[Federal Register Volume 77, Number 62 (Friday, March 30, 2012)]
[Notices]
[Pages 19322-19338]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-7619]



[[Page 19322]]

-----------------------------------------------------------------------

DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 10-59]


Daniel B. Brubaker, D.O.; Decision and Order

    On April 29, 2011, Administrative Law Judge (ALJ) Timothy D. Wing 
issued the attached recommended decision. Neither party filed 
exceptions to the decision.
    Having reviewed the record as a whole, I have decided to adopt the 
ALJ's recommended rulings, findings of fact, and conclusions of law in 
their entirety. Accordingly, I also adopt the ALJ's recommended order.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well 
as 28 CFR 0.100(b), I hereby order that the application of Daniel B. 
Brubaker, D.O., for a DEA Certificate of Registration as a 
practitioner, be, and it hereby is, denied. This order is effective 
immediately.

    Dated: March 16, 2012.
Michele M. Leonhart,
Administrator.
Frank Mann, Esq., for the Government
Ronald Kaldor, Esq., for the Respondent

Recommended Ruling, Findings of Fact, Conclusions of Law and Decision 
of the Administrative Law Judge

I. Introduction

A. The Order To Show Cause
    Timothy D. Wing, Administrative Law Judge. This proceeding is an 
adjudication pursuant to the Administrative Procedure Act (APA), 5 
U.S.C. Sec.  551 et seq., to determine whether the Drug Enforcement 
Administration (DEA) should deny a physician's application for a DEA 
Certificate of Registration (COR) as a practitioner pursuant to 21 
U.S.C. Sec.  823(f). Without this registration Respondent, Daniel B. 
Brubaker, D.O. (Respondent), of Fresno, California, will be unable to 
lawfully prescribe, dispense or otherwise handle controlled substances 
in the course of his practice.
    On May 27, 2010, the DEA Deputy Assistant Administrator, Office of 
Diversion Control, issued an Order to Show Cause (OSC) to Respondent, 
giving Respondent notice of an opportunity to show cause as to why the 
DEA should not deny Respondent's application for registration on 
grounds that his registration would be inconsistent with the public 
interest as that term is used in 21 U.S.C. Sec.  823(f).
    In substance, the OSC alleges that Respondent prescribed controlled 
substances to patients for no legitimate medical purpose and with 
``extreme deviations from the standard of care.'' The OSC further 
alleges that Respondent was arrested for driving under the influence of 
controlled substances on June 13, 2008, and that toxicology results 
revealed the presence of the controlled substances marijuana, 
modafinil, oxazepam and temazepam, for which Respondent lacked a 
prescription.
B. Prehearing Proceedings
    Because conduct by Respondent's counsel prior to hearing played a 
prominent role in the constriction of evidence that Respondent was 
permitted to present at hearing, I address the prehearing proceedings 
in some detail.
    Respondent, through his counsel Ronald Kaldor, Esq., requested a 
hearing on June 25, 2010. On July 6, 2010, I issued an Order for 
Prehearing Statements directing the Government to file a prehearing 
statement by July 13, 2010, and Respondent to file a prehearing 
statement by July 20, 2010. The Order for Prehearing Statements 
itemized numerous instructions designed to give the parties notice, 
inter alia, of the grounds upon which claims and defenses would be 
based, the identity and location of witnesses and the contents of their 
testimony, and the exhibits each party intended to introduce into 
evidence. The overriding purpose of prehearing statements in 
registration proceedings pursuant to section 304 of the Controlled 
Substances Act (CSA) is to provide parties with an opportunity to 
fairly and adequately prepare for hearing. See generally CBS Wholesale 
Distribs., Inc., 74 Fed. Reg. 36,746 (DEA 2009).
    The Government timely filed its prehearing statement on July 13, 
2010. Respondent filed a document entitled ``Respondent's Prehearing 
Statements'' on July 20, 2010. Although filed within the deadline for 
exchanging prehearing statements, this filing was deficient in numerous 
regards: Respondent failed to identify a single witness, summarize 
witness testimony, or describe any documents to be potentially offered 
as exhibits. Arguing that Respondent had impliedly withdrawn his 
request for a hearing by failing to file a compliant prehearing 
statement, the Government moved to terminate proceedings on July 22, 
2010. After providing Respondent an opportunity to respond to the 
Government's motion, I found that although Respondent's initial 
prehearing statement of July 20, 2010, was ``substantially deficient 
and does not comply with the directions set forth in the Order for 
Prehearing Statements or 21 C.F.R. Sec.  1316.57, I do not find at this 
time that Respondent's actions constitute a waiver of hearing.'' (Mem. 
to Counsel and Order, July 30, 2010.) I ordered Respondent to file a 
compliant supplemental prehearing statement no later than August 3, 
2010.
    On August 3, 2010, Respondent filed a supplemental prehearing 
statement. This document, too, was deficient in numerous respects. For 
instance, Respondent vaguely outlined the testimony of his witnesses 
instead of ``stat[ing] what the testimony will be rather than merely 
listing the areas to be covered,'' as required by the Order for 
Prehearing Statements. Respondent also failed to provide addresses for 
three witnesses. In addition, although the Order for Prehearing 
Statements directed that ``[i]f Respondent intends to testify, 
Respondent must be identified as a witness, and a summary of the 
testimony * * * must be provided,'' Respondent's August 3, 2010 
supplemental prehearing statement did not list Respondent as a witness.
    I issued a Prehearing Ruling on August 6, 2010. The Prehearing 
Ruling noted that any testimony not summarized in prehearing 
statements, and any documents not listed therein, could be excluded at 
hearing. The Prehearing Ruling also set a deadline of October 4, 2010, 
for the filing of supplemental prehearing statements; set November 8, 
2010, as the deadline for filing any anticipated motions and exchanging 
documents intended to be offered as exhibits at hearing; and set 
November 15, 2010, as the deadline for providing the Administrative Law 
Judge (ALJ) with copies of all such documents.\1\
---------------------------------------------------------------------------

    \1\ On November 15, 2010, the Government timely filed its 
exhibits in compliance with the August 6, 2010 Prehearing Ruling. 
Prior to hearing, Respondent did not file any exhibits with the ALJ, 
and the Government represents, and Respondent does not challenge, 
that Respondent did not serve on the Government any of the seven 
documents listed in his August 3, 2010, supplemental prehearing 
statement.
---------------------------------------------------------------------------

    On October 28, 2010, the Government filed a Motion of Government to 
File Supplemental Prehearing Statement Out of Time, seeking to 
eliminate several Government exhibits and add the curriculum vitae (CV) 
of the Government's expert witness. The Government represented that 
Respondent did not object, and I granted the Government's motion on 
October 29, 2010.
    On November 12, 2010, a telephonic Supplemental Prehearing 
Conference

[[Page 19323]]

was held with Government counsel and Respondent's counsel. At the 
Supplemental Prehearing Conference, counsel for Respondent withdrew 
Respondent's expert witness, Thomas O'Laughlin, M.D., and indicated 
Respondent's desire to obtain a replacement expert. Respondent also 
indicated his desire to call Respondent to testify as a witness, 
despite the fact that Respondent's prehearing statement and 
supplemental prehearing statement did not list Respondent as a 
witness.\2\ Counsel for the Government indicated, however, that from 
previous conversations with counsel, the Government was on notice of 
Respondent's intention to call Respondent as a witness.\3\
---------------------------------------------------------------------------

    \2\ The July 6, 2010 Order for Prehearing Statements states: 
``If Respondent intends to testify, Respondent must be listed as a 
witness, and a summary of the testimony * * * must be provided.''
    \3\ Counsel also suggested that James Hambuechen, previous 
Government counsel, requested a subpoena for Respondent's testimony. 
The record, however, reveals no such subpoena or request.
---------------------------------------------------------------------------

    In addition, counsel for Respondent stated that Respondent no 
longer intended to call Karen Fu, LMFT, as a witness.\4\ Finally, 
counsel for Respondent stated that he intended to provide addresses for 
Respondent's witnesses Stephen Duvall, Anita Peralda and ``Jerry 
MCDonadl'' [sic] (Resp't Supp. PHS at 2), and that he intended to 
indicate with specificity, albeit belatedly by approximately forty 
days,\5\ their proposed testimony.
---------------------------------------------------------------------------

    \4\ Ms. Fu's name appears as a potential witness in Respondent's 
August 3, 2010 ``Supplemental Respondent's Prehearing Statements.''
    \5\ The July 6, 2010 Order for Prehearing Statements set forth a 
deadline of July 20, 2010, for the filing of Respondent's prehearing 
statement. Per the August 6, 2010 Prehearing Ruling, supplemental 
prehearing statements were due on October 4, 2010.
---------------------------------------------------------------------------

    Counsel for Respondent further indicated his intention to file a 
(second) supplemental prehearing statement on Monday, November 15, 
2010, embracing the changes and updates to witness information 
discussed supra. Counsel for Respondent acknowledged that the August 6, 
2010 Prehearing Ruling set the deadline for supplemental prehearing 
statements at October 4, 2010, and set the deadline for filing motions 
at November 8, 2010. Counsel for Respondent accepted responsibility for 
missing these deadlines, but attributed this failure to a lack of 
familiarity with the ``federal rules.''
    I issued a Supplemental Prehearing Ruling on November 12, 2010, 
summarizing the Supplemental Prehearing Conference and ordering 
Respondent to file a proposed second supplemental prehearing statement, 
accompanied by a separate motion to accept late filing supported by a 
statement of good cause, no later than November 15, 2010.
    On Wednesday, November 17, 2010, Respondent filed, two days out of 
time, a document entitled ``Second Supplemental Respondent's Prehearing 
Statement,'' along with a Motion to Accept Late Filing, also filed two 
days out of time. On November 19, 2010, the Government filed its 
Opposition to Respondent's Motion to Accept Late Filing, Motion to 
Terminate Proceedings or, in the alternative, Motion In Limine. 
Pursuant to the August 6, 2010 Prehearing Ruling, Respondent had three 
business days after service of the Government's motions to file a 
response. Respondent did not respond.\6\
---------------------------------------------------------------------------

    \6\ Counsel for Respondent had indicated that ``I will be out of 
my office on vacation . . . from November 22 to November 29 and will 
not be able to access any communications.'' (Resp't Mot. Late 
Filing, Nov. 17, 2010, at 2.) Under the circumstances, I declined to 
construe this unsworn statement as a motion to extend the three-day 
deadline for responding to motions, established by the August 6, 
2010 Prehearing Ruling. Even so construed, I found there was no good 
cause for extending the filing deadline. First, counsel for 
Respondent's duty of diligence requires that he designate alternate 
counsel during his anticipated absence. Second, ``if one can find 
time to take vacation, he can also find time to file a . . . 
pleading . . ..'' Kamir Garces-Mejias, 72 Fed. Reg. 54,931-02, 
54,933 (DEA 2007).
---------------------------------------------------------------------------

    Ruling on Respondent's Motion to Accept Late Filing of his proposed 
supplemental prehearing statement on November 30, 2010, I found that

    Viewed as a whole, Respondent's failures are serious and present 
the specter of real prejudice to the Government. Because 
Respondent's motion to accept late filing was itself filed late 
without good cause, because the motion was not supported by good 
cause, and because the proposed second supplemental prehearing 
[statement] is noncompliant with the Order for Prehearing 
Statements, I reject the filing of Respondent's second supplemental 
prehearing statement.

(Mem. and Order, Nov. 30. 2010, at 9.)
    Turning to the Government's Motion to Terminate, I found that 
``although the deficiencies in Respondent's counsel's handling of 
Respondent's case are indeed serious, they cannot support a finding 
that Respondent has actually withdrawn or waived his request for a 
hearing.'' (Id. at 11.)
    Addressing the Government's Motion in limine, I found that fairness 
and Agency precedent required the constriction of the evidence that 
Respondent could permissibly present at hearing, in light of 
Respondent's numerous, repeated and prejudicial failures to comply with 
the Order for Prehearing Statements and subsequent Orders, as detailed 
above and analyzed in my November 30, 2010 ruling. I therefore ordered 
that with the exception of Respondent himself, no witness would be 
permitted to testify who was not named either by the Government in its 
prehearing statement, as duly supplemented on October 28, 2010, or by 
Respondent in Respondent's supplemental prehearing statement filed 
August 3, 2010; that Respondent would not be permitted to introduce 
documentary evidence regarding the prescribing, dispensing or 
administering of controlled substances to any of the patients named in 
the Government's prehearing statement, as supplemented; that Respondent 
would not be permitted to introduce documentary evidence that he 
legally consumed, or had legal authority to possess and consume, the 
controlled substances found in his system following his arrest on June 
13, 2008; and that Respondent would not be permitted to introduce any 
documentary evidence of any kind or manner, absent a specific showing 
of good cause at hearing. Respondent was not precluded from seeking 
admission of documents related to issues such as witness credibility or 
rebuttal of evidence.\7\
---------------------------------------------------------------------------

    \7\ See Mem. Order, Nov. 30, 2010, at 14 n.10. At hearing 
Respondent only offered, and subsequently withdrew, Respondent's CV. 
I indicated the document would in any case be excluded in accordance 
with an earlier ruling. (Tr. 299-300.) Respondent did not provide a 
copy of the CV to this tribunal, and consequently no copy is 
included in the record.
---------------------------------------------------------------------------

    On December 3, 2010, Respondent filed Respondent's Motion In 
Limine, seeking to prevent the Government's expert witness, Dr. James 
L. Gagn[eacute], from testifying at the hearing. In support of his 
motion, Respondent stated he interpreted my November 30, 2010 ruling on 
the Government's motion in limine to ``limit the testimony of 
Respondent in his defense,'' arguing that the Government's expert 
should not be permitted to testify because otherwise ``Respondent will 
be precluded from a fair opportunity to defend himself and from 
receiving his due process rights . . . .'' (Resp't Mot. in Limine, Dec. 
3, 2010, at 1.) Inasmuch as Respondent filed his motion two business 
days before the hearing, Respondent's motion was resolved on the record 
at the beginning of the hearing. After giving each party an opportunity 
to be heard, I denied Respondent's motion as meritless.\8\ (Transcript 
(Tr.) 21.)
---------------------------------------------------------------------------

    \8\ Respondent's testimony at hearing spans approximately 181 
transcript pages. (See Tr. 300-481.)
---------------------------------------------------------------------------

    Following prehearing procedures, a hearing was held in Fresno, 
California, between December 7, 2010, and December 8, 2010, with the 
Government represented by counsel and Respondent

[[Page 19324]]

represented by counsel. Both parties called witnesses to testify and 
both had the opportunity to introduce documentary evidence, although 
the evidence Respondent was ultimately permitted to introduce was 
limited by my November 30, 2010 ruling as noted above. After the 
hearing, both parties filed proposed findings of fact, conclusions of 
law, and argument.\9\ All of the evidence and post-hearing submissions 
have been considered, and to the extent the parties' proposed findings 
of fact have been adopted, they are substantively incorporated into 
those set forth below.
---------------------------------------------------------------------------

    \9\ In a December 27, 2010 letter to counsel, the Office of 
Administrative Law Judges advised that briefs would be due by 4 p.m. 
Eastern Daylight Time on January 25, 2011. The Government timely 
filed its brief. Respondent filed his brief on January 26, 2011, and 
on January 27, 2011, filed a motion to accept the late filing. In 
the absence of an objection from the Government, and inasmuch as it 
appeared no prejudice would result, I granted Respondent's motion. 
(See Ruling on Resp't Mot. to Accept Late Filing, Apr. 28, 2011.)
---------------------------------------------------------------------------

II. Issue

    Whether the record establishes by substantial evidence that 
Respondent's application for a DEA COR, assigned control number 
W09177610C, should be denied because Respondent's registration would be 
inconsistent with the public interest as that term is used in 21 U.S.C. 
Sec.  823(f).

