Registrant Actions - 2012
[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Notices]
[Pages 45663-45675]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-18747]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 12-27]
James William Eisenberg, M.D.; Decision and Order
On April 5, 2012, Administrative Law Judge Timothy D. Wing issued
the attached recommended decision.\1\ Neither party filed exceptions to
the ALJ's decision.
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\1\ All citations to the ALJ's decision are to the slip opinion
as originally issued.
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Having reviewed the entire record, I have decided to adopt the
ALJ's findings of fact and conclusions of law except as noted below.\2\
Based on a recent action of the Arizona Medical Board, which is
discussed more fully below, I reject the ALJ's conclusion that the
Arizona Medical Board's "action reflects a determination that
Respondent, notwithstanding findings of unprofessional conduct in the
recent past, can be entrusted with a medical license" and that "this
action * * * weigh[s] against a finding that Respondent's continued
registration would be inconsistent with the public interest under
Factor One." ALJ at 21.
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\2\ I do not adopt the ALJ's footnote 25. See Kwan Bo Jin, 77 FR
35021, 35021 n.2 (2012).
Moreover, regarding the ALJ's discussion of whether the Arizona
Board's 2011 order, see GX 11, which provided that Respondent's
admissions were "not intended or made for any other use, such as in
the context of another State or Federal government regulatory
proceeding," is binding on this Agency, see ALJ at 20 n. 29, I
further note that DEA has previously held that "[s]tate officials *
* * lack authority to resolve a matter pending before the [Agency]
and [a] stipulated settlement [between state officials and a
Registrant] cannot bind this Agency." Edmund Chein, 72 FR 6580,
6590 (2007), pet. for rev. denied, 533 F.3d 828 (DC Cir. 2008)). See
also Fourth Street Pharmacy v. DEA, 836 F.2d 1137, 1139 (8th Cir.
1988) (absent proof of an agency relationship between a state
Attorney General and the Agency regarding an agreement between the
State and a registrant, a state Attorney General "could not and did
not have authority to bind the DEA to a promise to refrain from
instituting lawful regulatory action to revoke" a registration).
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However, I do adopt the ALJ's findings and legal conclusions that
Respondent lacked a legitimate medical purpose and acted outside of the
usual course of professional practice when, on August 12, 2011, he
prescribed both oxycodone and Xanax to an undercover officer, as well
as on September 1, 2011, when he prescribed oxycodone to a second
undercover officer. ALJ at 30-31. As the ALJ found, substantial
evidence supports the conclusion that these were negotiated drug deals
in which for an additional fee, Respondent, upon the requests of the
undercover officers for the drugs, agreed to prescribe controlled
substances and negotiated with the undercover officers over the
quantity of the oxycodone and/or the strength of the drug.\3\ See id.
23-27. Indeed, with respect to the second undercover officer,
Respondent agreed to write a prescription for oxycodone before he had
even performed a physical examination. See id. at 25-26. The findings
with respect to the two undercover officers alone establish a prima
facie case that Respondent has committed acts which render his
registration inconsistent with the public interest. See 21 U.S.C.
824(a)(4); see also MacKay v. DEA, 664 F.3d 808, 821 (10th Cir. 2011);
Jayam Krishna-Iyer, 74 FR 459, 463 (2009) (citing Alan H. Olefsky, 57
FR 928, 928-29 (1992)).
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\3\ While I adopt the ALJ's findings and legal conclusions that
Respondent unlawfully distributed controlled substances to the
undercover officers, I rely solely on the evidence regarding the
circumstances of their visits with Respondent. To make clear, I
reject the ALJ's legal conclusion that the hearsay statement of a
former employee of AZ Go Green to the effect "that Respondent was
illegally prescribing oxycodone" constitutes substantial evidence
that Respondent was engaged in drug deals. ALJ at 27 n.35. Contrary
to the ALJ's assertion, this information was initially provided by
the informant to the Phoenix Police Department, which relayed it to
the Arizona Attorney General's Office, which then passed it on to
the DEA Special Agent, and was thus hearsay within hearsay within
hearsay. Tr. 23.
While the Special Agent testified that he knew the informant had
been a former employee, he offered no further evidence to support
that the declarant was reliable. See id. Most significantly, the
Government offered the testimony for the limited purpose of showing
what prompted the investigation, id. at 69, and when on cross-
examination, Respondent's counsel attempted to explore the issue of
the informant's potential bias, the Government objected that the
inquiry was not relevant to the issue of whether Respondent issued
prescriptions for a legitimate medical purpose in the usual course
of professional practice. Id. at 70-71. Indeed, the Government
itself later objected to a further question on cross-examination
contending that the informant's statements were hearsay, explaining
that it had offered the statements "just to show why the agents
were at AZ Go Green." Id. at 74.
I agree with the Government and conclude that the statement does
not constitute substantial evidence that Respondent was engaged in
drug deals. See Consolidated Edison Co. v. NLRB, 305 U.S. 197, 229
(1938) (Substantial evidence * * * means such relevant evidence as a
reasonable mind might accept as adequate to support a
conclusion."). Instead, I rely on the evidence pertaining to the
specific undercover visits.
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While I do not rely on the hearsay evidence cited by the ALJ as
support for his conclusion that Respondent was engaged in drug deals,
there is other evidence to support the conclusion that Respondent is a
drug dealer. I take official notice \4\ that on April 4, 2012, the
Arizona Medical Board issued to Respondent an Order For Decree Of
Censure And Practice Restriction And Consent To The Same. See In re
James W. Eisenberg, M.D. No. MD-11-1351A (Az. Med. Bd. Apr. 4, 2012).
Therein, the Board found, with respect to four patients (including the
owner of the clinic where he worked), that Respondent:
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\4\ Under the Administrative Procedure Act (APA), an agency
"may take official notice of facts at any stage in a proceeding--
even in the final decision." U.S. Dept. of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and
DEA's regulations, Respondent is "entitled on timely request to an
opportunity to show to the contrary." 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). To allow Respondent the opportunity to refute the
facts of which I take official notice, Respondent may file a motion
for reconsideration within fifteen days of service of this order
which shall commence with the mailing of the order.
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Failed to document any attempt to verify the diagnoses or to
obtain medical records, imaging, diagnostic work up or specialty
consultation. Respondent failed to consider any non-opioid
management other than cannabis, and failed to review the Controlled
Substance Prescription Monitoring Program (CSPMP); perform urine
drug testing; counsel the patients regarding precaution, risks and safe opioid use; or obtain a standard opioid treating agreement.
Id. at 2. The Board further found with respect to these patients, that
Respondent:
Deviated from the standard of care by performing an extremely
limited pain history and physical exam, by failing to perform a
medical record review or risk assessment for opioid use, by failing
to perform a diagnostic evaluation or consider a multidisciplinary
approach outside of cannabis and daily opioid, by failing to verify
a medical diagnosis appropriately treated with daily high dose
opioid, and by failing to monitor for compliance by urine drug
testing or review of the CSPMP.
Id. at 3. The Board thus concluded that Respondent had committed
"unprofessional conduct," by engaging in conduct "that is or might
be harmful or dangerous to the health of the patient or the public"
and by "failing or refusing to maintain adequate records
[[Page 45664]]
on a patient." Id. at 4 (citing Ariz. Rev. Stat. Sec. 32-1401(27)(q)
&(e)). Accordingly, the Arizona Board found that "a practice
restriction is needed in order to protect the public," and in addition
to issuing a "Decree of Censure," prohibited Respondent "from
prescribing, administering, or dispensing any [c]ontrolled [s]ubstances
for a period of five years." \5\ Id.
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\5\ Had Respondent been registered in Arizona, the Board's order
prohibiting him from dispensing controlled substances would have
provided a separate and independent ground to revoke his
registration. See 21 U.S.C. 824(a)(3).
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Substantial evidence also supports a finding that Respondent
violated federal law by prescribing controlled substances without being
registered in the State of Arizona. See ALJ at 35-36 (citing 21 U.S.C.
822(a)(2) & (e); 21 CFR 1301.12(b)(3)); see also Clarification of
Registration Requirements for Individual Practitioners, 71 FR 69478
(2006).\6\ In addition, substantial evidence supports a finding that
Respondent violated federal regulations by failing to include required
information such as a patient's address on numerous controlled
substance prescriptions he issued. ALJ at 31 (citing 21 CFR
1306.05(a)); see also GX 3.
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\6\ However, I do not adopt the ALJ's conclusion of law that
Respondent violated Arizona Rev. Stat. Ann. Sec. 36-2522(A)(2)
because he was not registered in Arizona. The Government raised no
such allegation in either the Show Cause Order (ALJ Ex. 1) or its
pre-hearing statement (ALJ Ex. 5), and it made no such argument in
its brief.
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I therefore conclude that Respondent has committed acts which
render his continued registration inconsistent with the public interest
and which support the revocation of his registration. See 21 U.S.C.
824(a)(4); see also ALJ at 39. Moreover, while the burden then shifted
to Respondent to accept responsibility for his misconduct and
demonstrate that he will not engage in future misconduct, see Patrick
W. Stodola, 74 FR 20727, 20734 (2009); the ALJ further found that
Respondent lacked "credibility during numerous material portions of
his testimony" and "has not accepted responsibility for his * * *
misconduct." ALJ at 38. See also MacKay, 664 F.3d at 821 ("Because
Dr. MacKay has not accepted responsibility for his conduct, revocation
of his registration is entirely consistent with DEA policy.").
Accordingly, I adopt the ALJ's conclusion that Respondent has not
rebutted the Government's prima facie case, id. at 39; and will order
that his registration be revoked and that any pending applications to
renew or modify his registration be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of
Registration AE5382724, issued to James William Eisenberg, M.D., be,
and it hereby is, revoked. I further order that any pending application
of James William Eisenberg, M.D., to renew or modify his registration,
be, and it hereby is, denied. This Order is effective immediately.\7\
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\7\ For the same reasons which led me to order the Immediate
Suspension of Respondent's registration, I conclude that the public
interest necessitates that this Order be effective immediately. 21
CFR 1316.67.
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Dated: July 24, 2012.
Michele M. Leonhart,
Administrator.
Carrie Bland, Esq., for the Government.
David K. Demergian, Esq., for Respondent.
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge
I. Introduction
This proceeding is an adjudication pursuant to the Administrative
Procedure Act, 5 U.S.C. 551 et seq., to determine whether the Drug
Enforcement Administration (DEA, Agency or Government) should revoke a
physician's DEA Certificate of Registration (COR) as a practitioner
pursuant to 21 U.S.C. 824(a)(4) and deny, pursuant to 21 U.S.C. 823(f),
any pending applications for renewal or modification and any
applications for any other DEA registrations. Without such
registration, the physician, James William Eisenberg, M.D.
(Respondent), of the State of California, would be unable to lawfully
prescribe, dispense or otherwise handle controlled substances in the
course of his practice.
