Notice2025-15866
Andrew Konen, M.D.; Decision and Order
Primary source
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Published
August 20, 2025
Issuing agencies
Justice DepartmentDrug Enforcement Administration
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<title>Federal Register, Volume 90 Issue 159 (Wednesday, August 20, 2025)</title>
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[Federal Register Volume 90, Number 159 (Wednesday, August 20, 2025)]
[Notices]
[Pages 40650-40659]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-15866]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Andrew Konen, M.D.; Decision and Order
I. Introduction
On August 12, 2024, the United States Department of Justice, Drug
Enforcement Administration (DEA or Government) issued an Order to Show
Cause (OSC) to Andrew Konen, M.D., of Dallas, Texas (Respondent). OSC,
at 1. The OSC proposes the revocation of Respondent's DEA certificate
of registration, BK4924139, (registration) on the ground that his
``continued registration is inconsistent with the public interest.''
Id. (citing 21 U.S.C. 824(a)(4), in conjunction with 21 U.S.C.
823(g)(1)). More specifically, the OSC alleges that Respondent issued
``numerous prescriptions for Schedule II-IV controlled substances
outside the course of professional practice and not for a legitimate
medical purpose.'' Id. at 3.
Respondent timely requested a hearing, and the matter was assigned
to an Administrative Law Judge (ALJ). Infra section II.D. After
Respondent's failures to comply timely with the ALJ's scheduling
Orders, and Respondent's failure to show good cause for his
noncompliance, the ALJ terminated the proceedings after deeming that
Respondent waived his right to a hearing and was in default. Id. The
matter is before the Agency on the Government's Request for Final
Agency Action (RFAA).
After accessing and carefully analyzing the entire record, infra,
the Agency finds substantial record evidence supporting the conclusion
that Respondent is deemed to be in default because he ``failed to . . .
otherwise defend.'' \1\ 21 CFR 1301.43(c); infra sections II.B., II.C.,
II.D., II.E., and II.F. Accordingly, based on Agency rule, the
[[Page 40651]]
Agency deems that Respondent admits the OSC's factual allegations. 21
CFR 1301.43(e). Infra section IV. After analyzing the deemed-admitted
facts, the Agency concludes that the Government presented a prima facie
case that Respondent issued Schedule II through IV controlled substance
prescriptions ``outside the course of professional practice and not for
a legitimate medical purpose'' from at least January 2016 to July 2020.
OSC, at 3-6; infra sections IV and V. After concluding that
Respondent's unlawful controlled substance prescribing makes his
continued registration inconsistent with the public interest, the
Agency finds that there is no record evidence that Respondent
unequivocally accepts responsibility for the founded violations. Infra
sections VI and VII. Accordingly, the Agency revokes Respondent's
registration and denies all pending applications by Respondent for
registration in Texas. Infra Section VII and Order.
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\1\ As the Government did not include the entire record in its
RFAA, the Agency accessed it from the Office of Administrative Law
Judges' docket and considered every item in it.
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II. The Default Rule and Its Application in this Matter
A. The Controlled Substances Act
The Controlled Substances Act (CSA) explicitly authorizes the
Attorney General to promulgate rules and regulations to support
implementation and enforcement of the statute.\2\ First, the Attorney
General ``is authorized to promulgate rules and regulations and to
charge reasonable fees relating to the registration and control of the
manufacture, distribution, and dispensing of controlled substances and
to listed chemicals.'' 21 U.S.C. 821. Second, the Attorney General
``may promulgate and enforce any rules, regulations, and procedures
which he may deem necessary and appropriate for the efficient execution
of his functions under this subchapter.'' 21 U.S.C. 871(b). Consistent
with these CSA provisions, the Agency promulgated a default rule. 21
CFR 1301.43.
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\2\ The Attorney General's CSA responsibilities have been
delegated to the DEA Administrator. 28 CFR 0.100(b).
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B. The ALJ's Powers and Duties
The Administrative Procedure Act (APA) and the CSA's implementing
regulations address the powers and duties of Agency ALJs. According to
the APA, an Agency ALJ, among other things, may ``regulate the course
of the hearing,'' ``dispose of procedural requests or similar
matters,'' and ``take other action authorized by agency rule consistent
with this subchapter.'' 5 U.S.C. 556(c)(5), (9), and (11).
The CSA's implementing regulations clearly state that an Agency
ALJ's duty is ``to conduct a fair hearing, to take all necessary action
to avoid delay, and to maintain order,'' and that the ALJ ``shall have
all powers necessary to these ends.'' 21 CFR 1316.52. The salient
provision also explicitly states that the ALJ's ``powers'' include
``any action permitted . . . by the provisions of the APA.'' Id.
Further, it provides a non-exclusive list of powers ``necessary'' to
the ``end'' of the ALJ's ``dut[ies],'' powers such as ``rul[ing] on
procedural items pending before him'' and ``[r]equir[ing] parties to
state their position in writing with respect to the various issues in
the hearing and to exchange such statements with all other parties.''
21 CFR 1316.52(c) and (g). The Agency notes, as particularly relevant
to this adjudication, that the latter is typically done in filings such
as Prehearing Statements.
Accordingly, the Agency concludes that the Agency ALJ assigned to
this matter clearly has the duty and the power to issue scheduling
orders, to rule on matters concerning those scheduling orders, and ``to
take all necessary action to avoid delay, and to maintain order.'' 21
CFR 1316.52.
C. Procedures Applicable to this Adjudication
Effective December 14, 2022, pursuant to the provisions of the CSA,
the Agency implemented a final rule to increase the efficient execution
of its CSA functions relating to the registration and control of the
manufacture, distribution, and dispensing of controlled substances and
to listed chemicals. 87 FR 68036 (2022) (amending 21 CFR 1301.37 and
1301.43). The final rule states that the person named in the OSC has
thirty days after receiving the OSC to request a hearing and to answer
the OSC's allegations. 21 CFR 1301.37(d). It also states that any
party's failure to comply with its terms may result in that party's
default, unless the party establishes ``good cause'' to excuse the
default. 21 CFR 1301.43. An unexcused default, the final rule provides,
``shall be deemed to constitute a waiver of the . . . right to a
hearing and an admission of the factual allegations of the order to
show cause.'' 21 CFR 1301.43(e). The final rule affords multiple
opportunities to establish ``good cause'' to excuse a deemed default.
Id. As this final rule was in effect when DEA issued the OSC to
Respondent, it applies to Respondent's response to the OSC.
Both the default rule's notice of proposed rulemaking (NPRM), 85 FR
61662 (2020), and the final rule use the phrase ``good cause''
throughout.\3\ Neither, though, defines ``good cause.'' \4\ As ``good
cause'' is a standard often used in federal legal authorities, the
Circuit Courts have addressed and applied it on many occasions in
contexts where, like here, there is noncompliance with a scheduling
order, a missed deadline, and the like. Infra section II.F.
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\3\ Indeed, ``good cause'' was the standard in the prior
iteration of 21 CFR 1301.43(d) (``If any person entitled to a
hearing or to participate in a hearing pursuant to . . . 1301.32 or
. . . 1301.34-1301.36 fails to file a request for a hearing or a
notice of appearance, or if such person so files and fails to appear
at the hearing, such person shall be deemed to have waived the
opportunity for a hearing or to participate in the hearing, unless
such person shows good cause for such failure.''). The prior
iteration of 21 CFR 1301.43 does not include the deemed admission of
the OSC's factual allegations.
\4\ The NPRM and final rule cite Kamir Garces Mejias, M.D., 72
FR 54931 (2007), an Agency decision issued under the last version of
the default rule. In that decision, DEA charged the doctor with
issuing controlled substance prescriptions in the absence of a
legitimate physician-patient relationship. Id. at 54931. When the
doctor failed to file a Prehearing Statement in timely compliance
with the ALJ's scheduling Order, the ALJ issued another Order
establishing a second deadline for that filing. Id. The doctor,
though, did not comply with the ALJ's second deadline. Id. The ALJ
issued a third Order setting another deadline and giving ``notice
that . . . [the doctor's] failure to comply could be deemed a waiver
of her right to a hearing.'' Id. The doctor, again, did not comply
with the ALJ's deadline. Id. The Government then filed a motion
asking the ALJ to find that the doctor ``waived her right to a
hearing'' and to terminate the proceeding. Id. The ALJ granted the
Government's motion and terminated the proceeding on March 7, 2007.
