Registrant Actions - 2011
[Federal Register Volume 76, Number 209 (Friday, October 28, 2011)]
[Notices]
[Pages 66986-66994]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-27985]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-73]
Shawn M. Gallegos, D.D.S., Decision and Order
On May 19, 2011, Administrative Law Judge (ALJ) Timothy D. Wing
issued the attached recommended decision. Neither party filed
exceptions to the decision.
Having reviewed the entire record, I have decided to adopt the
ALJ's findings of fact, conclusions of law and recommended order in its
entirety except as explained below.\1\ Accordingly, I will order that
the Respondent's application be denied.
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\1\ At page 19 of the slip opinion, the ALJ explained that
"Respondent's statement during the December 2, 2009 audit that the
dispensing records were located within his patient records was found
to be inaccurate. Even if true, the patient records would not
substitute for required copies of DEA Form 222 relating to the
Schedule II controlled substance oxycodone, among other
recordkeeping requirements." To make clear, a DEA Form 222, which
is otherwise known as an "order form," must be executed for each
distribution of a schedule II controlled substance with the
exception of those distributions which are exempt under 21 CFR
1305.03. This form is not required, however, to document a
practitioner's dispensing of controlled substances, which must be
recorded in a dispensing log. See 21 CFR 1304.03(b), 1304.22(c).
While the record establishes that Respondent ordered oxycodone only
a single time (for which he did not have a copy of the requisite
Form 222), Respondent was also required to maintain, for a period of
two years, records documenting the receipt of all controlled
substances he acquired, as well as an initial inventory when he
first engaged in controlled substances activities and biennial
inventories thereafter for each controlled substance he acquired.
Id. 1304.04(a), 1304.11, 1304.21(a). Respondent, however, had no
such records.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 28
CFR 0.100(b), I hereby order that the application of Shawn M. Gallegos,
D.D.S., for a DEA Certificate of Registration as a practitioner, be,
and it hereby is, denied. This Order is effective immediately.
Dated: October 7, 2011.
Michele M. Leonhart,
Administrator.
Theresa Krause, Esq. & Brian Bayly, Esq., for the Government
Shawn M. Gallegos, D.D.S., pro se, Respondent
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge
Introduction
Administrative Law Judge Timothy D. Wing. This proceeding is an
adjudication pursuant to the Administrative Procedure Act (APA), 5
U.S.C. 551 et seq., to determine whether the Drug Enforcement
Administration (DEA) should deny a dentist's application for a DEA
Certificate of Registration (COR) as a practitioner. Without this
registration the dentist, Shawn M. Gallegos, D.D.S. (Respondent or Dr.
Gallegos), of Martinez, California, will be unable to lawfully
prescribe, dispense or otherwise handle controlled substances in the
course of his practice.
On August 3, 2010, the DEA Deputy Assistant Administrator, Office
of Diversion Control, issued an Order to Show Cause (OSC) to
Respondent, giving Respondent notice of an opportunity to show cause
why the DEA should not deny Respondent's application for a DEA COR,
filed on or around January 27, 2010, pursuant to 21 U.S.C. 824(a)(4)
and 21 U.S.C. 823(f), on the grounds that Respondent's registration
would be inconsistent with the public interest as that term is used in
21 U.S.C. 824(a)(4) and 823(f).
In part and in substance, the OSC alleges that Respondent
voluntarily surrendered his DEA registration number BG6936491 for cause
on December 2, 2009, alleging that during the course of a DEA
investigation concerning suspicious orders of hydrocodone and
phentermine, Respondent stated the controlled substances were not used
in the normal course of his dental practice. The OSC further alleges
that on multiple occasions, Respondent failed in his responsibility as
a practitioner to ensure that the controlled substances ordered and
dispensed by him were for a legitimate medical purpose by a
practitioner acting in the usual course of professional practice, in
violation of 21 CFR 1306.04(a). Additional alleged violations include
the inability to account for the dispensing of the controlled
substances in violation of 21 CFR 1304.04(a); the failure to keep a
dispensing log for controlled substances, in violation of 21 CFR
1304.03(b); the failure to keep accurate, complete and mandatory
records of controlled substances in violation of 21 CFR 1304.21(a); the
failure to properly report the theft of hydrocodone and the
unauthorized use of Respondent's registration, in violation of 21 CFR
1301.76(b); the failure to establish a valid doctor-patient
relationship before issuing and dispensing controlled substances (diet
pills), which were for other than a legitimate medical purpose and
outside the usual course of professional practice, in violation of 21
CFR 1306.04; and the commission of "such acts that would render
Respondent's registration inconsistent
[[Page 66987]]
with the public interest, particularly in light of [the] failure to
comply with State and Federal laws relating to controlled substances,"
citing 21 U.S.C. 823(f)(4) and 824(a)(4).\2\
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\2\ ALJ Ex. 1.
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In addition to the OSC, the Government also noticed and alleged in
its September 24, 2010 prehearing statement that on January 16, 2010,
Respondent used his previously surrendered DEA registration to call in
a prescription for the controlled substance lorazepam, which was filled
and dispensed to patient [GS]. (Gov't PHS at 7.) The Government further
alleged that "DI Windsor will testify that this [lorazepam] controlled
substance is not used in the normal course of the Respondent's dental
practice." \3\ (Gov't PHS at 7-8.) The Government further alleged that
"Respondent will testify that he told DI Windsor and DI Myers that his
suspicious orders of hydrocodone and phentermine were not used in the
normal course of his dental practice." \4\ (Gov't PHS at 3.) Finally,
the Government alleged various instances of unprofessional conduct
contained within a document entitled: "In the Matter of the Accusation
Against [Respondent]," brought on behalf of the Dental Board of
California, and dated January 31, 2011. (Gov't Ex. 10.)
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\3\ At hearing, DI Windsor offered no testimony specifically
addressing this issue. The Government did offer testimony from Ms.
Muratalla which was mixed in terms of the use of lorazepam in
Respondent's dental practice. Ms. Muratalla testified in substance
that lorazepam was "used for other people" and also for dental
patients. (Tr. 63-64.)
\4\ Notably, the only testimony offered at hearing by DI Windsor
regarding Respondent's December 2, 2009 statements arguably relevant
to controlled substances not being used in the normal course of his
dental practice, consisted of the following: "Dr. Gallegos had said
that he ordered diet pills for his wife and he had also said that
she had ordered them for herself." (Tr. 146.) DI Windsor further
testified based on her knowledge and experience as a diversion
investigator that diet pills were inconsistent with a dental
practice. (Tr. 119-20.) There was no testimony supporting the
allegation that Respondent made similar reference to hydrocodone. DI
Myers was not called to testify at hearing and Respondent did not
testify. No written reports were offered memorializing any
statements made to DEA diversion investigators by Respondent.
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On September 13, 2010, Respondent, acting pro se, requested a
hearing on the allegations in the OSC. Following prehearing procedures,
a hearing was held on April 5, 2011, in San Francisco, California, with
the Government represented by counsel and Respondent appearing pro
se.\5\ Both parties called witnesses to testify and introduced
documentary evidence. Respondent elected not to testify. 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.
