[Federal Register Volume 72, Number 187 (Thursday, September 27, 2007)]
[Notices]
[Pages 54931-54936]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-19042]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Kamir Garces-Mejias, M.D.; Revocation of Registration

    On September 6, 2005, I, the Deputy Administrator of the Drug 
Enforcement Administration, issued an Order to Show Cause and Immediate 
Suspension of Registration to Kamir Garces-Mejias, M.D. (Respondent), 
of San Juan, Puerto Rico. The Order immediately suspended Respondent's 
Certificate of Registration, BG2453075, as a practitioner, on the 
ground that Respondent's continued registration during the pendency of 
the proceeding ``would constitute an imminent danger to the public 
health and safety,'' because Respondent had issued numerous 
prescriptions for controlled substances to persons who sought the drugs 
through internet sites and without ``establish[ing] legitimate 
physician-patient relationships.'' Show Cause Order at 6. The Order 
also sought the revocation of Respondent's registration and the denial 
of any pending applications for renewal or modification of the 
registration. Id. at 1.
    More specifically, the Show Cause Order alleged that Respondent was 
a participant in a scheme run by Mr. Johar Saran, the owner of 
Carrington Health System/Infiniti Services Group (CHS/ISG) of 
Arlington, Texas. Id. at 5. According to the allegations, CHS/ISG 
operated several DEA-registered pharmacies, which obtained their 
registrations through sham-nominees and which were used to order large 
amounts of highly abused controlled substances from licensed 
distributors. Id. The Show Cause Order alleged that the controlled 
substances were then diverted to CHS/ISG, where they were used to fill 
approximately 3,000 to 4,000 orders per day which had been placed by 
persons through various Web sites. Id.
    The Show Cause Order further alleged that Respondent ``participated 
in [this] scheme by authorizing drug orders under the guise of 
practicing medicine.'' Id. The Show Cause Order alleged that Respondent 
``did not see [the] customers, had no prior doctor-patient 
relationships with the Internet customers, did not conduct physical 
exams,'' and did not ``create or maintain patient records.'' Id. The 
Show Cause Order also alleged that between May 19 and May 27, 2005, 
Respondent issued 188 prescriptions to persons located in thirty-three 
different States, and that eighty-six percent of the prescriptions were 
for hydrocodone, a controlled substance. Id. at 6.
    On September 21, 2005, the Show Cause Order was personally served 
on Respondent. On October 7, 2005, Respondent, through her counsel, 
requested a hearing on the allegations. This letter was returned, 
however, by UPS as undelivered. Thereafter, on October 14, 2005, 
Respondent, through her counsel, against requested a hearing. 
Respondent also asserted that she ``may be the victim of a theft 
identity and [that] someone may have used, without her authorization, 
one of her prescriptions.'' Letter of Resp.'s Counsel at 1 (Oct. 14, 
2005). Respondent also denied having ever ``participated in any Web 
site related to Mr. Johar Saran's scheme.'' On November 16, 2005, based 
on Respondent's claim that she may have been the victim of identity 
theft, I stayed the Immediate Suspension of her registration.
    In the meantime, the matter had been placed on the docket of this 
Agency's Administrative Law Judges (ALJ) and assigned to Judge Gail 
Randall. On October 26, 2005, the ALJ ordered the parties to file their 
pre-hearing statements. Following my decision staying the suspension 
order, the Government moved to stay the filing of pre-hearing 
statements. On November 18, 2005, the ALJ granted the motion.
    In a December 4, 2006 joint status report, the parties informed the 
ALJ that they were unable to resolve the matter without a hearing. The 
Government thus requested that the matter be set for hearing. On 
December 13, 2006, the ALJ issued a Second Order for Pre-Hearing 
Statements. The Order directed that the Government file its statement 
on or before January 10, 2007, and that Respondent file her statement 
on or before January 31, 2007.
    On January 5, 2007, the Government filed its statement. Respondent 
did not, however, comply with the ALJ's order. Accordingly, on February 
15, 2007, the ALJ issued an additional order which directed Respondent 
to file her statement by February 28, 2007. The order also gave notice 
that Respondent's failure to comply could be deemed a waiver of her 
right to a hearing. See Third Order for Respondent's Prehearing 
Statement 1 (citing 21 CFR 1301.43(e)). Respondent also failed to 
comply with this order.
    Thereafter, on March 5, 2007, the Government moved to terminate the 
proceeding and requested that the ALJ find that Respondent had waived 
her right to a hearing. On March 7, 2007, the ALJ found that Respondent 
had waived her right to a hearing under 21 CFR 1301.43(e), granted the 
Government's motion, and ordered that the proceeding be terminated.
    On March 12, 2007, Respondent's counsel received a copy of the 
ALJ's termination order and moved for reconsideration. The basis for 
the motion was that Respondent's counsel ``is a solo practitioner in 
the island of Puerto Rico with an extensive practice on civil and 
federal criminal cases.'' Respondent's Req. for Reconsideration at 2. 
Respondent's counsel maintained that since January 6, 2007, he had 
``had an extremely busy Court calendar,''

