
pursuant to Cal. Penal Code § 17(b)(3)
(West 2012) and then dismissed
pursuant to Cal. Penal Code § 1203.4(a)
(West 2012). [Resp. Exh. A–17; Tr. 350–
351].
Pursuant to this felony conviction, the
Department of Health and Human
Services (‘‘HHS’’) excluded Dr.
Medinnus from participating as a
healthcare provider in Medicare for a
period of five years. [Resp. Exh. A86]. In
addition, on June 23, 2004, the Office of
Personnel Management (‘‘OPM’’)
debarred Respondent from participating
in the Federal Employees Health
Benefits Program. [Resp. Exh. A87]. On
April 20, 2009, HHS reinstated
Respondent’s eligibility to participate as
a Medicare provider and OPM
terminated Respondent’s debarment
from the Federal Employees Health
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On September 3, 2002, the Dental
Board of California (‘‘DBC’’ or ‘‘the
Board’’) filed an accusation against
Respondent seeking to suspend or
revoke his California dental license.
[Govt. Exh. 4; Tr. 327]. Therein, the DBC
alleged that Respondent had ordered
significant quantities of controlled
substances, including hydrocodone,
lorazepam, and diazepam, from
approximately January 2000 to
November 2001, for his own personal
use and to unlawfully distribute to
others. [Govt. Exh. 4 at 3–5].
Respondent entered into a Stipulated
Surrender of License and Order with the
Board on September 20, 2002, wherein
he admitted to the allegations contained
in the DBC’s accusation and
surrendered his dental license to the
Board. [Govt. Exh. 5; Tr. 328]. On
November 18, 2002, the Board adopted
the Stipulated Surrender of License and
Order in a Decision and Order which
became effective on December 18, 2002.
[Govt. Exh. 6; Tr. 329].
E. Respondent’s 2003 Felony Conviction
and Subsequent Exclusion From
Medicare
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Benefits Program. [Resp. Exh. A86–87;
Tr. 356–357].
F. Respondent’s Rehabilitation Program
and Dental License Reinstatement
Following Respondent’s felony
conviction, he began an intensive drug
rehabilitation program. [Govt. Exh. 7 at
2–3]. This program included attending
individual and group therapy sessions
with a licensed therapist to address
Respondent’s mental health and
substance abuse issues. [Resp. Exh. A5–
8]. In addition, Respondent received
psychiatric treatment, including
medication, to treat his symptoms of
depression. [Resp. Exh. A13–15].
Respondent also participated in
frequent twelve-step program meetings
and joined the board of a local
transitional housing facility for
recovering addicts. [Resp. Exh. A3–4;
A9–11].
On May 26, 2006, Respondent filed a
petition for reinstatement of his
California dental license. [Govt. Exh. 7
at 2]. As part of his petition, Dr.
Medinnus submitted letters of
recommendations from fellow dentists
regarding his clinical abilities. [Resp.
Exh. A32–34]. Respondent also
proffered evidence regarding his family
life, involvement in his stepchildren’s
elementary school and athletics
programs and his own volunteer
activities. [Resp. Exh. A19, A21, A25,
A26–27, A30–31, A91]. After an
administrative hearing, a state
administrative law judge recommended
that the DBC reinstate Respondent’s
dental license and place the Respondent
on probation for a period of five years.
[Govt. Exh. 7 at 5; Tr. 292–293]. The ALJ
made detailed factual findings regarding
Dr. Medinnus’ successful drug
rehabilitation program. [Govt. Exh. 7 at
3–4]. These included maintaining his
sobriety from March 7, 2003, receiving
outpatient medical and psychotherapy
treatment, attending NA and AA
meetings, and completing continuing
dental education courses. [Id.]. The ALJ
further found that Respondent had
complied with all the terms of his
criminal probation, recovered
completely from his cataract surgery,
and had credibly addressed the triggers
that led to his drug addiction and
diversion to his family members. [Id.].
The ALJ recommended that
Respondent’s dental license be subject
to several probationary conditions,
including that he maintain a separate
log of all controlled substances that he
prescribed, dispensed or administered
during his probationary period. [Govt.
Exh. 7 at 7; 293–294]. Among other
conditions, Dr. Medinnus was also
required to pass a dental licensing
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examination, undergo a psychiatric
evaluation, participate in a diversion
program offered by the Board, and be
subject to random drug screenings.
[Govt. Exh. 7 at 5–9]. On May 10, 2007,
the Board adopted the ALJ’s Decision,
which became effective on June 12,
2007. [Govt. Exh. 8; Tr. 330–331].
To regain his probationary dental
license, Dr. Medinnus successfully
completed the mandated dental
licensing examination on July 14, 2007.
[Resp. Exh. A61; A85]. Respondent also
received a comprehensive psychiatric
evaluation, which favorably reported his
ongoing recovery. [Resp. Exh. A57]. In
addition, on December 6, 2007,
Respondent was released from the
Board mandated diversion program.
[Resp. Exh. A58; Resp. Exh. 6]. During
this time, Dr. Medinnus took and passed
numerous random drug screens as
directed by the DBC. [Resp. Exh. A45–
47; A49; A51; A53–54]. When his
probationary dental license was issued,
Dr. Medinnus performed volunteer
dental consulting work at Milestones
Health Center in Weaverville,
California. [Resp. Exh. A68; A76].
G. Respondent’s Employment at RVIHC
After the reinstatement of his dental
license, Respondent negotiated an
employment contract to work as the
dental director at the Round Valley
Indian Health Center, (‘‘RVIHC’’) which
is located in Covelo, California. [Govt.
Exh. 9; Tr. 31]. One of the terms of the
employment contract was that the
Respondent agreed to ‘‘comply with all
policies and procedures, rules and
regulations of the RVIHC funding
agencies and federal and state laws
including all of the HIPPA
requirements.’’ [Govt. Exh. 9 at 2].
James Russ, the executive director of
RVIHC, testified at the hearing, and I
find his testimony credible and
consistent with the documentary
evidence. Mr. Russ testified that prior to
the negotiation of his contract, Dr.
Medinnus voluntarily and freely
disclosed his history of substance abuse
and the surrender of his dental license
and DEA registration in 2002 and its
subsequent reinstatement. [Tr. 34–35].
As RVIHC’s executive director, Mr.
Russ administers the day-to-day
operations of the clinic’s various
departments. [Tr. 23–24]. Mr. Russ
outlined RVIHC’s operation and the
services it provided including operating
a medical center, dental clinic,
outpatient physical or psychological
treatment, and a group home. [Tr. 24–
25]. He testified that all controlled
substances ordered by RVIHC were
stored in a central dispensary, which
contained a locked safe. [Tr. 25–26]. Mr.
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Russ further testified that RVIHC’s usual
suppliers of controlled substances were
McKesson and Pharmadex, and did not
include Henry Schein, a supplier from
whom RVIHC only ordered dental
supplies. [Tr. 40–41].
Linda Lohne, a registered nurse and
clinic manager at RVIHC, also testified
at the hearing. [Tr. 186]. I find her
testimony credible and consistent with
the documentary evidence. As part of
her clinic manager duties, Ms. Lohne
oversaw RVIHC’s ordering and
dispensing of controlled substances. [Tr.
187]. She likewise testified that all
controlled substances ordered under
RVIHC’s DEA registration were stored in
the clinic’s central dispensary. [Id.].
Mr. Russ testified that Dr. Medinnus
had discussed with him the possibility
of storing hydrocodone in the dental
department to obviate the need for
Respondent or his dental staff to pick up
the controlled substances at the
dispensary and then return to the dental
department to dispense them to the
patients. [Tr. 51, 90; Resp. Exh. A134–
135, A148]. Mr. Russ discussed his
concerns about this request with
Respondent, including his belief that
the controlled substances would be
more secure if they remained in the
central dispensary. [Tr. 70–71].
Dr. Medinnus testified that he sought
to order controlled substances to store
in the dental department because the
dispensary would occasionally run low
or out entirely of controlled substances.
[Tr. 464–466]. But, Ms. Lohne testified
that RVIHC never completely ran out of
hydrocodone during 2010, although she
did testify that the dispensary had run
low on controlled substances, including
having as little as five or seven dosage
units on hand. [Tr. 240–241]. Ms.
Lohne, however, also testified that
RVIHC’s dispensary might have run out
of controlled substances by the end of
some days. [Tr. 242–243].
H. November 29, 2010 Purchase Order
Kimberly Stillwell, a dental
sterilization technician at RVIHC, also
testified at the hearing. [Tr. 149]. I find
her testimony only partially credible.
Though called as a witness for
Respondent, her testimony suggested
that she bore Dr. Medinnus substantial
animus from his employment at RVIHC.
Her demeanor while testifying was
consistent with this animus towards
Respondent and was repeatedly
demonstrated by her nonresponsive
answers or unsolicited comments
adverse to Respondent. Therefore, I
decline to credit much of her testimony.
On November 29, 2010, Ms. Stillwell
prepared a purchasing order to obtain
supplies for RVIHC’s dental department.
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[Govt. Exh. 10; Tr. 151]. At the direction
of Dr. Medinnus, she included one
bottle of hydrocodone and one bottle of
APAP with codeine along with other
routine dental supplies in the order.
[Id.]. Prior to preparing the order, Dr.
Medinnus directed Ms. Stillwell to
obtain authorization for the purchase
order from Mr. Russ, specifically
concerning the inclusion of controlled
substances in the order. [Tr. 153, 155].
Ms. Stillwell testified that she spoke to
Mr. Russ before placing the purchase
order. [Tr. 155]. During this
conversation, Ms. Stillwell testified that
Mr. Russ said he ‘‘did not feel it was a
good idea’’ to order controlled
substances for the dental department to
dispense directly to patients. [Tr. 157–
158]. Mr. Russ though could not recall
the substance of this conversation with
Ms. Stillwell at the hearing. [Tr. 50–51].
Despite Mr. Russ’s misgivings, Ms.
Stillwell informed Respondent that Mr.
Russ had given his permission for the
purchase order. [Tr. 158; Resp. Exh.
A140].
The purchase order was then
ultimately approved by Jan Scribner, the
deputy director of RVIHC, who
possessed the ability to approve
purchase orders in the absence of Mr.
Russ. [Govt. Exh. 10; Govt. Exh. 21; Tr.
46]. Ms. Scribner did not realize that the
order contained a request to purchase
controlled substances. [Govt. Exh. 21].
Nor did Ms. Stillwell inform her that the
order contained a request to purchase
controlled substances for use in the
dental department. [Tr. 164–165]. Ms.
Stillwell received the controlled
substances from the purchase order on
December 7, 2010 [Govt. Exh. 10 at 4;
Tr. 48–49, 150]. She stored the bottle of
hydrocodone and the bottle of APAP
with codeine in a locked cabinet in the
dental department and informed Dr.
Medinnus of their arrival. [Tr. 169–170,
173].
I. Respondent’s Dispensing of
Controlled Substances at RVIHC
Dr. Medinnus testified that he began
to dispense hydrocodone directly to
dental patients beginning on January 18,
2011. [Tr. 418]. Respondent did not
dispense any of the APAP with codeine
during this period. [Tr. 432].
Respondent testified that he only
intended to dispense the hydrocodone
on an emergency basis. [Tr. 418; 475–
476]. He further testified that he was
experiencing serious marital and
personal problems during this period of
time and that he was under a great deal
of personal and professional stress due
to the absence of dental department
employees and the hospitalization of his
mother-in-law. [Tr. 436–437; Resp. Exh.
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A117, A123, A138]. Ms. Stillwell
testified that she never saw Dr.
Medinnus self-abuse any of the
hydrocodone kept in the dental
department. [Tr. 179–180].
Dr. Medinnus did acknowledge that
he did not keep a separate dispensing
log for hydrocodone that he dispensed
during this period. [Tr. 491; Govt. Exhs.
18, 19]. Instead, he notated the
dispensing of hydrocodone in each
patient’s dental chart. [Tr. 68; Govt. Exh.
13]. He testified that by not keeping a
separate dispensing log, he violated the
conditions of his DBC probation. [Tr.
509].
Respondent also testified that he
dispensed hydrocodone to one patient,
a transient named ‘‘JC’’, without
recording it in the patient’s chart. [Tr.
519–525]. Again, due to concerns about
the bias she displayed during her
testimony and her lack of recall
regarding this specific patient, I decline
to credit Ms. Stillwell’s account of the
dispensing of hydrocodone to this
patient. [Tr. 178, 180–184]. Dr.
Medinnus credibly testified that he had
examined the patient on January 20,
2011, and observed that he needed a
surgical extraction on two of his teeth.
[Tr. 421, 521–22]. When the patient
returned to RVIHC on January 24, 2011,
Dr. Medinnus could not perform the
extraction because of his busy schedule.
[Id.; Tr. 523]. When the patient reported
experiencing pain symptoms, Dr.
Medinnus agreed to provide him with
hydrocodone to temporarily alleviate
his symptoms. [Tr. 421–22, 522–523].
Although Ms. Stillwell offered to
retrieve the patient’s chart to record the
dispensing, Dr. Medinnus testified that
due to the clinic’s busy schedule, he did
not receive the patient chart and thus he
did not record the dispensing of
hydrocodone to this patient in the chart.
[Tr. 422, 523–525].
The Respondent accepted
responsibility for his failure to
document this dispensing to ‘‘JC’’. [Tr.
523]. Further, the Respondent offered to
stipulate to the audit numbers’
discrepancy, concluding that
‘‘[r]egardless, of course, the fault for this
confusion is mine alone.’’ [Resp. Brief at
7; see also Tr. 539–40; Govt. Exh. 19;
ALJ Exh. 6].
J. Discovery of Respondent’s Dispensing
of Controlled Substances
On December 14, 2010, independent
pharmacy consultant, Tom Reidenbach,
performed a quarterly drug utilization
audit for RVIHC. [Tr. 53–54; Govt. Exh.
15]. In that report, he wrote that ‘‘I
recommended to Dr. Medinnus that all
controlled substances continue to be
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dispensed from the dispensary.’’ [Govt.
Exh. 15 at 2].
On January 27, 2011, Mr. Reidenbach
conducted a chart audit related to the
dispensing of hydrocodone. In his
report, Mr. Reidenbach noted that there
‘‘were several deficiencies in the dental
clinic record keeping. There were 3
prescriptions that did not have chart
orders evident. There were also 9 chart
orders that were not dispensed from the
dispensary. These were all after 1/20/
11.’’
After receiving Mr. Reidenbach’s
report, Mr. Russ attended a meeting on
January 28, 2011, with RVIHC staff to
discuss Mr. Reidenbach’s findings. [Tr.
59–62, 82–84]. During this meeting, a
RVIHC staff member observed that the
dispensary had experienced a dramatic
decline in orders for hydrocodone from
the dental department. [Tr. 61–63]. Ms.
Lohne, who was also at this meeting,
had observed a similar gap in the
patient orders for controlled substances
from the dental department. [Tr. 193].
At the conclusion of this meeting, Mr.
Russ went to Dr. Medinnus’ office and
asked him if he had any hydrocodone in
his office. [Tr. 63]. Respondent
acknowledged that he had a bottle of
hydrocodone in the dental office and he
informed Mr. Russ that RVIHC
management had approved the purchase
order containing the hydrocodone
bottle. [Id.]. Mr. Russ instructed Dr.
Medinnus to take the hydrocodone
bottle to the dispensary. [Tr. 65]. That
same day, Dr. Medinnus turned over the
bottle of hydrocodone and the
unopened bottle of APAP with codeine
to Ms. Lohne in the dispensary. [Tr.
195–196]. He did not have a dispensing
log at that time. [Id.].
One or two days later, Mr. Russ asked
Dr. Medinnus if he had kept a
dispensing log to track the hydrocodone
he had dispensed. [Tr. 66–67].