On March 12, 2007, Respondent's counsel moved for
reconsideration, arguing that he is a solo practitioner, that he had
``an extremely busy Court calendar'' since January of that year, and
that ``it had not been his `intention to be disrespectful or to
willfully disobey the orders issued by the ALJ.' '' Id. at 54931-32.
The ALJ denied the request for reconsideration, stating that
Respondent had thus far in the proceedings failed to comply with all
of the ordered deadlines, that she had never submitted a written
request for an extension of any of the deadlines, and that
``Respondent's failure to pursue her case remains a waiver of her
right to a hearing.'' Id. at 54932. The ALJ also denied Respondent's
second request for reconsideration. Id. The Agency agreed with the
ALJ's termination of proceedings, writing that ``Respondent has not
shown `good cause' for failing to comply with the ALJ's orders and
[the Agency] thus find[s] that Respondent has waived her right to a
hearing.''
There are clear fact parallels between Kamir Garces Mejias,
M.D., and the instant facts: repeated failures to comply with the
ALJ's multiple deadlines for filing a Prehearing Statement, the
ultimate failure of Respondent ever to file a Prehearing Statement,
and the absence of good cause for the failures. Before issuing this
Decision/Order, the Agency read and analyzed the entire record
before it. It cites the record in detail in this Decision/Order and
explains the significance of its contents. The Agency concludes that
it is appropriate to apply the final rule to this record. Infra
sections II.D, II.E., and II.F.
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[[Page 40652]]
D. Respondent's Request For a Hearing and Conduct During Prehearing
Proceedings
As already discussed, Respondent timely requested a hearing.\5\
Order for Answer and Prehearing Statements, dated August 29, 2024
(OAPS), at 1. In the OAPS, issued the day after Respondent filed his
hearing request, and citing relevant authority, the ALJ points out that
the request for hearing ``does not satisfy the requirement of DEA's
regulations that the Respondent file an Answer . . . as the Respondent
did not answer the allegations contained in the OSC in his [request for
hearing].'' Id. (citing 21 CFR 1316.47 and 1301.37). The OAPS also
cites the default rule references on pages 6 and 7 of the OSC, stating
that a respondent's failure to answer timely, to plead, or ``otherwise
[to] defend'' may lead to the respondent's being ``deemed to otherwise
have waived the right to a hearing and to be in default.'' Id. The OAPS
orders Respondent to file a compliant answer ``by 5:00 p.m. Eastern
Time (`ET')/4:00 p.m. Central Time (`CT') on September 12, 2024.''
<SUP>6 7</SUP> Id. at 1-2.
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\5\ Based on the record evidence, the Agency finds that
Respondent's request for a hearing is dated August 28, 2024. As
August 28th is well within thirty days of the date of the OSC's
issuance on August 12, 2024, the Agency finds that Respondent timely
filed his request for a hearing. 21 U.S.C. 824(c)(2)(B); 21 CFR
1301.37(d)(1).
\6\ The OAPS cites Respondent's ``assert[ion]'' that he was
served with the OSC on August 13, 2024, when designating September
12, 2024, as the Answer's due date. OAPS, at 2, n.1.
\7\ The Agency finds unequivocal and uncontroverted record
evidence that the OAPS specifically sets out the time deadlines in
both Eastern Time, the ALJ's time zone, and in Central Time,
presumably Respondent's and Respondent's counsel's time zone in
Texas. OAPS, at 1-2. The Agency further finds unequivocal and
uncontroverted record evidence that the OAPS details the electronic
filing process for the parties, including that ``[y]our attention is
specifically directed to 21 CFR 1316.45, which provides, inter alia,
that ```[d]ocuments shall be dated and deemed filed upon receipt by
the Hearing Clerk.' . . . The email receipt date reflected by the
DEA Judicial Mailbox server shall conclusively control all issues
related to the date of service of all filed correspondence, provided
however, that correspondence received after 5:00 p.m., local
Washington, DC time, will be deemed to have been received on the
following business day.'' Id. at 3-4.
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The OAPS also addresses the filing of Prehearing Statements and the
scheduling of the Prehearing Conference. Id. at 2-3. As for Respondent,
the OAPS states that, ``[t]o the extent the Respondent timely files his
Answer,'' he is to file his Prehearing Statement ``no later than 2:00
p.m. ET/1:00 p.m. CT on October 3, 2024.'' Id. at 2. It also states
that ``[f]ailure to timely file a prehearing statement that complies
with the directions provided above may result in a sanction, including
(but not limited to) a waiver of hearing and an implied withdrawal of a
request for hearing.'' Id. at 4.
The Agency finds unequivocal and uncontroverted record evidence
that, on October 2, 2024, after 5:00 p.m. ET, Respondent filed a
request for an extension of time to file his Prehearing Statement
(Respondent's Motion for Time Extension).\8\ Order Granting in Part
Respondent's Motion for Extension of Time to File Prehearing Statement,
dated October 3, 2024 (Order Granting in Part), at 1, n.1. Respondent's
Motion for Time Extension, asking that the original October 3, 2024
Prehearing Statement filing deadline be extended to December 15, 2024,
is based on three grounds.<SUP>9 10</SUP> The first ground is that
``the Government and its expert witness . . . do not have access to the
complete medical and prescription records for each of the three named
patients in this case'' and, therefore, the Government's expert witness
``cannot opine on the nature, quality, and appropriateness of the
patient care and prescribing rendered by Respondent for each patient.''
Respondent's Motion for Time Extension, at 2. The ALJ's responsive
Order correctly points out that ``[i]t is unclear why this allegation
supports Respondent's request for additional time to file a prehearing
statement.'' Order Granting in Part, at 1.
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\8\ Although the ALJ's Order in response to Respondent's Motion
for Time Extension does not raise it, the Agency notes that the OAPS
``further Ordered'' that ``any requests for extension of time to
file must be made by written motion sufficiently in advance of
scheduled deadlines to be considered and ruled upon.'' OAPS, at 4
[emphasis added]. Respondent filed his motion for an extension of
time to file his Prehearing Statement after 5:00 p.m. the day before
the deadline for the filing of his Prehearing Statement.
Accordingly, as the OAPS states, Respondent's Motion for Time
Extension is deemed to have been received on October 3, 2024, the
ALJ-ordered deadline for Respondent to file his Prehearing Statement
and, therefore, was not filed ``sufficiently in advance of [the]
scheduled deadline[ ] to be considered and ruled upon.'' Id. at 3-4.
\9\ Respondent's Motion for Time Extension, at 1, asserts that
Respondent filed his answer timely. The Order Terminating
Proceedings, infra, confirms Respondent's assertion. Order
Termination Proceedings, at 1.
\10\ Respondent's Motion for Time Extension, at 3, asserts that
the ``Government has been consulted about the continuance and is
unopposed to the requested extension of time in which to submit
Respondent's written prehearing statement.'' Further, Respondent's
Motion for Time Extension includes a ``Certificate of Conference''
stating, among other things, that the ``parties . . . discussed the
estimated length of time needed for the hearing'' and the ``situs of
the hearing.'' Respondent's Motion for Time Extension, at 5.
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Respondent's second ground for a time extension is that ``there is
a parallel criminal case against Respondent.'' Respondent's Motion for
Time Extension, at 1. Respondent elaborates that he is ``in the process
of preparing a Sec. 41(g) motion to contest a search warrant that was
improper in that it failed to authorize a search at the location listed
in the warrant, resulting in an improper seizure of property that
Respondent is now attempting to reclaim,'' and that he ``is considering
whether to enter into a reverse proffer in the near future.'' Id. at 3.
Concerning Respondent's second ground, the ALJ's responsive Order
correctly states that ``[a]s the Agency has previously ruled, a stay of
DEA administrative enforcement proceedings based on a parallel criminal
proceeding `is unlikely to ever be justified.' '' Order Granting in
Part, at 1.
Respondent's third ground is that he ``has not yet retained an
expert to review the patient medical records, the Government's written
statement, applicable guidelines and standards, peer-reviewed
literature, and other relevant documents because the insurance carrier
has not yet approved the costs associated with retaining an expert in
this case.'' Respondent's Motion for Time Extension, at 3. Respondent
represents that he ``is working with the insurance carrier now to
follow up on retaining an expert to review the records and related
documents and to prepare expert testimony in this proceeding.'' Id.
