Satinder Dang, M.D.; Revocation of Registration, 51424-51430 [2011-21065]
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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]
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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
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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
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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
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office manager of the clinic where she
practiced with her husband] to
unlawfully distribute the drugs,
[Respondent] would still be liable for
the acts [R.K.] committed while being
allowed to use [her] registration.’’ Id.
(citations omitted).
The ALJ further found incredible
Respondent’s testimony that ‘‘she was
unaware of [R.K’s] actions.’’ Id. Noting
Respondent’s ‘‘admitted lack of
supervision’’ over R.K.—including that
Respondent would ‘‘tell [R.K.] which
drug she wanted to dispense,’’ R.K.
‘‘would retrieve the controlled
substances from the steel cabinet and
update the logbook,’’ and ‘‘only [R.K.]
had a key to the controlled substances
cabinet’’—placed R.K. in a ‘‘position
where she could take advantage of the
lax security’’ of Respondent’s controlled
substances, the ALJ rejected
Respondent’s contention that these were
‘‘minor record-keeping violations’’ and
held that she was ‘‘responsible for
enabling [R.K.’s] acts of unlawful
possession and distribution of the
controlled substances that [R.K.]
obtained under Respondent’s
registration.’’ Id. (citing Harrell E.
Robinson, M.D., 74 FR 61370, 61376–77
(2010)). The ALJ also found that
Respondent is ‘‘still engaged in an
ongoing working relationship with
[R.K.],’’ id. at 32, and held that ‘‘[a]
practitioner’s failure to properly
supervise patients or staff to prevent
them from personally abusing
controlled substances or selling them to
others constitutes conduct ‘inconsistent
with the public interest’ and can
support * * * the revocation of an
existing registration.’’ Id. at 33 (citing
Jeri Hassman, M.D., 75 FR 8194, 8227
(2010); Gonzales v. Oregon, 546 U.S.
243, 274 (2006)).
Noting that Respondent blamed her
husband and R.K. for her misconduct,
the ALJ further found that
‘‘Respondent’s acceptance of
responsibility has been minimal’’ and
‘‘weighs heavily against her continuing
registration.’’ Id. at 35. The ALJ further
held that Respondent’s ‘‘lack of
cooperation with the DEA investigation
nominally weighs against her continued
registration.’’ Id. at 36–37.
The ALJ also found that ‘‘the fact that
[Respondent] still works alongside
[R.K.] is an aggravating factor.’’ Id. at 35.
While noting Respondent had offered to
file quarterly reports of her
prescriptions with the Agency, the ALJ
found that ‘‘Respondent’s careless use of
her DEA Certificate of Registration
coupled with her lack of assurances that
she will no longer enable others such as
[R.K.] and her husband to abuse her
controlled substances registration
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weighs heavily against her continuing
registration.’’ Id. at 37. The ALJ
therefore recommended that
‘‘Respondent’s DEA Certificate of
Registration be revoked.’’ Id. at 38.
On August 9, 2010, Respondent filed
Exceptions to the ALJ’s Decision, and on
August 18, the ALJ forwarded the record
to me for Final Agency Action. On
September 10, 2010, the Government
filed a motion with my Office to accept
its response to Respondent’s Exceptions.
In its motion, the Government stated
that Respondent’s counsel had
consented to its filing. Accordingly, by
this Order I grant the Government’s
motion.
Having considered the entire record, I
adopt the ALJ 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,’’ ALJ at 38, and her
recommendation that her registration be
revoked. As ultimate factfinder, I make
the following findings:
Findings
Respondent is the holder of DEA
Certificate of Registration, AD9234446,
which authorizes her 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, 2007, id., on June 4,
2007, Respondent filed an application to
renew her registration. GX 2.
Accordingly, her 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 medical
license issued by the Medical Board of
California. Moreover, the Board has not
taken any formal action to limit her
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 Surinder
Dang, M.D.1 He and Respondent
practice medicine at Complete Medical
Care, Inc. (‘‘CMC’’). Tr. 188–189; GX 6,
at 20. Their son, Sameer Dang, also
works in the CMC office. Tr. 58, 188. At
all relevant times (including through the
date of the hearing), CMC’s office
1 Dr. Surinder Dang holds DEA Certificate of
Registration AD6122143; he is registered at the
same address as Respondent. ALJ Ex. 3, at 2, GX
2 at 2.
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manager was Ms. Rani K. (R.K.).2 Id. at
190–91, 194–95, 203–04.
In November 2005, a Diversion Group
Supervisor (GS) in DEA’s Riverside
Diversion Group reviewed ARCOS 3
records which showed that large
amounts of controlled substances,
including hydrocodone,4 were being
ordered under the DEA registration
numbers of both Respondent and her
husband.5 Tr. 30–32; GXs 3 & 4. 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 the
GS with copies of various documents,
including sales records, invoices,
statements of account, delivery
information, applications for credit, and
correspondence. See generally GX 5
(records from Moore Medical, L.L.C.),6
GX 6 (record from Henry Schein, Inc.),
GX 9 (records from ParMed
Pharmaceuticals, Inc.).
The majority of the controlled
substances ordered under Respondent’s
DEA registration were obtained from
Anda Pharmaceuticals. GX 3; Tr. 130,
139. The GS obtained purchase records
from Anda showing hydrocodone and
other controlled substances purchases
by both Respondent and her husband
between 2000 and 2005. GX 8; Tr. 47–
49. However, there is no evidence that
Respondent ever personally ordered
these controlled substances. Tr. 140.
CMC also ordered controlled
substances, primarily hydrocodone,
from another drug distributor, Henry
Schein, Inc. GX 6; Tr. 44. The Schein
records show that the orders were
placed under Respondent’s husband’s
name, but a number of the invoices note
Respondent’s name as well as her
husband’s. GX 6, at 8–9, 11, 14–15, 17–
18, 29. R.K.’s name was also listed as
2 In various documents R.K.’s first name was
spelled as both Rani and Roni. Compare GX 5, at
7, with GX 6, at 1, 5, 9, 14–15, 18, 29; see also GX
10 at 1.
3 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.
33.
4 As a combination product, hydrocodone is a
schedule III controlled substance. 21 CFR
1308.13(e)(1)(iv).
5 The ARCOS system reports the registration
number used, but not necessarily the person who
actually ordered the drugs. Tr. 114–16.
6 Moore Medical Supply reported to DEA that
CMC ordered excessive amounts of hydrocodone.
Tr. 32–34; GX 5. The order to Moore was placed
under Respondent’s husband’s DEA registration and
R.K.’s name appears on a fax sheet sent to Moore
Medical and related to CMC’s account number. GX
5, at 7; Tr. 131.
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the contact person for the Henry Schein
account. Tr. 132–34.
In a letter dated November 7, 2005,
Respondent’s husband explained to
Henry Schein that CMC would begin
ordering controlled substances so that
CMC’s physicians could dispense
medications directly to CMC’s patients.
GX 7; Tr. 46. This letter listed the CMC
physicians as Surinder Dang, M.D.;
Satinder Dang, M.D.; Robert Belanger,
D.O.; Huey Lin, M.D.; and Davinder
Singh, M.D. GX 7. The letter also stated:
‘‘We dispense medications to our
patients only. Our practice has been
growing.’’ Id. However, none of the
records obtained in the investigation
show that controlled substances were
ordered from Schein under the
registrations of any of the doctors
besides those of Respondent and her
husband. GX 6, at 7; Tr. 176–79.