III. Evidence and Incorporated Findings of Fact \10\
---------------------------------------------------------------------------

    \10\ In addition to the evidence discussed in this Section, 
additional evidence and findings of fact are discussed in later 
Sections of this Recommended Decision.
---------------------------------------------------------------------------

    I find, by a preponderance of the evidence, the following facts:
A. Stipulated Facts
    Respondent applied for a DEA registration as a practitioner in 
Schedules II through V on or around August 26, 2009. (ALJ Ex. 4.) 
Respondent surrendered his previous DEA registration on August 21, 
2008. (Id.)
B. The Government's Evidence
    DEA Diversion Investigator Jack L. Lewis (DI Lewis) has been a DEA 
Diversion Investigator for five years. (Tr. 271.) DI Lewis received 
training as a diversion investigator at a DEA training facility in 
Quantico, Virginia. (Tr. 272.)
    Dr. James Laurent Gagn[eacute] (Dr. Gagn[eacute]) is a physician. 
(Tr. 27.) He resides in Valley Village, California and received a 
bachelor's degree from Columbia University and a medical degree from 
Albert Einstein College of Medicine of Yeshiva University in Bronx, New 
York. (Gov't Ex. 4.) He is board certified in internal medicine, 
addiction medicine and pain medicine and presently sees several hundred 
patients. (Tr. 28.) Approximately one third of them are pain management 
patients. (Tr. 197.) He estimates that he prescribes opiates to 
approximately half of his pain patients. (Tr. 203.)
    Among other certifications, Dr. Gagn[eacute] holds Diplomates from 
the National Board of Medical Examiners and the American Board of 
Internal Medicine. (Gov't Ex. 4; see Tr. 29.) He is certified in 
addiction medicine by the American Society of Addiction Medicine, and 
holds a Diplomate from the American Board of Pain Medicine. (Gov't Ex. 
4; see Tr. 31.) Dr. Gagn[eacute] is a member of nineteen professional 
associations, including the International Association for the Study of 
Pain, the American Pain Society, the Western Pain Society, the American 
Association for Pain Medicine, the American Society for Addiction 
Medication and the California Society for Addiction Medicine. (Gov't 
Ex. 4.)
    Dr. Gagn[eacute] completed an internship and his first medical 
residency at Lincoln Hospital, Albert Einstein College of Medicine 
between 1973 and 1975. (Gov't Ex. 4; Tr. 32.) He completed a second 
residency at Kaiser-Permanente Medical Center in Santa Clara, 
California in 1976. (Gov't Ex. 4.) Between 1976 and the present, Dr. 
Gagn[eacute] has served in a variety of positions ranging from Clinical 
Medical Director, UCLA Pain Control Unit in Los Angeles, to Chairman of 
the Department of Medicine at the Verdugo Hills Hospital in Glendale, 
California. (Gov't Ex. 4; see Tr. 32-34.)
    Presently, Dr. Gagn[eacute] is an associate physician at a 
Glendale, California primary care internal medicine group and a 
consulting physician at a Malibu, California recovery home. (Gov't Ex. 
4.) He previously taught as an Assistant Professor of Family Medicine 
at USC Keck School of Medicine from 2000 to 2008. (Gov't Ex. 4; Tr. 
30.) Dr. Gagn[eacute] has also given numerous lectures, authored 
various publications and participated in continuing medical education 
programs. (Gov't Ex. 4; Tr. 35-36.) He has served as an expert reviewer 
for the California Medical Board and has served as an expert witness on 
two cases for the United States Department of Justice. (Tr. 36-39.)
    Dr. Gagn[eacute] was qualified and I have accepted him as an expert 
witness, without objection, in the profession of internal medicine, 
addiction medicine and pain management medicine in the State of 
California. (Tr. 39-40; Gov't Ex. 4.)

DEA Investigation of Respondent's Prescribing Practices

    Dr. Gagn[eacute] testified to being familiar with California and 
federal law regarding the prescribing of controlled substances. (Tr. 
40.) To issue a prescription for controlled substances within the usual 
course of a physician's professional practice, there must be a genuine 
and valid physician-patient relationship. (Tr. 40-41.) The physician 
must keep a medical record, determine the patient's history and 
symptoms, conduct a physical examination and document laboratory 
findings. (Tr. 41.) When prescribing drugs with side-effects, the 
physician must make a risk-benefit assessment. (Tr. 41.) Standards can 
differ depending on whether a patient is seeking treatment on an 
emergency basis, but Dr. Gagn[eacute] testified that none of the nine 
patients of Respondent whose files Dr. Gagn[eacute] reviewed sought 
treatment on an emergency basis. (Tr. 41-42.)
    Dr. Gagn[eacute] defined ``chronic pain'' as a painful condition 
lasting more than three months after the acute illness giving rise to 
the pain has been resolved. (Tr. 42, 209.) In determining whether a 
patient is truly suffering from chronic pain, a physician must trust 
the patient but also must compare objective evidence with a patient's 
subjective complaints because some patients exaggerate symptoms. (Tr. 
43.) A physician must listen both to what the patient says and to what 
the patient does not say, to ``learn[] some of the implications and 
context and things that people are not saying but are kind of present 
in the room.'' (Tr. 207.) In treating a pain patient, a physician must 
obtain several aspects of a patient's history, to include the patient's 
present illness, past medical history, social history, psychiatric 
history, family history, review of symptoms and addiction history.\11\ 
(Tr. 43-44.) In obtaining this information,\12\ Dr. Gagn[eacute] called 
the following components essential: How the pain began, the course of 
the illness, the course of treatment and diagnostic procedures and the 
patient's current symptoms, including neurological symptoms. (Tr. 45-
46.) When prescribing controlled

[[Page 19325]]

substances, it is critical to obtain a list of the patient's prior 
medications. (Tr. 47.) Among other reasons, a patient's history of 
medication gives a physician a ``sense of the appropriateness of the 
patient's use of the controlled substances and whether they're likely 
to be a problem.'' (Tr. 48.)
---------------------------------------------------------------------------

    \11\ In the case of a patient using marijuana or other illicit 
drugs, Dr. Gagn[eacute] ``would take 100 percent full-fledged 
addiction history.'' (Tr. 56-57.)
    \12\ As for the amount of time it takes to gather this 
information from the patient, Dr. Gagn[eacute] testified that ``I am 
very much of an outlier, so I take longer than most of my 
colleagues. And it takes me one or two hours [which is] not the 
standard of practice, that's how I do it.'' (Tr. 206.) Moreover, it 
is not necessarily required or advisable to obtain all this patient 
information at once or in a single visit. (Tr. 206.)
---------------------------------------------------------------------------

    It is also important to collaborate with a patient's previous 
physicians to verify that a patient has truthfully represented the 
amount of medication she has taken in the past. (Tr. 48.) The 
importance of obtaining a patient's prior medical records, and ordering 
X-rays or MRIs, varies with the patient based on the complexity of the 
illness and the previous course of treatment. (Tr. 48-49, 54.) The 
importance of obtaining such documentation increases when prescribing 
controlled substances because among therapies, controlled substances 
are unique in that some patients ``will engage in substantial 
misdirection, lying, and manipulation to obtain them.'' (See Tr. 51.)
    Conducting a physical examination is also critical prior to 
prescribing controlled substances. (Tr. 52.) In addition to at least 
one comprehensive ``head to toe'' exam, a physician should conduct a 
``relatively-detailed orthopedic-style examination or rheumatologic-
style evaluation.'' (Tr. 52.) In a patient with lower back pain, for 
instance, such an examination might include watching the patient walk 
and observing range of motion, checking for tenderness or deformity of 
the spine, checking the neurologic function for weakness or lack of 
sensation and checking muscles and joints for spasm or tenderness. (Tr. 
52.) Prescribing controlled substances without an office visit by the 
patient is something

that mostly you don't do, but there are circumstances in which you 
have a long-term patient who's stable, where the drug doses aren't 
changing, and there's absolutely no problem at all, and you know 
very well that they're doing well, and they're not going to come in 
and telling you they're crashing or they need more or this or that.

(Tr. 222.)
    The upshot, Dr. Gagn[eacute] explained, is that before prescribing 
controlled substances, ``there has to be enough information in the 
record to be meaningful, it has to add up to something. Or if you 
don't, you refer somebody out for * * * evaluation and then you base 
your treatment on a specialist's evaluation.'' (Tr. 213.)
    Documenting the various steps described above in a patient's 
medical record is important. Although it is not practical to document 
every word spoken or action taken at a patient consultation, the 
medical community nevertheless presumes that ``if it's not in the 
medical records, it's assumed not to have happened.'' \13\ (Tr. 54.) 
Dr. Gagn[eacute] elaborated that the burden of proof is on the 
physician: ``[T]he standard is that a competent physician can pick up 
the medical record and understand without too much trouble what 
happened.'' (Tr. 214.) Physicians who treat a patient based on an 
analysis not documented in the patient's medical chart are ``subjecting 
themselves to high risk of problems down the road.'' (Tr. 216.)
---------------------------------------------------------------------------

    \13\ For instance, a doctor should have a serious discussion 
with a chronic pain patient about the possibility of physical 
therapy, and document the conversation in the record. (Tr. 59.)
---------------------------------------------------------------------------

    Dr. Gagn[eacute] also clarified that there is a difference between 
a diagnosis and a symptom. Low back pain, for instance, is not a 
diagnosis of an illness but is instead a symptom that can be due to at 
least a dozen causes. (Tr. 56.) When patients seek controlled 
substances, it is important to perform an independent diagnosis 
regarding any possible addiction. (Tr. 56.)
    Dr. Gagn[eacute] recognizes the validity of opiates in the 
treatment of chronic pain and relies on opiates to treat some of his 
patients. (Tr. 57-58.) But even when a patient is in pain and the pain 
is confirmed by a doctor, it is not necessarily appropriate to 
prescribe opiates in all instances; other treatments may be more 
effective.\14\ (Tr. 57-58.) When prescribing controlled substances, the 
physician should give the lowest dose consistent with a beneficial 
clinical outcome and periodically review the treatment's efficacy. (Tr. 
59-60.) Although there is a legitimate ``role for dose finding,'' it is 
inappropriate to blindly increase a dosage when a given dosage isn't 
working. (Tr. 60.) Increasing a dosage on the sole grounds that a 
patient requests an increase is inappropriate without an assessment of 
the patient's symptoms, function, sleep, mood and other factors. (Tr. 
61.)
---------------------------------------------------------------------------

    \14\ Dr. Gagn[eacute] also cautioned that ``there is not one 
single medical or scientific study that shows that opiates are safe 
or effective in the treatment of chronic pain.'' (Tr. 57.)
---------------------------------------------------------------------------

    As signals indicating the potential addiction to or diversion of 
controlled substances, Dr. Gagn[eacute] identified a number of ``red 
flags.'' When a red flag occurs, ``one needs to sort out what's going 
on before continuing to prescribe the medications * * * there are kinds 
of red flags where you simply have to stop, you can't continue to 
prescribe controlled drugs.'' (Tr. 64-65.) Red flags include a patient 
asking for larger doses; a claim that ``my dog ate my prescription,'' 
that the patient dumped the prescription down the toilet, that the 
prescription was stolen or other ``dramatic stories of how my drugs 
suddenly disappeared and I need more''; a patient requesting an advance 
supply due to anticipated travel when the patient later tries to refill 
the prescription before the extra dosage should have been consumed; 
evidence that the patient has obtained controlled substances from more 
than one physician or is using more than one or two pharmacies; 
increasingly bizarre statements about the need for opiates; and missing 
appointments frequently. (Tr. 62-64.) Moreover, a patient who 
exaggerates the type of medication she has previously taken under the 
care of a prior doctor poses the sort of red flag that requires a 
physician to ``stop prescribing controlled substances until you sort 
out what's going on.'' (Tr. 63.) A patient who uses illicit drugs is a 
``huge red flag'' and ``it would be very inappropriate to prescribe 
controlled prescription medications to such a patient absent other 
extremes.'' (Tr. 63.) A patient's reluctance to provide medical records 
or claims of frequent injuries are also red flags. (Tr. 64.)
    As ``yellow flags'' that could signal addiction or diversion, Dr. 
Gagn[eacute] identified instances of patients requesting brand-name 
drugs instead of settling for generic alternatives; patients who pay by 
cash; patients who use marijuana for medicinal purposes \15\ (Tr. 62-
64); and a prescribing physician writing ``DAW'' or ``dispense as 
written'' on a prescription.\16\ (Tr. 93.)
---------------------------------------------------------------------------

    \15\ Dr. Gagn[eacute] elaborated that in California, where 
marijuana may legally be prescribed for medical purposes, a doctor 
must first establish a medical diagnosis and also conduct an 
addiction history, given the drug's high addiction potential. (Tr. 
77-78.)
    \16\ This practice can indicate a potential for diversion, as 
follows. (Tr. 94.) With respect to OxyContin and Vicodin ES, for 
example, there is no difference therapeutically between the brand 
name and the generic version. (Tr. 94.) Although some patients 
believe the brand name is more effective, requesting a brand name 
``can be a way of showing customers who are buying the drugs 
secondarily that this is the real thing, because generics are pretty 
nondescript tablets, and you don't know what you're getting.'' (Tr. 
94.)
---------------------------------------------------------------------------

    Dr. Gagn[eacute] also identified various controlled substances.\17\ 
Oxycodone is a powerful opiate with a high abuse potential. (Tr. 49.) 
Oxydose and Oxyfast are varieties of oxycodone.\18\ (Tr. 49, 113.) 
Hydrocodone is another powerful opiate with a lower strength but high 
abuse potential. (Tr. 49.) Norco is a brand name of hydrocodone mixed 
with Tylenol or acetaminophen. (Tr. 49.)

[[Page 19326]]

Kadian is a time-release form of morphine and Actiq is a brand name of 
fentanyl. (Tr. 49.) Xanax is a highly-addicting and frequently abused 
opiate. (Tr. 39, 78.) Valium is diazepam, a benzodiazepine and sedative 
with moderate addiction potential. (Tr. 50.) Dilaudid is ``the most 
powerful opiate that I'm aware of with an incredibly high addiction 
potential.'' (Tr. 50.) Phenergan is a powerful sedative with anti-
nausea properties, and codeine is an opiate with moderate abuse 
potential. (Tr. 50.)
---------------------------------------------------------------------------

    \17\ See generally 21 U.S.C. Sec.  812 (establishing five 
schedules of controlled substances); 21 C.F.R. Sec.  1308.11-15 
(2010) (listing the controlled substances in Schedules I--V).
    \18\ Dr. Gagn[eacute]'s also testified that OxyContin is a brand 
of oxycodone, an opiate and a controlled substance. (Tr. 39, 114, 
126.)
---------------------------------------------------------------------------

    Based upon a review of nine of Respondent's patient files offered 
at hearing,\19\ Dr. Gagn[eacute] opined that ``there were some patients 
where there was nothing that really approached what I consider anything 
like medical care, and others where it was more like medical care.'' 
(Tr. 215-16.) As detailed in a later Section of this Recommended 
Decision, Dr. Gagn[eacute] opined that Respondent's prescribing of 
controlled substances to his patients was characterized by
---------------------------------------------------------------------------

    \19\ The record reflects some variance on the number of files 
reviewed. The OSC indicated that Dr. Gagn[eacute] reviewed ten of 
Respondent's files. (ALJ Ex. 1.) Dr. Gagn[eacute]'s written report 
states that ``eight'' patient files were reviewed, but substantively 
addresses nine patients. (Gov't Ex. 3 at 1.) Testimony at hearing 
also indicated there was ``yet another file that Dr. Gagn[eacute] 
reviewed'' (Tr. 288) but that was not included in this particular 
case, reflecting a total of ten files reviewed by Dr. Gagn[eacute].

grossly inadequate medical records and virtually a complete absence 
of clinical information. No meaningful history, no meaningful 
physical examination, no past medical history, no family history, no 
review of systems, et cetera, nothing. No physical exam worthy of 
the name * * *. there were structures in the chart that had those 
titles, but the data was absent. Another reason is patients who it 
became clear were grossly misusing their medications or getting them 
from multiple sources. At that point there can no longer be a 
legitimate medical purpose of continuing controlled drugs. Or when a 
patient is being admitted [or referred] to rehabilitation facility 
for drugs * * * you don't keep just prescribing the same old 
---------------------------------------------------------------------------
controlled drugs you always were.