The ALJ's Order Granting in Part, after noting that the Government
timely filed its Prehearing Statement, cites its ``power to `conduct a
fair hearing, to take all necessary action to avoid delay, and to
maintain order . . . including . . . [a]rrange and change the date,
time and place of . . . prehearing conferences.' '' Order Granting in
Part, at 2, citing 21 CFR 1316.52(a). It states that ``[t]he tribunal
does not find that a nearly 75-day extension for Respondent to retain
the services of an expert witness and file his prehearing statement is
warranted,'' but that ``the tribunal will afford the Respondent a 2-
week extension of time to file his prehearing statement.'' Id. Thus,
the Order Granting in Part adjusts the deadline for Respondent to file
his Prehearing Statement to October 17, 2024, at 2:00 p.m. ET/1:00 p.m.
CT. Id.
Respondent did not file his Prehearing Statement on or before the
October 17, 2024 deadline. Order Directing Compliance for Respondent to
File Prehearing Statement, dated October 18, 2024 (Order Directing
Compliance), at 1. As already discussed, the OAPS reminds Respondent
that his ``[f]ailure to timely file a prehearing statement that
complies with the
[[Page 40653]]
directions provided . . . may result in a sanction, including (but not
limited to) a waiver of hearing and an implied withdrawal of a request
for hearing.'' OAPS, at 4. The Order Directing Compliance, though, does
not sanction Respondent. Instead, it affords Respondent an opportunity
to file his Prehearing Statement by October 23, 2024, at 2:00 p.m. ET/
1:00 p.m. CT, and to ``show good cause why he did not timely file such
prehearing statement in accordance with the directions set forth in the
Order'' Granting in Part. Order Directing Compliance, at 2. The Order
Directing Compliance further states that, if Respondent fails to comply
with the extended deadline, the ALJ ``will take appropriate action and
the Respondent will face an appropriate remedy (e.g., waiver of his
right to a hearing, entry of default, allegations being deemed
admitted, and/or dismissal of his request for hearing).'' Id.
When Respondent did not file his Prehearing Statement by the
October 23, 2024 deadline, the ALJ issued the Order Terminating
Proceedings. That Order recounts the requirements of the ALJ's prior
Orders about this matter, Respondent's compliance and non-compliance
with his Orders, and the ALJ's multiple avisos to Respondent warning
that non-compliance with his Orders ``may result in sanction, including
(but not limited to) waiver of Respondent's right to hearing, entry of
default, admittance of allegations, and implied withdrawal and
dismissal of Respondent's request for hearing.'' Order Terminating
Proceedings, dated October 23, 2024, at 1-2. Although Respondent was
granted two extensions of time to submit his Prehearing Statement, the
Order Terminating Proceedings states, Respondent ``failed to so
submit'' and ``supplied no good cause for his failure.'' Id. at 2. The
Order terminates the proceedings after deeming that Respondent waived
his right to a hearing and is in default. Id. at 3 (citing 21 CFR
1301.43(c)(1) and (e)).
Later on the day of October 23, 2024, Respondent filed his ``Motion
for Leave and Request for Reconsideration of Termination of Proceedings
and Reinstatement of Proceedings Filed for Good Cause'' (Motion for
Leave). Respondent's Motion for Leave does not include a Prehearing
Statement, but states that he ``will also file his Prehearing Statement
to the best of his ability despite genuine and real problems that
Respondent's counsel has experienced that led to the delay and the
Judge's order terminating the proceedings against Respondent.'' Motion
for Leave, at 1.
According to the Motion for Leave, the ``issue'' is whether
``Respondent can prove that his delay and failure to file the
prehearing statement as ordered by the ALJ was not due to neglect or
malfeasance but was based on legitimate circumstances beyond counsel
for Respondent's control.'' Id. The ``issue'' portion of the brief also
states that it would be ``unfair'' to Respondent, ``given the totality
of the circumstances and the immediate and sudden impact of the ALJ's
order terminating the proceedings,'' not to allow Respondent to
``present evidence in this proceeding.'' Id. at 1-2. Further, however,
the Motion for Leave states that Respondent's counsel ``would be able
to file an appropriate Prehearing Statement, despite the deficiencies
laid out . . . with respect to the records and timeliness of an
expert's retention which would assist the Government in its case.'' Id.
at 5; infra sections II.E. and II.F.
Broadly configured, Respondent's Motion for Leave makes five
points. First, it states that the Order to Show Cause ``arises from a
criminal investigation involving an active case in the Eastern District
of Texas,'' that Respondent ``is also the subject of a target letter
and criminal investigation involving others,'' and that the
investigation of Respondent has been going on for ``at least'' four to
five years. Motion for Leave, at 2. Second, according to the Motion for
Leave, Respondent's counsel ``is and has been quite ill, with at that
time an undiagnosed systemic infection throughout his body which
targeted the skin'' and which ``has made Respondent tired and has
forced him to work from home for the last few months.'' Id. at 2-3.
Further, ``[g]iven the unknown cause of . . . [his symptoms], counsel
for Respondent was concerned that his underlying issue may be
contagious.'' Id. at 3. Respondent's counsel ``was able to obtain an
appointment with a specialist for the morning of'' October 22, 2024.
Id. As Respondent and his counsel were scheduled to attend a ``reverse
proffer presented by the Assistant United States Attorneys (AUSAs)
handling the criminal investigation'' on that day, Respondent and his
counsel contacted the AUSAs ``with sufficient notice and in advance of
the meeting to inform them'' of Respondent's counsel's illness and
specialist appointment. Id. The AUSAs, ``without hesitation,''
rescheduled their meeting and ``wished counsel a successful physician
visit and a rapid recovery.'' Id.
Third, the Motion for Leave states that Respondent's counsel had
been ``attempting to retain co-counsel due to Respondent's counsel's
health issues,'' but was not successful at the time. Id. Fourth, the
Motion for Leave states that Respondent's counsel, ``over the last few
days,'' ``prepared and assembled a `Complaint and Request for
Declaratory and Injunctive Relief.' '' Id. Respondent's counsel
attached the ten-page ``Complaint and Request for Declaratory and
Injunctive Relief'' to the Motion for Leave. Id. at 11-20. The Motion
for Leave explains that, when he tried to file ``this petition as he
planned'' on the morning of October 23, 2024, Respondent's counsel, who
is ``primarily a healthcare lawyer who does not practice in federal
court with regularity,'' learned that his Pacer account was no longer
active and, therefore, he could not file the Complaint.\11\ Id.
According to Respondent's counsel, ``Based on the relief requested in
the petition, and the orders rendered to the co-Respondents['] similar
suits, all orders of this court would have been rendered stayed and the
Order Terminating the Proceedings without standing.'' Id. The Motion
for Leave says nothing else about this assertion. Id.
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\11\ Respondent's counsel attached to the Motion for Leave three
emails between him and the ``NextGen CM/ECF'' or PACER showing his
efforts to gain PACER access. Motion for Leave, at 8-10. The times
on the three emails are in the afternoon, between 1:41 p.m. and 3:12
p.m., on October 23, 2024. Id.
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Finally, the Motion for Leave states that Respondent's counsel,
because he was not able to ``obtain . . . [co-counsel] assistance'' and
``work efficiently and for a full day without exhaustion,'' ``found
himself behind and honestly did not recognize the court's 1:00 p.m.
deadline, but rather the date the motions and statements were due.''
\12\ Id. at 3-4. It states that Respondent's counsel was ``overloaded
and non-compliant with the ALJ's very specific order'' due to the
``departure of three attorneys who had been with the firm for ten years
or longer,'' causing
[[Page 40654]]
``administrative chaos and scheduling difficulties.'' \13\ Id. at 4.