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\5\ Throughout the course of prehearing procedures Respondent
was afforded various opportunities to obtain counsel, to include a
letter to Respondent from the Office of Administrative Law Judges
identifying Respondent's right to counsel pursuant to 21 CFR 1316.50 (2010) (ALJ Ex. 3), a similar notation in a November 12, 2010
prehearing ruling (ALJ Ex. 5 at 1-2) and the granting of a
continuance at Respondent's request so that Respondent might obtain
counsel. (ALJ Ex. 8 at 1-2.) At hearing, Respondent affirmed that he
wished to proceed with the hearing without the assistance of
counsel. (Tr. 4.)
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Issue
Whether the record establishes by substantial evidence that
Respondent's application for a DEA COR, W10004582C, as a practitioner,
should be denied pursuant to 21 U.S.C. 823(f) and 824(a)(4), because
Respondent's registration would be inconsistent with the public
interest as that term is used in 21 U.S.C. 823(f).
Evidence and Incorporated Findings of Fact
I. Background
Respondent was assigned DEA registration BG6936491 on September 7,
2000, as a practitioner in Schedules II-V. (Gov't Ex. 1.) The last
renewal of this registration was on October 1, 2009, at the address of
220 E. Alamo Plaza, Alamo, California. On December 2, 2009, Respondent
voluntarily surrendered this registration, "after which date no
controlled substances could be obtained, stored, administered,
prescribed, or dispensed under DEA registration BG6936491." (Gov't
Exs. 1 & 2.) On January 27, 2010, Respondent submitted an application
for registration W10004582C as a practitioner in Schedules II-V, at the
address of 220 E. Alamo Plaza, Alamo, California. (Gov't Exs. 1 & 3.)
II. The Government's Evidence
At hearing, the Government presented the testimony of three
witnesses: Respondent's former patient [GS]; \6\ Respondent's ex-wife
and former employee Maria Muratalla (Ms. Muratalla), and DEA Diversion
Investigator Jamee Windsor (DI Windsor). DI Windsor testified in
substance to having over ten years of experience in law enforcement,
and to having been a diversion investigator with DEA since July 2009.
(Tr. 107-109.) DI Windsor first became involved in an investigation of
Respondent following receipt of a June 11, 2009 "Suspicious Order"
report by The Harvard Drug Group (Harvard),\7\ noting Respondent's
order of four controlled substances that were inconsistent with his
dental practice.\8\ The report noted in bold print, with asterisks:
"*This dentist ordered the above items for their personal use.*" \9\
(Tr. 113; Gov't Ex. 5 at 1.) DI Windsor testified that the four
controlled substances in question \10\ are Schedule IV controlled
substances used as diet aids to treat moderate to extreme obesity. (Tr.
113-14.)
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\6\ The patient's initials are used to protect patient privacy.
\7\ Harvard was described by DI Windsor as a re-distributor of
controlled substances to DEA registrants. (Tr. 116.)
\8\ The report by Harvard contains a note at the bottom of the
page which was determined by DI Windsor to be an error by Harvard.
The notation "[p]lease note that these are 3 separate 222 forms * *
* all three signed by the same person" was acknowledged by Harvard
to be a mistake ("a typo") on Harvard's part, but the remaining
information in the report was believed to be accurate. (Tr. 127.)
\9\ No testimony or evidence was offered regarding what
knowledge or information formed the basis for this statement.
\10\ Adipex (100 count bottle), Fastin (1000 count bottle),
phentermine (1000 count bottle) and Tenuate (100 count bottle). (See
Gov't Ex. 5 at 1.)
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The evidence also included a transaction history report from DEA's
Automation of Reports and Consolidated Orders System (ARCOS),\11\
reflecting six controlled substance transactions between Harvard and
Respondent between October 2, 2007, and March 27, 2009. (Gov't Ex. 5 at
2-5; Tr. 121-22.) Five of the orders were for Schedule III controlled
substances, and one transaction, dated July 30, 2008, was for the
Schedule II controlled substance oxycodone. (Tr. 141; Gov't Ex. 5 at
2.)
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\11\ DI Windsor offered testimony regarding the system. I also
note that "Registrants are also required to report records of sales
or acquisitions of controlled substances in Schedules I and II, of
narcotic controlled substances listed in Schedules III, IV and V,
and of psychotropic controlled substances listed in Schedules III
and IV with the DEA's Automation of Reports and Consolidated Orders
System (ARCOS). 21 CFR 1304.33(c); 21 U.S.C. 827(d). These reports
must be filed every quarter not later than the 15th day of the month
succeeding the quarter for which it is submitted. 21 CFR
1304.33(b)." Easy Returns Worldwide, Inc. v. United States, 266 F.
Supp. 2d 1014, 1016 (E.D. Mo. 2003).
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DI Windsor next testified to visiting Respondent's registered
practice location on the morning of December 2, 2009, accompanied by
another DEA diversion investigator. (Tr. 129.) Respondent was present
in the office along with a receptionist, and possibly a third employee.
When the diversion investigators arrived they presented Respondent with
a DEA form entitled Notice of Inspection of Controlled Premises, which
was subsequently
[[Page 66988]]
signed by Respondent.\12\ (Tr. 131-34.) DI Windsor further testified
that the inspection included "an inventory of [Respondent's]
dispensing of his controlled substances * * *." (Tr. 134-35.) The
results of the inventory reflected 89.5 tablets of 5mg/500mg
hydrocodone present in the office. (Gov't Ex. 8; Tr. 138.) In addition
to the inventory, the inspection also sought to review required
records, to include biennial inventories, dispensing logs, copies of
DEA Form 222 for Schedule II controlled substances and other invoices
for Schedule III-V controlled substances. (Tr. 139-41.) DI Windsor
testified that none of the required records could be located and
Respondent was unable to produce any. (E.g., Tr. 141-42.) The diversion
investigators reviewed a random sampling of Respondent's patient files,
none of which included dispensing records for hydrocodone or oxycodone.
(Tr. 142-43.)
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\12\ The notice includes in pertinent part a statement of
rights, to include the right to "not have administrative inspection
without an administrative inspection warrant," and an
acknowledgment and consent section, requiring signature by the
registrant to consent to the inspection. (Gov't Ex. 4.)
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DI Windsor also testified regarding statements made by Respondent
during the inspection relating to controlled substances. With regard to
diet pills, DI Windsor testified that Respondent first raised the
issue, stating that "he had ordered diet pills for his wife [referring
to Ms. Muratalla] and he had also said that she ordered them for
herself." (Tr. 146.) DI Windsor did not recall specifically discussing
the diet pills Adipex, Fastin, phentermine or Tenuate with Respondent,
or the specific time frames for the orders. (Tr. 147.) The inspection
revealed no invoices, inventory or dispensing records of any type for
any of the diet pills referenced in shipment records to Respondent.
(Tr. 147-48.) DI Windsor further testified that Respondent stated he
purchased the diet pills with a company credit card, and informed DI
Windsor that he would work on getting a copy of the bill, but as
recently as the date of hearing Respondent had not produced a copy.
(Tr. 153.)
DI Windsor next testified that Respondent stated during the
inspection that there had been two occasions within the preceding one
or two years in which controlled substances believed to be hydrocodone
that had been placed on his desk "had come up missing." (Tr. 148,
150.) Respondent further stated that "on one occasion he did not
contact law enforcement [and] on the second occasion he thought law
enforcement had been contacted by one of his staff, but he wasn't
certain of that." (Tr. 149.) Respondent was certain that neither
incident had been reported to DEA. (Id.) The lack of available records
at Respondent's registered location precluded DI Windsor from
determining the amount of the loss.