The DEA registration numbers of both
Respondent and her husband were used
to order controlled substances from
Darby Medical Supply and ParMed
Pharmaceuticals. GX 16; GX 9, 11; Tr.
51, 61–62. The Darby records show that
Respondent ordered hydrocodone
fourteen times. GX 16, at 1, 5, 7, 11. The
ParMed records show that between
December 29, 2005 and January 4, 2006,
88,800 dosage units of hydrocodone
were ordered under Respondent’s
registration. GX 9, at 2. At one point,
D.L., ParMed’s Regulatory Affairs
officer, reported to the GS that CMC’s
orders were ‘‘excessive and suspicious’’;
D.L. also identified R.K. as the point of
contact for the clinic and that R.K. had
opened the CMC accounts. Tr. 51–53.
According to ARCOS records, while
in 2004, Respondent purchased 157,100
dosage units of hydrocodone, in 2005,
she purchased 2,272,800 dosage units.
GX 3, at 2–13. ARCOS data further
showed that in 2005, Respondent and
her husband had ordered a combined
total of 3,626,400 tablets of
hydrocodone. GX 3 at 13; GX 4, at 6; see
also Tr. 93–94 (GS’s testimony that
between January 1, 2005 and March 16,
2006, Respondent and her husband
purchased approximately 4 million
tablets of hydrocodone).7
Throughout the investigations, 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 (Henry Schein and Moore
Medical) that controlled substances
7 The GS stated that he analyzed ARCOS data,
distributors’ sales records, audit inventories, patient
files and dispensing logs when creating GX 15. Tr.
92–97.
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deliveries were to be made that day,
conducted surveillance at the [Dangs’]
clinic from approximately 9:00 a.m.
until 6:00 p.m. Tr. 43, 67–68, 75. During
the surveillance, the GS observed both
deliveries and noted that
‘‘approximately no more than a dozen’’
people entered the clinic that day. Id. at
75.
On January 13, 2006, the GS
conducted a second surveillance from
approximately 9:00 a.m. until 3 p.m. Id.
at 76–77. During the surveillance, the
GS saw R.K. ‘‘tak[ing] boxes from the
office and plac[ing] them in the trunk of
her * * * SUV.’’ Id. at 77.
On January 17, 2006, the GS, who had
received notice of a controlled
substance delivery from another
distributor (ParMed Pharmaceuticals,
Inc.), conducted another full-day
surveillance. Id. at 77–78. Once again,
Investigators observed R.K. ‘‘place
numerous boxes in her vehicle that had
been delivered to the clinic’’ and ‘‘put
them in the back of her * * * SUV.’’ Id.
at 78. The GS observed R.K. drive away
and notified the California Highway
Patrol (CHP). Id. at 78, 80, 147–48. After
observing R.K., who was driving forty
miles per hour, operate her vehicle
within five feet of the vehicle in front
of her, the CHP officer conducted a
traffic stop. Id. at 78; 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; 21
CFR 1308.13(e)(iv). 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 R.K. 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. R.K.
answered that she ran a medical office
and handed him a business card listing
her name 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
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had a locker in which to store the
Vicodin, R.K. answered ‘‘yes,’’ but 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,’’ she 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. at 3. After giving
R.K. a citation, the officer allowed her
to leave. Id.
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 drugs were
transferred to the TFO. Id. The TFO
gave the CHP Officer a receipt which
confirms the figures in the latter’s
report.8 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. 82. 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 83. 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, R.K. admitted that this was the
second time she had done so. Id.
8 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/apap 10/325 mg;
and 10 bottles of 100 count hydrocodone/apap 10/
500 mg. GX 10, at 6.
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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. at 84.
R.K. further said that she used her
personal credit card to purchase drugs
from wholesalers and that Respondent
would reimburse her. Id.
The Investigators then asked R.K. if
she would consent to a search of her
residence; she agreed. Id. According to
the GS, the Investigators found
approximately $69,500 in cash in an
upstairs closet, a ‘‘quantity of
hydrocodone and lorazepam in the
house’’ (2000 lorazepam tablets and
1400 hydrocodone tablets), ‘‘money
order receipts,’’ and receipts of
‘‘payments made to the credit card
companies by [R.K.].’’ Id. To explain the
cash found at her residence, R.K.
claimed the sum was a combination of
money received from the sale of a house
in India and a home-based business she
had previously run. Id. at 85–86.
On February 24, 2006, Respondent’s
husband wrote a letter to CHP
requesting the return of the
hydrocodone which had been seized
during the traffic stop of R.K. Tr. 88–89;
GX 12. The letter asserted that R.K. was
the clinic’s ‘‘office manager,’’ and 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. 90, 104.
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. Tr. at 90, 95. Later
that day, Investigators went to
Respondent’s residence and sought
consent to search her house. Tr. 103.
Respondent declined to provide consent
and refused to talk with Investigators
without an attorney present. Id.
R.K. was present during the search of
her residence and was interviewed. Id.
at 104. R.K. stated that since January 17,
2006, she had stopped purchasing the
drugs on her own, and that the drugs
were being purchased by Respondent’s
husband, Dr. Surinder Dang. Id. at 105.
R.K. stated that Respondent’s husband
was the clinic’s ‘‘primary dispenser’’ of
the drugs and that she ‘‘dispensed drugs
to the patients under the direction of
* * * Dr. Surinder Dang.’’ Id.
On March 16, 2006, the Diversion
Investigator (DI) interviewed several
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CMC employees, including A.N.,9
C.G.,10 L.Y.,11 and S.B.12 In April 2006,
the GS interviewed Dr. B., a physician
who had worked at CMC on a part-time
basis since approximately 2004. Id. 109–
110. Dr. B. also worked at a facility for
the local county government, but he saw
some of his patients at CMC. Id. at 110.
Dr. B. stated that while he worked at
CMC, he rarely, if ever, prescribed or
dispensed controlled substances to his
patients. Id. at 111. 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 114.
Using the records seized during the
search of Respondent’s clinic and its
patient files, ARCOS data, and
information provided by several of the
distributors,13 the GS conducted an
audit of the hydrocodone ordered under
both Respondent’s and her husband’s
registrations between January 1, 2005
and March 16, 2006. Tr. 93–96, 67; GX
15. Because CMC did not maintain
records of their inventory
(notwithstanding Federal law requiring
9 A.N. stated that Respondent, her husband, and
R.K. handled drug deliveries when they came into
CMC. Id. at 238–39. A.N. further stated that both
Respondent and her husband kept records of
dispensed drugs in the patient files and dispensing
logs; she identified the writing in the patient log as
R.K.’s. Id. at 239–40.
10 The transcript notes the coworker’s initials as
C.G.; however, other documents suggest that her
initials are K.G. See Resp. Brief at 8. C.G. stated that
both R.K and Respondent’s husband ordered the
drugs for CMC. Tr. 241, 249–250. R.K. usually
accepted deliveries of drug orders; however,
sometimes C.G. would sign for the delivery but not
open the boxes. Id. at 241–42. C.G. further stated
that she witnessed R.K. writing in the dispensing
log the day before the search warrant was executed
and heard R.K. comment that CMC’s drug
procedures had changed. Id. at 242.