Respondent's counsel ``denies that it was with disrespect or improper
intent to the ALJ and the proceeding'' that he missed the Prehearing
Statement deadline. Id. According to the Motion for Leave, Respondent's
counsel ``believes'' that the ``factual bases'' in the brief about his
being ``overloaded and non-compliant'' with the ALJ's ``very specific
order'' are ``sufficient to give the ALJ information to reconsider his
order terminating the proceedings.'' He also states that he is
``willing to supply statements from his treating physicians which
substantiate [the] . . . disease process.'' Id. at 5. The Motion for
Leave states, seeming to summarize the thrust of its argument, that
``[h]ealth concerns happen and it would be unfair to Respondent to
terminate his rights due to no fault of his own.'' Id. at 5.
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\12\ The Motion for Leave also states that Respondent's
insurance company has ``yet to approve his claim for coverage'' and
``as such, Respondent is unable to hire an expert witness to testify
after he rendered a consulting opinion.'' Motion for Leave, at 4. It
states that ``the records for each patient referenced in the
petition by the DEA in most cases triple the size of the files/
records noticed as reviewed by the Government's expert in
conjunction with his opinion.'' Id. The Motion for Leave asks why
the government's expert does not ``mention that he was opining on
partial treatment records that were missing service dates both
before and after'' the dates alleged in the OSC. It further states
that ``tracking . . . down and obtaining . . . the statement'' of
the ``patients . . . alleged to have not experienced benefit due to
treatment . . . has proved timely, especially coupled with
Respondent's counsel's recent health experience.'' Id.
\13\ The Motion for Leave also ``grant[s]'' that ``counsel took
on more than he should have, but it is arguably a lawyer's nature to
think they can accomplish more than may be reasonable given the
circumstances.'' Motion for Leave, at 5.
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The ALJ issued his ``Order Denying Respondent's Motion for Leave
and Request for Reconsideration of Termination of Proceedings and
Reinstatement of Proceedings Filed for Good Cause'' on October 24, 2024
(Order Denying Motion for Leave), appropriately rejecting Respondent's
Motion for Leave. Infra sections II.E. and II.F. The Order Denying
Motion for Leave acknowledges the points in Respondent's Motion for
Leave, including its assertions that the failure to file a timely
Prehearing Statement was not due to neglect or malfeasance, but to
legitimate circumstances beyond Respondent's control, that Respondent's
counsel is and has been quite ill, that Respondent's counsel had to
reschedule a conference with the prosecutors in the parallel criminal
investigation of Respondent, that Respondent's counsel researched,
prepared, and assembled, ``over the last few days,'' a complaint for
Declaratory and Injunctive Relief that ``would render `all orders of
[this tribunal] . . . stayed and the Order Terminating Proceedings
without standing,' '' and that Respondent's counsel ``did not recognize
the court's 1:00 p.m. deadline.'' Order Denying Motion for Leave, at 1-
2. The Order Denying Motion for Leave finds that the Motion for Leave
does not establish the requisite ``good cause,'' and does not include
Respondent's Prehearing Statement. Id. at 2. It highlights that
Respondent's counsel admits to engaging in multiple work efforts during
the period leading up to the Prehearing Statement deadline, ``all while
seemingly entirely neglecting these administrative proceedings and the
directions'' of the ALJ. Id.
E. Application of the Rule to Respondent's Prehearing Proceedings
Conduct
The record clearly shows that Respondent repeatedly failed to
comply with the ALJ's scheduling Orders. Supra section II.D. The Agency
concludes that the content of each of the ALJ's Orders is well within
the ALJ's powers and duties, and that the Orders support the conduct of
a fair hearing, avoid delay, and maintain order. Supra sections II.B.
and II.C.
Further, the Agency finds unequivocal and uncontroverted record
evidence that, in addition to the OSC, the ALJ's Orders repeatedly
include avisos to Respondent of the possible sanctions for failure to
comply. Supra section II.D. More specifically, the Agency finds
unequivocal and uncontroverted record evidence that the ALJ's avisos
warn that possible consequences of failure to comply with his Orders
include waiver of a hearing, entry of default, and OSC allegations
being deemed admitted. Id.
F. Legal Analysis of the Application of the Default Rule in This Matter
As already discussed, the Agency cited Kamir Garces-Mejias, M.D., a
2007 Agency decision, in the final rule. In Kamir Garces-Mejias, M.D.,
the Agency agreed with the ALJ that respondent had not shown good cause
for her failure to comply with the ALJ's Prehearing Statement filing
Order. 72 FR at 54932-33. In other words, for about fifteen years
before the formal premiere of the current default rule, the Agency was
supporting ALJs' prerogatives to use their statutorily granted power
and duties to ensure fair, efficient, and orderly hearings. Supra,
sections II.B. and II.C. The Agency concludes that this prior Agency
decision, among others, supports the ALJ's actions in this matter.
The Agency also examines relevant Supreme Court and Circuit Court
case law, including decisions applying ``good cause'' in missed
deadline-related situations. Although, as expected, the Agency found no
appellate decisions precisely on point, there are several that are
quite instructive. The Agency looks to these Article III decisions to
guide its application of ``good cause.''
The Supreme Court issued a decision in 1993 reaffirming its holding
in ``other contexts'' that ``clients must be held accountable for the
acts and omissions of their attorneys.'' Pioneer Investment Services
Co. v. Brunswick Assocs. Ltd, P'ship., 507 U.S. 380, 396 (1993). In
addition to stating that this holding applies in ``other contexts,''
the Court explains that ``[a]ny other notion would be wholly
inconsistent with our system of representative litigation, in which
each party is deemed bound by the acts of his lawyer-agent and is
considered to have `notice of all facts, notice of which can be charged
upon the attorney.' '' Id. at 397 (citing Link v. Wabash R. Co., 370
U.S. 626, 633-34 (1962)). The Supreme Court concludes that ``a client
may be made to suffer the consequence of dismissal of its lawsuit
because of its attorney's failure to attend a scheduled pretrial
conference.'' 507 U.S. at 396. Accordingly, the Agency rejects
Respondent's argument that he should not suffer the consequence of his
attorney's having missed the third deadline for filing his Prehearing
Statement. Motion for Leave, at 1-2.
While, again, the Agency found no Fifth Circuit decision exactly on
point, the Agency researched Fifth Circuit decisions interpreting the
scope of ``good cause'' in the contexts of a missed litigation
deadline, a failure to comply with a scheduling order, and the like, to
conduct another level of analysis for this adjudication. In Texas
Indigenous Council v. Simpkins, for example, the Fifth Circuit
explained, in the context of Federal Rule of Civil Procedure 16, that
``good cause'' requires a party to show that a deadline ``cannot
reasonably be met despite the diligence of the party needing the
extension.'' 544 F. App'x. 418, 420 (5th Cir. 2013) (citing S & W
Enters., L.L.C. v. Southtrust Bank of Ala., 315 F.3d 533, 535 (5th Cir.
2003)). In this adjudication, Respondent's Motion for Leave shows the
opposite when, despite its listing of personal, health, and
professional commitment challenges, it recites the legal work
Respondent's counsel did accomplish ``over the last few days''
immediately before the third ALJ-ordered Prehearing Statement deadline.
Those listed work accomplishments include contacting AUSAs and
negotiating the rescheduling of a ``reverse proffer,'' and researching,
preparing, and assembling a ``Complaint and Request for Declaratory and
Injunctive Relief '' related to this matter. Motion for Leave, at 2-3.;
supra section II.D. In other words, Respondent's Motion for Leave
demonstrates that the ALJ's already thrice ordered Prehearing Statement
deadline could reasonably have been met had Respondent's counsel not
chosen to prioritize other matters, the apparently more time-consuming
one of
[[Page 40655]]
which had no ALJ- or Court-ordered deadline. Supra section II.D.
There are many contexts in which the Fifth Circuit rejected
attempts to demonstrate ``good cause'' for extensions of time sought
after a deadline had passed. For example, in In re OHT Hawk AS v.