The evidence also included a form entitled Voluntary Surrender of
Controlled Substances Privileges, dated December 2, 2009, and signed by
Respondent. (Gov't Ex. 2.) DI Windsor testified that after the
completion of the closing inventory and request for documentation,
Respondent was presented the form, including an explanation of its
terms and Respondent's right to re-apply at a later date. (Tr. 155-56.)
Respondent signed the form but was unable to produce a copy of his DEA
COR. (Tr. 159; Gov't Ex. 9.)
On cross- and redirect examination, DI Windsor testified to being
at Respondent's office on December 2, 2009 for approximately two hours.
(Tr. 168.) DI Windsor testified that between December 2, 2009, and
August 3, 2010, she spoke with Respondent by telephone approximately
six times regarding Respondent's application and the California Dental
Board, but DI Windsor ceased communication with Respondent after
becoming aware that Respondent "had a patient call [DI Windsor]
pretending to be [Respondent's] attorney." (Tr. 169, 173.) DI Windsor
further testified that upon Respondent's request that she contact
Harvard to inquire about the ordering of diet pills, DI Windsor called
Harvard and was informed that the person who ordered the diet pills in
June 2009 was not Ms. Muratalla.\13\ (Tr. 170; 182-83.) DI Windsor's
testimony was fully credible. Her testimony was internally consistent,
corroborated by documentary evidence of record and the witness was able
to recall factual events with a reasonable level of certainty.
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\13\ No testimony or other evidence was offered regarding the
identity of the person Harvard said ordered the diet pills.
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The Government presented the testimony of Respondent's former
patient [GS], who credibly testified in substance to being Respondent's
patient from December 2009 until approximately March 2010. (Tr. 38-40.)
[GS] testified that Respondent treated her initially in December 2009
for an infected tooth, and later in or about January 2010 Respondent
performed a root canal. (Tr. 38.) [GS] further testified that
Respondent prescribed "two rounds of antibiotics * * * initially [and]
on the third visit * * * he gave me a prescription for lorazepam."
(Tr. 39.) [GS] specifically recalls being prescribed the lorazepam in
the latter part of January or February of 2010. (Id.) On cross-
examination, [GS] admitted to filing a complaint against Respondent
with the California Dental Board "for not finishing the work that I
paid for." \14\ (Tr. 41.)
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\14\ [GS] had also testified on direct examination to being
awarded a court judgment for $6649. (Tr. 40.)
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The evidence also included a pharmacy prescription record dated
January 16, 2010, detailing a prescription for "Amox" and
"Lorazepam" to patient [GS], and listing Respondent as the
prescriber. (Gov't Ex. 6.) DI Windsor credibly testified in relevant
part that the prescription was "phoned in" and lorazepam was the only
controlled substance prescribed and dispensed.\15\ (Tr. 162-63.)
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\15\ Lorazepam is a Schedule IV controlled substance. (Tr. 163.)
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The Government next offered the testimony of Ms. Muratalla, who
testified in substance to having married Respondent in 1999, separated
in May 2008, and divorced in June 2010. (Tr. 47-48.) Ms. Muratalla
explained that she also had a working relationship with Respondent,
initially working as colleagues and eventually opening their own
practice in September 2002. (Tr. 48.) Ms. Muratalla testified that her
primary duty was working as a dental hygienist, but also had
responsibilities such as "management, payroll * * * accounts
receivable and accounts payable, as well as * * * cleaning crew on
weekends." (Tr. 49.) Ms. Muratalla explained that she performed all of
the above duties until July 22, 2008, when Respondent removed her
access to his financial accounts. (Tr. 53-54.) From July 22, 2008,
until September 11, 2008, Ms. Muratalla testified that she was not
involved in any ordering of drugs and only worked in Respondent's
office as a hygienist.\16\ (Tr. 51 & 53.)
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\16\ Ms. Muratalla testified that she stopped working in
Respondent's office altogether on September 11, 2008, because "I
had an official restraining order that was placed by [Respondent] on
me." (Tr. 51.)
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Ms. Muratalla outlined the drug ordering system in Respondent's
office between 2002 and July 2008, noting that "I'm not sure how we
came across Harvard drugstore" but opened an account and eventually
began placing all orders through Harvard for financial reasons. (Tr.
49.) In terms of Respondent's role in ordering drugs, Ms. Muratalla
testified that Respondent did not make requests verbally, but was
"very specific as far as writing down a list for me. He did every
time." (Tr. 50.) Ms. Muratalla did not recall amounts ordered but did
not believe the amounts
[[Page 66989]]
were excessive. (Tr. 51.) Ms. Muratalla further explained that she was
the contact person in the office for drug orders which were sent to
Respondent's office address using only Respondent's DEA number, because
"[h]e was the sole proprietor * * * [and] only dentist working at the
practice." (Tr. 55.) Ms. Muratalla testified that Respondent had
"specific instructions to all staff members including myself, no one
to open the box from [Harvard], it had to be placed on his desk without
opening." (Id.) Respondent maintained the drugs in his office in a
locked drawer and maintained possession of the key as well as the key
to his office. (Tr. 60.)
Ms. Muratalla further testified about a series of drug orders
placed between October 2007 and March 2009. (Tr. 59; see Gov't Ex. 5 at
2.) Ms. Muratalla indicated that the October 2, 2007 and February 5,
2008 orders for hydrocodone and acetaminophen were common orders that
she placed for the office, but would not have placed the remaining four
orders.\17\ (Tr. 59.) Ms. Muratalla explained that she did not place
the July 30, 2008 order for oxycodone and never recalled the office
previously ordering or dispensing oxycodone. (Tr. 61.) Ms. Muratalla
next testified to ordering controlled substances at the request of
Respondent that she knew were used within and outside Respondent's
dental practice, to include phentermine, Valium and Ambien, as well as
"over-the-counter drugs." (Tr. 63-64.) With regard to diet pills, Ms.
Muratalla is positive she did not order any after July 2008 but did
make diet pill orders before that at the written direction of
Respondent, stating that none were for her use. (Tr. 64.) Ms. Muratalla
testified that she had suspicions as to who was using the diet pills
but had "never seen anyone take those pills." (Tr. 65.)
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\17\ July 30, 2008 (oxycodone); October 16, 2008 (hydrocodone
and acetaminophen); November 19, 2008 (hydrocodone); and March 27,
2009 (hydrocodone and acetaminophen). (Gov't Ex. 5 at 2.)
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On cross- and redirect examination, Ms. Muratalla testified that
prior to 2007 when the dental practice was very busy approximately 4500
hydrocodone pills could reasonably have been distributed to patients,
who were given ten to twenty pills at a time. (Tr. 76.) After 2007, Ms.
Muratalla testified that that level of distribution was not possible
because "there was absolutely no patients coming through the doors."
(Tr. 75-76.) Ms. Muratalla testified that she was familiar with a
person named Jennifer Savarese, a dental distributor who visited
Respondent's office, but she never reviewed a Harvard drug catalogue
with Ms. Savarese regarding diet pills and never handed diet pills to
Ms. Savarese. (Tr. 77-78; 81-82.) Ms. Muratalla further testified that
her relationship with Ms. Savarese was strictly professional, and she
did not socialize with Ms. Savarese or consider her a friend. (Tr. 80.)