[[Page 54932]]

which ``include[d] three * * * major criminal * * * jury trials before 
the United States District Court for the District of Puerto Rico.'' Id. 
Respondent's counsel also maintained that he had ``been involved in 
preparation for numerous appeals at the First Circuit Court of Appeals 
and the handling of other criminal and civil matters filed in the State 
and Federal Courts.'' Id. at 3. Respondent's counsel further stated 
that it had not been his ``intention to be disrespectful or to 
willfully disobey the orders issued by the ALJ.'' Id.
    The ALJ was not persuaded. The ALJ observed that in the three 
months prior to her order terminating the case, she had issued numerous 
other orders in the proceeding, three of which had required a response, 
and that each order had been sent by both facsimile and first-class 
mail to Respondent's counsel. Order Denying Request for Reconsideration 
at 1-2. The ALJ noted that ``[n]one of my orders, prior to the 
Termination Order * * * ha[d] elicited a response from the Respondent 
despite the deadlines to respond.'' Id. at 2. The ALJ also noted that 
``at no point did the Respondent request a written extension of time.'' 
Id. The ALJ thus concluded that ``Respondent's failure to pursue her 
case remains a waiver of her right to a hearing pursuant to 21 CFR 
1301.43(e),'' and denied Respondent's request for reconsideration. Id.
    Thereafter, Respondent filed a second motion for reconsideration. 
As grounds for the motion, Respondent asserted that her motion should 
be evaluated using the same standards that the federal courts apply 
under Rule 55(c) of the Federal Rules of Civil Procedure. Resp.'s 
Second Mot. for Reconsid. at 2. Respondent contends that the Agency has 
not been prejudiced by her failure to comply with the ALJ's orders; 
that her counsel is a solo practitioner who participated in three 
federal criminal trials between January 8th and February 20, 2007, 
which left him with ``literally no time for other meritorious cases''; 
that Respondent has meritorious defenses; and that Respondent's failure 
to timely respond to the ALJ's orders was her attorney's fault. See 
generally id. Respondent thus contends that she has shown good cause to 
set aside the ALJ's termination order.
    Thereafter, the ALJ ordered the Government to respond. The 
Government argued that having terminated the proceeding, the ALJ no 
longer had jurisdiction. Gov. Response to Respondent's Mot. Requesting 
Rescission of Termination Order. The Government also argued that 
Respondent had not demonstrated good cause to set aside the termination 
order. According to the Government, the ALJ's order for pre-hearing 
statements gave Respondent's counsel seven weeks to file her pre-
hearing statement, and that during that period, Respondent's counsel 
took nearly a two-week vacation. Moreover, the ALJ's Third Order had 
given Respondent's counsel an additional thirteen days to file her pre-
hearing statement and Respondent's counsel still had eight days to do 
so following the conclusion of his third trial.
    Finding ``the Government's argument compelling,'' the ALJ denied 
Respondent's motion. Order Denying Resp.'s Motion at 2. The ALJ 
reasoned that even if she still had jurisdiction, Respondent had not 
``provide[d] due cause for her failure to proceed in a timely 
fashion.'' Id. The ALJ thus held to her earlier decision that 
``Respondent's `failure to pursue her case remains a waiver of her 
right to [a] hearing pursuant to 21 CFR 1301.43(e),' '' and denied the 
motion. Id. (quoting Termination Order).
    The investigative file was then forwarded to me for final agency 
action. Having considered the various pleadings, I conclude that 
Respondent has not shown ``good cause'' for failing to comply with the 
ALJ's orders and thus find that Respondent has waived her right to a 