(Tr. 223-24.)
C. Respondent's Evidence
    Daniel B. Brubaker, D.O. (Respondent) is an osteopathic physician. 
(E.g., Tr. 204.) Respondent was previously registered with DEA as a 
practitioner and surrendered his registration on August 21, 2008. (ALJ 
Ex. 4.) Respondent subsequently applied for a new COR following the 
execution of a search warrant at his office. (E.g., Tr. at 273-74.) The 
number associated with Respondent's application is W09177610C. (Gov't 
Ex. 1.)
    Respondent attended Elizabethtown College in Pennsylvania and 
graduated from Philadelphia College of Osteopathic Medicine in 1974. 
(Tr. 300.) He undertook clinical and pathological training and 
completed a residency at the University of Pittsburgh. (Tr. 300.) 
Respondent is board certified in anatomic pathology, clinical pathology 
and immunohematology and holds certifications for various procedures. 
(Tr. 301.) He possesses seventeen years of experience in transfusion 
and transplantation medicine, has served as medical director of three 
different blood centers and has completed continuing medical education 
units since beginning his medical career. (See Tr. 301-02.) Respondent 
has also taught medical students, residents and interns at the 
University of Oklahoma and UCLA and has published in twenty-five peer-
reviewed journals, including articles on innovative approaches to 
making blood transfusions safer. (Tr. 301-02, 310.)
    Respondent also testified to his medical history. He developed 
cancer of the colon in late November 2000, which was resolved by 
chemotherapy and surgery in 2004. (Tr. 307.) Because the cancer had 
metastasized to his liver, Respondent underwent surgery to remove the 
right lobe of his liver in February 2002. (Tr. 307.) In 2004, 
Respondent underwent surgery for sleep apnea. (Tr. 311.) In 2005, 
Respondent underwent an invasive inpatient operation to perform three 
ablations to address atrial fibrillation. (Tr. 312.)
    Respondent further testified to marital and family issues, and his 
own related mental health issues. In 2004, Respondent was divorced. 
(Tr. 313.) In 2006, Respondent and his ex-wife disputed the custody of 
their son. (Tr. 313-14.) At that time, Respondent was experiencing 
depression. (Tr. 314.) As a result of the custody dispute, Respondent 
was permitted to see his son for three hours. (Tr. 314.) Thereafter, 
Respondent was not permitted to see his son. (See Tr. 314.)
    Turning to Respondent's medical practice, Respondent testified that 
in or around 1997, Respondent went into private practice as an 
internist. (Tr. 304-05.) For approximately ten years he performed 
workers' compensation assessments. (Tr. 305.) During this time 
Respondent worked under a grant from the National Institutes of Health 
to develop an in vitro bleeding time test. (Tr. 306.)
    From 2000 to the present, Respondent has taken pain management 
courses with the American Academy of Pain Management. (Tr. 308.) In 
2004 or 2005, Respondent purchased a medical practice in Fresno, 
California and began treating pain management patients at a time when 
approximately five or six area physicians practiced pain management. 
(Tr. 307, 315; 310.) The practice slowly evolved to the point where 
most of his patients were pain management patients. (Tr. 309.) 
Respondent testified to experiencing managerial difficulties and theft 
during the early years of this practice. (Tr. 316-20.)
    Paul J. Markowitz (Dr. Markowitz), a board-certified psychiatrist, 
testified on behalf of Respondent. (Tr. 258.) Dr. Markowitz received a 
bachelor's degree and subsequently completed the M.D.-Ph.D. program at 
Case Western Reserve University in Cleveland, Ohio. (Tr. 256.) 
Following an internship at the University Hospitals of Cleveland, Dr. 
Markowitz completed a post-doctoral fellowship in 
neuropsychopharmacology at Oxford through the National Science 
Foundation. (Tr. 257.) Following two years working at the Cleveland 
Clinic and a residency at the University Hospitals of Cleveland, Dr. 
Markowitz worked as a professor. (Tr. 257.) In approximately 2000 Dr. 
Markowitz moved to California, where he has practiced for the past ten 
years. (Tr. 257.) His practice consists of a sixty-hour week, with 
twenty or twenty-five hours devoted to seeing patients and the balance 
of his time spent on research trials. (Tr. 258.) Respondent became a 
patient of Dr. Markowitz in 2005. (Tr. 259.)
    David Smiley Purvis (Mr. Purvis), who testified on behalf of 
Respondent, is a licensed clinical social worker. (Tr. 292.) He holds a 
bachelor's degree from Fresno State University and in 1985 received a 
master's degree in social work. (Tr. 292.) Mr. Purvis testified to 
having counseled Respondent on a weekly basis on anger and frustration 
management since approximately May 2008. (Tr. 292, 294.) He explained 
that Respondent's divorce and lack of contact with his son, for whom 
Respondent cares deeply, were a very difficult and emotional experience 
for Respondent. (Tr. 293.) Mr. Purvis also testified to having visited 
Respondent's practice location to observe how Respondent treated pain 
management patients, based on Mr. Purvis's own professional and 
personal\20\ interest in how doctors treat pain management. (Tr. 294-
95.) Respondent expressed interest in how his own therapy with Mr. 
Purvis

[[Page 19327]]

could help Respondent's patients. (Tr. 297.)
---------------------------------------------------------------------------

    \20\ Mr. Purvis explained that his wife was on ``very, very 
serious medications'' to treat pain arising out of a 2005 airplane 
crash. (Tr. 295, 297.)
---------------------------------------------------------------------------

IV. The Parties' Contentions

A. The Government
    The Government urges that Respondent's registration would be 
inconsistent with the public interest and states as follows. (Tr. 8.) 
First, Respondent repeatedly issued large quantities of highly-
addictive controlled substances to patients without a legitimate 
medical purpose and outside the usual course of professional practice. 
(Tr. 8-9.) Some of these patients were suspected drug abusers, addicts 
and dealers, and yet Respondent continued to supply them with 
narcotics. (Tr. 9.) Second, Respondent has misused controlled 
substances, having been arrested while driving under the influence of 
controlled substances, and having tested positive for several 
controlled substances, including marijuana. (Tr. 8.)
    The Government argues in its post hearing brief that ``factors two, 
four and five are relevant in determining whether Respondent's 
application * * * should be denied.'' (Gov't Br. at 25.) The Government 
argues in substance that Respondent has been responsible for the 
diversion of large quantities of controlled substances by prescribing 
``controlled substances to patients without a legitimate medical 
purpose and/or outside the course of professional practice.'' (Id.) The 
Government further argues that Respondent ``arguably violated Federal 
and state law prohibiting the unauthorized use of marijuana and 
prescription drugs.'' (Id. at 28 (citing 21 U.S.C. Sec.  844).) The 
Government argues that ``Respondent's complete failure to admit fault 
or accept responsibility weighs heavily in the public interest 
determination.'' (Id. at 28.) Finally, the Government argues that 
Respondent has provided no facts demonstrating mitigating circumstances 
and due to Respondent's lack of credibility, his testimony should be 
given no weight. (Id. 29-31.)
B. Respondent
    Respondent argues that he is a competent, capable, able physician 
who is nothing like the image that the Government has portrayed. (Tr. 
11.) Respondent denies having prescribed large amounts of controlled 
substances without a legitimate medical purpose. (Tr. 12.) Moreover, 
Respondent contends that the Government's expert witness, Dr. 
Gagn[eacute], has a different approach to pain management than does 
Respondent. (Tr. 12.)
    Respondent also argues that evidence of medical and domestic issues 
affecting Respondent during the time period in question should inform 
an interpretation of Respondent's conduct. (Tr. 12.) In his post 
hearing brief, Respondent further argues that the voluntary surrender 
of his registration on August 21, 2008, is not a ground to support 
denial. (Resp't Br. at 8.) Similarly, Respondent argues that the ``sole 
conviction for a `wet and reckless' misdemeanor,'' in light of 
Respondent's medical and personal history, does not support a denial of 
his application for registration. (Id. at 8-9.)
    Respondent argues that Factors One and Three are inapplicable. 
Respondent maintains the major issue is his clinical treatment of nine 
patients, and notes there ``were specific mistakes which Respondent 
made in treating those patients.'' (Id. at 9.) Respondent argues in 
substance that there is ``little conclusive evidence'' of Respondent 
acting with disregard to the health of his patients or public, and that 
the record contains substantial evidence that Respondent ``was 
improving his pain and medical practice protocols.'' (Id.) Respondent 
``acknowledges that his record-keeping can improve'' but argues that he 
``had significant difficulties with office staff, burglaries and has 
taken a remedial records course.'' (Id.)

V. Discussion

A. The Applicable Statutory and Regulatory Provisions
    The CSA provides that any person who dispenses (including 
prescribing) a controlled substance must obtain a registration issued 
by the DEA in accordance with applicable rules and regulations.\21\ ``A 
prescription for a controlled substance to be effective must be issued 
for a legitimate medical purpose by an individual practitioner acting 
in the usual course of his professional practice. The responsibility 
for the proper prescribing and dispensing of controlled substances is 
upon the prescribing practitioner'' with a corresponding responsibility 
on the pharmacist who fills the prescription.\22\ It is unlawful for 
any person to possess a controlled substance unless that substance was 
obtained pursuant to a valid prescription from a practitioner acting in 
the course of his professional practice.\23\ In addition, I conclude 
that the reference in 21 U.S.C. Sec.  823(f)(5) to ``other conduct 
which may threaten the public health and safety'' would as a matter of 
statutory interpretation logically encompass the factors listed in 
Sec.  824(a).\24\
---------------------------------------------------------------------------

    \21\ 21 U.S.C. Sec.  822(a)(2); 21 U.S.C. Sec.  802(10).
    \22\ 21 C.F.R. Sec.  1306.04(a).
    \23\ 21 U.S.C. Sec.  844(a).
    \24\ See Kuen H. Chen, M.D., 58 Fed. Reg. 65,401, 65,402 (DEA 
1993).
---------------------------------------------------------------------------

B. The Public Interest Standard
    Pursuant to 21 U.S.C. Sec.  823(f), the Deputy Administrator may 
deny an application for a DEA COR if she determines that such 
registration would be inconsistent with the public interest. In 
determining the public interest, the Deputy Administrator is required 
to consider the following factors:
    (1) The recommendation of the appropriate state licensing board or 
professional disciplinary authority.
    (2) The applicant's experience in dispensing or conducting research 
with respect to controlled substances.
    (3) The applicant's conviction record under federal or state laws 
relating to the manufacture, distribution or dispensing of controlled 
substances.
    (4) Compliance with applicable state, federal or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.
    As a threshold matter, the factors specified in Section 823(f) are 
to be considered in the disjunctive: the Deputy Administrator may 
properly rely on any one or a combination of those factors, and give 
each factor the weight she deems appropriate, in determining whether a 
registration should be revoked or an application for registration 
denied. See David H. Gillis, M.D., 58 Fed. Reg. 37,507, 37,508 (DEA 
1993); see also D & S Sales, 71 Fed. Reg. 37,607, 37,610 (DEA 2006); 
Joy's Ideas, 70 Fed. Reg. 33,195, 33,197 (DEA 2005); Henry J. Schwarz, 
Jr., M.D., 54 Fed. Reg. 16,422, 16,424 (DEA 1989). Application of the 
public interest factors requires an individualized determination and 
assessment of prescribing and record-keeping practices that are 
``tethered securely to state law . . . and federal regulations.'' 
Volkman v. DEA, 567 F.3d 215, 223 (6th Cir. 2009). Additionally, in an 
action to deny a registrant's COR, the DEA has the burden of proving 
that the requirements for revocation are satisfied.\25\ The burden of 
proof shifts to the respondent once the Government has made its prima 
facie case.\26\
---------------------------------------------------------------------------

    \25\ See 21 C.F.R. Sec.  1301.44(e) (2010).
    \26\ See Medicine Shoppe--Jonesborough, 73 Fed. Reg. 364, 380 
(DEA 2008); see also Thomas E. Johnston, 45 Fed. Reg. 72,311, 72,311 
(DEA 1980).

---------------------------------------------------------------------------

[[Page 19328]]

C. The Factors To Be Considered
Factors 1 and 3: The Recommendation of the Appropriate State Licensing 
Board or Professional Disciplinary Authority and Conviction Record 
Under Federal or State Laws Relating to the Manufacture, Distribution 
or Dispensing of Controlled Substances
    In this case, regarding Factor One, it is undisputed that 
Respondent currently holds a valid unrestricted osteopathic medical 
license in California, but Respondent's license has been the subject of 
a ``review [by] the California Medical Board with regard to the 
appropriateness of [Respondent's] care'' (Tr. 71), the results of which 
are unknown.\27\ While not dispositive, Respondent's possession of a 
valid unrestricted osteopathic medical license in California does weigh 
in favor of a finding that Respondent's registration would not be 
inconsistent with the public interest. See Robert A. Leslie, M.D., 68 
Fed. Reg. 15,227, 15,230 (DEA 2003) (state license is a necessary, but 
not a sufficient condition for registration, and therefore, this factor 
is not dispositive).
---------------------------------------------------------------------------

    \27\ No further evidence or testimony was offered with regard to 
the status or outcome of the state review.
---------------------------------------------------------------------------

    Regarding Factor Three, there is no evidence that Respondent has 
ever been convicted under any federal or state law relating to the 
manufacture, distribution or dispensing of controlled substances. I 
therefore find that this factor, although not dispositive, see Leslie, 
68 Fed. Reg. at 15,230, weighs against a finding that Respondent's 
registration would be inconsistent with the public interest.
Factors 2 and 4: Respondent's Experience in Handling Controlled 
Substances; and Compliance With Applicable State, Federal or Local Laws 
Relating to Controlled Substances
    In this case, there is indeed evidence that Respondent has failed 
to remain in compliance with applicable federal and state law relating 
to controlled substances, and that his past experience in dispensing 
controlled substances with regard to nine patients was inconsistent 
with the public interest. The evidence at hearing centered in 
substantial part on nine patient files previously seized from 
Respondent's office on August 21, 2008.\28\ (ALJ Ex. 1; Tr. 336-38.) In 
addition to the patient files, the Government presented the testimony 
and written report of a medical expert witness, Dr. Gagn[eacute], with 
regard to his review of the nine patient files along with his opinion 
as to whether Respondent issued prescriptions in each instance for a 
legitimate medical purpose and in the usual course of professional 
practice. The patient files related to office visits with Respondent 
occurring at various dates between 2006 and 2008.\29\ Respondent 
testified as to his standard of care and treatment for each of the nine 
patients, along with his past experience, among other testimony.
---------------------------------------------------------------------------

    \28\ Testimony at hearing revealed that the process for 
selecting nine of Respondent's patient files began with the seizure 
of approximately seventy patient files pursuant to a search warrant, 
all of which were ``individuals that were known to have been either 
drug dealers or drug abusers and their associates.'' (Tr. 287.) A 
California Medical Board Investigator then selected the files to be 
reviewed by Dr. Gagn[eacute] based on the ``file structure'' and the 
fact that the ``files appeared to be incomplete.'' (Tr. 287.)
    \29\ As discussed below, however, not every prescription for 
controlled substance that Respondent issued is associated with an 
office visit.
---------------------------------------------------------------------------

    Evaluation of Respondent's prescribing conduct in this case is 
governed by applicable federal and state law. The applicable standard 
under federal law is whether a prescription for a controlled substance 
is ``issued for a legitimate medical purpose by an individual 
practitioner acting in the usual course of his professional practice.'' 
21 C.F.R. Sec.  1306.04(a). The standard of care refers to that 
generally recognized and accepted in the medical community rather than 
a standard unique to the practitioner. Robert L. Dougherty, M.D., 76 
Fed. Reg. 16,823, 16,832 (DEA 2011) (citing Brown v. Colm, 11 Cal.3d 
639, 642-43 (1974)). Although it is recognized that state law is a 
relevant factor in determining whether a practitioner is acting in the 
``usual course of professional practice,'' it is also appropriate in 
the context of an inquiry under federal law to also consider 
``generally recognized and accepted medical practices'' in the United 
States. Bienvenido Tan, M.D., 76 Fed. Reg. 17,673, 17,681 (DEA 2011).
    The applicable standards under California law may be found in 
various provisions of the California Business and Professional Code as 
well as the California Health and Safety Code. Mirroring federal law in 
substantial part, California law provides that:

[a] prescription for a controlled substance shall only be issued for 
a legitimate medical purpose by an individual practitioner acting in 
the usual course of his or her professional practice. The 
responsibility for the proper prescribing and dispensing of 
controlled substances is upon the prescribing practitioner, but a 
corresponding responsibility rests with the pharmacist who fills the 
prescription.