In addition to the foregoing, the Government also introduced a
document entitled: "In the Matter of the Accusation Against"
[Respondent], brought on behalf of the Dental Board of California, and
dated January 31, 2011.\18\ (Gov't Ex. 10 at 1, 14.) The Accusation
includes various allegations against Respondent to include, among
others, unprofessional conduct by: prescribing controlled substances
after voluntary surrender of privileges, citing California Health and
Safety Code 11155; procuring a prescription for controlled substances
by misrepresentation, concealment of material fact and making a false
statement, citing California Health and Safety Code 11173; obtaining,
possessing or administering to oneself cocaine between May and October
2008, and marijuana between March and April 2010, citing California
Health and Safety Code 11054 and 11055; and using alcohol in a
dangerous manner in or about January 8, 2010, citing California
Business and Professions Code 1681(b).
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\18\ When the document was tendered, DI Windsor testified in
response to a question of when it is dated: "This one. August 2nd,
2000 (sic), is when they got the complaint, and it expires on March
6th, 2011." (Tr. 188.) A review of the document reflects at
paragraph two that the August 2, 2000 date refers to the issue date
for Respondent's dental license with an expiration date of March 6,
2011, unless renewed. (Gov't Ex. 10 at 1.) The document is dated
January 31, 2011. (Id. at 14.)
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III. Respondent's Evidence
Respondent did not testify and presented only one witness, Jennifer
Yuen (n[eacute]e Savarese) (Ms. Savarese),\19\ a dental products
representative. Ms. Savarese testified in substance that she worked as
a dental products representative and was professionally introduced to
Respondent through a mutual acquaintance. Initially, Ms. Savarese had
only a business relationship with Respondent and Ms. Muratalla but over
time became friends, describing her relationship with Respondent as
"my dentist and friend." (Tr. 90.) Ms. Savarese described Ms.
Muratalla as "a very good friend of mine" to include going out to
lunch with Ms. Savarese and attending her wedding. (Id.)
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\19\ The witness testified that she married in June 2008, but
previously went by the last name Savarese. For purposes of this
Recommended Decision, the witness will be referred to as Ms.
Savarese.
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With regard to the issue of diet pills, Ms. Savarese recalled going
through a catalogue with Ms. Muratalla to order diet pills, and
testified that "she said she would order them through her rep for
me." (Id.) When the pills came back to the office "Maria gave them to
me [and] I gave her cash." (Tr. 91.) Ms. Savarese specifically
recalled that the only brand of diet pills ordered were phentermine,
recalling placing two separate orders prior to 2007. (Tr. 94; 99-100.)
She believed the total quantity ordered in 2006 and 2007 was at most
600 dosage units based on two separate orders of 300. (Tr. 101.) Ms.
Savarese also admitted that at the time she placed the order for
phentermine she did not "think that it was illegal" but now realizes
that it was illegal. (Tr. 105.)
Respondent's evidence also included a May 11, 2000 Certificate of
Recognition for high achievement in the Undergraduate Curriculum in
Dental Care for Persons with Disabilities, a daily schedule calendar
covering the period October 2007 to March 2009 and contact information
for a probation office in Utah.\20\ (Resp't Exs. 2-4.)
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\20\ Respondent stated that he had prior employment as a
probation officer with the State of Utah from 1992 to 1996. (Tr.
205.) Respondent also stated that the calendar was offered to show
how many patients he had seen over a seventeen month period and
"the work that I did, that [patients] would require pain
medication, and to where the 4500 pills would have went to, over 17
months." (Tr. 210.)
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I find the testimony of Ms. Savarese fully credible. Her testimony
was internally consistent, and the witness was able to recall factual
events with a reasonable level of certainty. There is no documentary
evidence of record that contradicts the testimony of Ms. Savarese, nor
was there any evidence to suggest that she had a bias or other personal
interest in the outcome of the case. Ms. Savarese's past relationship
to Respondent was both professional and social, but no evidence was
offered to suggest that the witness's relationship with Respondent or
Ms. Muratalla would influence her testimony. Ms. Savarese's demeanor
was serious and forthright throughout her testimony. The credibility of
Ms. Savarese's testimony was further enhanced by her statement against
interest, admitting that at the time she placed the order for
phentermine she did not "think that it was illegal" but now realizes
that it was illegal. (Tr. 105.)
I find the testimony of Ms. Muratalla only partially credible. I do
not find credible Ms. Muratalla's testimony that she never reviewed a
Harvard drug
[[Page 66990]]
catalogue with Ms. Savarese regarding diet pills and never handed the
pills to Ms. Muratalla. Nor do I find credible Ms. Muratalla's
testimony that she did not socialize with Ms. Savarese. Evidence of Ms.
Muratalla's past history with Respondent, including a severance of
their professional and personal relationship in 2008, suggests the
witness had a bias or interest in the outcome of the case. The
witness's demeanor while testifying was fully consistent with that bias
or interest, to include at various times nonresponsive answers or
unsolicited comments adverse to Respondent.
The Parties' Contentions
I. The Government
The Government argues in its post-hearing brief that "the ALJ and
Deputy Administrator may consider the Dental Board's complaint as a
recommendation * * * 'of the appropriate State licensing board.' "
\21\ (Gov't Br. at 21.) The Government further argues in substance that
Respondent issued a prescription for lorazepam without authorization
using his surrendered DEA registration, failed to keep records such as
invoices, dispensing logs and inventories related to his purchases of
hydrocodone and oxycodone and failed to keep required records related
to his purchases of controlled substance diet pills. (Id. 22-24.) The
Government further argues that Respondent failed to report thefts of
controlled substances on two occasions to DEA, as required by
regulation. Finally, the Government argues that "Respondent has not
demonstrated to DEA that the problems that have been on-going in his
practice since at least 2007 will not continue * * * [and] Respondent
has forfeited his opportunity to show remorse." (Id. at 27.)
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\21\ I have specifically declined to consider the California
Dental Board complaint as a "recommendation," because at most it
contains accusations that are unresolved.
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II. Respondent
Respondent argues in his post-hearing brief that the Government has
not met its burden to identify who ordered the diet pills from Harvard,
and further argues that the testimony of Ms. Muratalla should be given
no weight. (Resp't Br. at 8-9.) Respondent maintains that the DEA made
insufficient investigation regarding mistaken information contained
within Government Exhibit 5, noting that this "page could definitely
have altered the whole scope of this investigation if proper
investigation was done." (Id. at 3.)
Respondent argues at various points that the Government has not met
its burden of proof,\22\ noting in part that Respondent has been an
"outstanding citizen who served the country as a probation officer * *
* [and] was awarded an exclusive award from 'The Academy of Dentistry'
for working with people with Disabilities when no one else would."
(Id. at 9-10.) Respondent further argues that forms such as biennial
inventories and invoice records were in the possession of Ms. Muratalla
and the Government. (Id. at 6, 10.) Finally, Respondent argues in
substance that due to reliance on hearsay and "perjuries" the
Government has failed to establish by a preponderance of the evidence
that Respondent's registration would be inconsistent with the public
interest, and his application for registration should be granted. (Id.
at 10.)