Respondent said that he had not kept a
dispensing log, so Mr. Russ instructed
him to consult the patient charts and
recreate a dispensing log to account for
the dosage units he had dispensed. [Tr.
68]. Ms. Lohne also directed Dr.
Medinnus to prepare a dispensing log
for the bottle of hydrocodone. [Tr. 196].
Dr. Medinnus prepared this dispensing
log for the hydrocodone he dispensed
directly to patients from the dental
department, and he provided the log to
Ms. Lohne on February 2, 2011. [Govt.
Exh. 11; Resp. Exh. A161; Tr. 69, 198–
199, 203].
Mr. Russ then directed Ms. Lohne to
account for the apparent discrepancies
from Respondent’s dispensing log to the
number of dosage units left in the bottle
when Dr. Medinnus turned it in to the
dispensary. [Tr. 69–70, 188–189]. Ms.
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Lohne began by determining that the
bottle of hydrocodone originally
contained five hundred dosage units
when it was ordered from Henry Schein.
[Tr. 198]. And when Dr. Medinnus
provided the bottle to Ms. Lohne, she
and another nurse physically counted
the remaining pills and determined
there were one hundred and forty
dosage units left in the bottle. [Id.].
Then Ms. Lohne conducted a patient
chart audit to verify the Respondent’s
dispensing log and she prepared a
document summarizing the result of her
review. [Govt. Exh. 12; Tr. 204–212].
Her audit revealed that the dental
department patient charts showed that
Dr. Medinnus had dispensed three
hundred and eighty-eight dosage units
of hydrocodone, even though the
Respondent’s dispensing log showed he
only dispensed three hundred and sixty
dosage units of hydrocodone. [Govt.
Exh. 12; Govt. Exh. 13; 208–211]. Ms.
Lohne then crosschecked the patient
charts and Respondent’s dispensing log
with the carbon copy duplicates of the
prescription orders for hydrocodone
associated with each patient file, which
showed that Respondent had only
dispensed three hundred and twenty
dosage units of hydrocodone. [Govt.
Exh. 12; Tr. 206–207]. When Ms. Lohne
reviewed the patient charts, she noticed
that in some files, Dr. Medinnus had
altered the number of dosage units he
had dispensed. [Govt. Exhs. 13, 19–20;
Tr. 221–236].
Unwilling to credit the patient files
altered by Respondent, Ms. Lohne
concluded that RVIHC could not
account for approximately forty dosage
units of hydrocodone from the bottle
that Dr. Medinnus had ordered. [Tr.
237–238]. Thus, on February 4, 2011,
RVIHC filed a DEA Form 106, a Report
of Theft or Loss of Controlled
Substances, for forty hydrocodone
tablets. [Govt. Exh. 14; Tr. 238]. Ms.
Lohne testified that this figure came
from her audit, which showed three
hundred and twenty dosage units
dispensed from the dental department
according to duplicate prescription
orders from each patient file and one
hundred and forty dosage units
remaining in the bottle when it was
returned to the dispensary. [Tr. 238;
Govt. Exh. 12].
Following this report, Dr. Medinnus
offered to report himself to his
probation monitor, Shirley Boldrini, at
the DBC. [Tr. 109]. On February 9, 2011,
Respondent called and sent an email to
Ms. Boldrini reporting a violation of his
DBC probation. [Govt. Exhs. 18, 19].
That same day, Mr. Russ placed Dr.
Medinnus on a thirty-day suspension.
[Tr. 109–110, 145; Resp. Exh. 4 at 24].
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Respondent offered to perform a number
of conditions during this suspension,
including weekly drug testing, weekly
therapy and AA meetings, and taking
continuing dental education courses.
[Tr. 97–99; Govt. Exh. 18]. Mr. Russ did
not agree to these conditions. [Tr. 91].
However, during his suspension, Dr.
Medinnus notified Ms. Boldrini that he
was completing these self-imposed
conditions. [Resp. Exh. A125 at 1, 2, 11,
and 17].
The record also contains an email
dated February 11, 2011, from the
RVIHC psychologist, Dr. Mack, who had
been treating the Respondent since the
Fall of 2010. He concluded that ‘‘the
recent documentation error [by the
Respondent] was the result of acute
stress and fatigue and not an attempt to
be deceitful or abuse the medication.’’
[Resp. Exh. A123].
On March 10, 2011, Dr. Medinnus
resigned from RVIHC. [Resp. Exh. A126;
Govt. Exh. 17].
K. DBC and DEA Investigation of
Respondent
Geno Davis, a DBC investigator, also
testified at the hearing. [Tr. 286]. I find
his testimony credible and consistent
with the documentary evidence. Mr.
Davis serves as Respondent’s current
probation monitor for the Board. [Tr.
288]. When the Board was notified of a
potential narcotic or drug discrepancy
involving Dr. Medinnus while he was
employed at RVIHC, Mr. Davis was
assigned to be Respondent’s probation
monitor. [Tr. 289]. Mr. Davis
interviewed Respondent at the Board’s
office in Sacramento, California in
August 2011. [Tr. 294–295]. When asked
about the discrepancies in Respondent’s
dispensing log for the hydrocodone, Dr.
Medinnus told Mr. Davis that he had
poured the hydrocodone tablets into a
small envelope before giving it to each
patient, which may have accounted for
the discrepancies in the patient charts
and his dispensing log because he may
have inadvertently dispensed more
tablets than he had intended. [Tr. 295–
297].
Following this interview, Mr. Davis
contacted the Respondent by phone and
asked him if he had personally taken
any of the hydrocodone. [Tr. 298]. Dr.
Medinnus denied taking any of the
hydrocodone. [Id.]. Mr. Davis further
testified that Respondent had taken
drug-screening tests at the direction of
the Board in 2011 and that all of his
tests were negative. [Tr. 315; Resp. Exh.
A128]. Lastly, Mr. Davis testified that
the Board has filed an accusation
against Respondent with the California
Attorney General’s Office regarding the
lack of documentation in a dispensing
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log, and that the accusation is currently
pending with that office. [Tr. 316–317].
DEA Diversion Investigator Craig Tom
also testified at the hearing. [Tr. 318—
319]. I find his testimony credible and
consistent with the documentary
evidence. DI Tom was assigned to
investigate Respondent’s application for
registration. [Tr. 320]. DI Tom
coordinated his investigation with the
DBC and also spoke with Mr. Russ
regarding the Respondent’s conduct at
RVIHC. [Tr. 332–333]. DI Tom testified
that Dr. Medinnus was truthful in the
applications for registration that he
submitted to the DEA. [Tr. 333]. DI Tom
did not interview Dr. Medinnus. [Id.].
L. Respondent’s Current Situation
Dr. Medinnus currently possesses an
active California dental license, subject
to the probationary conditions imposed
by the DBC’s June 12, 2007 order. He is
currently employed as a dentist at the
ANAV Tribal Health Clinic in Fort
Jones, California, where he has worked
since April 21, 2011. [Resp. Exh. A129;
Tr. 541]. Dr. Medinnus has not
dispensed or prescribed any controlled
substances while working at the ANAV
Tribal Health Clinic. [Tr. 545].
Respondent credibly testified that
obtaining a DEA registration may be
necessary for him to continue at his
present position and to be eligible to
become the dental director. [Tr. 547–
548]. In addition, Respondent proffered
two letters of recommendation regarding
his application for a DEA Registration
from his supervisors at the ANAV Tribal
Health Clinic. [Resp. Exh. A151–152].
The ANAV Tribal Health Clinic does
not store or dispense any narcotic
medications and only faxes the
prescriptions to neighboring
pharmacies. [Id.].
IV. Statement of Law and Discussion
A. Position of the Parties
1. Government’s Position
The Government asserts that the
appropriate remedy in this matter is
denial of the Respondent’s application.
[Govt. Brief at 25–26]. First, the
Government argues that by procuring
the order of the bottle of hydrocodone
and then subsequently surreptitiously
dispensing it to dental patients,
Respondent violated federal law, the
terms of his DBC probation and his
RVIHC contract. [Id. at 20–21]. Next, the
Government cites Respondent’s failure
to maintain accurate dispensing records
as further evidence of his unfitness to
possess a DEA Registration. [Id. at 23–
24]. Lastly, the Government cites
Agency precedent and argues that
Respondent’s lack of candor at the
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hearing and his inability to accept
responsibility for his conduct also
supports the denial of Respondent’s
application. [Id. at 21–23].
The Government makes several
arguments to justify the denial of
Respondent’s application. Primarily, the
Government argues that Respondent
violated federal law and his DBC
probation by failing to maintain a
contemporaneous dispensing log for the
hydrocodone he dispensed to patients.
[Id. at 20, 25]. Similarly, the
Government contends that Respondent
demonstrated his inability to comply
with DEA recordkeeping requirements
because he could not even recreate an
accurate dispensing log from his own
patient records. [Id. at 22, 24–25]. And
the Government also highlighted
Respondent’s failure to record in the
patient chart the dispensing of
hydrocodone to one of his patients,
‘‘JC’’. [Id. at 23]. In addition, the
Government strenuously argues that
Respondent has not accepted
responsibility or shown any remorse for
his conduct. [Id. at 21–23]. Instead, the
Government argues that Respondent has
‘‘downplayed, indeed mischaracterized,
his violations’’ and ‘‘has not been
truthful as to what really happened.’’
[Id. at 21]. Nor, the Government
contends, was Respondent candid with
RVIHC personnel regarding his ordering
and usage of hydrocodone in the dental
department. [Id. at 22–23].
In conclusion, the Government argues
that Respondent’s application for a DEA
Certificate of Registration as practitioner
is inconsistent with the public interest
and that his application should be
denied. [Id. at 25–26].
2. Respondent’s Position
Respondent asserts that the
appropriate remedy in this matter is the
conditional granting of his application.
[Resp. Brief at 34–35]. First, Dr.
Medinnus acknowledges his
misconduct in not maintaining the
required dispensing log at RVIHC
pursuant to his DBC probation. [Id. at
7–8, 20]. In mitigation, Respondent
describes in detail the ‘‘profound
personal and professional hardship’’
that he experienced during his
employment at RVIHC. [Id. at 10–11,
20]. Respondent further notes that he
self-reported his violations to the DBC
and also fully disclosed the incident on
his DEA application. [Id. at 20].
Respondent also argues that he has
consistently taken responsibility for this
misconduct, including in his testimony
at the hearing. [Id. at 8–10, 20]. In
addition, Dr. Medinnus argues that the
record contains no evidence of selfabuse or diversion of controlled
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substances during his employment at
RVIHC. [Id. at 9–10, 20].
Next, Respondent argues that the
Government has failed to prove its
allegations that he made an
unauthorized purchase of hydrocodone
or that he violated RVIHC’s policies on
storing and dispensing by directly
dispensing to patients in the dental
department. [Id. at 20–33]. Respondent’s
primary claim is that Mr. Russ verbally
authorized the November 29, 2011
purchase order, which rendered
Respondent’s subsequent storing and
dispensing of the hydrocodone
compliant with RVIHC’s policy. [Id. at
26–31]. To this point, Respondent
meticulously details RVIHC’s changing
policy on the dispensing of controlled
substances during late 2010 and early
2011 and the problems that the
dispensary had in maintaining adequate
supplies of controlled substances. [Id. at
21–26]. Dr. Medinnus also argues that
these allegations concerning the
purchase and dispensing of
hydrocodone were never disclosed to
him or discussed with him until the
DEA initiated the Order to Show Cause
proceedings. [Id. at 31–33].
Lastly, Respondent argues that
denying his application for registration
would be a disproportionate penalty for
his conduct at RVIHC. [Id. at 20, 34].
Therefore, in light of Respondent’s
acceptance of responsibility,
Respondent argues that granting his
application for a restricted registration
would be consistent with the public
interest. [Id. at 34–35]. He recommends
that his registration be subject to several
conditions, including complying with
the terms of his California dental license
probation, being limited to only
prescribing controlled substances and
not administering, ordering, or
dispensing them, being prohibited from
prescribing controlled substances to
himself or any family members, and
maintaining a log of all controlled
substances prescriptions he authorizes
and providing this log to the local DEA
office on a quarterly basis. [Id.].
B. Statement of Law and Analysis
Pursuant to 21 U.S.C. 823(f) (2006),1
the Deputy Administrator may deny an
application for a DEA Certificate of
Registration if he determines that such
registration would be inconsistent with
the public interest. In determining the
public interest, the following factors are
considered:
1 The Deputy Administrator has the authority to
make such a determination pursuant to 28 CFR
0.100(b), 0.104 (2012).
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(1) The recommendation of the
appropriate State licensing board or
professional disciplinary authority.
(2) The applicant’s experience in
dispensing, or conducting research with
respect to controlled substances.
(3) The applicant’s conviction record
under Federal or State laws relating to
the manufacture, distribution, or
dispensing of controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to
controlled substances.
(5) Such other conduct which may
threaten the public health and safety.
21 U.S.C. 823(f) (2006).
These factors are to be considered in
the disjunctive; the Deputy
Administrator may rely on any one or a
combination of factors and may give
each factor the weight he deems
appropriate in determining whether a
registration should be revoked. See
Robert A. Leslie, M.D., 68 FR 15,227,
15,230 (DEA 2003). Moreover, the
Deputy Administrator is ‘‘not required
to make findings as to all of the factors.’’
Hoxie v. DEA, 419 F.3d 477, 482 (6th
Cir. 2005); see also Morall v. DEA, 412
F.3d 165, 173–74 (D.C. Cir. 2005).
The Government bears the ultimate
burden of proving that the requirements
for registration are not satisfied. 21 CFR
1301.44(d) (2012). However, where the
Government has made out a prima facie
case that Respondent’s application
would be ‘‘inconsistent with the public
interest,’’ the burden of production
shifts to the applicant to ‘‘present[]
sufficient mitigating evidence’’ to show
why he can be entrusted with a new
registration. See Medicine Shoppe—
Jonesborough, 73 FR 364, 387 (DEA
2008). To this point, the Agency has
repeatedly held that the ‘‘registrant must
accept responsibility for [his] actions
and demonstrate that [he] will not
engage in future misconduct.’’ Medicine
Shoppe—Jonesborough, 73 FR at 387;
see also Samuel S. Jackson, D.D.S., 72
FR 23,848, 23,853 (DEA 2007). In short,
after the Government makes its prima
facie case, the Respondent must
produce sufficient evidence that he can
be entrusted with the authority that a
registration provides by demonstrating
that he accepts responsibility for his
misconduct and that the misconduct
will not reoccur.
1. Factor One: Recommendation of
Appropriate State Licensing Board
Although the recommendation of the
applicable state licensing board is
probative to this factor, the Agency
possesses ‘‘a separate oversight
responsibility with respect to the
handling of controlled substances’’ and
therefore must make an ‘‘independent
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determination as to whether the
granting of [a registration] would be in
the public interest.’’ Mortimer B. Levin,
D.O., 55 FR 8,209, 8,210 (DEA 1990); see
also Jayam Krishna-Iyer,M.D., 74 FR
459, 461 (DEA 2009). The ultimate
responsibility to determine whether a
registration is consistent with the public
interest has been delegated exclusively
to the DEA, not to entities within state
government. Edmund Chein, M.D., 72
FR 6,580, 6,590 (DEA 2007), aff’d, Chein
v. DEA, 533 F.3d 828 (D.C. Cir. 2008).
So while not dispositive, state board
recommendations are relevant on the
issue of revoking or maintaining a DEA
registration. See Gregory D. Owens,
D.D.S., 74 FR 36,751, 36,755 (DEA
2009); Martha Hernandez, M.D., 62 FR
61,145, 61,147 (DEA 1997).
In this case, the DBC has not made a
specific recommendation concerning
the granting of a DEA registration to the
Respondent. The DBC has reinstated
Respondent’s dental license, subject to a
series of probationary conditions. [Govt.