hearing. See 21 CFR 1301.43(d). Before proceeding to make factual 
findings regarding the allegations of the Show Cause Order, a 
discussion of Respondent's motion is warranted.
    In seeking to set aside the ALJ's termination order, Respondent 
invokes various court decisions construing Rule 55(c) of the Federal 
Rules of Civil Procedure. Respondent's argument is misplaced. Agency 
proceedings brought under section 304 of the Controlled Substances Act 
are not governed by the Federal Rules of Civil Procedure, but rather, 
DEA's regulations and the rules set forth in the applicable provisions 
of the Act. See 21 CFR 1301.41. Indeed, this Agency has never held that 
the good cause standard of 21 CFR 1301.43(d), which addresses conduct 
constituting a waiver of the right to a hearing, is to be construed in 
the same manner as the federal courts interpret the good cause standard 
under F.R.C.P. 55(c) for setting aside the entry of a default.
    Moreover, Respondent has not demonstrated good cause. Respondent 
argues that her ``default in submitting timely response to the orders 
issued by [the ALJ] was not willful.'' Resp.'s Second Mot. at 6. 
Respondent further contends that there was ``no culpable conduct'' on 
her part and that she was not ``personally at fault'' because it was 
her attorney's responsibility to respond to the ALJ's orders and he was 
preoccupied with other matters. Id. The omissions of Respondent's 
counsel are, however, fairly charged to Respondent. Moreover, even if 
her counsel's failure to respond to the ALJ's orders does not rise to 
the level of willfulness, it is still sufficiently culpable to preclude 
a finding that there is good cause to set aside the ALJ's Termination 
Order.
    As the First Circuit has explained, Respondent's claim ``that [her] 
attorney was preoccupied with other matters * * * has been tried 
before, and regularly has been found wanting.'' De la Torre v. 
Continental Ins. Co., 15 F.3d 12, 15 (1st Cir. 1994) (citing Mendez v. 
Banco Popular de Puerto Rico, 900 F.2d 4, 7 (1st. Cir. 1990) (other 
citations omitted)). As the First Circuit has also noted: ``Most 
attorneys are busy most of the time and they must organize their work 
so as to be able to meet the time requirements of matters they are 
handling or suffer the consequences.'' Torre, 15 F.3d at 15 (quoting 
Pinero Schroeder v. FNMA, 574 F.2d 1117, 1118 (1st Cir. 1978)).
    Relatedly, the Supreme Court has observed that clients are 
``accountable for the acts and omissions of their attorneys.'' Pioneer 
Inv. Servs. Co. v. Brunswick Assoc. Limited Partnership, 507 U.S. 380, 
396 (1993). As the Court has further explained, one who ``voluntarily 
chose this attorney as [her] representative in the action * * * cannot 
* * * avoid the consequences of the acts or omissions of this freely 
selected agent. Any other notion would be wholly inconsistent with our 
system of representative litigation, in which each party is deemed 
bound by the acts of [her] lawyer-agent and is considered to have 
notice of all facts, notice of which can be charged upon the 
attorney.'' Id. at 397 (quoting Link v. Wabash Ry. Co., 370 U.S. 626, 
633-34 (1962) (other citation and int. quotations omitted)). 
Accordingly, that Respondent was not personally at fault in failing to 
respond to the ALJ's orders is irrelevant.
    As for the contention that the conduct of Respondent's counsel was 
not willful, it is still sufficiently culpable to preclude a finding 
that good cause exists to set aside the Termination Order. Here, the 
ALJ issued her second order for pre-hearing statements on December 13, 
2006. This Order was faxed to Respondent's counsel the following day 
(as well as mailed) and gave him seven weeks to submit his filing. 
While Respondent's counsel could not find the time to comply with the 
ALJ's order, by his own admission