On December 14, 2011, the Administrator, DEA, issued an Order to
Show Cause and Immediate Suspension of Registration (OSC/IS) to
Respondent. The OSC/IS alleged that Respondent's continued registration
constitutes an imminent danger to the public health and safety. The
OSC/IS also provided notice to Respondent of an opportunity to show
cause as to why the DEA should not revoke Respondent's DEA COR
AE5382724, pursuant to 21 U.S.C. 824(a)(4), and deny any pending
applications for renewal or modification of that registration and any
applications for any additional registrations, pursuant to 21 U.S.C.
823(f), alleging that Respondent's continued registration is
inconsistent with the public interest as that term is defined in 21
U.S.C. 823(f). (ALJ Ex. 1, at 1.)
The OSC/IS alleged that Respondent is registered with DEA as a
practitioner in Schedules II through V under DEA COR AE5382724 at 8466
Santa Monica Boulevard, West Hollywood, California 90069, with an
expiration date of August 31, 2013. (Id.) The OSC/IS further alleged
the following:
That from August to September 2011, law enforcement personnel
conducted two undercover visits to AZ Go Green, a clinic where
Respondent authorizes the use of marijuana, located at 426 East
Southern Avenue, Suite 102, Tempe, Arizona. That Respondent issued
prescriptions for oxycodone, a Schedule II controlled substance, and
alprazolam, a Schedule IV controlled substance, to the undercover
officers (UCs) without a legitimate medical purpose in the usual course
of professional practice, (ALJ Ex. 1, at 1-2);
That Respondent is not authorized by DEA to prescribe, dispense or
otherwise handle controlled substances in the State of Arizona;
Respondent allowed the UCs to dictate the type and amount of controlled
substances prescribed rather than prescribing based on his own medical
judgment; and Respondent charged the UCs based on the type of
prescriptions rather than on the medical treatment rendered, (ALJ Ex.
1, at 2); and
That Respondent authorized at least 190 controlled substance
prescriptions, seventy-five percent of which were for oxycodone, in
Arizona without a DEA registration for his Arizona practice location.
The prescriptions were issued for other than a legitimate medical
purpose in the usual course of professional practice in violation of 21
U.S.C. Sec. 822, 829, 841(a); 21 CFR 1301.12, 1306.04, (Id.).
In addition to the allegations set forth in the OSC/IS, the
Government also noticed and alleged in its prehearing statement and
documentary evidence that Respondent issued controlled substance
prescriptions to the owner and employees of AZ Go Green without
documenting the prescriptions in their respective patient charts, (ALJ
Ex. 5, at 2); Respondent issued prescriptions using a variety of
addresses, including the address for AZ Go Green, that were not
registered practice addresses with DEA, (Id. at 2-3); Respondent failed
to include the patients' addresses on prescriptions in violation of 21
CFR 1306.05, (Id. at 3); Respondent issued medical marijuana
authorizations and cards to the UCs (Id. at 3-4); and on February 3,
2012, the Arizona Medical Board (Board) issued an Order for Letter of
Reprimand and Consent to the Same (February 3, 2012 Order) finding that
Respondent engaged in unprofessional
[[Page 45665]]
conduct by knowingly making a false or fraudulent statement in the
practice of medicine, (Gov't Ex. 11).\1\
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\1\ I find in this case that the Government's prehearing
statements and documentary evidence noticed during prehearing
procedures comports with the due process requirement to "provide a
Respondent with notice of those acts which the Agency intends to
rely on in seeking the revocation of its registration so as to
provide a full and fair opportunity to challenge the factual and
legal basis for the Agency's action." CBS Wholesale Distributors,
74 Fed. Reg. 36,746 (DEA 2009) (citing NLRB v. I.W.G., Inc., 144
F.3d 685, 688-89 (10th Cir. 1998); Pergament United Sales, Inc., v.
NLRB, 920 F.2d 130, 134 (2d Cir. 1990)).
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Following prehearing procedures, a hearing was held in Phoenix,
Arizona on February 28, 2012, with the Government and Respondent each
represented by counsel. Both parties called witnesses to testify and
introduced documentary evidence. After the hearing, both parties filed
proposed findings of fact, conclusions of law and argument. All of the
evidence and post-hearing submissions have been considered, and to the
extent the parties' proposed findings of fact have been adopted, they
are substantively incorporated into those set forth below.
II. Issue
Whether the record establishes that Respondent's DEA COR AE5382724
as a practitioner should be revoked and any pending applications for
renewal or modification of that registration and any applications for
additional registrations should be denied on the grounds that
Respondent's continued registration would be inconsistent with the
public interest pursuant to 21 U.S.C. 824(a)(4) and 823(f).
III. Evidence and Incorporated Findings of Fact \2\
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\2\ In addition to the evidence discussed in this Section,
additional evidence and findings of fact are discussed in later
sections of this Recommended Decision.
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I find, by a preponderance of the evidence, the following facts:
Respondent graduated with a B.A. degree from the University of
Pennsylvania in 1962. He then obtained an M.D. degree in 1967 from the
New Jersey College of Medicine.\3\ (Tr. 154.) Respondent is licensed to
practice medicine in California and Arizona, and he is board certified
in internal medicine. (Tr. 154, 158.) Respondent is registered as a
practitioner with DEA, with a registered practice address at 8466 Santa
Monica Boulevard, West Hollywood, California 90069. (Tr. 28-29; Gov't
Ex. 1.)
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\3\ After graduating from medical school, Respondent interned in
the Columbia Division at Belleview Hospital in New York City, and
then completed his residency in internal medicine in the Columbia
Division at Harlem Hospital in New York City in 1970. (Tr. 154.) He
worked as a senior resident and assistant chief resident at New York
Hospital/Cornell Medical Center from 1970 to 1971, during which time
he was a post-doctoral fellow at the Rockefeller University in New
York. (Id.)
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Respondent practiced at AZ Go Green, located at 325 East Southern
Avenue, Suite 120, Tempe, Arizona,\4\ from April 2011 until December
2011. (Tr. 154-55; see Gov't Ex. 3.) It is undisputed that Respondent
did not register AZ Go Green as a practice location with DEA, nor did
he register any other Arizona practice location with DEA. (Tr. 165.)
Although he is still licensed to practice medicine in Arizona,
Respondent no longer practices there. He now conducts medical marijuana
evaluations and practices pain management in California. (Tr. 155.)
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\4\ But see ALJ Ex. 1, at 1 (alleging that AZ Go Green is
located at 426 East Southern Avenue, Suite 102, Tempe, Arizona).
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B. The Government's Evidence
The Government's evidence included testimony from Special Agent
(SA) Stephen Lamkin (SA Lamkin) and two UCs--Officer Dustin Melton
(Officer Melton) and Officer Bradford Knights (Officer Knights). In
addition to testimonial evidence, the Government also introduced
various documentary evidence, including, among others: an audio
recording and transcript of one undercover visit with Respondent at AZ
Go Green; \5\ copies of prescriptions issued by Respondent to the UCs
and other patients; \6\ patient files for the UCs and other patients;
\7\ and the February 3, 2012 Order entered by the Board.\8\
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\5\ Gov't Ex. 2.
\6\ Gov't Ex. 3.
\7\ Gov't Exs. 4-9.
\8\ Gov't Ex. 11.
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SA Lamkin \9\ testified that DEA began investigating AZ Go Green
and Respondent in the summer of 2011, after a former employee of AZ Go
Green filed a complaint with the Phoenix Police Department that AZ Go
Green was illegally distributing marijuana \10\ and oxycodone. (Tr. 22-
23, 69-71, 75.) Respondent was the physician at AZ Go Green,
responsible for "assessing and diagnosing patients who came in seeking
medical marijuana." (Tr. 23.)
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\9\ SA Lamkin has been a special agent with DEA for sixteen
years. He has been assigned to the Diversion Group, which
investigates the illegal use and distribution of pharmaceutical
grade controlled substances, since 2005. (Tr. 22.)
\10\ SA Lamkin testified that when the investigation was
initiated, "[t]here was no medical marijuana dispensaries allowed
to be operating at that time in the state. There was a hold from the
Department of Health Services on medical marijuana dispensaries
licensing and operating * * *." (Tr. 82-83.)
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SA Lamkin testified that DEA set up four undercover visits, using
three UCs, in an attempt to obtain marijuana or pharmaceuticals from AZ
Go Green. (Tr. 23-24, 77-78.) On all four visits, the UCs obtained
marijuana, and on two of the visits, the UCs obtained prescriptions for
oxycodone.\11\ (Tr. 26.) The first UC, Officer Melton, went to AZ Go
Green on two occasions using the undercover name "Dustin Darrow."
(Tr. 48-49.) On his first visit, Officer Melton received prescriptions
for 120 tablets of oxycodone 30 milligrams and 90 tablets of Xanax 2
milligrams. (Tr. 50; Gov't Ex. 3, at 1.) Officer Melton did not get
oxycodone on his second undercover visit because J.C., the owner of AZ
Go Green, told Officer Melton that he could not see Respondent. (Tr.
78-79.) The second UC, Officer Knights, conducted one undercover visit
to AZ Go Green using the undercover name "Bradley Kites." (Tr. 50,
77-78.) Officer Knights obtained a prescription for 150 tablets of
oxycodone 15 milligrams. (Tr. 50; Gov't Ex. 3, at 6-7.) The third UC,
patient L.V., was denied an oxycodone prescription. (Tr. 78.)
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\11\ One prescription for oxycodone was entered directly into
evidence and the other was actually filled at the pharmacy by the
UC. (Tr. 26.)
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SA Lamkin testified that he obtained the prescription monitoring
profile for Respondent through the Arizona Controlled Substances
Prescription Monitoring Program (CSPMP),\12\ which showed that
Respondent had issued controlled substance prescriptions in the State
of Arizona. (Tr. 33.) SA Lamkin explained, however, that the CSPMP
report should not have shown any prescriptions issued by Respondent in
Arizona because Respondent did not have a DEA registration in Arizona.
(Tr. 30, 32-33.) Respondent's only DEA registration was issued for a
practice address at 8466 Santa Monica Boulevard, West Hollywood,
California 90069. (Tr. 28-29, 30, 32-33; see Gov't Ex. 1.) SA Lamkin
explained that if a practitioner maintains a clinic in Arizona, the
practitioner must have a DEA registration for Arizona for that practice
location. (Tr. 30.)
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\12\ SA Lamkin testified that the CSPMP is a prescription
monitoring program set up by the Arizona Board of Pharmacy that
monitors any controlled substances, as defined by Arizona statutes.
(Tr. 26-27.) The prescription monitoring profile for Respondent
shows "all of the prescriptions he had written for patients * * *
in Arizona that had been filled. * * * The [CS]PMP lists the
patient's address as it's given on the prescription." (Tr. 28.)
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SA Lamkin testified that he retrieved some of the prescriptions
issued by Respondent in Arizona, including those issued to the UCs.
(Tr. 33-34; Gov't Ex. 3.) Additionally, SA Lamkin testified that on
September 29, 2011, he executed a search warrant at AZ Go Green, where
he seized approximately eight patient files, as well as other
documentary
[[Page 45666]]
evidence and marijuana products. (Tr. 35-37, 61; Gov't Exs. 4-9.)