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\22\ Respondent appears to assert that the applicable standard
of proof is the "beyond a reasonable doubt" standard. (See, e.g.,
Resp't Br. at 4.) Contrary to Respondent's argument, however, the
applicable standard of proof in this administrative proceeding is
"preponderance of the evidence." Arthur Sklar, R.Ph., d/b/a King
Pharmacy, 54 FR. 34,623, 34,627 (DEA 1989). "A sanction may not be
imposed* * *except on consideration of the whole record* * *and
supported by and in accordance with the reliable, probative, and
substantial evidence." See 5 U.S.C. 556(d). Respondent appears to
acknowledge as much, arguing that the "issue before the court is
whether the government has established by a preponderance of the
evidence that Respondent's continued registration would be
inconsistent with the public interest." (Resp't Br. at 8 (emphasis
supplied).)
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Discussion
I. 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.\23\ "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.\24\ 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.\25\ In addition, I conclude that the reference
in 21 U.S.C. 823(f)(5) to "other conduct which may threaten the public
health and safety" would as a matter of statutory interpretation
logically encompass the factors listed in 824(a).\26\
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\23\ 21 U.S.C. 822(a)(2); 21 U.S.C. 802(10).
\24\ 21 CFR 1306.04(a).
\25\ 21 U.S.C. 844(a).
\26\ See Kuen H. Chen, M.D., 58 FR. 65,401, 65,402 (DEA 1993).
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A. The Public Interest Standard
The CSA, at 21 U.S.C. 824(a)(4), provides, insofar as pertinent to
this proceeding, that the Deputy Administrator may revoke a COR if she
finds that the registrant's 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 Deputy Administrator is
required to consider the following factors:
(1) The recommendation of the appropriate state licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing or conducting research
with respect to controlled substances.
(3) The applicant's conviction record under federal or state laws
relating to the manufacture, distribution or dispensing of controlled
substances.
(4) Compliance with applicable state, federal or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
As a threshold matter, the factors specified in Section 823(f) are
to be considered in the disjunctive: The Deputy Administrator may
properly rely on any one or a combination of those factors, and give
each factor the weight deemed appropriate, in determining whether a
registration should be revoked or an application for registration
denied. See David H. Gillis, M.D., 58 FR. 37,507, 37,508 (DEA 1993);
see also D & S Sales, 71 FR. 37,607, 37,610 (DEA 2006); Joy's Ideas, 70
FR. 33,195, 33,197 (DEA 2005); Henry J. Schwarz, Jr., M.D., 54 FR.
16,422, 16,424 (DEA 1989). Additionally, in an action to deny a
registrant's COR application, the DEA has the burden of proving that
the requirements for revocation are satisfied.\27\ The burden of proof
shifts to the respondent once the Government has made its prima facie
case.\28\
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\27\ See 21 CFR 1301.44(e) (2010).
\28\ See Medicine Shoppe--Jonesborough, 73 FR. 364, 380 (DEA
2008); see also Thomas E. Johnston, 45 FR. 72,311, 72,311 (DEA
1980).
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B. Other Factors
In addition to the public interest factors discussed above, 21
U.S.C. 824(a) provides four other factors that
[[Page 66991]]
the Deputy Administrator may consider in a proceeding to suspend or
revoke a DEA COR.\29\ Despite the lack of an explicit provision
applying these factors to a denial of an application
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\29\ That subsection provides that a DEA COR may be revoked upon
a finding that the registrant: (1) has materially falsified an
application; (2) has been convicted of a felony under the CSA or any
other federal or state law relating to any controlled substance; (3)
has had a state license or registration suspended, revoked or denied
and is no longer authorized by state law to handle controlled
substances; (4) has committed such acts as would render his
registration under 21 U.S.C. 823 inconsistent with the public
interest; or (5) has been excluded from participation in a program
pursuant to 42 U.S.C. 1320a-7(a). It should also be noted that
824(a) contains a reciprocal reference incorporating the public
interest factors from 823(f). See 21 U.S.C. 824(a)(4).
[t]he agency has consistently held that the Administrator may also
apply these bases to the denial of a registration, since the law would
not require an agency to indulge in the useless act of granting a license on one day only to withdraw it on the next.\30\
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\30\ Kuen H. Chen, M.D., 58 FR. 65,401, 65,402 (DEA 1993)
(citing Serling Drug Co. & Detroit Prescription Wholesaler, Inc., 40
FR. 11,918, 11,919 (DEA 1975)); see also Scott J. Loman, D.D.S., 50
FR. 18,941 (DEA 1985); Roger Lee Palmer, D.M.D., 49 FR. 950 (DEA
1984).
In addition, I conclude that the reference in 823(f)(5) to "other
conduct which may threaten the public health and safety" would as a
matter of statutory interpretation logically encompass the factors
listed in 824(a).\31\
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\31\ See Chen, 58 FR. at 65,402.
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II. The Factors To Be Considered
Factors 1 and 3: The Recommendation of the Appropriate State Licensing
Board or Professional Disciplinary Authority and Conviction Record
Under Federal or State Laws Relating to the Manufacture, Distribution
or Dispensing of Controlled Substances
In this case, regarding Factor One, it is undisputed that
Respondent currently holds a valid dental license in California, but
Respondent's dental license is presently the subject of state
disciplinary action pursuant to a pending state Accusation against
Respondent, the results of which are unknown.\32\ (Gov't Ex. 10.) While
not dispositive, Respondent's possession of a valid unrestricted dental
license in California does weigh in favor of a finding that
Respondent's registration would not be inconsistent with the public
interest. See Robert A. Leslie, M.D., 68 FR. 15,227, 15,230 (DEA 2003)
(state license is a necessary, but not a sufficient condition for
registration, and therefore, this factor is not dispositive).
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\32\ No further evidence or testimony was offered with regard to
the status or outcome of the state review, and I give the
allegations contained within the Dental Board Accusation no
evidentiary weight for purposes of this Recommended Decision.
---------------------------------------------------------------------------
Regarding Factor Three, there is no evidence that Respondent has
ever been convicted under any federal or state law relating to the
manufacture, distribution or dispensing of controlled substances. I
therefore find that this factor, although not dispositive, see Leslie,
68 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
The Government alleges that Respondent failed to effectively
monitor the receipt and distribution of controlled substances because
Respondent did not maintain an effective recordkeeping system in
accordance with 21 CFR 1304.03, 1304.04 and 1304.21, among others. The
evidence and testimony in this case centered in significant part on
Respondent's failure to properly handle controlled substances, as well
as his failure to comply with applicable laws regarding mandatory
record keeping. As an initial matter, this is not a case of a
registrant failing to adhere to the finer points of record keeping. The
undisputed evidence of record is that Respondent's record keeping was
essentially non-existent.
Pursuant to 21 CFR 1304.03(b), 1304.21(a), 1304.22(a)(2)(iv),
1304.22(a)(2)(ix) and 1304.22(c), a registered individual practitioner
is required to maintain records of controlled substances in Schedules
II-V that are dispensed and received, including the number of dosage
units, the date of receipt or disposal and the name, address and
registration number of the distributor. It is unlawful to fail to make,
keep or furnish required records.\33\ DEA regulations require that
"each registered individual practitioner required to keep records"
shall maintain inventories and records of Schedule II controlled
substances "separately from all of the records of the registrant";
inventories and records of Schedule III-V controlled substances "shall
be maintained either separately from all other records of the
registrant or in such form that the information required is readily
retrievable from the ordinary business records of the registrant."