Cal. Health & Safety Code Sec.  11153(a). Except as authorized by Cal. 
Bus. & Prof. Code Sec.  2241,\30\ ``no person shall prescribe for, or 
administer, or dispense a controlled substance to, an addict, or to any 
person representing himself or herself as such. * * *'' Cal. Health & 
Safety code Sec.  11156(a).
---------------------------------------------------------------------------

    \30\ Sec.  2241 authorizes a practitioner to ``prescribe, 
dispense, or administer'' controlled substances to an addict ``for a 
purpose other than maintenance on, or detoxification from'' 
controlled substances. Moreover, ``a person whose drug-seeking 
behavior is primarily due to the inadequate control of pain is not 
an addict. * * *'' Cal. Health & Safety Code Sec.  11156(b)(2).
---------------------------------------------------------------------------

    Additionally, state law ``governing licentiates of the Osteopathic 
Medical Board of California is found in the Osteopathic Act and in 
Chapter 5 of Division 2, relating to medicine.'' Cal. Bus. & Prof. Code 
Sec.  3600. Relevant provisions of Chapter 5 include: ``Prescribing, 
dispensing, or furnishing dangerous drugs\31\ * * * without an 
appropriate prior examination and a medical indication, constitutes 
unprofessional conduct.'' Id. Sec.  2242(a). ``A physician * * * may 
prescribe * * * prescription drugs * * * to an addict for purposes of 
maintenance [or] detoxification. * * *'' only as set forth pursuant to 
specified provisions of law limiting continuing treatment to programs 
licensed by California. Id. Sec.  2441(b); Cal. Health & Safety Code 
Sec.  11217. This requirement does not apply ``during emergency 
treatment, or where the patient's addiction is complicated by the 
presence of incurable disease, serious accident, or injury, or the 
infirmities of old age.'' Cal. Health & Safety Code Sec.  11217(h).
---------------------------------------------------------------------------

    \31\ ``Dangerous drugs'' are broadly defined to include any 
``drug * * * that by federal or state law can be lawfully dispensed 
only on prescription. * * *'' Cal. Bus. & Prof. Code Sec.  4022.
---------------------------------------------------------------------------

    Turning to the evidence in the instant case, the testimony and 
written report of the Government's medical expert, Dr. Gagn[eacute], 
centered on a file review for patients [D.A.], [L.G.], [R.G.H.], 
[A.L.], [L.M.], [K.P.], [D.S.], [A.W.] and [T.W.].\32\ With regard to 
patient [D.A.], Dr. Gagn[eacute] noted in his report that the medical 
file consisting of five pages arguably ``establishes the minimal 
documentation necessary to treat a medical problem,'' but also noted 
the ``record omits the detail necessary to form a medical diagnosis, 
and there is no basis for the diagnosis stated.'' (Gov't Ex. 3 at 2.) 
Dr. Gagn[eacute] further noted that the ``standard of practice for 
patient records is to document all important aspects of the patient 
encounter, including: History, current medications, physical 
examination, tests, assessment, and plan.'' (Id.) Based on a review of 
[D.A.]'s medical record, Dr. Gagn[eacute] found

[[Page 19329]]

the ``record contains many of these elements in skeletal form,'' and 
further noted as a ``glaring omission'' with regard to Respondent's 
authorization of medicinal cannabis ``the absence of a psychiatric or 
addiction history or any notation as to the patient's response to 
cannabis to date.'' (Id. at 3.) Dr. Gagn[eacute] also noted the 
prescription for a large quantity of OxyContin to be ``an extreme 
deviation from the standard of practice, as is the absence of an 
adequate evaluation to support such a prescription on a medical 
basis.'' (Gov't Ex. 3 at 2-3; Gov't Ex. 8 at 5.)
---------------------------------------------------------------------------

    \32\ To protect patient privacy, patient initials are used in 
this Recommended Decision.
---------------------------------------------------------------------------

    Consistent with his written report, Dr. Gagn[eacute] testified at 
hearing that in his opinion Respondent prescribed controlled substances 
to patient [D.A.] without a legitimate medical purpose and outside of 
the usual course of professional practice because there was an 
inadequate medical evaluation. (Tr. 79-80.) Dr. Gagn[eacute] explained 
that it is outside of the usual course of professional practice to 
prescribe OxyContin without an appointment and without a treatment plan 
or some basis for issuing the prescription, which were lacking here. 
(Tr. 74-75.) Respondent's prescription for 180 OxyContin 40 mg was 
dated January 7, 2007, but the patient file contains no record of an 
office visit on that day, which occurred approximately four weeks after 
the previous appointment. (Tr. 74; Gov't Ex. 3 at 2.) Dr. Gagn[eacute] 
indicated that ``[t]here may be a medical purpose for prescribing 
OxyContin (chronic pain), but the record is completely inadequate as to 
why this is needed rather than a less dangerous alternative.'' (Gov't 
Ex. 3 at 2.) Dr. Gagn[eacute] further opined that there is no 
documented basis, such as an MRI or CT scan report, to support 
Respondent's diagnosis of annular tears in lumbar disks; without a 
basis for diagnosis there can be no basis for treatment. (Tr. 72-73.)
    On cross-examination, Dr. Gagn[eacute] elaborated on the level of 
detail required for a medical history and physical examination, noting 
that ``best practice is different from the standard practice, and it's 
different from the minimal standard one must meet in order to prescribe 
any treatment appropriately.'' (Tr. 212.)
    Respondent testified in substance that he initially saw patient 
[D.A.] on the evening of December 6, 2006, for a cannabis 
recommendation, and on January 3, 2007, for a pain management visit. 
(Tr. 345, 351.) Respondent indicated his practice was to see four or 
five cannabis recommendation patients two evenings per week, and if the 
patient requested to establish treatment with Respondent on an ongoing 
basis, the patient would be required to make another appointment during 
the day. (Tr. 345.) Respondent explained that he was able to determine 
that patient [D.A.] had ``annular tears'' by experience rather than 
with imaging such as an MRI. (Tr. 346-47.) In sharp contrast, Dr. 
Gagn[eacute] testified that an ``annular tear is a finding that one 
would obtain on imaging, probably an MRI or a CT scan, and no imaging 
was present in this file.'' (Tr. 73.) Respondent further explained his 
ability to diagnose ``annular tears'' from a variety of physical 
examination tests he performed, stating that the reason none of the 
tests were documented in the file was due to ``bouts of epicondylitis 
in my right elbow'' that limited his writing ability, among other 
reasons. (Tr. 348.) Somewhat inconsistently, Respondent also testified 
that he has ``had five of my charts reviewed by the University of 
California Davis, and they had no problems with what I was doing.'' 
(Tr. 349.) Respondent agreed with Dr. Gagn[eacute] insofar as the 
prescription dated January 3, 2007, did not have a corresponding chart 
entry associated with it. (Tr. 352.) Respondent testified that he 
prepared a chart ``every single time,'' but testified to the 
possibility the file was incomplete because of a staff error. (Id.)
    With regard to patient [D.A.], I do not find Respondent's testimony 
fully credible, particularly given Dr. Gagn[eacute]'s credible 
testimony that diagnosis of an annular tear would require imaging. 
Respondent's attempt to justify his findings based on ``experience'' 
and ``testing'' finds no objective support in the medical file or other 
record evidence. To the contrary, other patient files in this record 
contradict Respondent's assertion that he prepares a patient chart 
``every single time.'' I accept Dr. Gagn[eacute]'s findings and 
opinions regarding Respondent's deviations from the standard of care 
for [D.A.], as described above, which are well supported and consistent 
with the evidence of record.
    In the case of patient [L.G.], Dr. Gagn[eacute] noted in his report 
a medical file consisting of approximately 126 pages, commenting that 
``this is an average sort of workup for a primary care physician 
treating a pain problem,'' but noted a number of blank pain management 
forms and concluded that the ``physical examination is completely 
inadequate.'' (Gov't Ex. 3 at 4.) Dr. Gagn[eacute] noted that 
``immediately starting the patient on a high-dose OxyContin is 
extremely inappropriate without more information.'' (Id.) Dr. 
Gagn[eacute] concluded that the medical records for patient [L.G.] are 
a ``substantial departure from the standard of practice,'' further 
characterizing the departure as a difficult choice between ``simple and 
extreme departures'' but ultimately characterizing it as a simple 
departure.\33\ Finally, Dr. Gagn[eacute] opined that Respondent's 
``[p]rescribing controlled drugs (including opiates) to an addict [and] 
[p]rescribing sedating drugs to someone having recurrent falls and 
automobile accidents and altered mental status, presumably due to the 
drugs being prescribed'' was an extreme departure from the standard of 
care. (Gov't Ex. 3 at 9.)
---------------------------------------------------------------------------

    \33\ While not relevant to Respondent's prescribing practices, 
Dr. Gagn[eacute] characterized Respondent's failure to evaluate, 
treat or refer patient [L.G.] to a psychiatrist regarding [L.G.]'s 
depression as a simple departure. (Gov't Ex. 3 at 9.)
---------------------------------------------------------------------------

    Dr. Gagn[eacute] testified consistent with his report, stating that 
in his opinion prescribing controlled substances to patient [L.G.] 
``was inappropriate, it was without a medical basis, it was somebody 
having recurring problems as a result of the substances, falls and 
automobile accidents, and there was no medical basis.'' (Tr. 108.) Dr. 
Gagn[eacute] further testified that ``[i]t was clear from the medical 
record'' that [L.G.] was a drug addict. (Tr. 82.) [L.G.]'s urine 
toxicology screen showed drugs of abuse. (Tr. 83.) In particular, the 
patient file indicates that [L.G.] tested positive for methamphetamine, 
opiates, oxycodone and amphetamines even though a review of the patient 
file reveals the patient was not being prescribed amphetamine or 
methamphetamine. (Tr. 98; See Gov't Ex. 9 at 4-5.) \34\ Despite the 
evidence of drug addiction or drug abuse, Respondent did not take an 
addiction history for [L.G.] (Tr. 82.) And on February 20, 2008, the 
same day [L.G.] tested positive for methamphetamine and amphetamines, 
for which the patient lacked a prescription, Respondent issued a 
prescription for OxyContin, Roxicodone and an anti-inflammatory drug at 
the same levels the patient had previously been receiving. (Tr. 98-99.) 
Dr. Gagn[eacute] testified that Respondent therefore acted 
inappropriately, because the patient's positive test results for 
methamphetamine and amphetamines should have been ``the type of red 
flag that is a full stop, meaning that one

[[Page 19330]]

must stop providing controlled drugs and reevaluate the situation.'' 
(Tr. 99.)
---------------------------------------------------------------------------

    \34\ Although the transcript reflects that Dr. Gagn[eacute] 
referred to Government Exhibit 8, that file does not relate to 
patient [L.G.] and the pages referenced are inconsistent with a 
toxicology report. (See Gov't Ex. 8 at 4-5 (patient file for 
[D.A.]).) Under the circumstances it seems more likely that Dr. 
Gagn[eacute] intended to identify Government Exhibit 9. See Gov't 
Br. at 6 n.4 (acknowledging that Government failed to correct 
misstatement at hearing).
---------------------------------------------------------------------------

    Respondent testified that the pages of the medical chart for [L.G.] 
were not in the usual order but recalls first treating [L.G.] in 
December 2006. (Tr. 357.) Respondent acknowledged that he began a 
practice of urine drug testing toward the end of [L.G.]'s treatment, 
and that was when he first discovered improper drug use based on a 
positive test for methamphetamine, opiates, oxycodone and amphetamines. 
(Tr. 368; Gov't Ex. 9 at 4.) Respondent stated his intent was to refer 
[L.G.] to counseling and treat the patient's pain (Tr. 370) but that 
stopping the opioids immediately would have caused withdrawal. (Tr. 
371.) A February 20, 2008 follow-up consult report states: ``Patient 
took methamphetamine in her coffee a few days ago. She hasn't injected. 
She does it once to twice a week.'' (Gov't Ex. 9 at 32.) 
Notwithstanding this information, Respondent continued to prescribe 
controlled substances to [L.G.] until August 14, 2008. (Tr. 371.) 
Respondent further explained that between 2005 and 2008 he was on ``a 
learning curve'' and by 2008 ``I was getting much better at it. * * *'' 
(Tr. 373.) Respondent also testified that he did not treat [L.G.]'s 
depression with antidepressants, stating that ``I'm not sure why I 
didn't do that at the time.'' (Tr. 374.)
    I find Respondent's testimony with regard to patient [L.G.] not 
entirely credible insofar as he maintains his practice was getting much 
better by 2008. There is simply no credible evidence of record 
reflecting substantial improvement in Respondent's prescribing 
practices and compliance with applicable law. Additionally, 
Respondent's explanations that he intended to both refer [L.G.] to 
counseling and treat her pain is not credible. There is no evidence 
that a referral was made or any meaningful follow-up in that regard by 
Respondent. The testimony of Dr. Gagn[eacute], supported by [L.G.]'s 
patient file, reflects a prescribing pattern that is a substantial 
departure from the standard of care under federal and state law. Dr. 
Gagn[eacute]'s opinion that Respondent's conduct with regard to 
``[p]rescribing controlled drugs (including opiates) to an addict [and] 
[p]rescribing sedating drugs to someone having recurrent fall * * *, '' 
among other issues, constituted an extreme departure from the standard 
of care, is fully supported by the objective evidence of record.
    The medical chart pertaining to patient [R.G.H.] consisted of 
approximately seventy-seven pages. Dr. Gagn[eacute] commented that the 
documentation on the first visit of February 22, 2007, ``fills in all 
the blanks'' but ``is skeletal and grossly inadequate.'' (Gov't Ex. 3 
at 9.) Dr. Gagn[eacute] documented his review of a series of ongoing 
office visits by patient [R.G.H.] with Respondent from March 2007 to 
August 2008, concluding that Respondent had engaged in a number of 
extreme departures from the standard of care, to include inadequate 
medical records, prescribing controlled drugs (opiates) to an addict 
and using opiates with an inadequate evaluation or consideration of 
therapeutic alternatives. (Id. at 12.)
    Dr. Gagn[eacute] testified that [R.G.H.]'s patient file reflected a 
number of prescriptions for controlled substances for which there was 
no corresponding appointment with Respondent. (Tr. 112-117.) Dr. 
Gagn[eacute] was of the opinion that Respondent's issuance of 
prescriptions without a corresponding appointment ``was highly 
inappropriate and without a medical purpose.'' (Tr. 118.) Additionally, 
the patient file for [R.G.H.] included an undated notation indicating 
positive for ``Ecstasy'', ``Amph'', Methamph'', ``Benzo'' and 
``Methadone.'' (Gov't Ex. 10 at 1.) There is no other record evidence 
in the patient file further explaining the note, other than a July 9, 
2008 follow-up treatment report noting: ``Diversion: States [R.G.H.] is 
not diverting?'' (Id. at 14) and a July 22, 2008 report noting: 
``Diversion: Possibly.'' (Id. at 13.) Dr. Gagn[eacute] also testified 
in substance that [R.G.H.] clearly became addicted to powerful 
controlled substances and Respondent continued to prescribe controlled 
substances for [R.G.H.] after the addiction became apparent. (Tr. 110.) 
Dr. Gagn[eacute] testified to a number of ``red flags'' in the patient 
file suggestive of diversion or addiction. (See Tr. 110.)
    Respondent testified that he initially saw [R.G.H.] on an 
unscheduled visit while [R.G.H.] was with [R.G.H.]'s mother, for a non-
pain management matter, and Respondent referred [R.G.H.] to a 
specialist for treatment. (Tr. 376-77.) Respondent testified he next 
saw [R.G.H.] for a pain management appointment on February 22, 2007, 
when he diagnosed [R.G.H.] with ``lumbar disc problems from a motor 
vehicle accident.'' (Tr. 378.) Respondent testified to prescribing 
various controlled substances to [R.G.H.] at the initial appointment, 
as well as follow-up appointments, but was uncertain at various points 
in his testimony as to actions taken because of a lack of information 
in the chart. For example, when asked why he did not continue to 
prescribe Soma on a follow-up visit, Respondent indicated ``I'm not 
sure,'' further testifying that he would not ordinarily put information 
in a patient's chart if medication was reduced, and ``sometimes'' put a 
note in the chart for an increase. (Tr. 380.) When asked why he added 
Actiq during an April 24, 2007 follow-up appointment, Respondent 
testified that it was ``probably for breakthrough pain,'' and further 
explained that the only time he would prescribe Actiq was for 
``breakthrough pain or migraine headaches.'' (Tr. 381-82.)
    Respondent's testimony with regard to prescribing Actiq is 
inconsistent with his follow-up chart for the April 24, 2007 
appointment. (Gov't Ex. 10 at 26-27.) There is no reference to 
``migraine headaches'' other than a note in the history section 
indicating [R.G.H.] went to the emergency room after ``feeling really 
tired, sick, headache, etc.'' (Id. at 26.) Similarly, there is no 
reference in the chart to the addition of Actiq, nor any reference to 
problems with breakthrough pain. To the contrary, the pain scale is 
circled in the ``moderate'' pain category. (Id.) In fact the ``Interval 
History'' form bearing a signature consistent with [R.G.H.]'s name for 
the date of the appointment describes how [R.G.H.] has been doing since 
the last appointment which [R.G.H.] marks as ``same.'' (Id. at 27.) 
Respondent's explanation for prescribing Actiq to [R.G.H.] is simply 
not credible.
    Respondent next testified to believing that [R.G.H.] was ``using * 
* * and diverting'' controlled substances, stating ``I was prescribing 
OxyContin to her, and she was obviously not taking it since it wasn't 
in her urine.'' (Tr. 384.) Respondent initially testified he did not 
know when [R.G.H.] was tested because a lot of things ``are missing 
from this chart possibly because they were friends,'' further 
explaining that [R.G.H.] was friends with members of Respondent's 
staff. Respondent's testimony suggested that his medical assistant had 
taken documents out of the chart, but in the same sentence Respondent 
said he ``was not sure'' and had ``no way of knowing it.'' (Tr. 385.) 
Moreover, somewhat inconsistent with his initial statement that he did 
not know when [R.G.H.] was tested, Respondent next testified based on 
his chart notes of July 22, 2008, that he was aware of the urine test 
results on that date and refilled [R.G.H.]'s medications, elaborating 
that ``I only refilled it one time'' which would be within the thirty-
day discharge period for a patient. (Tr. 386)
    I find Respondent's testimony that he only refilled [R.G.H.]'s 
prescription for controlled substances one time on July 22, 2008, and 
subsequently discharged [R.G.H.], palpably not credible. The