Although there were more patient files at AZ Go Green, SA Lamkin
testified that DEA only seized the patient files "to show what we
needed to show. To marry it up with actual undercover visits or people
who were employees of the clinic who probably shouldn't have been
getting marijuana in any case from a doctor that worked at the
clinic." (Tr. 62, 67-68.)
SA Lamkin testified that Respondent issued controlled substance
prescriptions to patients M.F., L.H., and R.B., who were all AZ Go
Green employees. (Tr. 38-45, 52-54; see Gov't Ex. 4, at 4.) In
particular, Respondent issued a prescription for oxycodone to M.F. on
June 30, 2011. (Tr. 38-40; Gov't Ex. 3, at 23.) On September 2, 2011,
Respondent issued a prescription for testosterone to L.H. (Tr. 44-45,
90-91; Gov't Ex. 3, at 25.) Between April 1, 2011 and August 12, 2011,
Respondent issued the following controlled substance prescriptions to
R.B.: four prescriptions for oxycodone; two prescriptions for Xanax;
one prescription for codeine syrup; two prescriptions for Percocet; and
one prescription for Adderall. (Tr. 53; Gov't Ex. 3, at 2-3, 8-11, 16-
18, 21-22.) SA Lamkin testified that none of these prescriptions were
documented in the patient files for M.F., L.H., and R.B. (Tr. 43, 45,
53; Gov't Exs. 4-5, 9.) \13\
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\13\ But see Gov't Ex. 5, at 9 (noting that L.H. takes
testosterone, Xanax, and Percocet), and Gov't Ex. 9, at 15 (listing
four prescriptions issued by Respondent to R.B.).
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Additionally, between April 1, 2011 and October 20, 2011,
Respondent issued twelve controlled substance prescriptions to J.C.,
the owner of AZ Go Green. Specifically, Respondent issued eight
prescriptions for oxycodone, two prescriptions for Xanax, one
prescription for Adderall, and one prescription for Vicodin. (Tr. 46-
47; see Gov't Ex. 3, at 2-7, 12-15, 17-20, 24.) SA Lamkin testified
that there is nothing contained within J.C.'s patient file to indicate
that Respondent issued these prescriptions to J.C. (Tr. 48; see Gov't
Ex. 6.)
Finally, SA Lamkin testified that the controlled substance
prescriptions issued to the UCs were not documented in the patient
files for "Dustin Darrow" and "Bradley Kites." (Tr. 50-51; Gov't
Exs. 7-8.)
Although the prescriptions issued to the UCs and AZ Go Green
employees were not documented in the patient files, SA Lamkin testified
the prescriptions were "probably" written on duplicate or triplicate
prescription pads. (Tr. 85.) SA Lamkin testified that there was a
prescription pad in Respondent's exam room that may have contained the
carbon copies of the prescriptions. (Tr. 88-89, 93.) SA Lamkin
testified that he was not medically qualified to assess the
appropriateness of the prescriptions, but he is "qualified to comment
on whether [Respondent] met recordkeeping standards" with respect to
those prescriptions and patient files. (Tr. 89, 90, 92, 96, 98, 99.)
Finally, SA Lamkin testified that in the course of his
investigation of Respondent and AZ Go Green, he learned that the Board
entered the February 3, 2012 Order against Respondent. SA Lamkin
understood that the February 3, 2012 Order was the result of
Respondent's failure to query the CSPMP before issuing prescriptions.
(Tr. 56-57, 84-85; Gov't Ex. 11.)
Officer Melton \14\ testified that in August 2011, SA Lamkin asked
him to assist with the investigation of Respondent and AZ Go Green.
(Tr. 106, 120.) On August 12, 2011, Officer Melton participated in an
undercover visit to AZ Go Green, where his mission was to obtain a
doctor's referral for a medical marijuana card, marijuana, prescription
pills and any other drugs. (Tr. 107, 120.) Officer Melton went into AZ
Go Green using the alias "Dustin Darrow." (Tr. 107.) When he arrived
at AZ Go Green, he was told he had to leave his bag, which contained a
recording device, with security. (Tr. 107-08.) He then went to the
receptionist and told her that he wanted to obtain a doctor's referral
for a medical marijuana card. She told him it would cost $150.00, which
he paid in cash.\15\ He then filled out some paperwork about his
medical history, on which he indicated that he broke his back in 2010.
(Tr. 108-10; Gov't Ex. 7, at 7, 9.)
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\14\ Officer Melton testified that he has been in law
enforcement for approximately seven years. (Tr. 105.) He has worked
one year in investigations with the Arizona State University Police
Department, one year on a bicycle task force with the City of Tempe,
and approximately two years on a narcotics task force with the City
of Tempe. (Tr. 105-06.) He has worked with DEA "[o]n a couple of
occasions." (Tr. 106.)
\15\ Officer Melton also asked for cocaine, but he was told by
"[t]he lady at the back desk" that it was not available. (Tr. 120-
21.)
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Officer Melton then met with Respondent. Officer Melton told
Respondent that he fell off of an ATV and broke his back at his T3
vertebrae, which Officer Melton actually did fracture. (Tr. 111, 121-
23.) He told Respondent that he went to the emergency room, but stated
that he did not have a regular doctor. (Tr. 122-24.) When Respondent
asked Officer Melton if he had pain, Officer Melton hesitated and then
Respondent asked, "Does the pain come and go from time to time?"
Officer Melton replied "sure." (Tr. 111, 122.) Despite the notation
in the patient file for "Dustin Darrow," Officer Melton did not tell
Respondent that the pain persisted with activity in cold weather.
(Compare Gov't Ex. 7, at 10, with Tr. 124.) Respondent then asked
Officer Melton if marijuana would help relieve his pain and help him
sleep, to which Officer Melton replied, "Okay." (Tr. 111-12.) Officer
Melton does not recall stating that it would help, but told Respondent
that he used marijuana in the past. (Tr. 124.)
Respondent told Officer Melton about the benefits of medical
marijuana and explained alternatives to smoking, such as using a
vaporizer or taking edible marijuana. (Tr. 112.) Officer Melton
testified that Respondent then "put a pressure cuff on my right arm
and he had a stethoscope. Those were the only pieces of medical
equipment that I could see in the office." (Tr. 112, 127-28.)
Respondent instructed Officer Melton to stand up and bend over, and
Respondent pushed on the top portion of Officer Melton's spine while
having Officer Melton breathe deeply. (Tr. 112, 128.) Officer Melton
did not express any pain. (Tr. 128.) After the exam, Respondent told
Officer Melton to go to the front desk to complete the paperwork for
medical marijuana. (Tr. 113.)
At that point, Officer Melton asked Respondent if he could "get
some oxies," referring to oxycodone. Respondent told Officer Melton
"that was a different task" and would be an additional $200.00.
Officer Melton agreed and paid $200.00 cash, which Respondent "kept
himself." (Tr. 113, 125-26.) Respondent asked Officer Melton how many
oxycodone tablets he would get from his doctor, and Officer Melton told
him he had previously been prescribed 180 tablets of oxycodone 30
milligrams. (Tr. 114, 126.) Respondent told him that he would give him
a prescription for 120 tablets of oxycodone 30 milligrams. (Tr. 114.)
Officer Melton then asked for a Xanax prescription. Respondent told him
it would cost another $50.00, and Officer Melton agreed and paid $50.00
cash. (Tr. 115.) Respondent asked Officer Melton how many tablets he
wanted, and Officer Melton requested 90 tablets. Respondent issued
prescriptions for 120 tablets of oxycodone 30 milligrams and 90 tablets
of Xanax 2 milligrams.\16\ (Tr. 115-16, 127; Gov't Ex. 3, at 1.)
---------------------------------------------------------------------------
\16\ Officer Melton did not fill the prescriptions. (Tr. 127.)
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[[Page 45667]]
Officer Melton testified that he never complained of any anxiety to
Respondent, but did tell him that he had difficulty sleeping. (Tr. 116,
127.) He also testified that Respondent failed to discuss the risks and
benefits of oxycodone or Xanax. (Tr. 116.) Nor did Respondent ever ask
Officer Melton whether he was currently taking oxycodone or whether he
had ever taken or been prescribed Xanax. (Tr. 116, 127.) Officer Melton
did not provide any medical records, and Respondent never requested any
medical records. (Tr. 110, 112.) Officer Melton's visit lasted "[f]ive
to ten minutes." (Tr. 124-25.) Respondent did not set up a follow-up
visit for Officer Melton and did not indicate when he would see Officer
Melton again. (Tr. 116-17.)
Officer Melton went to AZ Go Green for a second undercover visit on
August 25, 2011. (Tr. 117.) Officer Melton told the receptionist that
he wanted to get medical marijuana and that he also wanted to see
Respondent. The receptionist told Officer Melton that he would have to
ask J.C. if he wanted to see Respondent, and told him to go to the back
office to obtain his marijuana. (Tr. 118.) After he obtained his
marijuana, Officer Melton asked J.C. if he could see Respondent, but
J.C. told him that he could not. J.C. did not give him a reason. (Tr.
119.)
Officer Knights \17\ testified that SA Lamkin asked him to
participate in an undercover visit to AZ Go Green to attempt to obtain
a medical marijuana permit and a prescription for oxycodone. (Tr. 132,
145.) On September 1, 2011, Officer Knights went to AZ Go Green using
the alias "Bradley Kites." (Tr. 133, 149; see Gov't Ex. 2.) Officer
Knights testified that when he entered AZ Go Green, he went to the
counter and told the employees that he wanted to be prescribed medical
marijuana. He was given three or four sheets of paper to fill out and
he paid $150.00 cash for the visit and the medical marijuana card. (Tr.
133-34, 143; Gov't Ex. 8, at 8-13.) \18\ He also paid an additional
$50.00 fee for AZ Go Green to submit his paperwork to the State of
Arizona so that he could get the medical marijuana card. (Tr. 143-44.)
---------------------------------------------------------------------------
\17\ Officer Knights went to the Arizona Law Enforcement Academy
in 1999, and then he worked in patrol for approximately six years.
In 2006, Officer Knights became a narcotics detective with the City
of Peoria, where he has worked for the past six years. He spent two-
and-a-half years assigned with the DEA Diversion Task Force. (Tr.
131-32.)
\18\ Officer Knights testified that although he filled out pages
8 through 13 of the patient file for "Bradley Kites," pages 10 and
13 also include somebody else's writing. (Tr. 143; see Gov't Ex. 8,
at 10, 13.)
---------------------------------------------------------------------------
Officer Knights then met with Respondent. (Tr. 134.) Respondent
asked Officer Knights why he was there, how much he weighed, and what
medical condition he suffered from. (Tr. 137.) Officer Knights told
Respondent that he had been suffering from fibromyalgia for the past
six years, but that he had not seen a doctor even though his pain had
gotten worse. (Tr. 137, 148.) Officer Knights told Respondent that the
pain interfered with his sleep, and that smoking cannabis helped with
the pain and helped him sleep. He told Respondent that he "had always
been smoking cannabis," but that he was not currently taking any other
medication. (Tr. 137, 148.)
