[Federal Register Volume 76, Number 160 (Thursday, August 18, 2011)]
[Notices]
[Pages 51424-51430]
From the Federal Register Online via the Government Publishing 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.
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\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.
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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.).
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\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 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\
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\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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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.
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\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. 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.
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\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.
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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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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