[[Page 19331]]

unequivocal evidence of record reflects that rather than discharge 
[R.G.H.], Respondent continued to treat and refill [R.G.H.]'s 
prescriptions for controlled substances on August 6 and August 20, 
2008, even though he knew [R.G.H.] was ``using and diverting.'' (Gov't 
Ex. 10 at 12, 34.) Dr. Gagn[eacute] found the August 6 and August 20, 
2008 prescriptions concerning and opined that they were issued outside 
the scope of usual professional practice in light of the patient's 
acknowledged addiction. (Tr. 123.) He observed:

    Having someone self-identify as an addict and be referred to 
addiction treatment produces an absolute contraindication to 
provision of any controlled drug whatsoever unless one is working 
with the diversion--or the addiction treatment program and does so 
under their direction. So you would need to have close coordination 
of care. And there's no evidence that any discussion was had with 
anybody else about her addiction.

(Tr. 122.) Dr. Gagn[eacute] opined that Respondent's controlled 
substances prescriptions were without medical foundation or basis and 
constituted prescribing to an addict. (Tr. 123.) I accept the findings 
and opinions of Dr. Gagn[eacute] as noted above, which are well 
supported and consistent with other credible evidence of record.
    Turning next to the medical chart of patient [A.L.], Dr. 
Gagn[eacute] noted in his report that it consisted of approximately 
fifty-four pages covering the time period from June to December 2006. 
(Gov't Ex. 3 at 12.) Dr. Gagn[eacute] noted that the initial visit 
resulted in a prescription dated June 22, 2006, for ``180 OxyContin 
80mg, 120 Actiq 1600 mcg, and 60 10-mg Valium'' along with another 
prescription with the same date for ``another 120 Actiq 1600 mcg and 
sixty Valium.'' (Id.) Dr. Gagn[eacute] further commented that ``[t]his 
is an enormous amount of medication and constitutes overprescribing on 
its face.'' (Id. at 13.) A comparative review of the two June 22, 2006 
prescriptions from the patient file reveals that one bears in capital 
letters the word ``VOID,'' as well as a line through it, indicating 
that only one prescription was actually issued. (Gov't Ex. 11 at 23-
24.) Accordingly, I give no weight to Dr. Gagn[eacute]'s specific 
finding of overprescribing on its face.
    In his report, Dr. Gagn[eacute] also commented that the ``initial 
two visits are an extreme example of form without content,'' noting 
``no good-faith attempt to obtain an adequate history, evaluate for 
possible addiction, detail precise symptoms, determine neurologic 
status, or perform an adequate physical evaluation.'' (Id.) After 
reviewing chart information for patient [A.L.] surrounding a September 
20, 2006 follow-up visit, Dr. Gagn[eacute] commented that this ``has 
now become bizarre,'' noting in part that the file contained a 
Controlled Substance Utilization Review & Evaluation System (CURES) 
report dated September 5, 2006, showing another doctor was prescribing 
to [A.L.] 90 OxyContin 80 mg once a month from March 22 to July 21, 
2006. Dr. Gagn[eacute] referenced a final office visit dated December 
14, 2006, in which the patient chart for [A.L.] contains a notation 
from Respondent regarding the patient's abuse of drugs and medications, 
stating

    I am upset and really let him know it. He kept making excuses. 
And I stopped the excuses. I will fill his meds, have him come back 
in a month. He has to come back with a drug treatment facility--
phone number, etc., then I may discharge. I will make that decision 
next time.

(Id. at 14; see Gov't Ex. 11 at 25.) \35\
---------------------------------------------------------------------------

    \35\ I give no weight to Dr. Gagn[eacute]'s reference in his 
written report to Respondent's credibility. (Gov't Ex. 3 at 14.)
---------------------------------------------------------------------------

    Consistent with his written report, Dr. Gagn[eacute]'s testimony 
emphasized that Respondent's prescribing of controlled substances to 
[A.L.] was not in the context of a good-faith physician-patient 
relationship, there was no medical purpose served and the prescriptions 
were not issued in the usual course of professional practice. (Tr. 
137.) In support of this conclusion, Dr. Gagn[eacute] explained that 
[A.L.] tested positive for metabolites of methadone, Soma, marijuana 
and benzodiazepines, based on a specimen given November 16, 2006, and a 
report printed November 21, 2006. (Gov't Ex. 11 at 48-53; Tr. 130-33.) 
The patient file contains a printed toxicology report containing a 
handwritten notation indicating that ``Benzo prescribed--last time was 
August,'' which Dr. Gagn[eacute] interpreted as referring to three 
months before [A.L.] underwent the drug test. (Gov't Ex. 11 at 53; see 
Tr. 130-31.) Dr. Gagn[eacute] further testified that although this 
handwritten comment did not raise any concerns because it can be 
appropriate for patients to take medication intermittently, three other 
handwritten comments are concerning. (Tr. 131.) The toxicology report 
reflects a handwritten notation next to ``methadone'' stating ``Not 
Prescribed by me--stated a Family Member Gave to Him;'' next to 
Carisoprodol, a note appears stating ``not Prescribed;'' next to 
Cannabinoids, a note states ``not Prescribed or Made Legal.'' (Gov't 
Ex. 11 at 53; see Tr. 131.)
    Dr. Gagn[eacute] further testified that these notes ``confirm[ ] 
that we have a problem here'' with respect to Respondent's prescribing 
practices. (Tr. 131.) Respondent received [A.L.]'s toxicology report at 
least as early as December 14, 2006 (Gov't Ex. 11 at 48; Tr. 132), 
confronted the patient about [A.L.]'s abusive drug habits (Gov't Ex. 11 
at 25; Tr. 133), but nevertheless prescribed to [A.L.] 240 OxyContin 80 
mg and 90 Roxicodone 30 mg on that day (Gov't Ex. 11 at 46; Tr. 132). 
Dr. Gagn[eacute] testified that Respondent issued the December 14, 2006 
prescriptions outside the usual course of professional practice in 
light of ``evidence that the patient is not only abusing drugs but has 
additional sources of opiates.'' (Tr. 134.)
    Respondent testified with varying levels of certainty and 
specificity with regard to his prescribing practices for patient [A.L.] 
(Tr. 387-395.) For example, when asked why there was a discrepancy in 
the chart as to an initial visit date of June 22, 2006, but a 
medication agreement was dated June 26, Respondent replied ``I don't 
know.'' (Tr. 394.) In terms of specifics of what he might do 
differently in the future, Respondent testified ``I think I'd be better 
educated in abuse * * * '' (Tr. 395.) As to the issue of diversion, 
Respondent testified that ``I noticed that he was either using or 
diverting. And we got a CURES Report that showed that * * * [A.L.] was 
discharged within six or so visits as well, but there's no discharge 
letter in this chart. And I know for a fact he was discharged. I know 
he was discharged.'' (Tr. 393.) But the evidence contradicts 
Respondent's testimony. The evidence reflects that after the September 
5, 2006 CURES report which Respondent acknowledges as confirmation of 
``using or diverting,'' Respondent continued to prescribe controlled 
substances on four additional occasions.\36\ Additionally, contrary to 
Respondent's testimony that [A.L.] was discharged, a phone message note 
in [A.L.]'s chart dated January 17, 2007, states: ``[A.L.] need his 
oxy. All the paperwork you asked for. Per Dr. B 1/17/07 just bring in 
paperwork will speak to rehab place 1st before meds are given.'' (Gov't 
Ex. 11 at 22.) This note directly contradicts Respondent's assertion 
that [A.L.] had been discharged.
---------------------------------------------------------------------------

    \36\ September 20, October 20, November 16 and December 14, 
2006. (Gov't Ex. 11 at 32, 28 & 25.)
---------------------------------------------------------------------------

    For the foregoing reasons, I find Respondent's testimony with 
regard to patient [A.L.] not credible. Dr. Gagn[eacute]'s conclusions 
and opinion of extreme deviations in Respondent's compliance with the 
standard of care as to patient [A.L.] pertaining to the absence of a 
good-faith medical evaluation prior to prescribing controlled drugs, 
prescribing controlled drugs to someone

[[Page 19332]]

Respondent knew or should have known was an addict and prescribing 
controlled drugs without a legitimate medical purpose, are fully 
consistent with the objective evidence of record. I also accept Dr. 
Gagn[eacute]'s opinion as to a ``simple deviation for the standard of 
practice'' as it pertains to [A.L.]'s medical records. (Gov't Ex. 3 at 
14.)
    With regard to patient [L.M.], the patient chart consisted of 
sixty-three pages covering the period from July 2006 to April 2007. Dr. 
Gagn[eacute] testified that based on his review of the chart, 
``medications were not given in a good-faith manner or for a legitimate 
medical purpose.'' (Tr. 139.) Dr. Gagn[eacute] noted in his report that 
the initial July 12, 2006 consultation note indicated: ``diagnosis is 
`chronic pain from fractured ankle,' and the treatment two OxyContin 80 
mg every 12 hours and two Norco 10/325 three times a day.'' (Gov't Ex. 
3 at 15.) Dr. Gagn[eacute] commented that the chart did not ``qualify 
as a good-faith medical evaluation'' and there was no basis for 
prescribing large quantities of opiates.'' (Id.) Of note, Dr. 
Gagn[eacute] stated ``[c]ertainly the dose of opiates provided would be 
fatal in an opiate-na[iuml]ve patient.'' (Id.) In summary, Dr. 
Gagn[eacute] found the overall chart contained ``elements of the 
history and physical exam'' but there was ``no meaningful content,'' 
and therefore ``the records themselves reflect a simple deviation from 
the standard of practice.'' (Id. at 17.) Additionally, Dr. Gagn[eacute] 
found extreme deviations from the standard of practice given the 
absence of a good-faith medical evaluation prior to prescribing 
controlled drugs, prescribing controlled drugs without legitimate 
medical purpose and overprescribing much larger doses of opiates than 
was indicated clinically. (Id.)
    Respondent testified that he could not explain the absence from the 
chart of items such as past medical history, review of alcohol or drug 
abuse, and work history. (Tr. 395-96.) Respondent stated he would 
ordinarily gather that information. Respondent explained that he was 
deceived by patients, but doing better now, ``although I'm not seeing 
any pain management patients * * * .'' (Tr. 397.) Respondent further 
testified that if given a DEA registration, he would never again 
prescribe OxyContin but was unsure if he would engage in pain 
management. (Tr. 398.) Respondent testified that he believes he first 
discovered [L.M.] was engaging in duplicitous conduct ``when we got the 
CURES Report.'' (Tr. 398.) Respondent next stated the ``patient was 
discharged as well'' but ``believed [L.M.] was discharged soon after * 
* * .'' the urine test and CURES report. (Tr. 399.) In contrast, 
Respondent testified on cross-examination that he did not know when he 
received the CURES report, claiming he did not see the report or ``it 
wasn't in the chart until later.'' (Tr. 460.)
    The patient file for [L.M.] contains a CURES report dated September 
22, 2006, bearing a handwritten notation consistent with the word 
``file.'' (Gov't Ex. 12 at 56.) \37\ A review of [L.M.]'s chart reveals 
no other reference to receipt of the CURES report.\38\ Contrary to 
Respondent's testimony, [L.M.] was not discharged. Rather, Respondent 
continued to prescribe controlled substances on successive follow-up 
visits dated: October 20, 2006; November 17, 2006; December 15, 2006; 
January 11, 2007; January 30, 2007; and February 28, 2007. (Gov't Ex. 
12 at 23-33.) In fact, the chart contains a ``communication log'' dated 
April 24 to 27, 2007, confirming conversations consistent with 
notations by a staff member in Respondent's office, indicating [L.M.] 
was ``asking for refill of Oxyfast was told had to ask Dr., come back 
tomorrow.'' (Id. at 15.) A subsequent entry reflects [L.M.] ``came back 
in late p.m. advised per doctor needs to have drug screen 1st before 
new RX,'' to which [L.M.] questioned the need, stated [L.M.] was unable 
to provide a urine sample and indicated an intention to return the next 
day. (Gov't Ex. 12 at 15.) The entry the next day indicated [L.M.] 
``never returned.'' (Gov't Ex. 12 at 15.) [L.M.]'s return to 
Respondent's office in April of 2007 for a ``refill'' is inconsistent 
with Respondent's assertion that [L.M.] had been discharged, at any 
time. Clearly, [L.M.] did not believe [L.M.] had been discharged and 
the chart notations suggest that Respondent had not discharged [L.M.], 
which if true would have precluded the necessity of a urine screen.
---------------------------------------------------------------------------

    \37\ The CURES Report is dated September 22, 2006 and reflects 
various prescriptions for [L.M.] between March 30, 2006 and August 
10, 2006, listing four other prescribers in addition to Respondent.
    \38\ A urine drug screen report for [L.M.] is dated November 22, 
2006. (Gov't Ex. 11 at 54.)
---------------------------------------------------------------------------

    Accordingly, I find Respondent's testimony with regard to [L.M.] 
not credible based in part on various factual inconsistencies, as well 
has his numerous non-responsive and evasive answers to questions posed 
on both direct and cross-examination. (See Tr. 396-99; 457-60.) I 
accept Dr. Gagn[eacute]'s findings and opinions regarding Respondent's 
deviations from the standard of care for [L.M.], as described above, 
which are well supported and consistent with the evidence of record.
    The evidence and testimony pertaining to patient [K.P.] included a 
patient chart consisting of forty-one pages covering the time period 
January to July 2007. The patient chart includes prescriptions for 
various controlled substances dated: January 11, 2007; February 8, 
2007; February 15, 2007; February 16, 2007; March 6, 2007 (``to pick up 
on March 14''); March 6, 2007; March 30, 2007; April 20, 2007; April 
30, 2007; May 16, 2007; June 8, 2007; June 18, 2007; July 3, 2007; July 
12, 2007; and July 12, 2007. (Gov't Ex. 13 at 24-38.) The patient chart 
reflects an initial consultation report dated January 11, 2007, with 
follow-up reports dated: February 8, 2007; March 6, 2007; March 30, 
2007; May 16, 2007; June 8, 2007; June 19, 2007; and July 5, 2007. (Id. 
at 5-15.)
    Dr. Gagn[eacute] commented in his written report that based on 
chart documentation relating to the initial January 11, 2007 
consultation,

    the information in this visit constitutes an inadequate basis 
for treating any disease or condition and does not in my view 
reflect a good-faith medical evaluation. There is no real diagnosis 
and no basis for a diagnosis of ``annular tears.'' \39\ The amount 
of medication prescribed is egregious: 750 mg/day of oxycodone. 
Finally, there is no information in the chart from any other 
physician, including the doctor who presumably referred the patient.
---------------------------------------------------------------------------

    \39\ The January 11, 2007 consult chart reflects ``current 
medications Dose/Freq'' as ``OxyContin 80 x 180;'' ``Roxicodone 30 x 
540.'' (Gov't Ex. 13 at 15.) This quantity reflected [K.P.]'s self-
reported current medications which Respondent recorded. (Tr. 460.) 
Dr. Gagn[eacute] noted in his report that this would reflect a daily 
dose of 1020 mg of oxycodone, which would be a ``staggering dose'' 
if accurate. (Gov't Ex. 3 at 17.)