Exh. 7, 8; Tr. 330–331]. Thus, Dr.
Medinnus currently possesses an active
dental license in the state of California.
[Id.]. Nevertheless, the Agency has
consistently held that a practitioner’s
possession of state authority, while a
prerequisite to seeking a registration, is
not dispositive of the public interest
determination. Mark De La Lama, P.A.,
76 FR 20,011, 20,018 (DEA 2011).
Therefore, I find that this factor does not
weigh in favor or against the granting of
Respondent’s application for a DEA
Certificate of Registration.
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2. Factor Three: Applicant’s Conviction
Record Relating to Controlled
Substances
The record contains evidence that the
Respondent has been convicted of an
offense related to the manufacture,
distribution or dispensing of controlled
substances, namely his 2003 felony
conviction for violating Cal. Health &
Safety Code § 11173(a) (West 2012) for
obtaining controlled substances by
fraud. [Resp. Exh. 3]. Thus, I find that
this factor weighs against the granting of
Respondent’s application for a DEA
Certificate of Registration. Scott H.
Nearing, 70 FR 33,200, 33,202 (DEA
2005).
3. Factor Five: Such Other Conduct
Which May Threaten the Public Health
and Safety
The Agency has long held that a
practitioner’s self-abuse of controlled
substances constitutes ‘‘conduct which
may threaten public health and safety.’’
21 U.S.C. 823(f)(5) (2006); see also Tony
T. Bui, M.D., 75 FR 49,979, 49,990 (DEA
2010); Kenneth Wayne Green, Jr., M.D.,
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59 FR 51,453 (DEA 1994); David E.
Trawick, D.D.S., 53 FR 5,326 (DEA
1988). Here, the Respondent self-abused
and diverted to his family members
significant quantities of hydrocodone,
lorazepam, and diazepam from
approximately January 2000 through
November 2001. [Govt. Exhs. 5, 6, and
7]. Such unlawful ingestion and
diversion of controlled substances
clearly places the public health and
safety in jeopardy. This unlawful
conduct led to the surrender of
Respondent’s California dental license
and initial DEA registration.
Yet, I find that the Respondent has
successfully addressed his addiction
problem and returned to the practice of
dentistry by regaining his dental license
in 2007. At the hearing, Dr. Medinnus
proffered substantial and detailed
evidence regarding his impressive
recovery program, including numerous
negative drug screens he has taken over
the past nine years. [Resp. Brief at 2–7,
9–10]. As the Deputy Administrator has
previously determined, ‘‘[t]he
paramount issue is not how much time
has elapsed since [the Respondent’s]
unlawful conduct, but rather, whether
during that time [the] Respondent has
learned from past mistakes and has
demonstrated that he would handle
controlled substances properly if
entrusted with a DEA registration.’’
Leonardo V. Lopez, M.D., 54 FR 36,915
(DEA 1989). Even though it has been
previously found that time, alone, is not
dispositive in such situations, it is
certainly an appropriate factor to be
considered. See Robert G. Hallermeier,
M.D., 62 FR 26,818 (DEA 1997) (four
years); John Porter Richards, D.O., 61 FR
13,878 (DEA 1996) (ten years); Norman
Alpert, M.D., 58 FR 67,420, 67,421 (DEA
1993) (seven years). In this case,
Respondent has conclusively
demonstrated his strong recovery from
his previous addiction and his
successful maintenance of his sobriety
for the past nine years. Therefore, I find
that Respondent’s history of substance
abuse does not weigh against the
granting of Respondent’s application for
a DEA Certificate of Registration.
4. Factors Two and Four: Applicant’s
Experience With Controlled Substances
and Compliance With Applicable State,
Federal, or Local Laws Relating To
Controlled Substances
Under the Controlled Substances Act
(‘‘CSA’’ or ‘‘the Act’’) and Agency
regulations, it is fundamental that a
practitioner who directly dispenses
controlled substances maintain an
effective recordkeeping system. This
includes maintaining inventories and
other records pursuant to 21 U.S.C.
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827(a) (2006). They are also required to
hold a DEA registration at any location
where they dispense controlled
substances, see 21 CFR 1301.12 (2012),
and to store controlled substances ‘‘in a
securely locked, substantially
constructed cabinet,’’ id. § 1301.75.
Lastly, practitioners who provide
controlled substances directly to
patients must maintain written records
of such dispensing covering a minimum
of two years; take an initial inventory of
all controlled substances on hand and
biennial inventories thereafter; and
maintain records of receipts,
dispensings, and transfers of controlled
substances. See id. §§ 1304.03(b),
1304.04, 1304.11, 1304.21, 1304.22(c);
see also Shawn M. Gallegos, D.D.S., 76
FR 66,986 (DEA 2011).
The Government brought three
primary allegations to support the
denial of Respondent’s application, the
unauthorized purchase order for the
controlled substances, Respondent’s
failure to abide by RVIHC’s storing and
dispensing policies for controlled
substances, and his failure to maintain
the required dispensing log for the
hydrocodone pursuant to his DBC
probation. I decline to credit the
Government’s first two allegations
although I find that the Government has
met its burden of proof concerning
Respondent’s failure to maintain the
required dispensing log pursuant to his
DBC probation and Agency regulations.
First, with regards to the
unauthorized purchase allegation, I find
that the Government has not sustained
its burden of proof. The testimony and
evidence elicited at the hearing
regarding this purchase order does not
support the Government’s claim that
Respondent was unauthorized to place
the order. Dr. Medinnus credibily
maintained that Ms. Stillwell told him
that Mr. Russ approved the order. [Tr.
158; Resp. Exh. A140; Resp. Brief at 28–
31]. As explained above, I decline to
credit much of Ms. Stillwell’s testimony
on her conversation with Mr. Russ
regarding this order. Furthermore, I also
note that Mr. Russ failed to recall many
of the details surrounding this particular
order including any conversation he had
with Ms. Stillwell prior to the
submission of the order to Ms. Scribner.
Thus, the evidence in the record does
not support a conclusion by a
preponderance of the evidence that Dr.
Medinnus was responsible for
knowingly submitting an unauthorized
purchase order for controlled
substances. More tellingly, the
submission of the purchase order on
behalf of the dental department and its
subsequent approval by Jan Scribner, a
duly authorized RVIHC representative
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who had the power to approve such
orders, appears to belie any contention
that the order itself was unauthorized by
RVIHC management. While it is likely
that RVIHC management, including Mr.
Russ and Ms. Lohne, failed to remember
that Dr. Medinnus had obtained a bottle
of hydrocodone for emergency use, I
conclude that the record does not show
that the placement of the November 29,
2010 purchase order was unauthorized.
And as the Respondent persuasively
argues, if Dr. Medinnus reasonably
believed the purchase order was duly
approved, the Government’s allegation
that he failed to abide by RVIHC
policies regarding the storage and
dispensing of controlled substances,
also fails. [Resp. Brief at 20–21]. While
the Government has elicited substantial
testimony and evidence regarding
RVIHC’s policies and procedures related
to dispensing controlled substances, it
has failed to link these policies to any
deliberate or knowing attempt on behalf
of the Respondent to violate them.
[Govt. Brief at 21–22]. Indeed, when Mr.
Russ confronted Dr. Medinnus regarding
the bottle of hydrocdone, Respondent
promptly admitted to ordering and
storing the controlled substances and
pointed to the approval of the purchase
order as justification for his conduct.
[Tr. 63]. Such a response supports
Respondent’s consistent position that he
honestly and reasonably believed he
possessed the necessary authority to
store and dispense controlled
substances in the dental department.
Therefore, I decline to credit the
Government’s allegation that
Respondent violated RVIHC’s policies
on the storage and dispensing of
controlled substances.
Both parties however, do
acknowledge that Dr. Medinnus failed
to maintain the required dispensing log
for these controlled substances. [Resp.
Brief at 7–8; Govt. Brief at 20]. In
addition, I find that Dr. Medinnus failed
to properly chart each dispensing of
hydrocodone he gave to a patient, most
notably with regards to his dispensing
to ‘‘JC’’, which represents another
serious violation of Agency
recordkeeping regulations. Nor was
Respondent’s clumsy attempt to
reconstruct a dispensing log and
alteration of patient charts consistent
with a registrant’s duty to maintain
complete and accurate records regarding
controlled substances. Therefore, I find
that Respondent committed several
serious violations of the Act’s
recordkeeping requirement, Agency
regulations, as well as the terms of his
DBC probation. Thus, in light of
Respondent’s serious and undisputed
violations of the CSA’s recordkeeping
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requirements and his DBC probation, I
conclude that the Government has
presented a prima facie case that
supports the denial of Respondent’s
application.
After the Government ‘‘has proved
that a registrant has committed acts
inconsistent with the public interest, a
registrant must ‘present sufficient
mitigating evidence to assure the
Administrator that [he] can be entrusted
with the responsibility carried by such
a registration.’ ’’ Medicine Shoppe—
Jonesborough, 73 FR 364, 387 (DEA
2008) (quoting Samuel S. Jackson,
D.D.S., 72 FR 23,848, 23,853 (DEA
2007). ‘‘Moreover, because ‘past
performance is the best predictor of
future performance,’ Alra Labs., Inc. v.
DEA, 54 F.3d 450, 452 (7th Cir. 1995),
‘‘[DEA] has repeatedly held that where
a registrant has committed acts
inconsistent with the public interest, the
registrant must accept responsibility for
his actions and demonstrate that he will
not engage in future misconduct.’’
Medicine Shoppe—Jonesborough, 73 FR
at 387; see also Samuel S. Jackson,
D.D.S., 72 FR 23, 848, 23,853 (DEA
2007); Hoxie v. DEA, 419 F.3d 477, 483
(6th Cir. 2005) (‘‘admitting fault’’ is
‘‘properly consider[ed]’’ by DEA to be
an ‘‘important factor[]’’ in the public
interest determination).
Here, I find that Respondent has both
taken responsibility for his actions and
shown remorse for his conduct. During
his testimony, Dr. Medinnus repeatedly
demonstrated remorse for his conduct at
the RVIHC. He also testified credibly
and candidly about the circumstances
surrounding the misconduct, including
the various personal and professional
challenges he faced during his
employment at RVIHC.
The Government argues that the
Respondent attempted to ‘‘minimize’’
his misconduct by testifying that he
could only not account for forty dosage
units of the hydrocodone. [Govt. Brief at
22]. I disagree. Instead, I find that while
this evidence, along with the evidence
regarding the circumstances
surrounding Respondent’s employment
at RVIHC does not excuse Respondent’s
conduct, it does provide appropriate
mitigating factors for this Court and the
Deputy Administrator to consider. See
Martha Hernandez, M.D., 62 FR 61,145
(DEA 1997) (holding that, in exercising
his discretion in determining the
appropriate remedy, the Administrator
should consider all of the facts and
circumstances of a particular case).
In light of the substantial evidence
that Respondent proffered regarding his
acceptance of responsibility for the
misconduct, I find that the
Government’s proposed sanction, the
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Fmt 4703
Sfmt 4703
62693
denial of Respondent’s application, is
too severe. As this Agency has
repeatedly held, a proceeding under the
Act ‘‘ ‘is a remedial measure, based
upon the public interest and the
necessity to protect the public from
those individuals who have misused
. . . their DEA Certificate of
Registration, and who have not
presented sufficient mitigating evidence
to assure the Administrator that they
can be entrusted with the responsibility
carried by such a registration.’ ’’ Jon Karl
Dively, D.D.S., 72 FR 74,332, 74,334
(DEA 2007) (quoting Samuel S. Jackson,
D.D.S., 72 FR 23,848, 23,853 (DEA
2007)). Despite the Government’s
strenuous arguments to the contrary, I
find that Dr. Medinnus’ restricted
registration does not represent a danger
to the public interest. Indeed, Dr.
Medinnus has sensibly requested the
issuance of a restricted registration,
which would ensure that he avoid any
repeat of the recordkeeping violations
he committed while at RVIHC. While
his misconduct was indeed serious, Dr.
Medinnus has now demonstrated that
he understands the responsibilities and
requirements of a DEA registrant.
V. Conclusion and Recommendation
Therefore, I conclude that the DEA
has met its burden of proof and has
established that grounds exist for
denying the Respondent’s application
for a DEA Certificate of Registration. I
do not condone nor minimize the
seriousness of the Respondent’s
misconduct. However, based on this
record, I recommend that the
Respondent be afforded an opportunity
to demonstrate that he can again
responsibly handle controlled substance
prescriptions by the granting of a
restricted registration. See Cecil E.
Oakes, Jr., M.D., 63 FR 11,907, 11,910
(DEA 1998) (‘‘Such a resolution will
provide Respondent with the
opportunity to demonstrate that he can
responsibly handle controlled
substances, while at the same time
protect the public health and safety, by
providing a mechanism for rapid
detection of any improper activity.’’).
The Agency has previously held that
‘‘such restrictions must be related to
what the Government has alleged and
proved in any case.’’ Janet L. Thornton,
D.O., 73 FR 50,354, 50,356 (DEA 2008).
Consistently, I suggest that the
conditions in this case be tailored to
ensure that the Respondent does not
personally handle or dispense
controlled substances. Thus, they
should include: That the registration
restricts his handling of controlled
substances to merely prescribing and
not storing, administering or dispensing
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62694
Federal Register / Vol. 78, No. 204 / Tuesday, October 22, 2013 / Notices
such drugs and that he be prohibited
from prescribing controlled substances
to himself or any family member.
Further, I recommend that the
Respondent be ordered to comply with
the terms of his DBC probation and
promptly notify the DEA if the DBC
takes any action against his dental
license. Lastly, I recommend that he
maintain and provide quarterly
prescription logs for all controlled
substances prescriptions he authorizes
to the local DEA office for monitoring.
I recommend these restrictions apply for
three years from the date of the final
order so directing this result. In this
way, the Respondent may safely
continue his return to the full practice
of dentistry, and the DEA can assure
itself of the Respondent’s compliance
with DEA regulations as well as the
protection of the public interest.
Dated: October 17, 2012.
Gail A. Randall,
Administrative Law Judge.
[FR Doc. 2013–24697 Filed 10–21–13; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
sroberts on DSK5SPTVN1PROD with FRONT MATTER
Hoi Y. Kam, M.D.; Decision and Order
On August 29, 2012, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Hoi Y. Kam, M.D.
(Respondent), of Fresh Meadows, New
York. The Show Cause Order proposed
the revocation of Respondent’s DEA
Certificate of Registration, which
authorizes him to dispense controlled
substances as a practitioner, as well as
the denial of any pending applications
to renew or modify his registration, on
the grounds that he: (1) Materially
falsified a renewal application, and (2)
committed acts which render his
registration inconsistent with the public
interest. Show Cause Order at 1 (citing
21 U.S.C. 824(a)(1) & (4)).
More specifically, the Show Cause
Order alleged that Respondent
materially falsified his December 1,
2011 renewal application, by falsely
answering the application question
which asked if he had ‘‘ever
surrendered for cause or had a state
professional license or controlled
substance registration revoked,
suspended, denied, restricted, or placed
on probation or is any such action
pending?’’ Id. at 2. The Government
alleged that Respondent gave a negative
answer to this question,
notwithstanding that on July 12, 2011,
VerDate Mar<15>2010
22:23 Oct 21, 2013
Jkt 232001
the New York State Department of
Health, Office of Professional
Misconduct and Discipline, had revoked
his medical license, based on a finding
that he had billed for Medicaid services
which he did not perform and ‘‘created
false entries in [his patient] charts to
conceal that fact.’’ Id. at 1–2. However,
the Government then alleged that
Respondent’s ‘‘medical license was
reinstated on October 27, 2011.’’ Id. at
1.
