Surinder Dang, M.D.; Revocation of Registration, 51417-51424 [2011-21062]
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Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices
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 FI1125651,
issued to Ideal Pharmacy Care, Inc.,
d/b/a/Esplanade Pharmacy, be, and it
hereby is, revoked.
I further order that any pending
application to renew or modify this
registration, be, and it hereby is, denied.
Dated: August 5, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–21060 Filed 8–17–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10–2]
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Surinder Dang, M.D.; Revocation of
Registration
On August 31, 2009, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Surinder Singh Dang,
M.D. (‘‘Respondent’’), of Fountain
Valley, California. The Order proposed
the revocation of Respondent’s DEA
Certificate of Registration, AD6122143,
as a practitioner, as well as the denial
of any pending applications to renew or
modify his registration ‘‘for reason that
[Respondent’s] continued registration[]
would be inconsistent with the public
interest, as that term is used in 21 U.S.C.
823(f) and 824(a)(4).’’ ALJ Ex.1, at 1.
The Order specifically alleged that
between January 2004 and July 2007,
Respondent and his wife, Dr. Satinder
Dang, ‘‘who also possesses a DEA
registration and shares [Respondent’s]
registered location,’’ ordered ‘‘more than
5,000,000 dosage units of hydrocodone’’
and that Respondent ‘‘failed to properly
account for, secure, and otherwise
handle these controlled substances.’’ Id.
The Order alleged that on January 17,
2006, one of Respondent’s ‘‘employees
removed 30,000 dosage units of
controlled substances’’ from his
registered location and ‘‘attempted to
take them to her residence.’’ Id. The
Order further alleged that on the same
day, ‘‘DEA Special Agents seized
another 10,000 dosage units of
controlled substances from this
employee’s residence.’’ Id. at 1–2.
Continuing, the Order alleged that on
March 16, 2006, ‘‘DEA Special Agents
on the State’s suspension. See 5 U.S.C. 554(b). I
therefore do not rely on it.
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seized 50,000 dosage units more from
this employee’s residence.’’ Id. at 2.
Next, the Order alleged that on March
16, 2006, DEA conducted an
accountability audit of Respondent’s
handling of hydrocodone and that
Respondent ‘‘could not account for
more than 3,500,000 dosage units’’ that
Respondent and his wife ‘‘had ordered,’’
and that Respondent ‘‘failed to keep
accurate and complete records of each
controlled substance received, sold,
delivered, or otherwise disposed of as
required by 21 U.S.C. 827(c) and 21 CFR
1304.01 et seq.’’ Id. Finally, the Order
alleged that when Respondent ‘‘made
dispensing records,’’ he ‘‘frequently
failed to indicate whether’’ he or his
wife ‘‘actually dispensed the controlled
substances as required by 21 CFR
1304.03(b).’’ 1 Id.
By letter of October 2, 2009,
Respondent, through his counsel,
requested a hearing on the allegations.
ALJ Ex. 2. The matter was then assigned
to an Administrative Law Judge (ALJ),
who conducted a hearing on March 3,
2010, in Santa Ana, California.
At the hearing, the Government called
one witness to testify and introduced
documentary evidence. Respondent did
not call any witnesses and introduced a
single exhibit, this being a letter from
the counsel for Respondent’s employee
R.K. stating that she intended to assert
her Fifth Amendment privilege if called
to testify. See RX 1. Following the
hearing, both parties submitted briefs
containing their proposed findings of
fact, conclusions of law and argument.
On May 19, 2010, the ALJ issued her
Recommended Decision (also ALJ).
Therein, the ALJ considered the five
public interest factors, see 21 U.S.C.
823(f), and concluded that Respondent’s
continued registration would be
inconsistent with the public interest and
recommended that his registration be
revoked. ALJ at 26, 30–31.
As to the first factor—the
recommendation of the appropriate
State licensing board or professional
disciplinary authority—the ALJ found
that the California Medical Board ‘‘has
not taken any formal action to limit
Respondent’s right to practice medicine
nor has it recommended limiting his
ability to prescribe controlled
substances.’’ Id. at 23. However, the ALJ
recognized that under Agency precedent
‘‘the fact that the Medical Board of
California has currently authorized
* * * Respondent to practice medicine
is not dispositive in this administrative
determination as to whether
continuation of a registration is
consistent with the public interest.’’ ALJ
at 22–23 (citing Patrick W. Stodola, 74
FR 20727, 20730 (2009); Jayam Krishna-
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51417
Iyer, 74 FR 459, 461 (2009)). The ALJ
thus concluded that ‘‘this factor does
not fall in favor of revocation.’’ Id. at 23.
Likewise, with respect to factor three—
Respondent’s record of convictions for
offenses relating to the manufacture,
distribution, or dispensing of controlled
substances—the ALJ found that
Respondent has not been convicted of
such an offense and that this factor also
did not ‘‘fall in favor of revocation.’’ Id.
The ALJ then considered factors two
and four—Respondent’s experience in
dispensing controlled substances and
his compliance with Federal, State, and
local laws relating to controlled
substances—together. Id. at 23–26. The
ALJ specifically found that: (1)
‘‘Respondent authorized’’ his employee
R.K. ‘‘to purchase large amounts of
hydrocodone using his DEA registration
and that of his wife’’; (2) another
physician who practiced at
Respondent’s clinic had ‘‘stated that the
patient load’’ at the clinic ‘‘would not
justify such large purchases of
controlled substances’’; (3) R.K.
remained in Respondent’s employ even
after ‘‘drugs were discovered in [her]
personal vehicle by the California
Highway Patrol’’; (4) ‘‘[l]arge bundles of
cash, controlled substances, and other
* * * evidence, such as receipts and
money order stubs were discovered at
[her] home’’; and (5) ‘‘[a]fter being
questioned, [R.K.] stated that she was
ordering and transporting controlled
substances all at the direction of the
Respondent.’’ Id. at 24. Based on these
findings, the ALJ concluded that ‘‘either
[Respondent] is personally involved in
hydrocodone diversion or he is
facilitating such diversion on the part of
his employee.’’ Id.
The ALJ further found that
Respondent ‘‘prescribed Vicodin,’’ a
schedule III controlled substance, to
patient B.R. ‘‘on many occasions
without a thorough examination.’’ Id.
Based on Cal. Bus. & Prof. Code
§ 2242(a), which provides that it is
‘‘unprofessional conduct’’ to
‘‘[p]rescrib[e], dispens[e] or furnish[ ]
dangerous drugs as defined in Section
4022 without an appropriate prior
examination and a medical indication,’’
the ALJ concluded that Respondent
prescribed Vicodin to B.R. without an
‘‘appropriate prior examination.’’ Id. at
25. The ALJ thus concluded that
Respondent ‘‘prescribed controlled
substances without establishing a bonafide patient relationship’’ and violated
both Federal and state law. Id. at 24–25.
Next, the ALJ found that Respondent
did not have any inventories for the
controlled substances his clinic
dispensed, that he ‘‘failed to maintain
accurate records of the controlled
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substances he dispensed,’’ and that an
audit could not account for ‘‘almost four
million dosage units of hydrocodone.’’
Id. at 26. The ALJ thus concluded that
Respondent ‘‘violated federal
regulations by not conducting a biennial
inventory and maintaining the
appropriate records of his controlled
substances.’’ Id. The ALJ further held
that the Government’s evidence under
factors two and four ‘‘established prima
facie grounds for revocation of * * *
Respondent’s DEA Certificate of
Registration.’’ Id.
Turning to factor five—other conduct
which may threaten the public health
and safety—the ALJ found ‘‘it likely that
* * * Respondent is engaged in the
illegal diversion of hydrocodone.’’ Id.
As support for her conclusion, the ALJ
noted her findings that Respondent
‘‘was involved in the ordering of the
hydrocodone,’’ that ‘‘[h]is colleagues
stated that his practice did not justify
such exorbitant purchases,’’ his inability
‘‘to account for the whereabouts of the
controlled substances,’’ and the
‘‘circumstances,’’ which she did not
further specify, ‘‘surrounding [the DEA
Group Supervisor’s] investigations.’’ Id.
According to the ALJ, these facts
‘‘suggest[ed] that * * * Respondent is at
least recklessly, if not intentionally,
contributing to this illegal diversion.’’
Id.
The ALJ further explained that
‘‘[e]ven if Respondent did not commit
the above violations of Federal law and
DEA regulations,’’ she would still find
that he had ‘‘committed acts which
constitute ‘conduct which may threaten
the public health and safety’ and which
render his registration ‘inconsistent
with the public interest.’’’ Id. (quoting
21 U.S.C. 823(f)(5) & 824(a)(4)). Noting
that ‘‘[u]nder DEA precedent, a
registrant who entrusts his registration
to another person is strictly liable for
the latter’s misuse of his registration,’’
the ALJ reasoned that ‘‘even if there had
been no conspiracy between
Respondent and [R.K.] to unlawfully
distribute the drugs, he would still be
liable for the acts she committed while
being allowed to use his registration.’’
ALJ at 26–27 (citations omitted). The
ALJ concluded that ‘‘Respondent is thus
liable for [R.K.’s] acts of unlawful
possession and distribution of the
controlled substances that she obtained
under his registration.’’ 2 Id. (citations
omitted).
The ALJ then addressed whether
Respondent had rebutted the
2 The ALJ also rejected Respondent’s argument
that R.K. had stolen the drugs, noting that as of the
hearing, she was still an employee. Id. at 27
(citations omitted).
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Government’s prima facie case. ALJ at
29–30. The ALJ found that ‘‘Respondent
has not admitted any fault whatsoever,’’
but rather ‘‘has merely pointed an
accusing finger at his employee.’’ Id. at
30. Noting that Respondent did not
testify in the proceeding, the ALJ
concluded that ‘‘[t]he fact that the
Respondent has chosen not to hold
himself accountable for his own
indiscretions weighs heavily against his
continued registration.’’ Id. While the
ALJ further considered facts she deemed
favorable to Respondent, she
nonetheless concluded that ‘‘none of
these factors outweigh the
overwhelming security violations and
evidence of diversion,’’ which she
deemed to be ‘‘egregious.’’ Id. at 31. The
ALJ therefore recommended that I
revoke Respondent’s registration. Id.
Neither party filed exceptions to the
ALJ’s decision. Thereafter, the record
was forwarded to me for Final Agency
Action. Having considered the entire
record, I adopt the ALJ’s findings of fact
and conclusions of law except as
expressly noted herein. I further adopt
the ALJ’s ultimate conclusion that
Respondent’s ‘‘continued registration is
not in the public interest,’’ id. at 30, and
her recommendation that his
registration be revoked. As ultimate
factfinder, I make the following
findings:
Findings
Respondent is the holder of DEA
Certificate of Registration, AD6122143,
which authorizes him to dispense
controlled substances in schedules II
through V, as a practitioner, at the
registered location of 17150 Euclid
#200, Fountain Valley, California. GX 1.
While Respondent’s registration was to
expire on June 30, 2009, Id., on May 13,
2009, Respondent filed an application to
renew his registration. GX 2.
Accordingly, his registration remains in
effect pending the issuance of this
Decision and Final Order. 5 U.S.C.
558(c); see also ALJ Ex. 3, at 2
(Prehearing Order; Stipulations).
Respondent currently holds a license
to practice medicine in California and
the California Medical Board has not
taken any formal action to limit his
ability to practice medicine or to
prescribe controlled substances. ALJ Ex.
3, at 3. Also, Respondent has not been
convicted of an offense related to the
manufacture, distribution, or dispensing
of controlled substances. Id.
Respondent is married to Satinder
Dang, M.D.3 She and Respondent
3 Dr. Satinder Dang holds DEA Certificate of
Registration, AD9234446; she is registered at the
same address as Respondent. ALJ Ex. 3, at 2
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practice medicine at Complete Medical
Care, Inc. (‘‘CMC’’). Tr. 41; GX 6, at 20.
Their son, Sameer Dang, also works in
the CMC office. Tr. 51. At all relevant
times (including through the date of the
hearing) CMC’s office manager was Ms.
Rani K.4 (R.K.). Id. at 26, 164.
In November 2005, a Diversion Group
Supervisor (GS) in DEA’s Riverside
Diversion Group reviewed ARCOS 5
records and found that Respondent was
the largest purchaser of controlled
substances from Anda Pharmaceuticals,
Inc. (‘‘Anda’’). Tr. 21. The GS also
determined that Respondent was buying
controlled substances ‘‘from other
companies too.’’ Id.
Of particular concern to the GS were
Respondent’s purchases of
hydrocodone, a schedule III controlled
substance. Tr. 22; 21 CFR 1308.13(e)(iv).
According to ARCOS records, while in
2004, Respondent purchased 190,600
tablets of hydrocodone from all
suppliers, in 2005, he purchased
1,353,600 such tablets. Tr. 24; GX 4, at
2–6. ARCOS data further showed that in
2005, Respondent and his wife had
ordered a combined total of 3,626,400
tablets of hydrocodone. GX 3, at 13; GX
4, at 6; see also Tr. 121, 124 (GS’s
testimony that between January 1, 2005
and March 16, 2006, Respondent and
his wife purchased approximately four
million tablets of hydrocodone).
Upon reviewing the ARCOS data, the
GS contacted several of the firms that
were distributing controlled substances
to Respondent. See, e.g., GX 6, at 7. At
several points throughout the
investigation, these firms provided
copies of various documents to the GS
including sales records, invoices,
statements of account, delivery records,
applications for credit, and
correspondence.6 See generally GX 5
(records from Moore Medical, L.L.C.),
GX 6 (record from Henry Schein, Inc.),
GX 9 (records from ParMed
Pharmaceuticals, Inc.).
Throughout the investigation, several
of the firms also provided the GS with
information regarding when various
deliveries were to be made to
Respondent’s clinic. On December 14,
2005, the GS, who had received
information from two different
distributors (Henderson and Moore
Medical) that controlled substances
4 R.K.’s first name is spelled as both Rani and
Roni in various documents.