[[Page 54933]]

he was able to take ``his annual vacation from December 24, 2006 to 
January 6, 2007.'' Resp. Second Mot. at 3. Surely, if one can find time 
to take vacation, he can also find time to file a necessary pleading 
and comply with the ALJ's orders.
    Moreover, even after Respondent's counsel failed to comply with the 
January 31, 2007 deadline, the ALJ granted him a second chance. On 
February 15, 2007, the ALJ issued her Third Order for Respondent's Pre-
hearing Statement, which gave Respondent's counsel until February 28, 
2007 to file the statement. The Third Order also gave notice that 
Respondent's failure to comply could be deemed a waiver of her right to 
a hearing. This Order was also served on Respondent's counsel by both 
First Class Mail and facsimile.
    Respondent's counsel again failed to comply with the ALJ's order. 
Indeed, Respondent's counsel did not submit his pre-hearing statement 
until after being served with the ALJ's Termination Order. While 
Respondent's counsel contends that he was involved in three federal 
criminal jury trials between January 8, 2007, and February 20, 2007, 
which ``left literally no time for other meritorious cases,'' and that 
it was not his ``intention to disregard'' the ALJ's orders, Resp. Sec. 
Mot. at 4, he offers no explanation for why he failed to comply with 
the ALJ's order following the conclusion of the third trial. Nor does 
he offer any explanation for why he did not contact the ALJ and request 
an extension during the two-and-a-half months that elapsed between the 
issuance of the Second Order and the deadline of the Third Order.\1\ 
Cf. Kirk v. INS, 927 F.2d 1106, 1108 (9th Cir. 1991) (rejecting 
contention that procedural default should be excused because party's 
counsel had ``been involved in three hearings over the last three weeks 
which required a great deal of time'').
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    \1\ He also offers no explanation as to why, in the period 
between the dismissal of the indictment in United States v. Bretton-
Castillo and the beginning of the trial in United States v. Cedeno-
Perez, he could not find the time to either file the pre-hearing 
statement or seek an extension.
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    Accordingly, even if the conduct of Respondent's counsel was not 
willful or intentional, it clearly was culpable in that it amounted to 
a reckless disregard of the ALJ's orders. ``Litigants must act 
punctually and not casually or indifferently if a judicial system is to 
function effectively.'' McKinnon v. Kwong Wah Restaurant, 83 F.3d 498, 
504 (1st Cir. 1996). This language is equally applicable to 
administrative proceedings. Respondent has therefore failed to show 
good cause to set aside the Termination Order.\2\
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    \2\ Respondent also asserts that I should consider ``whether the 
entry of termination would bring about a harsh or unfair result 
which would have a lifetime effect [on her] capacity to earn her 
living.'' Resp. Sec. Motion at 7. An order of revocation does not, 
however, impose a permanent prohibition on a practitioner's ability 
to obtain a new registration.
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    Accordingly, I hereby enter this final order without a hearing. See 
id. Sec.  1301.43(e). Based on relevant material in the investigative 
file, I make the following findings.