The Government further alleged that
between July 21 and October 4, 2011,
Respondent violated federal law and
regulations by ‘‘issu[ing] at least six (6)
prescriptions for controlled substances,
despite lacking legal authority to do so.’’
Id. (citing 21 U.S.C. 841(a)(1) & 21 CFR
1306.03). Specifically, the Government
alleged that Respondent had issued a
July 21, 2011 prescription for 240
dosage units of oxycodone 30mg; a
September 16, 2011 prescription for 30
dosage units of alprazolam 2mg; two
October 4, 2011 prescriptions for 30
dosage units of zolpidem tartrate 10mg;
an October 4, 2011 prescription for 60
dosage units of alprazolam .25mg; and
an October 4, 2011 prescription for 90
dosage units of oxycodone/
acetaminophen 7.5/500mg. Id. at 2.
On August 31, 2012, a DEA Diversion
Investigator (DI) ‘‘attempted to
personally serve the Order to Show
Cause on Respondent at his registered
address.’’ GX 2, at 3. According to the
DI, ‘‘[s]ince no one appeared to be at the
registered location, I left a copy of the
Order to Show Cause in Respondent’s
mailbox.’’ Id. Subsequently, on
September 10, 2012, Respondent wrote
a letter to DEA Counsel in which he
denied the allegations of the Show
Cause Order. GX 7.
Regarding the allegation that he had
written six prescriptions between July
10 and October 27, 2011, Respondent
denied writing them with the exception
of ‘‘the prescription dated July 21,
2011,’’ which it was ‘‘possible’’ he
‘‘predated.’’ Id. Respondent contended
that he was ‘‘so sure someone stole my
prescription pads without my
knowledge’’ and that he was ‘‘the victim
of prescription fraud.’’ Id. He also urged
the Government to check the
handwriting on the prescriptions. Id.
As for the material falsification
allegation, Respondent wrote that ‘‘I
probably did not pay attention to the
box. I marked on the wrong box. I
apologize for the mistake.’’ Id. And
regarding the basis for the action taken
by the State against his medical license,
Respondent wrote that he ‘‘never billed
for the Medicaid services,’’ that ‘‘[t]he
Medicaid provider number is not mine,’’
PO 00000
Frm 00112
Fmt 4703
Sfmt 4703
and that he ‘‘did render the services.’’
Id.1
However, while the Show Cause
Order notified Respondent that he had
a right to request a hearing and the
procedure for doing so, Respondent did
not request a hearing. Consistent with
21 CFR 1301.43(c), I deem Respondent’s
September 10, 2012 letter to be a
statement of his ‘‘position on the
matters of fact and law’’ asserted by the
Show Cause Order.
On September 23, 2012, Respondent
submitted a further letter to DEA
counsel, which he titled as his
‘‘response to’’ a ‘‘phone conversation’’
he had with the DI. GX 8, at 1. Therein,
Respondent asserted that the DI
‘‘admitted there are false accusations of
the prescriptions written.’’ Id.
Respondent also again admitted that he
‘‘predated the prescription for a patient
in June,’’ 2 and explained that he ’’could
not foresee my license revoked in early
July and I had only seventy-two hours
[sic] notice.’’ Id. Respondent further
wrote that there was ‘‘[n]o way [the]
patient was aware of what happened’’
and that the ‘‘patient is willing to testify
for me.’’ Id. Respondent included an
unsworn letter of the patient (N.I.), who
stated that he ‘‘got the prescription on
6/28/12 and I had no time in July 2011,’’
and that he ‘‘requested[ ] Respondent to
predate [sic] on July 28, 11.’’ Id. at 2.
The patient also wrote that he ‘‘did not
know [that] something happened to’’
Respondent. Id.
Regarding the prescription,
Respondent explained that ‘‘pharmacist
should call and verify each controlled
substances [sic] prescription’’ but that
‘‘[n]o one called me.’’ Id. at 1.
Continuing, Respondent wrote that
‘‘[s]ince July 11, 2011, no pharmacies
accepted my prescriptions anymore.
Why this pharmacy dispensed the
medication without following the
routine[?]’’ Id. Respondent then asserted
that the name of the drug was
misspelled on the prescription, and that
he ‘‘had the intention to misspell to
make sure the pharmacy . . . call[ed],
then I know what happens to the
prescriptions. Unfortunately, no
pharmacies called regarding to the
selling [sic] mistakes.’’ Id. Here again,
however, Respondent did not request a
hearing and ended the letter by stating
1 Respondent also disputed the findings of the
State Board, but then noted that his ‘‘[l]awyer told
[him] to forget about it,’’ that ‘‘[t]he appeal will not
change,’’ and that he ‘‘refused to beg [the State
board] because I believed I did not do anything
wrong.’’ GX 7.
2 If the prescription was written in June, it was
actually post-dated.
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Agencies
[Federal Register Volume 78, Number 204 (Tuesday, October 22, 2013)]
[Notices]
[Pages 62683-62694]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-24697]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 12-43]
Mark G. Medinnus, D.D.S.; Decision and Order
On October 17, 2012, Administrative Law Judge (ALJ) Gail A. Randall
issued the attached Recommended Decision (hereinafter, cited as
R.D.\1\). The Government filed Exceptions to the Recommended Decision.
---------------------------------------------------------------------------
\1\ All citations to the R.D. are to the ALJ's slip opinion.
---------------------------------------------------------------------------
Having reviewed the record in its entirety, I reject the
Government's Exceptions and adopt the ALJ's findings of fact and
conclusions of law except as discussed below. I also adopt in part, and
reject in part, the ALJ's recommended order. A discussion of the
Government's Exceptions follows.
The Government's Exceptions
The Unauthorized Purchase Allegation
The Government first takes exception to the ALJ's finding that it
failed to prove that Respondent, while serving as the dental director
of the Round Valley Indian Health Clinic (RVIHC), made an unauthorized
purchase of two controlled substances (hydrocodone and codeine).
Exceptions at 2. The contention is not well taken as either a factual
or legal matter.
The evidence showed that on November 29, 2010, Respondent prepared
a purchase order for various dental supplies, including one bottle of
500 tablets of hydrocodone/acetaminophen and one bottle of 500 tablets
of codeine/acetaminophen. GX 10, at 1-3; Tr. 151. The purchase order
comprised all of one page and listed a total of eleven items; the order
was approved by Jan Scribner, the deputy director of the RVIHC. Id.;
Tr. 158. The evidence further showed that Ms. Scribner had authority to
approve purchase orders in the absence of the RVIHC's executive
director. GX 21.
In challenging this finding, the Government takes issue with the
ALJ's credibility findings. Citing Ryan v. CFTC, 145 F.3d 910, 918 (7th
Cir. 1998), it argues that I am ``free to discount the weight that the
ALJ placed on the testimony when the record would support an
alternative finding.'' Exceptions at 1 (also citing Universal Camera
Corp. v. NLRB, 340 U.S. 474 (1951)).\2\
---------------------------------------------------------------------------
\2\ In the Show Cause Order, the Government alleged both that
Respondent made an unauthorized purchase of controlled substances,
and that he stored and dispensed controlled substances at the
RVIHC's dental clinic in violation of the RVIHC's guidelines for
storing and dispensing controlled substances. ALJ Ex. 1, at 2. The
ALJ reasoned that because Respondent ``reasonably believed the
purchase order was duly approved, the Government's allegation that
he failed to abide by RVIHC policies regarding the storage and
dispensing of controlled substances, also fails.'' R.D. at 28. It
is, however, far from clear why, even if Respondent had authority to
order controlled substances, this would necessarily lead to the
conclusion that he also had authority to store and dispense
controlled substances out of the dental clinic.
In taking exception to the ALJ's findings regarding the
purchase, the Government also takes issue with the ALJ's finding
that Respondent ``honestly and reasonably believed he possessed the
necessary authority to store and dispense controlled substances in
[the RVIHC] dental department.'' Exceptions at 2. To the extent the
Government has even properly put this finding at issue, I reject its
contention, because, by itself, it does not establish a violation of
the CSA or state law, or otherwise actionable misconduct under the
public interest standard.
---------------------------------------------------------------------------
More specifically, the Government requests that I reject the ALJ's
credibility findings regarding the testimony of both Respondent (whom
she found credible on the issue of whether a dental clinic employee had
told him that the executive director had approved the purchase order,
see R.D. at 12, 27) and the clinic employee (whom she found not
credible when she testified that the executive director did not think
it was a good idea because of Respondent's history of substance abuse,
see id.). See Exceptions at 2-6. While the Government clearly misreads
Ryan,\3\ I conclude that it is not
[[Page 62684]]
necessary to either adopt or reject the ALJ's credibility findings,
because even were I to reject the findings with respect to both
Respondent and the clinic employee, the Government cannot overcome the
evidence that the purchase order was approved by an official of the
clinic, who indisputably had authority to do so. R.D. at 12, 27; Tr.
158.
---------------------------------------------------------------------------
\3\ At issue in Ryan was whether an Agency was required to defer
to an ALJ's finding that an applicant for a trader's license ``was
fully rehabilitated and not a threat to the integrity of the
[commodities] markets,'' which was based on the ALJ having found
credible the testimony of the applicant's character witnesses. See
145 F.3d at 918. The Commission discredited the testimony because
``almost every one can produce'' a character witness who will
testify as to his/her ``belief that the defendant will not repeat
his violative conduct,'' and because the ``testimony reflected at
most a perfunctory concern with the customers harmed by Ryan's
wrongdoing.'' Id. (internal citation omitted).
The Seventh Circuit held that the Commission could ``discredit
the weight of a witness's testimony without impinging on an ALJ's
credibility determinations.'' Id. As the court of appeals further
explained:
The Commission must attribute significant weight to an ALJ's
findings based on a witness's demeanor because it does not have the
opportunity to observe a testifying witness. This recognition,
however, does not preclude the Commission from discounting the
weight that an ALJ places on witness's testimony when the Commission
questions the witness's basis of knowledge.
Id. In short, Ryan provides no support for the Government's
contention, which ignores that the ALJ's finding involves an issue
of historical fact and involves a classic situation in which an
assessment of each witness's demeanor is essential in making a
factual finding.
---------------------------------------------------------------------------
The Government attempts to overcome this evidence, arguing that in
an affidavit, the deputy director ``unequivocally states that she was
not aware [that] the purchase order, which contained a number of items,
also contained an order for controlled substances.'' Exceptions at 7.
The Government then argues that ``[a] review of the purchase order
shows that . . . the controlled substances order is buried in the
middle/end of the purchase order.'' Id.
The Government's argument is wholly unpersuasive. Notably, the
purchase order was but a single page in length and listed all of eleven
items. GX 10, at 1. Moreover, the purchase order clearly described the
respective controlled substances as ``1 bottle'' of ``Hydrocodone'' and
``1 bottle'' of ``APAP w/codeine.'' Id. Thus, even a cursory review of
the purchase order by the deputy director should have revealed that it
contained controlled substances. I thus give no weight to the assertion
of the deputy director that she inadvertently approved the order and
reject the Government's contention that Respondent's purchase of
controlled substances was unauthorized.\4\ Cf. Consolidated Edison Co.
v. United States, 221 F.3d 364, 371 (2d Cir. 2000) (``In general,
individuals are charged with knowledge of the contents of documents
they sign--that is, they have `constructive knowledge' of those
contents.'').\5\
---------------------------------------------------------------------------
\4\ In her affidavit, the Deputy Director also stated that
``RVIHC does not order controlled substances from Henry Schein,''
that it ``orders all controlled substances from other government
suppliers by RVIHC contracts with those venders [sic],'' and that
``[t]his procedure has been long standing and well known to all
relevant staff.'' GX 21, at 1. The Government, however, produced no
evidence that these purported procedures have been memorialized in
writing. Nor did the Government establish that Respondent was aware
of any such policy. Beyond this, the Deputy Director's assertion
that the procedure is well known undermines any claim that she is a
disinterested witness, which, given that her testimony constitutes
hearsay, is a relevant consideration in determining the reliability
of her statement.
\5\ Given that the purchase order was but a single page, listed
only eleven items, and clearly listed hydrocodone and codeine as
among the items to be purchased, see GX 10, it is fair to draw the
inference that the Deputy Director had actual knowledge that
Respondent was seeking controlled substances.
---------------------------------------------------------------------------
Even if the Government's contention was supported by substantial
evidence, I would nonetheless reject the exception. Notably, while the
Government argues--as an afterthought--that Respondent used the
clinic's ``DEA registration without authorization from RVIHC executive
personnel,'' it does not go so far as to maintain that this constitutes
a violation of the Controlled Substances Act. See Exceptions at 10, but
see 21 U.S.C. 843(a)(2) (``It shall be unlawful for any person
knowingly or intentionally . . . to use for the purpose of acquiring or
obtaining a controlled substance, a registration number which is . . .
issued to another person.''). Indeed, notwithstanding that Respondent
could not account for forty tablets of hydrocodone, the evidence showed
that the drugs were generally dispensed to patients in the course of
providing dental treatment. Finally, while in its post-hearing brief,
the Government notes that both factors four (compliance with applicable
controlled substance laws, 21 U.S.C. 823(f)(4)) and five (such other
conduct which may threaten public health and safety, id. Sec.
823(f)(5)), are to be considered in determining the public interest, it
does not cite to any provision of state law that Respondent violated in
making the purported unauthorized purchase.\6\ Nor does it cite to any
Agency decision holding that a violation of a clinic's internal
operating policies, which does not otherwise violate the CSA or state
law, constitutes conduct ``inconsistent with the public interest.'' 21
U.S.C. 824(a)(4). Thus, even if the Government had proved that
Respondent made an unauthorized purchase of the two drugs, I would
reject the exception because it fails to establish actionable
misconduct under the public interest standard.
---------------------------------------------------------------------------
\6\ Indeed, in its brief containing its proposed findings of
fact and conclusions of law, the only provisions of law or
regulations cited by the Government are various recordkeeping
requirements, which it is undisputed that Respondent violated. Gov't
Prop. Findings of Fact, Conclusions of Law, and Argument
(hereinafter, Gov't Post-Hrng. Br.) at 19 (citing 21 U.S.C.
827(a)(3); 21 CFR 1304.22(c)).
---------------------------------------------------------------------------
The ALJ's Finding That Respondent Has Accepted Responsibility
The ALJ found that Respondent took responsibility for his actions
and ``repeatedly demonstrated remorse for his conduct at the RVIHC.''
R.D. at 29. The Government takes exception to this finding, arguing
that while Respondent acknowledged the misconduct he committed prior to
2008, he ``was not candid and not willing to accept actual
responsibility for his [more recent] violations,'' which included his
``inaccurate dispensing records, the unlawful dispensing to an unknown
patient, and the failure to keep a dispensing log as required by'' the
probation imposed by the Dental Board of California when it issued him
a new license. Exceptions at 8 (emphasis added).
Respondent is, however, only required to accept responsibility for
the misconduct which the Government has proven on the record. See
Jeffrey P. Gunderson, 61 FR 26208, 26211 (1996) (a respondent must
``admit to the full extent of his involvement in documented
misconduct''). With respect to the alleged ``unlawful dispensing to an
unknown patient,'' Exceptions at 8, the Government points to evidence
that Respondent ``dispensed hydrocodone to a transient without eve
[sic] documenting that he ever saw this person as a patient at the time
he dispensed the Vicodin.'' Gov't Post-Hrng. Br. at 23. The Government
argues that ``[t]his incident is not just a `documentation' error but
is tantamount to outright diversion.'' Id. Yet, the ALJ found that
Respondent ``credibly testified that he had examined the patient on
January 20, 2011, and observed that he needed a surgical extraction,''
that ``[w]hen the patient returned to [the clinic] on January 24, 2011,
[Respondent] could not perform the extraction because of his busy
schedule,'' and that ``[w]hen the patient reported experiencing pain
symptoms, [he] agreed to provide him with hydrocodone to temporarily
alleviate his symptoms.'' R.D. at 14.