Offshore Heavy Transport AS, the Fifth Circuit found that ``good
cause'' did not excuse the late filing of a claim because notice of the
deadline was published in a Harrison County, Mississippi newspaper and
the claimant lived in New Orleans, Louisiana, ``just over seventy
miles'' away and in ``adjacent metropolitan regions.'' 2022 WL 1486778,
at *3 (5th Cir. 2022). Here, Respondent does not claim, or even
suggest, that he did not have actual notice of the ALJ-ordered
Prehearing Statement filing deadline that Respondent's counsel de-
prioritized for other legal work. After all, other than the first
missed deadline, the deadlines that Respondent ignored were set as a
result of Respondent's request for an extension of the ALJ's original
Prehearing Statement filing deadline. Supra section II.D (Respondent's
Motion for Time Extension). The Fifth Circuit found that claimant in In
re OHT Hawk AS failed to show ``good cause'' when notice was publicized
in the press, ``just over seventy miles'' away and in ``adjacent
metropolitan regions,'' and not directly to the claimant. Similarly,
the Fifth Circuit's analysis would conclude here that Respondent failed
to show ``good cause'' for failing to meet the first extended
Prehearing Statement filing deadline that he himself obtained from the
ALJ, as well as the subsequent deadline that the ALJ unilaterally
afforded him.
By way of further example, in T.O., a child; Terrence Outley, et
al. v. Fort Bend Independent School District, 2 F.4th 407 (5th Cir.
2021), cert. denied, 142 S.Ct. 2811 (2022), the Fifth Circuit addressed
whether there was good cause to excuse the plaintiffs' failure to
submit a timely amendment to their complaint.\14\ 2 F.4th at 418. The
Fifth Circuit's analysis was done in the context of Federal Rule of
Civil Procedure 15(a)(2)'s provision that ``[t]he court should freely
give leave when justice so requires,'' and of Federal Rule of Civil
Procedure 16(b)'s provision that a ``schedule may be modified only for
good cause and with the judge's consent.'' Id.
---------------------------------------------------------------------------
\14\ Plaintiffs-Appellants had already filed an amended
complaint, but it did not include the further factual allegations
that they sought to include in a second amended complaint. 2 F.4th
at 418.
---------------------------------------------------------------------------
In In re T.O., the Fifth Circuit examined the matters that the
Plaintiffs-Appellants sought to add to their second amended complaint
and concluded that the Plaintiffs-Appellants knew those matters when
they filed their original complaint. Id. Accordingly, the Fifth Circuit
ruled that the Plaintiffs-Appellants did not show good cause to support
their filing a second amended complaint because, ``[s]imply put, it is
difficult to conceive of a reason why Plaintiffs-Appellants would not
have been able to amend their complaint to include these various
allegations in a timely manner.'' Id. Similarly, in the instant matter,
Respondent is not claiming that he did not receive the ALJ's Orders
setting the deadlines for the filing of his Prehearing Statement, one
of which he, himself, instigated with his Motion for Time
Extension.\15\ Supra section II.D. Rather, the best Respondent offers
is to assert that he ``will also file his Prehearing Statement to the
best of his ability;'' but he never did. Respondent's Motion for Leave,
at 1.
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\15\ Respondent's Motion for Leave states that his counsel
``honestly did not recognize the court's 1:00 p.m. deadline [to file
his Prehearing Statement], but rather the date the motions and
statements were due.'' Motion for Leave, at 4. The Agency notes,
however, that, despite this statement and others in his Motion for
Leave, Respondent did not file his Prehearing Statement with his
Motion for Leave as the ALJ's Order Directing Compliance requires.
Order Directing Compliance, at 2.
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In sum, the Agency finds that the ALJ faithfully carried out his
duties and acted within his statutorily granted powers leading up to,
and concluding in, his entry of his Order Denying Motion for Leave. He
afforded Respondent three deadlines to file a Prehearing Statement. Not
only did Respondent never file a Prehearing Statement, his asserted
``good cause'' bases for failing to do so are belied by the tasks that
Respondent's attorney admits to completing instead of the Prehearing
Statement in the days before the third, and final, Prehearing Statement
deadline. The Agency concludes that the ALJ did not err in finding that
Respondent waived his right to a hearing, in ruling that Respondent was
in default, and in ordering the termination of proceedings.
III. The CSA and the Texas Physician Standard of Practice
The main objectives of the CSA, according to the Supreme Court, are
to ``conquer drug abuse and to control the legitimate and illegitimate
traffic in controlled substances.'' Gonzales v. Raich, 545 U.S. 1, at
12 (2005). Given these objectives, the Supreme Court states, particular
congressional concerns included ``the need to prevent the diversion of
drugs from legitimate to illicit channels.'' Id. at 12-13. Further,
according to the Supreme Court, to accomplish these goals in the CSA,
``Congress devised a closed regulatory system making it unlawful to . .
. dispense[ ] or possess any controlled substance except in a manner
authorized by'' the statute.\16\ Id. at 13. Accordingly, the Supreme
Court states, the ``CSA and its implementing regulations set forth
strict requirements regarding registration . . . and recordkeeping.''
Id. at 14.
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\16\ 21 U.S.C. 841(a)(1) (``Under the CSA, it is ``unlawful for
any person knowingly or intentionally . . . to . . . distribute[ ]
or dispense, or possess with intent to . . . distribute[ ] or
dispense, a controlled substance'' ``[e]xcept as authorized'' by the
Act.). The CSA defines ``dispense'' to include ``prescribing'' a
controlled substance. 21 U.S.C. 802(10).
---------------------------------------------------------------------------
As for a practitioner, such as Respondent, a medical doctor,
``[t]he Attorney General shall register practitioners . . . to dispense
. . . controlled substances . . . if the applicant is authorized to
dispense . . . controlled substances under the laws of the State in
which he practices.'' 21 U.S.C. 823(g)(1). The section further provides
that an application for a practitioner's registration may be denied
upon a determination that ``the issuance of such registration . . .
would be inconsistent with the public interest.'' Id. Congress directed
the Attorney General to consider five factors in making the public
interest determination. 21 U.S.C. 823(g)(1)(A-E).\17\ It also directed
the Attorney General to consider the same five factors when determining
whether to suspend or revoke the registration of a practitioner, such
as Respondent, due to the practitioner's commission of ``such acts as
would render his registration under . . . [21 U.S.C. 823] inconsistent
with the public interest.'' 21 U.S.C. 824(a)(4), infra section VI.A.
---------------------------------------------------------------------------
\17\ The five factors of 21 U.S.C. 823(g)(1)(A-E) are:
(A) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(B) The [registrant's] experience in dispensing, or conducting
research with respect to controlled substances.
(C) The [registrant's] conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(D) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(E) Such other conduct which may threaten the public health and
safety.
---------------------------------------------------------------------------
According to the CSA's implementing regulations, a lawful
controlled substance order or prescription is one that is ``issued for
a legitimate medical purpose by an individual practitioner acting in
the usual course of his
[[Page 40656]]
professional practice.'' 21 CFR 1306.04(a). As the Supreme Court
explained in the context of the Act's requirement that Schedule II
controlled substances may be dispensed only by written prescription,
``the prescription requirement . . . ensures patients use controlled
substances under the supervision of a doctor so as to prevent addiction
and recreational abuse . . . [and] also bars doctors from peddling to
patients who crave the drugs for those prohibited uses.'' Gonzales v.
Oregon, 546 U.S. 243, 274 (2006), see also United States v. Hayes, 595
F.2d 258 (5th Cir.), cert. denied, 444 U.S. 866 (1979).
The OSC is addressed to Respondent at his registered address in
Texas. Therefore, the Agency also evaluates Respondent's actions
according to Texas law, including the applicable Texas physician
standard of care. Gonzales v. Oregon, 546 U.S. at 269-71. As the
posture of this matter is Respondent's default and, therefore, there
was no opportunity for the parties to litigate legal theories not in
the OSC, the Agency confines its analysis of Texas law to the legal
provisions cited in the OSC.
According to Texas law applicable during the time period alleged in
the OSC, a ``practitioner . . . may not prescribe, dispense, [or]
deliver . . . a controlled substance . . . except for a valid medical
purpose and in the course of medical practice.'' Tex. Health and Safety
Code Ann. Sec. 481.071(a) (2025).\18\ Texas law elaborates on the
meaning of a ``valid medical purpose'' and ``in the course of medical
practice.'' For example, Texas law states that the ``treatment of pain
is a vital part of the practice of medicine,'' that ``[p]hysicians
should be able to treat their patients' pain using sound clinical
judgment without fear . . . [of] disciplinary action,'' and that
``[s]ound clinical judgment results from the use of generally accepted
standards of care, which include evidence-based medicine, when
available.'' 22 Tex. Admin. Code Sec. 170.1 (2016-2020). ``[T]o
protect the public and give guidance to physicians,'' this Texas
authority continues, it ``sets forth minimum requirements related to
the proper treatment of pain.'' Id. For example, it states that a
``license to practice medicine gives a physician legal authority to
prescribe drugs for pain,'' and the ``duty'' to ``help, and not to harm
patients and the public.'' Id. Sec. 170.1(3). The provision elaborates
further, stating that ``[h]arm can result when a physician does not use
sound clinical judgment in using drug therapy,'' such as either causing
the patient to suffer continued pain if the drug therapy is not
sufficient, or ``lead[ing] to or contribut[ing] to abuse, addiction,
and/or diversion of drugs.'' Id. Sec. 170.1(4).
