[Federal Register Volume 72, Number 18 (Monday, January 29, 2007)]
[Notices]
[Pages 4035-4042]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-1318]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 04-36]
Rose Mary Jacinta Lewis, M.D.; Affirmance of Immediate Suspension
On March 22, 2004, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Notice of
Immediate Suspension of the practitioner's Certificate of Registration,
AL8962993, held by Rose Mary Jacinta Lewis, M.D. (Respondent), of
Richmond, CA. The Notice of Immediate Suspension was based on my
preliminary finding that substantial amounts of Schedule III controlled
substances that had been ordered using Respondent's DEA registration
could not be accounted for. Show Cause Order at 7. Based on the
significant risk that these drugs had been diverted as well as evidence
showing that Respondent had allowed unregistered entities and
individuals to use her registration to obtain controlled substances, I
concluded that Respondent's continued registration ``would constitute
an imminent danger to the public health and safety.'' Id.
More specifically, the Show Cause Order alleged that in September
2003, R & S Sales, a registered distributor, had reported to DEA ``that
excessive amounts of controlled substances were being ordered under''
Respondent's name and registration number. Id. at 2. The Show Cause
Order further alleged that shortly thereafter, DEA investigators went
to Respondent's registered location and determined that Respondent was
no longer practicing medicine at the location and had retired from
practice and vacated the premises six months earlier. See id. During
the attempted visit, DEA investigators found several United Parcel
Service (UPS) delivery notices including one from R & S. See id.
According to the Show Cause Order, DEA investigators subsequently
determined that on September 10, 2003, an order for 300 bottles, each
containing 500 count hydrocodone/apap \1\ (7.5/75), a Schedule III
controlled substance, had been placed with R & S under Respondent's
registration and that UPS had been unable to deliver the order to
Respondent's former office. See id. The Show Cause Order further
alleged that the order was subsequently delivered to an entity known as
International Surplus Medical Products, Inc. (ISMP), at its Richmond,
California office. See id. The address was not, however, a registered
location. See id.
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\1\ Apap is an abbreviation for acetaminophen.
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The Show Cause Order next alleged that on November 24, 2003,
Respondent left a voicemail message with a DEA investigator in which
she stated that she was ISMP's medical director and was using her
medical license to order supplies. See id. According to the Show Cause
Order, a DEA investigator then called Respondent and advised her that R
& S could not ship supplies to ISMP's office because it was not a
registered location. Id. at 3. The Show Cause Order alleged that during
the conversation, Respondent stated that she was working for a non-
profit project that provided medical supplies for AIDS patients in
Nigeria, that the project ordered only AIDS-related drugs such as AZT,
and that it was not ordering controlled substances. See id.
The Show Cause Order further alleged that following the
conversation, Respondent submitted a written request to change the
address of her registered location to ISMP's Richmond office. Id. The
Show Cause Order alleged that in her letter requesting the change,
Respondent stated that she worked with ISMP, a non-profit entity that
``sends AIDS drugs to Nigeria.'' Id. On December 1, 2003, DEA personnel
changed the address of Respondent's registered location to ISMP's
office. Id.
The Show Cause Order next alleged that during the week of December
3, 2003, R & S notified DEA that on November 26, 2003, an order for 504
bottles, each containing 500 tablets of hydrocodone/apap, had been
placed using Respondent's registration. See id. The Show Cause Order
alleged that R & S was told to ship the order to Respondent's former
office, and that on December 1, 2003, 19 packages were received at that
address and an additional package was sent to ISMP's office. Id.
The Show Cause Order alleged that on December 10, 2003, DEA
investigators attempted to serve an Administrative Inspection Warrant
at ISMP's office but no one was present. See id. The Show Cause Order
next alleged that on January 15, 2004, DEA investigators interviewed
Respondent at her home. Id. During the interview Respondent allegedly
told investigators that she had retired from medical practice and was
working as ISMP's medical director. Id.
The Show Cause Order further alleged that Respondent told the
investigators that she had provided her DEA number to Mr. Chuka Ogele,
ISMP's Chief Executive Officer, so that he could order medical supplies
and controlled substances which were to be exported to Nigeria, and
that she denied personally
[[Page 4036]]
placing any orders for controlled substances. Id. at 4. The Show Cause
Order alleged that during the interview, Respondent stated that she did
not know how what drugs and quantities Ogele had ordered from R & S and
also had none of the records that she was required to maintain under
federal law. Id. According to the Show Cause Order, Respondent also
told the investigators that she did not have a key to the ISMP office,
notwithstanding that it was her new registered location. Id.
The Show Cause Order alleged that DEA investigators then contacted
Ogele, who stated that he did not keep the records at ISMP's office but
rather at his home. Id. According to the allegations, the investigators
subsequently interviewed Ogele, who told them that controlled
substances were ordered based on requests he received from Nigeria, and
that he either personally carried the drugs to Nigeria or arranged for
unidentified Nigerian ``diplomats'' to pick up the drugs in San
Francisco and take them to Nigeria. Id.
The Show Cause Order further alleged that the investigators
inventoried the controlled substances at the ISMP office. Id. The Show
Cause Order alleged that the office had neither a substantially
constructed cabinet nor an alarm system. Id. at 4-5.
The Show Cause Order next alleged that on January 22, 2004, an
employee of the physician who had purchased Respondent's former office
informed the investigators that several months earlier, a shipment of
controlled substances had been received by a workman who was renovating
the office and had been stored there. See id. at 5. The shipment was
turned over to the investigators, who determined based on a packing
slip, that five boxes were shipped by R & S on August 14, 2003, that
each box held 36 bottles (each containing 500 tables of hydrocodone/
apap), and that the order had been placed by Ogele. See id. The Show
Cause Order further alleged that the other four boxes have not been
accounted for. See id.