\34\
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\33\ 21 U.S.C. 842(a)(5).
\34\ 21 CFR 1304.04(g) & (f)(2).
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One mandatory recordkeeping vehicle is DEA Form 222, the "official
triplicate order form[] used by physicians to order scheduled
narcotics" and other controlled substances.\35\ A menu of federal
regulations specifies procedures relating to DEA Form 222, such as
obtaining, 21 CFR 1305.11, executing, 1305.12, filling, 1305.13, and
endorsing DEA Form 222, 1305.14, among other procedures.\36\ In
addition, 21 CFR 1305.03 requires that a DEA Form 222 be used for each
distribution of a controlled substance listed in Schedule I or II, and
Section 1305.17 provides that these order forms must be maintained
separately from all other records and that they "are required to be
kept available for inspection for a period of 2 years."
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\35\ Robert L. Dougherty, Jr., M.D., 60 FR. 55,047, 55,048 (DEA
1995).
\36\ See, e.g., 21 CFR 1305.15- .19.
---------------------------------------------------------------------------
Failing to comply with recordkeeping laws and regulations relating
to controlled substances can justify adverse action against a
registrant's COR. "[A] blatant disregard for statutory provisions
implemented to maintain a record of the flow of controlled substances
and to prevent the diversion of controlled substances to unauthorized
individuals, would justify revocation" of a certificate of
registration.\37\
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\37\ Robert L. Dougherty, Jr., M.D., 60 FR. 55,047, 55,050 (DEA
1995) (citing George D. Osafo, M.D., 58 FR 37,508, 37,509 (1993)
(revoking practitioner's registration where "[r]espondent failed to
comply with numerous recordkeeping requirements[, explaining that] *
* * it is a registrant's responsibility to be familiar with the
Federal regulations applicable to controlled substances")); see
also Hugh I. Schade, M.D., 60 FR. 56,354, 56,356 (DEA 1995) (noting
the inventory procedures required by Sections 1304.11 to 1304.13,
and 1305.06).
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DEA regulations state that a registered individual practitioner is
required to keep records of controlled substances in Schedules II, III,
IV and V which are dispensed.\38\ As a general matter, records are
required to be kept by the registrant and must be available for at
least two years.\39\
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\38\ 21 CFR 1304.03(b) (2010).
\39\ 21 CFR 1304.04.
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The undisputed evidence of record reflects that Respondent
consented to an inspection of his registered location on December 2,
2009, by two DEA diversion investigators. The evidence also reflects
that between October 2007 and March 2009, Respondent had received in
six separate shipments from his supplier, Harvard Drug Group, several
thousand tablets of hydrocodone, and in July 2008, a significant
quantity of oxycodone. (Gov't Ex. 5 at 2-5.) Additionally, the evidence
reflects Respondent's order and receipt in or before June 2009 of
significant quantities of the Schedule IV controlled substances Adipex,
Fastin,
[[Page 66992]]
phentermine, and Tenuate, referred to collectively as "diet pills."
As of December 2, 2009, Respondent had received thousands of tablets of
controlled substances, requiring various levels of record keeping. The
December 2, 2009 audit of Respondent's registered location, with
Respondent present, resulted in the inventory and accounting of only
89.5 tablets of hydrocodone. (Gov't Ex. 8.) Moreover, no copies were
found of required DEA Form 222, which should have documented each
distribution of the Schedule II controlled substance oxycodone. Nor
were any other required records found or produced by Respondent during
the inspection, to include biennial inventories, dispensing logs and
invoices for controlled substances. (Tr. 139-40.)
Respondent's statement during the December 2, 2009 audit that the
dispensing records were located within his patient records was found to
be inaccurate. Even if true, the patient records would not substitute
for required copies of DEA Form 222 relating to the Schedule II
controlled substance oxycodone, among other recordkeeping requirements.
Respondent's attempt to produce relevant patient records during the
audit to support his claim was also revealing. Respondent initially
produced patient records that were outside the scope of the inspection
period, and was redirected by the diversion investigators to produce
relevant files. (Tr. 142.) Respondent then produced a "printout of
patient names." (Tr. 143.) At that point, the diversion investigators
identified a random sample of patient files by name within the time
frame of the audit, which upon production and review were found to
contain no dispensing records. (Id.)
I find by a preponderance of the evidence that Respondent
unlawfully failed to make, keep or furnish required records relating to
his handling of controlled substances, in violation of 21 U.S.C.
842(a)(5) and 827(a) and applicable regulations.\40\
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\40\ Respondent argues for the first time in his post-hearing
brief that Ms. Muratalla and counsel for the Government had copies
at the hearing of Respondent's biennial inventories and invoices for
controlled substances. (Resp't Br. 6.) This unsworn assertion by
Respondent is neither evidence nor is it supported by testimonial or
documentary evidence of record. In fact, evidence of controlled
substance shipments to Respondent that post-date Ms. Muratalla's
access to the records plainly refutes the assertion. Moreover,
Respondent had the opportunity to cross-examine Ms. Muratalla at
hearing and declined to offer any evidence to support his claim. I
therefore find that Respondent's argument, that required records did
in fact exist, is without factual support.
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The Government also alleged and offered evidence of Respondent's
failure to properly report the theft of controlled substances, in
violation of 21 CFR 1301.76(b). During the December 2, 2009 audit,
Respondent stated to diversion investigators that there were two
separate occasions within the preceding two years in which Respondent
believed that hydrocodone which had been placed on his desk had come up
missing. (Tr. 148, 150.) Respondent was also certain that neither
incident had been reported to DEA. (Tr. 149.) The applicable regulation
unambiguously requires a registrant to notify the "Field Division
Office of [DEA] in writing, of the theft or significant loss of any
controlled substances within one business day of discovery * * *." 21
CFR 1301.76(b). In this case, Respondent's violation was not a de
minimis one, such as missing the one business day deadline or notifying
the wrong office in writing. Rather, Respondent stated that on one
occasion he recalls law enforcement was not notified at all, and the
second he "thought law enforcement had been contacted by one of his
staff, but he wasn't certain of that." (Tr. 149.) Notably,
Respondent's failure to maintain any required records precluded DI
Windsor from determining the amount of the loss. (Tr. 152-53.)
I find by a preponderance of the evidence that Respondent failed to
timely notify DEA of the theft or loss of controlled substances on two
separate occasions between 2007 and 2009, in violation of 21 U.S.C.
1301.76(b).
The Government also offered evidence of Respondent's unlawful use
of his surrendered DEA registration to issue a prescription for
lorazepam in January 2010. This evidence centered on the testimony of
patient [GS], along with the testimony of DI Windsor, as corroborated
by a pharmacy copy of the filled prescription. The evidence at hearing
clearly documented Respondent's voluntary surrender of his DEA
registration on December 2, 2009.\41\ (Gov't Ex. 2.) In relevant part,
the surrender form states: "I understand that I will not be permitted
to order, manufacture, distribute, possess, dispense, administer,
prescribe, or engage in any other controlled substance activities
whatever, until such time as I am again properly registered." (Id.)