---------------------------------------------------------------------------
\18\ This Texas authority was not amended during the time period
alleged in the OSC.
---------------------------------------------------------------------------
Texas law further specifies that the ``extent of medical records
must be legible, complete, accurate and current for each patient,'' and
that the treatment of chronic pain ``requires a reasonably detailed and
documented plan to assure that the treatment is monitored and evaluated
on an ongoing basis.'' \19\ Id. Sec. 170.1(5) and (6). In sum, the
``intent'' of these provisions is to ``set forth those items expected
to be done by any reasonable physician involved in the treatment of
pain.'' Id. Sec. 170.1(7).
---------------------------------------------------------------------------
\19\ The definition of ``chronic pain'' changed during the
period covered by the OSC. 22 TAC Sec. 170.2. The first definition
during the relevant time period was ``a state in which pain persists
beyond the usual course of an acute disease or healing of an injury.
Chronic pain may be associated with a chronic pathological process
that causes continuous or intermittent pain over months or years,''
(eff. through July 12, 2020). It changed to ``pain that is not
relieved with acute, post-surgical, post-procedure, or persistent
non-chronic pain treatment parameters and persists beyond the usual
course of an acute condition typically caused by, or resembling that
caused by, actual or potential tissue injury or trauma, disease
process, or operative procedure or the healing or recovery of such
condition with or without treatment. This type of pain is associated
with a chronic pathological process that causes continuous or
intermittent pain for no less than 91 days from the date of the
initial prescription for opioids,'' (eff. through Jan. 18, 2025).
These changes do not impact this Decision/Order.
---------------------------------------------------------------------------
In another provision, Texas law sets out ``minimum requirements for
the treatment of chronic pain'' that, along with compliance with the
generally accepted standard of care, are how the physician's treatment
of a patient's pain will be evaluated.\20\ Id. Sec. 170.3. Those
``minimum requirements'' include evaluating the patient by obtaining a
medical history and a physical examination ``that includes a problem-
focused exam specific to the chief presenting complaint of the
patient.'' Id. Sec. 170.3(1)(A). They state that a ``medical record
shall document the medical history and physical exam,'' and, in the
case of chronic pain, must document the ``nature and intensity of the
pain,'' ``current and past treatments for pain,'' ``underlying or
coexisting diseases and conditions,'' the ``effect of the pain on
physical and psychological function,'' ``any history and potential for
substance abuse or diversion,'' and the ``presence of one or more
recognized medical indications for the use of a dangerous or scheduled
drug.'' Id. Sec. 170.3(1)(B).
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\20\ During the time period addressed in the OSC, 22 Tex. Admin.
Code Sec. 170.3 was amended several times. Those amendments,
elaborating on existing minimum requirements for the treatment of
chronic pain, do not impact this Decision/Order.
---------------------------------------------------------------------------
Further, the Texas minimum requirements for physicians' treatment
of chronic pain under Texas law explicitly include having a written
treatment plan that addresses specified elements and that is documented
in the medical record; obtaining and documenting the patient's informed
consent for the use of controlled substances for chronic pain
treatment; and having a written pain management agreement with the
patient that covers patient responsibilities regarding physician-
ordered laboratory tests, physician-limited refills, and the
involvement of only one physician and one pharmacy for the drug
dispensing, and that states the reasons why the drug therapy may be
terminated. Id. Sec. 170.3(2), (3), and (4). Texas law's minimum
requirements for physicians treating chronic pain also include the
physician's seeing the patient for periodic reviews at ``reasonable
intervals,'' during which the physician assesses progress toward
treatment objectives and contemporaneously documents, in the medical
record, the visit and any adjustments to the treatment plan. Id. Sec.
170.3(5)(A-D). The minimum requirements in Texas law also state that a
physician treating chronic pain must base any continuation or
modification of the use of ``dangerous and scheduled drugs for pain
management'' on an ``evaluation of progress toward treatment
objectives.'' Id. Sec. 170.3(5)(E). They specifically address how the
physician is to evaluate the patient's progress toward treatment
objectives, requiring that progress or the lack of progress in
relieving pain ``must be documented in the patient's record,'' stating
that ``[s]atisfactory response to treatment'' may be indicated by the
``patient's decreased pain, increased level of function, and/or
improved quality of life,'' calling for the physician to monitor
``[o]bjective evidence'' of the patient's improved or diminished
function, including information ``offered or provided'' by family
members or other caregivers, and requiring the physician to ``reassess
the current treatment plan and consider the use of other therapeutic
modalities'' if the patient's progress is unsatisfactory. Id. Sec.
170.3(5)(E)(i-iv). The physician's evaluation of progress toward
treatment objectives, according to the Texas minimum requirements, must
also involve reviewing the ``patient's compliance with the prescribed
treatment plan and reevaluat[ing] for
[[Page 40657]]
any potential for substance abuse or diversion.'' Id. Sec.
170.3(5)(E)(v).
Finally, the Texas minimum standards also address ``consultation
and referral'' and ``medical records.'' Regarding ``consultation and
referral,'' Texas law states, among other things, that patients ``who
are at-risk for abuse or addiction require special attention,'' and
that patients ``with chronic pain and histories of substance abuse or
with co-morbid psychiatric disorders require even more care.'' Id.
Sec. 170.3(6). According to the Texas minimum standards, a ``consult
with or referral to an expert in the management of such patients must
be considered in their treatment.'' Id.
Texas law has a separate provision addressing medical records.\21\
Id. Sec. 165.1. According to that provision, a licensed physician
shall maintain an ``adequate medical record'' for each patient that is
complete, contemporaneous, and legible. Id. Sec. 165.1(a). The
statement of the standards that an ``adequate medical record'' should
meet, as particularly applicable to this adjudication, includes the
date of the encounter, documentation of the patient's noncompliance,
identification of relevant risk factors, and written consents for
treatment. Id. Sec. 165.1(a)(1)(D), (a)(4), (a)(5), and (a)(7).
---------------------------------------------------------------------------
\21\ The amendments made to this Texas law section during the
period covered by the OSC do not impact this Decision/Order.
---------------------------------------------------------------------------
IV. The Deemed-Admitted Facts
As Respondent defaulted, he is deemed to admit the facts alleged in
the OSC. 21 CFR 1301.43; supra section II.C. Accordingly, the Agency
finds, due to Respondent's deemed admissions, the OSC-alleged facts to
be uncontroverted and proven unequivocally, as follows:
1. Respondent is registered with the Agency as a practitioner
authorized to handle controlled substances in Schedules II through V
under Certificate of Registration No. BK4924139. OSC, at 3;
2. Respondent is a licensed physician under Texas license number
K0506. Id.;
3. From at least January 2016 through July 2020, Respondent issued
numerous prescriptions for Schedule II through IV controlled
substances, but:
a. failed to conduct or document adequate patient evaluations and
histories necessary to establish a medical diagnosis justifying the
necessity for the prescriptions,
b. failed to monitor patient progress adequately, and
c. prescribed dangerous combinations of controlled substances.
Id.
4. As for individual L.G., on a near monthly basis between at least
August 26, 2016, and July 1, 2020, Respondent issued prescriptions for
oxycodone 30 mg (a Schedule II opioid) and methadone 10 mg (a Schedule
II opioid) although he failed to establish a medical condition
sufficient to support the long-term use of opiates by, among other
things,
a. Failing to establish an objective diagnosis adequately supported
by physical examination, history of present illness, past medical
history, or imaging to medically justify the continued prescribing of
controlled substances. Id. at 3-4;
b. Continuing to prescribe a Morphine Milligram Equivalent (MME) as
high as 680;
c. Treating L.G. for several years despite L.G.'s not showing
clinical signs of functional improvement or reduction in pain,
illustrating a failed opioid regime;
d. Failing to address adequately, and assess, L.G.'s aberrant
behaviors, such as inconsistent urine drug screens and illicit drug
use;
e. Failing to address adequately L.G. co-morbidities, including
hypertension, altered mental status, and insomnia;
f. Prescribing a dangerous combination of methadone, oxycodone, and
Ambien for L.G., thus increasing L.G.'s risk of opioid harm.