The Show Court Order also alleged that on January 26, 2004, DEA
investigators went to ISMP's office to serve an administrative
inspection warrant. Id. According to the Order, the investigators
seized thirty thousand dosage units of hydrocodone/apap (in sixty 500-
count bottles) and 211,000 dosage units of codeine/apap (in 500 and
1,000 count bottles). Id. at 6.
Finally, the Show Cause Order alleged that Respondent did not
maintain any of the records documenting the receipt and disposition of
the controlled substances that were ordered under her registration. Id.
at 6-7. The Order further alleged that the disposition of ``the bulk of
the controlled substances ordered under [Respondent's] name and
registration from March 2003'' through the issuance of the Order of
Immediate Suspension were unknown. Id. at 7.
On April 5, 2004, DEA Investigators personally served Respondent
with the Order to Show Cause and Immediate Suspension. ALJ Ex. 2, at 1.
Thereafter, on May 3, 2004, Respondent through her counsel, timely
requested a hearing. See id. Respondent also responded to the Show
Cause Order's allegations.
The matter was assigned to Administrative Law Judge (ALJ) Gail
Randall, who conducted a hearing in San Francisco, CA, on August 2 and
3, 2005. At the hearing, both parties called witnesses and introduced
documentary evidence. Following the hearing, both parties submitted
proposed findings of fact and conclusions of law.
On September 26, 2006, the ALJ issued her decision. ALJ at 1. The
ALJ concluded that the Government had proved by a preponderance of the
evidence that the continuation of Respondent's registration would be
inconsistent with the public interest. The ALJ also concluded that
``Respondent's lack of responsible handling of the authority granted to
her through her DEA registration poses a threat to the public health
and safety,'' and recommended that I revoke her Certificate of
Registration. Id. at 38. Neither party filed exceptions.
Having carefully reviewed the record as a whole, 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 affirm
the immediate suspension of Respondent's registration and make the
following findings.
Findings Of Fact
Respondent has held a California Physician and Surgeon's license
since July 1, 1975, which remains in active status. Respondent
practiced medicine as a plastic surgeon from 1980 until March 2003.
During March 2003, Respondent closed her practice and sold her office
condominium to Dr. Randy Weil. Her state license has never been
subjected to disciplinary action. ALJ at 3-4.
Respondent held DEA Certificate of Registration, AL8962993, which
was issued on December 1, 2003, and expired on March 31, 2006. Gov. Ex.
1. According to DEA records, Respondent has not submitted a renewal
application.\2\ I thus find that Respondent is not currently
registered. Respondent testified, however, that ``[j]ust because [she]
closed [her] practice didn't mean [she] was never going to work
again.'' Tr. 353.
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\2\ Under the Administrative Procedure Act (APA), an agency
``may take official notice of facts at any stage in a proceeding-
even in the final decision.'' U.S. Dept. of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and
DEA regulations, Respondent is ``entitled on timely request, to an
opportunity to show to the contrary.'' 5 U.S.C. 556(e); see also 21
CFR 1316.59(e). To allow Respondent the opportunity to refute the
fact of which I am taking official notice, publication of this final
order shall be withheld for fifteen days, which shall begin on the
date of service by placing this order in the mail.
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With respect to the events which are the subject of this
proceeding, Respondent's registered location was initially 203 Willow
St., Suite 303, San Francisco, CA. On December 1, 2003, Respondent's
registered location was changed to 120 Broadway St. Suite 3, Richmond,
CA. Gov. Ex. 2.
On November 5, 1996, Chuka Ogele founded International Surplus
Medical Products, Inc. (ISMP), which was organized for charitable
purposes under section 501(c)(3), of the Internal Revenue Code. Resp.
Ex. 10, at 2. According to its articles of incorporation, ISMP's
purpose was ``to distribute medical supplies in developing nations.''
Id. Ogele appointed himself Chairman and Managing Director. Resp. Ex.
12.
Sometime in either 2001 or 2002, Respondent was introduced to Ogele
by Sherrone Smith, an ISMP board member who had taught Ogele at the
College of Alameda. Tr. at 66-67, 262. Respondent met with Ogele, who
told her that ISMP had been in existence for six or seven years and
that the entity provided vitamins to developing countries. Id. at 262-
63. Ogele told Respondent that he wanted to provide medications to
treat HIV/AIDS. Id. at 263. Ogele offered Respondent a position on
ISMP's board gave her the title of Associate Medical Director. Id. 263.
Respondent subsequently gave Ogele a copy of her state medical
license and her DEA registration. Id. 327. Respondent maintained that
she did so to enable Ogele to order supplies, that ``[a]ll the
suppliers require that you give them both licenses,'' and that she had
``never had one, even if [she was not] ordering * * * controlled
substances, [that] didn't request both licenses.'' Id. Respondent
further testified that she provided her DEA registration to Ogele
without checking out his background. Id. at 329.
The DEA Investigation
Respondent first came to the attention of DEA in September 2003,
when R &
[[Page 4037]]
S Sales notified the DEA Louisville office of Respondent's excessive
purchases of controlled substances including hydrocodone, acetaminophen
with codeine, and promethazine with codeine. ALJ at 4 (citing Tr. 12-
13). The information was forwarded to a Diversion Investigator (DI)
with the San Francisco Diversion Group.
The DI went to Respondent's registered location at 203 Willow
Street, San Francisco only to find that her office was vacant. Tr. 14-
15. The DI inquired with the building's management company as to
Respondent's whereabouts; the DI was told that, in March 2003, she had
retired and vacated her office. Id. 15.
The DI subsequently contacted R & S Sales. R & S advised the DI
that, on September 10, 2003, an additional purchase of a controlled
substance had been made with Respondent's registration. Tr. 15-16. The
purchase was for 300 bottles, each containing 500 tablets of
hydrocodone/apap. Gov. Ex. 17. The invoice lists the name ``CHUKA''
under the Purchase Order Number. Id. It also indicates that ISMP was to
be billed for the order and that the drugs were to be shipped to
Respondent at the Willow St. office which she had since vacated. Id.