Officer Knights testified that after Respondent conducted a "brief
physical exam, * * * I told him that oxies helped me and if I could
have some of those. And he said that that would be possible." (Tr.
137-38, 149.) Respondent told Officer Knights that the prescription
would cost $200.00 and then "he asked me what other prescriptions I
wanted." (Tr. 138; see also Gov't Ex. 2, at 2, 5.) Officer Knights
told Respondent that he only wanted "the cannabis and the oxy," and
Respondent then asked Officer Knights "if 15s would be okay. * * *
Because if I prescribe the 30's it will raise red flags. * * * But I
can write you more of the 15s." (Tr. 138, 151; see also Gov't Ex. 2,
at 5.) Officer Knights asked if the marijuana and oxycodone were
$200.00 total, and Respondent replied, "Oh yeah the $150 is for the
marijuana and the $200 is for the oxy * * *." (Gov't Ex. 2, at 5.)
Officer Knights gave Respondent $200.00 cash, and Respondent issued a
prescription for 150 tablets of oxycodone 15 milligrams. (Tr. 138-39;
Gov't Ex. 3, at 6.)
Officer Knights testified that during the visit, Respondent "did
talk to me about different ways to imbibe the cannabis and some
different things to do for pain, such as swimming, eating correctly, a
good diet and things like that." (Tr. 139-40; see Gov't Ex. 2, at 3-
4.) Respondent did not discuss the risks and benefits of taking
oxycodone. (Tr. 140.) Officer Knights also testified that he did not
bring any medical records and Respondent never asked him for any
medical records. When Officer Knights left Respondent's office,
Respondent stated, " 'I'll see you in about a year.' " (Tr. 140; see
also Gov't Ex. 2, at 6.)
C. Respondent's Evidence
Respondent's evidence included testimony from Respondent, as well
as two patient charts submitted as documentary evidence.\19\
---------------------------------------------------------------------------
\19\ Resp't Exs. 1, 3.
---------------------------------------------------------------------------
Respondent testified that he is licensed to practice medicine in
California and Arizona. (Tr. 154.) He conceded, however, that he is
only registered in California, and despite practicing at AZ Go Green in
Arizona, he never registered an Arizona practice address with DEA.
Respondent testified that he never knew that it was a requirement to
register with DEA in each state. (Tr. 165.)
Respondent testified that he has never had any of his state medical
licenses suspended, revoked, or denied. (Tr. 154, 159.) He testified
that he consented to the February 3, 2012 Order entered by the Board.
(Tr. 159; see Gov't Ex. 11.) He explained that before qualifying a
patient for medical marijuana in Arizona, a physician is required to
certify that the physician has reviewed the patient's profile on the
Arizona Board of Pharmacy's CSPMP.\20\ (Tr. 160-62; see, e.g., Gov't
Ex. 8, at 10.) Respondent testified:
---------------------------------------------------------------------------
\20\ The patient's CSPMP profile indicates whether the patient
has received any controlled substances, but it does not indicate
whether the patient has received medical marijuana. (Tr. 162-63.)
---------------------------------------------------------------------------
I had no idea what this Arizona Board of Pharmacy database was
or how to apply for it. There is nothing comparable in California
for physicians,\21\ so I was checking the boxes really based upon my
reviewing the * * * patient's medical records or their statements to
me * * *. As soon as I realized that--or became aware that--of how
to do it, I applied for and received my ID and password and from
that point onward continued to check the database on every
subsequent patient.
---------------------------------------------------------------------------
\21\ Respondent later clarified that California has something
similar to the Arizona CSPMP, called CURE, but "it's not a
requirement for doctors to use that as opposed to" Arizona. (Tr.
196-97.)
---------------------------------------------------------------------------
(Tr. 162.) Respondent admitted to the Board that from the time he
applied to the database until the time he received the information to
access the database, he continued to represent that he had verified
each patient's profile. (Tr. 164.) Respondent testified that he did not
obtain the patient profiles for any of the AZ Go Green employees to whom he issued prescriptions. (Tr. 201-02.)
Respondent next testified that while the goal of a pain management
practitioner is to relieve suffering, he is sensitive about addictive
issues. (Tr. 156.) He explained, however, that sometimes patients do
not want to take medical marijuana because they may be drug tested at
work, they're worried about dosage, or they travel across state lines.
Instead they prefer to take oxycodone. (Tr. 174-75.) He also testified
that sometimes medical
[[Page 45668]]
marijuana does not "completely control their pain and so they require
some additional medication in order to control their pain." (Tr. 175.)
Respondent testified that during his time practicing at AZ Go
Green, from April 2011 to December 2011, he saw approximately 800 to
1,000 patients. He testified that only about one percent of the
patients asked for a prescription other than marijuana. (Tr. 154-55,
166-67.) Of that one percent, Respondent declined a prescription for
something other than marijuana to "[p]robably fifty percent." (Tr.
167.)
Respondent testified that he refused to issue an oxycodone
prescription to the third UC, patient L.V., who requested an oxycodone
prescription at the end of her exam. (Tr. 167.) Likewise, L.V. asked
for Xanax, which Respondent also denied, explaining that "[a]t that
point I just wasn't writing [prescriptions], other than for the people
who were already under my care." (Tr. 168; see Resp't Ex. 3.)
Additionally, Respondent testified that he stopped treating patient
A.C., who was receiving oxycodone prescriptions, "because it seemed
that he was possibly diverting these medications. * * *" (Tr. 174.)
Respondent conceded that there is nothing in A.C.'s patient file
indicating that Respondent stopped treating A.C. (Tr. 208; see Resp't
Ex. 1.)
Respondent next testified that he is aware of a regulation that
discourages physicians from issuing prescriptions to family members,
but he is not aware of any similar regulation prohibiting physicians
from issuing prescriptions to employees. (Tr. 166.) Respondent
testified that he issued a prescription to M.F. for 120 tablets of
oxycodone 30 milligrams because she had back pain and "she felt [she]
was in need of additional medication and that was corroborated by my
exam. * * *" (Tr. 177.) Before issuing the prescription, Respondent
testified that he obtained her medical history and performed a physical
examination. (Tr. 178.) Additionally, because M.F. worked at AZ Go
Green, he "had some idea of both the nature of her illness and her
reliability." (Tr. 181.) Respondent testified that the prescription
was issued for a legitimate medical purpose in the course of his
practice, explaining that M.F.'s back pain was increasing despite using
cannabis. (Tr. 177, 179.) Respondent conceded, however, that although
M.F. had not taken oxycodone before, he prescribed her the highest
dosage unit possible. (Tr. 200-01.)
Next, Respondent testified that he prescribed testosterone to L.H.,
the security guard at AZ Go Green, because he was a body builder and
L.H. "felt that he was * * * starting to have just physical weakness *
* * so he requested the testosterone as a way of maintaining his
energy." (Tr. 181-82.) Respondent testified that in his opinion, it
was an appropriate prescription issued for a legitimate medical purpose
in the usual course of practice. (Tr. 182.)
Respondent testified that he initially issued a prescription for
Percocet to J.C., who had an MRI-documented herniated disc. Respondent
determined "it was safer" to prescribe just oxycodone rather than
Percocet, which is a combination of oxycodone and acetaminophen. (Tr.
184-85.) Respondent also prescribed Xanax to J.C., stating, "I think
he lived a complicated life. Let me just put it that way. And so he was
having high levels of anxiety and asked for Xanax to help him sleep."
(Tr. 185.) Based on J.C.'s medical history and the physical
examination, Respondent opined that Xanax was an appropriate
prescription. (Tr. 185-86.) Additionally, Respondent prescribed
Adderall to J.C. because J.C. was "having trouble concentrating and he
was kind of a hyper guy. * * *" (Tr. 186.) Respondent testified that
all of the medications were issued for a legitimate medical purpose in
the usual course of practice. Respondent followed J.C. on these
medications and they were all successful. (Tr. 186.)
Respondent testified that R.B. suffered from anxiety and "some
ADD," and she also suffered from severe low back pain from an injury
she suffered while moving. (Tr. 191.) Respondent testified that he saw
R.B. on "a more or less daily basis," and he observed that she was in
pain. (Tr. 191-92.) Respondent prescribed oxycodone for her severe
lower back pain. (Tr. 191.) Respondent testified, however, that despite
issuing so many prescriptions so frequently to J.C. and R.B., he never
required either patient to take a urine drug screen to confirm that
they were actually taking the medication as prescribed. (Tr. 206.)
With respect to the UCs, Respondent testified that Officer Knights
told Respondent that he suffered from fibromyalgia, and a physical
examination corroborated Officer Knights' complaints. (Tr. 187.)
Although Officer Knights told Respondent he had not seen another
doctor, Respondent testified that fibromyalgia can be self-diagnosed.
(Tr. 210, 213.) Respondent also testified that while there is no
objective test to diagnose fibromyalgia, such as an x-ray or MRI, the
"symptom complex [is] pretty well-defined" and Officer Knights met
each of the criteria. (Tr. 188-89.) Respondent conceded though that
Officer Knights never told Respondent where he had pain until
Respondent asked if he had pain in his back and shoulders. (Tr. 203-
04.)
Respondent testified that he told Officer Knights that oxycodone 30
milligrams would raise a red flag, explaining that
several patients that I had had who had gone--especially those
without insurance, who had gone to a pharmacy with a prescription
for 30 milligrams of oxycodone and paid cash, found that the
pharmacists either were unwilling to fill the prescription or made
them wait while they contacted me, and since I was not here in
Arizona continually, there were problems getting back to me for
verification of the prescriptions.
(Tr. 211.) He testified that it was not an effort to conceal his
prescription writing patterns. (Id.) Respondent testified that he based
the prescription to Officer Knights on the patient history and the
physical examination, and he "prescribed the oxycodone because
[Officer Knights] said that he had been taking it for two years." (Tr.
214.)
As for Officer Melton's undercover visit with Respondent,
Respondent testified that Officer Melton indicated that he suffered a
fracture of his T3 when he fell from an ATV. (Tr. 189.) Respondent
conducted a physical examination, which was consistent with Officer
Melton's complaint. (Tr. 189.) Although Officer Melton did not say
"ouch" or verbally indicate pain during the exam, Respondent
testified that Officer Melton agreed when he asked Officer Melton if
the pain came and went. (Tr. 202-03.) Respondent testified that he
could have further confirmed Officer Melton's complaint by "tak[ing]
another x-ray of his thoracic spine and see[ing] the fracture, but * *
* [h]e had said he had gone to the emergency room and they told him he
had a T3 fracture. I don't think an additional x-ray would be of any
value." (Tr. 190.)
Respondent conceded that he charged the UCs $200.00 each for the
oxycodone portion of the visit in addition to the $150.00 fee that he
charged them for the office visit. (Tr. 197-98.) He explained, however,
that since oxycodone can only be prescribed for a one-month supply, he
charges his patients $200.00 at the initial visit, but that charge
includes two additional "follow-up prescriptions and * * * additional
exam[s] at no charge because they'd already paid." (Tr. 156-57, 176.)