Findings

    Respondent currently holds DEA Certificate of Registration, 
BG2453075, which authorizes her to dispense controlled substances in 
Schedules II though V. Respondent's registration does not expire until 
September 30, 2008. Respondent's registered location is Torrecillap-2, 
Lomas De Carolina, Carolina, in Puerto Rico. According to the 
investigative file, Respondent is licensed to practice medicine in both 
Puerto Rico and Michigan.
    Respondent came to the attention of DEA during an investigation of 
Johar Saran, the owner of a majority stake in Carrington Healthcare 
Systems/Infiniti Services Group (CHS/ISG) of Arlington, Texas. 
According to the investigative file, CHS/ISG used several internet 
facilitation centers (IFCs) to solicit orders for controlled 
substances, which it then dispensed through numerous DEA registered 
pharmacies which CHS/ISG controlled. Under the scheme, a person seeking 
a controlled substance would go to a Web site, complete a 
questionnaire, and request a particular drug. The information would be 
forwarded to an IFC, which then sent the information on to a physician 
who would review the customer's information and authorize a 
prescription.
    Thereafter, an employee of CHS/ISG would access the Web site and 
download the prescriptions. The prescriptions were then filled by CHS/
ISG at its Arlington, Texas facility and sent to the purchaser using 
either FedEx or UPS.
    According to the investigative file, the IFCs that serviced CHS/ISG 
used at least 59 physicians including Respondent to write controlled-
substance prescriptions. The records of CHS/ISG indicated that on the 
dates of May 19, 24, 26, and 27, 2005, it filled a total of 188 
controlled substance prescriptions which were issued by Respondent for 
persons who were located in at least thirty-three different States.
    The prescriptions included 161 for drugs containing hydrocodone, 19 
for Xanax, 5 for phentermine, 2 for acetaminophen with codeine, and 1 
for diazepam. Moreover, Respondent issued the prescriptions to persons 
in such far-flung locations as Alaska (2 Rxs), California (21 Rxs), 
Colorado (3 Rxs), Florida (13 Rxs), Maryland (5 Rxs), Massachusetts (7 
Rxs), Mississippi (4 Rxs), New Jersey (11 Rxs), New York (7 Rxs), Ohio 
(7 Rxs), Oklahoma (2 Rxs), Texas (9 Rxs), Virginia (13 Rxs), and 
Washington (5 Rxs).
    The investigative file also establishes that on June 14, 2005, a 
UPS facility in Pittston, Pennsylvania, notified DEA investigators that 
an individual had attempted to pick up four packages that it suspected 
contained narcotic drugs and which were addressed to four different 
persons at four different addresses. Instead, UPS turned the packages 
over to DEA. Each of the packages contained ninety tablets of generic 
Lorcet, 10/650, a schedule III controlled substance containing 
hydrocodone and acetaminophen. Respondent was listed as the prescribing 
physician on two of the bottles, which were to be dispensed to persons 
allegedly residing in Plymouth and Dallas, Pennsylvania.
    DEA personnel were later contacted by a person who claimed to have 
ordered the drugs off the internet for herself, her daughter and her 
father. This person further stated that to obtain the prescriptions she 
had completed an on-line medical evaluation. When asked by a DEA 
investigator whether she had used fictitious names to pick up the drugs 
at UPS, the person would neither confirm nor deny doing so.
    The investigative file also included the sworn declaration of a 
detective (TFO) who served on the Northern Vermont Drug Task Force from 
January 2003 until October 2005. According to the TFO, on July 20, 
2005, he was advised by UPS in Rutland, Vermont, that it had two 
packages which were addressed to a person (J.S.) whom it suspected was 
purchasing controlled substances over the internet. UPS opened the 
packages (which were shipped COD) and found that they contained 
hydrocodone.
    Later that day, the TFO went to UPS to confront J.S., who had 
arrived to pick up the packages. After being notified by a UPS employee 
that J.S. had picked up one of the packages,\3\ the TFO identified 
himself and questioned him regarding its contents. J.S. claimed that he 
did not know specifically what was in the envelope but claimed to have 
a prescription for it. During the interview,

[[Page 54934]]