5 Pursuant to 21 CFR 1304.33(c), manufacturers
and distributors of various controlled substances
including schedule III narcotics are required to
report their distributions of controlled substances to
DEA through the Automated Records and
Consolidated Orders System (ARCOS). See also Tr.
21–22.
6 Some of the documents may have been obtained
pursuant to a search warrant.
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deliveries were to be made that day,
conducted ‘‘surveillance at the [Dangs’s]
clinic’’ from 9 a.m. to 6 p.m. Tr. 39–42.
During the surveillance, the GS
observed both deliveries and noted that
‘‘no more than ten or fifteen’’ people
entered the clinic that day. Id. at 41–42.
On January 13, 2006, from ‘‘[m]orning
till late afternoon,’’ the GS conducted a
second surveillance. Id at 42. During the
surveillance, the GS saw Ms. R.K.
‘‘taking boxes out of the clinic and
plac[ing] them in her vehicle,’’ which
was ‘‘a green SUV.’’ Id. at 42–43.
On January 17, 2006, from 9 a.m. to
6 p.m., the GS, who had received notice
of a controlled substance delivery from
another distributor (ParMed
Pharmaceuticals, Inc.), conducted
another surveillance. Id. at 43. Once
again, Investigators observed R.K.
‘‘tak[e] boxes from the clinic’’ and place
them in ‘‘her vehicle.’’ Id. at 44. The GS
observed R.K. drive away and notified
the California Highway Patrol (CHP). Id.
at 44–45. After observing R.K., who was
driving forty miles per hour, operate her
vehicle within five feet of the vehicle in
front of her, a CHP officer conducted a
traffic stop. Id. at 45; GX 10 at 2.
As he approached R.K., the CHP
officer observed ‘‘cardboard boxes that
were taped shut in the rear cargo area.’’
GX 10, at 2. The CHP officer advised
R.K. of the reason for the stop and
requested her license, registration, and
insurance. Id. He then asked R.K. ‘‘what
the boxes were.’’ Id. R.K. stated that the
boxes held Vicodin, a schedule III
controlled substance which contains
hydrocodone. Id.; ALJ Ex. 3, at 1. When
the CHP officer asked R.K. if she was a
doctor, she stated that ‘‘she was the
president of a medical facility and that
she was going to give the Vicodin to the
doctor at her facility.’’ GX 10, at 2. The
CHP Officer asked her a second time if
she was a doctor; R.K. again said ‘‘no’’
and became ‘‘extremely nervous.’’ Id.
After the CHP Officer asked R.K. to
step out of her car, he asked ‘‘why she
had cases of Vicodin.’’ Id. She
responded that she ran a medical office
and handed him a business card listing
her name as R.K. and her position as
‘‘president.’’ Id. R.K. further stated that
‘‘she received a delivery of Vicodin from
a delivery company at about 1100 hours
and that she needed to give it to’’
Respondent. Id. When the Officer asked
R.K. if the Vicodin had been delivered
‘‘to her car or to her office,’’ R.K. stated
that it had been delivered to the office.
Id. When the Officer asked if her office
had a locker in which to store the
Vicodin, R.K. answered ‘‘yes,’’ but
added that she had to personally give
the drugs to Respondent. Id.
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The CHP Officer then asked how the
Vicodin had ended up in her vehicle,
R.K. stated that ‘‘she [had] carried the
boxes to her vehicle around noon time
and left them there,’’ and that she had
stayed in her office until about 5 p.m.,
at which point ‘‘she left * * * to get
something to eat.’’ Id. When the Officer
told R.K. that he was ‘‘concerned that
she was in possession of so much of a
controlled substance,’’ R.K. said she
would return it to the office. Id. R.K.
then stated that Respondent was ‘‘doing
a procedure at an unknown hospital and
he would be returning at an unknown
time to the office’’ and that she would
then give him the Vicodin. Id.
The CHP Officer then ‘‘asked R.K. to
open the boxes’’ to confirm that they
contained Vicodin. Id. R.K. opened six
boxes containing a total of 70 bottles of
hydrocodone bitartrate/acetaminophen
(hereinafter, hydrocodone/apap or
hydrocodone). Id. at 2–3. Each of the
bottles contained between 100 and 500
tablets (for a total of ‘‘approximately
31,000 tablets’’) in 7.5/500 mg, 10/500
mg, and 10/325 mg strengths. Id. The
Officer then seized the Vicodin and gave
R.K. a receipt for it. Id. After giving R.K.
a citation, the officer allowed her to
leave. Id. at 3.
The CHP Officer then contacted a
DEA Task Force Officer (TFO) and
arranged to transfer custody of the drugs
to DEA; upon the TFO’s arrival at the
Officer’s location, the TFO took
possession of the drugs. Id. The TFO
gave the CHP Officer a receipt which
confirms the figures in the latter’s
report.7 Id. at 6.
R.K. then drove to her residence in
Anaheim Hills; Investigators followed
her there in order to question her about
the drugs that were found in her
vehicle. Tr. 47. R.K. told the
Investigators that she had taken the
hydrocodone with her for safekeeping
because Respondent was out of the
office; she also maintained that she
intended to return them to the office
after she ate. Id. at 47–48. While R.K.
initially claimed that this was the first
time she had done this, upon being
confronted with the fact that
Investigators had on another occasion
observed her placing boxes in her
vehicle, she admitted that this was the
second time she had done so. Id. at 48.
R.K. stated that there were about five
physicians who worked at Respondent’s
clinic, that they dispensed the pills in
30 and 60-count bottles, and that the
7 More specifically, there were 14 bottles of 500
count of hydrocodone/apap 7.5/500 mg, 10 bottles
of 500 count hydrocodone/apap 10/500 mg, 36
bottles of 500 count hydrocodone/apap10/325 mg,
and 10 bottles of 100 count hydrocodone/apap 10/
500 mg. GX 10, at 6.
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clinic had approximately twenty to
twenty-five patients per day. Id. R.K.
further said that she used her personal
credit card to purchase drugs from
wholesalers and that Respondent would
reimburse her with cash. Id. at 49. R.K.
would then obtain money orders to pay
off her credit card bills. Id.
The Investigators then asked R.K. if
she would consent to a search of her
residence; she agreed. Id. at 49–50.
According to the GS, the Investigators
found approximately $69,500 in cash in
an upstairs closet, which was ‘‘wrapped
up in paper’’; a ‘‘small quantity of
drugs,’’ which included 2000 lorazepam
tablets and 1400 hydrocodone tablets;
‘‘a lot of money order stubs’’; ‘‘some
bank records’’; and ‘‘[s]ome credit card
information.’’ Id. at 50, 113, 117. The GS
testified that these records confirmed
that R.K. paid her credit card bills with
money orders. Id. at 50. However, on
cross-examination, the GS
acknowledged that he had no
documentary evidence to substantiate
R.K.’s assertion that Respondent
reimbursed her in cash. Id. at 146. To
explain the cash, R.K. claimed the sum
was a combination of money she
received from the sale of a house in
India, a home-based business she had
previously run, and a gift from relatives.
Id. at 51, 142.
On cross-examination, the GS
acknowledged that the amount of drugs
found at R.K.’s residence could indicate
she was stealing drugs from
Respondent’s clinic. Id. at 116. The GS
further testified that at the time of the
search, the street value of hydrocodone
tablets was between three and five
dollars per pill. Id. at 132.
On February 7, 2006, the GS obtained
notice of another delivery of controlled
substances and conducted another
surveillance. Id. at 51–52. While on this
date, UPS made a delivery, nothing was
moved out of CMC. Id. at 52.
On February 24, 2006, Respondent
wrote a letter to CHP requesting the
return of the hydrocodone which had
been seized during the traffic stop of
R.K. Tr. 52–53; GX 12. The letter stated
that R.K. was Respondent’s ‘‘office
manager,’’ and that she had ‘‘informed
CHP that the property was not hers, and
instead belonged to her employer,
Complete Medical Care Inc.’’ GX 12.
On March 16, 2006, DEA executed
search warrants at both Respondent’s
clinic and R.K.’s residence. Tr. 61, 67–
68, 70. At the clinic, the Investigators
took an inventory of the controlled
substances on hand and found 48,000
tablets of hydrocodone, which they
seized; the Investigators also seized
CMC’s controlled substance purchasing
records and dispensing log. Id. at 94.
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During the search of the clinic,
Respondent declined to be
interviewed.8 Tr. 68.
The Investigators did, however,
interview four of Respondent’s
employees and a patient who was
present. A.N. had been a medical
assistant at CMC since 1992; her duties
involved taking patients to the
examination room. Id. at 86–87. A.N.
told the Investigators that R.K.
inventoried the drugs when they arrived
at CMC and also maintained the
dispensing log. Id. at 89–91. She also
stated that the dispensings to patients
were noted in the patient records and
identified the handwriting in the
dispensing log as R.K’s. Id. at 89, 91–92.
K.G. had been a medical assistant at
CMC for seven months; her duties
included taking patients’ blood
pressure, drawing blood, and
performing other tests. Id. at 92–93. K.G.
stated that both R.K and Respondent
ordered the drugs for CMC. Id. at 94.
K.G. further stated that R.K. usually
accepted deliveries of drug orders;
however, sometimes K.G. would accept
delivery of drug orders and she ‘‘would
leave them unopened for R.K. to
handle.’’ Id. at 93. K.G. commented that
she saw only R.K. write in the
dispensing log. Id. at 95.
L.Y. had been hired as medical
assistant in November 2005; her
responsibilities included the scheduling
of appointments and flu shots. Id. at 95–
96. According to L.Y., the clinic saw
twenty to twenty-five patients per day.
Id. at 97. L.Y. also stated that both
Respondent and R.K. handled the drugs
once they had arrived. Id. at 96. When
shown the dispensing log, L.Y.
identified handwriting belonging to
both Respondent and R.K.; she also
stated that Respondent’s wife primarily
prescribed drugs, while Respondent
typically dispensed them. Id. at 97.
S.B. had worked at CMC for three
years and did patient billing. Id. at 98.
S.B. stated that R.K. would order the
drugs and that Sameer Dang
(Respondent’s son) would check the
deliveries. Id. at 98–99. She also stated
that R.K. handled the dispensing log. Id.
at 100.
S.B. further stated that CMC had
approximately twenty-five patients per
day, of which fifteen saw Respondent
and ten saw his wife. Id. According to
S.B., both Sameer Dang and R.K. paid
for the drugs.9 Id. She also said that both
8 Later that day, Investigators went to
Respondent’s residence and sought consent to
search his house. Tr. 69. Respondent and his wife
declined to provide consent. Id.
9 S.B. also told Investigators that Respondent had
changed the clinic’s procedures and now required
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Respondent and R.K. had access to the
controlled substances received at the
CMC office. Id. at 103.
As found above, on March 16, 2006,
DEA Investigators also executed a
search warrant at R.K.’s residence. Id. at
70. R.K. was present during the search
and was interviewed during which she
provided ‘‘the same information’’ as she
had two months earlier. Id. at 71. R.K.
stated that since January 17, 2006, she
had stopped using her personal credit
card to order the drugs and only
dispensed drugs in the presence of a
physician. Id. at 72. R.K. also stated that
all of the clinic’s drug orders were
approved by Respondent. Id. Finally,
R.K. stated that Respondent was the
clinic’s ‘‘primary dispenser’’ of the
drugs. Id.
In April 2006, the GS interviewed Dr.
B., one of the physicians listed as being
part of Respondent’s clinic. Id. at 76. Dr.
B. stated that he had worked at CMC for
about five years on a part-time basis. Id.
Dr. B., who also worked at a psychiatric
facility for the local county government,
saw some of these patients at
Respondent’s clinic. Id. at 77–78.
Dr. B. stated that he rarely prescribed
controlled substances to his patients,
and that when he did, he did not
dispense drugs. Id. at 78. He also stated
that the patient load at CMC did not
justify the quantities of controlled
substances that were being purchased
by the clinic. Id. at 79.
In May 2006, a Diversion Investigator
(DI) interviewed one of Respondent’s
patients, A.A., who said that she saw
him for knee pain and ‘‘asthmatic
issues.’’ Tr. 81. A.A. had worked for
twelve years as a patient care
representative in ‘‘a couple hospitals’’;
at one, she was the Quality Care
Coordinator with ‘‘duties related to
medical, financial counseling and
medical billing.’’ Id. at 81–82.
A.A. stated that on several occasions
during her visits to Respondent’s clinic,
she observed R.K. take persons ‘‘into a
back room’’ and that ‘‘several minutes
later,’’ these persons ‘‘would come out
with bags in their hands.’’ Id. at 83. A.A.
stated that she did not believe these
persons had seen Respondent. Id. A.A.
further stated (and wrote a letter to DEA
to the same effect) that she had told
Respondent that R.K. ‘‘was * * *
dispensing drugs in some form or
fashion, or selling medications without’’
the patients ‘‘seeing the doctor.’’ Id.
The Government also submitted into
evidence a portion of a Report of
Investigation relating an interview of
another of Respondent’s patients, B.R.
R.K. to get his approval before she dispensed any
drugs. Tr. 101–02.
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Fmt 4703
Sfmt 4703
Tr. 167; see also GX 17. According to
the Report, B.R. told Investigators that
she had been Respondent’s patient since
2001 and had been treated for leg pain.
GX 17, at 1. B.R. stated that Respondent
‘‘did not examine her thoroughly and
did not request any tests,’’ yet he
dispensed Vicodin to her. Id. B.R.
further stated that she had started seeing
another physician who examined her
thoroughly and ordered an MRI and Xray. Id. B.R.’s new doctor concluded
that her back was the cause of her leg
pain and that she was over-medicated;
he referred her to a pain clinic. Id.