He testified that he failed to tell either of the UCs that the $200.00
fee was good for three months though. (Tr. 197.)
Nonetheless, Respondent testified that in his opinion, the
prescriptions to the UCs were issued for a legitimate medical purpose
in the usual course of professional practice. (Tr. 187-88, 190-91.)
Respondent conceded that he
[[Page 45669]]
issued the prescriptions without asking either of the UCs for past
medical records. (Tr. 207-08.) He also testified that while he believed
he kept adequate patient records, he agreed that there was nothing in
the UCs' respective patient files to show that they were prescribed
oxycodone. (Tr. 205.)
Respondent testified that he kept carbon copies of all
prescriptions that he wrote, which would "eventually" get put into
the patient's file. (Tr. 170-71.) He did not have a timeframe for
putting the copies into the patient files and agreed that waiting five
to six months was a long time. (Tr. 204, 205-06.) Respondent also
testified that to his knowledge he has not issued a prescription that
was not for a legitimate medical purpose in the usual course of
practice. (Tr. 159.) He explained:
I come from a prior era of medical care where * * * MRI's were
not available. And so I was taught about physical diagnosis. That
you took a careful history from the patient, you performed a
physical examination on the patient carefully and that was more
valuable than even many diagnostic tests, which could be equivocal.
And so that's part of how I practice medicine over the years as I've
been trying to keep cost conscious and not over utilize diagnostic
testing unless it's absolutely necessary.
(Tr. 193.)
IV. Discussion
A. The Applicable Statutory and Regulatory Provisions
The Controlled Substances Act (CSA) provides that any person who
dispenses (including prescribing) a controlled substance must obtain a
registration issued by the DEA in accordance with applicable rules and
regulations.\22\ "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.\23\ 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.\24\
---------------------------------------------------------------------------
\22\ 21 U.S.C. Sec. Sec. 802(1), 822(a)(2).
\23\ 21 CFR 1306.04(a).
\24\ 21 U.S.C. 844(a).
---------------------------------------------------------------------------
B. The Public Interest Standard
The CSA, at 21 U.S.C. 824(a)(4), provides, insofar as pertinent to
this proceeding, that the Administrator may revoke a DEA COR if she
finds that the continued registration would be inconsistent with the
public interest as that term is used in 21 U.S.C. 823(f). In
determining the public interest, the 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.\25\
---------------------------------------------------------------------------
\25\ I conclude that the reference 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). See Kuen H. Chen, M.D., 58 FR 65,401, 65,402 (DEA
1993).
---------------------------------------------------------------------------
As a threshold matter, these factors are to be considered in the
disjunctive: The Administrator may properly rely on any one or a
combination of those factors, and give each factor the weight she deems
appropriate, in determining whether a registration should be revoked or
an application for registration denied. See David H. Gillis, M.D., 58
FR 37,507, 37,508 (DEA 1993); see also D & S Sales, 71 FR 37,607,
37,610 (DEA 2006); Joy's Ideas, 70 FR 33,195, 33,197 (DEA 2005); Henry
J. Schwarz, Jr., M.D., 54 FR 16,422, 16,424 (DEA 1989). 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 revoke a registrant's COR, the DEA has the burden of proving
that the requirements for revocation are satisfied.\26\ The burden of
proof shifts to the respondent once the Government has made its prima
facie case.\27\
---------------------------------------------------------------------------
\26\ See 21 CFR 1301.44(e).
\27\ See Medicine Shoppe--Jonesborough, 73 Fed. Reg. 364, 380
(DEA 2008); see also Thomas E. Johnston, 45 FR 72311 (DEA 1980).
---------------------------------------------------------------------------
C. The Factors To Be Considered
Factor 1: The Recommendation of the Appropriate State Licensing Board
or Professional Disciplinary Authority
In this case, regarding Factor One, it is undisputed that
Respondent currently holds valid medical licenses in Arizona and
California, but Respondent's Arizona medical license has been the
subject of recent disciplinary action.\28\ On December 21, 2011,
Respondent signed a consent agreement with the Arizona Medical Board
(Board), which ultimately resulted in a February 3, 2012 Order for
Letter of Reprimand and Consent to the Same (February 3, 2012
Order).\29\ (Gov't Ex. 11.) The February 3, 2012 Order included various
factual findings to include Respondent's admission to the allegation
that he "wrote 483 Medical Marijuana Certifications in which he
attested to reviewing the qualifying patient's profile on the Arizona
Board of Pharmacy Controlled Substances Prescription Monitoring Program
(CSPMP) database prior to ever accessing the database through the
Arizona Board of Pharmacy (Pharmacy Board) Web site." (Id. at 1.)
Additionally, during the relevant time period, Respondent had not
registered with the database "so he was unable to access or make
queries of the CSPMP prior to that time." (Id.; Tr. 163-64.)
---------------------------------------------------------------------------
\28\ Respondent has never had his medical license in any state
where he has held one suspended, revoked, or denied. (Tr. 159.)
\29\ Respondent asserts that the February 3, 2012 Order includes
a provision that his admissions to the Board for purposes of the
February 3, 2012 Order were "not intended or made for any other
use, such as in the context of another State or Federal government
regulatory agency proceeding, * * *" (Resp't Br., at 9.) I do not
find this argument to be persuasive, however, because the Government
was not a party to those proceedings and is not bound by those
terms. Cf. Robert Raymond Reppy, D.O., 76 FR 61,154, 61,159-60 (DEA
2011) (refusing to apply res judicata where the respondent was not a
party to the prior proceedings); see also United Ass'n of Journeymen
& Apprentices of Plumbing & Pipefitting Indus., Steamfitters and
Refrigeration Unit v. Valley Engineers, 975 F.2d 611, 615 (9th Cir.
1992) ("The general rule is that a litigant is not bound by a prior
decision in a proceeding to which it was not a party." (citing
Hansberry v. Lee, 311 U.S. 32, 40 (1940))).
---------------------------------------------------------------------------
The Board concluded that Respondent's conduct constituted
"unprofessional conduct pursuant to A.R.S. Sec. 32-1401(27)(t)
('[k]nowingly making any false or fraudulent statement, written or
oral, in connection with the practice of medicine or if applying for
privileges or renewing an application for privileges at a health care
institution')." (Id. at 2.) As a result of the foregoing findings of
fact and conclusions of law, the Board issued Respondent a "Letter of
Reprimand." (Id.)
The Board's action reflects a determination that Respondent,
notwithstanding findings of unprofessional conduct in the recent past,
can be entrusted with a medical
[[Page 45670]]
license. While not dispositive,\30\ this action by the State of Arizona
does weigh against a finding that Respondent's continued registration
would be inconsistent with the public interest under Factor One. Cf.
Robert A. Leslie, M.D., 68 FR 15,227, 15,230 (DEA 2003) (under Factor
One, prior suspension of respondent's state medical license held not
dispositive where state license currently under no restrictions).
---------------------------------------------------------------------------
\30\ Mortimer B. Levin, D.O., 55 Fed. Reg. 8,209, 8,210 (DEA
1990) (finding DEA maintains separate oversight responsibility and
statutory obligation to make independent determination whether to
grant registration).
---------------------------------------------------------------------------
Factor 3: Conviction Record under Federal or State Laws Relating to the
Manufacture, Distribution or Dispensing of Controlled Substances
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. (See
Tr. 159.) I therefore find that this factor, although not dispositive,
see Leslie, 68 FR 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, the evidence demonstrates that Respondent has failed
to remain in compliance with applicable federal and state law relating
to controlled substances, and that his past experience in prescribing
controlled substances is inconsistent with the public interest.
Additionally, evidence at hearing centered on Respondent's record-
keeping practices, as well as his dispensing practices from an
unregistered location.
1. Respondent's Prescribing Practices
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 CFR 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 FR 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 consider "generally recognized and
accepted medical practices" in the United States. Bienvenido Tan,
M.D., 76 FR 17,673, 17,681 (DEA 2011).
"Under the CSA, it is fundamental that a practitioner must
establish a bona fide doctor-patient relationship in order to act 'in
the usual course of * * * professional practice' and to issue a
prescription for a 'legitimate medical purpose' as required by 21 CFR
1306.04(a)." Gilbert Eugene Johnson, M.D., 75 FR 65,663, 65,666 (DEA
2010) (citing Patrick W. Stodola, M.D., 74 FR 20,727, 20,731 (DEA 2009)
(citing United States v. Moore, 423 U.S. 122, 135, 143 (1975))). "The
CSA generally looks to state law to determine 'whether a doctor and
patient have established a bona fide patient relationship.' " Id.; see
also Kamir Garces-Mejias, M.D., 72 FR 54,931, 54,935 (DEA 2007); United
Prescription Services, Inc., 72 FR 50,397, 50,407 (DEA 2007).
Under applicable Arizona law, grounds for disciplinary action
include "[u]nprofessional conduct" further defined as "[v]iolating
any federal or state laws, rules or regulations applicable to the
practice of medicine." Ariz. Rev. Stat. Sec. 32-1401(27)(a).
Additionally, unprofessional conduct includes "[a]ny conduct or
practice that is or might be harmful or dangerous to the health of the
patient or the public." Ariz. Rev. Stat. Sec. 32-1401(27)(q).
(a) Undercover Law Enforcement Patient Visits
Turning to the evidence in the instant case, the Government alleged
and presented evidence that Respondent issued prescriptions for
controlled substances in Arizona to two undercover law enforcement
officers (UCs) posing as patients on August 12, 2011 and September 1,
2011, that were not issued for a legitimate medical purpose and outside
the usual course of professional practice.\31\ (ALJ Ex. 1, at 1-2;
Gov't Exs. 2-3.) The Government's evidence also credibly established
through the testimony of SA Lamkin that the undercover visits with
Respondent during 2011 were initiated based on information provided by
a former employee of Respondent's practice location, AZ Go Green, that
Respondent and the owner of the clinic "were illegally distributing
marijuana out of the clinic and prescriptions for oxycodone as well."
(Tr. 23.) SA Lamkin further explained that the primary purpose of his
investigation was the oxycodone distribution. (Tr. 75.)
---------------------------------------------------------------------------
\31\ The evidence at hearing also referenced a third UC, patient
L.V., who went to Respondent's practice on September 22, 2011, but
was denied oxycodone and Xanax prescriptions by Respondent. (Tr. 77-
78, 169; Resp't Ex. 3.)
---------------------------------------------------------------------------
With regard to the August 12, 2011 undercover patient visit with
Respondent, the Government presented testimony from Officer Melton, who
credibly testified in substance that he visited Respondent's Arizona
practice location for the purpose of obtaining a medical marijuana card
and prescription pills. (Tr. 107.) Notably, office staff informed
Officer Melton that any backpacks or purses must be left by the front
door of the clinic.\32\ (Tr. 108.) The visit required the payment of
$150.00 cash in advance to the receptionist, who informed Officer
Melton the fee was required to "obtain a referral from the doctor."