(Gov't Ex. 3 at 18.) The chart information for the February 8, 2007 
follow-up visit reflects an increase in medication at the request of 
[K.P.], noting ``pt would like to [uarr] oxy to 240'' (Gov't 
Ex. 13 at 13.) A corresponding prescription ``dated 2/8/07 is for 240 
OxyContin 80 mg (taken as four every 12 hours) and 240 Roxicodone 30 
mg, for a total of 1,200 mg daily.'' (Id.) The evidence also reflects 
two additional prescriptions issued to [K.P.] on February 15 and 16, 
2007, with no associated clinic note present in the chart. (Id. at 35-
36.) Dr. Gagn[eacute] noted the prescription dated ``2/15/07 is for 150 
Actiq 1600 mcg * * * and ten 100-mcg/hour fentanyl patches [and] yet 
another prescription on 2/16/07 is for another sixty OxyContin.'' 
(Gov't Ex. 3 at 18.) Dr. Gagn[eacute] commented in his report that 
there ``is no legitimate medical purpose for this medication. Anyone 
who actually took this much would be at risk

[[Page 19333]]

for extreme opiate side effects, including seizure and death.'' (Id.)
    Consistent with his report, Dr. Gagn[eacute] testified that the 
indication in [K.P.]'s patient file that the patient was receiving 540 
Roxicodone 30 mg from another doctor constitutes a ``huge red flag full 
stop * * * when you see something like that, you can't prescribe 
controlled drugs until you sort out what's going on.'' (Tr. 162.) Dr. 
Gagn[eacute] also noted that the patient file contains the notation 
``Patient of Dr. [W.]'s,'' with no corresponding evidence that 
Respondent consulted with or obtained records from Dr. [W.] (Tr. 162-
63.) The patient file also indicates that [K.P.] rated [K.P.]'s level 
of aerobic exercise as moderate, which raises a red flag because 
``[i]t's inconsistent with somebody who has extreme pain requiring 
stupendous doses of opiates.'' (Tr. 163.) The patient file further 
reflects a notation by Respondent ``Need to do drug screen,'' but the 
record contains no evidence that a drug screen was performed and 
further reflects that Respondent later prescribed Roxicodone, fentanyl, 
Dilaudid and two prescriptions for OxyContin in July of 2007. (Tr. 163, 
164.) To Dr. Gagn[eacute], this ``reinforces the impression that 
there's no legitimate medical purpose underway here.'' (Tr. 163-64.) 
Dr. Gagn[eacute] further testified that Respondent's prescribing 
behavior with respect to [K.P.] was ``completely inconsistent'' with 
someone who is concerned that a person is diverting drugs. (Tr. 163.) 
Dr. Gagn[eacute] opined that in prescribing to [K.P.] Respondent 
overlooked the high probability of diversion, lacked a good-faith 
medical evaluation and issued prescriptions outside the usual course of 
professional practice. (Tr. 165.)
    Respondent testified in substance that [K.P.] came to him from Dr. 
[W.] who Respondent described as ``doing pain management in town, who I 
got a lot of patients from and who I discovered were abusing their 
medications. In fact, there's at least a handful of patients I reduced 
their medications significantly.'' (Tr. 401.) Respondent further 
testified regarding the current level of medication [K.P.] self-
reported, stating this ``is what Dr. [W.] had a lot of patients on. And 
it is absurd.'' (Tr. 461.) Respondent could not explain the absence of 
records from Dr. [W.] in the patient chart, stating that ``most all my 
charts have records from Dr. [W.]'' (Tr. 401.) Respondent suggested 
that the absence of records were not due to a lack of request on his 
part, but due to staff problems in his office at the time. ``It was--it 
was a problem in the office that I had so much turnover between 2003 
and 2007. You know how costly it is and how difficult it is to keep 
training new help. * * *'' (Tr. 403-04.) Respondent's knowledge that 
``a lot'' of patients from Dr. [W.] were abusing their medications, and 
that Dr. [W.] was prescribing absurd amounts of medications, at a 
minimum should have caused Respondent to have a heightened level of 
scrutiny in the case of [K.P.] Instead, the patient chart is 
effectively devoid of any evidence that Respondent took any reasonable 
action to meet his ``responsibility for the proper prescribing * * * of 
controlled substances.'' \40\
---------------------------------------------------------------------------

    \40\ 21 C.F.R. Sec.  1306.04(a).
---------------------------------------------------------------------------

    Respondent also testified with regard to dosage levels, stating 
that he first prescribes the medication and then over a three or four 
month period evaluates the patient's medical problems and determines if 
an increase or decrease is warranted. (Tr. 402.) That testimony is 
inconsistent with Respondent's treatment of [K.P.], because the 
objective chart information indicates Respondent increased [K.P.]'s 
medication less than thirty days from the initial consult visit, 
notably at the patient's request, rather than for a stated medical 
reason. In fact, on the ``Interval History'' form bearing [K.P.]'s 
signature for the February 8, 2007 appointment, which asks the patient 
to assess how the patient has been doing since the last visit with 
regard to back pain, [K.P.] notes ``same.'' (Gov't Ex. 13 at 14.)
    Respondent also testified that he had gone through ``these records 
about a half dozen times'' and noticed ``yesterday'' that several 
signatures relating to prescriptions for [K.P.] were not his, 
apparently suggesting that people other than Respondent wrote the 
prescriptions. (Tr. 404-05.) Referring to page numbers of prescriptions 
contained in Government Exhibit 13, Respondent elaborated further on 
direct examination: ``The prescription on 38 is not my signature''; 
``Page 34 is not my signature''; ``The one on page 31 is not my 
signature. I'm not sure about 29 * * * I can't really tell.'' (Tr. 405-
06.) On cross-examination, Respondent presented conflicting testimony. 
Respondent acknowledged his signature with regard to most 
prescriptions,\41\ but testified initially that ``34 looks like it's 
mine'' but later testified ``Looks like it's not mine.'' (Tr. 465, 
466.) Directly contradicting his earlier testimony with regard to page 
twenty-nine, Respondent testified ``That appears to be mine.'' (Tr. 
465.) Similarly, Respondent directly contradicted his earlier testimony 
with regard to page 38, testifying ``It's mine.'' (Tr. 467.) 
Respondent's testimony with regard to the questionable signatures for 
three other prescriptions was vague: ``This one I can't tell * * * I do 
not know'' (Tr. 466 (Page 31).); ``I'm not sure'' (Id. (Page 35).); ``I 
can't tell on that.'' (Tr. 467 (Page 37).)
---------------------------------------------------------------------------

    \41\ Page numbers referenced herein refer to page numbers on 
bottom center of Government Exhibit 13, consistent with the 
presentation of evidence at hearing. Respondent acknowledged his 
signature on pages twenty-four to thirty, thirty-three, thirty-six 
and thirty-eight. (Tr. 465-67.) No testimony was offered with regard 
to the March 30, 2007 prescription. (Gov't Ex.13, at 32.)
---------------------------------------------------------------------------

    I do not find credible Respondent's testimony suggesting that 
several signatures on prescriptions issued to [K.P.] may be forged. 
There is no objective evidence of record to support the suggestion that 
someone else forged Respondent's signature, and Respondent's 
conflicting testimony on something as fundamental as recognition of his 
own signature, particularly with regard to the prescriptions reproduced 
in Government Exhibit 13 at pages twenty-nine, thirty-four and thirty-
eight, is plainly incredible. I also do not find credible Respondent's 
testimony suggesting his staff may have been at fault for the lack of 
follow-up or documentation in the patient chart. There is simply no 
evidence to support the assertion and Respondent's demonstrated lack of 
credibility in numerous specific portions of his testimony casts 
significant doubt on his entire testimony.
    I accept Dr. Gagn[eacute]'s conclusions and opinion of extreme 
deviations in the standard of care for patient [K.P.] pertaining to 
Respondent's: Grossly inadequate medical records, including no visit at 
all for several prescriptions; prescribing of controlled drugs without 
a legitimate medical purpose; lack of a good-faith medical evaluation 
prior to prescribing controlled drugs; and overlooking of the high 
probability of diversion. (Gov't Ex. 3 at 19.) As to the last point, 
Respondent not only overlooked but in fact knowingly accepted a high 
probability of diversion by admittedly accepting what he agreed was an 
``absurd'' level of dosing for [K.P.] (Tr. 461.)
    I do not, however, accept Dr. Gagn[eacute]'s conclusion and opinion 
with regard to Respondent's ``prescribing controlled drugs to an addict 
or to someone he should have known was an addict.'' There is no 
reference in [K.P.]'s patient chart to drug use or addiction. Any 
opinion or conclusion in that regard by Dr. Gagn[eacute] is mere 
speculation.\42\
---------------------------------------------------------------------------

    \42\ Dr. Gagn[eacute] also speculates that the ``only reason I 
can fathom for someone requesting all this medication is so [K.P.] 
can sell it,'' which notably conflicts with his opinion as to 
addiction. (Gov't Ex. 3 at 18.) I give no weight to these comments 
as to [K.P.]'s specific intent. Intent aside, the evidence is fully 
consistent with a high probability of diversion.

---------------------------------------------------------------------------

[[Page 19334]]

    The evidence as to patient [D.S.] included a patient chart 
numbering thirty-one pages covering the time period from October 2007 
to January 2008. The chart includes a ``Consultation'' note dated 
October 29, 2007, stating ``Pt was seen during cannibus nite [sic],'' 
with no other entries for history of present illness, current 
medications, physical exam or diagnosis, among other fields. (Gov't Ex. 
14 at 31.) The patient chart also contains a copy of a prescription 
dated October 24, 2007 \43\ for ``180 Norco 10/325 with two refills, 
180 soma with two refills, and a pint of Phenergan with Codeine'' 
although there is no corresponding entry in the chart documenting a 
clinical visit consistent with the prescribed medication. (Gov't Ex. 3 
at 20.) A follow-up report dated December 15, 2007, under ``History of 
Present Illness'' stated ``med refill'' and included a diagnosis of 
``Lumbar disc degeneration, chronic pain, depression.'' (Id.; Gov't Ex. 
14 at 30.) A copy of a prescription \44\ dated December 15, 2007 is for 
180 OxyContin 80 mg, 180 Norco 10/325, 180 soma, a pint of Phenergan 
with codeine, and 60 Zoloft 100 mg. (Gov't Ex. 3 at 20; see Gov't Ex. 
14 at 2 & 25.)
---------------------------------------------------------------------------

    \43\ The date could arguably read October 29, 2007, coinciding 
with chart information of an office visit for ``cannabis night.'' 
(Gov't Ex. 14 at 24.) Further confusing the issue, Respondent's 
counsel asked Respondent to describe this patient ``when she 
presented in your office apparently October 27th, '07,'' to which 
Respondent replied in context stating that he first saw [D.S.] on 
December 15, 2007. (Tr. 408.) In any event, there is no supporting 
chart information for prescribing controlled substances on October 
29, 2007. (See Gov't Ex. 14 at 31.)
    \44\ Notes related to the prescription reflect that Respondent 
prescribed a three-month supply because the patient stated ``she was 
going to Texas to see family & would not be back for 3 mo.'' (Gov't 
Ex. 14 at 30.) Dr. Gagn[eacute] commented in his report that 
``[g]iving someone who is depressed and possibly suicidal enough 
controlled and sedating medication to kill themselves and then 
planning not to see them for three months is extraordinarily poor 
care to say the least.'' (Gov't Ex. 3 at 20.)
---------------------------------------------------------------------------

    The testimony and report by Dr. Gagn[eacute] include findings and 
opinions as to extreme deviations from the standard of practice: 
Grossly inadequate medical records, including no visit at all when 
Respondent wrote one prescription; prescribing large quantities of 
dangerous, potentially lethal sedating medications to a depressed 
patient for whom no assessment was made for suicidal ideation or 
intent; absence of good-faith medical evaluation prior to prescribing 
controlled drugs; prescribing controlled drugs without a legitimate 
medical purpose; prescribing controlled drugs to an addict or to 
someone Respondent should have known was an addict; and overlooking a 
high probability of diversion. (Gov't Ex. 3 at 21.) Dr. Gagn[eacute] 
testified in substance that Respondent prescribed ``large quantities of 
controlled drugs with multiple refills with no legitimate medical 
purpose.'' (Tr. 148, 154.) He also testified that Respondent's 
diagnosis of lumbar disc disease and chronic pain lacks a medical 
basis. (Tr. 148-49.)
    Respondent testified in substance to first seeing [D.S.] on 
December 15, 2007, and said the patient ``was in for pain medications 
and cough and colds.'' (Tr. 408.) Respondent testified that he noted on 
[D.S.]'s chart ``that she doesn't have her pain managed'' but did not 
``understand why'' he stated that. (Id.) Respondent then explained that 
he was ``really putting the history of present illness down'' noting 
that [D.S.] had injured [D.S.]'s back while lifting. (Id.) Respondent 
further explained that he diagnosed lumbar disc degeneration, chronic 
pain and depression, and ``I ordered an X-ray be done on her.'' (Id.) 
Inconsistent with Respondent's testimony, the corresponding chart does 
not reflect a contemporaneous order of an X-ray but rather includes a 
January 15, 2008 order for a ``Lumbar spine X-ray Multiview.'' (Gov't 
Ex. 14 at 26.)
    By way of explanation for prescribing a three-month supply, 
Respondent testified: ``And then I gave her a three-month supply where 
she stated she was going to Texas to visit family. And I trusted that 
was the truth, and so I wrote it out for three months or enough for 
three months.'' (Tr. 409.) Respondent testified in substance that, 
other than [D.S.], he has not had a patient on an initial visit ask for 
a three-month supply, and even for longstanding patients it is ``not 
usually something that I normally do.'' (Tr. 411-12.) Respondent 
explained that in retrospect he would have questioned [D.S.] 
differently and ``I wouldn't prescribe it.'' (Tr. 412.) Respondent 
further acknowledged that with regard to his initial evaluation of 
[D.S.] ``there is room for improvement'' but never suspected at the 
time of [D.S.]'s first visit that [D.S.] was an addict or was diverting 
the medication. (Id.)
    The evidence of record is consistent with Respondent's testimony 
that he normally does not prescribe a three-month supply. Respondent 
also testified that in January 2008 when [D.S.] came in on an 
unscheduled walk-in visit, [D.S.] was discharged. (Tr. 410.) A follow-
up patient chart report is consistent with Respondent's testimony, 
reflecting in part a notation: ``No longer Seeing Patient. I think this 
patient has scammed me'' and another notation: ``Patient threatened me 
to have my license revoked.'' (Gov't Ex. 14 at 29.)
    Although I find Respondent's testimony partially credible as noted 
above, there is no testimony or other evidence of record addressing in 
any way the October 24, 2007 prescription signed by Respondent, nor 
does any credible testimony or evidence rebut the findings of the only 
expert witness in the case, Dr. Gagn[eacute], concerning his findings 
and opinions of extreme deviations from the standard of practice for 
patient [D.S.] Accordingly, I accept the findings and opinions of Dr. 
Gagn[eacute] pertaining to extreme deviations from the standard of 
practice as noted above, with the exception of Dr. Gagn[eacute]'s 
opinion that Respondent prescribed ``controlled drugs to an addict or 
to someone he should have known was an addict.'' (Gov't Ex. 3 at 21.) 
There is insufficient evidence of record to support such a finding as 
to patient [D.S.]
    The patient record for [A.W.] included a patient chart numbering 
205 pages covering the time period from November 2005 to August 2008. 
Dr. Gagn[eacute]'s initial findings and opinion regarding the 
prescribing practices for [A.W.] differed in some respects from his 
testimony at hearing. Dr. Gagn[eacute] stated in his written report 
that he is ``of two minds about this case,'' noting at one point that 
Respondent ``treats the patient's symptoms without establishing a 
medical diagnosis,'' but also stating shortly thereafter ``I did feel 
the diagnoses at the initial visit of plantar fasciitis and possible 
facet arthropathy had some basis.'' (Gov't Ex. 3 at 24.) Dr. 
Gagn[eacute] further stated in his report: ``I do not see 
overprescribing or sense the patient is abusing or diverting the 
medications.'' (Id.) Dr. Gagn[eacute]'s report also included a notation 
consistent with the foregoing, to include a review of records 
pertaining to [A.W.]'s January 2007 hospital admission, where Dr. 
Gagn[eacute] noted: ``Chemistries are unremarkable, as is the 
urinalysis.'' (Id. at 22 (interpreting Gov't Ex. 15 at 189-205).)
    On direct examination, Dr. Gagn[eacute] testified in substance that 
although ``I had not spotted this in my initial review,'' there was a 
urine drug screen dated January 2007 that was positive for cocaine. 
(Tr. 181-82.) Dr. Gagn[eacute] further testified in substance that this 
report was in the patient chart but Respondent ``had not ordered it * * 
* [so] we have no idea [if] it was something that he saw [but] I think 
there's plenty of evidence of doctor shopping and other aberrant 
medication behaviors.'' (Tr. 182.) Dr.