11 According to L.Y., the clinic saw twenty to
twenty-five patients per day. Id. at 244. L.Y. also
stated that R.K. handled the drugs once they
arrived. Id. at 243. When shown the dispensing log,
L.Y. identified the handwriting as belonging to R.K.
Id. at 243–44. She further stated that Respondent
only wrote prescriptions. Id. at 250.
12 S.B. stated that R.K. and Respondent’s husband
handled the drugs that were dispensed directly to
patients and that R.K. handled the drug inventory
and payment for the drugs that were ordered. Id. at
246. S.B. also stated that R.K. handled the
dispensing log. Id. at 247. S.B. further stated that
CMC had approximately twenty-five patients per
day, of whom ten saw Respondent. Id. According
to S.B., both Sameer Dang and R.K. paid for the
drugs. Id. She also stated that R.K. had access to the
controlled substances received at the CMC office.
Id. at 248.
13 Moore Medical provided DEA with sales
records under Respondent’s registration for
hydrocodone from late 2005 to early 2006. Tr. 34,
43; GX 5. ANDA provided DEA with a spreadsheet
listing all sales under the registrations of
Respondent and her husband from May 2000
through mid-October 2005. Tr. 47–49; 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. Tr. 51–52; GX 9.
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51427
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
controlled substances were then on
hand; for the closing inventory, the GS
used the inventory taken (48,000 tablets)
when the search warrant was
executed.14 Tr. 92–93, 95; GX 15. To
this latter figure, the GS added the
hydrocodone that was seized during the
January 17, 2006 traffic stop of R.K.
(31,000 tablets) and the 1,200 tablets15
found during the search of R.K.’s
residence which occurred later that day.
Tr. 95; GX 12, 15.
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. Tr. 94; 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; 16 in addition, the GS
reviewed the clinic’s patient files and
credited another 75,000 tablets as
having been dispensed.17 Tr. 95–96; GX
15. Accordingly, CMC could only
account for approximately 167,000
tablets of hydrocodone.18 Tr. 96–97; GX
15. While the DI combined the
purchases of Respondent and her
husband, the ARCOS data and
distributor invoices did list whose
registration was used to place the
various orders. See, e.g., GXs 3 & 4. This
evidence shows that in 2005 alone,
2,272,800 dosage units of hydrocodone
were ordered under Respondent’s
registration. Accordingly, Respondent
still could not account for more than
two million dosage units.19 GX 3, at 13.
Respondent testified that she had no
knowledge that her ‘‘DEA registration
14 If any controlled substances were in fact on
hand on the starting date of the audit period,
assigning a zero starting inventory would reduce
the size of any shortage.
15 I acknowledge that this figure differs from the
quantity of 1,400 tablets which, according to the
GS’s testimony, was found in R.K.’s house. The
difference, however, is inconsequential given the
result of the audit.
16 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. 90;
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. See GX 14.
17 The GS credited CMC with dispensing a total
of 87,000 hydrocodone tablets; this calculation
counted the prescriptions issued by Respondent or
her husband, because the prescriptions may have
been filled in the office. Tr. 100; GX 15.
18 Neither Respondent nor her husband had
reported to DEA any thefts, losses, or destructions
of controlled substances. Tr. 99–101.
19 This calculation gives Respondent credit for all
of the 167,000 tablets for which the GS could
account.
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number was being used to order large
quantities of hydrocodone that were
being delivered to CMC.’’ Tr. 192. She
asserted that she did not order any
controlled substances between 2002 and
March 16, 2006, and that she did not
order any controlled substances after
that period. Id. at 195–96. Specifically,
she testified that she did not order
Lorazepam in October 2006. Id.
Respondent testified that while
during this time period, she was aware
that her husband was ordering drugs for
his pain management practice, she did
not know how much he was ordering.
Id. at 201. Respondent stated that she
had no knowledge of the controlled
substances being delivered to CMC
during this time period; while she
admitted to having seen boxes being
delivered to the clinic, she claimed to
not know what they contained. Id. 197–
198. Respondent further stated that R.K.
would open the boxes after they were
delivered. Id. at 200.
Respondent further testified that she
was unaware that R.K. had taken drugs
from CMC to her residence until
learning of it through these proceedings;
she also stated that she was not sure if
her husband had instructed R.K.
regarding taking drugs to her residence.
Id. at 204–205. However, the ALJ did
not find credible Respondent’s
testimony that she was unaware of
R.K.’s activities. ALJ at 30.
Regarding the controlled substance
drug storage area, Respondent stated
that she had ‘‘no idea’’ how the drugs
were organized. Tr. 198–99. Respondent
testified that she did not pay attention
to what was in that storage area, but
then stated there was a basic cabinet
that was locked at night and that she did
not have a key. Id. at 200–01. According
to Respondent, the key was either kept
by R.K. or in a place where her husband
could find it; Respondent also did not
know if the storage cabinet was locked
during the day. Id. at 234.
While Respondent testified on direct
examination that she had not dispensed
drugs at CMC, on cross-examination,
she stated ‘‘I don’t recall. I might have
dispensed but I dispensed rarely.’’ Id. at
195. Respondent then admitted
dispensing, stating ‘‘maybe I might have
given [hydrocodone] once or twice to
my patients only.’’ Id. She stated that
other people had ordered these drugs
that she dispensed. Id. at 229. On the
occasions that she did dispense,
Respondent asked R.K. for the drug. Id.
at 230. R.K. would retrieve the
controlled substances from the cabinet
and give them to Respondent to hand to
the patient. Id. In these instances, R.K.
would record the dispensed controlled
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16:04 Aug 17, 2011
Jkt 223001
substances in a ‘‘separate log.’’ Id. at
228.
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
[her] 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 factor, 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 by showing that a registrant has
committed acts which are inconsistent
with the public interest, the burden then
shifts to the applicant to demonstrate
why he can be entrusted with a
registration. Medicine ShoppeJonesboro, 73 FR 364, 380 (2008).
In this matter, having considered the
entire record and all of the factors, I
agree with the ALJ’s conclusions that
the Government’s evidence under
factors two, four, and five makes out a
prima facie that Respondent has
committed acts which render her
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Sfmt 4703
registration inconsistent with the public
interest.20 ALJ at 29. I further agree with
the ALJ’s conclusion that Respondent
has not accepted responsibility for her
misconduct and has thus not rebutted
the Government’s prima facie case.
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 her and her husband’s DEA
registrations, approximately 2.3 million
of which were ordered under her
registration during 2005 alone. When
DEA Investigators audited Respondent’s
and her husband’s handling of the
hydrocodone, they could account for
only 167,000 tablets, leaving
Respondent with over two million
20 I acknowledge that Respondent holds a valid
medical license from the State of California.
Moreover, the State Board has not taken action
against her, nor made any recommendation in this
matter (factor one). ALJ at 27.
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 [continuation] 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 her 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 at 27–28. 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 her
registration is consistent with the public interest.
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tablets unaccounted for. 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
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,’’ she 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. However, as found above,
during the audit, Respondent could not
produce an inventory record for any of
the controlled substances that were
purchased under her 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 [her].’’ 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.