Id. at 4.
5. As for individual E.C., on a near monthly basis between at least
January 18, 2016, and June 1, 2020, Respondent issued multiple
prescriptions for hydromorphone 8 mg (a Schedule II opioid), oxycodone
60 mg (a Schedule II opioid), morphine 30 mg (a Schedule II opioid),
and carisoprodol (a Schedule IV muscle relaxant) although he failed to
establish a medical condition sufficient to support the long-term use
of opiates by, among other things,
a. Failing to establish an objective diagnosis adequately supported
by physical examination, history of present illness, past medical
history, or imaging to justify medically the continued prescribing of
controlled substances;
b. Continuing to prescribe a MME as high as 312;
c. Treating E.C. for several years despite E.C.'s not showing
clinical signs of functional improvement or reduction in pain. Id.;
d. Failing to address adequately E.C's aberrant behaviors, such as
at least four inconsistent urine drug screens;
e. Failing to address adequately E.C. co-morbidities, such as
depression, anxiety, and pulmonary status;
f. Failing to address adequately, and assess, E.C.'s aberrant
behaviors, such as clear indications of abuse and past overdoses and
inability to self-administer medications;
g. Failing to address adequately with E.C. the risks associated
with long-term opioid use;
h. Failing to maintain adequate medical charts related to the
treatment of E.C.;
i. Prescribing for E.C. a combination of opioids, a benzodiazepine,
and a muscle relaxant, specifically carisoprodol, constituting a
highly-addictive ``drug cocktail'' known as the ``Holy Trinity,''
putting E.C. at increased risk for harm, including overdose or death.
Id. at 5.
6. As for individual D.S., on a near monthly basis between at least
October 19, 2016, and July 17, 2020, Respondent issued multiple
prescriptions for controlled substances hydromorphone 4 mg and fentanyl
25 mg (a Schedule II opioid) although he failed to establish a medical
condition sufficient to support the long-term use of opiates by, among
other things,
a. Failing to establish an objective diagnosis adequately supported
by physical examination, history of present illness, past medical
history, or imaging to justify medically the continued prescribing of
controlled substances. Id. at 5-6;
b. Continuing to prescribe an MME as high as 156;
c. Treating D.S. for several years despite D.S.'s not showing
clinical signs of functional improvement or reduction in pain;
d. Failing to address adequately, and assess, D.S.'s aberrant
behaviors, such as at least four inconsistent urine drug screens;
e. Failing to address adequately D.S. co-morbidities, including
hypertension, altered mental status, and insomnia;
f. Failing to maintain adequate medical charts related to the
treatment of D.S., specifically, detailing office visits and
evaluations with D.S. when no such visits occurred; and
g. Prescribing a combination of opioids, a benzodiazepine, and a
muscle relaxant, specifically carisoprodol, the Holy Trinity drug
cocktail, putting D.S. at increased risk for harm, including overdose
or death. Id. at 6.
7. The independent medical expert with whom the Government
consulted about Respondent's medical files concluded that Respondent's
issuance of the above-described controlled substance prescriptions
``fell outside the standard of care applicable to the
[[Page 40658]]
practice[ ] of . . . medicine in the State of Texas.''
Given these ``deemed-admitted'' facts due to Respondent's default,
the Agency now determines whether they constitute a prima facie case
that Respondent's continued registration is inconsistent with the
public interest. OSC, at 1. The Agency conducts this analysis based on
the federal and Texas law applicable during the timeframe of
Respondent's OSC-alleged violations: January 2016 through July 2020.
Id. at 3; see also id. at 4, 5; supra section III.
V. Allegation That Respondent Illegally Prescribed Controlled
Substances
According to the OSC, Respondent ``issued numerous prescriptions
for Schedule II-IV controlled substances outside the course of
professional practice and not for a legitimate medical purpose.'' OSC,
at 3. The facts deemed admitted due to Respondent's default establish
that Respondent violated multiple provisions of the applicable Texas
standard of practice and, thus, that he prescribed controlled
substances outside the course of professional practice and not for a
legitimate medical purpose. 21 CFR 1306.04(a). For example, under Texas
law, a ``practitioner . . . may not prescribe . . . a controlled
substance . . . except for a valid medical purpose and in the course of
medical practice.'' Tex. Health and Safety Code Ann. Sec. 481.071(a).
Further, according to Texas law, a physician is to use ``sound clinical
judgement,'' resulting from the use of ``generally accepted standards
of care,'' in prescribing controlled substances, so that patients use
those substances in a ``therapeutic manner'' to ``relieve'' pain, and
so that the physician uses his medical licenses to ``help, and not to
harm patients and the public.'' 22 TAC Sec. 170.1.
The deemed-admitted facts establish that Respondent prescribed
``dangerous combinations'' of controlled substances to three persons,
thus increasing the risk of harm to them and to the public. OSC, at 4-
6. Also pursuant to the deemed-admitted facts, Respondent continued to
prescribe controlled substances to three persons for ``several years''
even though the drug therapies he prescribed did not bring about signs
of functional improvement or reduction of pain for any of them. For the
above reasons, the Agency concludes that Respondent violated applicable
Texas law on all of these occasions.
In addition, the applicable Texas standard of practice states that
the physician is responsible for obtaining and documenting a medical
history and a physical examination that includes a problem-focused exam
specific to the chief presenting complaint, and that the rationale for
and results of diagnostic and other ancillary services should be
included in the medical record. 22 TAC Sec. 165.1(a), see id.
170.3(1)(B) (Minimum Requirements for the Treatment of Chronic Pain).
According to the deemed-admitted facts, though, Respondent failed to
establish an adequately supported diagnosis to justify the prescribing
of controlled substances for three persons. OSC, at 3-5. As such, the
Agency concludes that Respondent's failures are a violation of the
applicable Texas standard of practice.
Also, the applicable Texas standard of practice requires that, to
be considered an ``adequate medical record,'' the medical record
includes the date of the patient encounter. 22 TAC Sec.
165.1(a)(1)(D). The deemed-admitted facts establish, though, that
Respondent's medical records for D.S. ``detail[ ] office visits and
evaluations . . . when no such visits occurred.'' Id. at 6; see also
OSC, at 5 (``inadequate medical chart'' for E.C.). Accordingly, the
Agency concludes that, under Texas law, Respondent's medical record
about a visit that never occurred is not an ``adequate medical record''
and, therefore, that Respondent violated applicable Texas law.
By way of further example, the applicable Texas standard of
practice states that the minimum requirements for a physician's
treatment of chronic pain include obtaining and documenting the
patient's informed consent for the use of controlled substances. 22 TAC
Sec. 170.3(3). The deemed-admitted facts, however, establish that
Respondent failed to address adequately with E.C. the risks of long-
term opioid use. OSC, at 5. The Agency thus concludes that Respondent
violated the applicable Texas standard of practice concerning informed
consent.
Also, according to the Texas minimum requirements, a physician's
continuation of the use of scheduled drugs for pain management must be
based on an evaluation of progress toward treatment objectives and must
be reevaluated periodically for any potential for substance abuse or
diversion. 22 TAC Sec. 170.3(5). The deemed-admitted facts, however,
establish that three individuals for whom Respondent prescribed
controlled substances for several years showed no functional
improvement or reduction in pain, and that the three individuals
exhibited aberrant behaviors, such as multiple inconsistent urine drug
screens, indications of abuse, and illicit drug use. OSC, at 4-6. Thus,
the Agency concludes that Respondent violated the applicable Texas
minimum requirements for controlled substance prescribing on multiple
occasions.
