Harrell E. Robinson, M.D.; Revocation of Registration, 61370-61377 [E9-28190]
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ailment, injury, infirmity, deformity,
pain or other condition, physical or
mental, real or imaginary, by any means
or instrumentality.’’ Ala. Code § 34–24–
50(1). Under Alabama law, ‘‘the practice
of medicine * * * across state lines’’ as
it applies to ‘‘[t]he rendering of
treatment to a patient located within
[Alabama] by a physician located
outside [Alabama] as a result of
transmission of individual patient data
by electronic or other means from this
state to such physician or his or her
agent’’ constitutes the ‘‘practice of
medicine,’’ such that ‘‘[n]o person shall
engage in the practice of medicine
* * * across state lines in [Alabama]’’
unless he or she has ‘‘been issued a
special purpose license to practice
medicine * * * across state lines.’’ Ala.
Code § 34–24–501 & 34–24–502(a). As
Respondent did not possess a special
purpose license from Alabama, his
prescribing over the internet to these
patients constituted violations of
Alabama law. In issuing these
controlled-substance prescriptions,
Respondent acted outside the usual
course of professional practice and
violated the CSA. See 21 CFR
1306.04(a).
Respondent wrote nineteen
prescriptions for schedule III drugs
containing hydrocodone to residents of
North Carolina. Under North Carolina
law prior to 2007, ‘‘prescribing
medication by use of the internet or a
toll-free number,’’ was ‘‘regarded as
practicing medicine’’ in North Carolina.
N.C. Gen. Stat. Ann. 90–18(b).6 As such,
it subjected a practitioner to North
Carolina law and the regulation of the
North Carolina Medical Board. Id. North
Carolina prohibits the practice of
medicine without the appropriate
license and registration and makes outof-state violators guilty of a ‘‘Class I
felony.’’ N.C. Gen. Stat. Ann. 90–18(a).
Respondent’s prescribing to North
Carolina residents via the internet
clearly violated North Carolina law.
Additionally, in February 2001, the
North Carolina Medical Board issued its
position statement, ‘‘Contact with
Patients Before Prescribing,’’ which
stated that ‘‘prescribing drugs to an
individual the prescriber has not
personally examined is inappropriate.’’
Contact with Patients before Prescribing,
at 1 (available at https://
www.ncmedboard.org/
position_statements/). The Board further
explained that ‘‘[o]rdinarily, this will
require that the physician personally
perform an appropriate history and
physical examination, make a diagnosis,
6 This provision was deleted, effective October 1,
2007, by S.L. 2007–346, section 23.
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and formulate a therapeutic plan, a part
of which might be a prescription.’’ Id.
As Respondent failed to perform
physical examinations of these patients,
his conduct was not in the usual course
of professional practice. He
consequently violated the CSA in
writing these prescriptions as well. See
21 CFR 1306.04(a).
As the foregoing demonstrates,
Respondent repeatedly violated state
laws and regulations prohibiting the
unlicensed practice of medicine and
establishing standards of medical
practice by prescribing controlled
substances to persons he never
physically examined and who resided
in States where he was not licensed to
practice and prescribe drugs. In issuing
the prescriptions, Respondent also acted
outside of ‘‘the usual course of
professional practice’’ and lacked ‘‘a
legitimate medical purpose’’ and thus
repeatedly violated the CSA. I therefore
conclude that Respondent has
committed acts which render his
continued registration ‘‘inconsistent
with the public interest.’’ 21 U.S.C.
824(a)(4). Accordingly, Respondent’s
registration will be revoked.
Order
Pursuant to the authority vested in me
by 21 U.S.C. §§ 823(f) and 824(a), as
well as 28 CFR 0.100(b) and 0.104, I
hereby order that DEA Certificate of
Registration, BA6015158, issued to
Mohammed F. Abdel-Hameed, M.D., be,
and it hereby is, revoked. I further order
that any pending application to renew
or modify the registration be, and it
hereby is, denied. This order is effective
December 24, 2009.
Dated: November 17, 2009
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–28189 Filed 11–23–09; 8:45 am]
BILLING CODE 4410–09–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09–32]
Harrell E. Robinson, M.D.; Revocation
of Registration
On February 26, 2009, I, the Deputy
Administrator of the Drug Enforcement
Administration, issued an Order to
Show Cause and Immediate Suspension
of Registration to Harrell E. Robinson,
M.D. (Respondent), of Santa Ana,
California. The Order proposed the
revocation of Respondent’s DEA
Certificate of Registration, AR8613487,
which authorizes him to dispense
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controlled substances in schedules II
through V as a practitioner, on the
ground that Respondent’s continued
registration is ‘‘inconsistent with the
public interest, as that term is defined
in 21 U.S.C. 823(f), 824(a)(4).’’ Show
Cause Order at 1. The Order also
proposed the denial of any pending
applications for renewal or modification
of Respondent’s registration. Id.
Specifically, the Show Cause Order
alleged that from February 2007 through
October 2008, Respondent ‘‘purchased
approximately 613,000 dosage units of
hydrocodone combination products and
unlawfully distributed these drugs to an
unregistered individual in exchange for
$10,000 per month * * * in violation of
21 U.S.C. 841(a)(1).’’ Id. In addition, the
Show Cause Order alleged that from
September 2007 through October 2008,
Respondent ‘‘purchased approximately
397,000 dosage units of hydrocodone
combination products using the DEA
registration numbers of two other
practitioners in violation of 21 U.S.C.
843(a)(2) and (3).’’ Id. at 2. Further,
Respondent allegedly then ‘‘distributed
these drugs to an unregistered
individual, in violation of 21 U.S.C.
841(a)(1).’’ Id.
Based on the above, I further
concluded that Respondent’s
‘‘continued registration while these
proceedings are pending constitutes an
imminent danger to the public health
and safety.’’ Show Cause Order at 2.
Consequently, pursuant to my authority
under 21 U.S.C. 824(d) and 21 CFR
1301.36(e), I immediately suspended
Respondent’s registration, with the
suspension to remain in effect until the
issuance of this Final Order. Id.
Respondent requested a hearing on
the allegations. The case was placed on
the docket of the Agency’s
Administrative Law Judges (ALJ) and a
hearing was scheduled for May 12,
2009. On April 9, 2009, the ALJ ordered
Respondent to file a prehearing
statement no later than May 4, 2009.
ALJ at 2 n.1; ALJ Ex. 3. The same day,
the ALJ’s law clerk faxed Respondent a
letter advising him of his right to
counsel. ALJ at 2 n.1; ALJ Ex. 4.
On May 1, Respondent requested an
extension of time to file his prehearing
statement, advising that he was
retaining counsel that afternoon. ALJ at
2 n.1. On May 4, the ALJ granted
Respondent an extension of time to May
7, noting that the hearing was set for
May 12 and that Respondent had not
asked for a postponement of the hearing.
Id.
On May 6, Respondent filed a request
to postpone the hearing; in response, the
ALJ’s law clerk ‘‘left a telephone
message for Respondent advising that
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before [the ALJ] could act on his request
to postpone the hearing, his attorney
must contact [the ALJ’s] office and that
all communication with [the ALJ’s]
office should be accomplished through
the attorney.’’ Id. However, no attorney
contacted the ALJ’s office on
Respondent’s behalf. Accordingly, on
May 7, the ALJ denied Respondent’s
request to postpone the hearing. Id.; ALJ
Ex. 6.
On May 12, 2009, the hearing was
held as originally scheduled in
Arlington, Virginia. ALJ at 2. At the
hearing, the Government was
represented by counsel. Id. By contrast,
neither Respondent, nor anyone
purporting to represent him, appeared,
and thereafter, Respondent ‘‘filed
nothing further’’ with the office of the
ALJ. Id. at 2 & 2 n.1; see also 21 CFR
1301.43(d) (‘‘If any person entitled to a
hearing * * * files [a request for a
hearing] and fails to appear at the
hearing, such person shall be deemed to
have waived the opportunity * * * to
participate in the hearing, unless such
person shows good cause for such
failure.’’).
At the hearing, the Government called
witnesses to testify and introduced
documentary evidence. ALJ at 2.
Thereafter, the Government filed
proposed findings of fact, conclusions of
law, and argument.
On May 29, 2009, the ALJ issued her
Opinion and Recommended Ruling. On
June 24, noting that neither party had
filed exceptions to the opinion, the ALJ
forwarded the matter to me for final
agency action.
In her discussion of the public
interest factors, the ALJ noted that
‘‘[t]here is no indication that
Respondent is not fully licensed to
practice medicine in California.’’ ALJ at
17. She therefore found that ‘‘this factor
weighs in favor of a finding that his
continued registration would be in the
public interest.’’ Id. The ALJ further
explained, however, that because ‘‘state
licensure is a necessary but not
sufficient condition for DEA
registration,’’ this factor was ‘‘not
dispositive.’’ Id. As for factors two and
four—Respondent’s experience in
dispensing controlled substances and
compliance with applicable laws—the
ALJ concluded that Respondent violated
21 U.S.C. 841 by distributing
hydrocodone combination products at
unregistered locations to unregistered
persons who were not legitimate
patients and by arranging with other
physicians to use their DEA registration
numbers to purchase hydrocodone
combination products which were also
distributed unlawfully. Id. at 17–18. She
also concluded that Respondent
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violated 21 U.S.C. 822(a)(1) by
distributing the products without a
registration to do so. Id. at 18.
Furthermore, the ALJ concluded that
Respondent violated 21 CFR 1301.71(a)
by not maintaining effective controls
against diversion of controlled
substances. Id. Finally, the ALJ
determined that Respondent had
violated California State Business and
Professions Code sections 2242 and
2241.5 in that (1) he failed to physically
examine the individual to whom he had
distributed the drugs and to determine
that she had a medical indication for
treatment with hydrocodone
combination products, and that (2) he
failed to maintain records of his
handling of controlled substances as
required by state law. Id. Accordingly,
the ALJ found that ‘‘these factors weigh
in favor of a finding that Respondent’s
continued registration would be
inconsistent with the public interest.’’
Id.
Noting that the record did not include
any evidence that Respondent had been
convicted under any federal or state law
relating to the manufacture,
distribution, or dispensing of controlled
substances, the ALJ concluded that the
Respondent’s conviction record
‘‘although not dispositive, weighs
against finding that Respondent’s
registration would be inconsistent with
the public interest.’’ Id. at 18–19.
Finally, crediting the Diversion
Investigator’s (DI’s) testimony that
Respondent had ‘‘told him that
Respondent’s status as a physician
allowed him to order hydrocodone and
that his orders were acceptable because
the drugs were going to poor people,’’
the ALJ concluded that ‘‘[t]his ludicrous
attempt to justify his activities indicates
that Respondent has neither respect for
nor a willingness to accept the
responsibilities adherent to a DEA
registration.’’ Id. at 19. Accordingly, she
found that factor five—such other
conduct which may threaten public
health or safety—weighed ‘‘in favor of a
finding that Respondent’s continued
registration would not be consistent
with the public interest.’’ Id.
Considering all the factors together,
the ALJ concluded that ‘‘a
preponderance of the evidence
establishes that Respondent’s continued
registration with the DEA would be
inconsistent with the public interest.’’
Id. The ALJ therefore recommended that
I revoke Respondent’s registration and
deny any pending applications. Id.
On August 6, 2009, the Government
filed a Motion to Reopen Record. The
basis of the motion was that on June 22,
2009, Respondent, in a proceeding
before the Medical Board of California
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61371
(‘‘the Board’’), ‘‘signed a stipulation
which acknowledged that the Board
could establish a factual basis for a
series of allegations contained in a
Fourth Amended Accusation, which
included twelve (12) causes of action
against him.’’ Gov’t Mot. at 2. In support
of its motion, the Government attached
a copy of the Fourth Amended
Accusation and the Board’s Decision
and Order of July 20, 2009. Id.
The Board’s Decision and Order
provided that the attached Stipulated
Surrender of License and Order of June
22, 2009, was ‘‘adopted by the Medical
Board of California * * * as its
Decision’’ in the matter. Gov’t Mot.,
Exh. A, at 1. The Decision provided that
the Stipulated Surrender of License and
Order ‘‘shall become effective at 5 p.m.
on September 30, 2009.’’ Id. (emphasis
in original).
Because the Board’s order is clearly
material to the public interest inquiry,
see 21 U.S.C. 823(f)(1), was not available
at the time of the hearing, and therefore
could not have been presented at the
original hearing, I conclude that the
Government has set forth a prima facie
case for reopening the record. Cf. INS v.
Abudu, 485 U.S. 94, 97 (1988). I
therefore grant the Government’s motion
to reopen the record and admit the
Board’s order to the record.
Having considered the record in its
entirety, I hereby issue this Decision
and Final Order. I adopt the ALJ’s
findings of fact and conclusions of law
except as expressly noted herein. I
further adopt the ALJ’s recommended
sanction. I make the following findings.