The Government did not, however, take exception to these
findings.\7\ Thus, while in its post-hearing brief, the Government
argued that Respondent engaged in ``outright diversion'' when he
provided hydrocodone to this patient, and in its Exceptions, it argues
that he has failed to accept
[[Page 62685]]
responsibility for the ``unlawful dispensing,'' I conclude that
Government has offered no reason to reject the ALJ's findings.
Moreover, Respondent acknowledged that he failed to properly document
the dispensing. Tr. 523. Because Respondent accepted responsibility
with respect to the only misconduct the Government proved with respect
to this patient, I reject the Government's contention to the extent it
relies on Respondent's act of dispensing a controlled substance to this
patient.
---------------------------------------------------------------------------
\7\ Nor did the Government offer any evidence at the hearing as
to the standards of dental practice and establishing that Respondent
acted outside of the usual course of professional practice when he
dispensed hydrocodone to this patient. See 21 CFR 1306.04(a).
---------------------------------------------------------------------------
The record, however, does establish that Respondent failed to
maintain accurate dispensing records, as well as a dispensing log,
which was required under the terms of the Dental Board's order, which
restored his dental license. While there is some evidence to support
the Government's contention that Respondent did not accept
responsibility for his failure to maintain accurate records, I conclude
that the ALJ's finding is supported by the record as a whole.
At the hearing, Government counsel asked Respondent whether it was
correct that he did not keep ``a separate dispensing record when [he]
started to use the Vicodin . . . that [he] had ordered.'' Tr. 491.
Respondent answered that this was ``[a]bsolutely correct.'' Id. When
asked by the Government whether he had ``the legal duty to keep
accurate records of th[e] Vicodin supply,'' Respondent answered: ``I
do.'' Id. at 498. And when asked whether it was correct that because he
``had the supply, . . . did the dispensing directly to the patients, .
. . [he] had the obligations to keep an accurate patient chart as well
as a log,'' Respondent answered: ``Absolutely. That's why I say I
didn't do it right.'' Id. at 499.
Subsequently, the Government asked Respondent whether ``hav[ing]
shortages and . . . overages'' is ``a violation of DEA law?'' Id. at
509. Respondent answered that he knew that he had violated the State
Board's order but that he did not know if this was a violation of
federal law. Id. The Government then asked Respondent if it was ``a
violation of DEA law not to keep a separate dispensing log for narcotic
controlled substances?'' Id. at 509-10. Respondent answered:
I don't know, but I do know that I violated [the State] order.
I'm willing to stipulate that I violated that too. However you want
to characterize it, they wouldn't have happened if I hadn't made my
mistakes. There would be no three separate logs. So if you want to
say that I violated a couple of steps, of course, I'm willing to
stipulate that there was a tough time in my life. I'm sorry. I don't
mean, if I get argumentative, I ask the Court's forgiveness.
Id.
Respondent also testified that he had abused the public trust in
his handling of Vicodin while at the RVIHC. Tr. 539-40. While
Respondent subsequently testified that there was a difference in degree
between his previous violations and the violations he committed at
RVIHC, he testified that ``I abused the public trust here'' and ``I
screwed up.'' Id. And while his closing statement is not technically
evidence, therein, Respondent stated: ``I'm sorry that I made the
mistakes in the past and then more recently.'' Id. at 554.
Ignoring nearly all of the evidence which supports the ALJ's
finding, the Government argues that ``Respondent repeatedly minimized
the significance of his dispensing-record violations.'' Exceptions at
10. As support for this contention, it quotes Respondent's testimony
that ``we're talking about 40 tabs. . . . so I'm going to jeopardize my
licenses for 40 Vicodin tabs . . . [f]or forty tabs?'' \8\ Respondent
did not, however, offer this testimony to downplay the dispensing
record violations but rather to respond to the insinuation (which
permeates the proceeding but which is unproven on the record) that he
had resumed self-abusing controlled substances. Accordingly, I reject
the Government's contention that Respondent has failed to accept
responsibility for his misconduct.
---------------------------------------------------------------------------
\8\ The Government points to several other portions of
Respondent's testimony which it asserts provide evidence that he has
not admitted to his misconduct. See Exceptions at 8-9. As support
for these assertions, the Government did not cite to the specific
pages of the transcript or exhibits, as is required by DEA's
regulation, see 21 CFR 1316.66(a), but to a document which is
abbreviated as ``FCA.'' Id. Nowhere in its Exceptions does the
Government identify what this term means, and while it may be a
reference to the Government's proposed findings of fact, conclusion
of law, and argument, the Agency has previously held that citation
to a post-hearing brief does not comply with the regulation and is
ground to reject an exception. See Carlos Gonzales, 76 FR 63118,
63119 (2011).
In any event, I have considered the entirety of Respondent's
testimony in reviewing the ALJ's finding and conclude that much of
the testimony cited by the Government is not probative of whether he
has accepted responsibility for his failure to maintain accurate
records. For example, the Government contends that ``Respondent did
not admit to wrongdoing when he was asked during cross-examination
whether the audit shortages could be partially attributable to the
hydrocodone he gave to the transient patient.'' Exceptions at 9. A
review of what appears to be the relevant portion of the transcript
shows that the Government asked Respondent whether the forty dosage
unit shortage ``could be accounted for, if not in total, at least in
part based on the amount of Vicodin that [he] dispensed to [the]
transient that did not get charted.'' Tr. 528. Respondent answered:
``I suppose some of the Vicodin, some of those 40 tabs could have
been it. I don't know. I'm confused. Do you want me to confess to
something?'' Id. The Government offers no further explanation as to
why this testimony supports rejection of the ALJ's finding.
The Government also points to a question it asked Respondent
about an email to the RVIHC Executive Director, in which he wrote
that he ``desperately wanted to be liked by the natives so I
prescribed Vicodin too liberally.'' Exceptions at 9; see also Tr.
506. When asked whether this was ``a true statement,'' Respondent
answered: ``No, I was being disingenuous.'' Tr. 506. While this
answer does not inspire confidence in Respondent's credibility, the
Government neither alleged, nor established that he acted outside of
the usual course of professional practice and lacked a legitimate
medical purpose with respect to any of the dispensings he made to
the clinic's patients, and by itself, the testimony is insufficient
to support rejection of the ALJ's credibility findings.
---------------------------------------------------------------------------
However, while I adopt the ALJ's finding that Respondent has
accepted responsibility for his misconduct, I nonetheless conclude that
the ALJ's proposed sanction does not adequately protect the public
interest. As noted above, pursuant to the Dental Board's order which
restored his dental license, Respondent was required to ``maintain a
record of all controlled substances prescribed, dispensed or
administered by [him] during probation.'' GX 7, at 7. This record was
required to be maintained ``in a separate file or ledger,'' and to
include, ``in chronological order,'' each patient's name and address,
the date, the controlled substances and quantity, and ``the pathology
and purpose for which the controlled substance was furnished.'' Id.
Moreover, under federal law, Respondent was required to maintain a
complete and accurate record of all controlled substances he dispensed.
21 U.S.C. 827(a)(3); 21 CFR 1304.22(c).
Notwithstanding the egregiousness of his prior misconduct,
Respondent did not appreciate the forbearance shown by the Board \9\
and this Agency in granting him a second chance. Accordingly, while
Respondent's application will be granted, his registration will be
subject to the following conditions:
---------------------------------------------------------------------------
\9\ As the ALJ found, Respondent has a history of substance
abuse and in February 2003, pled guilty to one felony count of
obtaining controlled substances by fraud in violation of Cal. Health
& Safety Code Sec. 11173(a). R.D. at 8. While upon Respondent's
successful completion of his probation, the conviction was reduced
to a misdemeanor and then dismissed entirely, the record shows that
Respondent unlawfully obtained approximately 30,000 dosage units of
controlled substances. GX 3; GX 4, at 4-5; GX 5, at 2.
Based on this misconduct, in September 2002, the Dental Board of
California (DBC) filed an accusation against Respondent and he
surrendered his state dental license. GX 5. On May 26, 2006,
Respondent filed a petition to reinstate his dental license; on June
12, 2007, the DBC granted the petition. GX 7.
---------------------------------------------------------------------------
1. Upon the granting of Respondent's application, his registration
will be suspended outright for a period of six months. Thereafter,
Respondent's
[[Page 62686]]
registration will be suspended through the expiration of his
registration; however, this portion of the suspension shall be stayed
provided Respondent fully complies with the conditions imposed on his
registration, the conditions of any existing or future Dental Board
order which relate to the use or handling of controlled substances, as
well as all federal and state controlled-substance laws and
regulations.
2. Respondent is prohibited from administering or dispensing
directly controlled substances. Respondent is authorized only to
prescribe controlled substances.
3. Respondent is required to maintain a log, in chronological
order, of all controlled-substance prescriptions he issues. The log
must include the following information: (1) the date; (2) the patient's
name and address; (3) the drug name, its strength, and quantity; and
(4) the pathology and purpose of the prescription. Respondent shall
maintain the log at his registered address. In addition, Respondent
must provide a copy of the log to the nearest DEA field division
office, on a quarterly basis, within seven calendar days of the last
day of each quarter ending on March 31st, June 30th, September 30th,
and December 31st.
4. Respondent shall not prescribe any controlled substance to
himself or a family member.
5. Respondent is required to notify the nearest DEA field division
office within 72 hours of any violation of this Order, any Dental Board
Order, or any provision of federal or state law related to controlled
substances.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b), I order that the application of Mark G. Medinnus,
D.D.S., for a DEA Certificate of Registration as a practitioner, be,
and it hereby is, granted, subject to the conditions set forth above.
This Order is effective November 21, 2013.
Dated: September 22, 2013.
Michele M. Leonhart,
Administrator.
Brian Bayly, Esq., for the Government
Mark Medinnus, D.D.S., pro se, for the Respondent
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
I. Procedural Background
Gail A. Randall, Administrative Law Judge. The Deputy Assistant
Administrator, Office of Diversion Control, Drug Enforcement
Administration (``DEA'' or ``Government''), issued an Order to Show
Cause (``Order'' or ``OSC'') dated March 22, 2012, proposing to deny
the application of Mark G. Medinnus, D.D.S. (``Respondent'' or ``Dr.
Medinnus'') for a DEA Certificate of Registration pursuant to 21 U.S.C.
824(a)(2)-(4) and Sec. 823(f)(2)-(5), because the registration of the
Respondent would be inconsistent with the public interest, as that term
is used in 21 U.S.C. 823(f). [Administrative Law Judge Exhibit (``ALJ
Exh.'') 1 at 1].
The Order stated that Respondent had been previously registered
with the DEA as a practitioner with authority to handle controlled
substances in Schedules II-IV under DEA Certificate of Registration
BM0207678. [Id.]. The Order stated that Respondent had voluntarily
surrendered this registration on January 16, 2002. [Id.].
The Order further stated that on July 30, 2008, Respondent had been
granted a DEA Certificate of Registration FM0982808 as a practitioner
with authority to handle controlled substances in Schedules II-IV.
[Id.]. The Order stated that this registration expired without a timely
renewal on January 31, 2011. [Id.].
The Order also stated that on December 18, 2002, Respondent entered
into a Stipulated Surrender of License and Order with the Dental Board
of California wherein Dr. Medinnus surrendered his rights and
privileges as a dentist in the state of California. [Id.]. The Order
went on to state that on June 12, 2007, Respondent's dental license was
reinstated subject to probationary conditions for a period of five
years, including that he maintain a controlled substance dispensing log
in chronological order. [Id. at 2]. The Order alleged that Respondent
failed to maintain this required dispensing log. [Id.].
The Order also stated that on February 23, 2003, Respondent pled
guilty to a felony violation of Cal. Health & Safety Code Sec.
11173(a) (West 2012) for obtaining controlled substances by fraud.
[Id.]. The Order stated that the basis of this conviction was
Respondent's use of DEA Certificate of Registration BM0207678 to divert
more than 30,000 dosage units of hydrocodone, lorazepam, and diazepam
for his personal use from approximately January 2000 through November
2001. [Id.].
Lastly, the Order alleged that in December 2010, while Respondent
was an employee of the Round Valley Indian Health Center (``RVIHC''),
Dr. Medinnus made an unauthorized purchase of bottles of hydrocodone
and codeine using RVIHC's DEA registration. [Id.]. In addition, the
Order alleged that in January 2011, Respondent failed to comply with
RVIHC's guidelines regarding the storage and dispensing of controlled
substances and that Respondent could not account for approximately
sixty-eight tablets of hydrocodone/apap which he allegedly dispensed.
[Id.]. The Deputy Assistant Administrator then gave the Respondent the
opportunity to show cause as to why his application should not be
denied on the basis of these allegations. [Id.].
On April 5, 2012, Respondent timely filed a request for a hearing
in the above-captioned matter. [ALJ Exh. 2].
After authorized delays, the hearing was conducted on July 10-11,
2012, in Sacramento, California. [ALJ Exh. 5]. At the hearing, counsel
for the DEA called four witnesses to testify and introduced documentary
evidence. [Transcript (``Tr.'') Volume I-II]. The Respondent called two
witnesses to testify, including himself, and introduced documentary
evidence. [Id.].
After the hearing, the Government and the Respondent submitted
Proposed Findings of Fact, Conclusions of Law and Argument (``Govt.
Brief'' and ``Resp. Brief'').
II. Issue
The issue in this proceeding is whether or not the record as a
whole establishes by a preponderance of the evidence that the Drug
Enforcement Administration should deny the application for a DEA
Certificate of Registration of Mark G. Medinnus, D.D.S. as a
practitioner, pursuant to 21 U.S.C. 824(a)(2)-(4) (2006), and pursuant
to 21 U.S.C. 823(f)(2)-(5), because the Respondent's registration would
be inconsistent with the public interest, as that term is used in 21
U.S.C. 823(f). [ALJ Exh. 4; Tr. 7].
III. Findings of Fact
A. Stipulated Facts
1. On September 19, 2011, Dr. Medinnus applied for registration
with DEA as a practitioner in Schedules II through V at 9024 Sniktaw
Lane, Fort Jones, CA 96032.
2. Dr. Medinnus was previously registered with DEA as a
practitioner in Schedules II through IV under DEA Certificate of
Registration BM0207678 at 1680 Westwood Drive, Suite C, San Jose, CA
95125. Dr. Medinnus voluntarily surrendered this registration on
January 16, 2002.
3. On July 30, 2008, Dr. Medinnus was granted DEA Certificate of
Registration FM0982808 as a
[[Page 62687]]
practitioner, in Schedules II through IV, at P.O. Box 459, Lewiston, CA
96052. This registration expired without a timely renewal on January
31, 2011.
4. On September 3, 2002, the Dental Board of California, Department
of Consumer Affairs, (hereinafter ``Dental Board'') issued an
``Accusation'' which sought to revoke or suspend Dr. Medinnus' dental
license. The ``Accusation'' alleged that Dr. Medinnus ordered
controlled substances in order for his own and others illegal use and
not in the course of his dental practice.
5. On September 20, 2002, Dr. Medinnus entered into a ``Stipulated
Surrender of License and Order'' with the Dental Board as a result of
the September 3, 2002, Dental Board ``Accusation.'' In the September
20, 2002, ``Stipulated Surrender of License and Order,'' Dr. Medinnus
agreed to surrender his California dental license.
6. Effective December 18, 2002, the Dental Board adopted the
September 20, 2002, ``Stipulated Surrender of License and Order.''
7. On February 27, 2003, Dr. Medinnus pled guilty in Santa Clara
County to one felony count of a violation of California Health & Safety
Code 11173, obtaining controlled substances by fraud. Dr. Medinnus was
sentenced to probation.