In sum, based on the deemed-admitted facts and applicable law, the
Agency concludes that Respondent prescribed controlled substances on
multiple occasions outside the course of professional practice and not
for a legitimate medical purpose and, thus, in violation of applicable
law. 21 CFR 1306.04(a); Tex. Health and Safety Code Ann. Sec. 481.071;
22 TAC Sec. Sec. 170.1, 170.3, 165.1.
VI. Discussion
A. The CSA and the Public Interest Factors
As already discussed, Congress directed the Attorney General to
consider five factors in making the determination of whether to suspend
or revoke a registration due to the registrant's commission of such
acts as would render his registration inconsistent with the public
interest. 21 U.S.C. 824(a)(4), supra section II.A., supra n. 17 (public
interest factors). The five factors are considered in the disjunctive.
Gonzales v. Oregon, 546 U.S. at 292-93 (Scalia, J., dissenting) (``It
is well established that these factors are to be considered in the
disjunctive,'' citing In re Arora, 60 FR 4447, 4448 (1995)); Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003). Each factor is weighed on a
case-by-case basis. Morall v. Drug Enf't Admin., 412 F.3d 165, 173-74
(DC Cir. 2005). Any one factor, or combination of factors, may be
decisive. Penick Corp. v. Drug Enf't Admin., 491 F.3d 483, 490 (DC Cir.
2007); Morall, 412 F.3d at 185 n.2; David H. Gillis, M.D., 58 FR 37507,
37508 (1993).
The Agency ``may rely on any one or a combination of factors and
may give each factor the weight [it] deems appropriate. Morall, 412
F.3d at 185 n.2; see also Jones Total Health Care Pharmacy, LLC v. Drug
Enf't Admin., 881 F.3d 823, 830 (11th Cir. 2018) (citing Akhtar-Zaidi
v. Drug Enf't Admin., 841 F.3d 707, 711 (6th Cir. 2016)); MacKay v.
Drug Enf't Admin., 664 F.3d 808, 816 (10th Cir. 2011); Volkman v. U.S.
Drug Enf't Admin., 567 F.3d 215, 222 (6th Cir. 2009); Hoxie v. Drug
Enf't Admin., 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while the
Agency is required to consider each of the factors, it ``need not make
explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting
Volkman, 567 F.3d at 222); see also Hoxie, 419 F.3d at 482. ``In short,
. . . the Agency is not
[[Page 40659]]
required to mechanically count up the factors and determine how many
favor the Government and how many favor the registrant. Rather, it is
an inquiry which focuses on protecting the public interest; what
matters is the seriousness of the registrant's misconduct.'' Jayam
Krishna-Iyer, M.D., 74 FR 459, 462 (2009). Accordingly, as the Tenth
Circuit has recognized, findings under a single factor can support the
revocation of a registration. MacKay, 664 F.3d at 821.
While the Agency considered all of the 21 U.S.C. 823(g)(1) factors
in this matter, the Agency finds that the Government's prima facie case
is confined to factors B and D. The Government has the burden of proof
in this proceeding. 21 CFR 1301.44(e). The Agency finds that the
deemed-admitted facts with respect to Factors B and D satisfy the
Government's prima facie burden of showing that Registrant's continued
registration would be ``inconsistent with the public interest.'' 21
U.S.C. 824(a)(4).
B. Factors B And D--Respondent's Experience Dispensing Controlled
Substances and Compliance With Applicable Laws Relating to Controlled
Substances
Allegation That Respondent's Registration Is Inconsistent With the
Public Interest
As detailed above, the Agency concludes that Respondent violated
the applicable Texas standard of practice on multiple occasions over
the course of several years while prescribing controlled substances for
three individuals. Supra sections IV and V. Thus, the Agency further
concludes that Respondent issued prescriptions that lacked a legitimate
medical purpose outside the usual course of his professional practice
contrary to 21 CFR 1306.04. Accordingly, the Agency finds that the
Government presented a prima facie case for which the Agency may impose
a sanction on Respondent, and that Respondent, due to his default, did
not rebut the Government's prima facie case. 21 U.S.C. 824(a)(4).
VII. Sanction
Where, as here, (1) Respondent is deemed to have admitted the
factual allegations in the OSC, (2) the deemed-admitted facts are
substantial evidence proving the legal violations alleged to support
revocation based on acts inconsistent with the public interest, (3) the
Government met its prima facie burden of showing that Respondent's
continued registration is inconsistent with the public interest due to
his experience dispensing controlled substances and his numerous
failures to comply with laws relating to controlled substances, and (4)
Respondent did not rebut the Government's prima facie case, the burden
shifts to Respondent to show why he can be entrusted with a
registration. Morall, 412 F.3d. at 174; Jones Total Health Care
Pharmacy, 881 F.3d at 830; Garrett Howard Smith, M.D., 83 FR 18,882
(2018).
The issue of trust is necessarily a fact-dependent determination
based on the circumstances presented by the individual respondent.
Jeffrey Stein, M.D., 84 FR 46968, 46972 (2019); see also Jones Total
Health Care Pharmacy, 881 F.3d at 833. Moreover, as past performance is
the best predictor of future performance, the Agency has required that
a registrant who has committed acts inconsistent with the public
interest must accept responsibility for those acts and demonstrate that
he will not engage in future misconduct. Jones Total Health Care
Pharmacy, 881 F.3d at 833 (citing authority including Alra Labs., Inc.
v. Drug Enf't Admin., 54 F.3d 450, 452 (7th Cir. 1995) (``An agency
rationally may conclude that past performance is the best predictor of
future performance.'')), MacKay, 664 F.3d at 820 (``[Whether the
registrant will change his behavior in the future] is vital to whether
continued registration is in the public interest.''). A registrant's
acceptance of responsibility must be unequivocal. Jones Total Health
Care Pharmacy, 881 F.3d at 830-31.
Further, the Agency has found that the egregiousness and extent of
the misconduct are significant factors in determining the appropriate
sanction. Id. at 834 and n.4. The Agency has also considered the need
to deter similar acts by the respondent and by the community of
registrants. Jeffrey Stein, M.D., 84 FR at 46972-73.
Regarding these matters, there is no record evidence that
Respondent takes responsibility, let alone unequivocal responsibility,
for the founded violations. As such, Respondent has not presented any
evidence showing that he can be entrusted with a registration.
Accordingly, the record supports the imposition of a sanction.
The interests of specific and general deterrence weigh in favor of
revocation given the egregiousness of the founded violations,
violations that go to the heart of the CSA and of this Agency's law
enforcement mission. E.g., Jones Total Health Care Pharmacy, 881 F.3d
at 834 and n.4; Garrett Howard Smith, M.D., 83 FR at 18910 (collecting
cases), supra sections IV and V. In addition, as Respondent has not
unequivocally accepted responsibility for the founded violations, it is
not reasonable to believe that Respondent's future controlled substance
prescribing will comply with legal requirements. Supra. Further, given
the foundational nature and vast number of Respondent's violations, a
sanction less than revocation would send a message to the existing and
prospective registrant community that compliance with the law is not
essential to maintaining a registration.
Accordingly, the Agency shall order the revocation of Respondent's
registration.
Order
Pursuant to 28 CFR 0.100(b) and the authority vested in me by 21
U.S.C. 824(a)(4) and 21 U.S.C. 823(g)(1), I hereby revoke DEA
Certificate of Registration No. BK4924139 issued to Andrew Konen, M.D.
Further, pursuant to 28 CFR 0.100(b) and the authority vested in me by
21 U.S.C. 824(a) and 21 U.S.C. 823(g)(1), I hereby deny any pending
application of Andrew Konen, M.D., to renew or modify this
registration, as well as any other pending application of Andrew Konen,
M.D., for registration in Texas. This Order is effective September 19,
2025.
Signing Authority
This document of the Drug Enforcement Administration was signed on
August 13, 2025, by Administrator Terrance Cole. That document with the
original signature and date is maintained by DEA. For administrative
purposes only, and in compliance with requirements of the Office of the
Federal Register, the undersigned DEA Federal Register Liaison Officer
has been authorized to sign and submit the document in electronic
format for publication, as an official document of DEA. This
administrative process in no way alters the legal effect of this
document upon publication in the Federal Register.
Heather Achbach,
Federal Register Liaison Officer, Drug Enforcement Administration.
[FR Doc. 2025-15866 Filed 8-19-25; 8:45 am]
BILLING CODE 4410-09-P
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</html>Indexed from Federal Register on August 20, 2025.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.