Findings
Respondent is the holder of DEA
Certificate of Registration, AR8613487,
which prior to the issuance of the Order
of Immediate Suspension, authorized
him to dispense controlled substances
in schedules II through V as a
practitioner at the registered location of
1523 North Broadway in Santa Ana,
California. GX 1; Tr. 110. While the
registration certificate indicates that the
registration was to expire on April 30,
2008; on March 12, 2008, Respondent
submitted a renewal application. GX 9,
at 1. Because Respondent timely filed
his renewal application, and his
registration was not then suspended,
Respondent retains a current
registration (albeit one which is
suspended) pending the issuance of this
Final Order. See 5 U.S.C. 558(c); 21 CFR
1301.36(i).
In February 2008, Respondent also
applied for registrations at the locations
of 145 South Chaparral in Anaheim
Hills, California, and 1421 North
Broadway in Santa Ana. Id. at 111, 134,
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136; GX 7. Both the 1523 North
Broadway and the 1421 North Broadway
locations were owned by a Dr. Joy
Johnson, but she ‘‘delegated’’ the
responsibility for leasing the premises to
Ms. Magdalena Annan, an individual
identified as having hired Respondent
as the medical director of the clinic on
1523 North Broadway. Tr. 100, 141.
At the hearing, an Agency Investigator
(DI) testified that he visited the 1523
North Broadway location, which was a
house converted into a business
premises; on the front of the house was
a sign indicating the business name as
the Madre Maria Ines Teresa Health
Center. Tr. 75. Although the DI observed
the property for between two and three
hours, he never saw an individual who
appeared to be a patient entering or
exiting the premises. Id. at 75–76.
The DEA Investigation
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DEA commenced investigating
Respondent in November 2007 because
he was the sixth largest purchaser of
hydrocodone combination products
among California physicians for the year
2007. Tr. 55–56, 63; GX 34. Respondent
was known to have purchased
controlled substances from four
different wholesalers, including Top
RX, Inc., the Harvard Drug Group, and
A.F. Hauser. Tr. 59–60.
The DI confirmed through a
Compliance Officer for Top Rx, Inc.
(Top RX), a Tennessee drug wholesaler,
that Respondent had purchased 336,000
dosage units 1 of hydrocodone
products 2 from Top RX between
February 2 and November 12, 2007. Tr.
63–64; GXs 14 & 15. At least one order
was paid for with a check in the name
of Madre Maria Ines Teresa Health
Center, 1523 Broadway Street, Santa
Ana, California; the holder of that
checking account was Magdalena
(‘‘Maggie’’) Annan. Tr. 72–73; GX 16, at
96. According to the Compliance
Officer, the ‘‘contact name’’ on the
account was ‘‘Maggee.’’ GX 14.
In some cases, Ms. Annan ordered the
hydrocodone products, and her name
was listed as the accounts payable
manager on Respondent’s account with
Top RX and the Harvard Drug Group.
1 The ALJ found that Respondent had purchased
only 228,700 dosage units from Top Rx, finding that
the Compliance Officer had ‘‘advised’’ the DI as to
that number. ALJ at 3. The DI did not so testify, and
the letter from Compliance Officer did not include
any total of drug dosage units, See GX 14. Rather,
only the letter’s attachment provided the data from
the orders. See GX 15. In totaling those orders, I
find that Respondent bought 336,000 dosage units
from Top Rx.
2 Throughout this Order any reference to
hydrocodone products refers to schedule III drugs
which combine hydrocodone with another active
pharmaceutical ingredient such as acetaminophen.
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Tr. 64–65; 73–74; 99–100; GXs 16 & 27.
On other occasions, Respondent
personally ordered the hydrocodone
combination products. Id. at 10–12, 14.
By January 2008, Respondent ceased
to purchase hydrocodone combination
products from Top RX. Instead, in
December 2007, he started purchasing
the same type of drugs from Harvard
Drug Group (Harvard), a wholesaler in
Michigan. Tr. 8, 79. Mr. S. S., Harvard’s
Vice President for Regulatory Affairs,
testified that Respondent opened an
account with Harvard in December
2007, indicating that it was an account
for a clinic he owned. Tr. 11. To open
the account, on December 26, 2007,
Respondent signed an affidavit in which
he attested that he was not engaged in
business as an Internet pharmacy, that
he did not dispense prescriptions by
mail to patients, that he was located in
an area accessible to the public, and that
walk-in customers were welcome. Tr.
29; GX 24. On his credit application to
Harvard, Respondent listed the accounts
payable manager as ‘‘Maggie.’’ GX 27.
S.S. testified that he did not know who
this individual was. Tr. 43.
In January 2008, Respondent opened
a second account with Harvard,
indicating that he owned a second
medical clinic whose medical director,
Scott Bickman, M.D.,3 would also be
purchasing controlled substances under
his own DEA registration. Tr. 11; GX 28.
While the drugs ordered by Dr. Bickman
were to be shipped to the second clinic
(145 Chaparral Court in Anaheim Hills),
bills were to be sent to Respondent’s
main office. Tr. 11–12, 20; GX 30, at 9.
Respondent was listed on the invoices
as the person billed. GX 30, at 9, 20.
At some point, Respondent opened a
third account in the name of Thomas
Mitchell, M.D. Tr. 14, 30. Both Drs.
Bickman and Mitchell provided Harvard
with affidavits similar to that provided
by Respondent when he opened the
account. Tr. 29–30; GXs 25 & 26.
S.S. testified that Harvard sends its
local DEA office (Detroit) computergenerated reports of orders that the
company considers excessive. Tr. 47. He
also testified that Harvard ‘‘reported’’
Drs. Robinson and Bickman ‘‘pretty
much every month from January 2008
onward.’’ Id. at 49. He additionally
testified that Harvard imposes a quota
on the quantity of hydrocodone
combination products that a customer
may receive in a given month. Id. at 48.
The evidence further shows that
hydrocodone combination products
were the sole products that were
3 Dr. Bickman was the sixth largest purchaser of
hydrocodone products in California for 2008. Tr.
57; GX 36.
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purchased from Harvard by Respondent
and Drs. Bickman and Mitchell. GX 29;
Tr. 25. Respondent ordered the drugs by
telephone, a matter confirmed to the DI
by G.B., an inside sales representative
for Harvard, as well as by e-mail from
S.S. to the DI. Tr. 18–19, 116–17; GX 31,
at 3.4
During the months of March through
May 2008, S.S. provided e-mail alerts to
the DI regarding Respondent’s ordering
for the three clinics. See GX 31. On
March 18, S.S. e-mailed the DI,
indicating that ‘‘last night’’ Respondent
had called and left a message to order
more hydrocodone combination
products. GX 31, at 9. S.S. wrote: ‘‘We
have not shipped this order as account
has reached its total quantity allowed
for Hydrocodone items for the month.’’
Id. Again, on March 18, S.S. e-mailed as
follows:
I spoke with [Respondent] this afternoon.
I explained our company’s policy when his
orders get cut off when they order group [sic]
of products (Controlled Drugs) which reaches
25,000 tablets a month. He insisted that his
other clinic in Anaheim Hills has not reached
his monthly limit and wants his order
shipped at that location. We ran reports to
find out what quantity he has purchased at
his Anaheim Hills clinic. We have so far
shipped 17,500 tablets of Hydrocodone so
since he wants balanced [sic] of order
shipped, here is what we have shipped today
* * *.
This will be his last shipment for the
month. I have explained to him that any
additional orders for Hydrocodone must be
placed with other wholesale distributors as
we will not be able to ship any quantity to
either of his clinic [sic] until April 1st.
Id. at 11.
On April 15, S.S. again e-mailed the
DI indicating that Respondent had
placed an order for his Anaheim Hills
clinic and that Respondent ‘‘also asked
if we can ship similar order to his other
location but we have refused to ship
because that location has already
reached its monthly purchase limits for
above items.’’ Id. at 20. Similarly, on
April 22, S.S. advised the DI by e-mail
that Respondent ‘‘called to place
additional orders but we refused to fill
orders as he has reached his monthly
maximum limit that he could get so we
have not filled any additional orders
since our last shipment.’’ Id. at 26. S.S.
further advised that Respondent ‘‘may
be purchasing from other wholesalers.’’
Id.
4 Sometime prior to March 2008, the DI had
contacted S.S. and asked him to provide historical
information on Respondent’s purchases. Tr. 78–79.
Starting in March 2008, the DI asked S.S. to provide
advanced notice of controlled substance deliveries
to Respondent and Drs. Mitchell and Bickman. Tr.
14, 16, 79; GX 31. S.S. complied with this request,
typically, by e-mail. See id.
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In October 2008, Harvard generated
computer printouts of the controlled
substances orders it had received from
Respondent, Dr. Mitchell and Dr.
Bickman. The printouts showed that
Respondent had ordered 263,500 dosage
units 5 of hydrocodone between
December 11, 2007 and October 10,
2008; that Dr. Bickman ordered 213,000
dosage units 6 of hydrocodone between
December 18, 2007 and October 15,
2008; and that Dr. Mitchell ordered
43,500 dosage units 7 of hydrocodone
between July 31 and October 15, 2008.
GX 29. Most of the orders were for 10milligram strength product; others were
for 7.5-milligram strength product. Id.
The DI testified that Respondent
purchased about 800,000 pills using his,
Dr. Bickman’s, and Dr. Mitchell’s DEA
registrations. Tr. 113–14.8 According to
DEA’s Automated Reports and
Consolidated Ordering System
(ARCOS), Respondent purchased a total
of 641,400 dosage units of hydrocodone
products under his name between
February 2, 2007 and October 10, 2008
(the period of his ordering from Top RX
and Harvard). GX 37. ARCOS data
further indicates that 265,500 dosage
units of hydrocodone products were
purchased under Dr. Bickman’s DEA
registration between October 8, 2007,
and September 29, 2008.9 GX 38; Tr.
158. Finally, ARCOS data indicates that
51,500 dosage units of hydrocodone
products were purchased under Dr.
Mitchell’s DEA registration between
August 22 and October 15, 2008. GX 39;
Tr. 158.
Based on the evidence establishing
that Respondent had entered into
arrangements with Drs. Bickman and
Mitchell to use their registration
numbers, I find that the purchases made
under their registrations are attributable
to Respondent. I further find that
between February 2, 2007 and October
10, 2008, Respondent purchased a total
of 958,400 dosage units of hydrocodone
products.
5 The ALJ found only 93,000 dosage units. ALJ at
5. The ALJ appears to have multiplied the bottlecount (500) by the number of orders rather than by
the number of bottles per order.
6 The ALJ found only 77,000 dosage units. ALJ at
5. See supra note 4 for the explanation of the
discrepancy.
7 The ALJ found only 16,500 dosage units. ALJ at
5. See supra note 4 for the explanation of the
discrepancy.
8 This figure includes the approximately 336,000
tablets obtained from Top RX and the
approximately 263,500 obtained from Harvard on
his own account, plus the approximately 213,000
and 43,500 obtained from Harvard on the accounts
of Drs. Bickman and Mitchell. The ALJ’s figures are
therefore rejected as inconsistent with the evidence.
9 A comparison of ARCOS data with the Harvard
data suggests that Dr. Bickman’s account was used
to order from an additional wholesaler.
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Agency Investigators, with the help of
officers from the Costa Mesa, California
Police Department, conducted
surveillance of the delivery of packages
from Harvard to Respondent’s clinics on
five occasions. Tr. 80–81. In the first
such instance, in mid-February 2008,
the DHL driver could not complete the
delivery. Id. at 83.
However, at 9 a.m. on March 12,
during a surveillance of the Anaheim
Hills clinic, Investigators observed a
delivery which was taken into the
office. Id. Later that morning, at about
11:45 a.m., Respondent arrived in his
car and went into the office; fifteen
minutes later he emerged with the box,
and placed it in the trunk of his car. Id.
at 83–84. Moments later, Respondent
got into another car in the parking lot
which was driven by a woman, who
then drove him to his car, where he
retrieved the box and placed it in the
trunk of the woman’s car. Id. at 84–85,
87. Respondent and the woman then
drove approximately twenty miles to
pick up two children at a school and
then returned with the children to the
Anaheim Hills clinic. Id. at 86–87. Some
ten or fifteen minutes later, the woman
and children got back in the car and
drove to Respondent’s residence at 1880
Seabiscuit Run, Yorba Linda, California.
Id. at 87. The woman parked the car in
the garage, leaving the children and the
box in the car. Id. at 87–88.
Moments later, the woman emerged,
drove to the 1421 North Broadway
clinic, and parked at the rear of the
building. Id. at 88. After going into the
office, she returned to the car with
another woman, and put the box in a
third car. Id. The other woman then
drove away with the box. Id. at 88–89.
The second woman drove
approximately five miles to another
house in Santa Ana where another
woman got in the car with her; the two
then drove to the Madre Maria Ines
Teresa Health Center, where they
entered the building and left the box in
the car. Id. at 89. The surveillance
ended at that point. Id.
On March 20, Investigators conducted
a third surveillance at the Anaheim
Hills clinic. Id. at 94–95. The
surveillance began at approximately
8:45 a.m.; about one hour later, a
woman arrived in a Mercedes-Benz and
walked into the building. Id. at 95.