(Tr. 109.) Prior to seeing Respondent, Officer Melton was also required
to fill out forms to include a patient attestation not to divert
marijuana and a form entitled Medical Marijuana Patient Summary, on
which Officer Melton indicated a medical history of "Broken Back 10/
2010." (Tr. 108-10; Gov't Ex. 7, at 7, 9.)
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\32\ Officer Melton was equipped with a recording device for
purposes of the undercover visit, but it was not located on his
person. Accordingly, the device remained with his belongings in the
lobby area and no recording was made of his encounter with
Respondent. (Tr. 107.)
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The testimony from Officer Melton also reflects that Respondent
neither asked for nor obtained any medical records during the visit,
and was told upon inquiry that Officer Melton did not currently have a
doctor. (Tr. 110-12.) Respondent nonetheless falsely indicated in the
patient chart that he had reviewed the patient's medical records,
including medical records from other treating physicians. (Gov't Ex. 7,
at 6.) The evidence further reflects that Respondent asked Officer
Melton if he had pain from his broken back, suggesting that the pain
comes and goes from time to time, to which Officer Melton agreed. (Tr.
111.) After this exchange, Respondent asked if medical marijuana would
help with pain and sleep, and Officer Melton replied "Okay." (Tr.
111-12.) Respondent then explained the benefits of marijuana and
alternative means of ingestion, followed by an examination of Officer
Melton that consisted of a "pressure cuff" and stethoscope, along
with having Officer Melton stand, bend, and take deep breaths.
Additionally, Respondent pushed on the top portions of Officer
[[Page 45671]]
Melton's spine, followed by a statement that the "exam was over."
(Tr. 112.)
Respondent then informed Officer Melton about "edibles" and how
to obtain marijuana, and "walked him to the door suggesting we should
leave." (Tr. 113.) At that point Officer Melton asked Respondent if he
"could obtain some oxies" referring to an oxycodone prescription, to
which Respondent replied that was a "different task" and would
require payment of an additional $200.00, to which Officer Melton
stated "fine" and paid Respondent $200.00 in cash. (Tr. 114.) Officer
Melton described Respondent's issuance of a prescription for 120
tablets of oxycodone 30 milligrams and 90 tablets of Xanax 2 milligrams
as follows:
He then sat down at the desk and filled out a prescription pad,
which he gave to me. He asked me questions. He said, 'How many would
you get from your doctor?' I said, '180.' He said he would only
write it for 120. And actually before he asked that, I told him I
got 30's from my doctor and he did complete the prescription for 30
milligram oxycodone at a quantity of 120.
(Id.)
Officer Melton testified that after Respondent handed him the
prescription for oxycodone,\33\ he then asked Respondent for Xanax:
---------------------------------------------------------------------------
\33\ Gov't Ex. 3, at 1.
---------------------------------------------------------------------------
I asked him if I could get a prescription for Xanax and he said
that would cost an additional $50.00. I said that was okay and I
gave him $50.00 cash and he began to fill out another prescription.
He asked how many I wanted. I said, '90.' And he completed a
prescription for 90 2 milligram Xanax tablets and gave me the prescription for those.
(Tr. 115; Gov't Ex. 3, at 1.)
Of significance, the evidence reflected that upon Officer Melton's
return to Respondent's practice on August 25, 2011, he was told that he
could not see Respondent, although no reason was given. (Tr. 119.)
With regard to the September 1, 2011 undercover patient visit with
Respondent, the Government presented testimony from Officer Knights,
who credibly testified that he visited Respondent's Arizona practice
location for the purpose of obtaining a "medical marijuana license and
a prescription for oxycodone." \34\ (Tr. 132.) Upon arrival, he
indicated to AZ Go Green staff that he wanted to be prescribed
marijuana and was given paperwork to fill out. He paid $150.00 cash for
the visit and an additional $50.00 fee for the staff to submit his
paperwork to the State of Arizona. (Tr. 143-44.)
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\34\ Officer Knights was wearing a recording device during the
visit, the results of which are reflected in an audio recording and
transcript admitted at hearing. (Gov't Ex. 2.)
---------------------------------------------------------------------------
The recording and transcript of the encounter with Respondent
reflects that Officer Knights related to Respondent a six-year history
of fibromyalgia with problems in the shoulders and neck, and pain
becoming worse. (Tr. 137; Gov't Ex. 2, at 1.) Officer Knights also
noted sleep disturbance and told Respondent that he had not treated
with a doctor at the time nor had he seen one after the pain became
worse. (Gov't Ex. 2, at 1.) Officer Knights indicated to Respondent
that he was not taking any medications, but stated cannabis had helped
in the past. Prior to any physical examination, Officer Knights
inquired of Respondent if oxycodone prescriptions were possible.
[RESPONDENT]: Do you have a regular doctor that you see now?
KNIGHTS: Um, no not regularly. But, um I mean oxy seemed to help
too, I don't know if you guys doing anything like that here or * *
*?
[RESPONDENT]: Have * * * how long have you been taking
oxycodone?
KNIGHTS: Um, when I can get it for probably about 2 years.
[RESPONDENT]: Mm-hmm.
KNIGHTS: On and off.
[RESPONDENT]: Mm-hmm.
KNIGHTS: But um that really seems to help too.
[RESPONDENT]: Okay, that's a separate fee but we can, I can
write you a prescription.
KNIGHTS: I, that would be great that would be awesome.
(Gov't Ex. 2, at 2.)
Notably, Respondent's statement that he can write a prescription
for oxycodone at the outset of the patient visit, prior to any
examination and in response to a specific request by the patient, is
inconsistent with a prescription being issued for a legitimate medical
purpose or in the usual course of professional practice. 21 CFR
1306.04(a).
The patient visit continued with Respondent discussing diet along
with alternatives to using marijuana, as well as a discussion about the
appropriate amount to use to relieve symptoms. (Gov't Ex. 2, at 4.) The
patient visit next turned back to the issue of oxycodone:
[RESPONDENT]: Okay. Now it's $200 for today. I only do 15s. Is
that ok?
KNIGHTS: Oxy 15s?
[RESPONDENT]: Yeah.
KNIGHTS: I mean if that's all you can do I guess.
[RESPONDENT]: Yeah that's all * * * it's just, it's such a red
flag, the 30s are such a red flag, you know, but I will give you a
few more, I'll give you a little bit more so that should help.
* * * * *
KNIGHTS: How many can you do?
[RESPONDENT]: 150.
KNIGHTS: Alright 15s?
[RESPONDENT]: Yeah.
KNIGHTS: Alright. What's a, what's a red flag? What do you mean?
[RESPONDENT]: You know when you go to the pharmacy when you
bring in (unintelligible) you know they flag it with the Board of
Pharmacy and it just becomes a problem for you and for me.
KNIGHTS: Oh really?
[RESPONDENT]: Yeah, (unintelligible) * * * with the 15s they
don't really they don't have a problem with, but when you do the
30s, that's when they get, you know, they just, they make a red flag
and you know my name and your name get on to a list and you end up
you know with a problem.
KNIGHTS: Wow, I didn't know.
(Gov't Ex. 2, at 6.)
Respondent concluded the visit with Officer Knights by stating that
"we will see you in another year." (Id.) Respondent issued a
prescription to Officer Knights for 150 tablets of oxycodone 15
milligrams. (Gov't Ex. 3, at 6.)
In response to the evidence regarding the two undercover visits by
Officers Melton and Knights, Respondent testified in relevant part that
he was of the opinion that his prescriptions in each instance were
issued for a legitimate medical purpose while acting in the usual
course of his professional practice. (Tr. 187-88, 190-91.) I do not
find Respondent's testimony credible in various respects. As an initial
matter, I find Respondent's prescribing of controlled substances to
Officers Melton and Knights to reflect a cash transaction for
controlled substances at the request of the UCs, to include a
negotiated quantity, strength, and type, which was effectively devoid
of any credible relationship to the purported medical reason for the
visit. Simply put, these were transparent unlawful "drug deals." \35\
21 U.S.C. 841 (a)(1); see Homayoun Homayouni, M.D., 61 FR 1,406, 1,408-
09 (DEA 1996).
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\35\ The credible evidence at hearing is consistent with the
hearsay statement from a former employee of AZ Go Green that
Respondent was illegally prescribing oxycodone. For purposes of this
recommended decision, I find that the foregoing hearsay statement by
the former employee constitutes substantial evidence, particularly
in light of the fact that the informant was known to SA Melton and
corroborated by extensive credible evidence of record. Calhoun v.
Bailar, 626 F.2d 145, 149 (9th Cir. 1980); see also Richardson v.
Perales, 402 U.S. 389, 402-06 (1971).
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Respondent's relatively brief testimony explaining the basis for
his prescribing controlled substances to Officers Melton and Knights
was inconsistent with other objective and credible evidence of record.
Respondent testified in relevant part that he was of the opinion after
his examination of
[[Page 45672]]
Officer Knights that the results were consistent with a diagnosis of
fibromyalgia, which "sometimes is associated with chronic fatigue."
(Tr. 187.) While the patient file for Officer Knights briefly notes
"fibromyalgia," the transcript of the encounter clearly demonstrates
that Respondent had already agreed to issue Officer Knights a
prescription for oxycodone in exchange for a separate cash fee in
advance of the examination. Even more telling is Respondent's later
statement to Officer Knights that he only does "15s," followed by
asking Officer Knights if that "is ok" with him, essentially
deferring the strength of the prescription to the patient. Respondent's
added explanation that issuance of 30s raises red flags with the
pharmacy board, and that he will give Officer Knights "a few more" is
fully inconsistent with any arguable legitimate medical purpose.
Rather, it is fully consistent with an unlawful drug transaction.
Respondent's testimony explaining the controlled substance
prescriptions for oxycodone and Xanax to Officer Melton is equally
incredible. Respondent testified in relevant part that in his
experience fractures of the type reported by Officer Melton are
"very" painful, and found Officer Melton's symptomology consistent
with that type of injury. (Tr. 189.) Respondent further explained that
the examination performed for the medical marijuana evaluation
encompassed many of the same things that would be examined for an
oxycodone prescription, noting that he did not "think that an
additional x-ray would be of any value." (Tr. 190.)
Respondent's testimony is significantly at odds with the credible
testimony of Officer Melton. The timing of Respondent's issuance of two
prescriptions to Officer Melton significantly undermines any legitimacy
to Respondent's actions, as well as the credibility of his testimony at
hearing. The issue of oxycodone came up after Respondent's examination
was over and Officer Melton was being escorted to the door. Only after
Officer Melton raised the issue of "oxies" did Respondent indicate
that would be a different task and fee, and immediately proceed to sit
down and issue a prescription for oxycodone in a strength that Officer
Melton requested. Respondent's reluctance to issue the requested
quantity of 150, settling instead on a quantity of 120, is consistent
with Respondent's concerns expressed to Officer Knights about "red
flags" with the pharmacy board.
Officer Melton's patient file and evaluation is also inconsistent
with Respondent's purported basis for issuing the oxycodone
prescription. Respondent asked Officer Melton how many he would get
from his doctor, yet Respondent's signed evaluation notes indicate
"none" for physician and medication.\36\ Respondent's own
documentation reflects his actual knowledge that Officer Melton's
statement of how many he would get from his doctor had no correlation
to ongoing medical care.