B.R. further said that she was buying
bottles of 100 tablets of Vicodin 7.5 mg
every two weeks for $20 per bottle and
that Respondent had instructed her to
take the Vicodin as needed with no
further instructions. Id. Both R.K. and
Respondent had given Vicodin to her,
and on occasion she would simply
telephone R.K. for a refill and receive it
from her without seeing Respondent. Id.
at 2.
However, the report of B.R.’s
interview contains no evidence
suggesting that she was not a legitimate
patient. Moreover, the Government did
not introduce B.R.’s patient record into
evidence and offered no evidence
(beyond the conclusory assertion that
his exam was not thorough) regarding
the scope of the physical examination
Respondent performed on her. Nor did
it offer any evidence from an Expert
(whether through testimony or a report)
establishing that Respondent failed to
perform a medically appropriate prior
examination and lacked a medical
indication when he prescribed Vicodin
to B.R.
Using the records seized during the
search of Respondent’s clinic and its
patient files (which were subsequently
obtained with Respondent’s consent),
ARCOS data, and information provided
by several of the distributors,10 the GS
conducted an audit of the hydrocodone
ordered under both Respondent’s and
his wife’s registrations between January
1, 2005 and March 16, 2006. Tr. 59–60,
67; GX 15. Because the Dangs did not
maintain records of their inventory
(notwithstanding Federal law requiring
them to do so, see 21 U.S.C. 827(a) &
(b)), the GS chose January 1, 2005 as the
starting date and assumed that no
10 Moore Medical provided DEA with records of
its hydrocodone sales under Respondent’s
registration from late 2005 to early 2006. Tr. 25; GX
5. ANDA provided DEA with a spreadsheet listing
all sales under the registrations of Respondent and
his wife from May 2000 through mid-October 2005.
Tr. 30; GX 8. DEA also acquired sales records and
a sales summary from ParMed which show
Respondent’s purchases of controlled substances
between November 28, 2005 and January 4, 2006.
GX 9.
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controlled substances were then on
hand; for the closing inventory, the GS
used the inventory taken (48,000 tablets)
when the search warrant was issued.11
Tr. 59–60; GX 15. To this latter figure,
the DI added the hydrocodone that was
seized during the January 17, 2006
traffic stop of R.K. (31,000 tablets) and
the 1,400 tablets found during the
search of R.K.’s residence which
occurred later that day.12
Using both the ARCOS data and
distributor invoices, the GS determined
that 4,037,900 tablets of hydrocodone
had been ordered during the audit
period.13 Tr. 61; GX 15. The clinic’s
dispensing logs, which did not identify
which doctor had authorized the
various dispensings, see GX 14, showed
that only 12,000 tablets had been
dispensed; 14 in addition, the GS
reviewed the clinic’s patient files and
determined that another 75,000 tablets
had been dispensed.15 Tr. 61–63, 119,
129; GXs 12, 15. Accordingly, the Dangs
could only account for approximately
167,000 tablets of hydrocodone.16 Tr.
64–65, 119; GX 15. Thus, Respondent
(and his wife) could not account for
approximately 3,870,500 tablets.17 Tr.
66, 119; GX 15.
Among the documents the
Government entered into evidence is a
November 7, 2005 letter from
Respondent to J.N., a compliance
coordinator at Henry Schein. GX 6, at
20. Therein, Respondent wrote that he
11 The practical effect of assigning a zero starting
inventory is to reduce the size of any shortage.
12 According to the computation chart prepared
by the GS, he used 1200 tablets as the amount
seized during the search of R.K.’s residence. GX 15,
at 1. As the ALJ noted, given that the audit found
that nearly four million tablets could not be
accounted for, the error is inconsequential. ALJ at
13 n.5.
13 Respondent does not contend that the GS
double-counted any of the orders that were used in
calculating this figure.
14 The dispensing logs also did not contain the
name of the dispensing physician, the initials of the
person dispensing the drugs, and the patient’s
address as required by 21 CFR 1304.22(c). Tr. 58,
147; see also GX 14. Moreover, while there were
some dispensing logs from 2003, the remaining logs
only covered the period from February 28 through
March 15, 2006. Tr. 57; see also GX 14.
15 The GS credited CMC with dispensing 87,000
tablets of hydrocodone as he could not determine
whether the dispensings recorded in the dispensing
logs overlapped with those noted in the patient
files. Tr. 129–30.
16 Neither Respondent nor his wife had reported
to DEA any thefts, losses, or destructions of
controlled substances. Tr. 65.
17 According to the GS, the street value of a
hydrocodone tablet is between three to five dollars,
Tr. 132, and that the value of the drugs, which
Respondent could not account for, would be about
$15 to 20 million. Id. at 133. The GS also
acknowledged that although the Government had
seized various accounts controlled by R.K.,
Respondent and his wife, he found no evidence of
bank deposits approaching this amount; nor did he
find evidence of extravagant purchases. Tr. 134–35.
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was the Medical Director of ‘‘a multiple
specialty medical group,’’ comprised of
five physicians including himself, his
wife, the aforementioned Dr. B., as well
as Drs. H.L. and D.S. Id. Respondent
further wrote that the clinic had
‘‘introduced a program of dispensing
some medications to our patients’’ for
their ‘‘convenience * * * and to help
them save some money.’’ Id.
Respondent also wrote that his clinic
‘‘provide[s] physical therapy and pain
management to our patients,’’ that it
‘‘dispense[d] medications to our
patients only,’’ and that the ‘‘practice
has been growing.’’ Id.
The Government also entered into
evidence a credit application submitted
on behalf of CMC to ParMed. GX 9, at
4. The application, which is dated
November 21, 2005, lists Respondent as
the person making the application; his
name is printed in the signature block
(which is signed), and the application
also contains the name of a ParMed
Sales Representative.18 See id.
The Government further entered into
evidence reports prepared by ParMed on
January 5, 2006, which list ParMed’s
controlled substance distributions to
Respondent and his wife. See id. at 1–
2. The report for Respondent’s wife
bears a handwritten note, which
according to the GS, was written by
D.L., an employee of ParMed’s
regulatory affairs section. Tr. 34–35. The
note read: ‘‘pain management—group of
Dr’s—about 30 Dr’s in this medical
group & she purchases for all Dr’s (as
per sales rep).’’ GX 9, at 2. The note then
listed the names and registration
numbers of Respondent and his wife
and stated: ‘‘Both new accounts from
11–05.’’19 Id.
Respondent did not testify in the
proceeding and offered only one exhibit,
a letter from R.K.’s attorney stating that
she would invoke her Fifth Amendment
privilege if called to testify. RX1.
Discussion
Section 304(a) of the Controlled
Substances Act (CSA) provides that ‘‘[a]
registration pursuant to section 823 of
this title to * * * dispense a controlled
substance * * * may be suspended or
revoked by the Attorney General upon
a finding that the registrant * * * has
committed such acts as would render
his registration under section 823 of this
18 The application also lists R.K. as the ‘‘accounts
payable contact.’’ GX 9, at 4.
19 The GS testified that on or about January 6,
2006, he had spoken with D.L., who told him that
R.K. was the contact person for Respondent and his
wife, and that R.K. had represented to ParMed that
the reason for the quantities of controlled
substances that were being ordered was that there
were thirty doctors at the clinic. Tr. 36–37.
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51421
title inconsistent with the public
interest as determined under such
section.’’ 21 U.S.C. 824(a)(4). In making
the public interest determination in the
case of a practitioner, Congress directed
that the following factors be considered:
(1) The recommendation of the appropriate
State licensing board or professional
disciplinary authority.
(2) The applicant’s experience in
dispensing * * * controlled substances.
(3) The applicant’s conviction record under
Federal or State laws relating to the
manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State,
Federal, or local laws relating to controlled
substances.
(5) Such other conduct which may threaten
the public health and safety.
21 U.S.C. 823(f).
‘‘[T]hese factors are considered in the
disjunctive.’’ Robert A. Leslie, 68 FR
15227, 15230 (2003). I may rely on any
one or a combination of factors and may
give each factor the weight I deem
appropriate in determining whether to
revoke an existing registration or to
deny an application. Id. Moreover, I am
‘‘not required to make findings as to all
of the factors.’’ Hoxie v. DEA, 419 F.3d
477, 482 (6th Cir. 2005) (citing Morall v.
DEA, 412 F.3d 165, 173–74 (DC Cir.
2005)).
With respect to a practitioner’s
registration, the Government bears the
burden of proving by a preponderance
of the evidence that the continuation of
a registration would be inconsistent
with the public interest. 21 CFR
1301.44(d). However, where the
Government satisfies its prima facie
burden, as for example, by showing that
a registrant has committed acts which
are inconsistent with the public interest,
the burden then shifts to the registrant
to demonstrate why he can be entrusted
with a registration. Medicine ShoppeJonesboro, 73 FR 363, 380 (2008).
In this matter, having considered the
entire record and all of the statutory
factors, I reject the ALJ’s finding that
Respondent violated Federal and State
law when he prescribed Vicodin to B.R.
However, I agree with the ALJ’s
conclusions that the Government’s
evidence under factors two, four, and
five makes out a prima facie case that
Respondent has committed acts which
render his registration inconsistent with
the public interest.20 ALJ at 26, 30. I
20 I acknowledge that Respondent holds a valid
medical license from the State of California.
Moreover, the State Board has not taken action
against him nor made any recommendation in this
matter (factor one). ALJ Ex. 3, at 3.
Be that as it may, in enacting the CSA, Congress
vested this Agency with ‘‘a separate oversight
responsibility [apart from that which exists in state
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further agree with the ALJ’s conclusion
that Respondent has not accepted
responsibility for his misconduct and
that he has not rebutted the
Government’s prima facie case.
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Factors Two, Four, and Five—
Respondent’s Experience in Dispensing
Controlled Substances, Compliance
With Applicable Laws Related to
Controlled Substances, and Other
Conduct Which May Threaten Public
Health and Safety
The Government’s case implicates
each of these factors. As found above,
during an approximately fifteen month
period, more than four million tablets of
highly abused combination drugs
containing hydrocodone, a schedule III
controlled substance, were purchased
by R.K., Respondent’s office manager,
using his and his wife’s DEA
registrations. When DEA Investigators
audited Respondent’s handling of
hydrocodone, they could account for
only 167,000 tablets, leaving nearly 3.9
million tablets unaccounted for.21 In
addition, law enforcement authorities
found that R.K. had large quantities of
hydrocodone in her possession during
both a traffic stop and a search of her
residence; Investigators also found a
large quantity of cash in R.K.’s home.
At a minimum, the evidence clearly
shows that Respondent violated the
authorities] with respect to the handling of
controlled substances.’’ Mortimer B. Levin, 55 FR
8209, 8210 (1990). DEA has therefore long
recognized that it has ‘‘a statutory obligation to
make its independent determination as to whether
the granting of [a registration] would be in the
public interest.’’ Id. Accordingly, ‘‘a State’s failure
to take action against a registrant’s medical license
is not dispositive in determining whether the
continuation of a registration is in the public
interest.’’ Jayam Krishna-Iyer, 74 FR 459, 461
(2009); see also Levin, 55 FR at 8210 (holding that
practitioner’s reinstatement by state board ‘‘is not
dispositive’’ in public interest inquiry). Thus, that
the Medical Board of California has taken no action
with respect to Respondent’s medical license is not
dispositive in determining whether his continued
registration is consistent with the public interest.
There is also no evidence that Respondent has
been convicted of an offense related to the
manufacture, distribution, or dispensing of
controlled substances under either Federal or state
law (factor three). ALJ Ex. 3. However, while a
history of criminal convictions for offenses
involving the distribution or dispensing of
controlled substances is a highly relevant
consideration, there are any number of reasons why
a registrant may not have been convicted of (or even
prosecuted for) such an offense, and thus, the
absence of such a conviction is of considerably less
consequence in the public interest inquiry. KrishnaIyer, 74 FR at 461; Edmund Chein, 72 FR 6580, 6593
n.22 (2007). Accordingly, that Respondent has not
been convicted of an offense related to the
distribution or dispensing of controlled substances
is not dispositive of whether the continuation of his
registration is consistent with the public interest.
21 During 2005 alone, approximately 1.35 million
dosage units were ordered under Respondent’s
registration. Thus, Respondent could not account
for at least 1.1 million tablets.
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CSA’s various recordkeeping provisions.
Under Federal law, as soon as
Respondent ‘‘first engage[d] in the
* * * distribution or dispensing of
controlled substances, and every second
year thereafter,’’ he was required ‘‘to
make a complete and accurate record of
all stocks thereof on hand.’’ 21 U.S.C.
827(a)(1) (emphasis added); see also 21
CFR 1304.03(a)–(b), 1304.04(a) & (g),
1304.11. As found above, during the
audit, Respondent could not produce an
inventory record for any of the
controlled substances that were
purchased under his registration.
Under Federal law, Respondent was
also required to ‘‘maintain, on a current
basis, a complete and accurate record of
each such substance * * * received,
sold, delivered, or otherwise disposed of
by him.’’ 21 U.S.C. 827(a)(3) (emphasis
added). With respect to a practitioner
who engages in dispensing, DEA
regulations require that the record
include ‘‘the number of units or volume
of such finished form dispensed, * * *
the name and address of the person to
whom it was dispensed, the date of
dispensing, the number of units or
volume dispensed and the written or
typewritten name or initials of the
individual who dispensed * * * the
substance on behalf of the dispenser.’’
21 CFR 1304.22(c); see also id.; 21 CFR
1304.03(a)–(b), 1304.04(a) & (g),
1304.21, 1304.22(c). However, as found
above, while Respondent had purchased
large quantities of controlled substances
throughout 2004 and 2005, he had no
dispensing logs for these years and his
2006 logs covered only from February
28 through March 15. Moreover, the logs
that were maintained lacked required
information such as the name of the
dispensing doctor, the initials/name of
the person doing the dispensing, and
the address of the patient. GX 14.