Respondent arrived by car at about
11:15 a.m. and also entered the
building. Id. DHL delivered a box at
11:40 a.m. Id. At 1:30 p.m., two women
and a man left the office carrying the
box and a flower arrangement, which
they placed in the trunk of one of the
cars. Id. The women drove to a
restaurant a few blocks away, dined,
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and then drove to the 1421 North
Broadway location, taking the flower
arrangement inside. Id. at 96. One of the
women returned to the car, driving it to
a shopping center in Santa Ana. Id. As
the car lacked license plates, the officers
copied the vehicle identification
number (VIN) and determined from the
Department of Motor Vehicles that the
car was registered in Respondent’s
name. Id. at 96–97. The woman returned
to the car, drove elsewhere to pick up
two children, went to a pharmacy and
then to the Seabiscuit Run address
arriving there at about 5:45 p.m. Id. at
97. Surveillance terminated some fifteen
minutes later. Id. The DI testified that
the woman driving the car was Alinka
Robinson, Respondent’s wife. Id. at 98.
On May 9, law enforcement officers
conducted a fourth surveillance. Id. at
104. A box was delivered at 10:12 a.m.,
and Respondent arrived at his office by
car at approximately 12:15 p.m. Id. At
around 2:15 p.m., Respondent placed
the box in his car and returned to the
office; at about 4:30 p.m., Respondent
again left the office and drove to a bank
and a restaurant. Id. In the restaurant
parking lot, Respondent parked next to
a black Humvee that investigators
identified as belonging to Ms. Annan.
Id. at 105–06. Respondent moved three
boxes from his car to the Humvee and
talked for about fifteen minutes with
Ms. Annan in her car; Respondent then
returned to his car and drove away. Id.
at 105. The investigators followed Ms.
Annan to her home in Santa Ana, but
the boxes remained in her car until the
surveillance terminated at 6:30 p.m. Id.
The DI testified that he had opened this
box before it was delivered and that it
contained bottles of hydrocodone. Id. at
107–08.
On May 14, the fifth and final
surveillance was conducted at the 1523
North Broadway location in Santa Ana.
Id. at 106. At 9:24 a.m., DHL delivered
a box. Later, Respondent arrived, and at
about 11:20 a.m., Ms. Annan arrived in
a black Mercedes-Benz. At around noon,
Ms. Annan and another woman put the
box in Ms. Annan’s car and returned to
the building. Id. at 106–07. At
approximately 12:40 p.m., Ms. Annan
left the building and drove to her home,
where she stayed until surveillance
terminated at 6:30 p.m. Id. at 107.
On October 16, 2008, investigators
executed search warrants at the 1523
and 1421 North Broadway locations in
Santa Ana, at the 145 South Chaparral
location in Anaheim Hills, and at Ms.
Annan’s and Respondent’s residences.
Id. at 110. During the search, the
Investigators did not find any records
documenting the disposition of the
hydrocodone products Respondent had
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purchased such as dispensing records.
Id. at 112. While there were some
purchase invoices at Ms. Annan’s
residence, Ms. Annan does not hold a
DEA registration. Id. at 122–23.
During the search of the 1421 North
Broadway location, the Investigators
found a box of hydrocodone products
which had been delivered that very day.
Id. at 124–25; GX 40. At the South
Chaparral location, which was an
operating medical clinic, they found
patient records but no records
documenting the receipt and dispensing
of the hydrocodone products
Respondent had purchased. Tr. 126.
The DI interviewed Respondent, who
reported that he had given the
hydrocodone products to Ms. Annan,
who had told him ‘‘that she was taking
these pills into Mexico to give them to
either the Catholic health clinics or a
doctor down there for poor or people
who can’t get medication on their own.’’
Id. at 114. Respondent provided the
name of a doctor, but no address. Id. at
114–15. However, the DIs were unable
to verify Respondent’s story. Id. at 115.
Respondent does not hold either a
distributor’s or an exporter’s registration
under the Controlled Substances Act. Id.
at 115; GX 1.
Respondent further stated that Ms.
Annan had hired him as medical
director of a clinic, for which she paid
him $10,000 per month, but that he
‘‘rarely went to the clinic at all as far as
seeing patients or to do records.’’ Id. He
indicated that he had given Ms. Annan
permission to order drugs and that she
would either place the orders or tell him
which orders to place. Id. at 116. He
would then ‘‘transfer the boxes to her,
the pills to her.’’ Id. Respondent paid for
the orders with a credit card but then
was reimbursed in cash by Ms. Annan.
Id. at 117. According to the DI,
Respondent said that ‘‘because he was a
doctor he was allowed to order these
pills and that because they were being
delivered to Mexico for poor people it
was okay.’’ Id. at 119. At no point did
Respondent attempt to confirm Ms.
Annan’s statements about where the
drugs were going. Id.
According to Respondent, Ms. Annan
approached him in 2007, and requested
that he open another clinic through
which he could order more pills. Id. at
118. At that point, Respondent opened
the second clinic at the South Chaparral
location in Anaheim Hills and asked Dr.
Bickman to serve as the medical director
so he could order supplies and drugs
under his registration. Id. Later, Ms.
Annan and Respondent ‘‘approached’’
Dr. Mitchell about a third location, the
1421 North Broadway site, ‘‘as a third
office to buy pills.’’ Id. Respondent
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reportedly paid Drs. Bickman and
Mitchell $2,000 per month and $1,000
per month, respectively; both
physicians knew that Respondent was
ordering controlled substances in their
names and using their DEA registration
numbers to do so. Id. at 120–21.10
During the execution of the search
warrants, another DI interviewed Ms.
Annan at her residence. Id. at 145. Ms.
Annan denied that she had ever
received anything from Respondent,
that Respondent had ever put anything
in her vehicle, and that he had ever
given her money. Id. According to Ms.
Annan, Respondent paid half the rent
for the Madre Maria Ines Teresa Health
Center and he also paid her referral fees
for patients that she referred to him for
plastic surgery. Id. at 146. She indicated
that she had worked for a number of
physicians and that the physicians had
always ordered their own drugs. Id.
While executing the warrant at Ms.
Annan’s residence, Investigators found a
black garbage bag in her kitchen which
contained medications, including some
controlled substances. Id. at 147–48. Ms.
Annan indicated that she was taking
them to the Department of Health
Services for destruction. Id. at 148. Ms.
Annan also directed investigators to a
hall closet containing miscellaneous
drugs which she alleged she had
brought home from the office of a Dr.
Marini on instructions from the
Anaheim Police Department, due to
break-ins at the doctor’s office. Id. at
148–49. Ms. Annan denied that she sold
drugs. Id. at 150.
The State Proceeding
On June 3, 2009, the Executive
Director of the Medical Board of
California (‘‘the Board’’) filed a Fourth
Amended Accusation with the Board,
citing twelve different causes for
discipline against Respondent’s state
medical license. Gov’t Mot. Ex. A, at 10,
18–37. On June 22, 2009, Respondent
signed a Stipulated Surrender of License
and Order, in which he agreed that the
Board ‘‘could establish a factual basis
for the First [Cause for Discipline] * * *
in the Fourth Amended Accusation and
that those allegations constitute cause
for discipline.’’ Gov’t Mot., Ex. A, at 4.
10 This is further confirmed by two notes written
by Dr. Bickman to Harvard. A note dated February
21, 2008, signed by Scott Bickman, M.D., requested
that Harvard ‘‘[p]lease change the previous ordering
arrangement for my account to holding all orders
until I have been notified and give verbal
authorization for them to be honored by The
Harvard Group.’’ GX 22, at 2. Then, in a note dated
February 27, 2008, Dr. Bickman requested that
Harvard ‘‘DISREGARD ALL PREVIOUS FAXES
DEMANDING MANAGEMENT OF MY ACCOUNT
AND ALLOW DR. ROBINSON’S OFFICE TO PLACE
ORDERS AS NEEDED.’’ GX 23, at 2.
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Furthermore, Respondent, ‘‘g[a]ve[] up
his right to contest that cause for
discipline exists based on those
charges.’’ 11Id.
The First Cause for Discipline
specifically alleged that between
February 2007 and October 2008,
Respondent ‘‘purchased approximately
613,000 dosage units of hydrocodone
and unlawfully distributed them to an
unregistered individual in exchange for
$10,000.00 per month in violation of 21
U.S.C. 841(a)(1).’’ Id. at 10. It further
alleged that ‘‘[f]rom September 2007
through October 2009, [R]espondent
purchased approximately 397,000
dosage units 12 of hydrocodone using
the DEA registration numbers of two
other practitioners in violation of 21
U.S.C. 843(a)(2) and (3),’’ and ‘‘then
distributed these drugs to an
unregistered individual in violation of
21 U.S.C. 841(a)(1).’’ Id.
The First Cause also alleged that in an
interview on or about October 16, 2008,
Respondent admitted that he had
diverted the aforementioned
hydrocodone products to ‘‘Magdalena
‘Maggie’ Annan’’; that he had given Ms.
Annan ‘‘permission for her to order
drugs’’ such that ‘‘Annan would place
the orders or would tell [R]espondent
what to order and then [R]espondent
would give the hydrocodone to her’’;
that Annan ‘‘was reimbursing
[R]espondent for the cost of the
narcotics and paying [R]espondent
$10,000.00 a month to work as her
medical director * * * at 1523 North
Broadway in Santa Ana’’; and that
Respondent ‘‘rarely went to Annan’s
clinic to see patients and/or review
medical records.’’ Id. at 10–11.
The First Cause further alleged that
Annan asked Respondent to open a
second medical clinic on South
Chaparral so that they could order more
pills and that Respondent asked another
physician, Dr. Scott Bickman, to be the
medical director of this clinic and paid
him $2,000.00 per month; that
Respondent then approached another
physician, Dr. Thomas Mitchell, about
opening a third medical clinic at 1421
11 The Stipulated License Surrender further stated
that the ‘‘admissions made by Respondent herein
are only for the purposes of this proceeding, or any
other proceeding in which the Medical Board of
California or other professional licensing agency is
involved, and shall not be admissible in any other
criminal, civil, administrative, or other
proceeding.’’ Id. DEA is not, however, bound by the
stipulation. See Edmund Chein, 72 FR 6580, 6590
(2007), aff’d Chein v. DEA, 533 F.3d 828 (D.C. Cir.
2008) (stipulated settlement agreed to by a state
board does not bind DEA). In any event, in
enforcing the registration provisions of the CSA,
DEA acts as a professional licensing agency.
12 This figure is even larger than the ARCOS
figures of 265,500 dosage units for Dr. Bickman and
51,500 dosage units for Dr. Mitchell.
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North Broadway, Santa Ana, and paid
him for ‘‘$1,000.00 per month for
permission to use [his] DEA registration
to purchase narcotics and have them
shipped to the 1421 North Broadway
office’’; and that while Annan ‘‘claimed
she was taking the hydrocodone to
Mexico to give to either the Catholic
health services or a doctor for poor
people who could not get medication on
their own,’’ Respondent ‘‘did not know
the name of the organization that Annan
was allegedly giving the narcotics to and
made no efforts to verify Annan’s
claim.’’ Id. at 11.
In the Stipulated Surrender,
Respondent agreed to surrender his
California Physician’s and Surgeon’s
Certificate and that he would ‘‘lose all
rights and privileges as a Physician and
Surgeon in California as of September
30, 2009.’’ Stipulated Surrender and
Order at 4. On July 20, 2009, the
Medical Board of California adopted the
Stipulated Surrender of License and
Order as its decision. The Board further
ordered that its decision would become
effective at 5:00 p.m. on September 30,
2009. Gov’t Mot. Ex. A, at 1.
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Discussion
As an initial matter, I note that
Respondent initially requested a hearing
in this matter. ALJ Ex. 2. While
Respondent was provided with notice of
the date, time and place of the hearing,
he failed to appear. ALJ Ex 1, at 1.
Accordingly, pursuant to 21 CFR
1301.43(d), I conclude that Respondent
has waived his right to a hearing.
Section 304(a) of the Controlled
Substances Act (CSA) provides that a
registration to ‘‘dispense a controlled
substance * * * may be suspended or
revoked by the Attorney General upon
a finding that the registrant * * * has
committed such acts as would render
his registration under section 823 of this
title inconsistent with the public
interest as determined under such
section.’’ 21 U.S.C. 824(a)(2). Moreover,
section 303(f) of the CSA provides that
‘‘[t]he Attorney General may deny an
application for a [practitioner’s]
registration if he determines that the
issuance of such a registration would be
inconsistent with the public interest.’’
21 U.S.C. 823(f). In making the public
interest determination, the CSA requires
the consideration of the following
factors:
(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
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15:15 Nov 23, 2009
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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.
Id.
‘‘[T]hese factors are * * * considered
in the disjunctive.’’ Robert A. Leslie,
M.D., 68 FR 15227, 15230 (2003). I may
rely on any one or a combination of
factors and may give each factor the
weight I deem appropriate in
determining whether to revoke an
existing registration or to deny an
application either to renew an existing
registration or for a new registration. Id.
Moreover, I am ‘‘not required to make
findings as to all of the factors.’’