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\36\ Tr. 114; Gov't Ex. 7, at 10.
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Respondent's testimony regarding his refusal to prescribe
controlled substances to undercover patient L.V. on September 22, 2011,
is also inconsistent with other credible evidence of record. (Tr. 167-
68; Resp't Ex. 3.) Respondent testified that he refused to issue a
requested prescription for oxycodone and Xanax, explaining that "[a]t
that point I just wasn't writing * * * other than [for] the people who
were, you know, in their cycle of receiving the prescriptions from
previously--previous exams." (Tr. 168.) Respondent also testified that
the $200.00 fee associated with the first examination for controlled
substance prescriptions was good for two additional follow-up visits
for three months.\37\ (Tr. 157, 176, 197.) Respondent elaborated on the
purpose of the additional examinations: "I wanted to see how they
responded to the medication and how their condition had changed in any
way. And of course, I thought it was necessary to do an exam before I
could prescribe the medication." (Tr. 176.)
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\37\ Respondent acknowledged during cross-examination that he
never informed the undercover patients that the fees related to
oxycodone and Xanax prescriptions included follow-up visits good for
three months. (Tr. 197.)
---------------------------------------------------------------------------
While Respondent's testimony that he was no longer writing
controlled substance prescriptions for new patients as of September 22,
2011 may be accurate, his assertion that he was only writing
prescriptions for patients "in their cycle of receiving"
prescriptions is wholly at odds with his prescribing practices for
Officers Melton and Knights. In the case of Officer Knights, Respondent
concluded the visit with a statement that "we will see you in another
year." (Tr. 140; Gov't Ex. 2, at 6.) No follow-up appointment was
scheduled nor is one indicated in the patient chart. (Gov't Ex. 8.)
Contrary to Respondent's testimony, the evidence clearly indicates no
intention to follow-up with Officer Knights during the three-month
period after the initial visit.
Respondent's prescribing practice with regard to Officer Melton is
similar. At no time during the visit did Respondent indicate when or if
he would see Officer Melton again. (Tr. 117.) Nor is there any mention
of follow-up in the patient chart. (Gov't Ex. 7.) In fact, when Officer
Melton returned to Respondent's Arizona office on August 25, 2011, his
request to see Respondent was refused.
In light of the foregoing, I do not find Respondent's testimony
that he issued controlled substances to Officers Melton and Knights for
a legitimate medical purpose and in the usual course of his medical
practice remotely credible. Although the Government did not present any
expert testimony pertaining to the undercover visits to AZ Go Green,
other credible substantial evidence of record supports a finding by a
preponderance of the evidence that Respondent's prescriptions for
oxycodone and Xanax to Officer Melton on August 12, 2011, and his
prescription of oxycodone to Officer Knights on September 1, 2011, were
unlawful. 21 U.S.C. 841(a)(1); 21 CFR 1306.04(a); Ariz. Rev. Stat.
Sec. 32-1401(27)(a). See Cynthia M. Cadet, M.D., 76 FR 19,450, 19,450
n.3 (DEA 2011) (explaining that in cases of particularly flagrant
conduct by a registrant "expert testimony adds little to the proof
necessary to establish a violation of Federal law"); see also Randall
L. Wolff, M.D., 77 FR 5,106, 5,151-52 (DEA 2012) (giving little weight
to the respondent's testimony that a prescription issued to an
undercover agent was appropriate, despite the lack of medical expert
testimony to the contrary, in light of other record evidence).\38\
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\38\ Respondent argues that the prescriptions presented by the
Government, including those issued to the UCs, "were written for
legitimate medical purposes in the course of Respondent's practices,
the evidence is undisputed that they were. The government has
introduced not a scintilla of evidence to the contrary." (Resp't
Br., at 13-14.) While I acknowledge Respondent's argument, I wholly
reject it with regards to the prescriptions issued to the UCs. As
noted above, I find Respondent's self-serving testimony on this
matter incredible, and the evidence of record demonstrates that
Respondent's prescribing to the UCs were transparent unlawful drug
deals.
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(b) Lack of Patient Address on Controlled Substance Prescriptions
The Government alleged and presented evidence at hearing that
Respondent failed to include patient addresses on controlled substance
prescriptions in violation of 21 CFR 1306.05(a). (See ALJ Ex. 5, at 3.)
Although the Government did not produce any testimonial evidence
regarding this allegation, it introduced approximately thirty
controlled substance prescriptions issued by Respondent between April
2011 and
[[Page 45673]]
October 2011, to patients C.C., J.C., R.B., J.B., D.B., M.F., and L.H.,
as well as the UCs, that do not include the patients' addresses on the
prescriptions. (Gov't Ex. 3.) Respondent did not dispute that he issued
these prescriptions. (See Tr. 177-92.)
In light of the undisputed evidence of record, I find by a
preponderance of the evidence that Respondent knowingly issued numerous
prescriptions between April and October 2011 in violation of 21 CFR
1306.05(a) ("All prescriptions for controlled substances shall * * *
bear the full name and address of the patient, * * *."). See
Christopher E. Castle, M.D., 67 Fed. Reg. 71,196, 71,198 (DEA 2002).
(c) Respondent's Positive Prescribing Practices
Respondent presented evidence to demonstrate that in other cases,
he acted in accord with the public interest standard. Respondent
testified that he has not, to his knowledge, ever issued a prescription
that was not for a legitimate medical purpose in the usual course of
his practice. (Tr. 159.) He testified that he is "sensitive to
patients increasing their usage," and often denies prescribing the
"amount or frequency" that a patient requests. (Tr. 157.) He also
testified that he has declined to issue controlled substance
prescriptions to many patients, and he has stopped prescribing to
patients who were receiving medication from other physicians. (Tr. 158,
166.) In particular, Respondent testified that he denied issuing
prescriptions for oxycodone to undercover patient L.V., and he stopped
treating patient A.C. after learning that A.C. was "possibly
diverting" his oxycodone. (Tr. 167-68, 172-74.)
I do not find Respondent's testimony to credibly demonstrate
positive prescribing practices. With regards to patient L.V.,
Respondent testified that he did not issue a controlled substance
prescription to her because at the time of her undercover visit, he was
not writing prescriptions for people who were not already receiving
controlled substances prescriptions. (Tr. 168.) His basis for denying
her a controlled substance prescription was not related in any way to
his medical evaluation of L.V., or his medical judgment that a
controlled substance prescription would not be appropriate for that
particular patient. Regarding patient A.C., I do not find Respondent's
testimony credible in light of the fact that A.C.'s patient chart
contains no documentation that Respondent was either concerned with
A.C. diverting medication or that Respondent ultimately terminated
treatment of A.C. (See Resp't Ex. 1.)
Even if Respondent's testimony was credible, it is, nonetheless,
unavailing. Agency precedent has held that even a single act of
intentional diversion is sufficient grounds upon which to revoke a
registration,\39\ and "evidence that a practitioner has properly
treated thousands of patients does not negate a prima facie showing
that the practitioner has committed acts inconsistent with the public
interest." Jayam Krishna-Iyer, M.D., 74 FR 459, 463 (DEA 2009).
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\39\ See, e.g., Cynthia M. Cadet, M.D., 76 FR 19,450, 19,450 n.3
(DEA 2011).
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2. Respondent's Record-Keeping Practices
Under Arizona law, unprofessional conduct includes "[f]ailing or
refusing to maintain adequate records on a patient." Ariz. Rev. Stat.
Sec. 32-1401(27)(e). "Adequate records" is further defined as
follows:
[L]egible medical records containing, at a minimum, sufficient
information to identify the patient, support the diagnosis, justify
the treatment, accurately document the results, indicate advice and
cautionary warnings provided to the patient and provide sufficient
information for another practitioner to assume continuity of the
patient's care at any point in the course of treatment.
Ariz. Rev. Stat. Sec. 32-1401(2).
Although the Government did not allege violations of federal
record-keeping regulations, it did allege that Respondent violated
state law by failing to maintain adequate patient records. In
particular, the Government alleged that Respondent prescribed Schedule
II and IV controlled substances to various employees, as well as the
owner of AZ Go Green, between April 2011 and October 2011, but made
"no reference to the controlled substances prescribed were [sic] found
in the medical files seized in violation of Arizona law." (ALJ Ex. 5,
at 2.)
Specifically, Respondent prescribed controlled substances to M.F.,
L.H., J.C., and R.B., however, SA Lamkin testified that there was
nothing contained within each patient's chart to show that Respondent
issued those prescriptions. (Gov't Exs. 3-6, 9; Tr. 38-45, 52-54.)
Respondent did not dispute issuing these prescriptions, but instead
testified that he is not aware of any regulation prohibiting him from
writing prescriptions to employees of the clinic. (Tr. 166.) Respondent
further testified, consistent with SA Lamkin's testimony, that he
maintained carbon copies of prescriptions for controlled substances
that he wrote on a prescription pad. (Tr. 93; 170-71.) Respondent
testified that his intent was that "[e]ventually they would get to the
file." (Tr. 171.)
The foregoing evidence arguably supports a finding that
Respondent's failure to reference prescriptions for controlled
substances in the patient files is contrary to applicable Arizona law.
However, the plain language of the statute does not specifically
require documentation of controlled substance prescriptions,\40\ and
the Government offered no authority to support a finding that a patient
chart must contain a carbon copy of a prescription for controlled
substance. Nor did the Government produce any medical expert testimony
or other qualified opinion evidence to establish that Respondent's
charts for patients M.F., L.H., J.C., and R.B., were inadequately
maintained under applicable Arizona law. In fact, the patient chart for
R.B. does include a prescribing history for oxycodone and alprazolam on
various dates in 2011.\41\ (Gov't Ex. 9, at 15.)
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\40\ See Arizona Medical Board, Guidelines for the Use of
Controlled Substances for the Treatment of Chronic Pain (available
at http://www.azmd.gov/Statutes-Rules/7_policy.aspx) (stating that
to maintain "adequate records" for a chronic pain patient, "the
documentation should include * * * [p]rescribed medications and
treatment." (emphasis supplied)).
\41\ While the prescribing history is not complete, notably,
Respondent submits that none of the prescriptions were noted in
R.B.'s patient file. (See Resp't Br., at 7-8.)
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While I do not find Respondent's testimony that carbon copies of
the prescriptions for controlled substances would "eventually" get to
the patient file particularly credible, especially in light of his
testimony as a whole, I nonetheless find that the Government has not
sustained its burden to establish by a preponderance of the evidence
that Respondent's record-keeping for Patients M.F., L.H., J.C., and
R.B. violated applicable Arizona law.\42\
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\42\ Similarly, I do not find that the Government has adequately
alleged or established a violation of Arizona law as it relates to
Respondent's prescribing of controlled substances to "employees,"
as compared to immediate family members. See e.g. Ariz. Rev. Stat.
Sec. 32-1401(13).