Recordkeeping is one of the central
features of the CSA’s closed system of
distribution. See Paul H. Volkman, 73
FR 30630, 30644 (2008), pet. for rev.
denied 567 F.3d 215, 224 (6th Cir.
2009). As I have previously explained,
‘‘a registrant’s accurate and diligent
adherence to this obligation is
absolutely essential to protect against
the diversion of controlled substances.’’
Id. Given that millions of dosage units
of a highly abused controlled substance
that were ordered under Respondent’s
registration cannot be accounted for, his
failure to comply with the CSA’s
recordkeeping requirements is
egregious. This finding provides reason
alone to conclude (with respect to
factors two and four) that his continued
registration ‘‘is inconsistent with the
public interest.’’ 21 U.S.C. 823(f); see
also Volkman, 73 FR at 30644 (holding
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Fmt 4703
Sfmt 4703
that recordkeeping violations alone
supported denial of practitioner’s
application).
While in his brief, Respondent, who
did not testify, acknowledges that ‘‘he
failed * * * to maintain complete
records reflecting his dispensing of
controlled substances,’’ Resp. Br. at 6,
he argues that R.K. ‘‘ordered, received
and paid for’’ the drugs, and that she
‘‘distributed or sold the drugs outside
[of] the CMC practice.’’ Id. at 5.
Respondent’s brief implies that he was
unaware of R.K.’s illegal activities, and
his brief is otherwise silent on the issue
of whether he bears any responsibility
for the missing drugs. See generally id.
He does.
DEA has long held that a registrant is
strictly liable for the misuse of his
registration by a person to whom he
entrusts his registration. See Anthony L.
Capelli, 59 FR 42288 (1994); see also
Harrell E. Robinson, 74 FR 61376, 61377
(2009); Paul H. Volkman, 73 FR 30630,
30644 n.42 (2008); Rosemary Jacinta
Lewis, 72 FR 4035, 4041 (2007) (citing
Capelli); Leonard Merkow, 60 FR 22075,
22076 (1995). The record clearly
supports the conclusion that
Respondent entrusted his registration to
R.K.
Moreover, several documents in
evidence support the conclusion that
Respondent was clearly aware that
controlled substances were being
ordered under his registration. These
include Respondent’s November 2005
letter to Schein declaring that he had
‘‘decided to order medications through
your company,’’ GX 7, and the credit
application he submitted to ParMed. GX
9, at 4.
The evidence also supports the
inference that Respondent authorized
R.K. to use his registration to order
controlled substances. Several clinic
employees told Investigators that R.K.
would order the drugs. See, e.g., Tr. 94.
Moreover, several invoices prepared by
Schein, both before and after
Respondent’s November 2005 letter,
include the notation: ‘‘Roni, Thank you
for your order,’’ GX 6, at 9, 14–15, 18;
and on the ParMed credit application,
Respondent listed R.K. as his accounts
payable contact. GX 9, at 4. Finally, R.K.
stated in her January 2006 interview
that, while she paid for the drugs with
her personal credit card, Respondent
reimbursed her with cash. Tr. 94.
Thus, it is clear that Respondent
authorized R.K. to order controlled
substances using his registration. And
even if it were the case that Respondent
was unaware of R.K.’s illegal activities
(although it is not), he is still strictly
liable for her misuse of his registration
and his failure to properly monitor how
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his registration was being used. See
Jacinta Lewis, 72 FR at 4041–42;
Robinson, 74 FR at 61377; Volkman, 73
FR at 30644 n.42; Capelli, 59 FR at
49288.
As for Respondent’s implicit
suggestion that he lacked knowledge of
R.K.’s activities, the evidence is to the
contrary. See Resp. Br. at 5. Most
significantly, as demonstrated by the
letter Respondent sent seeking the
return of the hydrocodone seized during
the traffic stop of R.K., he knew that she
had removed 31,000 tablets from his
clinic. GX 12. Yet even after this,
Respondent continued to employ R.K.
(indeed, the evidence shows that she
was still employed by him as of the date
of the hearing) and R.K. continued to
order controlled substances. See GX 6,
at 5 (Schein invoice dated March 13,
2006 for hydrocodone and temazepam
and stating: ‘‘RONI, Thank You For
Your Order’’); Tr. 72. This begs the
question—which is unanswered because
Respondent did not testify—as to what
he thought R.K. planned to do with the
drugs she had in her possession when
she was stopped by the CHP.22
It is well established that the Agency
may draw an adverse inference from a
respondent’s failure ‘‘to testify in
response to probative evidence offered
against’’ him. Baxter v. Palmigiano, 425
U.S. 308, 318 (1976); see also United
States v. Solano-Godines, 120 F.3d 957,
962 (9th Cir. 1997) (‘‘In civil
proceedings * * * the Fifth
Amendment does not forbid fact finders
from drawing adverse inferences against
a party who refuses to testify.’’); Dewey
C. MacKay, 75 FR 49956, 49977 (2010).
It is appropriate to draw an adverse
inference here, where the Government
produced evidence showing that
Respondent authorized R.K. to use his
registration to obtain massive quantities
of controlled substances, of which only
a small fraction can be accounted for,
and Respondent failed to testify and
respond to this evidence.
I thus conclude that Respondent knew
that R.K. was engaging in illegal activity
and did nothing to prevent it.
Respondent’s misconduct clearly
threatened public health and safety, 21
U.S.C. 823(f)(5), and is especially
egregious given that nearly four million
dosage units of hydrocodone cannot be
accounted for and were likely
diverted.23 These findings provide
22 The GS also related that a patient (A.A.) had
told Respondent that she believed that R.K. was
selling drugs to patients who did not see him. Tr.
83.
23 Respondent elicited testimony from the G.S.
that when the Government seized the accounts and/
or cash of R.K., Respondent, and his wife, it did not
find a money trail consistent with the potential
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16:04 Aug 17, 2011
Jkt 223001
further reason to conclude that
Respondent’s registration is
‘‘inconsistent with the public
interest.’’ 24 21 U.S.C. 823(f); 824(a)(4).
Sanction
Under Agency precedent, where the
Government has made out a prima facie
case that a registrant has committed acts
which render his ‘‘registration
inconsistent with the public interest,’’
he must ‘‘‘present[] sufficient mitigating
evidence to assure the Administrator
that [he] can be entrusted with the
responsibility carried by such a
registration.’’’ Samuel S. Jackson, 72 FR
23848, 23853 (2007) (quoting Leo R.
Miller, 53 FR 21931, 21932 (1988)).
‘‘Moreover, because ‘past performance is
the best predictor of future
performance,’ ALRA Labs., Inc. v. DEA,
54 F.3d 450, 452 (7th Cir. 1995), this
Agency has repeatedly held that where
a registrant has committed acts
inconsistent with the public interest, the
registrant must accept responsibility for
his actions and demonstrate that [he]
will not engage in future misconduct.’’
Medicine Shoppe-Jonesborough, 73 FR
at 387.
As noted above, Respondent failed to
testify in this proceeding. While in his
brief, he now acknowledges that he
violated Federal law and DEA
regulations by failing to maintain proper
records, notably, he does not
acknowledge his misconduct in failing
to properly monitor how R.K. was using
his registration.25 I thus conclude that
sales value in the illicit market of the unaccounted
for hydrocodone. However, Respondent offered no
evidence challenging the results of the audit. Nor
has he offered any explanation as to the disposition
of the unaccounted for drugs. The audit results
alone provide enough evidence to support the
conclusion that the drugs were diverted; the
Government is not obligated to show that it found
a money trail consistent with the potential sales
value of the drugs in the illicit market.
24 The ALJ further found that Respondent
‘‘prescribed controlled substances without
establishing a bona-fide doctor-patient
relationship’’ with B.R. ALJ at 24–25 (citing Cal.
Bus. & Prof. Code § 2242(a)). The ALJ apparently
based her conclusion on B.R.’s statement that
Respondent ‘‘did not examine her thoroughly and
did not request any tests.’’ GX 17, at 1.
The evidence suggests, however, that B.R. had a
legitimate medical complaint, and there is
absolutely no evidence (such as B.R.’s medical
record) other than the conclusory assertion set forth
above as to the scope of the examination
Respondent performed. Finally, there is no
evidence as to the scope of the medical examination
necessary to properly diagnose and treat B.R.’s
condition. I therefore conclude that the ALJ’s
finding is not supported by substantial evidence.
25 Because Respondent has not addressed his
misconduct in failing to prevent the misuse of his
registration, I need not decide whether the assertion
in his brief that he ‘‘recognizes that he failed * * *
to maintain complete records,’’ Resp. Br. at 6,
satisfies the Agency’s rule requiring that he accept
responsibility for his misconduct. Respondent
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51423
Respondent has not accepted
responsibility for his misconduct and
has not rebutted the Government’s
prima facie case.26
Given the grievous nature of
Respondent’s misconduct and his
failure to accept responsibility, none of
the ‘‘favorable facts’’ cited by the ALJ
provide any reason to impose a sanction
less than revocation. While the record
may contain no other evidence of
misconduct on Respondent’s part, ALJ
at 31, as I have previously explained,
the fact that a practitioner can point to
even an extensive body of compliance
with the CSA does not negate a prima
facie showing that he has committed
acts inconsistent with the public
interest.27 Jayam Krishna-Iyer, 74 FR
459, 463 (2009). While such evidence is
entitled to some weight in assessing
whether a practitioner has credibly
shown that he has reformed his
practices, where, as here, a practitioner
commits egregious acts (whether
intentional or not) that have likely
resulted in diversion, and fails to accept
responsibility for his actions, ‘‘such
evidence is entitled to no weight.’’ Id.
Indeed, that there is no other evidence
of misconduct on his part does nothing
to mitigate the harm Respondent has
caused to public health and safety.
Finally, given Respondent’s failure to
accept responsibility, and the nature of
his misconduct, I conclude that it would
be inconsistent with the public interest
to grant him even a restricted
registration. Accordingly, I will order
that Respondent’s registration be
revoked and that any pending
application be denied.
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) and 824(a), as well
as by 28 CFR 0.100(b), I hereby order
that DEA Certificate of Registration,
AD6122143, issued to Surinder Singh
Dang, M.D., be, and it hereby is,
revoked. I further order that any
pending application of Surinder Singh
offered no evidence to support this assertion, and
statements of counsel in a brief are not evidence.
See INS v. Phinpathya, 464 U.S. 183, 186 n.6
(1984).
26 While the ALJ concluded that ‘‘Respondent has
not admitted any fault’’ and that he was ‘‘either
intentionally engaged in diversion or * * * at least
facilitating such diversion on the part of his
employee,’’ she nonetheless concluded that ‘‘the
inquiry does not end here’’ and proceeded to
analyze what she deemed to be favorable facts. ALJ
at 30 (citing Martha Hernandez, 62 FR 61,145, 147
(1997)).
27 To similar effect, the ALJ found that
Respondent ‘‘warned at least one patient about the
dangers surrounding narcotics.’’ ALJ at 31. As
explained in Krishna-Iyer, this finding is too
insubstantial to warrant any further discussion. 74
FR at 463.
E:\FR\FM\18AUN1.SGM
18AUN1
51424
Federal Register / Vol. 76, No. 160 / Thursday, August 18, 2011 / Notices
Dang, M.D., to renew or modify his
registration be, and it hereby is, denied.
This Order is effective September 19,
2011.
Dated: August 5, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–21062 Filed 8–17–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10–4]
mstockstill on DSK4VPTVN1PROD with NOTICES
Satinder Dang, M.D.; Revocation of
Registration
On August 31, 2009, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Satinder K. Dang, M.D.
(Respondent), of Fountain Valley,
California. The Order proposed the
revocation of Respondent’s DEA
Certificate of Registration, AD9234446,
as a practitioner, as well as the denial
of any pending applications to renew or
modify her registration, ‘‘for reason that
[Respondent’s] continued registration[]
would be inconsistent with the public
interest, as that term is used in 21 U.S.C.
823(f) and 824(a)(4).’’ ALJ Ex.1, at 1.
The Order specifically alleged that
between January 2004 and July 2007,
Respondent and her husband Surinder
Dang, ‘‘who also possesses a DEA
registration and shares [Respondent’s]
registered location,’’ ordered ‘‘more than
5,000,000 dosage units of hydrocodone’’
and that Respondent ‘‘failed to properly
account for, secure, and otherwise
handle these controlled substances.’’ Id.
The Order alleged that on January 17,
2006, one of Respondent’s ‘‘employees
removed 30,000 dosage units of
controlled substances’’ from her
registered location and ‘‘attempted to
take them to her residence.’’ Id. The
Order further alleged that on the same
day, ‘‘DEA Special Agents seized
another 10,000 dosage units of
controlled substances from this
employee’s residence.’’ Id. Continuing,
the Order alleged that on March 16,
2006, ‘‘DEA Special Agents seized
50,000 dosage units more from this
employee’s residence.’’ Id.
Next, the Order alleged that on March
16, 2006, DEA conducted an
accountability audit of Respondent’s
handling of hydrocodone and that
Respondent ‘‘could not account for
more than 3,500,000 dosage units’’ that
Respondent and her husband ‘‘had
ordered’’; the Order thus also alleged
VerDate Mar<15>2010
16:04 Aug 17, 2011
Jkt 223001
that Respondent ‘‘failed to keep accurate
and complete records of each controlled
substance received, sold, delivered, or
otherwise disposed of as required by 21
U.S.C. 827(c) and 21 CFR 1304.01 et
seq.’’ Id. at 2. Finally, the Order alleged
that, when Respondent ‘‘made
dispensing records,’’ she ‘‘frequently
failed to indicate whether’’ she or her
husband ‘‘actually dispensed the
controlled substances as required by 21
CFR 1304.03(b).’’ Id.