8. On April 27, 2006, Dr. Medinnus' felony conviction of California
Health & Safety Code 11173 was reduced to a misdemeanor conviction
under California Penal Code, Section 17, and then the conviction was
dismissed under California Penal Code, Section 1203.4.
9. On or about May 26, 2006, Dr. Medinnus petitioned the Dental
Board to re-instate his license. On March 15, 2007, a Dental Board
Administrative Law Judge submitted a ``Proposed Decision'' to grant Dr.
Medinnus' petition to re-instate his dental license subject to
probation for five years. The ``Proposed Decision'' was adopted by the
Dental Board in a ``Decision'' on May 10, 2007. The ``Decision'' became
effective on June 12, 2007.
10. Hydrocodone, in combination dosage unit form, is a Schedule III
narcotic controlled substance. Its brands, inter alia, include Lortab,
Lorcet and Vicodin.
11. Codeine with apap, in dosage unit form, is a Schedule III
narcotic controlled substance.
12. Lorazepam and diazepam are both Schedule IV depressant
controlled substances.
13. The Respondent stipulates that the Government can establish a
prima facie case supporting the denial of his pending DEA Certificate
of Registration application. [ALJ Exh. 6].
B. Respondent's Registration History
The Respondent was first licensed to practice dentistry in 1985.
[Govt. Exh. 5]. On November 25, 1985, the Agency issued a Certificate
of Registration Number BM0207678 to Respondent as a practitioner with
authority to handle controlled substances in schedules II-IV. [Govt.
Exh. 2; Tr. 323]. Respondent voluntarily surrendered this registration
for cause on January 18, 2002. [Govt. Exh. 2; Tr. 323-24].
On July 23, 2008, Respondent applied for a new DEA Certificate of
Registration. [Tr. 326]. This application was granted and the Agency
issued Certificate of Registration Number FM0982808 to Respondent as a
practitioner with authority to handle controlled substances in
schedules II-IV. [Govt. Exh. 3; Resp. Exh. A74; Tr. 325-326]. This
registration expired on January 31, 2011 and was retired from the DEA
computer system on December 5, 2011. [Govt. Exh. 3].
On September 19, 2011, Respondent submitted a new application for
registration under DEA control number W11065544C. [Govt. Exh. 1; Tr.
321]. This application is the subject of these proceedings. [Id.].
C. Respondent's Addiction History
Respondent began experiencing headaches and tinnitus in
approximately 1996 while he was working in a private family dentistry
practice in San Jose, California. [Govt. Exh. 7 at 2]. To treat these
conditions, Dr. Medinnus began to take Vicodin tablets from his office.
[Id.]. By 1999, Respondent was addicted to Vicodin and he had begun to
supply his family members with Vicodin for non-dental medical
conditions. [Id.]. Respondent's headaches were eventually diagnosed as
resulting from cataracts, and he underwent surgery. [Id.]. During his
recovery from surgery and while suffering from depression, Respondent
closed his dental practice in June 2000. [Id.]. Despite the closure of
his practice, Dr. Medinnus continued to order large quantities of
controlled substances to support his addiction and provide pills for
his family members from approximately 2000 to 2001. [Id.; Tr. 426-427].
When confronted by a Dental Board of California (``DBC'' or ``the
Board'') investigator in January 2002 regarding these orders,
Respondent admitted to illegally obtaining these controlled substances
and using them to support his addiction. [Govt. Exh. 7 at 2]. Dr.
Medinnus voluntarily surrendered his DEA registration on January 18,
2002 by signing a DEA Form 104. [Tr. 323].
D. 2002 DBC Action Against Respondent
On September 3, 2002, the Dental Board of California (``DBC'' or
``the Board'') filed an accusation against Respondent seeking to
suspend or revoke his California dental license. [Govt. Exh. 4; Tr.
327]. Therein, the DBC alleged that Respondent had ordered significant
quantities of controlled substances, including hydrocodone, lorazepam,
and diazepam, from approximately January 2000 to November 2001, for his
own personal use and to unlawfully distribute to others. [Govt. Exh. 4
at 3-5]. Respondent entered into a Stipulated Surrender of License and
Order with the Board on September 20, 2002, wherein he admitted to the
allegations contained in the DBC's accusation and surrendered his
dental license to the Board. [Govt. Exh. 5; Tr. 328]. On November 18,
2002, the Board adopted the Stipulated Surrender of License and Order
in a Decision and Order which became effective on December 18, 2002.
[Govt. Exh. 6; Tr. 329].
E. Respondent's 2003 Felony Conviction and Subsequent Exclusion From
Medicare
On February 27, 2003, Dr. Medinnus pled guilty in Santa Clara
County, California to one felony count of a violation of Cal. Health &
Safety Code Sec. 11173(a) (West 2012) for obtaining controlled
substances by fraud. [Resp. Exh. 3]. Dr. Medinnus was sentenced to
three years' probation. [Govt. Exh. 7 at 2]. Respondent successfully
complied with all his probationary conditions and on April 27, 2006,
Dr. Medinnus successfully petitioned to reduce his felony conviction to
a misdemeanor pursuant to Cal. Penal Code Sec. 17(b)(3) (West 2012)
and then dismissed pursuant to Cal. Penal Code Sec. 1203.4(a) (West
2012). [Resp. Exh. A-17; Tr. 350-351].
Pursuant to this felony conviction, the Department of Health and
Human Services (``HHS'') excluded Dr. Medinnus from participating as a
healthcare provider in Medicare for a period of five years. [Resp. Exh.
A86]. In addition, on June 23, 2004, the Office of Personnel Management
(``OPM'') debarred Respondent from participating in the Federal
Employees Health Benefits Program. [Resp. Exh. A87]. On April 20, 2009,
HHS reinstated Respondent's eligibility to participate as a Medicare
provider and OPM terminated Respondent's debarment from the Federal
Employees Health
[[Page 62688]]
Benefits Program. [Resp. Exh. A86-87; Tr. 356-357].
F. Respondent's Rehabilitation Program and Dental License Reinstatement
Following Respondent's felony conviction, he began an intensive
drug rehabilitation program. [Govt. Exh. 7 at 2-3]. This program
included attending individual and group therapy sessions with a
licensed therapist to address Respondent's mental health and substance
abuse issues. [Resp. Exh. A5-8]. In addition, Respondent received
psychiatric treatment, including medication, to treat his symptoms of
depression. [Resp. Exh. A13-15]. Respondent also participated in
frequent twelve-step program meetings and joined the board of a local
transitional housing facility for recovering addicts. [Resp. Exh. A3-4;
A9-11].
On May 26, 2006, Respondent filed a petition for reinstatement of
his California dental license. [Govt. Exh. 7 at 2]. As part of his
petition, Dr. Medinnus submitted letters of recommendations from fellow
dentists regarding his clinical abilities. [Resp. Exh. A32-34].
Respondent also proffered evidence regarding his family life,
involvement in his stepchildren's elementary school and athletics
programs and his own volunteer activities. [Resp. Exh. A19, A21, A25,
A26-27, A30-31, A91]. After an administrative hearing, a state
administrative law judge recommended that the DBC reinstate
Respondent's dental license and place the Respondent on probation for a
period of five years. [Govt. Exh. 7 at 5; Tr. 292-293]. The ALJ made
detailed factual findings regarding Dr. Medinnus' successful drug
rehabilitation program. [Govt. Exh. 7 at 3-4]. These included
maintaining his sobriety from March 7, 2003, receiving outpatient
medical and psychotherapy treatment, attending NA and AA meetings, and
completing continuing dental education courses. [Id.]. The ALJ further
found that Respondent had complied with all the terms of his criminal
probation, recovered completely from his cataract surgery, and had
credibly addressed the triggers that led to his drug addiction and
diversion to his family members. [Id.].
The ALJ recommended that Respondent's dental license be subject to
several probationary conditions, including that he maintain a separate
log of all controlled substances that he prescribed, dispensed or
administered during his probationary period. [Govt. Exh. 7 at 7; 293-
294]. Among other conditions, Dr. Medinnus was also required to pass a
dental licensing examination, undergo a psychiatric evaluation,
participate in a diversion program offered by the Board, and be subject
to random drug screenings. [Govt. Exh. 7 at 5-9]. On May 10, 2007, the
Board adopted the ALJ's Decision, which became effective on June 12,
2007. [Govt. Exh. 8; Tr. 330-331].
To regain his probationary dental license, Dr. Medinnus
successfully completed the mandated dental licensing examination on
July 14, 2007. [Resp. Exh. A61; A85]. Respondent also received a
comprehensive psychiatric evaluation, which favorably reported his
ongoing recovery. [Resp. Exh. A57]. In addition, on December 6, 2007,
Respondent was released from the Board mandated diversion program.
[Resp. Exh. A58; Resp. Exh. 6]. During this time, Dr. Medinnus took and
passed numerous random drug screens as directed by the DBC. [Resp. Exh.
A45-47; A49; A51; A53-54]. When his probationary dental license was
issued, Dr. Medinnus performed volunteer dental consulting work at
Milestones Health Center in Weaverville, California. [Resp. Exh. A68;
A76].
G. Respondent's Employment at RVIHC
After the reinstatement of his dental license, Respondent
negotiated an employment contract to work as the dental director at the
Round Valley Indian Health Center, (``RVIHC'') which is located in
Covelo, California. [Govt. Exh. 9; Tr. 31]. One of the terms of the
employment contract was that the Respondent agreed to ``comply with all
policies and procedures, rules and regulations of the RVIHC funding
agencies and federal and state laws including all of the HIPPA
requirements.'' [Govt. Exh. 9 at 2].
James Russ, the executive director of RVIHC, testified at the
hearing, and I find his testimony credible and consistent with the
documentary evidence. Mr. Russ testified that prior to the negotiation
of his contract, Dr. Medinnus voluntarily and freely disclosed his
history of substance abuse and the surrender of his dental license and
DEA registration in 2002 and its subsequent reinstatement. [Tr. 34-35].
As RVIHC's executive director, Mr. Russ administers the day-to-day
operations of the clinic's various departments. [Tr. 23-24]. Mr. Russ
outlined RVIHC's operation and the services it provided including
operating a medical center, dental clinic, outpatient physical or
psychological treatment, and a group home. [Tr. 24-25]. He testified
that all controlled substances ordered by RVIHC were stored in a
central dispensary, which contained a locked safe. [Tr. 25-26]. Mr.
Russ further testified that RVIHC's usual suppliers of controlled
substances were McKesson and Pharmadex, and did not include Henry
Schein, a supplier from whom RVIHC only ordered dental supplies. [Tr.
40-41].
Linda Lohne, a registered nurse and clinic manager at RVIHC, also
testified at the hearing. [Tr. 186]. I find her testimony credible and
consistent with the documentary evidence. As part of her clinic manager
duties, Ms. Lohne oversaw RVIHC's ordering and dispensing of controlled
substances. [Tr. 187]. She likewise testified that all controlled
substances ordered under RVIHC's DEA registration were stored in the
clinic's central dispensary. [Id.].
Mr. Russ testified that Dr. Medinnus had discussed with him the
possibility of storing hydrocodone in the dental department to obviate
the need for Respondent or his dental staff to pick up the controlled
substances at the dispensary and then return to the dental department
to dispense them to the patients. [Tr. 51, 90; Resp. Exh. A134-135,
A148]. Mr. Russ discussed his concerns about this request with
Respondent, including his belief that the controlled substances would
be more secure if they remained in the central dispensary. [Tr. 70-71].
Dr. Medinnus testified that he sought to order controlled
substances to store in the dental department because the dispensary
would occasionally run low or out entirely of controlled substances.
[Tr. 464-466]. But, Ms. Lohne testified that RVIHC never completely ran
out of hydrocodone during 2010, although she did testify that the
dispensary had run low on controlled substances, including having as
little as five or seven dosage units on hand. [Tr. 240-241]. Ms. Lohne,
however, also testified that RVIHC's dispensary might have run out of
controlled substances by the end of some days. [Tr. 242-243].
H. November 29, 2010 Purchase Order
Kimberly Stillwell, a dental sterilization technician at RVIHC,
also testified at the hearing. [Tr. 149]. I find her testimony only
partially credible. Though called as a witness for Respondent, her
testimony suggested that she bore Dr. Medinnus substantial animus from
his employment at RVIHC. Her demeanor while testifying was consistent
with this animus towards Respondent and was repeatedly demonstrated by
her nonresponsive answers or unsolicited comments adverse to
Respondent. Therefore, I decline to credit much of her testimony.
On November 29, 2010, Ms. Stillwell prepared a purchasing order to
obtain supplies for RVIHC's dental department.
[[Page 62689]]
[Govt. Exh. 10; Tr. 151]. At the direction of Dr. Medinnus, she
included one bottle of hydrocodone and one bottle of APAP with codeine
along with other routine dental supplies in the order. [Id.]. Prior to
preparing the order, Dr. Medinnus directed Ms. Stillwell to obtain
authorization for the purchase order from Mr. Russ, specifically
concerning the inclusion of controlled substances in the order. [Tr.
153, 155]. Ms. Stillwell testified that she spoke to Mr. Russ before
placing the purchase order. [Tr. 155]. During this conversation, Ms.
Stillwell testified that Mr. Russ said he ``did not feel it was a good
idea'' to order controlled substances for the dental department to
dispense directly to patients. [Tr. 157-158]. Mr. Russ though could not
recall the substance of this conversation with Ms. Stillwell at the
hearing. [Tr. 50-51]. Despite Mr. Russ's misgivings, Ms. Stillwell
informed Respondent that Mr. Russ had given his permission for the
purchase order. [Tr. 158; Resp. Exh. A140].
The purchase order was then ultimately approved by Jan Scribner,
the deputy director of RVIHC, who possessed the ability to approve
purchase orders in the absence of Mr. Russ. [Govt. Exh. 10; Govt. Exh.
21; Tr. 46]. Ms. Scribner did not realize that the order contained a
request to purchase controlled substances. [Govt. Exh. 21]. Nor did Ms.
Stillwell inform her that the order contained a request to purchase
controlled substances for use in the dental department. [Tr. 164-165].
Ms. Stillwell received the controlled substances from the purchase
order on December 7, 2010 [Govt. Exh. 10 at 4; Tr. 48-49, 150]. She
stored the bottle of hydrocodone and the bottle of APAP with codeine in
a locked cabinet in the dental department and informed Dr. Medinnus of
their arrival. [Tr. 169-170, 173].
I. Respondent's Dispensing of Controlled Substances at RVIHC
Dr. Medinnus testified that he began to dispense hydrocodone
directly to dental patients beginning on January 18, 2011. [Tr. 418].
Respondent did not dispense any of the APAP with codeine during this
period. [Tr. 432]. Respondent testified that he only intended to
dispense the hydrocodone on an emergency basis. [Tr. 418; 475-476]. He
further testified that he was experiencing serious marital and personal
problems during this period of time and that he was under a great deal
of personal and professional stress due to the absence of dental
department employees and the hospitalization of his mother-in-law. [Tr.
436-437; Resp. Exh. A117, A123, A138]. Ms. Stillwell testified that she
never saw Dr. Medinnus self-abuse any of the hydrocodone kept in the
dental department. [Tr. 179-180].
Dr. Medinnus did acknowledge that he did not keep a separate
dispensing log for hydrocodone that he dispensed during this period.
[Tr. 491; Govt. Exhs. 18, 19]. Instead, he notated the dispensing of
hydrocodone in each patient's dental chart. [Tr. 68; Govt. Exh. 13]. He
testified that by not keeping a separate dispensing log, he violated
the conditions of his DBC probation. [Tr. 509].
Respondent also testified that he dispensed hydrocodone to one
patient, a transient named ``JC'', without recording it in the
patient's chart. [Tr. 519-525]. Again, due to concerns about the bias
she displayed during her testimony and her lack of recall regarding
this specific patient, I decline to credit Ms. Stillwell's account of
the dispensing of hydrocodone to this patient. [Tr. 178, 180-184]. Dr.