[[Page 19335]]

Gagn[eacute]'s reference to ``plenty of evidence'' was a reference to 
other aspects of his testimony on direct examination that highlighted 
chart information inconsistent with prescribing for a legitimate 
medical purpose. For example, Dr. Gagn[eacute] was of the opinion that 
Respondent issued various prescriptions for controlled substances for 
other than a legitimate medical purpose or outside the usual course of 
professional practice. (Tr. 170-78.) The patient record for [A.W.] 
reflects additional warning signs. Dr. Gagn[eacute] testified that 
[A.W.]'s medical record in multiple instances contains evidence of 
phone calls from other clinics to the extent that [A.W.] ``has been 
getting pain medications referred by multiple physicians and three 
different pharmacies.'' (Tr. 179.) Upon specific questioning about an 
April 2006 chart note and a July 2008 letter, Dr. Gagn[eacute] 
testified that ``this is clear-cut evidence of * * * doctor shopping.'' 
(Tr. 179; see Gov't Ex. 15 at 7 & 72.) Moreover, Dr. Gagn[eacute] 
stated that a note by Respondent that ``History of Present Illness: She 
gives me very little information to obtain those records'' would 
``absolutely'' give a practitioner cause for concern before prescribing 
opiates. (Tr. 180.) Additionally, [A.W.]'s patient file indicates that 
the patient requested--and Respondent denied--early refills. (Tr. 180.) 
Another yellow flag is an indication that the patient requested a brand 
name medication. (Tr. 180-81.) And significantly, a drug screen report 
also showed that [A.W.] tested positive for cocaine, and there is no 
evidence that Respondent discharged the patient for using illegal 
substances.\45\ (Tr. 181-82.)
---------------------------------------------------------------------------

    \45\ Moreover, Dr. Gagn[eacute] testified that Respondent did 
not order the drug screen that there is no indication whether 
Respondent saw the drug screen report. (Tr. 182.) But because the 
drug screen report was in Respondent's patient file for [A.W.], I 
find that Respondent was on inquiry notice of the contents of the 
report, even if he did not possess actual knowledge of it. There is 
no indication that the drug screen report was added to the patient 
file after the file left Respondent's custody and control following 
the execution of a warrant at Respondent's registered location 
(e.g., Tr. 324), and counsel for Respondent did not object to the 
report's admission at hearing. (Tr. 183.)
---------------------------------------------------------------------------

    Respondent testified in substance with regard to [A.W.] that [A.W.] 
``came to me from the other practice in central Fresno'' where 
Respondent believed a full history and physical had been conducted. 
(Tr. 414.) Respondent testified that he did not ``recall if I had 
[A.W.] on OxyContin from the other office or whether I just started 
treating [A.W.] then with OxyContin.'' (Id.) Respondent also testified 
that staff should have obtained prior records but did not, and 
acknowledged in retrospect that he should have done another history and 
physical examination. (Id.) Respondent testified that he never believed 
[A.W.] was drug seeking when he began treatment and never determined 
that [A.W.] was diverting. (Tr. 416; 421.) Respondent further testified 
that he does not consider therapeutic alternatives with every patient 
but does have a mission statement to ``use as many different modalities 
as possible to help the patient with pain.'' (Tr. 422.)
    Respondent's testimony with regard to his knowledge of possible 
diversion by [A.W.] is not consistent with the objective evidence of 
record, as early as April 2006. Dr. Gagn[eacute] testified that the 
January 2007 lab report finding [A.W.] positive for cocaine, and 
related chart information, does not indicate whether Respondent was 
aware of such a finding, particularly because it was not ordered by 
Respondent. Standing alone, the possibility of overlooking such a 
finding is not unreasonable, and in fact Dr. Gagn[eacute] overlooked it 
in his initial file review. The same cannot be said for the April 2006 
chart notation and the July 19, 2008 letter addressed to Respondent. 
The chart contains a prescription log bearing an entry dated April 10, 
2006:

    Margie from central Valley Clinic called to inform us that 
patient is getting Valium, Lortab & Soma from their office. Also she 
says that patient uses Valium, Lortab & Soma from their office. Also 
she says that patient uses various pharmacies using different 
insurances to refill [A.W.]'s meds.

(Gov't Ex. 15 at 7.) A second entry dated April 19, 2006, states:

    Patient given a RX for [O]xy[C]ontin since we had to reschedule 
appt. [A.W.] was advise[d] to keep [A.W.]'s appt. This is the last 
Rx because [A.W.] will be discharged per Dr. Brubaker.

(Id. (emphasis added).)

    Clearly Respondent was aware of diversion issues related to [A.W.] 
no later than April 19, 2006, because he had instructed his staff that 
[A.W.] was to be discharged. Notably, patient chart notes on and after 
April 10, 2006, make no reference to the known issue of diversion, or 
to discharge. To the contrary, a follow-up report dated July 11, 2006, 
notes in part ``No evidence of abuse * * * .'' (Id. at 139.) A letter 
addressed to Respondent from the pharmacy benefit manager Wellpoint 
Next Rx dated July 19, 2008, is further to the point, stating in 
relevant part: ``Our pharmacy claim records indicate that your patient 
listed above has had pain medications prescribed by you and at least 2 
other physicians and have filled prescriptions in at least 3 different 
pharmacies in a 3-month period.'' (Id. at 72.) This evidence 
unequivocally contradicts Respondent's testimony suggesting he had no 
knowledge of diversion by [A.W.] Rather, the July 19, 2008 letter 
confirms [A.W.]'s ongoing diversion of controlled substances consistent 
with information known to Respondent in April 2006. As with other 
material portions of Respondent's testimony, I find Respondent's 
relatively brief testimony on this issue not credible.
    Dr. Gagn[eacute] concluded in his written report for patient [A.W.] 
that Respondent's medical records are ``a substantial departure from 
the standard of practice,'' further characterizing it as a simple 
rather than extreme departure. (Gov't Ex. 3 at 25.) Dr. Gagn[eacute] 
also concluded that ``the final simple departure from the standard of 
practice is using opiates without consideration of therapeutic 
alternatives.'' (Id.) I accept the findings and opinions of Dr. 
Gagn[eacute] with the exception of his opinion that there is no 
evidence of ``overprescribing'' or evidence that ``the patient is 
abusing or diverting the medications,'' as reflected in his written 
report. That finding is inconsistent with the objective chart 
information, as early as April 2006, and Dr. Gagn[eacute] credibly 
testified that he had overlooked the information for purposes of his 
written report.
    The evidence as to patient [T.W.] included a patient chart 
numbering forty-six pages covering the time period from September 2006 
to January 2007. Dr. Gagn[eacute] noted that the initial visit resulted 
in a diagnosis of chronic hip, back and leg pain from stress fracture 
and that Respondent's ``recommended treatment is `herbal meds.' '' (Id. 
(citing Gov't Ex. 16 at 42).) The chart contains a corresponding 
prescription dated September 20, 2006, ``for 180 OxyContin 20 mg, three 
every 12 hours, 120 Norco 10/325, 1-2 every 4 hours as needed, and 90 
Xanax 2 mg, one 3 times a day.'' (Gov't Ex. 16 at 39.) Dr. Gagn[eacute] 
commented in his report that ``[t]here is no basis in this record for 
any but the most minimal treatment; there is certainly no legitimate 
medical purpose to prescribe such enormous quantities of opiates, which 
would be fatal in an opiate-na[iuml]ve person.'' (Gov't Ex. 3 at 25; 
see Gov't Ex. 16 at 39.) The patient chart contains a November 1, 2006 
prescription for ``120 Dilaudid 8 mg, 120 Norco 10/325, and 90 Xanax 2 
mg,'' with no evidence of a corresponding clinic visit. (See Gov't Ex. 
3 at 25.)
    Dr. Gagn[eacute]'s report outlines additional visits by [T.W.] with 
corresponding controlled substances prescriptions, noting finally that 
a


[[Page 19336]]


    ``Consultation'' note dated 1/31/07 is clearly not a patient 
visit: ``Discovered in the Fresno Bee [newspaper] that this patient 
has been selling drugs of abuse and [T.W.]'s pain meds and cannabis. 
This type of behavior ruins treatment for other patients. I hope 
[T.W.]'s put away for 10+ years. [T.W.] sure had me fooled. This 
patient has note in the computer now to never be seen again, ever.''

(Id. at 26 (citing Gov't Ex. 16 at 8).) Dr. Gagn[eacute]'s findings and 
opinion with regard to Respondent's standard of practice for [T.W.] 
included extreme departures in the following areas: grossly inadequate 
medical records, including no visit at all when Respondent wrote one 
prescription; absence of a good faith medical evaluation prior to 
prescribing controlled drugs; prescribing controlled drugs without a 
legitimate medical purpose; prescribing controlled drugs to an addict; 
\46\ and overlooking a high probability of diversion. (Id. at 27; see 
Tr. 189.) Elaborating on his report, Dr. Gagn[eacute] testified that 
[T.W.]'s patient file reflects that Respondent prescribed Dilaudid to 
[T.W.] on November 1, 2006, without an associated patient consultation, 
and without mention in the medical notes that Respondent wrote such a 
prescription. (Tr. 184-85.) Nor is there any mention of Dilaudid in 
contemporaneous patient notes. (Tr. 185.) Dr. Gagn[eacute] opined that 
there is no record that would justify the prescription. (Tr. 185.) The 
record further reflects a significant increase in an OxyContin 
prescription from 20 mg, 180 count on September 20, 2006, to 80 mg, 300 
count on November 21, 2006. (Tr. 186.) The record associated with 
[T.W.]'s November 21, 2006 doctor's appointment does not justify 
increasing the patient's OxyContin by that amount. (Tr. 186.) Dr. 
Gagn[eacute] testified that the entire situation ``has a trolling-for-
drugs quality.'' (Tr. 186.) Dr. Gagn[eacute] further found it unusual 
that on the day Respondent increased the dose to 300 pills a month, 
Respondent wrote ``Stable on 5 OC two 12 H,'' because the patient was 
not yet taking that many pills. (Tr. 187.) Patient [T.W.]'s medical 
file also contains references to MRI and X-ray reports that are not 
contained in the patient's medical file. (Tr. 187.)
---------------------------------------------------------------------------

    \46\ In support of this opinion, Dr. Gagn[eacute] notes in his 
report [T.W.]'s self-reported ``huge marijuana habit'' which is 
``telegraphing that he's an addict.'' (Gov't Ex. 3 at 26.)
---------------------------------------------------------------------------

    Respondent testified he initially saw [T.W.] on September 20, 2006, 
for a ``cannabis recommendation.'' (Tr. 424; Gov't Ex. 16 at 41.) 
Respondent further testified that he did not learn who was prescribing 
[T.W.]'s current medications, stating ``I don't really do that for 
cannabis recommendations.'' \47\ Respondent testified in substance that 
he normally handled cannabis recommendations at night, but after review 
of [T.W.]'s chart information testified that [T.W.] must have come in 
during the afternoon for a cannabis recommendation and pain management 
visit. (Tr. 426 & 435-36.) Respondent testified that during the initial 
consult with [T.W.] he prescribed the same medications [T.W.] had 
stated [T.W.] was already prescribed. (Tr. 427.) Respondent provided no 
credible explanation for the November 1, 2006 prescription that is not 
associated with a corresponding clinical visit, other than to refer to 
the November 21, 2006 note.\48\ (Tr. 428.) Respondent testified 
consistent with the November 21, 2006 chart note that his plan was to 
have [T.W.] obtain an X-ray, adding: ``[T.W.] never did it, so I 
discharged [T.W.]'' (Tr. 428.) On the issue of suspecting [T.W.] may be 
diverting, Respondent testified: ``Intuitively I felt there was 
something wrong with this patient, and I couldn't in just a few visits 
really tell what--what [T.W.] was up to. But in retrospect, he was one 
of the patients that sold, along with one other patient that sold * * * 
.'' (Tr. 429.)
---------------------------------------------------------------------------

    \47\ Respondent qualified his testimony, stating that he 
currently determines who is prescribing medications for a new 
patient, but was not doing so at the time of [T.W.]'s initial visit. 
(Tr. 424.)
    \48\ Reference to the November 21, 2006 chart note is irrelevant 
to the November 1, 2006 prescriptions, which precede the November 
21, 2006 visit. In any event, there is another prescription for 
controlled substances associated with the November 21, 2006 visit. 
(See Gov't Ex. 16 at 36.)
---------------------------------------------------------------------------

    I do not find Respondent's testimony credible. Contrary to his 
assertion that he ``discharged'' [T.W.] because of lack of an X-ray 
following the November 21, 2006 appointment, the patient chart reflects 
a follow-up note dated January 15, 2007, stating in part ``Refill med 
Patient stable * * * Need to repeat CT scan * * * .'' (Gov't Ex. 16 at 
9.) There is no credible evidence of record to support the suggestion 
that [T.W.] was discharged by Respondent at any point prior to the 
January 31, 2007 chart note indicating [T.W.] had been arrested for 
``selling.'' \49\ Accordingly, I accept the findings and opinions of 
Dr. Gagn[eacute] pertaining to extreme deviations from the standard of 
practice as noted above, which are well supported and consistent with 
other credible evidence of record.
---------------------------------------------------------------------------

    \49\ There is evidence of Respondent's lack of truthfulness with 
regard patient [T.W.] after January 31, 2007. Apparently following a 
telephone conversation with staff members of the facility detaining 
[T.W.], Respondent wrote a letter to ``Physician's at the Prison & 
His attorney'' stating in relevant part, ``I saw [T.W.] a few visits 
in my office where I prescribed [T.W.] [X]anax * * * for anxiety * * 
* wellbutrin * * * for ADHD * * * Norco 10/325 * * * .'' (Gov't Ex. 
16 at 16; see Tr. 432.) On cross-examination Respondent stated he 
was confused and did not ``understand what was transpiring between 
the prison doctor and myself at this time.'' (Tr. 433.) Respondent 
admitted he wrote the letter and the statement as to prescribed 
medications was ``not a true statement.'' (Id.)
---------------------------------------------------------------------------

    In addition to the foregoing, Respondent also testified at various 
points that the nine patient files admitted as evidence may be 
incomplete, or may otherwise have been altered, but offered no credible 
evidence to support this suggestion.\50\ Respondent suggested staff 
problems may have been the cause, but testified that ``overall I'm 
responsible because I'm the physician, owner of the practice; but when 
you have difficulties with staff, they can burn you, they can burn you 
bad.'' (Tr. 353.) I do not find credible Respondent's testimony 
suggesting that his files would have been complete but for staff 
neglect or tampering. As an initial matter, there is no objective 
evidence of record to support Respondent's claim. To the contrary, as 
discussed above, the objective record in numerous instances calls into 
question the accuracy of Respondent's chart entries, Respondent's 
testimony, or both.\51\ Additionally, the overall credibility of 
Respondent's testimony was significantly undermined in numerous other 
material areas, making it less likely that Respondent's unsupported 
claims of tampering are true. In any event, Respondent is ultimately 
responsible for the proper prescribing and dispensing of controlled 
substances. 21 CFR Sec.  1306.04.
---------------------------------------------------------------------------

    \50\ For example, Respondent testified at one point that ``a lot 
of things, I think are missing from this chart possibly because they 
were friends. And the MA took it out and excluded it. I'm not sure. 
I have no way of knowing it.'' (Tr. 385.) Respondent also testified 
to a March 2007 theft of a computer containing prescription 
information. (Tr. 316-19.)
    \51\ See, e.g., Tr. 73 (finding annular tears absent medical 
imaging); Tr. 394 (unexplained discrepancy in patient file as to 
initial visit date and medication agreement); Tr. 424 (recording 
``current medications'' on patient representations alone, absent 
corroboration from other prescriber); Gov't Ex. 15 at 7, 139 
(notations in chart of ``no evidence of abuse * * *'' when 
Respondent in fact did have such evidence).
---------------------------------------------------------------------------

    Respondent also testified that he never received copies of the 
fifty to seventy files seized by the police in August 2008, and 
maintained that he was unaware the files had been returned to his 
attorney. (Tr. 325-26.) On the issue of seized files, DI Lewis 
testified that after the patient files were seized from Respondent 
pursuant to a search warrant, two copies were made and one ``copy of 
these records w[as] returned through [Respondent's] attorney at the 
time, and a second copy was provided to the Medical Board of 
California.'' (Tr.