The DI contacted UPS to ascertain whether the shipment had been
delivered. Tr. at 16. UPS informed the DI that it had attempted two
deliveries at Respondent's former office and that someone had changed
the address of the delivery to ISMP's office at 120 Broadway in
Richmond. Id. UPS subsequently delivered the drugs to Chuka Ogele at
this address. Id.
On November 26, 2003, the DI received a voicemail message from
Respondent. In this message, Respondent stated that Chuka Ogele, ISMP's
chairman, had been attempting to call the DI regarding the ordering of
supplies. Id. at 17. In the message, Respondent also stated that she
was ISMP's medical director and that ISMP ``was using her medical
license to order medical supplies.'' Id. Respondent requested that the
DI call her. Id. at 18.
The DI phoned Respondent. Respondent told the DI that R & S would
not deliver medical products to ISMP's office because it was not
registered under her name and address. Id. The DI told Respondent that
she needed to change the address of her registration. Id. According to
the DI, Respondent said during the call that ``she was not ordering
controlled substances, but was ordering * * * AIDS drugs such as AZT.''
Id.
Subsequently, Respondent submitted a letter requesting a change of
the address of her registered location. Id. On December 1, 2003, DEA
changed the address of her registered location to ISMP's office. Id. at
19.
Shortly thereafter, the DI received another phone call from R & S.
Id. During this call, the DI was informed that on November 26, 2003,
another order for controlled substances had been placed using
Respondent's registration and her former office as the address that the
drugs were to be shipped to. Id.; see also Gov. Ex. 16, at 2. This
order was for 504 bottles each containing 500 count of hydrocodone/apap
7.5/750mg.\3\
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\3\ The order also included one bottle of 100 ativan (2 mg.)
tablets. Gov. Ex. 16, at 2.
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Following the receipt of this information, the DI obtained an
administrative inspection warrant for the ISMP's office. Tr. 19. On
December 10, 2003, the DI, along with other DEA investigators,
attempted to serve the warrant. Id. Upon their arrival at ISMP's
office, the DIs could not serve the warrant because no one was present.
Id. at 20.
On January 15, 2004, the DI, accompanied by another DI and a
Special Agent, went to Respondent's residence to interview her
regarding the large quantities of controlled substances that were being
ordered using her registration. Id. at 20-21. During the interview,
Respondent told the investigators that she was the medical director of
ISMP, that the organization assisted AIDS patients in Nigeria, and that
Chuka Ogele was the chairman. Id. at 21.
Respondent further told the DIs that Ogele was using her DEA number
to order medical supplies from R & S Sales and that she had not
personally placed any of the orders. Id. at 23. Respondent told the DI
that ``she did not know what types of controlled substances [were]
being ordered by Ogele,'' id., but indicated that the drugs were being
ordered for AIDS patients. Id. at 24. Respondent did not have any
records documenting the purchases of the controlled substances but
thought that the records might be at ISMP's office. Id. Respondent did
not, however, have access to the office as Ogele ``had the only key.''
Id.
During the interview, the other DI told Respondent that she was
liable for giving her registration to another person and not knowing
what drugs were being ordered. Id. at 25. Respondent stated that she
understood. Id. The investigators also told Respondent that they needed
to see the records. Id. Respondent contacted Ogele, who agreed to meet
with the investigators later that day at ISMP's office. Id. at 25-26.
The investigators subsequently met with Ogele at ISMP's office. Id.
at 26. During the meeting, Ogele told the investigators that he was
ISMP's chairman and that the controlled substances he was ordering from
R & S were for Nigerian AIDS patients. Id. at 27-28. Ogele provided the
investigators with several documents from officials of the Government
of Benue State, Nigeria. Id. at 30; see also Gov. Ex. 6 & 7. While
these documents show that Benue State Ministry of Health requested that
ISMP supply it with various drugs for treating HIV and other
opportunistic infections, Benue State officials did not request that
ISMP supply any controlled substances. See Gov. Exs. 6 & 7.
As for the controlled substance records, Ogele provided the
investigators with four invoices for the purchase of controlled
substances. Tr. 30. Subsequently, a DI determined that about thirteen
orders for controlled substances had, in fact, been placed with R & S
using Respondent's registration. Id. at 29.
Moreover, Ogele did not provide any records documenting the
distribution of the controlled substances. Id. at 27. During the
interview, Ogele stated that he would sometimes take controlled
substances to Nigeria in his luggage. Id. at 31. Ogele also stated that
sometimes Nigerian diplomats would come to San Francisco to obtain the
controlled substances and take them back to Nigeria. Id. Ogele did not
hold any DEA registration and Respondent was not registered as an
exporter. Id. at 31-32. The investigators told Ogele that he did not
have the registration required under federal law to export controlled
substances. Id. at 31. The investigators also determined that there
were controlled substances on the premises and took an inventory. Id.
at 32.
On January 22, 2004, an employee of Dr. Randall Weil (who had
purchased Respondent's former office) contacted DEA. Id. at 32-33. Dr.
Weil's employee informed DEA that the office had received a shipment of
controlled substances that had been shipped to Respondent. Id. at 33.
The next day, the DI and her supervisor went to Dr. Weil's office and
retrieved one box holding 36 bottles, each containing 500 tablets, of
hydrocodone/apap 7.5/750. Id. at 34. The shipment's packing slip, which
was dated August 14, 2003, indicated that a total of 180 bottles (five
boxes) of the drug had been ordered. Resp. Ex 3, at 2. The
investigators have not been able to determine the disposition of the
other 144 bottles. Tr. 34.
[[Page 4038]]
On January 26, 2004, the DI obtained and served another
administrative inspection warrant at ISMP's office. Id. at 34-35. DEA
personnel went to ISMP's office but found no one present. Id. at 37.
