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Rose Mary Jacinta Lewis, M.D.; Affirmance of Immediate
Suspension
FR Doc E7-1318 [Federal Register: January 29, 2007 (Volume 72, Number 18)]
[Notices] [Page 4035-4042] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29ja07-64]
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.
---------------------------------------------------------------------------
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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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