Volkman v. DEA, 567 F.3d 215, 222 (6th
Cir. 2009); see also Morall v. DEA, 412
F.3d 165, 173–74 (D.C. Cir. 2005).13
Factor One—The Recommendation of
the State Licensing Board
At the time the ALJ rendered her
recommended decision, Respondent
had yet to sign the Stipulated Surrender
of License, and the Board had not
entered its Decision rendering the
surrender of Respondent’s state medical
license effective at 5 p.m. on September
30, 2009. Based on her finding that
‘‘[t]here is no indication that
Respondent is not fully licensed to
practice medicine in California,’’ the
ALJ concluded that this factor weighed
‘‘in favor of a finding that
[Respondent’s] continued registration
would be in the public interest.’’ ALJ at
17.
However, subsequent to the ALJ’s
decision, Respondent agreed to
surrender his state medical license and
that he would ‘‘lose all rights and
privileges as a Physician and Surgeon in
California as of September 30, 2009.’’
Stipulated Surrender and Order at 4.
Accordingly, I conclude that
Respondent no longer holds authority to
dispense controlled substances in
California, the State in which he
practiced medicine. Because the
possession of authority under state law
to dispense controlled substances is an
essential condition for holding a
registration under the CSA, Respondent
is not entitled to maintain his DEA
registration.14 See 21 U.S.C. 823(f),
13 The CSA further provides that ‘‘[t]he Attorney
General may, in his discretion, suspend any
registration simultaneously with the institution of
proceedings under this section, in cases where he
finds that there is an imminent danger to the public
health or safety.’’ 21 U.S.C. 824(d).
14 I therefore reject the ALJ’s findings as to factor
one. Having also considered factor two
(Respondent’s experience in dispensing controlled
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61375
824(a)(3), 802(21). In accordance with
long settled Agency precedent,
Respondent’s loss of his state authority
requires that his CSA registration be
revoked. See John B. Freitas, D.O., 74 FR
17524, 17525 (2009) (collecting cases).
While this provides reason alone to
revoke Respondent’s registration, see 21
U.S.C. 824(a)(3), because Respondent is
not permanently barred from seeking
reinstatement of his State license, I
conclude that a discussion of the
remaining and relevant public interest
factors is warranted.
Factors Four and Five—Respondent’s
Compliance With Applicable Controlled
Substances Laws and Such Other
Conduct Which May Threaten Public
Health and Safety
Under the CSA, a registered
practitioner is authorized to dispense,
21 U.S.C. 823(f), which is defined as ‘‘to
deliver a controlled substance to an
ultimate user * * * by, or pursuant to
the lawful order of, a practitioner.’’ Id.
§ 802(10). See also Rose Mary Jacinta
Lewis, 72 FR 4035, 4040 (2007) (‘‘A
practitioner’s registration * * * grants
its holder authority to obtain controlled
substances for the limited purposes of
conducting research or dispensing them
to an ultimate user.’’) (citing 21 U.S.C.
802(10) & (21), 822(b)).
The CSA further defines the ‘‘[t]he
term ‘distribute’ [as] mean[ing] to
deliver (other than by administering or
dispensing) a controlled substance.’’ Id.
§ 802(11). Moreover, ‘‘[p]ersons
registered * * * under [the CSA] to
* * * dispense controlled substances
* * * are authorized possess * * * or
dispense such substances [only] to the
extent authorized by their registration
and in conformity with the other
provisions of’’ the Act. 21 U.S.C. 822(b);
see also 21 CFR 1301.13(e) (‘‘Any
person who engages in more than one
group of independent activities shall
obtain a separate registration for each
group of activities’’); compare 21 U.S.C.
823(e) (requiring registration ‘‘to
distribute controlled substances in
schedules’’
III–V), with id. § 823(f) (requiring
registration ‘‘to dispense’’ controlled
substances’’ in schedules III–V). Except
for when distributing to another
registered practitioner in accordance
with 21 CFR 1307.11(a), a practitioner
may only engage in dispensing. 21
U.S.C. 822(b).
Accordingly, a practitioner who
delivers a controlled substance to a nonsubstances) and factor three (Respondent’s
conviction record under laws relating to controlled
substances), I conclude that it is not necessary to
make findings as to either factor.
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registered person outside of the course
of professional practice and without a
legitimate medical purpose in doing so
violates Federal law. See 21 U.S.C.
841(a) (‘‘Except as authorized by this
subchapter, it shall be unlawful for any
person knowingly or intentionally
* * * to * * * dispense * * * a
controlled substance.’’). Cf. id. § 844(a)
(‘‘It shall be unlawful for any person
knowingly or intentionally to possess a
controlled substance unless such
substance was obtained directly, or
pursuant to a valid prescription or
order, from a practitioner, while acting
in the course of his professional
practice[.]’’).
The evidence clearly establishes that
Respondent violated Federal law by
distributing controlled substances to
Ms. Annan. See id. § 841(a). As found
above, in a period just exceeding twenty
months, Respondent ordered 640,000
dosage units of schedule III controlled
substances containing hydrocodone on
his own account, or allowed his coconspirator Ms. Annan to do so.
During an interview with a DI,
Respondent admitted that that he had
distributed the drugs to Ms. Annan, who
does not hold a DEA registration.
Moreover, Respondent did not maintain
that he had dispensed the drugs to Ms.
Annan in the course of his professional
practice and pursuant to the rendering
of legitimate medical treatment.15 See 21
U.S.C. 802(21) (defining the term
‘‘practitioner’’ as meaning ‘‘a physician
* * * licensed, registered, or otherwise
permitted, by the United States or the
jurisdiction in which he practices * * *
to dispense * * * a controlled
substance in the course of professional
practice’’); id. § 822(c) (authorizing ‘‘an
ultimate user’’ to possess a controlled
substance’’ for purposes of legitimate
medical treatment without holding a
registration); id. § 802(27) (‘‘The term
‘ultimate user’ means a person who has
lawfully obtained, and who possesses, a
controlled substance for his own use or
for the use of a member of his
household or for an animal owned by
him or by a member of his household.’’).
Moreover, Respondent admitted that he
was paid $10,000 a month by Ms.
Annan in exchange for his obtaining the
drugs for her. Undoubtedly, the drugs
found their way into the illicit market,
either here or in Mexico.16
15 Respondent’s distributions of hydrocodone to
Ms. Annan averaged approximately 47,000 dosage
units a month. This quantity would supply a
significant number of drug abusers.
16 While Respondent maintained that Annan
claimed that she was taking the drugs to Mexico to
give to either ‘‘Catholic health services or a doctor
for poor people,’’ he did nothing to verify her story,
which even if it was true, still implicated her in
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The evidence further shows that
Respondent ordered more than 300,000
dosage units using the DEA registrations
of Drs. Bickman and Mitchell (which
drugs were also distributed to Ms.
Annan), and did so in furtherance of a
conspiracy with Ms. Annan to enable
her to circumvent the maximum order
ceilings of several drug wholesalers. In
addition to constituting violations of 21
U.S.C. 841(a), this conduct was
unlawful for the further reason that
federal law prohibits a person from
‘‘knowingly or intentionally’’ using ‘‘in
the course of the * * * distribution
* * * of a controlled substance, or
* * * us[ing] for the purpose of
acquiring or obtaining a controlled
substance, a registration number which
is * * * issued to another person.’’ 21
U.S.C. 843(a)(2).
Respondent also violated Federal law
and DEA regulations because he failed
to maintain records documenting the
receipt, sale, delivery, and disposition
of controlled substances. See 21 U.S.C.
827(a)(1) (requiring that ‘‘every
registrant * * * shall * * * as soon
* * * as such registrant first engages in
the manufacture, distribution, or
dispensing of controlled substances, and
every second year thereafter, make a
complete and accurate record of all
stocks thereof on hand’’) & (a)(3) (‘‘every
registrant under this subchapter * * *
distributing, or dispensing a controlled
substance or substances shall maintain,
on a current basis, a complete and
accurate record of each such substance
* * * received, sold, delivered, or
otherwise disposed of by him’’).
Moreover, Respondent was required
to maintain these records for at least two
years. Id. § 827(b) (‘‘every inventory or
other record required under this section
* * * shall be kept and be available, for
at least two years, for inspection and
copying’’). See also 21 CFR 1304.03
(‘‘Each registrant shall maintain the
records and inventories and shall file
the reports required by this part, except
as exempted by this section.’’); id.
§ 1304.04 (mandating that records be
maintained for at least two years and be
available for inspection and copying).17
criminal activity. See 21 U.S.C. 953(a) (prohibiting
the exporting of any narcotic drug in schedule
* * * III unless’’ various requirements are met
including that the consignee in the country of
import hold ‘‘a permit or license to import such
drug [which] has been issued by the country of
import’’); 957(a) (requiring registration to ‘‘export
from the United States any controlled substance’’);
960(a) (rendering unlawful the knowing or
intentional exportation of a controlled substance in
violation of sections 953 or 957). However, as found
above, the record amply demonstrates the absurdity
and disingenuousness of Respondent’s contention.
17 In her recommended decision, the ALJ
concluded that the CSA’s recordkeeping provisions
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As found above, during the execution
of the search warrants, the Investigators
did not find any of the required records
at either Respondent’s registered
location or at the two other clinics. See
21 CFR 1304.04.18 I thus conclude that
Respondent violated Federal law and
DEA regulations for this reason as well.
See 21 U.S.C. 842(a)(5) (‘‘It shall be
unlawful for any person * * * to refuse
or negligently fail to make, keep, or
furnish any record, * * * statement,
invoice, or information required under
this subchapter.’’).
Even if Respondent had not
committed the above violations of
Federal law and DEA regulations, I
would nonetheless find that he
committed acts which constitute
‘‘conduct which may threaten the public
health and safety’’ and which render his
registration ‘‘inconsistent with the
public interest.’’ Id. §§ 823(f)(5) &
824(a)(4). More specifically, even if
there had been no conspiracy between
Respondent and Ms. Annan to
unlawfully acquire and distribute the
drugs, he would still be liable for the
acts she committed while being allowed
to use his registration.
Under DEA precedent, a registrant
who entrusts his registration to another
person is strictly liable for the latter’s
misuse of his registration. See Rose
‘‘do not apply’’ to Respondent. ALJ at 18–10 n.22.
Apparently, the ALJ reasoned that because
Respondent was not registered as a distributor, the
recordkeeping provisions applicable to distributors
did not apply to him, and that while he was
registered as a practitioner, because his conduct did
not involve dispensing, but rather distribution, the
recordkeeping requirements applicable to a
practitioner also did not apply. Id. Under the ALJ’s
strange logic, any practitioner who engages in the
criminal distribution of controlled substances
would be immunized for failing to maintain records
documenting his receipt and distribution of
controlled substances.
The ALJ did not cite any authority to support her
reasoning. Contrary to the ALJ’s understanding, the
CSA itself requires that ‘‘every registrant * * *
manufacturing, distributing, or dispensing a
controlled substance or substances shall maintain,
on a current basis, a complete and accurate record
of each such substance manufactured, received,
sold, delivered, or otherwise disposed of by him.’’
21 U.S.C. 827(a)(3). This provision does not make
a registrant’s recordkeeping obligations dependent
on whether the activities he engages in are
permitted by, or exceed, the authority of his
registration.
Moreover, as I have previously explained,
‘‘[r]ecordkeeping is one of the CSA’s central
features,’’ and ‘‘a registrant’s accurate and diligent
adherence to this obligation is absolutely essential
to protect against the diversion of controlled
substances.’’ Paul H. Volkman, 73 FR30630, 30644
(2008), aff’d 567 F.3d 215, 224 (6th Cir. 2009).
Because the ALJ’s conclusion is clearly contrary to
the text of the CSA and would gut an essential
feature of the Act, I reject it.
18 While the Investigators found some invoices at
Ms. Annan’s residence, Respondent was not
authorized to keep his records there. See 21 CFR
1304.04(a)(1).
E:\FR\FM\24NON1.SGM
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Federal Register / Vol. 74, No. 225 / Tuesday, November 24, 2009 / Notices
Mary Jacinta Lewis, M.D., 72 FR 4035
(2007) (affirming immediate suspension
of practitioner’s registration when she
allowed an unregistered person to use
her registration to order controlled
substances, supposedly for exportation
to HIV–AIDS patients in Nigeria). DEA
has repeatedly revoked the registrations
of practitioners for such conduct. See
also Paul Volkman, 73 FR 30630, 30644
& n.42 (2008); Anthony L. Cappelli, 59
FR 42288 (1994). Respondent is thus
liable for Ms. Annan’s acts of unlawful
possession, distribution, and/or
exportation of the controlled substances
that she obtained under his registration.
As the forgoing demonstrates,
Respondent engaged in the knowing and
intentional diversion of controlled
substances and is an egregious violator
of the CSA. In essence, he leased his
DEA registration to Ms. Annan to enable
her to obtain extraordinary quantities of
schedule III narcotics containing
hydrocodone, a drug which is highly
popular with drug abusers and which
was undoubtedly distributed through
illegitimate channels. Moreover, in
furtherance of the conspiracy,
Respondent also paid other doctors to
obtain their DEA numbers so that he
could order even more drugs for her.
Respondent’s conduct does not
remotely resemble the legitimate
practice of medicine. Rather, he engaged
in a criminal conspiracy to distribute
controlled substances. His conduct
clearly constituted ‘‘an imminent danger
to the public health or safety,’’ 21 U.S.C.