The investigators then contacted Ogele by phone. Id. Following Ogele's
arrival, the investigators informed Ogele that he was improperly using
Respondent's registration. Id. at 39. The investigators then seized
approximately 300 bottles of hydrocodone/apap and codeine/apap, which
were taken to the DEA office. Id. at 39-40; Gov. Ex. 8. The
investigators subsequently contacted Respondent and offered to arrange
for the drugs to be returned to R & S with a credit to her account. Id.
at 40.
Respondent agreed and, on January 30, 2004, went to the DEA office
to assist in the inventory. Id. at 40-41. The inventory differed,
however, from the inventory that was taken during the January 26
administrative inspection by one bottle of hydrocodone/apap. Id. at
171.
During this meeting, the DI told Respondent that DEA was concerned
about the large orders of controlled substances that were placed with
her registration. Id. at 41. The DI also told Respondent that it was
improper to allow Ogele to use her DEA registration to order controlled
substances for export to Nigeria.\4\ Id. The DI also discussed with
Respondent the shipment that DEA had retrieved from her former office.
Id. at 42. Respondent told the DIs that she had not ordered those
drugs. Id.
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\4\ On some date which the record does not clearly establish,
Ogele played for the ISMP board a tape recording of a phone message
from a Mr. Dan Neeson, an employee of the Department of Commerce's
Bureau of Export Administration. The message stated that ``[m]ost
medical products do not require an export license. And if you do
require a license it would be for a particular country for a
particular transaction. If you want more information, give me a
call.'' Resp. Ex. 36. Respondent asserted that Ogele told the board
that he had contacted DEA and that Mr. Neeson had left the above
message. Tr. 293. The Bureau of Export Administration is not part of
DEA and does not enforce the Controlled Substances Act.
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The DI advised Respondent that DEA was seeking to suspend her
registration. Id. at 45-46. The DI asked Respondent whether she would
voluntarily surrender her registration. Id. Respondent refused. Id. at
46.
The investigators subsequently obtained from R & S Sales, copies of
the invoices documenting the controlled substance purchases made using
Respondent's registration between August 15, 2002, and December 29,
2003. Tr. 52, Gov. Exs. 12 & 17. The Government also introduced into
evidence a compilation of the purchases. See Gov. Ex.13.
The compilation shows that Ogele used Respondent's registration to
obtain from R & S, 1,537,500 tablets of hydrocodone/apap in various
strengths and 450,000 dosage units of codeine/apap in various
strengths; these drugs are schedule III controlled substances. See 21
CFR 1308.13(e). The compilation further shows that Respondent's
registration was used to purchase from R & S, 97,340 dosage units of
lorazepam (in various strengths), 19,900 dosage units of phenobarbital
(in various strengths), 9700 dosage units of ativan (2mg.), 400 tablets
of diazepam, and 3100 tablets of flurazepam. All of these drugs are
schedule IV controlled substances. Id. 1308.14(c). Finally, the
compilation shows that Respondent's registration was used to order
13,800 tablets of diphenoxylate/atropine sulfate, and 455,040
milliliters of promethazine/codeine cough syrup; both drugs are
schedule V controlled substances. Id. 1308.15
The investigation also determined that Ogele used Respondent's
registration to order controlled substances from an additional
supplier, Priority Healthcare, between July 16, 2003, and September 15,
2004.\5\ See Gov. Ex. 10. The compilation of these purchases shows that
Ogele obtained 285,900 dosage units of codeine (30mg.)/apap and 135,900
dosage units of codeine (60 mg.)/apap. See Gov. Ex. 11, ALJ at 3. The
compilation also shows that Ogele obtained 77,100 dosage units of
hydrocodone/apap (of various strengths). Id. Finally, the compilation
shows that Ogele obtained 46,694 sixteen oz. bottles of promethazine w/
codeine, the wholesale price of this medication was approximately
$664,900.
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\5\ DEA did not become aware that Ogele had also made purchases
from Priority Healthcare until after his arrest on September 22,
2004, at Hobby Airport in Houston, Texas.
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Ogele purchased the majority of the drugs from Priority after the
service of the Notice of Immediate Suspension. See Gov. Exs. 10 & 11.
Respondent did not become aware of the purchases from Priority until a
few months before the hearing when Ogele's wife apparently found an
invoice or some other document from Priority and told Respondent. Tr.
347. Respondent did not provide DEA with any records related to the
receipt and distribution of these drugs. Id. 54-55.
DEA has been unable to determine the disposition of the great
majority of the drugs Ogele ordered using Respondent's registration.
See ALJ at 15; Tr. at 53, 55, 64. The only drugs which can be accounted
for are those which DEA retrieved from Respondent's former office and
those seized during the execution of the warrant at ISMP's office. Tr.
53.
On September 2, 2004, Ogele was arrested by local authorities at
the George Bush Intercontinental Airport in Houston, Texas. Id. at 55.
At the time, Ogele was carrying $975,481 in cash and 395 Vicodin
tablets for which he lacked a prescription. Id.; see also Gov. Ex. 22.
During an interview with Houston police, Ogele claimed that the cash
had been donated to ISMP. Tr. 56. Ogele further stated that a person
named Mike, who lived in Houston, would sometimes hold fundraisers at
churches for ISMP. Id. at 56-57. Ogele did not, however, know Mike's
last name or his address. Id. Initially, Ogele told the police that he
did not know how to contact Mike. Id. at 57. Ogele later changed his
story and stated that Mike had called him upon his arrival at his hotel
and brought the cash to him. Id. Subsequently, Ogele waived his
interest in the cash and forfeited it. Gov. Ex. 22. He was also charged
with unlawful possession of controlled substances. Tr. 58.
On September 22, 2004, Ogele was arrested at another Houston
airport (William P. Hobby). Gov. Ex. 19. On this occasion, Ogele was
carrying $7774 in cash and various controlled substances including 24
Vicodin tablets, 135 Ativan tablets, and two Lortab tablets. Id. at 2.