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3. Respondent's Prescribing From an Unregistered Location
Federal law requires every person who dispenses (including
prescribing) any controlled substance to obtain a registration from the
Attorney General.\43\ "A separate registration shall be required at
each principal place of business or professional practice where the
applicant manufactures, distributes, or dispenses controlled substances
or list I chemicals.\44\ Federal regulations further mandate that a
"separate
[[Page 45674]]
registration is required for each principal place of business or
professional practice at one general location where controlled
substances are manufactured, distributed, imported, exported, or
dispensed by a person." \45\
Applicable regulations exempt certain locations from the
requirement of a separate registration to include "a practitioner (who
is registered at another location in the same state or jurisdiction of
the United States) where controlled substances are prescribed but
neither administered or dispensed as a regular part of the professional
practice of the practitioner at such office * * *."\46\ On December 1,
2006, DEA amended its registration regulations to make it clear that
when an individual practitioner practices in more than one state, the
practitioner must obtain a separate DEA registration for each state.
Clarification of Registration Requirements for Individual
Practitioners, 71 FR 69,478 (DEA 2006.) The amended regulation makes
clear that the secondary location exemption is limited to "location[s]
within the same State in which the practitioner maintains his/her
registration." Id. at 69,479.
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\43\ 21 U.S.C. 822(a)(2).
\44\ 21 U.S.C. 822(e).
\45\ 21 CFR 1301.12(a). The term dispense includes the delivery
of a controlled substance by prescribing. 21 U.S.C. Sec. 802(10).
\46\ 21 CFR 1301.12(b)(3).
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Additionally, Arizona law requires that "[e]very person who * * *
prescribes * * * any controlled substance within this state * * * must
first * * * [b]e a registrant under the federal controlled substances
act (Pub. L. 91-513; 84 Stat. 1242; 21 United States Code section 801 et seq.)." Ariz. Rev. Stat. Ann. Sec. 36-2522(A)(2) (emphasis
supplied).
The evidence of record establishes that Respondent is licensed to
practice medicine in Arizona and California, and his DEA registered
practice address is 8466 Santa Monica Boulevard, West Hollywood,
California 90069. (Gov't Ex. 1; see also Tr. 28-29, 154.) From April
2011 until December 2011, Respondent practiced at AZ Go Green, located
at 325 East Southern Avenue, Suite 120, Tempe, Arizona 85282. (Tr. 154-
55; see Gov't Ex. 3.) Respondent admits that he did not obtain a DEA
registration for AZ Go Green, or any other Arizona practice location.
(Tr. 165.)
Despite not having a DEA registration in the State of Arizona, SA
Lamkin testified that the CSPMP showed that Respondent issued
controlled substance prescriptions to patients in Arizona.\47\ (Tr. 28-
33.) Specifically, Respondent issued at least twenty-three controlled
substance prescriptions between June 2011 and October 2011 while
practicing at AZ Go Green in Arizona to patients M.F., L.H., R.B.,
J.C., C.C., J.B. and D.B., as well as to the UCs. (See Gov't Ex. 3, at
1-11, 16-20, 23-32.) Additionally, from April 2011 to May 2011, while
Respondent was practicing at AZ Go Green in Arizona, he issued at least
seven prescriptions to patients J.C., J.B., and R.B. using a
prescription pad that listed an unregistered California address: 1017
North La Cienega Boulevard, Suite 110, West Hollywood, California
90069. (See Gov't Ex. 3, at 12-15, 17-18, 21-22; Tr. 28-29, 30, 154-
55.) \48\
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\47\ Despite the allegation in the OSC/IS that Respondent
"authorized at least 190 prescriptions for controlled substances,
more than 75 percent of which were for oxycodone," in Arizona, (ALJ
Ex. 1, at 1; see also ALJ Ex. 5, at 2) there was no evidence
produced at hearing to indicate the total number of controlled
substance prescriptions Respondent issued in Arizona, or what
percentage of those prescriptions pertained to oxycodone. See Gregg
& Son Distributors, 74 FR 17,517, 17,517 n.1 (DEA 2009) (noting that
it is the Government's obligation, as part of its burden of proof,
"to sift through the records and highlight that information which
is probative of the issues in the proceeding").
\48\ There is evidence of record that Respondent prescribed
controlled substances while in Arizona using his 1017 North La
Cienega Boulevard address. (Compare Gov't Ex. 3, at 14, with Gov't
Ex. 6, at 5.)
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Respondent testified in relevant part that he never registered his
Arizona practice location with DEA, explaining that in his over forty
years of practice, he "had never heard that that was a requirement."
(Tr. 165.) Respondent elaborated: "I mean, just my common sense, I'm
wrong of course, but my common sense is, it's a federal drug license.
So why shouldn't it be transferable from state-to-state?" (Id.) As
with other areas of Respondent's testimony, I do not find his testimony
that he had never heard of the requirement credible. For example, a
review of Respondent's DEA COR, issued on July 21, 2010, bearing a
registration address in West Hollywood, California, states in bold
print: "THIS CERTIFICATE IS NOT TRANSFERABLE ON CHANGE OF OWNERSHIP,
CONTROL, LOCATION, OR BUSINESS ACTIVITY, AND IS NOT VALID AFTER THE
EXPIRATION DATE." (Gov't Ex. 1.)
Aside from the statutory and regulatory notice, Respondent was
clearly on actual notice that his DEA registration was not transferable
to an Arizona location.\49\ Thus, I find by substantial evidence that
Respondent knowingly issued prescriptions for controlled substances
from an unregistered practice location on numerous occasions between
April and October 2011 in violation of applicable state and federal
law. 21 U.S.C. 822 (a)(2), (e); 21 CFR 1301.12 (b)(3); Ariz. Rev. Stat.
Ann. Sec. 36-2522(A)(2).
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\49\ Although Respondent stopped practicing in Arizona in
December 2011, I do not find this to be sufficient mitigating
evidence, particularly in light of the fact that the OSC/IS was
issued in December 2011. (See ALJ Ex. 1, at 1.)
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Based upon the foregoing, I find the Government has established by
a preponderance of the evidence under Factors Two and Four that
Respondent's prescribing practices and compliance with applicable state
and federal law from April 2011 until October 2011 was inconsistent
with the public interest. This weighs heavily in favor of a finding
that Respondent's continued registration would be inconsistent with the
public interest.
Factor 5: Such Other Conduct Which May Threaten the Public Health and
Safety
Under Factor Five, the Administrator is authorized to consider
"other conduct which may threaten the public health and safety." 5
U.S.C. 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 FR 20,727, 20,734 (DEA 2009).\50\ 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 FR 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 FR 10,083, 10,094 (DEA 2009).
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\50\ 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.")
---------------------------------------------------------------------------
Turning first to "other conduct," the Government alleged and
presented evidence related to the illegal distribution of marijuana at
Respondent's Arizona practice location. The evidence included testimony
from SA Lamkin that a former employee of AZ Go Green stated Respondent
and the owner of the clinic "were illegally distributing marijuana out
of the clinic and prescriptions for oxycodone as well." (Tr. 23.)
While the evidence of record corroborated the prescribing of oxycodone
by Respondent, SA Lamkin's credible testimony at hearing does not
support a finding that Respondent participated in the illegal
distribution of marijuana.
SA Lamkin testified that Respondent "took it a little farther"
than just
[[Page 45675]]
certifying or diagnosing a patient as needing medical marijuana, but
acknowledged a lack of investigative information that Respondent "ever
handed any marijuana to anybody for cash." (Tr. 77-78.) The weight of
the evidence demonstrates that Respondent's activities, as it relates
to marijuana, were primarily limited to medical marijuana
recommendations. (See, e.g., Gov't Ex. 2, at 3-4.)
Accordingly, I find that the Government has not established by a
preponderance of the evidence that Respondent "distributed
marijuana[,] * * * aided and abetted the distribution of marijuana[,]"
or engaged in other related conduct. Cf. Marion "Molly" Fry, M.D., 67
Fed. Reg. 78,015 (DEA 2002) (the respondent's registration not revoked
"'merely because' she recommended marijuana to a patient 'based on a
sincere medical judgment' " but primarily because she distributed
marijuana and aided and abetted in distribution of marijuana).
A remaining issue in this case is whether Respondent has accepted
responsibility for his past misconduct, and demonstrated that he will
not engage in future misconduct. The Government argues that there "is
nothing in the record that evinces Respondent's acceptance of
responsibility * * *." (Gov't Br., at 18.) The Government also notes
that Respondent lacked candor throughout his testimony, simply claiming
that he was unaware of certain regulations or attempting to justify his
prescribing practices by "fabricat[ing] a story * * *." (Id. at 18-
19.) Respondent does not specifically address acceptance of
responsibility in his post-hearing brief, but he instead claims that
the Government did not meet its burden of proof because he did not
intentionally violate any state or federal regulations, and because
"the government's case rests entirely upon a web of lies spun by two
undercover agents * * *." (Resp't Br., at 14-15.)
As discussed above, Respondent's testimony as a whole fails to
adequately accept responsibility for his past misconduct, particularly
with regard to his prescribing practices to the UCs. Under Agency
precedent, in the absence of a credible explanation by the
practitioner, as few as two incidents of diversion are sufficient to
revoke a registration. Alan H. Olefsky, M.D., 57 FR 928, 929 (DEA
1992). Respondent's lack of credibility during numerous material
portions of his testimony weighs heavily against a finding that
Respondent has accepted responsibility, let alone demonstrated that he
will not engage in future misconduct. 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).
I find by a preponderance of the evidence that Respondent has not
accepted responsibility for his past misconduct, nor has he credibly
demonstrated that he has learned from his past mistakes and would
properly handle controlled substances in the future. An "agency
rationally may conclude that past performance is the best predictor of
future performance." Alra Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th
Cir. 1995). 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 revoking Respondent's DEA COR AE5382724, based on
Factors Two, Four and Five of 21 U.S.C. 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 (DC Cir.
2005); Humphreys v. DEA, 96 F.3d 658, 661 (3d Cir. 1996); Shatz v.
United States Dep't of Justice, 873 F.2d 1089, 1091 (8th Cir. 1989);
Thomas E. Johnston, 45 Fed. Reg. 72, 311 (DEA 1980).
The record reveals that Respondent has not sustained his burden in
this regard. In fact, as discussed above, Respondent's testimony in
numerous instances was not credible and reflected an overall lack of
admission of past misconduct. Respondent's testimony was also
effectively devoid of any credible demonstration that he has learned
from his past mistakes and will not engage in future misconduct. In
light of the foregoing, Respondent's evidence as a whole fails to
sustain his burden to accept responsibility for his past misconduct and
demonstrate that he will not engage in future misconduct.
I recommend revocation of Respondent's DEA COR AE5382724 as a
practitioner, and denial of any pending applications for renewal or
modification, on the grounds that Respondent's continued registration
would be fully inconsistent with the public interest as that term is
used in 21 U.S.C.Sec. 824(a)(4) and 823(f).
Dated: April 5, 2012
s/Timothy D. Wing
Administrative Law Judge
[FR Doc. 2012-18747 Filed 7-31-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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