By letter of October 2, 2009,
Respondent, through her counsel,
requested a hearing on the allegations.
ALJ Ex. 2. The matter was then assigned
to an Administrative Law Judge (ALJ),
who conducted a hearing on March 2–
3, 2010, in Santa Ana, California.
At the hearing, the Government called
two witnesses to testify and introduced
documentary evidence. Respondent
testified on her own behalf. Following
the hearing, both parties submitted
briefs containing their proposed
findings of fact, conclusions of law and
argument.
On June 18, 2010, the ALJ issued her
Recommended Decision (also ALJ).
Therein, the ALJ considered the five
public interest factors, see 21 U.S.C.
823(f), and concluded that Respondent’s
continued registration would be
inconsistent with the public interest and
recommended that her registration be
revoked. ALJ at 29, 37–38.
As to the first factor—the
recommendation of the appropriate
State licensing board or professional
disciplinary authority—the ALJ found
‘‘no evidence that the Medical Board of
California has taken any action against
the Respondent.’’ Id. at 27. However, the
ALJ recognized that under Agency
precedent, ‘‘the fact that the Medical
Board of California has currently
authorized * * * Respondent to
practice medicine is not dispositive in
this administrative determination as to
whether continuation of a registration is
consistent with the public interest.’’ Id.
(citing Patrick W. Stodola, 74 FR 20727,
20730 (2009); Jayam Krishna-Iyer, 74 FR
459, 461 (2009)). The ALJ then
concluded that ‘‘this factor does not fall
in favor of revocation.’’ Id. Likewise,
with respect to factor three—
Respondent’s record of convictions for
offenses relating to the manufacture,
distribution, or dispensing of controlled
substances—the ALJ found that
Respondent has not been convicted of
such an offense and that this factor also
did not ‘‘fall in favor of revocation.’’ Id.
at 27–28.
The ALJ then considered factors two
and four—Respondent’s experience in
dispensing controlled substances and
her compliance with Federal, State, and
PO 00000
Frm 00082
Fmt 4703
Sfmt 4703
local laws relating to controlled
substances—together. Id. at 28–29. The
ALJ found that the record was ‘‘replete
with Respondent’s lack of oversight
concerning the use of her controlled
substances registration.’’ Id. at 28.
Specifically, the ALJ found that: (1)
Respondent’s clinic was unable to
provide a biennial inventory (or an
inventory of any kind); (2) ‘‘Respondent
was unable to account for any of the
controlled substances ordered using her
DEA registration number’’; and (3)
Respondent had admitted that ‘‘she did
not maintain a key to the controlled
substance cabinet’’ at her clinic. Id. at
28–29. Further, the ALJ found that an
‘‘audit revealed that the approximately
3,870,700 dosage units of hydrocodone
were unaccounted for.’’ Id. at 29. Based
on these findings, the ALJ concluded
that ‘‘Respondent failed to maintain
adequate records.’’ Id.
The ALJ rejected Respondent’s
argument that ‘‘the DEA’s findings did
not distinguish between the controlled
substances prescribed or dispensed to
Respondent’s patients versus the
patients of’’ her husband. Id. The ALJ
found that ‘‘the missing controlled
substances were ordered under both
DEA registration numbers in a
haphazard manner and subsequently
´
mixed into an incoherent melange.’’ Id.
The ALJ reasoned that if ‘‘Respondent
maintained some oversight of her
controlled substances registration, then
DEA would most likely be able to
‘distinguish between controlled
substances prescribed or dispensed to
Respondent’s patients versus’ those of
her husband.’’ Id. Based on these
findings, the ALJ concluded that
‘‘Respondent’s circular reasoning does
not absolve her [of] culpability.’’ Id. The
ALJ thus held that the Government’s
evidence under factors two and four
‘‘established prima facie grounds for
revocation of * * * Respondent’s DEA
Certificate of Registration.’’ Id.
Turning to factor five—such other
conduct as may threaten the public
health and safety—the ALJ explained
that ‘‘[e]ven if Respondent was not
directly involved in the illegal diversion
of controlled substances * * * she
committed acts which constitute
‘conduct which may threaten the public
health and safety’ and which render her
registration ‘inconsistent with the
public interest.’ ’’ Id. (quoting 21 U.S.C.
823(f)(5), 824(a)(4)). Noting that
‘‘[u]nder DEA precedent, a registrant
who entrusts [her] registration to
another person is strictly liable for the
latter’s misuse of [her] registration,’’ the
ALJ reasoned that ‘‘even if there had
been no conspiracy amongst
Respondent, her husband, and [R.K., the
E:\FR\FM\18AUN1.SGM
18AUN1
Agencies
[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51417-51424]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21062]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-2]
Surinder Dang, M.D.; Revocation of Registration
On August 31, 2009, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Surinder Singh Dang, M.D. (``Respondent''), of Fountain
Valley, California. The Order proposed the revocation of Respondent's
DEA Certificate of Registration, AD6122143, as a practitioner, as well
as the denial of any pending applications to renew or modify his
registration ``for reason that [Respondent's] continued registration[]
would be inconsistent with the public interest, as that term is used in
21 U.S.C. 823(f) and 824(a)(4).'' ALJ Ex.1, at 1.
The Order specifically alleged that between January 2004 and July
2007, Respondent and his wife, Dr. Satinder Dang, ``who also possesses
a DEA registration and shares [Respondent's] registered location,''
ordered ``more than 5,000,000 dosage units of hydrocodone'' and that
Respondent ``failed to properly account for, secure, and otherwise
handle these controlled substances.'' Id. The Order alleged that on
January 17, 2006, one of Respondent's ``employees removed 30,000 dosage
units of controlled substances'' from his registered location and
``attempted to take them to her residence.'' Id. The Order further
alleged that on the same day, ``DEA Special Agents seized another
10,000 dosage units of controlled substances from this employee's
residence.'' Id. at 1-2. Continuing, the Order alleged that on March
16, 2006, ``DEA Special Agents seized 50,000 dosage units more from
this employee's residence.'' Id. at 2.
Next, the Order alleged that on March 16, 2006, DEA conducted an
accountability audit of Respondent's handling of hydrocodone and that
Respondent ``could not account for more than 3,500,000 dosage units''
that Respondent and his wife ``had ordered,'' and that Respondent
``failed to keep accurate and complete records of each controlled
substance received, sold, delivered, or otherwise disposed of as
required by 21 U.S.C. 827(c) and 21 CFR 1304.01 et seq.'' Id. Finally,
the Order alleged that when Respondent ``made dispensing records,'' he
``frequently failed to indicate whether'' he or his wife ``actually
dispensed the controlled substances as required by 21 CFR 1304.03(b).''
\1\ Id.
---------------------------------------------------------------------------
\1\ In its Prehearing Statement, the Government also alleged
that ``two agents interviewed patient [B.R.]'' who Respondent had
``treated for leg pain'' and that he ``did not examine [B.R.]
thoroughly * * * but did dispense Vicodin to her.'' Gov. Prehearing
Statement at 10. The Government further alleged that B.R.
subsequently saw ``another physician who informed her she was being
overmedicated with Vicodin and * * * [who] ordered a number of tests
* * * and determined that a problem in her back was causing her
pain.'' Id. Finally, the Government alleged that sometimes R.K.
``dispensed the Vicodin to [B.R.] instead of [Respondent]'' and that
``[o]ften she came to the office to have [R.K.] dispense the Vicodin
to her without ever seeing or consulting with'' Respondent. Id.
---------------------------------------------------------------------------
By letter of October 2, 2009, Respondent, through his counsel,
requested a hearing on the allegations. ALJ Ex. 2. The matter was then
assigned to an Administrative Law Judge (ALJ), who conducted a hearing
on March 3, 2010, in Santa Ana, California.
At the hearing, the Government called one witness to testify and
introduced documentary evidence. Respondent did not call any witnesses
and introduced a single exhibit, this being a letter from the counsel
for Respondent's employee R.K. stating that she intended to assert her
Fifth Amendment privilege if called to testify. See RX 1. Following the
hearing, both parties submitted briefs containing their proposed
findings of fact, conclusions of law and argument.
On May 19, 2010, the ALJ issued her Recommended Decision (also
ALJ). Therein, the ALJ considered the five public interest factors, see
21 U.S.C. 823(f), and concluded that Respondent's continued
registration would be inconsistent with the public interest and
recommended that his registration be revoked. ALJ at 26, 30-31.
As to the first factor--the recommendation of the appropriate State
licensing board or professional disciplinary authority--the ALJ found
that the California Medical Board ``has not taken any formal action to
limit Respondent's right to practice medicine nor has it recommended
limiting his ability to prescribe controlled substances.'' Id. at 23.
However, the ALJ recognized that under Agency precedent ``the fact that
the Medical Board of California has currently authorized * * *
Respondent to practice medicine is not dispositive in this
administrative determination as to whether continuation of a
registration is consistent with the public interest.'' ALJ at 22-23
(citing Patrick W. Stodola, 74 FR 20727, 20730 (2009); Jayam Krishna-
Iyer, 74 FR 459, 461 (2009)). The ALJ thus concluded that ``this factor
does not fall in favor of revocation.'' Id. at 23. Likewise, with
respect to factor three--Respondent's record of convictions for
offenses relating to the manufacture, distribution, or dispensing of
controlled substances--the ALJ found that Respondent has not been
convicted of such an offense and that this factor also did not ``fall
in favor of revocation.'' Id.
The ALJ then considered factors two and four--Respondent's
experience in dispensing controlled substances and his compliance with
Federal, State, and local laws relating to controlled substances--
together. Id. at 23-26. The ALJ specifically found that: (1)
``Respondent authorized'' his employee R.K. ``to purchase large amounts
of hydrocodone using his DEA registration and that of his wife''; (2)
another physician who practiced at Respondent's clinic had ``stated
that the patient load'' at the clinic ``would not justify such large
purchases of controlled substances''; (3) R.K. remained in Respondent's
employ even after ``drugs were discovered in [her] personal vehicle by
the California Highway Patrol''; (4) ``[l]arge bundles of cash,
controlled substances, and other * * * evidence, such as receipts and
money order stubs were discovered at [her] home''; and (5) ``[a]fter
being questioned, [R.K.] stated that she was ordering and transporting
controlled substances all at the direction of the Respondent.'' Id. at
24. Based on these findings, the ALJ concluded that ``either
[Respondent] is personally involved in hydrocodone diversion or he is
facilitating such diversion on the part of his employee.'' Id.
The ALJ further found that Respondent ``prescribed Vicodin,'' a
schedule III controlled substance, to patient B.R. ``on many occasions
without a thorough examination.'' Id. Based on Cal. Bus. & Prof. Code
Sec. 2242(a), which provides that it is ``unprofessional conduct'' to
``[p]rescrib[e], dispens[e] or furnish[ ] dangerous drugs as defined in
Section 4022 without an appropriate prior examination and a medical
indication,'' the ALJ concluded that Respondent prescribed Vicodin to
B.R. without an ``appropriate prior examination.'' Id. at 25. The ALJ
thus concluded that Respondent ``prescribed controlled substances
without establishing a bona-fide patient relationship'' and violated
both Federal and state law. Id. at 24-25.
Next, the ALJ found that Respondent did not have any inventories
for the controlled substances his clinic dispensed, that he ``failed to
maintain accurate records of the controlled
[[Page 51418]]
substances he dispensed,'' and that an audit could not account for
``almost four million dosage units of hydrocodone.'' Id. at 26. The ALJ
thus concluded that Respondent ``violated federal regulations by not
conducting a biennial inventory and maintaining the appropriate records
of his controlled substances.'' Id. The ALJ further held that the
Government's evidence under factors two and four ``established prima
facie grounds for revocation of * * * Respondent's DEA Certificate of
Registration.'' Id.
Turning to factor five--other conduct which may threaten the public
health and safety--the ALJ found ``it likely that * * * Respondent is
engaged in the illegal diversion of hydrocodone.'' Id. As support for
her conclusion, the ALJ noted her findings that Respondent ``was
involved in the ordering of the hydrocodone,'' that ``[h]is colleagues
stated that his practice did not justify such exorbitant purchases,''
his inability ``to account for the whereabouts of the controlled
substances,'' and the ``circumstances,'' which she did not further
specify, ``surrounding [the DEA Group Supervisor's] investigations.''
Id. According to the ALJ, these facts ``suggest[ed] that * * *
Respondent is at least recklessly, if not intentionally, contributing
to this illegal diversion.'' Id.
The ALJ further explained that ``[e]ven if Respondent did not
commit the above violations of Federal law and DEA regulations,'' she
would still find that he had ``committed acts which constitute `conduct
which may threaten the public health and safety' and which render his
registration `inconsistent with the public interest.''' Id. (quoting 21
U.S.C. 823(f)(5) & 824(a)(4)). Noting that ``[u]nder DEA precedent, a
registrant who entrusts his registration to another person is strictly
liable for the latter's misuse of his registration,'' the ALJ reasoned
that ``even if there had been no conspiracy between Respondent and
[R.K.] to unlawfully distribute the drugs, he would still be liable for
the acts she committed while being allowed to use his registration.''
ALJ at 26-27 (citations omitted). The ALJ concluded that ``Respondent
is thus liable for [R.K.'s] acts of unlawful possession and
distribution of the controlled substances that she obtained under his
registration.'' \2\ Id. (citations omitted).
---------------------------------------------------------------------------
\2\ The ALJ also rejected Respondent's argument that R.K. had
stolen the drugs, noting that as of the hearing, she was still an
employee. Id. at 27 (citations omitted).