However, as found above, while large
quantities of controlled substances were
purchased under her registration
throughout 2004 and 2005, Respondent
had no dispensing logs for these years
and the 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). ‘‘[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
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16:04 Aug 17, 2011
Jkt 223001
registration cannot be accounted for, her
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 her 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).
In her Exceptions to the ALJ’s
decision, Respondent argues that ‘‘she
had no knowledge that her DEA
Registration was being used by her
husband or [R.K.] to order controlled
substances’’ until DEA executed the
search warrant on March 16, 2006.
However, DEA has long held that a
registrant is strictly liable for the misuse
of her registration by a person to whom
she entrusts her registration. See also
Harrell E. Robinson, 74 FR 61370, 61377
(2009); Paul H. Volkman, 73 FR 30630,
30644 n.42 (2008); Rose Mary Jacinta
Lewis, 72 FR 4035, 4041 (2007) (citing
Anthony L. Capelli, 59 FR 42288
(1994)); Leonard Merkow, 60 FR 22075,
22076 (1995); Capelli, 59 FR at 49288.
The record clearly supports the
conclusion that Respondent entrusted
her registration number to R.K. Thus,
even if it were the case that Respondent
was unaware of R.K.’s illegal activities,
she is still strictly liable for R.K.’s
misuse of her registration and her
failure to properly monitor how her
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.
Contrary to Respondent’s
understanding, the purpose of this
proceeding is to protect the public
interest, and in determining whether a
registrant has committed acts which
render her registration ‘‘inconsistent
with the public interest,’’ 21 U.S.C.
824(a)(4), the standards of mens rea for
imposing criminal liability are not
controlling. Accordingly, the
Government is not required to show that
Respondent had knowledge that her
DEA Registration was being used by her
husband or R.K. to order controlled
substances.
In any event, the ALJ did not find
credible Respondent’s testimony that
she was unaware of R.K.’s activities. ALJ
at 30. I agree. Given the duration and
scope of R.K.’s activities, Respondent’s
denial of knowledge is implausible.
In her Exceptions, Respondent also
argues that the ALJ’s decision ‘‘fails to
distinguish between the drugs ordered
under Respondent’s DEA Registration
and the drugs ordered under her
husband’s.’’ Res. Exc. at 22. This is true.
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51429
However, as ultimate factfinder, I have
reviewed the evidence and found that
the ARCOS data shows that in 2005
alone, more than 2.27 million dosage
units of hydrocodone were ordered
under Respondent’s registration, and
that at most, 167,000 dosage units can
be accounted for. Thus, Respondent is
responsible for more than two million
dosage units that cannot be accounted
for and were likely diverted.
Respondent’s misconduct thus clearly
threatened public health and safety. See
21 U.S.C. § 823(f)(5). Moreover, the
scope of the diversion is egregious. I
therefore conclude that the Government
has satisfied its prima facie burden of
showing that Respondent has
committed acts which render her
registration is ‘‘inconsistent with the
public interest.’’ 21 U.S.C. 824(a)(4);
823(f).
Sanction
Under Agency precedent, where the
Government has made out a prima facie
case that a registrant has committed acts
which render her ‘‘registration
inconsistent with the public interest,’’
she must ‘‘‘present[] sufficient
mitigating evidence to assure the
Administrator that [she] 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
[her] actions and demonstrate that [she]
will not engage in future misconduct.’’
Medicine Shoppe-Jonesborough, 73 FR
at 387.
During her testimony, Respondent
continued to deny that she was
responsible for the unaccounted-for
hydrocodone and blamed her husband
and R.K. Furthermore, the ALJ found
incredible Respondent’s denial that she
had knowledge of R.K.’s illegal
activities. DEA has repeatedly held that
a registrant’s lack of candor is a highly
relevant consideration in determining
the appropriate sanction. See Hoxie v.
DEA, 419 F.3d 477, 483 (6th Cir. 2005);
Robert F. Hunt, 75 FR 49995, 50004
(2010); Rosemary Jacinta Lewis, 72 FR
4035, 4042 (2007). Respondent’s lack of
candor further supports the revocation
of her registration.
Given the scope of the diversion
which likely occurred here and what the
ALJ characterized as Respondent’s
minimal acceptance of responsibility
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(which was limited to the statements of
counsel in a post-hearing brief and
which do not constitute evidence, see
INS v. Phinpathya, 464 U.S. 183, 186
n.6 (1984)), I conclude that none of the
‘‘favorable facts’’ cited by the ALJ
provide any reason to impose a sanction
less than revocation. Jayam KrishnaIyer, 74 FR 459, 463 (2009). Indeed,
none of Respondent’s proposed
remedial measures mitigate the
egregious harm Respondent has caused
to public health and safety.
I therefore conclude that it would be
inconsistent with the public interest to
grant her 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,
AD9234446, issued to Satinder K. Dang,
M.D., be, and it hereby is, revoked. I
further order that any pending
application of Satinder K. Dang, M.D., to
renew or modify her registration be, and
it hereby is, denied. This Order is
effective September 22, 2011.
Dated: August 9, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–21065 Filed 8–17–11; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
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Roots Pharmaceuticals, Inc.;
Revocation of Registration
On September 9, 2010, the Deputy
Assistant Administrator, Office of
Diversion Control, Drug Enforcement
Administration, issued an Order to
Show Cause to Roots Pharmaceuticals,
Inc. (Registrant), of American Fork,
Utah. The Show Cause Order proposed
the revocation of Registrant’s DEA
Certificate of Registration BR9610571,
which authorizes it to dispense
controlled substances as a retail
pharmacy, on the ground that
Registrant’s state pharmacy and
controlled substance licenses had
expired on September 30, 2009, and that
it therefore lacks authority under the
laws of the State in which it is
registered with DEA to dispense
controlled substances. Show Cause
Order at 1 (citing 21 U.S.C. 823(f) and
824(a)(3)). The Show Cause Order also
notified Registrant of its right to request
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16:04 Aug 17, 2011
Jkt 223001
a hearing on the allegations or to submit
a written statement in lieu of a hearing,
the procedures for doing either, and the
consequence for failing to do either. Id.
at 2.
The Government’s initial attempt to
serve Registrant by certified mail was
unsuccessful. Thereafter, as evidenced
by the signed return receipt card, on
January 14, 2011, the Government
accomplished service by mailing the
Show Cause Order to Registrant’s
Registered Agent. On January 11, 2011,
the Government also sent an electronic
version of the Show Cause Order to
Registrant’s Registered Agent at the email address he had previously
provided to the Agency. However, since
the date of service of the Show Cause
Order, no person has requested a
hearing, or submitted a written
statement in lieu of a hearing, on behalf
of Registrant. Because thirty days have
now passed since service of the Show
Cause Order, I find that Registrant has
waived its right to request a hearing or
to submit a written statement in lieu of
a hearing. See 21 CFR 1301.43(a), (c),
and (d). I therefore issue this Decision
and Final Order without a hearing based
on relevant evidence contained in the
record submitted by the Government. Id.
§ 1301.43(e).
Findings
Registrant is the holder of DEA
Certificate of Registration BR9610571,
which authorizes it to dispense
controlled substances in schedules II
through V as a retail pharmacy, at the
registered location of 12 W 100N, Suite
201B, American Fork, Utah. GX A.
Registrant’s registration does not expire
until April 30, 2012. Id.