He did not have a valid prescription for any of these drugs. Tr. 58. He
also had in his possession thirteen invoices from Priority Healthcare.
Id. at 58-59. The cash was again seized and forfeited. Id. at 58. Ogele
was subsequently convicted of delivery of a controlled substance, a
felony offense under Texas law, and sentenced to eight years of
community supervision. Gov. Ex. 20.
Respondent's Knowledge of Ogele's Use of Her DEA Registration
One of the central issues in this case is whether Respondent knew
that Ogele was using her DEA registration to order controlled
substances. Both in her testimony and her post-hearing brief,
Respondent has maintained that prior to the January 15, 2004 interview
with DEA, she ``did not know about the ordering of [the] controlled
substances and is not responsible for record keeping involved with such
orders.'' Resp. Br. at 20. See also id. at 6 (Respondent ``did no[t]
anticipate that there would be any controlled substances ordered to be
used in the project.'').
In reference to Respondent's giving her DEA registration to Ogele,
the ALJ found that ``Respondent credibly
[[Page 4039]]
testified that she told Mr. Ogele that she understood that ISMP would
order `medications, primarily AIDS and AIDS-related medications, but no
IV injectables and no narcotics.''' ALJ at 5-6 (FOF 17) (quoting Tr. at
351). The ALJ also found that ``Respondent did not anticipate that
there would be any controlled substances ordered by ISMP. '' Id. at 6
(quoting Tr. at 351).
In her testimony, Respondent further maintained that she did not
become aware that Ogele was using her registration to order controlled
substances until January 15, 2004, when she was told this while being
interviewed by DEA investigators. During cross examination, Respondent
was asked whether she knew ``there were any controlled substances being
ordered?'' Tr. 326. Respondent answered ``No.'' Id. The Government then
asked Respondent: ``[Y]ou didn't know there were any controlled
substances being ordered until DEA informed you in January of 2004,
correct?'' Id. Respondent answered: ``Yes.'' Id.
The ALJ found, however, that a preponderance of the evidence
``supports the conclusion that * * * Respondent knew that controlled
substances were being ordered using her DEA registration.'' ALJ at 16
(FOF 61). Among other evidence, the ALJ noted the testimony of Dr.
Green, another ISMP board member. Dr. Green testified that she had
knowledge that Respondent allowed her registration to be used to obtain
AIDS and pain medications, and that she and Ogele had also visited a
company in the Midwest after which ISMP began receiving from it AIDS
and ``pain medications.'' Tr. 236.
The ALJ's finding does not, however, specify at what point in time
Respondent knew that Ogele was using her registration to order
controlled substances. Another finding appears to credit Respondent's
testimony that she did not learn of this until the January 2004 DEA
meeting and ``was surprised'' to find that Ogele was ordering
controlled substances. ALJ at 10 (FOF 42).
To the extent this finding was intended to credit Respondent's
testimony that she did not learn of the controlled substance purchases
until January 2004, I reject it. Instead, I find that Respondent knew
at least as early as May 2003, that Ogele was using her registration to
order controlled substances.
In her letter requesting a hearing, Respondent filed a lengthy
point by point response to the allegations of the Show Cause Order. See
ALJ Ex. 2. In this filing, Respondent ``admit[ted] that between May
2003 and August 2003 she authorized the ordering of hydrocodone or
vicodin from R & S Sales.'' ALJ 2 at 2. Respondent further stated that
``[t]he purpose of these orders was to ship the vicodin to Nigeria to
aid in the treatment of women with AIDS and HIV.'' Id. More
specifically, Respondent ``admit[ted] to authorizing the ordering of
three hundred bottles of hydrocodone (vicodin) from R & S * * * between
May 2003 and August 2003,'' that the ``drugs were ordered on behalf
of'' ISMP, and that they ``were purchased under [Respondent's] license
for the purposes of export to Nigeria to fulfill existing commitments
that [ISMP] has with the Nigerian military and other Nigerian
government entities.'' Id.
In this same document, Respondent further stated that in her
November 24, 2003 telephone conversation with a DEA investigator, she
``never said she was `not ordering controlled substances' because
vicodin and [T]ylenol 3 is an integral part of the treatment
of AIDS/HIV in Nigeria.'' Id. at 3-4. Moreover, with respect to the
order that was placed with R & S on November 26, 2003, Respondent
``denie[d] ever having told the DEA agent that she was not ordering
[V]icodin and Tylenol 4 for the Nigeria project.'' Id. at 4.
Respondent further ``admit[ted] authorizing the order and that the
drugs were shipped to the Broadway Street address.'' Id. Finally,
Respondent stated that she ``may not always have known the quantities
of the substances ordered but she always knew what the drugs were that
were being ordered and shipped. The orders are for standard quantities
of particular drugs and do not vary very much, order to order.'' Id. at
4-5.
The ALJ did not acknowledge these admissions and thus did not
discuss the fundamental inconsistencies between them and Respondent's
statements under oath at the hearing. While I am mindful that the ALJ
observed Respondent's testimony, deference to the ALJ's findings is
clearly not appropriate where, as here, a witness tells two materially
different tales and the ALJ gives no explanation as to why one is more
credible than the other. Based on her written admissions, I thus find
disingenuous Respondent's testimony on cross-examination that she did
not become aware that Ogele was ordering controlled substances until
the January 2004 interview with DEA investigators. And consistent with
her admissions, I further find that Respondent knew at least as early
as May 2003 that Ogele was ordering controlled substances.
Respondent's Response to Ogele's Misuse of Her Registration
On January 15, 2004, DEA investigators informed Respondent that an
excessive amount of controlled substances had been ordered under her
registration. Tr. 302. Furthermore, on January 26, 2004, DEA executed
an administrative search warrant at ISMP's office and seized a
substantial quantity of controlled substances.