824(d), as well as acts which render his
continued registration ‘‘inconsistent
with the public interest.’’ Id. § 824(a)(4).
For these reasons (as well as my finding
that he lacks authority under California
law to dispense controlled substances,
id. § 824(a)(3)), Respondent’s
registration will be revoked and his
pending applications will be denied.
WReier-Aviles on DSKGBLS3C1PROD with NOTICES
Order
Pursuant to the authority vested in me
by 21 U.S.C. 823(f) & 824(a), as well as
28 CFR 0.100(b) & 0.104, I order that
DEA Certificate of Registration,
AR8613487, issued to Harrell E.
Robinson, M.D., be, and it hereby is,
revoked. I further order that
Respondent’s pending applications for
the renewal or modification of this
registration, as well as for additional
registrations, be, and they hereby are,
denied.
Dated: November 17, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9–28190 Filed 11–23–09; 8:45 am]
BILLING CODE 4410–09–P
VerDate Nov<24>2008
15:15 Nov 23, 2009
Jkt 220001
MILLENNIUM CHALLENGE
CORPORATION
[MCC FR 10–01]
Notice of the December 11, 2008
Millennium Challenge Corporation
Board of Directors Meeting; Sunshine
Act Meeting
AGENCY: Millennium Challenge
Corporation.
TIME AND DATE: 10 a.m. to 12 p.m.,
Wednesday, December 9, 2009.
PLACE: Department of State, 2201 C
Street, NW., Washington, DC 20520.
FOR FURTHER INFORMATION CONTACT:
Information on the meeting may be
obtained from Romell Cummings via email at Board@mcc.gov or by telephone
at (202) 521–3600.
STATUS: Meeting will be closed to the
public.
MATTERS TO BE CONSIDERED: The Board
of Directors (the ‘‘Board’’) of the
Millennium Challenge Corporation
(‘‘MCC’’) will hold a meeting to consider
the selection of countries that will be
eligible for FY 2010 Millennium
Challenge Account (‘‘MCA’’) assistance
under Section 607 of the Millennium
Challenge Act of 2003 (the ‘‘Act’’),
codified at 22 U.S.C. 7706; discuss
proposed restructuring of the Mongolia
Compact; and certain administrative
matters. The agenda items are expected
to involve the consideration of classified
information and the meeting will be
closed to the public.
Dated: November 20, 2009.
Henry C. Pitney,
(Acting) Vice President and General Counsel,
Millennium Challenge Corporation.
[FR Doc. E9–28268 Filed 11–20–09; 4:15 pm]
BILLING CODE 9211–03–P
61377
DATES: All comments should be
submitted within 60 calendar days from
the date of this publication.
ADDRESSES: All comments should be
addressed to Mrs. Lori Parker, National
Aeronautics and Space Administration,
Washington, DC 20546–0001.
FOR FURTHER INFORMATION CONTACT:
Requests for additional information or
copies of the information collection
instrument(s) and instructions should
be directed to Mrs. Lori Parker, NASA
PRA Officer, NASA Headquarters, 300 E
Street SW., JF000, Washington, DC
20546, (202) 358–1351, Lori.Parker1@nasa.gov.
SUPPLEMENTARY INFORMATION:
I. Abstract
Pursuant to 35 U.S.C. 209, applicants
for a license under a patent or patent
application must submit information in
support of their request for a license.
NASA uses the submitted information
to grant the license.
II. Method of Collection
The current paper-based system is
used to collect the information. It is
deemed not cost effect to collect the
information using a Web site form since
the applications submitted vary
significantly in format and volume.
III. Data
Title: Application for Patent License.
OMB Number: 2700–0039.
Type of review: Extension of currently
approved collection.
Affected Public: Business or other forprofit, and individuals or households.
Number of Respondents: 60.
Responses per Respondent: 1.
Annual Responses: 60.
Hours per Request: 10 hours.
Annual Burden Hours: 600.
IV. Request for Comments
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
Notice of Information Collection
AGENCY: National Aeronautics and
Space Administration (NASA).
ACTION: Notice of information collection.
Notice: (09—101).
The National Aeronautics and
Space Administration, as part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public and other Federal
agencies to take this opportunity to
comment on proposed and/or
continuing information collections, as
required by the Paperwork Reduction
Act of 1995 (Pub. L. 104–13, 44 U.S.C.
3506(c)(2)(A)).
SUMMARY:
PO 00000
Frm 00061
Fmt 4703
Sfmt 4703
Comments are invited on: (1) Whether
the proposed collection of information
is necessary for the proper performance
of the functions of NASA, including
whether the information collected has
practical utility; (2) the accuracy of
NASA’s estimate of the burden
(including hours and cost) of the
proposed collection of information; (3)
ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) ways to minimize the
burden of the collection of information
on respondents, including automated
collection techniques or the use of other
forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the request for OMB
approval of this information collection.
E:\FR\FM\24NON1.SGM
24NON1
Agencies
[Federal Register Volume 74, Number 225 (Tuesday, November 24, 2009)]
[Notices]
[Pages 61370-61377]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-28190]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 09-32]
Harrell E. Robinson, M.D.; Revocation of Registration
On February 26, 2009, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration to Harrell E. Robinson, M.D. (Respondent),
of Santa Ana, California. The Order proposed the revocation of
Respondent's DEA Certificate of Registration, AR8613487, which
authorizes him to dispense controlled substances in schedules II
through V as a practitioner, on the ground that Respondent's continued
registration is ``inconsistent with the public interest, as that term
is defined in 21 U.S.C. 823(f), 824(a)(4).'' Show Cause Order at 1. The
Order also proposed the denial of any pending applications for renewal
or modification of Respondent's registration. Id.
Specifically, the Show Cause Order alleged that from February 2007
through October 2008, Respondent ``purchased approximately 613,000
dosage units of hydrocodone combination products and unlawfully
distributed these drugs to an unregistered individual in exchange for
$10,000 per month * * * in violation of 21 U.S.C. 841(a)(1).'' Id. In
addition, the Show Cause Order alleged that from September 2007 through
October 2008, Respondent ``purchased approximately 397,000 dosage units
of hydrocodone combination products using the DEA registration numbers
of two other practitioners in violation of 21 U.S.C. 843(a)(2) and
(3).'' Id. at 2. Further, Respondent allegedly then ``distributed these
drugs to an unregistered individual, in violation of 21 U.S.C.
841(a)(1).'' Id.
Based on the above, I further concluded that Respondent's
``continued registration while these proceedings are pending
constitutes an imminent danger to the public health and safety.'' Show
Cause Order at 2. Consequently, pursuant to my authority under 21
U.S.C. 824(d) and 21 CFR 1301.36(e), I immediately suspended
Respondent's registration, with the suspension to remain in effect
until the issuance of this Final Order. Id.
Respondent requested a hearing on the allegations. The case was
placed on the docket of the Agency's Administrative Law Judges (ALJ)
and a hearing was scheduled for May 12, 2009. On April 9, 2009, the ALJ
ordered Respondent to file a prehearing statement no later than May 4,
2009. ALJ at 2 n.1; ALJ Ex. 3. The same day, the ALJ's law clerk faxed
Respondent a letter advising him of his right to counsel. ALJ at 2 n.1;
ALJ Ex. 4.
On May 1, Respondent requested an extension of time to file his
prehearing statement, advising that he was retaining counsel that
afternoon. ALJ at 2 n.1. On May 4, the ALJ granted Respondent an
extension of time to May 7, noting that the hearing was set for May 12
and that Respondent had not asked for a postponement of the hearing.
Id.
On May 6, Respondent filed a request to postpone the hearing; in
response, the ALJ's law clerk ``left a telephone message for Respondent
advising that
[[Page 61371]]
before [the ALJ] could act on his request to postpone the hearing, his
attorney must contact [the ALJ's] office and that all communication
with [the ALJ's] office should be accomplished through the attorney.''
Id. However, no attorney contacted the ALJ's office on Respondent's
behalf. Accordingly, on May 7, the ALJ denied Respondent's request to
postpone the hearing. Id.; ALJ Ex. 6.
On May 12, 2009, the hearing was held as originally scheduled in
Arlington, Virginia. ALJ at 2. At the hearing, the Government was
represented by counsel. Id. By contrast, neither Respondent, nor anyone
purporting to represent him, appeared, and thereafter, Respondent
``filed nothing further'' with the office of the ALJ. Id. at 2 & 2 n.1;
see also 21 CFR 1301.43(d) (``If any person entitled to a hearing * * *
files [a request for a hearing] and fails to appear at the hearing,
such person shall be deemed to have waived the opportunity * * * to
participate in the hearing, unless such person shows good cause for
such failure.'').
At the hearing, the Government called witnesses to testify and
introduced documentary evidence. ALJ at 2. Thereafter, the Government
filed proposed findings of fact, conclusions of law, and argument.
On May 29, 2009, the ALJ issued her Opinion and Recommended Ruling.
On June 24, noting that neither party had filed exceptions to the
opinion, the ALJ forwarded the matter to me for final agency action.
In her discussion of the public interest factors, the ALJ noted
that ``[t]here is no indication that Respondent is not fully licensed
to practice medicine in California.'' ALJ at 17. She therefore found
that ``this factor weighs in favor of a finding that his continued
registration would be in the public interest.'' Id. The ALJ further
explained, however, that because ``state licensure is a necessary but
not sufficient condition for DEA registration,'' this factor was ``not
dispositive.'' Id. As for factors two and four--Respondent's experience
in dispensing controlled substances and compliance with applicable
laws--the ALJ concluded that Respondent violated 21 U.S.C. 841 by
distributing hydrocodone combination products at unregistered locations
to unregistered persons who were not legitimate patients and by
arranging with other physicians to use their DEA registration numbers
to purchase hydrocodone combination products which were also
distributed unlawfully. Id. at 17-18. She also concluded that
Respondent violated 21 U.S.C. 822(a)(1) by distributing the products
without a registration to do so. Id. at 18. Furthermore, the ALJ
concluded that Respondent violated 21 CFR 1301.71(a) by not maintaining
effective controls against diversion of controlled substances. Id.
Finally, the ALJ determined that Respondent had violated California
State Business and Professions Code sections 2242 and 2241.5 in that
(1) he failed to physically examine the individual to whom he had
distributed the drugs and to determine that she had a medical
indication for treatment with hydrocodone combination products, and
that (2) he failed to maintain records of his handling of controlled
substances as required by state law. Id. Accordingly, the ALJ found
that ``these factors weigh in favor of a finding that Respondent's
continued registration would be inconsistent with the public
interest.'' Id.
Noting that the record did not include any evidence that Respondent
had been convicted under any federal or state law relating to the
manufacture, distribution, or dispensing of controlled substances, the
ALJ concluded that the Respondent's conviction record ``although not
dispositive, weighs against finding that Respondent's registration
would be inconsistent with the public interest.'' Id. at 18-19.
Finally, crediting the Diversion Investigator's (DI's) testimony that
Respondent had ``told him that Respondent's status as a physician
allowed him to order hydrocodone and that his orders were acceptable
because the drugs were going to poor people,'' the ALJ concluded that
``[t]his ludicrous attempt to justify his activities indicates that
Respondent has neither respect for nor a willingness to accept the
responsibilities adherent to a DEA registration.'' Id. at 19.
Accordingly, she found that factor five--such other conduct which may
threaten public health or safety--weighed ``in favor of a finding that
Respondent's continued registration would not be consistent with the
public interest.'' Id.
Considering all the factors together, the ALJ concluded that ``a
preponderance of the evidence establishes that Respondent's continued
registration with the DEA would be inconsistent with the public
interest.'' Id. The ALJ therefore recommended that I revoke
Respondent's registration and deny any pending applications. Id.
On August 6, 2009, the Government filed a Motion to Reopen Record.
The basis of the motion was that on June 22, 2009, Respondent, in a
proceeding before the Medical Board of California (``the Board''),
``signed a stipulation which acknowledged that the Board could
establish a factual basis for a series of allegations contained in a
Fourth Amended Accusation, which included twelve (12) causes of action
against him.'' Gov't Mot. at 2. In support of its motion, the
Government attached a copy of the Fourth Amended Accusation and the
Board's Decision and Order of July 20, 2009. Id.
The Board's Decision and Order provided that the attached
Stipulated Surrender of License and Order of June 22, 2009, was
``adopted by the Medical Board of California * * * as its Decision'' in
the matter. Gov't Mot., Exh. A, at 1. The Decision provided that the
Stipulated Surrender of License and Order ``shall become effective at 5
p.m. on September 30, 2009.'' Id. (emphasis in original).
Because the Board's order is clearly material to the public
interest inquiry, see 21 U.S.C. 823(f)(1), was not available at the
time of the hearing, and therefore could not have been presented at the
original hearing, I conclude that the Government has set forth a prima
facie case for reopening the record. Cf. INS v. Abudu, 485 U.S. 94, 97
(1988). I therefore grant the Government's motion to reopen the record
and admit the Board's order to the record.
Having considered the record in its entirety, I hereby issue this
Decision and Final Order. I adopt the ALJ's findings of fact and
conclusions of law except as expressly noted herein. I further adopt
the ALJ's recommended sanction. I make the following findings.