Medinnus credibly testified that he had examined the patient on January
20, 2011, and observed that he needed a surgical extraction on two of
his teeth. [Tr. 421, 521-22]. When the patient returned to RVIHC on
January 24, 2011, Dr. Medinnus could not perform the extraction because
of his busy schedule. [Id.; Tr. 523]. When the patient reported
experiencing pain symptoms, Dr. Medinnus agreed to provide him with
hydrocodone to temporarily alleviate his symptoms. [Tr. 421-22, 522-
523]. Although Ms. Stillwell offered to retrieve the patient's chart to
record the dispensing, Dr. Medinnus testified that due to the clinic's
busy schedule, he did not receive the patient chart and thus he did not
record the dispensing of hydrocodone to this patient in the chart. [Tr.
422, 523-525].
The Respondent accepted responsibility for his failure to document
this dispensing to ``JC''. [Tr. 523]. Further, the Respondent offered
to stipulate to the audit numbers' discrepancy, concluding that
``[r]egardless, of course, the fault for this confusion is mine
alone.'' [Resp. Brief at 7; see also Tr. 539-40; Govt. Exh. 19; ALJ
Exh. 6].
J. Discovery of Respondent's Dispensing of Controlled Substances
On December 14, 2010, independent pharmacy consultant, Tom
Reidenbach, performed a quarterly drug utilization audit for RVIHC.
[Tr. 53-54; Govt. Exh. 15]. In that report, he wrote that ``I
recommended to Dr. Medinnus that all controlled substances continue to
be dispensed from the dispensary.'' [Govt. Exh. 15 at 2].
On January 27, 2011, Mr. Reidenbach conducted a chart audit related
to the dispensing of hydrocodone. In his report, Mr. Reidenbach noted
that there ``were several deficiencies in the dental clinic record
keeping. There were 3 prescriptions that did not have chart orders
evident. There were also 9 chart orders that were not dispensed from
the dispensary. These were all after 1/20/11.''
After receiving Mr. Reidenbach's report, Mr. Russ attended a
meeting on January 28, 2011, with RVIHC staff to discuss Mr.
Reidenbach's findings. [Tr. 59-62, 82-84]. During this meeting, a RVIHC
staff member observed that the dispensary had experienced a dramatic
decline in orders for hydrocodone from the dental department. [Tr. 61-
63]. Ms. Lohne, who was also at this meeting, had observed a similar
gap in the patient orders for controlled substances from the dental
department. [Tr. 193].
At the conclusion of this meeting, Mr. Russ went to Dr. Medinnus'
office and asked him if he had any hydrocodone in his office. [Tr. 63].
Respondent acknowledged that he had a bottle of hydrocodone in the
dental office and he informed Mr. Russ that RVIHC management had
approved the purchase order containing the hydrocodone bottle. [Id.].
Mr. Russ instructed Dr. Medinnus to take the hydrocodone bottle to the
dispensary. [Tr. 65]. That same day, Dr. Medinnus turned over the
bottle of hydrocodone and the unopened bottle of APAP with codeine to
Ms. Lohne in the dispensary. [Tr. 195-196]. He did not have a
dispensing log at that time. [Id.].
One or two days later, Mr. Russ asked Dr. Medinnus if he had kept a
dispensing log to track the hydrocodone he had dispensed. [Tr. 66-67].
Respondent said that he had not kept a dispensing log, so Mr. Russ
instructed him to consult the patient charts and recreate a dispensing
log to account for the dosage units he had dispensed. [Tr. 68]. Ms.
Lohne also directed Dr. Medinnus to prepare a dispensing log for the
bottle of hydrocodone. [Tr. 196]. Dr. Medinnus prepared this dispensing
log for the hydrocodone he dispensed directly to patients from the
dental department, and he provided the log to Ms. Lohne on February 2,
2011. [Govt. Exh. 11; Resp. Exh. A161; Tr. 69, 198-199, 203].
Mr. Russ then directed Ms. Lohne to account for the apparent
discrepancies from Respondent's dispensing log to the number of dosage
units left in the bottle when Dr. Medinnus turned it in to the
dispensary. [Tr. 69-70, 188-189]. Ms.
[[Page 62690]]
Lohne began by determining that the bottle of hydrocodone originally
contained five hundred dosage units when it was ordered from Henry
Schein. [Tr. 198]. And when Dr. Medinnus provided the bottle to Ms.
Lohne, she and another nurse physically counted the remaining pills and
determined there were one hundred and forty dosage units left in the
bottle. [Id.]. Then Ms. Lohne conducted a patient chart audit to verify
the Respondent's dispensing log and she prepared a document summarizing
the result of her review. [Govt. Exh. 12; Tr. 204-212].
Her audit revealed that the dental department patient charts showed
that Dr. Medinnus had dispensed three hundred and eighty-eight dosage
units of hydrocodone, even though the Respondent's dispensing log
showed he only dispensed three hundred and sixty dosage units of
hydrocodone. [Govt. Exh. 12; Govt. Exh. 13; 208-211]. Ms. Lohne then
crosschecked the patient charts and Respondent's dispensing log with
the carbon copy duplicates of the prescription orders for hydrocodone
associated with each patient file, which showed that Respondent had
only dispensed three hundred and twenty dosage units of hydrocodone.
[Govt. Exh. 12; Tr. 206-207]. When Ms. Lohne reviewed the patient
charts, she noticed that in some files, Dr. Medinnus had altered the
number of dosage units he had dispensed. [Govt. Exhs. 13, 19-20; Tr.
221-236].
Unwilling to credit the patient files altered by Respondent, Ms.
Lohne concluded that RVIHC could not account for approximately forty
dosage units of hydrocodone from the bottle that Dr. Medinnus had
ordered. [Tr. 237-238]. Thus, on February 4, 2011, RVIHC filed a DEA
Form 106, a Report of Theft or Loss of Controlled Substances, for forty
hydrocodone tablets. [Govt. Exh. 14; Tr. 238]. Ms. Lohne testified that
this figure came from her audit, which showed three hundred and twenty
dosage units dispensed from the dental department according to
duplicate prescription orders from each patient file and one hundred
and forty dosage units remaining in the bottle when it was returned to
the dispensary. [Tr. 238; Govt. Exh. 12].
Following this report, Dr. Medinnus offered to report himself to
his probation monitor, Shirley Boldrini, at the DBC. [Tr. 109]. On
February 9, 2011, Respondent called and sent an email to Ms. Boldrini
reporting a violation of his DBC probation. [Govt. Exhs. 18, 19]. That
same day, Mr. Russ placed Dr. Medinnus on a thirty-day suspension. [Tr.
109-110, 145; Resp. Exh. 4 at 24]. Respondent offered to perform a
number of conditions during this suspension, including weekly drug
testing, weekly therapy and AA meetings, and taking continuing dental
education courses. [Tr. 97-99; Govt. Exh. 18]. Mr. Russ did not agree
to these conditions. [Tr. 91]. However, during his suspension, Dr.
Medinnus notified Ms. Boldrini that he was completing these self-
imposed conditions. [Resp. Exh. A125 at 1, 2, 11, and 17].
The record also contains an email dated February 11, 2011, from the
RVIHC psychologist, Dr. Mack, who had been treating the Respondent
since the Fall of 2010. He concluded that ``the recent documentation
error [by the Respondent] was the result of acute stress and fatigue
and not an attempt to be deceitful or abuse the medication.'' [Resp.
Exh. A123].
On March 10, 2011, Dr. Medinnus resigned from RVIHC. [Resp. Exh.
A126; Govt. Exh. 17].
K. DBC and DEA Investigation of Respondent
Geno Davis, a DBC investigator, also testified at the hearing. [Tr.
286]. I find his testimony credible and consistent with the documentary
evidence. Mr. Davis serves as Respondent's current probation monitor
for the Board. [Tr. 288]. When the Board was notified of a potential
narcotic or drug discrepancy involving Dr. Medinnus while he was
employed at RVIHC, Mr. Davis was assigned to be Respondent's probation
monitor. [Tr. 289]. Mr. Davis interviewed Respondent at the Board's
office in Sacramento, California in August 2011. [Tr. 294-295]. When
asked about the discrepancies in Respondent's dispensing log for the
hydrocodone, Dr. Medinnus told Mr. Davis that he had poured the
hydrocodone tablets into a small envelope before giving it to each
patient, which may have accounted for the discrepancies in the patient
charts and his dispensing log because he may have inadvertently
dispensed more tablets than he had intended. [Tr. 295-297].
Following this interview, Mr. Davis contacted the Respondent by
phone and asked him if he had personally taken any of the hydrocodone.
[Tr. 298]. Dr. Medinnus denied taking any of the hydrocodone. [Id.].
Mr. Davis further testified that Respondent had taken drug-screening
tests at the direction of the Board in 2011 and that all of his tests
were negative. [Tr. 315; Resp. Exh. A128]. Lastly, Mr. Davis testified
that the Board has filed an accusation against Respondent with the
California Attorney General's Office regarding the lack of
documentation in a dispensing log, and that the accusation is currently
pending with that office. [Tr. 316-317].
DEA Diversion Investigator Craig Tom also testified at the hearing.
[Tr. 318--319]. I find his testimony credible and consistent with the
documentary evidence. DI Tom was assigned to investigate Respondent's
application for registration. [Tr. 320]. DI Tom coordinated his
investigation with the DBC and also spoke with Mr. Russ regarding the
Respondent's conduct at RVIHC. [Tr. 332-333]. DI Tom testified that Dr.
Medinnus was truthful in the applications for registration that he
submitted to the DEA. [Tr. 333]. DI Tom did not interview Dr. Medinnus.
[Id.].
L. Respondent's Current Situation
Dr. Medinnus currently possesses an active California dental
license, subject to the probationary conditions imposed by the DBC's
June 12, 2007 order. He is currently employed as a dentist at the ANAV
Tribal Health Clinic in Fort Jones, California, where he has worked
since April 21, 2011. [Resp. Exh. A129; Tr. 541]. Dr. Medinnus has not
dispensed or prescribed any controlled substances while working at the
ANAV Tribal Health Clinic. [Tr. 545]. Respondent credibly testified
that obtaining a DEA registration may be necessary for him to continue
at his present position and to be eligible to become the dental
director. [Tr. 547-548]. In addition, Respondent proffered two letters
of recommendation regarding his application for a DEA Registration from
his supervisors at the ANAV Tribal Health Clinic. [Resp. Exh. A151-
152]. The ANAV Tribal Health Clinic does not store or dispense any
narcotic medications and only faxes the prescriptions to neighboring
pharmacies. [Id.].
IV. Statement of Law and Discussion
A. Position of the Parties
1. Government's Position
The Government asserts that the appropriate remedy in this matter
is denial of the Respondent's application. [Govt. Brief at 25-26].
First, the Government argues that by procuring the order of the bottle
of hydrocodone and then subsequently surreptitiously dispensing it to
dental patients, Respondent violated federal law, the terms of his DBC
probation and his RVIHC contract. [Id. at 20-21]. Next, the Government
cites Respondent's failure to maintain accurate dispensing records as
further evidence of his unfitness to possess a DEA Registration. [Id.
at 23-24]. Lastly, the Government cites Agency precedent and argues
that Respondent's lack of candor at the
[[Page 62691]]
hearing and his inability to accept responsibility for his conduct also
supports the denial of Respondent's application. [Id. at 21-23].
The Government makes several arguments to justify the denial of
Respondent's application. Primarily, the Government argues that
Respondent violated federal law and his DBC probation by failing to
maintain a contemporaneous dispensing log for the hydrocodone he
dispensed to patients. [Id. at 20, 25]. Similarly, the Government
contends that Respondent demonstrated his inability to comply with DEA
recordkeeping requirements because he could not even recreate an
accurate dispensing log from his own patient records. [Id. at 22, 24-
25]. And the Government also highlighted Respondent's failure to record
in the patient chart the dispensing of hydrocodone to one of his
patients, ``JC''. [Id. at 23]. In addition, the Government strenuously
argues that Respondent has not accepted responsibility or shown any
remorse for his conduct. [Id. at 21-23]. Instead, the Government argues
that Respondent has ``downplayed, indeed mischaracterized, his
violations'' and ``has not been truthful as to what really happened.''
[Id. at 21]. Nor, the Government contends, was Respondent candid with
RVIHC personnel regarding his ordering and usage of hydrocodone in the
dental department. [Id. at 22-23].
In conclusion, the Government argues that Respondent's application
for a DEA Certificate of Registration as practitioner is inconsistent
with the public interest and that his application should be denied.
[Id. at 25-26].
2. Respondent's Position
Respondent asserts that the appropriate remedy in this matter is
the conditional granting of his application. [Resp. Brief at 34-35].
First, Dr. Medinnus acknowledges his misconduct in not maintaining the
required dispensing log at RVIHC pursuant to his DBC probation. [Id. at
7-8, 20]. In mitigation, Respondent describes in detail the ``profound
personal and professional hardship'' that he experienced during his
employment at RVIHC. [Id. at 10-11, 20]. Respondent further notes that
he self-reported his violations to the DBC and also fully disclosed the
incident on his DEA application. [Id. at 20]. Respondent also argues
that he has consistently taken responsibility for this misconduct,
including in his testimony at the hearing. [Id. at 8-10, 20]. In
addition, Dr. Medinnus argues that the record contains no evidence of
self-abuse or diversion of controlled substances during his employment
at RVIHC. [Id. at 9-10, 20].
Next, Respondent argues that the Government has failed to prove its
allegations that he made an unauthorized purchase of hydrocodone or
that he violated RVIHC's policies on storing and dispensing by directly
dispensing to patients in the dental department. [Id. at 20-33].
Respondent's primary claim is that Mr. Russ verbally authorized the
November 29, 2011 purchase order, which rendered Respondent's
subsequent storing and dispensing of the hydrocodone compliant with
RVIHC's policy. [Id. at 26-31]. To this point, Respondent meticulously
details RVIHC's changing policy on the dispensing of controlled
substances during late 2010 and early 2011 and the problems that the
dispensary had in maintaining adequate supplies of controlled
substances. [Id. at 21-26]. Dr. Medinnus also argues that these
allegations concerning the purchase and dispensing of hydrocodone were
never disclosed to him or discussed with him until the DEA initiated
the Order to Show Cause proceedings. [Id. at 31-33].
Lastly, Respondent argues that denying his application for
registration would be a disproportionate penalty for his conduct at
RVIHC. [Id. at 20, 34]. Therefore, in light of Respondent's acceptance
of responsibility, Respondent argues that granting his application for
a restricted registration would be consistent with the public interest.
[Id. at 34-35]. He recommends that his registration be subject to
several conditions, including complying with the terms of his
California dental license probation, being limited to only prescribing
controlled substances and not administering, ordering, or dispensing
them, being prohibited from prescribing controlled substances to
himself or any family members, and maintaining a log of all controlled
substances prescriptions he authorizes and providing this log to the
local DEA office on a quarterly basis. [Id.].
B. Statement of Law and Analysis
Pursuant to 21 U.S.C. 823(f) (2006),\1\ the Deputy Administrator
may deny an application for a DEA Certificate of Registration if he
determines that such registration would be inconsistent with the public
interest. In determining the public interest, the following factors are
considered:
---------------------------------------------------------------------------
\1\ The Deputy Administrator has the authority to make such a
determination pursuant to 28 CFR 0.100(b), 0.104 (2012).
---------------------------------------------------------------------------
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f) (2006).
These factors are to be considered in the disjunctive; the Deputy
Administrator may rely on any one or a combination of factors and may
give each factor the weight he deems appropriate in determining whether
a registration should be revoked. See Robert A. Leslie, M.D., 68 FR
15,227, 15,230 (DEA 2003). Moreover, the Deputy Administrator is ``not
required to make findings as to all of the factors.'' Hoxie v. DEA, 419
F.3d 477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165,
173-74 (D.C. Cir. 2005).