Notwithstanding these two events, Respondent did not demand that
Ogele produce the invoices. Furthermore, she did not even talk to Ogele
about the matter until ``probably April.'' Id. at 313.
In her testimony, Respondent asserted that the reason she did not
talk to Ogele about the matter was because he ``left the country * * *
early the next morning.'' Id. Respondent testified, however, that Ogele
had called her on January 26, 2004, the day that DEA investigators
served the administrative warrant and told her that the investigators
had already shown up at ISMP's office. Id. at 304. Respondent further
testified that Ogele called her and asked her to go to the DEA office
to conduct an inventory of the controlled substances because he ``was
getting ready to leave the country.'' Id. at 305. The inventory
occurred on January 30. While Respondent did not testify as to the date
this phone call occurred, it is clear that Ogele was in the country for
a substantial period of time following Respondent's receipt of
information that her registration was being misused (during the January
15, 2004 interview) and that she made no effort to investigate the
matter for at least three months.
Respondent had long known that R & S Sales was one of ISMP's
primary suppliers. Respondent testified that R & S was sending orders
to her medical practice and that she contacted R & S in an attempt to
have the orders shipped to the ISMP office. Id. at 267. Respondent did
not, however, contact R & S during the period between the January 15
interview and service of the Show Cause Order to obtain copies of the
invoices for the orders that had been placed under her registration.
Furthermore, even following the service of the Show Cause Order,
Respondent did not promptly contact R & S to obtain the invoices. Id.
at 347; ALJ Ex. 2, at 5. While the record does not specify when
Respondent finally contacted R & S, in her response to the Show Cause
Order, Respondent stated that ISMP ``has records of each drug
shipment,'' ALJ Ex. 2, at 5, and made no mention that she had obtained
or was then attempting to
[[Page 4040]]
obtain the records from R & S. Furthermore, when asked whether after
service of the Show Cause Order she had ``ask[ed] any of the suppliers
for records?,'' Respondent answered: ``[n]ot at that time.'' Tr. 347.
Respondent further testified that she did not contact R & S until
``later.'' Id.
Respondent did not obtain copies of the invoices from Priority
Healthcare until ``a few months'' before the hearing, when Ogele's wife
found some invoices from Priority and contacted it to obtain copies of
them for her. Id. Finally, Respondent did not testify that she ever
attempted to exercise her right as a director of ISMP to examine its
books, records, and documents. See, e.g., Cal. Corp. Code section 6334
(West 2006).
Discussion
Section 304(a) of the Controlled Substances Act 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 [her]
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). In making the public interest determination, the Act
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. section 823(f).
``[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 a registration should be
revoked.'' Id. Moreover, case law establishes that I am ``not required
to make findings as to all of the factors.'' Hoxie v. DEA, 419 F.3d
477, 482 (6th Cir. 2005); see also Morall v. DEA, 412 F.3d 165, 173-74
(D.C. Cir. 2005).
Finally, section 304(d) 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). In this case I conclude that Factors Four and Five
conclusively establish that allowing Respondent to hold a registration
would be inconsistent with the public interest.\6\ Analyzing these
factors, I also conclude that Respondent's conduct created ``an
imminent danger to the public health or safety,'' id., and thus affirm
the immediate suspension of her registration.\7\
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\6\ Having considered all of the factors, I deem it unnecessary
to make findings on factors one, two, and three.
\7\ While Respondent's registration has expired and she did not
submit a renewal application, this case began with the immediate
suspension of her registration and thus is not moot. See William R.
Lockridge, 71 FR 77791, 77796-97 (2006). Furthermore, Respondent
testified that while she had closed her office, she might return to
the practice of medicine.
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Factor Four--Respondent's Compliance With Applicable Laws
The evidence in this case establishes that Respondent acted with
complete disregard for the obligations imposed on her as a registrant
under federal law and regulations. These actions included entrusting
her registration to someone she had no effective control over and knew
little about, her total failure to comply with the CSA's recordkeeping
requirements and to ensure the security of controlled substances, and
her authorizing Ogele to use her registration to obtain controlled
substances knowing that they would be exported to a foreign country
without a registration. While the record shows that Respondent was
motivated by humanitarian concerns and was likely duped by Ogele,
Respondent's disregard for federal law cannot be excused.
As the evidence shows, Respondent entrusted her DEA number to Ogele
shortly after meeting him and joining the ISMP board. She did so
without investigating Ogele's background \8\ and even though she had no
effective control over him. Respondent's conduct violated the CSA
because the Act does not authorize a registrant to allow an
unregistered person to use her registration to handle controlled
substances unless the latter is the employee or agent of the
registrant. See 22 U.S.C. 822(c) (exempting from registration ``an
agent or employee'' of a registrant but only ``if such agent or
employee is acting in the usual course of his business or
employment'').
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\8\ DEA regulations provide that a ``registrant shall not employ
as an agent or employee who has access to controlled substances, any
person who has been convicted of a felony offense relating to
controlled substances.'' 21 CFR 1301.76(a). As explained in the
text, Ogele was neither an employee nor an agent of Respondent.
While by its terms the regulation does not apply to Respondent, it
nonetheless demonstrates the recklessness of Respondent's
authorizing Ogele to use her registration without conducting a
background investigation.
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Respondent argues that authorizing Ogele to use her DEA number is
``no different[t]'' than ``what goes on in the normal medical
practice'' where ``[t]he doctor tells her nurse to order drugs under
her number and the nurse does it on the doctor's behalf.'' ALJ Ex. 2 at
4. Contrary to Respondent's contention, there is a fundamental
difference between what she did and what goes on in normal medical
practices because Ogele was not her employee and thus was not subject
to her control through the measures employers customarily use to
discipline employees.