---------------------------------------------------------------------------
The ALJ then addressed whether Respondent had rebutted the
Government's prima facie case. ALJ at 29-30. The ALJ found that
``Respondent has not admitted any fault whatsoever,'' but rather ``has
merely pointed an accusing finger at his employee.'' Id. at 30. Noting
that Respondent did not testify in the proceeding, the ALJ concluded
that ``[t]he fact that the Respondent has chosen not to hold himself
accountable for his own indiscretions weighs heavily against his
continued registration.'' Id. While the ALJ further considered facts
she deemed favorable to Respondent, she nonetheless concluded that
``none of these factors outweigh the overwhelming security violations
and evidence of diversion,'' which she deemed to be ``egregious.'' Id.
at 31. The ALJ therefore recommended that I revoke Respondent's
registration. Id.
Neither party filed exceptions to the ALJ's decision. Thereafter,
the record was forwarded to me for Final Agency Action. Having
considered the entire record, I adopt the ALJ's findings of fact and
conclusions of law except as expressly noted herein. I further adopt
the ALJ's ultimate conclusion that Respondent's ``continued
registration is not in the public interest,'' id. at 30, and her
recommendation that his registration be revoked. As ultimate
factfinder, I make the following findings:
Findings
Respondent is the holder of DEA Certificate of Registration,
AD6122143, which authorizes him to dispense controlled substances in
schedules II through V, as a practitioner, at the registered location
of 17150 Euclid 200, Fountain Valley, California. GX 1. While
Respondent's registration was to expire on June 30, 2009, Id., on May
13, 2009, Respondent filed an application to renew his registration. GX
2. Accordingly, his registration remains in effect pending the issuance
of this Decision and Final Order. 5 U.S.C. 558(c); see also ALJ Ex. 3,
at 2 (Prehearing Order; Stipulations).
Respondent currently holds a license to practice medicine in
California and the California Medical Board has not taken any formal
action to limit his ability to practice medicine or to prescribe
controlled substances. ALJ Ex. 3, at 3. Also, Respondent has not been
convicted of an offense related to the manufacture, distribution, or
dispensing of controlled substances. Id.
Respondent is married to Satinder Dang, M.D.\3\ She and Respondent
practice medicine at Complete Medical Care, Inc. (``CMC''). Tr. 41; GX
6, at 20. Their son, Sameer Dang, also works in the CMC office. Tr. 51.
At all relevant times (including through the date of the hearing) CMC's
office manager was Ms. Rani K.\4\ (R.K.). Id. at 26, 164.
---------------------------------------------------------------------------
\3\ Dr. Satinder Dang holds DEA Certificate of Registration,
AD9234446; she is registered at the same address as Respondent. ALJ
Ex. 3, at 2
\4\ R.K.'s first name is spelled as both Rani and Roni in
various documents.
---------------------------------------------------------------------------
In November 2005, a Diversion Group Supervisor (GS) in DEA's
Riverside Diversion Group reviewed ARCOS \5\ records and found that
Respondent was the largest purchaser of controlled substances from Anda
Pharmaceuticals, Inc. (``Anda''). Tr. 21. The GS also determined that
Respondent was buying controlled substances ``from other companies
too.'' Id.
---------------------------------------------------------------------------
\5\ Pursuant to 21 CFR 1304.33(c), manufacturers and
distributors of various controlled substances including schedule III
narcotics are required to report their distributions of controlled
substances to DEA through the Automated Records and Consolidated
Orders System (ARCOS). See also Tr. 21-22.
---------------------------------------------------------------------------
Of particular concern to the GS were Respondent's purchases of
hydrocodone, a schedule III controlled substance. Tr. 22; 21 CFR
1308.13(e)(iv). According to ARCOS records, while in 2004, Respondent
purchased 190,600 tablets of hydrocodone from all suppliers, in 2005,
he purchased 1,353,600 such tablets. Tr. 24; GX 4, at 2-6. ARCOS data
further showed that in 2005, Respondent and his wife had ordered a
combined total of 3,626,400 tablets of hydrocodone. GX 3, at 13; GX 4,
at 6; see also Tr. 121, 124 (GS's testimony that between January 1,
2005 and March 16, 2006, Respondent and his wife purchased
approximately four million tablets of hydrocodone).
Upon reviewing the ARCOS data, the GS contacted several of the
firms that were distributing controlled substances to Respondent. See,
e.g., GX 6, at 7. At several points throughout the investigation, these
firms provided copies of various documents to the GS including sales
records, invoices, statements of account, delivery records,
applications for credit, and correspondence.\6\ See generally GX 5
(records from Moore Medical, L.L.C.), GX 6 (record from Henry Schein,
Inc.), GX 9 (records from ParMed Pharmaceuticals, Inc.).
---------------------------------------------------------------------------
\6\ Some of the documents may have been obtained pursuant to a
search warrant.
---------------------------------------------------------------------------
Throughout the investigation, several of the firms also provided
the GS with information regarding when various deliveries were to be
made to Respondent's clinic. On December 14, 2005, the GS, who had
received information from two different distributors (Henderson and
Moore Medical) that controlled substances
[[Page 51419]]
deliveries were to be made that day, conducted ``surveillance at the
[Dangs's] clinic'' from 9 a.m. to 6 p.m. Tr. 39-42. During the
surveillance, the GS observed both deliveries and noted that ``no more
than ten or fifteen'' people entered the clinic that day. Id. at 41-42.
On January 13, 2006, from ``[m]orning till late afternoon,'' the GS
conducted a second surveillance. Id at 42. During the surveillance, the
GS saw Ms. R.K. ``taking boxes out of the clinic and plac[ing] them in
her vehicle,'' which was ``a green SUV.'' Id. at 42-43.
On January 17, 2006, from 9 a.m. to 6 p.m., the GS, who had
received notice of a controlled substance delivery from another
distributor (ParMed Pharmaceuticals, Inc.), conducted another
surveillance. Id. at 43. Once again, Investigators observed R.K.
``tak[e] boxes from the clinic'' and place them in ``her vehicle.'' Id.
at 44. The GS observed R.K. drive away and notified the California
Highway Patrol (CHP). Id. at 44-45. After observing R.K., who was
driving forty miles per hour, operate her vehicle within five feet of
the vehicle in front of her, a CHP officer conducted a traffic stop.
Id. at 45; GX 10 at 2.
As he approached R.K., the CHP officer observed ``cardboard boxes
that were taped shut in the rear cargo area.'' GX 10, at 2. The CHP
officer advised R.K. of the reason for the stop and requested her
license, registration, and insurance. Id. He then asked R.K. ``what the
boxes were.'' Id. R.K. stated that the boxes held Vicodin, a schedule
III controlled substance which contains hydrocodone. Id.; ALJ Ex. 3, at
1. When the CHP officer asked R.K. if she was a doctor, she stated that
``she was the president of a medical facility and that she was going to
give the Vicodin to the doctor at her facility.'' GX 10, at 2. The CHP
Officer asked her a second time if she was a doctor; R.K. again said
``no'' and became ``extremely nervous.'' Id.
After the CHP Officer asked R.K. to step out of her car, he asked
``why she had cases of Vicodin.'' Id. She responded that she ran a
medical office and handed him a business card listing her name as R.K.
and her position as ``president.'' Id. R.K. further stated that ``she
received a delivery of Vicodin from a delivery company at about 1100
hours and that she needed to give it to'' Respondent. Id. When the
Officer asked R.K. if the Vicodin had been delivered ``to her car or to
her office,'' R.K. stated that it had been delivered to the office. Id.
When the Officer asked if her office had a locker in which to store the
Vicodin, R.K. answered ``yes,'' but added that she had to personally
give the drugs to Respondent. Id.
The CHP Officer then asked how the Vicodin had ended up in her
vehicle, R.K. stated that ``she [had] carried the boxes to her vehicle
around noon time and left them there,'' and that she had stayed in her
office until about 5 p.m., at which point ``she left * * * to get
something to eat.'' Id. When the Officer told R.K. that he was
``concerned that she was in possession of so much of a controlled
substance,'' R.K. said she would return it to the office. Id. R.K. then
stated that Respondent was ``doing a procedure at an unknown hospital
and he would be returning at an unknown time to the office'' and that
she would then give him the Vicodin. Id.
The CHP Officer then ``asked R.K. to open the boxes'' to confirm
that they contained Vicodin. Id. R.K. opened six boxes containing a
total of 70 bottles of hydrocodone bitartrate/acetaminophen
(hereinafter, hydrocodone/apap or hydrocodone). Id. at 2-3. Each of the
bottles contained between 100 and 500 tablets (for a total of
``approximately 31,000 tablets'') in 7.5/500 mg, 10/500 mg, and 10/325
mg strengths. Id. The Officer then seized the Vicodin and gave R.K. a
receipt for it. Id. After giving R.K. a citation, the officer allowed
her to leave. Id. at 3.
The CHP Officer then contacted a DEA Task Force Officer (TFO) and
arranged to transfer custody of the drugs to DEA; upon the TFO's
arrival at the Officer's location, the TFO took possession of the
drugs. Id. The TFO gave the CHP Officer a receipt which confirms the
figures in the latter's report.\7\ Id. at 6.
---------------------------------------------------------------------------
\7\ More specifically, there were 14 bottles of 500 count of
hydrocodone/apap 7.5/500 mg, 10 bottles of 500 count hydrocodone/
apap 10/500 mg, 36 bottles of 500 count hydrocodone/apap10/325 mg,
and 10 bottles of 100 count hydrocodone/apap 10/500 mg. GX 10, at 6.
---------------------------------------------------------------------------
R.K. then drove to her residence in Anaheim Hills; Investigators
followed her there in order to question her about the drugs that were
found in her vehicle. Tr. 47. R.K. told the Investigators that she had
taken the hydrocodone with her for safekeeping because Respondent was
out of the office; she also maintained that she intended to return them
to the office after she ate. Id. at 47-48. While R.K. initially claimed
that this was the first time she had done this, upon being confronted
with the fact that Investigators had on another occasion observed her
placing boxes in her vehicle, she admitted that this was the second
time she had done so. Id. at 48.
R.K. stated that there were about five physicians who worked at
Respondent's clinic, that they dispensed the pills in 30 and 60-count
bottles, and that the clinic had approximately twenty to twenty-five
patients per day. Id. R.K. further said that she used her personal
credit card to purchase drugs from wholesalers and that Respondent
would reimburse her with cash. Id. at 49. R.K. would then obtain money
orders to pay off her credit card bills. Id.
The Investigators then asked R.K. if she would consent to a search
of her residence; she agreed. Id. at 49-50. According to the GS, the
Investigators found approximately $69,500 in cash in an upstairs
closet, which was ``wrapped up in paper''; a ``small quantity of
drugs,'' which included 2000 lorazepam tablets and 1400 hydrocodone
tablets; ``a lot of money order stubs''; ``some bank records''; and
``[s]ome credit card information.'' Id. at 50, 113, 117. The GS
testified that these records confirmed that R.K. paid her credit card
bills with money orders. Id. at 50. However, on cross-examination, the
GS acknowledged that he had no documentary evidence to substantiate
R.K.'s assertion that Respondent reimbursed her in cash. Id. at 146. To
explain the cash, R.K. claimed the sum was a combination of money she
received from the sale of a house in India, a home-based business she
had previously run, and a gift from relatives. Id. at 51, 142.
On cross-examination, the GS acknowledged that the amount of drugs
found at R.K.'s residence could indicate she was stealing drugs from
Respondent's clinic. Id. at 116. The GS further testified that at the
time of the search, the street value of hydrocodone tablets was between
three and five dollars per pill. Id. at 132.
On February 7, 2006, the GS obtained notice of another delivery of
controlled substances and conducted another surveillance. Id. at 51-52.
While on this date, UPS made a delivery, nothing was moved out of CMC.
Id. at 52.
On February 24, 2006, Respondent wrote a letter to CHP requesting
the return of the hydrocodone which had been seized during the traffic
stop of R.K. Tr. 52-53; GX 12. The letter stated that R.K. was
Respondent's ``office manager,'' and that she had ``informed CHP that
the property was not hers, and instead belonged to her employer,
Complete Medical Care Inc.'' GX 12.
On March 16, 2006, DEA executed search warrants at both
Respondent's clinic and R.K.'s residence. Tr. 61, 67-68, 70. At the
clinic, the Investigators took an inventory of the controlled
substances on hand and found 48,000 tablets of hydrocodone, which they
seized; the Investigators also seized CMC's controlled substance
purchasing records and dispensing log. Id. at 94.
[[Page 51420]]
During the search of the clinic, Respondent declined to be
interviewed.\8\ Tr. 68.
---------------------------------------------------------------------------
\8\ Later that day, Investigators went to Respondent's residence
and sought consent to search his house. Tr. 69. Respondent and his
wife declined to provide consent. Id.
---------------------------------------------------------------------------
The Investigators did, however, interview four of Respondent's
employees and a patient who was present. A.N. had been a medical
assistant at CMC since 1992; her duties involved taking patients to the
examination room. Id. at 86-87. A.N. told the Investigators that R.K.
inventoried the drugs when they arrived at CMC and also maintained the
dispensing log. Id. at 89-91. She also stated that the dispensings to
patients were noted in the patient records and identified the
handwriting in the dispensing log as R.K's. Id. at 89, 91-92.
K.G. had been a medical assistant at CMC for seven months; her
duties included taking patients' blood pressure, drawing blood, and
performing other tests. Id. at 92-93. K.G. stated that both R.K and
Respondent ordered the drugs for CMC. Id. at 94. K.G. further stated
that R.K. usually accepted deliveries of drug orders; however,
sometimes K.G. would accept delivery of drug orders and she ``would
leave them unopened for R.K. to handle.'' Id. at 93. K.G. commented
that she saw only R.K. write in the dispensing log. Id. at 95.
L.Y. had been hired as medical assistant in November 2005; her
responsibilities included the scheduling of appointments and flu shots.
Id. at 95-96. According to L.Y., the clinic saw twenty to twenty-five
patients per day. Id. at 97. L.Y. also stated that both Respondent and
R.K. handled the drugs once they had arrived. Id. at 96. When shown the
dispensing log, L.Y. identified handwriting belonging to both
Respondent and R.K.; she also stated that Respondent's wife primarily
prescribed drugs, while Respondent typically dispensed them. Id. at 97.