According to a Pharmacy Licensing
Specialist with the State of Utah,
Department of Commerce, Division of
Occupational and Professional
Licensing, Registrant’s Utah Pharmacy
License and Utah Controlled Substance
Dispensing License expired on
September 30, 2009. GX B. Registrant
did not renew either license. Id.
Discussion
Under the Controlled Substances Act
(CSA), a practitioner must be currently
authorized to handle controlled
substances in the ‘‘jurisdiction in which
[it] practices’’ in order to maintain a
DEA registration. See 21 U.S.C. 802(21)
(‘‘[t]he term ‘practitioner’ means a * * *
pharmacy * * * licensed, registered, or
otherwise permitted, by * * * the
jurisdiction in which [it] practices
* * * to * * * dispense * * * a
controlled substance in the course of
professional practice’’). See also id.
§ 823(f) (The Attorney General shall
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register practitioners * * * to dispense
* * * controlled substances * * * if
the applicant is authorized to dispense
* * * controlled substances under the
laws of the State in which [it]
practices.’’). As these provisions make
plain, possessing authority under state
law to handle controlled substances is
an essential condition for obtaining and
maintaining a DEA registration.
The CSA further authorizes the
Agency to revoke a registration ‘‘upon a
finding that the registrant * * * has had
[its] State license or registration
suspended [or] revoked * * * and is no
longer authorized by State law to engage
in the * * * distribution [or] dispensing
of controlled substances.’’ 21 U.S.C.
824(a)(3). Moreover, because holding
state authority is a statutory requirement
for registration as a practitioner, see 21
U.S.C. 802(21) and 823(f), DEA has held
that revocation is warranted even when
a registrant has merely allowed his state
licenses to expire. James Stephen
Ferguson, 75 FR 49994, 49995 (2010);
Mark L. Beck, 64 FR 40899, 40900
(1999). See also Anne Lazar Thorn, 62
FR 12847, 12848 (1997) (‘‘the
controlling question is not whether a
practitioner’s license to practice
medicine in the state is suspended or
revoked; rather, it is whether the
Respondent is currently authorized to
handle controlled substances’’).
As found above, Registrant allowed its
state pharmacy and controlled
substance licenses to expire, and thus,
it no longer holds authority under Utah
law to dispense controlled substances.
See Utah Code Ann. §§ 58–17b–302(1);
58–37–6(2)(a)(i). Accordingly, Registrant
no longer satisfies the CSA’s
requirement that it be currently
‘‘authorized to dispense controlled
substances’’ under Utah law. 21 U.S.C.
823(f). Accordingly, its DEA registration
will be revoked. Id. § 824(a)(3).
Order
Pursuant to the authority vested in me
by 21 U.S.C. 824(a)(3), as well as 28 CFR
0.100(b), I order that DEA Certificate of
Registration BR9610571, issued to Roots
Pharmaceuticals, Inc., be, and it hereby
is, revoked. I further order that any
pending application of Roots
Pharmaceuticals, Inc., to renew or
modify its registration, be, and it hereby
is, denied. This Order is effective
September 19, 2011.
Dated: August 5, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011–21063 Filed 8–17–11; 8:45 am]
BILLING CODE 4410–09–P
E:\FR\FM\18AUN1.SGM
18AUN1
]]>Agencies
[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51424-51430]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21065]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-4]
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 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 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 m[eacute]lange.'' 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
[[Page 51425]]
office manager of the clinic where she practiced with her husband] to
unlawfully distribute the drugs, [Respondent] would still be liable for
the acts [R.K.] committed while being allowed to use [her]
registration.'' Id. (citations omitted).
The ALJ further found incredible Respondent's testimony that ``she
was unaware of [R.K's] actions.'' Id. Noting Respondent's ``admitted
lack of supervision'' over R.K.--including that Respondent would ``tell
[R.K.] which drug she wanted to dispense,'' R.K. ``would retrieve the
controlled substances from the steel cabinet and update the logbook,''
and ``only [R.K.] had a key to the controlled substances cabinet''--
placed R.K. in a ``position where she could take advantage of the lax
security'' of Respondent's controlled substances, the ALJ rejected
Respondent's contention that these were ``minor record-keeping
violations'' and held that she was ``responsible for enabling [R.K.'s]
acts of unlawful possession and distribution of the controlled
substances that [R.K.] obtained under Respondent's registration.'' Id.
(citing Harrell E. Robinson, M.D., 74 FR 61370, 61376-77 (2010)). The
ALJ also found that Respondent is ``still engaged in an ongoing working
relationship with [R.K.],'' id. at 32, and held that ``[a]
practitioner's failure to properly supervise patients or staff to
prevent them from personally abusing controlled substances or selling
them to others constitutes conduct `inconsistent with the public
interest' and can support * * * the revocation of an existing
registration.'' Id. at 33 (citing Jeri Hassman, M.D., 75 FR 8194, 8227
(2010); Gonzales v. Oregon, 546 U.S. 243, 274 (2006)).
Noting that Respondent blamed her husband and R.K. for her
misconduct, the ALJ further found that ``Respondent's acceptance of
responsibility has been minimal'' and ``weighs heavily against her
continuing registration.'' Id. at 35. The ALJ further held that
Respondent's ``lack of cooperation with the DEA investigation nominally
weighs against her continued registration.'' Id. at 36-37.
The ALJ also found that ``the fact that [Respondent] still works
alongside [R.K.] is an aggravating factor.'' Id. at 35. While noting
Respondent had offered to file quarterly reports of her prescriptions
with the Agency, the ALJ found that ``Respondent's careless use of her
DEA Certificate of Registration coupled with her lack of assurances
that she will no longer enable others such as [R.K.] and her husband to
abuse her controlled substances registration weighs heavily against her
continuing registration.'' Id. at 37. The ALJ therefore recommended
that ``Respondent's DEA Certificate of Registration be revoked.'' Id.
at 38.
On August 9, 2010, Respondent filed Exceptions to the ALJ's
Decision, and on August 18, the ALJ forwarded the record to me for
Final Agency Action. On September 10, 2010, the Government filed a
motion with my Office to accept its response to Respondent's
Exceptions. In its motion, the Government stated that Respondent's
counsel had consented to its filing. Accordingly, by this Order I grant
the Government's motion.
Having considered the entire record, I adopt the ALJ 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,'' ALJ at 38, and her
recommendation that her registration be revoked. As ultimate
factfinder, I make the following findings:
Findings
Respondent is the holder of DEA Certificate of Registration,
AD9234446, which authorizes her 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, 2007, id., on June
4, 2007, Respondent filed an application to renew her registration. GX
2. Accordingly, her 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 medical license issued by the Medical
Board of California. Moreover, the Board has not taken any formal
action to limit her 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 Surinder Dang, M.D.\1\ He and Respondent
practice medicine at Complete Medical Care, Inc. (``CMC''). Tr. 188-
189; GX 6, at 20. Their son, Sameer Dang, also works in the CMC office.
Tr. 58, 188. At all relevant times (including through the date of the
hearing), CMC's office manager was Ms. Rani K. (R.K.).\2\ Id. at 190-
91, 194-95, 203-04.
---------------------------------------------------------------------------
\1\ Dr. Surinder Dang holds DEA Certificate of Registration
AD6122143; he is registered at the same address as Respondent. ALJ
Ex. 3, at 2, GX 2 at 2.