Findings
Respondent is the holder of DEA Certificate of Registration,
AR8613487, which prior to the issuance of the Order of Immediate
Suspension, authorized him to dispense controlled substances in
schedules II through V as a practitioner at the registered location of
1523 North Broadway in Santa Ana, California. GX 1; Tr. 110. While the
registration certificate indicates that the registration was to expire
on April 30, 2008; on March 12, 2008, Respondent submitted a renewal
application. GX 9, at 1. Because Respondent timely filed his renewal
application, and his registration was not then suspended, Respondent
retains a current registration (albeit one which is suspended) pending
the issuance of this Final Order. See 5 U.S.C. 558(c); 21 CFR
1301.36(i).
In February 2008, Respondent also applied for registrations at the
locations of 145 South Chaparral in Anaheim Hills, California, and 1421
North Broadway in Santa Ana. Id. at 111, 134,
[[Page 61372]]
136; GX 7. Both the 1523 North Broadway and the 1421 North Broadway
locations were owned by a Dr. Joy Johnson, but she ``delegated'' the
responsibility for leasing the premises to Ms. Magdalena Annan, an
individual identified as having hired Respondent as the medical
director of the clinic on 1523 North Broadway. Tr. 100, 141.
At the hearing, an Agency Investigator (DI) testified that he
visited the 1523 North Broadway location, which was a house converted
into a business premises; on the front of the house was a sign
indicating the business name as the Madre Maria Ines Teresa Health
Center. Tr. 75. Although the DI observed the property for between two
and three hours, he never saw an individual who appeared to be a
patient entering or exiting the premises. Id. at 75-76.
The DEA Investigation
DEA commenced investigating Respondent in November 2007 because he
was the sixth largest purchaser of hydrocodone combination products
among California physicians for the year 2007. Tr. 55-56, 63; GX 34.
Respondent was known to have purchased controlled substances from four
different wholesalers, including Top RX, Inc., the Harvard Drug Group,
and A.F. Hauser. Tr. 59-60.
The DI confirmed through a Compliance Officer for Top Rx, Inc. (Top
RX), a Tennessee drug wholesaler, that Respondent had purchased 336,000
dosage units \1\ of hydrocodone products \2\ from Top RX between
February 2 and November 12, 2007. Tr. 63-64; GXs 14 & 15. At least one
order was paid for with a check in the name of Madre Maria Ines Teresa
Health Center, 1523 Broadway Street, Santa Ana, California; the holder
of that checking account was Magdalena (``Maggie'') Annan. Tr. 72-73;
GX 16, at 96. According to the Compliance Officer, the ``contact name''
on the account was ``Maggee.'' GX 14.
---------------------------------------------------------------------------
\1\ The ALJ found that Respondent had purchased only 228,700
dosage units from Top Rx, finding that the Compliance Officer had
``advised'' the DI as to that number. ALJ at 3. The DI did not so
testify, and the letter from Compliance Officer did not include any
total of drug dosage units, See GX 14. Rather, only the letter's
attachment provided the data from the orders. See GX 15. In totaling
those orders, I find that Respondent bought 336,000 dosage units
from Top Rx.
\2\ Throughout this Order any reference to hydrocodone products
refers to schedule III drugs which combine hydrocodone with another
active pharmaceutical ingredient such as acetaminophen.
---------------------------------------------------------------------------
In some cases, Ms. Annan ordered the hydrocodone products, and her
name was listed as the accounts payable manager on Respondent's account
with Top RX and the Harvard Drug Group. Tr. 64-65; 73-74; 99-100; GXs
16 & 27. On other occasions, Respondent personally ordered the
hydrocodone combination products. Id. at 10-12, 14.
By January 2008, Respondent ceased to purchase hydrocodone
combination products from Top RX. Instead, in December 2007, he started
purchasing the same type of drugs from Harvard Drug Group (Harvard), a
wholesaler in Michigan. Tr. 8, 79. Mr. S. S., Harvard's Vice President
for Regulatory Affairs, testified that Respondent opened an account
with Harvard in December 2007, indicating that it was an account for a
clinic he owned. Tr. 11. To open the account, on December 26, 2007,
Respondent signed an affidavit in which he attested that he was not
engaged in business as an Internet pharmacy, that he did not dispense
prescriptions by mail to patients, that he was located in an area
accessible to the public, and that walk-in customers were welcome. Tr.
29; GX 24. On his credit application to Harvard, Respondent listed the
accounts payable manager as ``Maggie.'' GX 27. S.S. testified that he
did not know who this individual was. Tr. 43.
In January 2008, Respondent opened a second account with Harvard,
indicating that he owned a second medical clinic whose medical
director, Scott Bickman, M.D.,\3\ would also be purchasing controlled
substances under his own DEA registration. Tr. 11; GX 28. While the
drugs ordered by Dr. Bickman were to be shipped to the second clinic
(145 Chaparral Court in Anaheim Hills), bills were to be sent to
Respondent's main office. Tr. 11-12, 20; GX 30, at 9. Respondent was
listed on the invoices as the person billed. GX 30, at 9, 20.
---------------------------------------------------------------------------
\3\ Dr. Bickman was the sixth largest purchaser of hydrocodone
products in California for 2008. Tr. 57; GX 36.
---------------------------------------------------------------------------
At some point, Respondent opened a third account in the name of
Thomas Mitchell, M.D. Tr. 14, 30. Both Drs. Bickman and Mitchell
provided Harvard with affidavits similar to that provided by Respondent
when he opened the account. Tr. 29-30; GXs 25 & 26.
S.S. testified that Harvard sends its local DEA office (Detroit)
computer-generated reports of orders that the company considers
excessive. Tr. 47. He also testified that Harvard ``reported'' Drs.
Robinson and Bickman ``pretty much every month from January 2008
onward.'' Id. at 49. He additionally testified that Harvard imposes a
quota on the quantity of hydrocodone combination products that a
customer may receive in a given month. Id. at 48.
The evidence further shows that hydrocodone combination products
were the sole products that were purchased from Harvard by Respondent
and Drs. Bickman and Mitchell. GX 29; Tr. 25. Respondent ordered the
drugs by telephone, a matter confirmed to the DI by G.B., an inside
sales representative for Harvard, as well as by e-mail from S.S. to the
DI. Tr. 18-19, 116-17; GX 31, at 3.\4\
---------------------------------------------------------------------------
\4\ Sometime prior to March 2008, the DI had contacted S.S. and
asked him to provide historical information on Respondent's
purchases. Tr. 78-79. Starting in March 2008, the DI asked S.S. to
provide advanced notice of controlled substance deliveries to
Respondent and Drs. Mitchell and Bickman. Tr. 14, 16, 79; GX 31.
S.S. complied with this request, typically, by e-mail. See id.
---------------------------------------------------------------------------
During the months of March through May 2008, S.S. provided e-mail
alerts to the DI regarding Respondent's ordering for the three clinics.
See GX 31. On March 18, S.S. e-mailed the DI, indicating that ``last
night'' Respondent had called and left a message to order more
hydrocodone combination products. GX 31, at 9. S.S. wrote: ``We have
not shipped this order as account has reached its total quantity
allowed for Hydrocodone items for the month.'' Id. Again, on March 18,
S.S. e-mailed as follows:
I spoke with [Respondent] this afternoon. I explained our
company's policy when his orders get cut off when they order group
[sic] of products (Controlled Drugs) which reaches 25,000 tablets a
month. He insisted that his other clinic in Anaheim Hills has not
reached his monthly limit and wants his order shipped at that
location. We ran reports to find out what quantity he has purchased
at his Anaheim Hills clinic. We have so far shipped 17,500 tablets
of Hydrocodone so since he wants balanced [sic] of order shipped,
here is what we have shipped today * * * .
This will be his last shipment for the month. I have explained
to him that any additional orders for Hydrocodone must be placed
with other wholesale distributors as we will not be able to ship any
quantity to either of his clinic [sic] until April 1st.
Id. at 11.
On April 15, S.S. again e-mailed the DI indicating that Respondent
had placed an order for his Anaheim Hills clinic and that Respondent
``also asked if we can ship similar order to his other location but we
have refused to ship because that location has already reached its
monthly purchase limits for above items.'' Id. at 20. Similarly, on
April 22, S.S. advised the DI by e-mail that Respondent ``called to
place additional orders but we refused to fill orders as he has reached
his monthly maximum limit that he could get so we have not filled any
additional orders since our last shipment.'' Id. at 26. S.S. further
advised that Respondent ``may be purchasing from other wholesalers.''
Id.
[[Page 61373]]
In October 2008, Harvard generated computer printouts of the
controlled substances orders it had received from Respondent, Dr.
Mitchell and Dr. Bickman. The printouts showed that Respondent had
ordered 263,500 dosage units \5\ of hydrocodone between December 11,
2007 and October 10, 2008; that Dr. Bickman ordered 213,000 dosage
units \6\ of hydrocodone between December 18, 2007 and October 15,
2008; and that Dr. Mitchell ordered 43,500 dosage units \7\ of
hydrocodone between July 31 and October 15, 2008. GX 29. Most of the
orders were for 10-milligram strength product; others were for 7.5-
milligram strength product. Id.
---------------------------------------------------------------------------
\5\ The ALJ found only 93,000 dosage units. ALJ at 5. The ALJ
appears to have multiplied the bottle-count (500) by the number of
orders rather than by the number of bottles per order.
\6\ The ALJ found only 77,000 dosage units. ALJ at 5. See supra
note 4 for the explanation of the discrepancy.
\7\ The ALJ found only 16,500 dosage units. ALJ at 5. See supra
note 4 for the explanation of the discrepancy.
---------------------------------------------------------------------------
The DI testified that Respondent purchased about 800,000 pills
using his, Dr. Bickman's, and Dr. Mitchell's DEA registrations. Tr.
113-14.\8\ According to DEA's Automated Reports and Consolidated
Ordering System (ARCOS), Respondent purchased a total of 641,400 dosage
units of hydrocodone products under his name between February 2, 2007
and October 10, 2008 (the period of his ordering from Top RX and
Harvard). GX 37. ARCOS data further indicates that 265,500 dosage units
of hydrocodone products were purchased under Dr. Bickman's DEA
registration between October 8, 2007, and September 29, 2008.\9\ GX 38;
Tr. 158. Finally, ARCOS data indicates that 51,500 dosage units of
hydrocodone products were purchased under Dr. Mitchell's DEA
registration between August 22 and October 15, 2008. GX 39; Tr. 158.
---------------------------------------------------------------------------
\8\ This figure includes the approximately 336,000 tablets
obtained from Top RX and the approximately 263,500 obtained from
Harvard on his own account, plus the approximately 213,000 and
43,500 obtained from Harvard on the accounts of Drs. Bickman and
Mitchell. The ALJ's figures are therefore rejected as inconsistent
with the evidence.
\9\ A comparison of ARCOS data with the Harvard data suggests
that Dr. Bickman's account was used to order from an additional
wholesaler.
---------------------------------------------------------------------------
Based on the evidence establishing that Respondent had entered into
arrangements with Drs. Bickman and Mitchell to use their registration
numbers, I find that the purchases made under their registrations are
attributable to Respondent. I further find that between February 2,
2007 and October 10, 2008, Respondent purchased a total of 958,400
dosage units of hydrocodone products.
Agency Investigators, with the help of officers from the Costa
Mesa, California Police Department, conducted surveillance of the
delivery of packages from Harvard to Respondent's clinics on five
occasions. Tr. 80-81. In the first such instance, in mid-February 2008,
the DHL driver could not complete the delivery. Id. at 83.
However, at 9 a.m. on March 12, during a surveillance of the
Anaheim Hills clinic, Investigators observed a delivery which was taken
into the office. Id. Later that morning, at about 11:45 a.m.,
Respondent arrived in his car and went into the office; fifteen minutes
later he emerged with the box, and placed it in the trunk of his car.
Id. at 83-84. Moments later, Respondent got into another car in the
parking lot which was driven by a woman, who then drove him to his car,
where he retrieved the box and placed it in the trunk of the woman's
car. Id. at 84-85, 87. Respondent and the woman then drove
approximately twenty miles to pick up two children at a school and then
returned with the children to the Anaheim Hills clinic. Id. at 86-87.
Some ten or fifteen minutes later, the woman and children got back in
the car and drove to Respondent's residence at 1880 Seabiscuit Run,
Yorba Linda, California. Id. at 87. The woman parked the car in the
garage, leaving the children and the box in the car. Id. at 87-88.
Moments later, the woman emerged, drove to the 1421 North Broadway
clinic, and parked at the rear of the building. Id. at 88. After going
into the office, she returned to the car with another woman, and put
the box in a third car. Id. The other woman then drove away with the
box. Id. at 88-89. The second woman drove approximately five miles to
another house in Santa Ana where another woman got in the car with her;
the two then drove to the Madre Maria Ines Teresa Health Center, where
they entered the building and left the box in the car. Id. at 89. The
surveillance ended at that point. Id.