S.B. had worked at CMC for three years and did patient billing. Id.
at 98. S.B. stated that R.K. would order the drugs and that Sameer Dang
(Respondent's son) would check the deliveries. Id. at 98-99. She also
stated that R.K. handled the dispensing log. Id. at 100.
S.B. further stated that CMC had approximately twenty-five patients
per day, of which fifteen saw Respondent and ten saw his wife. Id.
According to S.B., both Sameer Dang and R.K. paid for the drugs.\9\ Id.
She also said that both Respondent and R.K. had access to the
controlled substances received at the CMC office. Id. at 103.
---------------------------------------------------------------------------
\9\ S.B. also told Investigators that Respondent had changed the
clinic's procedures and now required R.K. to get his approval before
she dispensed any drugs. Tr. 101-02.
---------------------------------------------------------------------------
As found above, on March 16, 2006, DEA Investigators also executed
a search warrant at R.K.'s residence. Id. at 70. R.K. was present
during the search and was interviewed during which she provided ``the
same information'' as she had two months earlier. Id. at 71. R.K.
stated that since January 17, 2006, she had stopped using her personal
credit card to order the drugs and only dispensed drugs in the presence
of a physician. Id. at 72. R.K. also stated that all of the clinic's
drug orders were approved by Respondent. Id. Finally, R.K. stated that
Respondent was the clinic's ``primary dispenser'' of the drugs. Id.
In April 2006, the GS interviewed Dr. B., one of the physicians
listed as being part of Respondent's clinic. Id. at 76. Dr. B. stated
that he had worked at CMC for about five years on a part-time basis.
Id. Dr. B., who also worked at a psychiatric facility for the local
county government, saw some of these patients at Respondent's clinic.
Id. at 77-78.
Dr. B. stated that he rarely prescribed controlled substances to
his patients, and that when he did, he did not dispense drugs. Id. at
78. He also stated that the patient load at CMC did not justify the
quantities of controlled substances that were being purchased by the
clinic. Id. at 79.
In May 2006, a Diversion Investigator (DI) interviewed one of
Respondent's patients, A.A., who said that she saw him for knee pain
and ``asthmatic issues.'' Tr. 81. A.A. had worked for twelve years as a
patient care representative in ``a couple hospitals''; at one, she was
the Quality Care Coordinator with ``duties related to medical,
financial counseling and medical billing.'' Id. at 81-82.
A.A. stated that on several occasions during her visits to
Respondent's clinic, she observed R.K. take persons ``into a back
room'' and that ``several minutes later,'' these persons ``would come
out with bags in their hands.'' Id. at 83. A.A. stated that she did not
believe these persons had seen Respondent. Id. A.A. further stated (and
wrote a letter to DEA to the same effect) that she had told Respondent
that R.K. ``was * * * dispensing drugs in some form or fashion, or
selling medications without'' the patients ``seeing the doctor.'' Id.
The Government also submitted into evidence a portion of a Report
of Investigation relating an interview of another of Respondent's
patients, B.R. Tr. 167; see also GX 17. According to the Report, B.R.
told Investigators that she had been Respondent's patient since 2001
and had been treated for leg pain. GX 17, at 1. B.R. stated that
Respondent ``did not examine her thoroughly and did not request any
tests,'' yet he dispensed Vicodin to her. Id. B.R. further stated that
she had started seeing another physician who examined her thoroughly
and ordered an MRI and X-ray. Id. B.R.'s new doctor concluded that her
back was the cause of her leg pain and that she was over-medicated; he
referred her to a pain clinic. Id.
B.R. further said that she was buying bottles of 100 tablets of
Vicodin 7.5 mg every two weeks for $20 per bottle and that Respondent
had instructed her to take the Vicodin as needed with no further
instructions. Id. Both R.K. and Respondent had given Vicodin to her,
and on occasion she would simply telephone R.K. for a refill and
receive it from her without seeing Respondent. Id. at 2.
However, the report of B.R.'s interview contains no evidence
suggesting that she was not a legitimate patient. Moreover, the
Government did not introduce B.R.'s patient record into evidence and
offered no evidence (beyond the conclusory assertion that his exam was
not thorough) regarding the scope of the physical examination
Respondent performed on her. Nor did it offer any evidence from an
Expert (whether through testimony or a report) establishing that
Respondent failed to perform a medically appropriate prior examination
and lacked a medical indication when he prescribed Vicodin to B.R.
Using the records seized during the search of Respondent's clinic
and its patient files (which were subsequently obtained with
Respondent's consent), ARCOS data, and information provided by several
of the distributors,\10\ the GS conducted an audit of the hydrocodone
ordered under both Respondent's and his wife's registrations between
January 1, 2005 and March 16, 2006. Tr. 59-60, 67; GX 15. Because the
Dangs did not maintain records of their inventory (notwithstanding
Federal law requiring them to do so, see 21 U.S.C. 827(a) & (b)), the
GS chose January 1, 2005 as the starting date and assumed that no
[[Page 51421]]
controlled substances were then on hand; for the closing inventory, the
GS used the inventory taken (48,000 tablets) when the search warrant
was issued.\11\ Tr. 59-60; GX 15. To this latter figure, the DI added
the hydrocodone that was seized during the January 17, 2006 traffic
stop of R.K. (31,000 tablets) and the 1,400 tablets found during the
search of R.K.'s residence which occurred later that day.\12\
---------------------------------------------------------------------------
\10\ Moore Medical provided DEA with records of its hydrocodone
sales under Respondent's registration from late 2005 to early 2006.
Tr. 25; GX 5. ANDA provided DEA with a spreadsheet listing all sales
under the registrations of Respondent and his wife from May 2000
through mid-October 2005. Tr. 30; GX 8. DEA also acquired sales
records and a sales summary from ParMed which show Respondent's
purchases of controlled substances between November 28, 2005 and
January 4, 2006. GX 9.
\11\ The practical effect of assigning a zero starting inventory
is to reduce the size of any shortage.
\12\ According to the computation chart prepared by the GS, he
used 1200 tablets as the amount seized during the search of R.K.'s
residence. GX 15, at 1. As the ALJ noted, given that the audit found
that nearly four million tablets could not be accounted for, the
error is inconsequential. ALJ at 13 n.5.
---------------------------------------------------------------------------
Using both the ARCOS data and distributor invoices, the GS
determined that 4,037,900 tablets of hydrocodone had been ordered
during the audit period.\13\ Tr. 61; GX 15. The clinic's dispensing
logs, which did not identify which doctor had authorized the various
dispensings, see GX 14, showed that only 12,000 tablets had been
dispensed; \14\ in addition, the GS reviewed the clinic's patient files
and determined that another 75,000 tablets had been dispensed.\15\ Tr.
61-63, 119, 129; GXs 12, 15. Accordingly, the Dangs could only account
for approximately 167,000 tablets of hydrocodone.\16\ Tr. 64-65, 119;
GX 15. Thus, Respondent (and his wife) could not account for
approximately 3,870,500 tablets.\17\ Tr. 66, 119; GX 15.
---------------------------------------------------------------------------
\13\ Respondent does not contend that the GS double-counted any
of the orders that were used in calculating this figure.
\14\ The dispensing logs also did not contain the name of the
dispensing physician, the initials of the person dispensing the
drugs, and the patient's address as required by 21 CFR 1304.22(c).
Tr. 58, 147; see also GX 14. Moreover, while there were some
dispensing logs from 2003, the remaining logs only covered the
period from February 28 through March 15, 2006. Tr. 57; see also GX
14.
\15\ The GS credited CMC with dispensing 87,000 tablets of
hydrocodone as he could not determine whether the dispensings
recorded in the dispensing logs overlapped with those noted in the
patient files. Tr. 129-30.
\16\ Neither Respondent nor his wife had reported to DEA any
thefts, losses, or destructions of controlled substances. Tr. 65.
\17\ According to the GS, the street value of a hydrocodone
tablet is between three to five dollars, Tr. 132, and that the value
of the drugs, which Respondent could not account for, would be about
$15 to 20 million. Id. at 133. The GS also acknowledged that
although the Government had seized various accounts controlled by
R.K., Respondent and his wife, he found no evidence of bank deposits
approaching this amount; nor did he find evidence of extravagant
purchases. Tr. 134-35.
---------------------------------------------------------------------------
Among the documents the Government entered into evidence is a
November 7, 2005 letter from Respondent to J.N., a compliance
coordinator at Henry Schein. GX 6, at 20. Therein, Respondent wrote
that he was the Medical Director of ``a multiple specialty medical
group,'' comprised of five physicians including himself, his wife, the
aforementioned Dr. B., as well as Drs. H.L. and D.S. Id. Respondent
further wrote that the clinic had ``introduced a program of dispensing
some medications to our patients'' for their ``convenience * * * and to
help them save some money.'' Id. Respondent also wrote that his clinic
``provide[s] physical therapy and pain management to our patients,''
that it ``dispense[d] medications to our patients only,'' and that the
``practice has been growing.'' Id.
The Government also entered into evidence a credit application
submitted on behalf of CMC to ParMed. GX 9, at 4. The application,
which is dated November 21, 2005, lists Respondent as the person making
the application; his name is printed in the signature block (which is
signed), and the application also contains the name of a ParMed Sales
Representative.\18\ See id.
---------------------------------------------------------------------------
\18\ The application also lists R.K. as the ``accounts payable
contact.'' GX 9, at 4.
---------------------------------------------------------------------------
The Government further entered into evidence reports prepared by
ParMed on January 5, 2006, which list ParMed's controlled substance
distributions to Respondent and his wife. See id. at 1-2. The report
for Respondent's wife bears a handwritten note, which according to the
GS, was written by D.L., an employee of ParMed's regulatory affairs
section. Tr. 34-35. The note read: ``pain management--group of Dr's--
about 30 Dr's in this medical group & she purchases for all Dr's (as
per sales rep).'' GX 9, at 2. The note then listed the names and
registration numbers of Respondent and his wife and stated: ``Both new
accounts from 11-05.''\19\ Id.
---------------------------------------------------------------------------
\19\ The GS testified that on or about January 6, 2006, he had
spoken with D.L., who told him that R.K. was the contact person for
Respondent and his wife, and that R.K. had represented to ParMed
that the reason for the quantities of controlled substances that
were being ordered was that there were thirty doctors at the clinic.
Tr. 36-37.
---------------------------------------------------------------------------
Respondent did not testify in the proceeding and offered only one
exhibit, a letter from R.K.'s attorney stating that she would invoke
her Fifth Amendment privilege if called to testify. RX1.
Discussion
Section 304(a) of the Controlled Substances Act (CSA) provides that
``[a] registration pursuant to section 823 of this title to * * *
dispense a controlled substance * * * may be suspended or revoked by
the Attorney General upon a finding that the registrant * * * has
committed such acts as would render his registration under section 823
of this title inconsistent with the public interest as determined under
such section.'' 21 U.S.C. 824(a)(4). In making the public interest
determination in the case of a practitioner, Congress directed that the
following factors be considered:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f).
``[T]hese factors are considered in the disjunctive.'' Robert A.
Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a
combination of factors and may give each factor the weight I deem
appropriate in determining whether to revoke an existing registration
or to deny an application. Id. Moreover, I am ``not required to make
findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482
(6th Cir. 2005) (citing Morall v. DEA, 412 F.3d 165, 173-74 (DC Cir.
2005)).
With respect to a practitioner's registration, the Government bears
the burden of proving by a preponderance of the evidence that the
continuation of a registration would be inconsistent with the public
interest. 21 CFR 1301.44(d). However, where the Government satisfies
its prima facie burden, as for example, by showing that a registrant
has committed acts which are inconsistent with the public interest, the
burden then shifts to the registrant to demonstrate why he can be
entrusted with a registration. Medicine Shoppe-Jonesboro, 73 FR 363,
380 (2008).
In this matter, having considered the entire record and all of the
statutory factors, I reject the ALJ's finding that Respondent violated
Federal and State law when he prescribed Vicodin to B.R. However, I
agree with the ALJ's conclusions that the Government's evidence under
factors two, four, and five makes out a prima facie case that
Respondent has committed acts which render his registration
inconsistent with the public interest.\20\ ALJ at 26, 30. I
[[Page 51422]]
further agree with the ALJ's conclusion that Respondent has not
accepted responsibility for his misconduct and that he has not rebutted
the Government's prima facie case.
---------------------------------------------------------------------------
\20\ I acknowledge that Respondent holds a valid medical license
from the State of California. Moreover, the State Board has not
taken action against him nor made any recommendation in this matter
(factor one). ALJ Ex. 3, at 3.
Be that as it may, in enacting the CSA, Congress vested this
Agency with ``a separate oversight responsibility [apart from that
which exists in state authorities] with respect to the handling of
controlled substances.'' Mortimer B. Levin, 55 FR 8209, 8210 (1990).
DEA has therefore long recognized that it has ``a statutory
obligation to make its independent determination as to whether the
granting of [a registration] would be in the public interest.'' Id.
Accordingly, ``a State's failure to take action against a
registrant's medical license is not dispositive in determining
whether the continuation of a registration is in the public
interest.'' Jayam Krishna-Iyer, 74 FR 459, 461 (2009); see also
Levin, 55 FR at 8210 (holding that practitioner's reinstatement by
state board ``is not dispositive'' in public interest inquiry).
Thus, that the Medical Board of California has taken no action with
respect to Respondent's medical license is not dispositive in
determining whether his continued registration is consistent with
the public interest.