\2\ In various documents R.K.'s first name was spelled as both
Rani and Roni. Compare GX 5, at 7, with GX 6, at 1, 5, 9, 14-15, 18,
29; see also GX 10 at 1.
---------------------------------------------------------------------------
In November 2005, a Diversion Group Supervisor (GS) in DEA's
Riverside Diversion Group reviewed ARCOS \3\ records which showed that
large amounts of controlled substances, including hydrocodone,\4\ were
being ordered under the DEA registration numbers of both Respondent and
her husband.\5\ Tr. 30-32; GXs 3 & 4. 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 the GS with copies
of various documents, including sales records, invoices, statements of
account, delivery information, applications for credit, and
correspondence. See generally GX 5 (records from Moore Medical,
L.L.C.),\6\ GX 6 (record from Henry Schein, Inc.), GX 9 (records from
ParMed Pharmaceuticals, Inc.).
---------------------------------------------------------------------------
\3\ 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. 33.
\4\ As a combination product, hydrocodone is a schedule III
controlled substance. 21 CFR 1308.13(e)(1)(iv).
\5\ The ARCOS system reports the registration number used, but
not necessarily the person who actually ordered the drugs. Tr. 114-
16.
\6\ Moore Medical Supply reported to DEA that CMC ordered
excessive amounts of hydrocodone. Tr. 32-34; GX 5. The order to
Moore was placed under Respondent's husband's DEA registration and
R.K.'s name appears on a fax sheet sent to Moore Medical and related
to CMC's account number. GX 5, at 7; Tr. 131.
---------------------------------------------------------------------------
The majority of the controlled substances ordered under
Respondent's DEA registration were obtained from Anda Pharmaceuticals.
GX 3; Tr. 130, 139. The GS obtained purchase records from Anda showing
hydrocodone and other controlled substances purchases by both
Respondent and her husband between 2000 and 2005. GX 8; Tr. 47-49.
However, there is no evidence that Respondent ever personally ordered
these controlled substances. Tr. 140.
CMC also ordered controlled substances, primarily hydrocodone, from
another drug distributor, Henry Schein, Inc. GX 6; Tr. 44. The Schein
records show that the orders were placed under Respondent's husband's
name, but a number of the invoices note Respondent's name as well as
her husband's. GX 6, at 8-9, 11, 14-15, 17-18, 29. R.K.'s name was also
listed as
[[Page 51426]]
the contact person for the Henry Schein account. Tr. 132-34.
In a letter dated November 7, 2005, Respondent's husband explained
to Henry Schein that CMC would begin ordering controlled substances so
that CMC's physicians could dispense medications directly to CMC's
patients. GX 7; Tr. 46. This letter listed the CMC physicians as
Surinder Dang, M.D.; Satinder Dang, M.D.; Robert Belanger, D.O.; Huey
Lin, M.D.; and Davinder Singh, M.D. GX 7. The letter also stated: ``We
dispense medications to our patients only. Our practice has been
growing.'' Id. However, none of the records obtained in the
investigation show that controlled substances were ordered from Schein
under the registrations of any of the doctors besides those of
Respondent and her husband. GX 6, at 7; Tr. 176-79.
The DEA registration numbers of both Respondent and her husband
were used to order controlled substances from Darby Medical Supply and
ParMed Pharmaceuticals. GX 16; GX 9, 11; Tr. 51, 61-62. The Darby
records show that Respondent ordered hydrocodone fourteen times. GX 16,
at 1, 5, 7, 11. The ParMed records show that between December 29, 2005
and January 4, 2006, 88,800 dosage units of hydrocodone were ordered
under Respondent's registration. GX 9, at 2. At one point, D.L.,
ParMed's Regulatory Affairs officer, reported to the GS that CMC's
orders were ``excessive and suspicious''; D.L. also identified R.K. as
the point of contact for the clinic and that R.K. had opened the CMC
accounts. Tr. 51-53.
According to ARCOS records, while in 2004, Respondent purchased
157,100 dosage units of hydrocodone, in 2005, she purchased 2,272,800
dosage units. GX 3, at 2-13. ARCOS data further showed that in 2005,
Respondent and her husband had ordered a combined total of 3,626,400
tablets of hydrocodone. GX 3 at 13; GX 4, at 6; see also Tr. 93-94
(GS's testimony that between January 1, 2005 and March 16, 2006,
Respondent and her husband purchased approximately 4 million tablets of
hydrocodone).\7\
---------------------------------------------------------------------------
\7\ The GS stated that he analyzed ARCOS data, distributors'
sales records, audit inventories, patient files and dispensing logs
when creating GX 15. Tr. 92-97.
---------------------------------------------------------------------------
Throughout the investigations, 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 (Henry Schein and
Moore Medical) that controlled substances deliveries were to be made
that day, conducted surveillance at the [Dangs'] clinic from
approximately 9:00 a.m. until 6:00 p.m. Tr. 43, 67-68, 75. During the
surveillance, the GS observed both deliveries and noted that
``approximately no more than a dozen'' people entered the clinic that
day. Id. at 75.
On January 13, 2006, the GS conducted a second surveillance from
approximately 9:00 a.m. until 3 p.m. Id. at 76-77. During the
surveillance, the GS saw R.K. ``tak[ing] boxes from the office and
plac[ing] them in the trunk of her * * * SUV.'' Id. at 77.
On January 17, 2006, the GS, who had received notice of a
controlled substance delivery from another distributor (ParMed
Pharmaceuticals, Inc.), conducted another full-day surveillance. Id. at
77-78. Once again, Investigators observed R.K. ``place numerous boxes
in her vehicle that had been delivered to the clinic'' and ``put them
in the back of her * * * SUV.'' Id. at 78. The GS observed R.K. drive
away and notified the California Highway Patrol (CHP). Id. at 78, 80,
147-48. After observing R.K., who was driving forty miles per hour,
operate her vehicle within five feet of the vehicle in front of her,
the CHP officer conducted a traffic stop. Id. at 78; 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; 21 CFR 1308.13(e)(iv). 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 R.K. 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. R.K. answered that she ran a
medical office and handed him a business card listing her name 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 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,'' she 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. at 3. After giving R.K. a citation, the officer
allowed her to leave. Id.
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 drugs were transferred to the
TFO. Id. The TFO gave the CHP Officer a receipt which confirms the
figures in the latter's report.\8\ Id. at 6.
---------------------------------------------------------------------------
\8\ 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/apap 10/325 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. 82. 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 83. 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, R.K. admitted that this was the second
time she had done so. Id.
[[Page 51427]]
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. at 84. R.K. further said that she used her
personal credit card to purchase drugs from wholesalers and that
Respondent would reimburse her. Id.
The Investigators then asked R.K. if she would consent to a search
of her residence; she agreed. Id. According to the GS, the
Investigators found approximately $69,500 in cash in an upstairs
closet, a ``quantity of hydrocodone and lorazepam in the house'' (2000
lorazepam tablets and 1400 hydrocodone tablets), ``money order
receipts,'' and receipts of ``payments made to the credit card
companies by [R.K.].'' Id. To explain the cash found at her residence,
R.K. claimed the sum was a combination of money received from the sale
of a house in India and a home-based business she had previously run.