Moreover, Ogele was not Respondent's agent. The evidence clearly
shows that Ogele did not act on Respondent's behalf but rather on
behalf of ISMP and himself. The evidence further shows that Ogele was
not Respondent's agent because while Respondent was a member of ISMP's
board, she could not unilaterally remove him and had no effective means
of controlling him. See, e.g., Restatement (Second) of Agency section 1
(1958) (comment a) (``The relation of agency is created as a result of
conduct by two parties manifesting that one of them is willing for the
other to act for him subject to his control * * *. [T]he agent must act
or agree to act on the principal's behalf and subject to his
control.''); \9\ Resp. Ex. 11. Respondent thus violated the CSA by
entrusting her registration to Ogele, who was neither her employee nor
her agent.
---------------------------------------------------------------------------
\1\ Cf. id. Sec. 14 C (comment b) (``An individual director * *
* has no power of [her] own to act on the corporation's behalf, but
only as one of the body of directors acting as a board.'') (emphasis
added).
---------------------------------------------------------------------------
Respondent's conduct in authorizing Ogele to use her registration
to order controlled substances violated the CSA for an additional
reason. Respondent clearly contemplated that the drugs were being
ordered to be shipped to Nigeria. A practitioner's registration,
however, grants its holder authority to obtain controlled substances
only for the limited purposes of conducting research or dispensing them
to an ultimate user. See 21 U.S.C. 802(10) & (21); section 822(b). It
does not provide its holder with authority to export a controlled
substance. Id. section 822(b) (``Persons registered * * * under this
subchapter to * * * dispense controlled substances * * * are authorized
to possess * * * or dispense [controlled] substances * * * to the
extent authorized by their registration.''). See also id. section
957(a) (``No person may * * * export from the United States any
[[Page 4041]]
controlled substance * * * unless there is in effect with respect to
such person a registration issued * * * under section 958 of this
title.'').
Consistent with the statutory scheme, DEA regulations provide that
dispensing and exporting are activities which are ``deemed to be
independent of each other,'' 21 CFR 1301.13(e); exporting is not a
``coincident activity'' which is authorized under a practitioner's
registration. Id. (Table). DEA regulations further require that ``[a]ny
person who engages in more than one group of independent activities
shall obtain a separate registration for each group of activities.''
Id. 1301.13(e).
While there is some question regarding the extent to which the
controlled substances were actually exported to Nigeria (as opposed to
being sold by Ogele in this country)--largely because of Respondent's
failure to ensure that proper records were being maintained--Ogele told
DEA investigators that he was personally carrying drugs to Nigeria.
Moreover, Respondent made numerous admissions that show that she was
aware that the controlled substances were being ordered for the purpose
of export to Nigeria. Thus, it is clear that Respondent violated 21
U.S.C. Sec. 957(a) by exporting controlled substances without a
registration.
Respondent also violated the Act by failing to adequately supervise
Ogele's activities. Under DEA regulations, a registrant ``shall provide
effective controls and procedures to guard against theft and diversion
of controlled substances,'' 21 CFR 1301.71(a), including adequate
systems ``for monitoring the receipt, * * * distribution, and
disposition of controlled substances in its operations. Id.
1301.71(b)(14). Cf. id. 1301.71(b)(11) (require an assessment of
``[t]he adequacy of supervision over employees having access'' to
controlled substances).
Respondent's supervision of Ogele's use of her registration was
non-existent. As Respondent admitted, she ``may not always have known
the quantities of the substances ordered.'' ALJ Ex. 2, at 4. Indeed,
Respondent was clueless as to the scope of Ogele's ordering of
controlled substances. See Tr. 328-29 (``I didn't supervise him''
(Ogele) to ensure that he was keeping records.); id. at 329 (``I wasn't
following those records, no.'').
As the ALJ found, this was because Respondent did not ensure that
the required records documenting the purchase and distribution of
controlled substances were maintained. ALJ at 34; see, e.g., 21 CFR
1304.21(a) (``Every registrant required to keep records * * * shall
maintain on a current basis a complete and accurate record of each such
substance * * * received, sold, delivered, exported, or otherwise
disposed of * * *.''). See also 21 CFR 1304.22. Nor did she ensure that
the required inventories were conducted. See id. 1304.11.
The direct consequence of Respondent's abdication of her
obligations as a registrant is that the disposition of an extraordinary
quantity of controlled substances cannot be accounted for and the drugs
have likely been diverted. Of the drugs Ogele obtained from R & S, more
than 2.1 million dosage units are unaccounted for. Moreover, none of
the drugs Ogele obtained from Priority Healthcare (which included
nearly 47,000 dosage units of promethazine with codeine cough syrup,
with a wholesale price of nearly $ 65,000) have been accounted for.
To be sure, Ogele ordered many of the drugs from Priority after DEA
had told him to stop and Respondent was likely unaware of this. The
fact remains, however, that Ogele would not have been able to do so if
Respondent had never entrusted her registration to him in the first
place. This Agency has previously held that a registrant who allows a
non-registrant to use her registration is strictly liable for any
misuse of the registration. See Anthony L. Cappelli, 59 FR 42,288
(1994).
Finally, the record establishes that Respondent authorized the
ordering of controlled substances that were shipped to her former
office in San Francisco which remained her registered location until
December 1, 2003. Because Respondent had sold and vacated her office
some eight months earlier, she had no effective means of securing the
drugs that were delivered to this address. The record also establishes
that with Respondent's authorization, controlled substances were being
stored at ISMP's Richmond office even though this facility was not a
registered location. Indeed, she did not even have a key for the
office. Both the shipping of drugs to her former office and the
shipping of drugs to the ISMP office when it was not her registered
location violated the CSA.\10\
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\10\ Under the CSA, ``[a] separate registration [is] required at
each principal place of business or professional practice where the
[registrant] * * * distributes, or dispenses controlled
substances.'' 21 U.S.C. 822(e). The primary purpose of this
requirement is to ensure that adequate security exists at each
location. See 21 CFR 1301.71.