[[Page 19337]]

289.) The issue of whether Respondent ever received copies of his 
patient files from his then-attorney is not directly relevant to the 
instant case, because it is undisputed that Respondent received copies 
of the patient files discussed herein well in advance of hearing.\52\
---------------------------------------------------------------------------

    \52\ At no time during pre-hearing proceedings did Respondent 
raise by motion or otherwise this issue of unavailable files despite 
numerous opportunities to do so, as more fully explained in the 
procedural portion of this Recommended Decision. Respondent's 
suggestion in testimony that the missing files impeded his ability 
to take care of his patients is not a relevant issue in the instant 
proceeding, even if true, because Respondent's misconduct at issue 
in this proceeding predated the seizure of the nine patient files 
discussed above. (Tr. 325.)
---------------------------------------------------------------------------

    For the foregoing reasons, I find by substantial evidence that 
Respondent issued a substantial number of controlled substance 
prescriptions for other than a legitimate medical purpose and outside 
the usual course of professional practice, in violation of federal and 
state law.\53\ This finding weighs heavily in favor of a finding under 
Factors Two and Four of 21 U.S.C. Sec.  823(f) that Respondent's 
registration would be inconsistent with the public interest.
---------------------------------------------------------------------------

    \53\ See 21 CFR Sec.  1306.04(a); 21 U.S.C. Sec.  841(a)(1); and 
Cal. Health & Safety code Sec. Sec.  11217; 11153(a) and 11156(a); 
Cal. Bus. & Prof. Code Sec. Sec.  2241; 2442(a) and 3600.
---------------------------------------------------------------------------

Factor 5: Such Other Conduct Which May Threaten the Public Health and 
Safety
    Under Factor Five, the Deputy Administrator is authorized to 
consider ``other conduct which may threaten the public health and 
safety.'' 5 U.S.C. Sec.  823(f)(5). The Agency has accordingly held 
that ``where a registrant has committed acts inconsistent with the 
public interest, the registrant must accept responsibility for his or 
her actions and demonstrate that he or she will not engage in future 
misconduct. Patrick W. Stodola, 74 Fed. Reg. 20,727, 20,734 (DEA 
2009).\54\ A ``[r]espondent's lack of candor and inconsistent 
explanations'' may serve as a basis for denial of a registration. John 
Stanford Noell, M.D., 59 Fed. Reg. 47,359, 47,361 (DEA 1994). 
Additionally, ``[c]onsideration of the deterrent effect of a potential 
sanction is supported by the CSA's purpose of protecting the public 
interest.'' Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,094 (DEA 
2009).
---------------------------------------------------------------------------

    \54\ See also Hoxie v. DEA, 419 F.3d 477, 484 (6th Cir. 2005) 
(decision to revoke registration ``consistent with the DEA's view of 
the importance of physician candor and cooperation.'')
---------------------------------------------------------------------------

    There was evidence presented at hearing pertaining to ``other 
conduct which may threaten the public health and safety.'' 5 U.S.C. 
Sec.  823(f)(5). The OSC alleges that Respondent was arrested for 
driving under the influence of controlled substances on June 13, 2008, 
and that toxicology results revealed the presence of the controlled 
substances marijuana, modafinil, oxazepam and temazepam, for which 
Respondent lacked a prescription. The Government's evidence at hearing 
included the testimony of DI Lewis, along with related alcohol and 
toxicology reports and California Highway Patrol arrest reports. (Gov't 
Exs. 6 & 7.) DI Lewis testified in substance that based on his 
investigation, including a review of a CURES Report, there were 
corresponding prescriptions for identified controlled substances in 
Respondent's system with the exception of temazepam and marijuana. (Tr. 
278-79.)
    Respondent argues in substance that the ``sole conviction for a 
`wet and reckless' misdemeanor, to which Respondent pleaded guilty, and 
which there is little evidence of any drugs for which he did not have a 
valid prescription,'' as a single error, ``is not any indication of 
impairment or abuse, nor is there any other evidence of impairment or 
abuse.'' (Resp't Br. at 8-9.) Respondent presented testimony from Dr. 
Markowitz, who testified in substance that he is board-certified and 
currently practicing psychiatry. (Tr. 257-58.) Dr. Markowitz testified 
that he began treating Respondent in 2005, noting that Respondent was 
``pretty severely depressed at the time,'' for which Dr. Markowitz 
prescribed medications and Respondent ``improved markedly pretty 
quickly.'' (Tr. 259.) Dr. Markowitz diagnosed Respondent with major 
depression along with generalized anxiety disorder, noting past 
stressors of divorce, health, child visitation and financial issues. 
(Tr. 260.) Dr. Markowitz further testified that upon review of the 
toxicology document (Gov't Ex. 6) he prescribed two of the listed 
medications, namely clorazepate, sold under the trade name Tranxene, 
and Provigil, referred to on the toxicology report as ``modafinil.'' 
(Tr. 263-64.) Dr. Markowitz also opined that Respondent is not 
``depressed at this time'' and ``from a psychiatric perspective, I 
don't have any issues with his ability to practice.'' (Tr. 265.)
    David Smiley Purvis also credibly testified to counseling 
Respondent on a weekly basis since May 2008 for anger and frustration 
management issues related to family matters. (Tr. 292-93.)
    Respondent presented testimony in response to the June 2008 arrest, 
along with testimony explaining his health and other personal issues 
leading up to his August 2008 surrender of registration. Respondent 
testified in substance to having serious health issues and surgery 
between 2000 and 2002, as well as surgery again in 2004, and a heart 
condition in 2005 that involved inpatient treatment. (Tr. 307.) 
Additionally, Respondent testified to personal problems impacting his 
life including a 2004 divorce with custody issues involving his child. 
(Tr. 313-14.) Respondent further testified to ongoing issues with 
depression, staff problems in his office, and two break-ins and thefts 
from his office in 2007.
    Turning to the June 2008 arrest, Respondent testified to pleading 
to a ``wet reckless'' charge,\55\ and then took six months of classes 
which ``were about alcohol addiction.'' \56\ (Tr. 330.) Respondent 
testified that he was taking three medications at the time: 
``Provigil,'' ``Tranxene,'' and an antidepressant which Respondent 
thinks was ``Pristiq.'' (Tr. 328.) Respondent testified that all three 
were prescribed by Dr. Markowitz. Respondent's counsel then reminded 
Respondent that Dr. Markowitz only identified two prescriptions, ``but 
you mentioned you were on three medications,'' to which Respondent 
stated ``[w]ell the third one was the metabolite of benzodiazepine.'' 
\57\
---------------------------------------------------------------------------

    \55\ No further evidence or explanation at hearing of term ``wet 
reckless'' was offered, although as a matter of California practice 
the term refers to violations of Cal. Veh. Code Sec.  23103.5 (West 
2009). See, e.g., People v. Claire, 280 Cal. Rptr. 269, 271 n.2 
(Cal. Ct. App. 1991) (``For the sake of convenience, we adopt this 
sodden terminology.'').
    \56\ Respondent presented testimony regarding events surrounding 
his arrest for driving under the influence, including testimony of 
consumption of ``one'' glass of ``ale.'' I note that Respondent's 
testimony differs in various respects from the California Highway 
Patrol report, including notations in the police reports that 
Respondent admitted to drinking two beers. (See Gov't Ex. 7 at 2, 
10.) In any event, given the absence of other evidence or 
explanation for the discrepancies, I generally accept the testimony 
of Respondent that this was an isolated incident involving 
consumption of a relatively small quantity of alcohol. I also accept 
Respondent's testimony that he completed a class on alcohol 
addiction.
    \57\ Respondent's answer regarding the ``third'' prescription is 
at best non-responsive. Whether or not the third one was a 
metabolite of benzodiazepine does not respond to the substantive 
issue of whether Respondent had a prescription for the controlled 
substance, nor does it explain Respondent's earlier testimony that 
he thinks it was ``Pristiq.'' No other testimony or evidence was 
offered.
---------------------------------------------------------------------------

    I find by a preponderance of the evidence that Respondent used 
controlled substances, namely temazepam and marijuana, without a valid 
prescription and contrary to state and federal law in or about June 
2008.\58\

[[Page 19338]]

Respondent's argument that he was prescribed all of the controlled 
substances in his system is directly contradicted by the credible 
testimony of Dr. Markowitz and DI Lewis. I find no evidence of any 
alcohol or other non-prescribed controlled substance use by Respondent 
after June 2008, which is consistent with Dr. Markowitz's testimony and 
opinion that Respondent is not currently suffering from depression.
---------------------------------------------------------------------------

    \58\ Gov't Ex. 6 at 3; 21 U.S.C. Sec.  844(a); 21 CFR Sec.  
1306.04(a); Cal. Bus. & Prof. Code. Sec.  4060.
---------------------------------------------------------------------------

    Agency precedent has ``long held that a practitioner's self-abuse 
of a controlled substance is a relevant consideration under factor five 
and has done so even when there is no evidence that the registrant 
abused his prescription writing authority.'' Tony T. Bui, M.D., 75 Fed. 
Reg. 49,979, 49,989 (DEA 2010). Respondent's unlawful conduct in June 
2008, which was associated with his use of alcohol and non-prescribed 
controlled substances, is clearly an ``indication of impairment or 
abuse'' at least in June 2008, and Respondent's argument to the 
contrary is without merit. That said, Respondent's conduct appears to 
be a relatively isolated event. Respondent testified to completing a 
class on alcohol addiction and there is no evidence to support a 
finding of alcohol or controlled substance abuse after June of 2008. 
See Azen v. DEA, 1996 WL 56114 at *2 (9th Cir. Feb. 9, 1996) 
(impressive evidence of rehabilitation and continued abstinence 
important consideration). Accordingly, I find Respondent's conduct in 
June 2008 to be inconsistent with the public interest and a relevant 
consideration weighing somewhat against registration.\59\ See David E. 
Trawick, D.D.S., 53 Fed. Reg. 5326, 5326 (DEA 1988) (holding that 
``offences or wrongful acts committed by a registrant outside of his 
professional practice, but which relate to controlled substances may 
constitute sufficient grounds'' for denying relief favorable to 
Respondent, where Respondent had history of alcohol and controlled 
substances abuse).
---------------------------------------------------------------------------

    \59\ In light of the absence of other evidence of controlled 
substance and alcohol abuse, the passage of time, and Respondent's 
attendance at alcohol addiction classes, I give this issue little 
overall weight for purposes of my recommended decision.
---------------------------------------------------------------------------

    Because the Government has made out a prima facie case against 
Respondent, a remaining issue in this case is whether Respondent has 
adequately accepted responsibility for his past misconduct such that 
his registration might nevertheless be consistent with the public 
interest. See Patrick W. Stodola, 74 Fed. Reg. 20,727, 20,734 (DEA 
2009). Respondent argues generally that the Government has failed to 
demonstrate that granting Respondent a new registration would be 
inconsistent with the public interest. But across various dimensions, 
the record reveals that Respondent has not sustained his burden in this 
regard. In fact, as discussed above, Respondent's testimony in numerous 
material instances was not credible and reflected an overall lack of 
admission of past misconduct, let alone acceptance of responsibility. 
The passage of time since Respondent's misconduct is of no consequence 
with regard to the issue of acceptance of responsibility. ``DEA has 
long held that `[t]he paramount issue is not how much time has elapsed 
since [his] unlawful conduct, but rather, whether during that time * * 
* Respondent has learned from past mistakes and has demonstrated that 
he would handle controlled substances properly if entrusted with a' new 
registration.'' Robert L. Dougherty, M.D., 76 Fed. Reg. 16,823, 16,835 
(DEA 2011) (citing Leonardo V. Lopez, M.D., 54 Fed. Reg. 36,915, 36,915 
(DEA 1989) and Robert A. Leslie, M.D., 68 Fed. Reg. 15,227, 15,227 (DEA 
2003)). Respondent's testimony with regard to his June 2008 misconduct, 
and his misconduct pertaining to Factors Two and Four, clearly indicate 
a complete lack of acceptance of responsibility.
    I find that Respondent's lack of credibility during numerous 
material portions of his testimony weighs heavily in favor of denying 
Respondent's application. See Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 
2005) (DEA properly considers physician's candor, forthrightness in 
assisting investigation and admitting of fault as important factors in 
determining whether registration is consistent with public interest). 
In light of the foregoing, Respondent's evidence as a whole fails to 
sustain his burden to accept responsibility for his misconduct and 
demonstrate that he will not engage in future misconduct. I find that 
Factor Five weighs heavily in favor of a finding that Respondent's 
registration would be inconsistent with the public interest.

VI. Conclusion and Recommendation

    After balancing the foregoing public interest factors, I find that 
the Government has established by substantial evidence a prima facie 
case in support of denying Respondent's application for registration, 
based on Factors Two, Four and Five of 21 U.S.C. Sec.  823(f). Once DEA 
has made its prima facie case for revocation or denial, the burden 
shifts to the respondent to show that, given the totality of the facts 
and circumstances in the record, revoking or denying the registration 
would not be appropriate. See Morall v. DEA, 412 F.3d 165, 174 (D.C. 
Cir. 2005); Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v. 
United States Dep't of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989); 
Thomas E. Johnston, 45 Fed. Reg. 72, 311 (DEA 1980).
    Additionally, where a registrant has committed acts inconsistent 
with the public interest, he must accept responsibility for his actions 
and demonstrate that he will not engage in future misconduct. See 
Patrick W. Stodola, 74 Fed. Reg. 20,727, 20,735 (DEA 2009). Also, 
``[c]onsideration of the deterrent effect of a potential sanction is 
supported by the CSA's purpose of protecting the public interest.'' 
Joseph Gaudio, M.D., 74 Fed. Reg. 10,083, 10,094 (DEA 2009). An 
agency's choice of sanction will be upheld unless unwarranted in law or 
without justification in fact. A sanction must be rationally related to 
the evidence of record and proportionate to the error committed. See 
Morall v. DEA, 412 F.3d 165, 181 (D.C. Cir. 2005). Finally, an ``agency 
rationally may conclude that past performance is the best predictor of 
future performance.'' Alra Laboratories, Inc. v. DEA, 54 F.3d 450, 452 
(7th Cir. 1995).
    I recommend denial of Respondent's application for a COR. I find 
the evidence as a whole demonstrates that Respondent has not accepted 
responsibility and his registration would be inconsistent with the 
public interest. Respondent's overall lack of candor while testifying 
at hearing is fully consistent with a denial of Respondent's 
application for a DEA COR.

Dated: April 29, 2011.

Timothy D. Wing,
Administrative Law Judge.
[FR Doc. 2012-7619 Filed 3-29-12; 8:45 am]
BILLING CODE 4410-09-P