Id. at 85-86.
On February 24, 2006, Respondent's husband wrote a letter to CHP
requesting the return of the hydrocodone which had been seized during
the traffic stop of R.K. Tr. 88-89; GX 12. The letter asserted that
R.K. was the clinic's ``office manager,'' and 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. 90, 104. 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. Tr. at 90, 95. Later that day, Investigators went
to Respondent's residence and sought consent to search her house. Tr.
103. Respondent declined to provide consent and refused to talk with
Investigators without an attorney present. Id.
R.K. was present during the search of her residence and was
interviewed. Id. at 104. R.K. stated that since January 17, 2006, she
had stopped purchasing the drugs on her own, and that the drugs were
being purchased by Respondent's husband, Dr. Surinder Dang. Id. at 105.
R.K. stated that Respondent's husband was the clinic's ``primary
dispenser'' of the drugs and that she ``dispensed drugs to the patients
under the direction of * * * Dr. Surinder Dang.'' Id.
On March 16, 2006, the Diversion Investigator (DI) interviewed
several CMC employees, including A.N.,\9\ C.G.,\10\ L.Y.,\11\ and
S.B.\12\ In April 2006, the GS interviewed Dr. B., a physician who had
worked at CMC on a part-time basis since approximately 2004. Id. 109-
110. Dr. B. also worked at a facility for the local county government,
but he saw some of his patients at CMC. Id. at 110. Dr. B. stated that
while he worked at CMC, he rarely, if ever, prescribed or dispensed
controlled substances to his patients. Id. at 111. 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 114.
---------------------------------------------------------------------------
\9\ A.N. stated that Respondent, her husband, and R.K. handled
drug deliveries when they came into CMC. Id. at 238-39. A.N. further
stated that both Respondent and her husband kept records of
dispensed drugs in the patient files and dispensing logs; she
identified the writing in the patient log as R.K.'s. Id. at 239-40.
\10\ The transcript notes the coworker's initials as C.G.;
however, other documents suggest that her initials are K.G. See
Resp. Brief at 8. C.G. stated that both R.K and Respondent's husband
ordered the drugs for CMC. Tr. 241, 249-250. R.K. usually accepted
deliveries of drug orders; however, sometimes C.G. would sign for
the delivery but not open the boxes. Id. at 241-42. C.G. further
stated that she witnessed R.K. writing in the dispensing log the day
before the search warrant was executed and heard R.K. comment that
CMC's drug procedures had changed. Id. at 242.
\11\ According to L.Y., the clinic saw twenty to twenty-five
patients per day. Id. at 244. L.Y. also stated that R.K. handled the
drugs once they arrived. Id. at 243. When shown the dispensing log,
L.Y. identified the handwriting as belonging to R.K. Id. at 243-44.
She further stated that Respondent only wrote prescriptions. Id. at
250.
\12\ S.B. stated that R.K. and Respondent's husband handled the
drugs that were dispensed directly to patients and that R.K. handled
the drug inventory and payment for the drugs that were ordered. Id.
at 246. S.B. also stated that R.K. handled the dispensing log. Id.
at 247. S.B. further stated that CMC had approximately twenty-five
patients per day, of whom ten saw Respondent. Id. According to S.B.,
both Sameer Dang and R.K. paid for the drugs. Id. She also stated
that R.K. had access to the controlled substances received at the
CMC office. Id. at 248.
---------------------------------------------------------------------------
Using the records seized during the search of Respondent's clinic
and its patient files, ARCOS data, and information provided by several
of the distributors,\13\ the GS conducted an audit of the hydrocodone
ordered under both Respondent's and her husband's registrations between
January 1, 2005 and March 16, 2006. Tr. 93-96, 67; GX 15. Because CMC
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 controlled
substances were then on hand; for the closing inventory, the GS used
the inventory taken (48,000 tablets) when the search warrant was
executed.\14\ Tr. 92-93, 95; GX 15. To this latter figure, the GS added
the hydrocodone that was seized during the January 17, 2006 traffic
stop of R.K. (31,000 tablets) and the 1,200 tablets\15\ found during
the search of R.K.'s residence which occurred later that day. Tr. 95;
GX 12, 15.
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\13\ Moore Medical provided DEA with sales records under
Respondent's registration for hydrocodone from late 2005 to early
2006. Tr. 34, 43; GX 5. ANDA provided DEA with a spreadsheet listing
all sales under the registrations of Respondent and her husband from
May 2000 through mid-October 2005. Tr. 47-49; 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. Tr. 51-52; GX 9.
\14\ If any controlled substances were in fact on hand on the
starting date of the audit period, assigning a zero starting
inventory would reduce the size of any shortage.
\15\ I acknowledge that this figure differs from the quantity of
1,400 tablets which, according to the GS's testimony, was found in
R.K.'s house. The difference, however, is inconsequential given the
result of the audit.
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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. Tr. 94; 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; \16\ in addition, the GS reviewed the clinic's patient files
and credited another 75,000 tablets as having been dispensed.\17\ Tr.
95-96; GX 15. Accordingly, CMC could only account for approximately
167,000 tablets of hydrocodone.\18\ Tr. 96-97; GX 15. While the DI
combined the purchases of Respondent and her husband, the ARCOS data
and distributor invoices did list whose registration was used to place
the various orders. See, e.g., GXs 3 & 4. This evidence shows that in
2005 alone, 2,272,800 dosage units of hydrocodone were ordered under
Respondent's registration. Accordingly, Respondent still could not
account for more than two million dosage units.\19\ GX 3, at 13.
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\16\ 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. 90; 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. See GX 14.
\17\ The GS credited CMC with dispensing a total of 87,000
hydrocodone tablets; this calculation counted the prescriptions
issued by Respondent or her husband, because the prescriptions may
have been filled in the office. Tr. 100; GX 15.
\18\ Neither Respondent nor her husband had reported to DEA any
thefts, losses, or destructions of controlled substances. Tr. 99-
101.
\19\ This calculation gives Respondent credit for all of the
167,000 tablets for which the GS could account.
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Respondent testified that she had no knowledge that her ``DEA
registration
[[Page 51428]]
number was being used to order large quantities of hydrocodone that
were being delivered to CMC.'' Tr. 192. She asserted that she did not
order any controlled substances between 2002 and March 16, 2006, and
that she did not order any controlled substances after that period. Id.
at 195-96. Specifically, she testified that she did not order Lorazepam
in October 2006. Id.
Respondent testified that while during this time period, she was
aware that her husband was ordering drugs for his pain management
practice, she did not know how much he was ordering. Id. at 201.
Respondent stated that she had no knowledge of the controlled
substances being delivered to CMC during this time period; while she
admitted to having seen boxes being delivered to the clinic, she
claimed to not know what they contained. Id. 197-198. Respondent
further stated that R.K. would open the boxes after they were
delivered. Id. at 200.
Respondent further testified that she was unaware that R.K. had
taken drugs from CMC to her residence until learning of it through
these proceedings; she also stated that she was not sure if her husband
had instructed R.K. regarding taking drugs to her residence. Id. at
204-205. However, the ALJ did not find credible Respondent's testimony
that she was unaware of R.K.'s activities. ALJ at 30.