On March 20, Investigators conducted a third surveillance at the
Anaheim Hills clinic. Id. at 94-95. The surveillance began at
approximately 8:45 a.m.; about one hour later, a woman arrived in a
Mercedes-Benz and walked into the building. Id. at 95. Respondent
arrived by car at about 11:15 a.m. and also entered the building. Id.
DHL delivered a box at 11:40 a.m. Id. At 1:30 p.m., two women and a man
left the office carrying the box and a flower arrangement, which they
placed in the trunk of one of the cars. Id. The women drove to a
restaurant a few blocks away, dined, and then drove to the 1421 North
Broadway location, taking the flower arrangement inside. Id. at 96. One
of the women returned to the car, driving it to a shopping center in
Santa Ana. Id. As the car lacked license plates, the officers copied
the vehicle identification number (VIN) and determined from the
Department of Motor Vehicles that the car was registered in
Respondent's name. Id. at 96-97. The woman returned to the car, drove
elsewhere to pick up two children, went to a pharmacy and then to the
Seabiscuit Run address arriving there at about 5:45 p.m. Id. at 97.
Surveillance terminated some fifteen minutes later. Id. The DI
testified that the woman driving the car was Alinka Robinson,
Respondent's wife. Id. at 98.
On May 9, law enforcement officers conducted a fourth surveillance.
Id. at 104. A box was delivered at 10:12 a.m., and Respondent arrived
at his office by car at approximately 12:15 p.m. Id. At around 2:15
p.m., Respondent placed the box in his car and returned to the office;
at about 4:30 p.m., Respondent again left the office and drove to a
bank and a restaurant. Id. In the restaurant parking lot, Respondent
parked next to a black Humvee that investigators identified as
belonging to Ms. Annan. Id. at 105-06. Respondent moved three boxes
from his car to the Humvee and talked for about fifteen minutes with
Ms. Annan in her car; Respondent then returned to his car and drove
away. Id. at 105. The investigators followed Ms. Annan to her home in
Santa Ana, but the boxes remained in her car until the surveillance
terminated at 6:30 p.m. Id. The DI testified that he had opened this
box before it was delivered and that it contained bottles of
hydrocodone. Id. at 107-08.
On May 14, the fifth and final surveillance was conducted at the
1523 North Broadway location in Santa Ana. Id. at 106. At 9:24 a.m.,
DHL delivered a box. Later, Respondent arrived, and at about 11:20
a.m., Ms. Annan arrived in a black Mercedes-Benz. At around noon, Ms.
Annan and another woman put the box in Ms. Annan's car and returned to
the building. Id. at 106-07. At approximately 12:40 p.m., Ms. Annan
left the building and drove to her home, where she stayed until
surveillance terminated at 6:30 p.m. Id. at 107.
On October 16, 2008, investigators executed search warrants at the
1523 and 1421 North Broadway locations in Santa Ana, at the 145 South
Chaparral location in Anaheim Hills, and at Ms. Annan's and
Respondent's residences. Id. at 110. During the search, the
Investigators did not find any records documenting the disposition of
the hydrocodone products Respondent had
[[Page 61374]]
purchased such as dispensing records. Id. at 112. While there were some
purchase invoices at Ms. Annan's residence, Ms. Annan does not hold a
DEA registration. Id. at 122-23.
During the search of the 1421 North Broadway location, the
Investigators found a box of hydrocodone products which had been
delivered that very day. Id. at 124-25; GX 40. At the South Chaparral
location, which was an operating medical clinic, they found patient
records but no records documenting the receipt and dispensing of the
hydrocodone products Respondent had purchased. Tr. 126.
The DI interviewed Respondent, who reported that he had given the
hydrocodone products to Ms. Annan, who had told him ``that she was
taking these pills into Mexico to give them to either the Catholic
health clinics or a doctor down there for poor or people who can't get
medication on their own.'' Id. at 114. Respondent provided the name of
a doctor, but no address. Id. at 114-15. However, the DIs were unable
to verify Respondent's story. Id. at 115. Respondent does not hold
either a distributor's or an exporter's registration under the
Controlled Substances Act. Id. at 115; GX 1.
Respondent further stated that Ms. Annan had hired him as medical
director of a clinic, for which she paid him $10,000 per month, but
that he ``rarely went to the clinic at all as far as seeing patients or
to do records.'' Id. He indicated that he had given Ms. Annan
permission to order drugs and that she would either place the orders or
tell him which orders to place. Id. at 116. He would then ``transfer
the boxes to her, the pills to her.'' Id. Respondent paid for the
orders with a credit card but then was reimbursed in cash by Ms. Annan.
Id. at 117. According to the DI, Respondent said that ``because he was
a doctor he was allowed to order these pills and that because they were
being delivered to Mexico for poor people it was okay.'' Id. at 119. At
no point did Respondent attempt to confirm Ms. Annan's statements about
where the drugs were going. Id.
According to Respondent, Ms. Annan approached him in 2007, and
requested that he open another clinic through which he could order more
pills. Id. at 118. At that point, Respondent opened the second clinic
at the South Chaparral location in Anaheim Hills and asked Dr. Bickman
to serve as the medical director so he could order supplies and drugs
under his registration. Id. Later, Ms. Annan and Respondent
``approached'' Dr. Mitchell about a third location, the 1421 North
Broadway site, ``as a third office to buy pills.'' Id. Respondent
reportedly paid Drs. Bickman and Mitchell $2,000 per month and $1,000
per month, respectively; both physicians knew that Respondent was
ordering controlled substances in their names and using their DEA
registration numbers to do so. Id. at 120-21.\10\
---------------------------------------------------------------------------
\10\ This is further confirmed by two notes written by Dr.
Bickman to Harvard. A note dated February 21, 2008, signed by Scott
Bickman, M.D., requested that Harvard ``[p]lease change the previous
ordering arrangement for my account to holding all orders until I
have been notified and give verbal authorization for them to be
honored by The Harvard Group.'' GX 22, at 2. Then, in a note dated
February 27, 2008, Dr. Bickman requested that Harvard ``DISREGARD
ALL PREVIOUS FAXES DEMANDING MANAGEMENT OF MY ACCOUNT AND ALLOW DR.
ROBINSON'S OFFICE TO PLACE ORDERS AS NEEDED.'' GX 23, at 2.
---------------------------------------------------------------------------
During the execution of the search warrants, another DI interviewed
Ms. Annan at her residence. Id. at 145. Ms. Annan denied that she had
ever received anything from Respondent, that Respondent had ever put
anything in her vehicle, and that he had ever given her money. Id.
According to Ms. Annan, Respondent paid half the rent for the Madre
Maria Ines Teresa Health Center and he also paid her referral fees for
patients that she referred to him for plastic surgery. Id. at 146. She
indicated that she had worked for a number of physicians and that the
physicians had always ordered their own drugs. Id.
While executing the warrant at Ms. Annan's residence, Investigators
found a black garbage bag in her kitchen which contained medications,
including some controlled substances. Id. at 147-48. Ms. Annan
indicated that she was taking them to the Department of Health Services
for destruction. Id. at 148. Ms. Annan also directed investigators to a
hall closet containing miscellaneous drugs which she alleged she had
brought home from the office of a Dr. Marini on instructions from the
Anaheim Police Department, due to break-ins at the doctor's office. Id.
at 148-49. Ms. Annan denied that she sold drugs. Id. at 150.
The State Proceeding
On June 3, 2009, the Executive Director of the Medical Board of
California (``the Board'') filed a Fourth Amended Accusation with the
Board, citing twelve different causes for discipline against
Respondent's state medical license. Gov't Mot. Ex. A, at 10, 18-37. On
June 22, 2009, Respondent signed a Stipulated Surrender of License and
Order, in which he agreed that the Board ``could establish a factual
basis for the First [Cause for Discipline] * * * in the Fourth Amended
Accusation and that those allegations constitute cause for
discipline.'' Gov't Mot., Ex. A, at 4. Furthermore, Respondent,
``g[a]ve[] up his right to contest that cause for discipline exists
based on those charges.'' \11\Id.
---------------------------------------------------------------------------
\11\ The Stipulated License Surrender further stated that the
``admissions made by Respondent herein are only for the purposes of
this proceeding, or any other proceeding in which the Medical Board
of California or other professional licensing agency is involved,
and shall not be admissible in any other criminal, civil,
administrative, or other proceeding.'' Id. DEA is not, however,
bound by the stipulation. See Edmund Chein, 72 FR 6580, 6590 (2007),
aff'd Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008) (stipulated
settlement agreed to by a state board does not bind DEA). In any
event, in enforcing the registration provisions of the CSA, DEA acts
as a professional licensing agency.
---------------------------------------------------------------------------
The First Cause for Discipline specifically alleged that between
February 2007 and October 2008, Respondent ``purchased approximately
613,000 dosage units of hydrocodone and unlawfully distributed them to
an unregistered individual in exchange for $10,000.00 per month in
violation of 21 U.S.C. 841(a)(1).'' Id. at 10. It further alleged that
``[f]rom September 2007 through October 2009, [R]espondent purchased
approximately 397,000 dosage units \12\ of hydrocodone using the DEA
registration numbers of two other practitioners in violation of 21
U.S.C. 843(a)(2) and (3),'' and ``then distributed these drugs to an
unregistered individual in violation of 21 U.S.C. 841(a)(1).'' Id.
---------------------------------------------------------------------------
\12\ This figure is even larger than the ARCOS figures of
265,500 dosage units for Dr. Bickman and 51,500 dosage units for Dr.
Mitchell.
---------------------------------------------------------------------------
The First Cause also alleged that in an interview on or about
October 16, 2008, Respondent admitted that he had diverted the
aforementioned hydrocodone products to ``Magdalena `Maggie' Annan'';
that he had given Ms. Annan ``permission for her to order drugs'' such
that ``Annan would place the orders or would tell [R]espondent what to
order and then [R]espondent would give the hydrocodone to her''; that
Annan ``was reimbursing [R]espondent for the cost of the narcotics and
paying [R]espondent $10,000.00 a month to work as her medical director
* * * at 1523 North Broadway in Santa Ana''; and that Respondent
``rarely went to Annan's clinic to see patients and/or review medical
records.'' Id. at 10-11.
The First Cause further alleged that Annan asked Respondent to open
a second medical clinic on South Chaparral so that they could order
more pills and that Respondent asked another physician, Dr. Scott
Bickman, to be the medical director of this clinic and paid him
$2,000.00 per month; that Respondent then approached another physician,
Dr. Thomas Mitchell, about opening a third medical clinic at 1421
[[Page 61375]]
North Broadway, Santa Ana, and paid him for ``$1,000.00 per month for
permission to use [his] DEA registration to purchase narcotics and have
them shipped to the 1421 North Broadway office''; and that while Annan
``claimed she was taking the hydrocodone to Mexico to give to either
the Catholic health services or a doctor for poor people who could not
get medication on their own,'' Respondent ``did not know the name of
the organization that Annan was allegedly giving the narcotics to and
made no efforts to verify Annan's claim.'' Id. at 11.
In the Stipulated Surrender, Respondent agreed to surrender his
California Physician's and Surgeon's Certificate and that he would
``lose all rights and privileges as a Physician and Surgeon in
California as of September 30, 2009.'' Stipulated Surrender and Order
at 4. On July 20, 2009, the Medical Board of California adopted the
Stipulated Surrender of License and Order as its decision. The Board
further ordered that its decision would become effective at 5:00 p.m.
on September 30, 2009. Gov't Mot. Ex. A, at 1.
Discussion
As an initial matter, I note that Respondent initially requested a
hearing in this matter. ALJ Ex. 2. While Respondent was provided with
notice of the date, time and place of the hearing, he failed to appear.
ALJ Ex 1, at 1. Accordingly, pursuant to 21 CFR 1301.43(d), I conclude
that Respondent has waived his right to a hearing.
Section 304(a) of the Controlled Substances Act (CSA) provides that
a registration to ``dispense a controlled substance * * * may be
suspended or revoked by the Attorney General upon a finding that the
registrant * * * has committed such acts as would render his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(2). Moreover, section 303(f) of the CSA provides that ``[t]he
Attorney General may deny an application for a [practitioner's]
registration if he determines that the issuance of such a registration
would be inconsistent with the public interest.'' 21 U.S.C. 823(f). In
making the public interest determination, the CSA requires the
consideration of the following factors:
(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.
Id.
``[T]hese factors are * * * considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). I may rely on any one or a
combination of factors and may give each factor the weight I deem
appropriate in determining whether to revoke an existing registration
or to deny an application either to renew an existing registration or
for a new registration. Id. Moreover, I am ``not required to make
findings as to all of the factors.'' Volkman v. DEA, 567 F.3d 215, 222
(6th Cir. 2009); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C.
Cir. 2005).\13\
---------------------------------------------------------------------------
\13\ The CSA further provides that ``[t]he Attorney General may,
in his discretion, suspend any registration simultaneously with the
institution of proceedings under this section, in cases where he
finds that there is an imminent danger to the public health or
safety.'' 21 U.S.C. 824(d).