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\41\ DI Windsor testified in relevant part that Respondent's
surrender of his registration included an oral discussion between
Respondent and investigators, as well as a written surrender form
(DEA-104) that Respondent read and signed. (Tr. 154-59.) DI Windsor
also testified in response to Respondent's question about his state
of mind at the time of surrender, that he appeared "overwhelmed",
but Respondent offered no testimony or documentary evidence to
contradict the voluntariness of his surrender. I find by a
preponderance of the evidence that Respondent's surrender of
registration on December 2, 2009, was in fact voluntary.
---------------------------------------------------------------------------
In addition to the actual notice Respondent received as to his lack
of authority to handle controlled substances on and after December 2,
2009, applicable law and regulations provide clear guidance. "Except
as authorized by this title, it shall be unlawful for any person
knowingly or intentionally * * * to * * * dispense[] a controlled
substance." 21 U.S.C. 841(a). Moreover, "[e]very person who dispenses
* * * any controlled substance, shall obtain from the Attorney General
a registration," \42\ 21 U.S.C. 822(a)(2), with the exception of
"[a]n agent or employee of any registered * * * dispenser of any
controlled substance if such agent or employee is acting in the usual
course of his business or employment," id. 822(c)(1). "Every person
who manufactures, distributes, dispenses, imports or exports any
controlled substance or who proposes to [do so] * * * shall obtain a
registration unless exempted by law or pursuant to 1301.22-1301.26."
21 CFR 1301.11(a) (2010). Although a person may apply for registration
at any time, "[n]o person required to be registered shall engage in
any activity for which registration is required until the application
for registration is granted and a Certificate of Registration is issued
by the Administrator to such person." 21 CFR 1301.13(a) (2010).\43\
Respondent did not submit an application for a new DEA registration
until approximately January 27, 2010. (Gov't Ex. 1.)
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\42\ See also 21 CFR 1301.11 (2010).
\43\ Applicable California law also prohibits the prescribing of
controlled substances without "current registration from the
appropriate federal agency as provided by law. Cal. Health & Safety
Code 11155. "No person shall issue a prescription that is false or
fictitious in any respect." Id. 11157.
---------------------------------------------------------------------------
The uncontroverted evidence of record reflects that notwithstanding
his lack of DEA registration, Respondent unlawfully prescribed the
Schedule IV controlled substance lorazepam to patient [GS] on January
16, 2010. Patient [GS] credibly testified to being treated by
Respondent for an infected tooth beginning in December 2009 and further
testified that in the latter part of January 2010, Respondent performed
a root canal on [GS]. (Tr. 38.) [GS] specifically recalls Respondent
prescribing lorazepam on a third office visit, recalling the time frame
as the latter part of January or February 2010. (Tr. 39.) Corroborating
[GS]'s testimony, the
[[Page 66993]]
evidence included a pharmacy copy of a phoned-in prescription for [GS]
issued in Respondent's name dated January 16, 2010, using Respondent's
surrendered DEA registration number, prescribing "Amox" and
"Lorazepam", the latter being a Schedule IV controlled substance.
(Gov't Ex. 6; Tr. 163.)
I find by a preponderance of the evidence that Respondent violated
federal and state law by prescribing a Schedule IV controlled substance
on January 16, 2010, knowing that he lacked a DEA registration and was
prohibited from prescribing any controlled substance.\44\
---------------------------------------------------------------------------
\44\ See 21 U.S.C. 841(a)(1); 21 CFR 1301.11(a); 1301.13(a);
Cal. Health & Safety Code 11155 & 11157.
---------------------------------------------------------------------------
Another issue in this case concerns Respondent's prescribing
practices with regard to hydrocodone and phentermine, which the
Government alleges were not prescribed pursuant to a legitimate medical
purpose or within the usual course of professional practice, contrary
to 21 CFR 1306.04(a) (2010). (Gov't PHS at 7.) 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 also consider "generally recognized and accepted
medical practices" in the United States. Bienvenido Tan, M.D., 76 FR.
17,673, 17,681 (DEA 2011).
The applicable standards under California law may be found in
various provisions of the California Business and Professional Code as
well as the California Health and Safety Code. Mirroring federal law in
substantial part, California law provides that
[a] prescription for a controlled substance shall only be issued for
a legitimate medical purpose by an individual practitioner acting in
the usual course of his or her professional practice. The
responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner, but a
corresponding responsibility rests with the pharmacist who fills the
prescription.
Cal. Health & Safety Code 11153(a).
Turning to the evidence of record, with regard to Respondent's
prescribing practices for hydrocodone, no specific evidence was offered
other than the evidence discussed above as to a complete lack of
documentation. The evidence pertaining to Respondent's prescribing
practices for phentermine and related diet pills included Respondent's
admission on December 2, 2009, that "he had ordered diet pills for his
wife [Ms. Muratalla] and he had also said that she ordered them for
herself." (Tr. 146.) The evidence with regard to the 2200 tablets of
diet pills that formed the basis of the investigation of Respondent
after Harvard's June 11, 2009 Suspicious Order Report was minimal, as
DI Windsor testified that she did not recall specifically discussing
with Respondent the diet pills Adipex, Fastin, phentermine or Tenuate,
with reference to a specific time frame for the orders. (Tr. 146-47.)
Ms. Muratalla testified that she ordered diet pills on Respondent's
behalf prior to July 2008, but is certain she did not order any after
that date. (Tr. 64.) Ms. Savarese testified that she ordered
phentermine from Ms. Muratalla, recalling placing two separate orders
prior to 2007. (Tr. 94; 99-100.)
Although the foregoing evidence is vague as to time frames and
mixed as to who placed each order, there is no ambiguity in the
evidence that Respondent ordered and dispensed the Schedule IV
controlled substances phentermine, Adipex-P, Fastin and Tenuate in or
before December 2009, without a legitimate medical purpose and not in
the usual course of his professional practice. Respondent admitted on
December 2, 2009, that he had ordered diet pills for his wife and knew
that she had ordered them for herself. Ms. Savarese also credibly
testified that she received two separate orders of phentermine from Ms.
Muratalla in exchange for cash, without a prescription between 2006 and
2007. The evidence of record reflects a shipment of phentermine,
Adipex, Fastin, and Tenuate to Respondent in June 2009, none of which
was present or accounted for at Respondent's registered location in
December 2009.
Accordingly, I find by a preponderance of the evidence that
Respondent violated applicable federal and state law in ordering and
prescribing Schedule IV controlled substances without a legitimate
medical purpose and outside the usual course of professional practice
at various times between 2006 and December 2, 2009. Additionally,
Respondent's handling of these controlled substances failed to comply
with any of the mandated record keeping requirements under the CSA,
discussed above.\45\
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\45\ See 21 U.S.C. 841(a)(1), 827(a) and (b); 21 CFR 1306.04(a);
Cal. Health & Safety Code 11153(a).