Regarding the controlled substance drug storage area, Respondent
stated that she had ``no idea'' how the drugs were organized. Tr. 198-
99. Respondent testified that she did not pay attention to what was in
that storage area, but then stated there was a basic cabinet that was
locked at night and that she did not have a key. Id. at 200-01.
According to Respondent, the key was either kept by R.K. or in a place
where her husband could find it; Respondent also did not know if the
storage cabinet was locked during the day. Id. at 234.
While Respondent testified on direct examination that she had not
dispensed drugs at CMC, on cross-examination, she stated ``I don't
recall. I might have dispensed but I dispensed rarely.'' Id. at 195.
Respondent then admitted dispensing, stating ``maybe I might have given
[hydrocodone] once or twice to my patients only.'' Id. She stated that
other people had ordered these drugs that she dispensed. Id. at 229. On
the occasions that she did dispense, Respondent asked R.K. for the
drug. Id. at 230. R.K. would retrieve the controlled substances from
the cabinet and give them to Respondent to hand to the patient. Id. In
these instances, R.K. would record the dispensed controlled substances
in a ``separate log.'' Id. at 228.
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 [her] 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 factor, 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 by showing that a registrant has committed acts
which are inconsistent with the public interest, the burden then shifts
to the applicant to demonstrate why he can be entrusted with a
registration. Medicine Shoppe-Jonesboro, 73 FR 364, 380 (2008).
In this matter, having considered the entire record and all of the
factors, I agree with the ALJ's conclusions that the Government's
evidence under factors two, four, and five makes out a prima facie that
Respondent has committed acts which render her registration
inconsistent with the public interest.\20\ ALJ at 29. I further agree
with the ALJ's conclusion that Respondent has not accepted
responsibility for her misconduct and has thus not rebutted the
Government's prima facie case.
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\20\ I acknowledge that Respondent holds a valid medical license
from the State of California. Moreover, the State Board has not
taken action against her, nor made any recommendation in this matter
(factor one). ALJ at 27.
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
[continuation] 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 her 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 at 27-28. 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 her registration is consistent with the public
interest.
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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 her and her husband's DEA
registrations, approximately 2.3 million of which were ordered under
her registration during 2005 alone. When DEA Investigators audited
Respondent's and her husband's handling of the hydrocodone, they could
account for only 167,000 tablets, leaving Respondent with over two
million
[[Page 51429]]
tablets unaccounted for. 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 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,'' she 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. However, as
found above, during the audit, Respondent could not produce an
inventory record for any of the controlled substances that were
purchased under her 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 [her].'' 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. However, as found
above, while large quantities of controlled substances were purchased
under her registration throughout 2004 and 2005, Respondent had no
dispensing logs for these years and the 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). ``[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, her 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
her 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).
In her Exceptions to the ALJ's decision, Respondent argues that
``she had no knowledge that her DEA Registration was being used by her
husband or [R.K.] to order controlled substances'' until DEA executed
the search warrant on March 16, 2006. However, DEA has long held that a
registrant is strictly liable for the misuse of her registration by a
person to whom she entrusts her registration. See also Harrell E.
Robinson, 74 FR 61370, 61377 (2009); Paul H. Volkman, 73 FR 30630,
30644 n.42 (2008); Rose Mary Jacinta Lewis, 72 FR 4035, 4041 (2007)
(citing Anthony L. Capelli, 59 FR 42288 (1994)); Leonard Merkow, 60 FR
22075, 22076 (1995); Capelli, 59 FR at 49288. The record clearly
supports the conclusion that Respondent entrusted her registration
number to R.K. Thus, even if it were the case that Respondent was
unaware of R.K.'s illegal activities, she is still strictly liable for
R.K.'s misuse of her registration and her failure to properly monitor
how her 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.
Contrary to Respondent's understanding, the purpose of this
proceeding is to protect the public interest, and in determining
whether a registrant has committed acts which render her registration
``inconsistent with the public interest,'' 21 U.S.C. 824(a)(4), the
standards of mens rea for imposing criminal liability are not
controlling. Accordingly, the Government is not required to show that
Respondent had knowledge that her DEA Registration was being used by
her husband or R.K. to order controlled substances.
In any event, the ALJ did not find credible Respondent's testimony
that she was unaware of R.K.'s activities. ALJ at 30. I agree. Given
the duration and scope of R.K.'s activities, Respondent's denial of
knowledge is implausible.
In her Exceptions, Respondent also argues that the ALJ's decision
``fails to distinguish between the drugs ordered under Respondent's DEA
Registration and the drugs ordered under her husband's.'' Res. Exc. at
22. This is true. However, as ultimate factfinder, I have reviewed the
evidence and found that the ARCOS data shows that in 2005 alone, more
than 2.27 million dosage units of hydrocodone were ordered under
Respondent's registration, and that at most, 167,000 dosage units can
be accounted for. Thus, Respondent is responsible for more than two
million dosage units that cannot be accounted for and were likely
diverted.
Respondent's misconduct thus clearly threatened public health and
safety. See 21 U.S.C. Sec. 823(f)(5). Moreover, the scope of the
diversion is egregious. I therefore conclude that the Government has
satisfied its prima facie burden of showing that Respondent has
committed acts which render her registration is ``inconsistent with the
public interest.'' 21 U.S.C. 824(a)(4); 823(f).
Sanction
Under Agency precedent, where the Government has made out a prima
facie case that a registrant has committed acts which render her
``registration inconsistent with the public interest,'' she must
```present[] sufficient mitigating evidence to assure the Administrator
that [she] 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
[her] actions and demonstrate that [she] will not engage in future
misconduct.'' Medicine Shoppe-Jonesborough, 73 FR at 387.
During her testimony, Respondent continued to deny that she was
responsible for the unaccounted-for hydrocodone and blamed her husband
and R.K. Furthermore, the ALJ found incredible Respondent's denial that
she had knowledge of R.K.'s illegal activities. DEA has repeatedly held
that a registrant's lack of candor is a highly relevant consideration
in determining the appropriate sanction. See Hoxie v. DEA, 419 F.3d
477, 483 (6th Cir. 2005); Robert F. Hunt, 75 FR 49995, 50004 (2010);
Rosemary Jacinta Lewis, 72 FR 4035, 4042 (2007). Respondent's lack of
candor further supports the revocation of her registration.
Given the scope of the diversion which likely occurred here and
what the ALJ characterized as Respondent's minimal acceptance of
responsibility
[[Page 51430]]
(which was limited to the statements of counsel in a post-hearing brief
and which do not constitute evidence, see INS v. Phinpathya, 464 U.S.
183, 186 n.6 (1984)), I conclude that none of the ``favorable facts''
cited by the ALJ provide any reason to impose a sanction less than
revocation. Jayam Krishna-Iyer, 74 FR 459, 463 (2009). Indeed, none of
Respondent's proposed remedial measures mitigate the egregious harm
Respondent has caused to public health and safety.
I therefore conclude that it would be inconsistent with the public
interest to grant her 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, AD9234446, issued to Satinder K. Dang,
M.D., be, and it hereby is, revoked. I further order that any pending
application of Satinder K. Dang, M.D., to renew or modify her
registration be, and it hereby is, denied. This Order is effective
September 22, 2011.
Dated: August 9, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-21065 Filed 8-17-11; 8:45 am]
BILLING CODE 4410-09-P