The Government bears the ultimate burden of proving that the
requirements for registration are not satisfied. 21 CFR 1301.44(d)
(2012). However, where the Government has made out a prima facie case
that Respondent's application would be ``inconsistent with the public
interest,'' the burden of production shifts to the applicant to
``present[] sufficient mitigating evidence'' to show why he can be
entrusted with a new registration. See Medicine Shoppe--Jonesborough,
73 FR 364, 387 (DEA 2008). To this point, the Agency has repeatedly
held that the ``registrant must accept responsibility for [his] actions
and demonstrate that [he] will not engage in future misconduct.''
Medicine Shoppe--Jonesborough, 73 FR at 387; see also Samuel S.
Jackson, D.D.S., 72 FR 23,848, 23,853 (DEA 2007). In short, after the
Government makes its prima facie case, the Respondent must produce
sufficient evidence that he can be entrusted with the authority that a
registration provides by demonstrating that he accepts responsibility
for his misconduct and that the misconduct will not reoccur.
1. Factor One: Recommendation of Appropriate State Licensing Board
Although the recommendation of the applicable state licensing board
is probative to this factor, the Agency possesses ``a separate
oversight responsibility with respect to the handling of controlled
substances'' and therefore must make an ``independent
[[Page 62692]]
determination as to whether the granting of [a registration] would be
in the public interest.'' Mortimer B. Levin, D.O., 55 FR 8,209, 8,210
(DEA 1990); see also Jayam Krishna-Iyer,M.D., 74 FR 459, 461 (DEA
2009). The ultimate responsibility to determine whether a registration
is consistent with the public interest has been delegated exclusively
to the DEA, not to entities within state government. Edmund Chein,
M.D., 72 FR 6,580, 6,590 (DEA 2007), aff'd, Chein v. DEA, 533 F.3d 828
(D.C. Cir. 2008). So while not dispositive, state board recommendations
are relevant on the issue of revoking or maintaining a DEA
registration. See Gregory D. Owens, D.D.S., 74 FR 36,751, 36,755 (DEA
2009); Martha Hernandez, M.D., 62 FR 61,145, 61,147 (DEA 1997).
In this case, the DBC has not made a specific recommendation
concerning the granting of a DEA registration to the Respondent. The
DBC has reinstated Respondent's dental license, subject to a series of
probationary conditions. [Govt. Exh. 7, 8; Tr. 330-331]. Thus, Dr.
Medinnus currently possesses an active dental license in the state of
California. [Id.]. Nevertheless, the Agency has consistently held that
a practitioner's possession of state authority, while a prerequisite to
seeking a registration, is not dispositive of the public interest
determination. Mark De La Lama, P.A., 76 FR 20,011, 20,018 (DEA 2011).
Therefore, I find that this factor does not weigh in favor or against
the granting of Respondent's application for a DEA Certificate of
Registration.
2. Factor Three: Applicant's Conviction Record Relating to Controlled
Substances
The record contains evidence that the Respondent has been convicted
of an offense related to the manufacture, distribution or dispensing of
controlled substances, namely his 2003 felony conviction for violating
Cal. Health & Safety Code Sec. 11173(a) (West 2012) for obtaining
controlled substances by fraud. [Resp. Exh. 3]. Thus, I find that this
factor weighs against the granting of Respondent's application for a
DEA Certificate of Registration. Scott H. Nearing, 70 FR 33,200, 33,202
(DEA 2005).
3. Factor Five: Such Other Conduct Which May Threaten the Public Health
and Safety
The Agency has long held that a practitioner's self-abuse of
controlled substances constitutes ``conduct which may threaten public
health and safety.'' 21 U.S.C. 823(f)(5) (2006); see also Tony T. Bui,
M.D., 75 FR 49,979, 49,990 (DEA 2010); Kenneth Wayne Green, Jr., M.D.,
59 FR 51,453 (DEA 1994); David E. Trawick, D.D.S., 53 FR 5,326 (DEA
1988). Here, the Respondent self-abused and diverted to his family
members significant quantities of hydrocodone, lorazepam, and diazepam
from approximately January 2000 through November 2001. [Govt. Exhs. 5,
6, and 7]. Such unlawful ingestion and diversion of controlled
substances clearly places the public health and safety in jeopardy.
This unlawful conduct led to the surrender of Respondent's California
dental license and initial DEA registration.
Yet, I find that the Respondent has successfully addressed his
addiction problem and returned to the practice of dentistry by
regaining his dental license in 2007. At the hearing, Dr. Medinnus
proffered substantial and detailed evidence regarding his impressive
recovery program, including numerous negative drug screens he has taken
over the past nine years. [Resp. Brief at 2-7, 9-10]. As the Deputy
Administrator has previously determined, ``[t]he paramount issue is not
how much time has elapsed since [the Respondent's] unlawful conduct,
but rather, whether during that time [the] Respondent has learned from
past mistakes and has demonstrated that he would handle controlled
substances properly if entrusted with a DEA registration.'' Leonardo V.
Lopez, M.D., 54 FR 36,915 (DEA 1989). Even though it has been
previously found that time, alone, is not dispositive in such
situations, it is certainly an appropriate factor to be considered. See
Robert G. Hallermeier, M.D., 62 FR 26,818 (DEA 1997) (four years); John
Porter Richards, D.O., 61 FR 13,878 (DEA 1996) (ten years); Norman
Alpert, M.D., 58 FR 67,420, 67,421 (DEA 1993) (seven years). In this
case, Respondent has conclusively demonstrated his strong recovery from
his previous addiction and his successful maintenance of his sobriety
for the past nine years. Therefore, I find that Respondent's history of
substance abuse does not weigh against the granting of Respondent's
application for a DEA Certificate of Registration.
4. Factors Two and Four: Applicant's Experience With Controlled
Substances and Compliance With Applicable State, Federal, or Local Laws
Relating To Controlled Substances
Under the Controlled Substances Act (``CSA'' or ``the Act'') and
Agency regulations, it is fundamental that a practitioner who directly
dispenses controlled substances maintain an effective recordkeeping
system. This includes maintaining inventories and other records
pursuant to 21 U.S.C. 827(a) (2006). They are also required to hold a
DEA registration at any location where they dispense controlled
substances, see 21 CFR 1301.12 (2012), and to store controlled
substances ``in a securely locked, substantially constructed cabinet,''
id. Sec. 1301.75. Lastly, practitioners who provide controlled
substances directly to patients must maintain written records of such
dispensing covering a minimum of two years; take an initial inventory
of all controlled substances on hand and biennial inventories
thereafter; and maintain records of receipts, dispensings, and
transfers of controlled substances. See id. Sec. Sec. 1304.03(b),
1304.04, 1304.11, 1304.21, 1304.22(c); see also Shawn M. Gallegos,
D.D.S., 76 FR 66,986 (DEA 2011).
The Government brought three primary allegations to support the
denial of Respondent's application, the unauthorized purchase order for
the controlled substances, Respondent's failure to abide by RVIHC's
storing and dispensing policies for controlled substances, and his
failure to maintain the required dispensing log for the hydrocodone
pursuant to his DBC probation. I decline to credit the Government's
first two allegations although I find that the Government has met its
burden of proof concerning Respondent's failure to maintain the
required dispensing log pursuant to his DBC probation and Agency
regulations.
First, with regards to the unauthorized purchase allegation, I find
that the Government has not sustained its burden of proof. The
testimony and evidence elicited at the hearing regarding this purchase
order does not support the Government's claim that Respondent was
unauthorized to place the order. Dr. Medinnus credibily maintained that
Ms. Stillwell told him that Mr. Russ approved the order. [Tr. 158;
Resp. Exh. A140; Resp. Brief at 28-31]. As explained above, I decline
to credit much of Ms. Stillwell's testimony on her conversation with
Mr. Russ regarding this order. Furthermore, I also note that Mr. Russ
failed to recall many of the details surrounding this particular order
including any conversation he had with Ms. Stillwell prior to the
submission of the order to Ms. Scribner. Thus, the evidence in the
record does not support a conclusion by a preponderance of the evidence
that Dr. Medinnus was responsible for knowingly submitting an
unauthorized purchase order for controlled substances. More tellingly,
the submission of the purchase order on behalf of the dental department
and its subsequent approval by Jan Scribner, a duly authorized RVIHC
representative
[[Page 62693]]
who had the power to approve such orders, appears to belie any
contention that the order itself was unauthorized by RVIHC management.
While it is likely that RVIHC management, including Mr. Russ and Ms.
Lohne, failed to remember that Dr. Medinnus had obtained a bottle of
hydrocodone for emergency use, I conclude that the record does not show
that the placement of the November 29, 2010 purchase order was
unauthorized.
And as the Respondent persuasively argues, if Dr. Medinnus
reasonably believed the purchase order was duly approved, the
Government's allegation that he failed to abide by RVIHC policies
regarding the storage and dispensing of controlled substances, also
fails. [Resp. Brief at 20-21]. While the Government has elicited
substantial testimony and evidence regarding RVIHC's policies and
procedures related to dispensing controlled substances, it has failed
to link these policies to any deliberate or knowing attempt on behalf
of the Respondent to violate them. [Govt. Brief at 21-22]. Indeed, when
Mr. Russ confronted Dr. Medinnus regarding the bottle of hydrocdone,
Respondent promptly admitted to ordering and storing the controlled
substances and pointed to the approval of the purchase order as
justification for his conduct. [Tr. 63]. Such a response supports
Respondent's consistent position that he honestly and reasonably
believed he possessed the necessary authority to store and dispense
controlled substances in the dental department. Therefore, I decline to
credit the Government's allegation that Respondent violated RVIHC's
policies on the storage and dispensing of controlled substances.
Both parties however, do acknowledge that Dr. Medinnus failed to
maintain the required dispensing log for these controlled substances.
[Resp. Brief at 7-8; Govt. Brief at 20]. In addition, I find that Dr.
Medinnus failed to properly chart each dispensing of hydrocodone he
gave to a patient, most notably with regards to his dispensing to
``JC'', which represents another serious violation of Agency
recordkeeping regulations. Nor was Respondent's clumsy attempt to
reconstruct a dispensing log and alteration of patient charts
consistent with a registrant's duty to maintain complete and accurate
records regarding controlled substances. Therefore, I find that
Respondent committed several serious violations of the Act's
recordkeeping requirement, Agency regulations, as well as the terms of
his DBC probation. Thus, in light of Respondent's serious and
undisputed violations of the CSA's recordkeeping requirements and his
DBC probation, I conclude that the Government has presented a prima
facie case that supports the denial of Respondent's application.
After the Government ``has proved that a registrant has committed
acts inconsistent with the public interest, a registrant must `present
sufficient mitigating evidence to assure the Administrator that [he]
can be entrusted with the responsibility carried by such a
registration.' '' Medicine Shoppe--Jonesborough, 73 FR 364, 387 (DEA
2008) (quoting Samuel S. Jackson, D.D.S., 72 FR 23,848, 23,853 (DEA
2007). ``Moreover, because `past performance is the best predictor of
future performance,' Alra Labs., Inc. v. DEA, 54 F.3d 450, 452 (7th
Cir. 1995), ``[DEA] has repeatedly held that where a registrant has
committed acts inconsistent with the public interest, the registrant
must accept responsibility for his actions and demonstrate that he will
not engage in future misconduct.'' Medicine Shoppe--Jonesborough, 73 FR
at 387; see also Samuel S. Jackson, D.D.S., 72 FR 23, 848, 23,853 (DEA
2007); Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005) (``admitting
fault'' is ``properly consider[ed]'' by DEA to be an ``important
factor[]'' in the public interest determination).
Here, I find that Respondent has both taken responsibility for his
actions and shown remorse for his conduct. During his testimony, Dr.
Medinnus repeatedly demonstrated remorse for his conduct at the RVIHC.
He also testified credibly and candidly about the circumstances
surrounding the misconduct, including the various personal and
professional challenges he faced during his employment at RVIHC.
The Government argues that the Respondent attempted to ``minimize''
his misconduct by testifying that he could only not account for forty
dosage units of the hydrocodone. [Govt. Brief at 22]. I disagree.
Instead, I find that while this evidence, along with the evidence
regarding the circumstances surrounding Respondent's employment at
RVIHC does not excuse Respondent's conduct, it does provide appropriate
mitigating factors for this Court and the Deputy Administrator to
consider. See Martha Hernandez, M.D., 62 FR 61,145 (DEA 1997) (holding
that, in exercising his discretion in determining the appropriate
remedy, the Administrator should consider all of the facts and
circumstances of a particular case).
In light of the substantial evidence that Respondent proffered
regarding his acceptance of responsibility for the misconduct, I find
that the Government's proposed sanction, the denial of Respondent's
application, is too severe. As this Agency has repeatedly held, a
proceeding under the Act `` `is a remedial measure, based upon the
public interest and the necessity to protect the public from those
individuals who have misused . . . their DEA Certificate of
Registration, and who have not presented sufficient mitigating evidence
to assure the Administrator that they can be entrusted with the
responsibility carried by such a registration.' '' Jon Karl Dively,
D.D.S., 72 FR 74,332, 74,334 (DEA 2007) (quoting Samuel S. Jackson,
D.D.S., 72 FR 23,848, 23,853 (DEA 2007)). Despite the Government's
strenuous arguments to the contrary, I find that Dr. Medinnus'
restricted registration does not represent a danger to the public
interest. Indeed, Dr. Medinnus has sensibly requested the issuance of a
restricted registration, which would ensure that he avoid any repeat of
the recordkeeping violations he committed while at RVIHC. While his
misconduct was indeed serious, Dr. Medinnus has now demonstrated that
he understands the responsibilities and requirements of a DEA
registrant.
V. Conclusion and Recommendation
Therefore, I conclude that the DEA has met its burden of proof and
has established that grounds exist for denying the Respondent's
application for a DEA Certificate of Registration. I do not condone nor
minimize the seriousness of the Respondent's misconduct. However, based
on this record, I recommend that the Respondent be afforded an
opportunity to demonstrate that he can again responsibly handle
controlled substance prescriptions by the granting of a restricted
registration. See Cecil E. Oakes, Jr., M.D., 63 FR 11,907, 11,910 (DEA
1998) (``Such a resolution will provide Respondent with the opportunity
to demonstrate that he can responsibly handle controlled substances,
while at the same time protect the public health and safety, by
providing a mechanism for rapid detection of any improper activity.'').
The Agency has previously held that ``such restrictions must be related
to what the Government has alleged and proved in any case.'' Janet L.
Thornton, D.O., 73 FR 50,354, 50,356 (DEA 2008).
Consistently, I suggest that the conditions in this case be
tailored to ensure that the Respondent does not personally handle or
dispense controlled substances. Thus, they should include: That the
registration restricts his handling of controlled substances to merely
prescribing and not storing, administering or dispensing
[[Page 62694]]
such drugs and that he be prohibited from prescribing controlled
substances to himself or any family member. Further, I recommend that
the Respondent be ordered to comply with the terms of his DBC probation
and promptly notify the DEA if the DBC takes any action against his
dental license. Lastly, I recommend that he maintain and provide
quarterly prescription logs for all controlled substances prescriptions
he authorizes to the local DEA office for monitoring. I recommend these
restrictions apply for three years from the date of the final order so
directing this result. In this way, the Respondent may safely continue
his return to the full practice of dentistry, and the DEA can assure
itself of the Respondent's compliance with DEA regulations as well as
the protection of the public interest.
Dated: October 17, 2012.
Gail A. Randall,
Administrative Law Judge.
[FR Doc. 2013-24697 Filed 10-21-13; 8:45 am]
BILLING CODE 4410-09-P