There is also no evidence that Respondent has been convicted of
an offense related to the manufacture, distribution, or dispensing
of controlled substances under either Federal or state law (factor
three). ALJ Ex. 3. However, while a history of criminal convictions
for offenses involving the distribution or dispensing of controlled
substances is a highly relevant consideration, there are any number
of reasons why a registrant may not have been convicted of (or even
prosecuted for) such an offense, and thus, the absence of such a
conviction is of considerably less consequence in the public
interest inquiry. Krishna-Iyer, 74 FR at 461; Edmund Chein, 72 FR
6580, 6593 n.22 (2007). Accordingly, that Respondent has not been
convicted of an offense related to the distribution or dispensing of
controlled substances is not dispositive of whether the continuation
of his registration is consistent with the public interest.
---------------------------------------------------------------------------
Factors Two, Four, and Five--Respondent's Experience in Dispensing
Controlled Substances, Compliance With Applicable Laws Related to
Controlled Substances, and Other Conduct Which May Threaten Public
Health and Safety
The Government's case implicates each of these factors. As found
above, during an approximately fifteen month period, more than four
million tablets of highly abused combination drugs containing
hydrocodone, a schedule III controlled substance, were purchased by
R.K., Respondent's office manager, using his and his wife's DEA
registrations. When DEA Investigators audited Respondent's handling of
hydrocodone, they could account for only 167,000 tablets, leaving
nearly 3.9 million tablets unaccounted for.\21\ In addition, law
enforcement authorities found that R.K. had large quantities of
hydrocodone in her possession during both a traffic stop and a search
of her residence; Investigators also found a large quantity of cash in
R.K.'s home.
---------------------------------------------------------------------------
\21\ During 2005 alone, approximately 1.35 million dosage units
were ordered under Respondent's registration. Thus, Respondent could
not account for at least 1.1 million tablets.
---------------------------------------------------------------------------
At a minimum, the evidence clearly shows that Respondent violated
the CSA's various recordkeeping provisions. Under Federal law, as soon
as Respondent ``first engage[d] in the * * * distribution or dispensing
of controlled substances, and every second year thereafter,'' he was
required ``to make a complete and accurate record of all stocks thereof
on hand.'' 21 U.S.C. 827(a)(1) (emphasis added); see also 21 CFR
1304.03(a)-(b), 1304.04(a) & (g), 1304.11. As found above, during the
audit, Respondent could not produce an inventory record for any of the
controlled substances that were purchased under his registration.
Under Federal law, Respondent was also required to ``maintain, on a
current basis, a complete and accurate record of each such substance *
* * received, sold, delivered, or otherwise disposed of by him.'' 21
U.S.C. 827(a)(3) (emphasis added). With respect to a practitioner who
engages in dispensing, DEA regulations require that the record include
``the number of units or volume of such finished form dispensed, * * *
the name and address of the person to whom it was dispensed, the date
of dispensing, the number of units or volume dispensed and the written
or typewritten name or initials of the individual who dispensed * * *
the substance on behalf of the dispenser.'' 21 CFR 1304.22(c); see also
id.; 21 CFR 1304.03(a)-(b), 1304.04(a) & (g), 1304.21, 1304.22(c).
However, as found above, while Respondent had purchased large
quantities of controlled substances throughout 2004 and 2005, he had no
dispensing logs for these years and his 2006 logs covered only from
February 28 through March 15. Moreover, the logs that were maintained
lacked required information such as the name of the dispensing doctor,
the initials/name of the person doing the dispensing, and the address
of the patient. GX 14.
Recordkeeping is one of the central features of the CSA's closed
system of distribution. See Paul H. Volkman, 73 FR 30630, 30644 (2008),
pet. for rev. denied 567 F.3d 215, 224 (6th Cir. 2009). As I have
previously explained, ``a registrant's accurate and diligent adherence
to this obligation is absolutely essential to protect against the
diversion of controlled substances.'' Id. Given that millions of dosage
units of a highly abused controlled substance that were ordered under
Respondent's registration cannot be accounted for, his failure to
comply with the CSA's recordkeeping requirements is egregious. This
finding provides reason alone to conclude (with respect to factors two
and four) that his continued registration ``is inconsistent with the
public interest.'' 21 U.S.C. 823(f); see also Volkman, 73 FR at 30644
(holding that recordkeeping violations alone supported denial of
practitioner's application).
While in his brief, Respondent, who did not testify, acknowledges
that ``he failed * * * to maintain complete records reflecting his
dispensing of controlled substances,'' Resp. Br. at 6, he argues that
R.K. ``ordered, received and paid for'' the drugs, and that she
``distributed or sold the drugs outside [of] the CMC practice.'' Id. at
5. Respondent's brief implies that he was unaware of R.K.'s illegal
activities, and his brief is otherwise silent on the issue of whether
he bears any responsibility for the missing drugs. See generally id. He
does.
DEA has long held that a registrant is strictly liable for the
misuse of his registration by a person to whom he entrusts his
registration. See Anthony L. Capelli, 59 FR 42288 (1994); see also
Harrell E. Robinson, 74 FR 61376, 61377 (2009); Paul H. Volkman, 73 FR
30630, 30644 n.42 (2008); Rosemary Jacinta Lewis, 72 FR 4035, 4041
(2007) (citing Capelli); Leonard Merkow, 60 FR 22075, 22076 (1995). The
record clearly supports the conclusion that Respondent entrusted his
registration to R.K.
Moreover, several documents in evidence support the conclusion that
Respondent was clearly aware that controlled substances were being
ordered under his registration. These include Respondent's November
2005 letter to Schein declaring that he had ``decided to order
medications through your company,'' GX 7, and the credit application he
submitted to ParMed. GX 9, at 4.
The evidence also supports the inference that Respondent authorized
R.K. to use his registration to order controlled substances. Several
clinic employees told Investigators that R.K. would order the drugs.
See, e.g., Tr. 94. Moreover, several invoices prepared by Schein, both
before and after Respondent's November 2005 letter, include the
notation: ``Roni, Thank you for your order,'' GX 6, at 9, 14-15, 18;
and on the ParMed credit application, Respondent listed R.K. as his
accounts payable contact. GX 9, at 4. Finally, R.K. stated in her
January 2006 interview that, while she paid for the drugs with her
personal credit card, Respondent reimbursed her with cash. Tr. 94.
Thus, it is clear that Respondent authorized R.K. to order
controlled substances using his registration. And even if it were the
case that Respondent was unaware of R.K.'s illegal activities (although
it is not), he is still strictly liable for her misuse of his
registration and his failure to properly monitor how
[[Page 51423]]
his registration was being used. See Jacinta Lewis, 72 FR at 4041-42;
Robinson, 74 FR at 61377; Volkman, 73 FR at 30644 n.42; Capelli, 59 FR
at 49288.
As for Respondent's implicit suggestion that he lacked knowledge of
R.K.'s activities, the evidence is to the contrary. See Resp. Br. at 5.
Most significantly, as demonstrated by the letter Respondent sent
seeking the return of the hydrocodone seized during the traffic stop of
R.K., he knew that she had removed 31,000 tablets from his clinic. GX
12. Yet even after this, Respondent continued to employ R.K. (indeed,
the evidence shows that she was still employed by him as of the date of
the hearing) and R.K. continued to order controlled substances. See GX
6, at 5 (Schein invoice dated March 13, 2006 for hydrocodone and
temazepam and stating: ``RONI, Thank You For Your Order''); Tr. 72.
This begs the question--which is unanswered because Respondent did not
testify--as to what he thought R.K. planned to do with the drugs she
had in her possession when she was stopped by the CHP.\22\
---------------------------------------------------------------------------
\22\ The GS also related that a patient (A.A.) had told
Respondent that she believed that R.K. was selling drugs to patients
who did not see him. Tr. 83.
---------------------------------------------------------------------------
It is well established that the Agency may draw an adverse
inference from a respondent's failure ``to testify in response to
probative evidence offered against'' him. Baxter v. Palmigiano, 425
U.S. 308, 318 (1976); see also United States v. Solano-Godines, 120
F.3d 957, 962 (9th Cir. 1997) (``In civil proceedings * * * the Fifth
Amendment does not forbid fact finders from drawing adverse inferences
against a party who refuses to testify.''); Dewey C. MacKay, 75 FR
49956, 49977 (2010). It is appropriate to draw an adverse inference
here, where the Government produced evidence showing that Respondent
authorized R.K. to use his registration to obtain massive quantities of
controlled substances, of which only a small fraction can be accounted
for, and Respondent failed to testify and respond to this evidence.
I thus conclude that Respondent knew that R.K. was engaging in
illegal activity and did nothing to prevent it. Respondent's misconduct
clearly threatened public health and safety, 21 U.S.C. 823(f)(5), and
is especially egregious given that nearly four million dosage units of
hydrocodone cannot be accounted for and were likely diverted.\23\ These
findings provide further reason to conclude that Respondent's
registration is ``inconsistent with the public interest.'' \24\ 21
U.S.C. 823(f); 824(a)(4).
---------------------------------------------------------------------------
\23\ Respondent elicited testimony from the G.S. that when the
Government seized the accounts and/or cash of R.K., Respondent, and
his wife, it did not find a money trail consistent with the
potential sales value in the illicit market of the unaccounted for
hydrocodone. However, Respondent offered no evidence challenging the
results of the audit. Nor has he offered any explanation as to the
disposition of the unaccounted for drugs. The audit results alone
provide enough evidence to support the conclusion that the drugs
were diverted; the Government is not obligated to show that it found
a money trail consistent with the potential sales value of the drugs
in the illicit market.
\24\ The ALJ further found that Respondent ``prescribed
controlled substances without establishing a bona-fide doctor-
patient relationship'' with B.R. ALJ at 24-25 (citing Cal. Bus. &
Prof. Code Sec. 2242(a)). The ALJ apparently based her conclusion
on B.R.'s statement that Respondent ``did not examine her thoroughly
and did not request any tests.'' GX 17, at 1.
The evidence suggests, however, that B.R. had a legitimate
medical complaint, and there is absolutely no evidence (such as
B.R.'s medical record) other than the conclusory assertion set forth
above as to the scope of the examination Respondent performed.
Finally, there is no evidence as to the scope of the medical
examination necessary to properly diagnose and treat B.R.'s
condition. I therefore conclude that the ALJ's finding is not
supported by substantial evidence.
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Sanction
Under Agency precedent, where the Government has made out a prima
facie case that a registrant has committed acts which render his
``registration inconsistent with the public interest,'' he must
```present[] sufficient mitigating evidence to assure the Administrator
that [he] can be entrusted with the responsibility carried by such a
registration.''' Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting
Leo R. Miller, 53 FR 21931, 21932 (1988)). ``Moreover, because `past
performance is the best predictor of future performance,' ALRA Labs.,
Inc. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), this Agency has
repeatedly held that where a registrant has committed acts inconsistent
with the public interest, the registrant must accept responsibility for
his actions and demonstrate that [he] will not engage in future
misconduct.'' Medicine Shoppe-Jonesborough, 73 FR at 387.
As noted above, Respondent failed to testify in this proceeding.
While in his brief, he now acknowledges that he violated Federal law
and DEA regulations by failing to maintain proper records, notably, he
does not acknowledge his misconduct in failing to properly monitor how
R.K. was using his registration.\25\ I thus conclude that Respondent
has not accepted responsibility for his misconduct and has not rebutted
the Government's prima facie case.\26\
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\25\ Because Respondent has not addressed his misconduct in
failing to prevent the misuse of his registration, I need not decide
whether the assertion in his brief that he ``recognizes that he
failed * * * to maintain complete records,'' Resp. Br. at 6,
satisfies the Agency's rule requiring that he accept responsibility
for his misconduct. Respondent offered no evidence to support this
assertion, and statements of counsel in a brief are not evidence.
See INS v. Phinpathya, 464 U.S. 183, 186 n.6 (1984).
\26\ While the ALJ concluded that ``Respondent has not admitted
any fault'' and that he was ``either intentionally engaged in
diversion or * * * at least facilitating such diversion on the part
of his employee,'' she nonetheless concluded that ``the inquiry does
not end here'' and proceeded to analyze what she deemed to be
favorable facts. ALJ at 30 (citing Martha Hernandez, 62 FR 61,145,
147 (1997)).
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Given the grievous nature of Respondent's misconduct and his
failure to accept responsibility, none of the ``favorable facts'' cited
by the ALJ provide any reason to impose a sanction less than
revocation. While the record may contain no other evidence of
misconduct on Respondent's part, ALJ at 31, as I have previously
explained, the fact that a practitioner can point to even an extensive
body of compliance with the CSA does not negate a prima facie showing
that he has committed acts inconsistent with the public interest.\27\
Jayam Krishna-Iyer, 74 FR 459, 463 (2009). While such evidence is
entitled to some weight in assessing whether a practitioner has
credibly shown that he has reformed his practices, where, as here, a
practitioner commits egregious acts (whether intentional or not) that
have likely resulted in diversion, and fails to accept responsibility
for his actions, ``such evidence is entitled to no weight.'' Id.
Indeed, that there is no other evidence of misconduct on his part does
nothing to mitigate the harm Respondent has caused to public health and
safety. Finally, given Respondent's failure to accept responsibility,
and the nature of his misconduct, I conclude that it would be
inconsistent with the public interest to grant him even a restricted
registration. Accordingly, I will order that Respondent's registration
be revoked and that any pending application be denied.
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\27\ To similar effect, the ALJ found that Respondent ``warned
at least one patient about the dangers surrounding narcotics.'' ALJ
at 31. As explained in Krishna-Iyer, this finding is too
insubstantial to warrant any further discussion. 74 FR at 463.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as by 28 CFR 0.100(b), I hereby order that DEA
Certificate of Registration, AD6122143, issued to Surinder Singh Dang,
M.D., be, and it hereby is, revoked. I further order that any pending
application of Surinder Singh
[[Page 51424]]
Dang, M.D., to renew or modify his registration be, and it hereby is,
denied. This Order is effective September 19, 2011.
Dated: August 5, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-21062 Filed 8-17-11; 8:45 am]
BILLING CODE 4410-09-P