---------------------------------------------------------------------------
Respondent elected not to testify in this case and the Government
suggests summarily in its post-hearing brief that "DEA may draw an
adverse interest (sic) that Respondent presented no testimony on his
own behalf." (Gov't Br. at 20; see Tr. 201-05.) Agency precedent
permits but does not require the drawing of an adverse inference from a
Respondent's silence in the face of accusation, "since it is assumed
in such circumstances [one] would be more likely than not to dispute an
untrue accusation." Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005)
(citing United States v. Hale, 422 U.S. 171, 176 (1975)). Although
Respondent's decision not to testify could arguably support an adverse
inference in the face of accusation as to some allegations, I decline
to do so on the facts of this case, other than in the context of
Respondent's failure to accept responsibility for his misconduct.\46\
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\46\ The Government's invitation to draw an adverse inference
does not refer to any particular allegation, leaving open to
question whether the request was intended to apply to all
allegations noticed in the OSC and prehearing proceedings. For
example, the Government alleged and proffered that "Respondent had
been hospitalized in August 2008 for alcohol and cocaine abuse."
(Gov't Supp. Preh'g Statement (SPHS) at 4.) The proffered testimony
at hearing by Ms. Muratalla directly contradicted that allegation
and was consistent with Respondent's unsworn statements during the
hearing that he was hospitalized due to an assault and related
trauma. (Compare Tr. 67-68, with Tr. 74.) Respondent's testimonial
silence as to that allegation does not seem to make the allegation
any truer. I also note that the Government listed Respondent as a
witness, but chose not to call him at hearing. (Gov't PHS at 3; Tr.
201.) In light of the foregoing, I find that drawing an adverse
inference in this case is unwarranted, particularly given the lack
of focus to the Government's request.
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The evidence of Respondent's experience in dispensing controlled
substances and compliance with applicable law and regulations weighs
heavily in favor of a finding that Respondent's registration would be
inconsistent with the public interest under Factors Two and Four.
Factor 5: Such Other Conduct Which May Threaten the Public Health and
Safety
Under Factor Five, the Deputy Administrator is authorized to
consider "other conduct which may threaten the public health and
safety." 5 U.S.C. 823(f)(5). The Agency has accordingly
[[Page 66994]]
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).\47\ A
respondent's acceptance of responsibility must be "clear and
manifest." Mark De La Lama, P.A., 76 FR. 20,011, 20,020 n.19 (DEA
2011). 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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\47\ 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.")
---------------------------------------------------------------------------
The Government alleged "other conduct" relevant to Factor Five
during the course of prehearing procedures in the form of a February
24, 2011 Motion to Include Dental Board of California Complaint. The
proposed document is entitled: "In the Matter of the Accusation
Against" [Respondent], brought on behalf of the Dental Board of
California, and dated January 31, 2011. (Gov't Ex. 10.) The California
Dental Board allegations relevant to Factor Five include obtaining,
possessing or administering to oneself, cocaine between May and October
2008, and marijuana between March and April 2010, citing California
Health and Safety Code 11054 and 11055; and using alcohol in a
dangerous manner in or about January 8, 2010, citing California
Business and Professions Code 1681(b). The Government's prehearing
notice of evidence to support the above issues consisted of a
supplemental prehearing statement dated January 21, 2011, stating in
relevant part "Ms. Murutalla (sic) will testify that she told the DEA
that the Respondent had been hospitalized in August 2008 for alcohol
and cocaine abuse." (Gov't SPHS at 4.)
At hearing, I excluded Ms. Muratalla's proposed testimony on the
limited issue of alcohol and cocaine abuse based in part on lack of
adequate notice, particularly given the brevity of the noticed
testimony and variance from allegations of the California Dental Board.
I did allow the Government to proffer in detail Ms. Muratalla's
proposed testimony, which produced even greater variance from the
alleged conduct.\48\ Even if Ms. Muratalla's proposed testimony had
been adequately noticed, her proffered testimony at hearing provided no
substantive basis to support the allegations by the California Dental
Board pertaining to cocaine, alcohol and marijuana. (See Tr. 73-74.) I
do take note of Respondent's admission in a February 9, 2011 prehearing
filing that he used marijuana one time "during a dark day in April"
of 2010, while intoxicated, which he states he did while unemployed and
not seeing patients.\49\
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\48\ See Gov't SPHS at 4. At hearing and consistent with
Respondent's prehearing objection to the issue, Respondent timely
objected to the testimony related to his hospitalization. (Tr. 65.)
I requested the Government to proffer the proposed testimony of Ms.
Muratalla given the very limited disclosure of proposed testimony
contained in the Government's SPHS. The proffer was similarly brief
in content and varied somewhat from the SPHS insofar as the proffer
lacked a reference to alcohol. (Tr. 69.) Following argument, I
excluded the testimony based on notice and relevance issues. (Tr.
71.) At the Government's request, I did allow the Government to
question Ms. Muratalla by way of proffer regarding the alleged
August 2008 hospitalization. Notably, Ms. Muratalla's proposed
testimony made no reference to cocaine, alcohol or any other
substance abuse, nor was any other testimonial evidence on the topic
offered by the Government at hearing. (Tr. 73-74.)
\49\ Respondent's Reply Regarding Government Request for Motion
dated February 9, 2011.
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Agency precedent has "long held that a practitioner's self-abuse
of a controlled substance is a relevant consideration under factor five
and has done so even when there is no evidence that the registrant
abused his prescription writing authority." Tony T. Bui, M.D., 75 FR.
49,979, 49,989 (DEA 2010). Respondent's admitted misuse of marijuana
while intoxicated is a relevant consideration as to whether granting
Respondent a DEA COR would be consistent with the public interest. See
David E. Trawick, D.D.S., 53 FR. 5326, 5326 (DEA 1988) (holding that
"offences or wrongful acts committed by a registrant outside of his
professional practice, but which relate to controlled substances may
constitute sufficient grounds" for denying relief favorable to
respondent, where respondent had history of alcohol and controlled
substance abuse).
Although I have considered Respondent's prehearing admission of a
single instance of marijuana use while intoxicated in April 2010, I
give it little overall weight for purposes of this Recommended
Decision, particularly given the absence of any other credible evidence
of record to support allegations of other drug or alcohol abuse by
Respondent at any other time.
Conclusion and Recommendation
I find by a preponderance of the evidence that the Government has
met its burden to establish a prima facie case based on substantial
evidence of record. After considering all of the relevant factors, the
evidence is fully consistent with a denial of Respondent's application
for a DEA COR as a practitioner, because Respondent's registration
would be inconsistent with the public interest. See 21 U.S.C. 823(f)
and 824(a)(4). Because the Government has made out a prima facie case
against Respondent, a remaining issue in this case is whether
Respondent has adequately accepted responsibility for his past
misconduct such that his registration might nevertheless be consistent
with the public interest. See Patrick W. Stodola, 74 FR. 20,727, 20,734
(DEA 2009).
Respondent has not sustained his burden in this regard. Respondent
did not testify and did not accept responsibility for his past
misconduct. Moreover, Respondent presented no credible evidence to
demonstrate that he has learned from his past mistakes or to
demonstrate that he would now handle controlled substances properly if
granted a registration.
In light of the foregoing, Respondent's evidence as a whole fails
to sustain his burden to accept responsibility for his misconduct and
demonstrate that he will not engage in future misconduct. I find that
Factor Five strongly weighs in favor of a finding that Respondent's
registration would be inconsistent with the public interest.
Accordingly, I recommend denial of Respondent's application for a
COR. I find the evidence as a whole demonstrates that Respondent has
not accepted responsibility, and Respondent's registration would be
inconsistent with the public interest.
Dated: May 19, 2011
Timothy D. Wing,
Administrative Law Judge.
[FR Doc. 2011-27985 Filed 10-27-11; 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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