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I thus conclude that Respondent's record of non-compliance with
federal law is extensive and egregious. As the ALJ explained,
Respondent's conduct ``evidences a reckless disregard for the legal
obligations and responsibilities'' of a registrant. ALJ at 34. The
direct consequence of Respondent's indifference to her obligations
under the CSA was to provide a drug dealer with the means to obtain his
wares and to create an ``imminent danger to the public health or
safety.'' 21 U.S.C. 824(d).
I thus affirm the immediate suspension of Respondent's
registration. I further conclude that this factor provides reason alone
to conclude that allowing Respondent to hold a DEA registration would
be ``inconsistent with the public interest.'' 21 U.S.C. 823(f).
Factor Five: Such Other Conduct Which May Threaten Public Health and
Safety
As explained above, because of Respondent's failure to comply with
the CSA and DEA regulations, it is likely that over two million dosage
units of controlled substances have been diverted. Respondent, however,
engaged in additional conduct which threatened public health and safety
by failing to take prompt and reasonable action to investigate the
circumstances surrounding Ogele's misuse of her registration.
On January 15, 2004, DEA investigators told Respondent that an
excessive amount of controlled substances had been ordered under her
registration. Tr. 302. Moreover, on January 26, 2004, DEA seized
controlled substances that Ogele had ordered under her registration.
Notwithstanding the seriousness of each of these events, Respondent did
not demand that Ogele produce the invoices. Indeed, she did not even
talk to Ogele about the matter until ``probably April.'' Id. at 313.
Nor did she contact R & S Sales to independently obtain the invoices
until some date after May 3, 2004.
Relatedly, the Show Cause Order, which was served on Respondent on
April 5, 2004, alleged that ``the bulk of the controlled substances
ordered under [her] * * * registration,'' which ``include[d] over
750,000 dosage units of Schedule III controlled substances'' could not
be accounted for. Show Cause Order at 7. Furthermore, while there is
conflicting evidence as to whether Respondent then attempted to obtain
the invoices from Ogele, even giving her the benefit of the doubt on
the issue,\11\
[[Page 4042]]
Respondent did not then contact R & S to independently verify whether
Ogele had provided her with all of the invoices. See Tr. 347. Those
invoices would have shown that Ogele had ordered large amounts of
additional controlled substances such as promethazine cough syrup with
codeine and various benzodiazepines that were unrelated to ``the
Nigeria project.'' Gov. Ex. 12 at 8, 13, 15, & 20. Nor did she exercise
her right as a director of ISMP to inspect its books, records, and
documents. See Cal. Corp. Code section 6334 (West 2006) (``Every
director shall have the absolute right at any reasonable time to
inspect and copy all books, records and documents of every kind * * *
of the corporation of which such person is a director.'').
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\11\ Compare Tr. 334 (Respondent answered ``no'' to Government's
question regarding whether she had then attempted to obtain the
invoices from Ogele) with ALJ Exh. 2 at 9 (listing in response to
Show Cause Order seven different purchases of controlled
substances).
---------------------------------------------------------------------------
By the date the Show Cause Order was served on her, Ogele had
obtained other drugs from R & S and had also placed numerous orders
with Priority Healthcare. See Gov. Ex. 11. Taking timely action such as
obtaining the invoices from R & S would have uncovered the fact that
Ogele was ordering additional controlled substances and engaged in
diversion. Furthermore, exercising her right as a director to inspect
all of ISMP's records including its accounts payable and checking
account records would likely have shown that Ogele was ordering from an
additional supplier.
To be sure, Ogele may have attempted to obstruct any such inquiry
by withholding documents that showed that he was ordering controlled
substances from Priority Healthcare. Respondent did not, however, take
anything bordering on timely action to investigate the extent of
Ogele's illegal use of her registration. Her failure to take even the
most rudimentary steps to investigate the misuse of her registration
was a breach of her duty as a registrant. Moreover, it likely allowed
Ogele to continue his criminal activity well past the point at which it
should have been stopped.
Consistent with a registrant's obligation to ``provide effective
controls and procedures to guard against theft and diversion of
controlled substances,'' 21 CFR 1301.71(a), every registrant has a duty
to conduct a reasonable investigation upon receiving credible
information to suspect that a theft or diversion has occurred.
Performing a reasonable investigation is essential to preventing the
continuation of criminal activity. While the precise scope of this duty
necessarily depends upon the facts and circumstances, doing nothing for
months--as Respondent did here--clearly warrants a finding that a
registrant has committed acts which threaten public health and safety.
In her analysis of factor five, the ALJ further observed that
Respondent ``exhibited no remorse for her conduct at the hearing'' and
``downplayed her misconduct.'' Id. at 36-37. I agree. Beyond that, I am
especially disturbed by Respondent's testimony under oath that she did
not know that Ogele was ordering controlled substances until DEA
investigators informed her of this during the January 15, 2004 meeting.
As explained above, this testimony was fundamentally inconsistent with
the letter Respondent submitted in response to the Show Cause Order in
which she stated that she had authorized the ordering of 300 bottles of
hydrocodone and vicodin between May 2003 and August 2003. See, e.g.,
ALJ Ex. 2, at 2. Of course, Respondent's written statement was
submitted before Ogele was arrested and pled guilty to drug offenses. I
thus conclude that Respondent lied under oath to downplay her
responsibility for supplying Ogele with the means to obtain his wares.
Such conduct buttresses the conclusion that Respondent cannot be
entrusted with a registration.
Order
Pursuant to the authority vested in me by 21 U.S.C. 824, as well as
28 CFR 0.100(b) & 0.104, the order of immediate suspension of DEA
Certificate of Registration, AL8962993, issued to Rose Mary Jacinta
Lewis, M.D., is hereby affirmed. The Office of Diversion Control is
further directed to cancel Respondent's DEA number. This order is
effective February 28, 2007.
Dated: January 19, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-1318 Filed 1-26-07; 8:45 am]
BILLING CODE 4410-09-P