---------------------------------------------------------------------------
Factor One--The Recommendation of the State Licensing Board
At the time the ALJ rendered her recommended decision, Respondent
had yet to sign the Stipulated Surrender of License, and the Board had
not entered its Decision rendering the surrender of Respondent's state
medical license effective at 5 p.m. on September 30, 2009. Based on her
finding that ``[t]here is no indication that Respondent is not fully
licensed to practice medicine in California,'' the ALJ concluded that
this factor weighed ``in favor of a finding that [Respondent's]
continued registration would be in the public interest.'' ALJ at 17.
However, subsequent to the ALJ's decision, Respondent agreed to
surrender his state medical license and that he would ``lose all rights
and privileges as a Physician and Surgeon in California as of September
30, 2009.'' Stipulated Surrender and Order at 4. Accordingly, I
conclude that Respondent no longer holds authority to dispense
controlled substances in California, the State in which he practiced
medicine. Because the possession of authority under state law to
dispense controlled substances is an essential condition for holding a
registration under the CSA, Respondent is not entitled to maintain his
DEA registration.\14\ See 21 U.S.C. 823(f), 824(a)(3), 802(21). In
accordance with long settled Agency precedent, Respondent's loss of his
state authority requires that his CSA registration be revoked. See John
B. Freitas, D.O., 74 FR 17524, 17525 (2009) (collecting cases). While
this provides reason alone to revoke Respondent's registration, see 21
U.S.C. 824(a)(3), because Respondent is not permanently barred from
seeking reinstatement of his State license, I conclude that a
discussion of the remaining and relevant public interest factors is
warranted.
---------------------------------------------------------------------------
\14\ I therefore reject the ALJ's findings as to factor one.
Having also considered factor two (Respondent's experience in
dispensing controlled substances) and factor three (Respondent's
conviction record under laws relating to controlled substances), I
conclude that it is not necessary to make findings as to either
factor.
---------------------------------------------------------------------------
Factors Four and Five--Respondent's Compliance With Applicable
Controlled Substances Laws and Such Other Conduct Which May Threaten
Public Health and Safety
Under the CSA, a registered practitioner is authorized to dispense,
21 U.S.C. 823(f), which is defined as ``to deliver a controlled
substance to an ultimate user * * * by, or pursuant to the lawful order
of, a practitioner.'' Id. Sec. 802(10). See also Rose Mary Jacinta
Lewis, 72 FR 4035, 4040 (2007) (``A practitioner's registration * * *
grants its holder authority to obtain controlled substances for the
limited purposes of conducting research or dispensing them to an
ultimate user.'') (citing 21 U.S.C. 802(10) & (21), 822(b)).
The CSA further defines the ``[t]he term `distribute' [as]
mean[ing] to deliver (other than by administering or dispensing) a
controlled substance.'' Id. Sec. 802(11). Moreover, ``[p]ersons
registered * * * under [the CSA] to * * * dispense controlled
substances * * * are authorized possess * * * or dispense such
substances [only] to the extent authorized by their registration and in
conformity with the other provisions of'' the Act. 21 U.S.C. 822(b);
see also 21 CFR 1301.13(e) (``Any person who engages in more than one
group of independent activities shall obtain a separate registration
for each group of activities''); compare 21 U.S.C. 823(e) (requiring
registration ``to distribute controlled substances in schedules'' III-
V), with id. Sec. 823(f) (requiring registration ``to dispense''
controlled substances'' in schedules III-V). Except for when
distributing to another registered practitioner in accordance with 21
CFR 1307.11(a), a practitioner may only engage in dispensing. 21 U.S.C.
822(b).
Accordingly, a practitioner who delivers a controlled substance to
a non-
[[Page 61376]]
registered person outside of the course of professional practice and
without a legitimate medical purpose in doing so violates Federal law.
See 21 U.S.C. 841(a) (``Except as authorized by this subchapter, it
shall be unlawful for any person knowingly or intentionally * * * to *
* * dispense * * * a controlled substance.''). Cf. id. Sec. 844(a)
(``It shall be unlawful for any person knowingly or intentionally to
possess a controlled substance unless such substance was obtained
directly, or pursuant to a valid prescription or order, from a
practitioner, while acting in the course of his professional
practice[.]'').
The evidence clearly establishes that Respondent violated Federal
law by distributing controlled substances to Ms. Annan. See id. Sec.
841(a). As found above, in a period just exceeding twenty months,
Respondent ordered 640,000 dosage units of schedule III controlled
substances containing hydrocodone on his own account, or allowed his
co-conspirator Ms. Annan to do so.
During an interview with a DI, Respondent admitted that that he had
distributed the drugs to Ms. Annan, who does not hold a DEA
registration. Moreover, Respondent did not maintain that he had
dispensed the drugs to Ms. Annan in the course of his professional
practice and pursuant to the rendering of legitimate medical
treatment.\15\ See 21 U.S.C. 802(21) (defining the term
``practitioner'' as meaning ``a physician * * * licensed, registered,
or otherwise permitted, by the United States or the jurisdiction in
which he practices * * * to dispense * * * a controlled substance in
the course of professional practice''); id. Sec. 822(c) (authorizing
``an ultimate user'' to possess a controlled substance'' for purposes
of legitimate medical treatment without holding a registration); id.
Sec. 802(27) (``The term `ultimate user' means a person who has
lawfully obtained, and who possesses, a controlled substance for his
own use or for the use of a member of his household or for an animal
owned by him or by a member of his household.''). Moreover, Respondent
admitted that he was paid $10,000 a month by Ms. Annan in exchange for
his obtaining the drugs for her. Undoubtedly, the drugs found their way
into the illicit market, either here or in Mexico.\16\
---------------------------------------------------------------------------
\15\ Respondent's distributions of hydrocodone to Ms. Annan
averaged approximately 47,000 dosage units a month. This quantity
would supply a significant number of drug abusers.
\16\ While Respondent maintained that Annan claimed that she was
taking the drugs to Mexico to give to either ``Catholic health
services or a doctor for poor people,'' he did nothing to verify her
story, which even if it was true, still implicated her in criminal
activity. See 21 U.S.C. 953(a) (prohibiting the exporting of any
narcotic drug in schedule * * * III unless'' various requirements
are met including that the consignee in the country of import hold
``a permit or license to import such drug [which] has been issued by
the country of import''); 957(a) (requiring registration to ``export
from the United States any controlled substance''); 960(a)
(rendering unlawful the knowing or intentional exportation of a
controlled substance in violation of sections 953 or 957). However,
as found above, the record amply demonstrates the absurdity and
disingenuousness of Respondent's contention.
---------------------------------------------------------------------------
The evidence further shows that Respondent ordered more than
300,000 dosage units using the DEA registrations of Drs. Bickman and
Mitchell (which drugs were also distributed to Ms. Annan), and did so
in furtherance of a conspiracy with Ms. Annan to enable her to
circumvent the maximum order ceilings of several drug wholesalers. In
addition to constituting violations of 21 U.S.C. 841(a), this conduct
was unlawful for the further reason that federal law prohibits a person
from ``knowingly or intentionally'' using ``in the course of the * * *
distribution * * * of a controlled substance, or * * * us[ing] for the
purpose of acquiring or obtaining a controlled substance, a
registration number which is * * * issued to another person.'' 21
U.S.C. 843(a)(2).
Respondent also violated Federal law and DEA regulations because he
failed to maintain records documenting the receipt, sale, delivery, and
disposition of controlled substances. See 21 U.S.C. 827(a)(1)
(requiring that ``every registrant * * * shall * * * as soon * * * as
such registrant first engages in the manufacture, distribution, or
dispensing of controlled substances, and every second year thereafter,
make a complete and accurate record of all stocks thereof on hand'') &
(a)(3) (``every registrant under this subchapter * * * distributing, or
dispensing a controlled substance or substances shall maintain, on a
current basis, a complete and accurate record of each such substance *
* * received, sold, delivered, or otherwise disposed of by him'').
Moreover, Respondent was required to maintain these records for at
least two years. Id. Sec. 827(b) (``every inventory or other record
required under this section * * * shall be kept and be available, for
at least two years, for inspection and copying''). See also 21 CFR
1304.03 (``Each registrant shall maintain the records and inventories
and shall file the reports required by this part, except as exempted by
this section.''); id. Sec. 1304.04 (mandating that records be
maintained for at least two years and be available for inspection and
copying).\17\
---------------------------------------------------------------------------
\17\ In her recommended decision, the ALJ concluded that the
CSA's recordkeeping provisions ``do not apply'' to Respondent. ALJ
at 18-10 n.22. Apparently, the ALJ reasoned that because Respondent
was not registered as a distributor, the recordkeeping provisions
applicable to distributors did not apply to him, and that while he
was registered as a practitioner, because his conduct did not
involve dispensing, but rather distribution, the recordkeeping
requirements applicable to a practitioner also did not apply. Id.
Under the ALJ's strange logic, any practitioner who engages in the
criminal distribution of controlled substances would be immunized
for failing to maintain records documenting his receipt and
distribution of controlled substances.
The ALJ did not cite any authority to support her reasoning.
Contrary to the ALJ's understanding, the CSA itself requires that
``every registrant * * * manufacturing, distributing, or dispensing
a controlled substance or substances shall maintain, on a current
basis, a complete and accurate record of each such substance
manufactured, received, sold, delivered, or otherwise disposed of by
him.'' 21 U.S.C. 827(a)(3). This provision does not make a
registrant's recordkeeping obligations dependent on whether the
activities he engages in are permitted by, or exceed, the authority
of his registration.
Moreover, as I have previously explained, ``[r]ecordkeeping is
one of the CSA's central features,'' and ``a registrant's accurate
and diligent adherence to this obligation is absolutely essential to
protect against the diversion of controlled substances.'' Paul H.
Volkman, 73 FR30630, 30644 (2008), aff'd 567 F.3d 215, 224 (6th Cir.
2009). Because the ALJ's conclusion is clearly contrary to the text
of the CSA and would gut an essential feature of the Act, I reject
it.
---------------------------------------------------------------------------
As found above, during the execution of the search warrants, the
Investigators did not find any of the required records at either
Respondent's registered location or at the two other clinics. See 21
CFR 1304.04.\18\ I thus conclude that Respondent violated Federal law
and DEA regulations for this reason as well. See 21 U.S.C. 842(a)(5)
(``It shall be unlawful for any person * * * to refuse or negligently
fail to make, keep, or furnish any record, * * * statement, invoice, or
information required under this subchapter.'').
---------------------------------------------------------------------------
\18\ While the Investigators found some invoices at Ms. Annan's
residence, Respondent was not authorized to keep his records there.
See 21 CFR 1304.04(a)(1).
---------------------------------------------------------------------------
Even if Respondent had not committed the above violations of
Federal law and DEA regulations, I would nonetheless find that he
committed acts which constitute ``conduct which may threaten the public
health and safety'' and which render his registration ``inconsistent
with the public interest.'' Id. Sec. Sec. 823(f)(5) & 824(a)(4). More
specifically, even if there had been no conspiracy between Respondent
and Ms. Annan to unlawfully acquire and distribute the drugs, he would
still be liable for the acts she committed while being allowed to use
his registration.
Under DEA precedent, a registrant who entrusts his registration to
another person is strictly liable for the latter's misuse of his
registration. See Rose
[[Page 61377]]
Mary Jacinta Lewis, M.D., 72 FR 4035 (2007) (affirming immediate
suspension of practitioner's registration when she allowed an
unregistered person to use her registration to order controlled
substances, supposedly for exportation to HIV-AIDS patients in
Nigeria). DEA has repeatedly revoked the registrations of practitioners
for such conduct. See also Paul Volkman, 73 FR 30630, 30644 & n.42
(2008); Anthony L. Cappelli, 59 FR 42288 (1994). Respondent is thus
liable for Ms. Annan's acts of unlawful possession, distribution, and/
or exportation of the controlled substances that she obtained under his
registration.
As the forgoing demonstrates, Respondent engaged in the knowing and
intentional diversion of controlled substances and is an egregious
violator of the CSA. In essence, he leased his DEA registration to Ms.
Annan to enable her to obtain extraordinary quantities of schedule III
narcotics containing hydrocodone, a drug which is highly popular with
drug abusers and which was undoubtedly distributed through illegitimate
channels. Moreover, in furtherance of the conspiracy, Respondent also
paid other doctors to obtain their DEA numbers so that he could order
even more drugs for her.
Respondent's conduct does not remotely resemble the legitimate
practice of medicine. Rather, he engaged in a criminal conspiracy to
distribute controlled substances. His conduct clearly constituted ``an
imminent danger to the public health or safety,'' 21 U.S.C. 824(d), as
well as acts which render his continued registration ``inconsistent
with the public interest.'' Id. Sec. 824(a)(4). For these reasons (as
well as my finding that he lacks authority under California law to
dispense controlled substances, id. Sec. 824(a)(3)), Respondent's
registration will be revoked and his pending applications will be
denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) &
824(a), as well as 28 CFR 0.100(b) & 0.104, I order that DEA
Certificate of Registration, AR8613487, issued to Harrell E. Robinson,
M.D., be, and it hereby is, revoked. I further order that Respondent's
pending applications for the renewal or modification of this
registration, as well as for additional registrations, be, and they
hereby are, denied.
Dated: November 17, 2009.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E9-28190 Filed 11-23-09; 8:45 am]
BILLING CODE 4410-09-P