J.S. also stated that he had refused the second package because he did 
not know anything about it. J.S. also told the TFO that he purchased 
the drugs over the internet because it was cheaper and he did not have 
health insurance; he also claimed that his local physician had sent his 
medical records to the prescriber. The TFO subsequently interviewed 
J.S.'s local doctor, who denied sending the records to another 
physician.
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    \3\ According to the affidavit, J.S. did not have sufficient 
funds to pay for the second package.
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    The next day, the TFO obtained a warrant to search both packages. 
The search revealed that one of the packages held a bottle which 
contained 90 tablets of hydrocodone, listed Respondent as the 
prescribing physician, and was dated July 17, 2005. The bottle gave the 
name and address of the dispensing pharmacy as ASI-2129 S. Great 
Southwest Parkway, Suite 304, Grand Prarie, TX. The TFO subsequently 
determined that the pharmacy was named Avatar Corporation.
    The following day, the TFO contacted the pharmacy. A pharmacy 
employee confirmed that Avatar was a closed-door pharmacy which filled 
mail-order prescriptions. The pharmacy employee stated that Avatar 
filled prescriptions issued by Respondent on a regular basis and 
provided her phone number. The pharmacy employee also told the TFO that 
Respondent had a web page which was run by person named Juan Almeida.
    The TFO called Respondent's phone number and heard a recording by 
Respondent which gave a second phone number. The TFO called that number 
and left a voice mail message.
    Several hours later, Respondent called the TFO and spoke with him. 
Respondent denied issuing the prescription to J.S. and stated that she 
was in Puerto Rico. The TFO then asked Respondent how her name came to 
be on the prescription; Respondent answered that ``they have my 
signature on the Web site.''
    Having heard Respondent's denial, the TFO called the pharmacy 
again. The pharmacy employee reaffirmed that Respondent sent Avatar 
prescriptions on a regular basis.
    Later that day, the TFO was contacted by Mr. Almeida. Mr. Almeida 
told the TFO that he was a co-worker of Respondent and had been given 
his number by her. Mr. Almeida told the TFO that he managed a Web site 
where people could fill-out an online application to obtain 
medications; the applications were then reviewed by Respondent who 
determined whether to issue a prescription. When the detective told Mr. 
Almeida that Respondent had denied issuing prescriptions over the 
internet, Mr. Almeida said that she certainly did and that the 
prescriptions were then faxed to the pharmacy. Mr. Almeida eventually 
provided the detective with the name of the Web site. When the 
detective asked Mr. Almeida whether the Web site had any process in 
place to verify the on-line applications, he became defensive and 
claimed that it was no different than when a person went to see a 
physician.
    On September 6, 2006, DEA investigators interviewed Respondent in 
the presence of her attorney. During the interview, Respondent denied 
having ever reviewed questionnaires and having ever prescribed 
controlled substances over the internet. Respondent further asserted 
that she was the victim of identity theft and claimed that her DEA 
registration had been misused.
    Respondent further denied issuing the prescriptions to the two 
Pennsylvania residents which were intercepted by UPS. She also denied 
having knowledge of the ASI/Avatar pharmacy and denied knowing the 
employee who had provided information to the TFO.
    As for her relationship with Mr. Almeida, Respondent stated that 
she had talked on the telephone with him regarding a job advertisement 
which had appeared in the ``El Nuevo Dia'' sometime in January 2005, 
and which had sought physicians for services related to the internet. 
Respondent further stated that Mr. Almeida was located in Miami and had 
initially answered her phone call in response to the advertisement, but 
then transferred her call to one Dr. Rodriguez.
    Respondent maintained that she asked Dr. Rodriguez whether the job 
had something to do with prescribing medication or was associated with 
a hospital. Respondent stated that Rodriguez told her that it was not 
hospital related. Respondent told investigators that after speaking 
with Dr. Rodriguez she sent in a resume which listed her DEA number. 
Respondent further told investigators that Dr. Rodriguez never called 
her back.
    During the interview, the investigators presented copies of the 
prescriptions which listed Respondent as the prescribing physician, and 
asked her whether the signature on the prescriptions was hers. 
Respondent acknowledged that the signature was hers but denied issuing 
the prescriptions. She also denied knowing the patients listed on the 
prescriptions. Finally, Respondent denied knowing Johar Saran.
    The investigative file also contains an e-mail dated July 24, 2005 
to Joe Saran and signed by Mr. Almeida. In the e-mail, Mr. Almeida 
related that he had been informed by the ASI/Avatar employee ``that 
certain law enforcement officials were asking questions about an 
individual they apprehended who[] allegedly possessed an excessive 
amount of hydro.'' The e-mail specifically referenced J.S. Mr. Almeida 
then stated that he had ``pulled his records and confirmed that he 
[J.S.] is legitimate in that he is who[] he said he was on the 
medical'' questionnaire and that his ``DOB and address match.''
    Next, the e-mail recounted that the ASI/Avatar employee had 
``provided Law Enforcement officials with my telephone number as well 
as'' that of Respondent and specifically referenced the TFO. According 
to the e-mail, ``[s]hortly thereafter, [Respondent] was contacted by a 
task force officer who[] asked a series of questions.'' Continuing, Mr. 
Almeida wrote that he was ``not sure'' that Respondent ``was the best 
at answering questions unannounced, but nonetheless, she answered in 
the affirmative, that if he possessed prescription drugs with her name 
on it that it was likely prescribed by her, but that she had to review 
her records in order to confirm any thing further.'' The e-mail added 
that when the TFO had asked Respondent if she ``had seen'' J.S., ``she 
replied by stating she is in Puerto Rico.''
    Mr. Almeida then proceeded to describe his subsequent telephone 
conversation with the TFO. According to the e-mail, Mr. Almeida 
discussed the process by which ``an individual goes on the net to 
purchase prescription drugs.'' The e-mail further stated that Mr. 
Almeida told the TFO that following the ``verification of id'' by the 
Web site, ``the request is transferred to the doctor for review.'' Mr. 
Almeida further related that he had told the TFO that ``[d]octors are 
the ones making the decision whether or not to prescribe the medication 
based on the question[naire] provided,'' and ``that calls are made by 
the doctors to [the] patients.''

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:


[[Page 54935]]


    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The applicant's experience in dispensing * * * controlled 
substances.
    (3) The applicant's conviction record under Federal or State 
laws relating to the manufacture, distribution, or dispensing of 
controlled substances.
    (4) Compliance with applicable State, Federal, or local laws 
relating to controlled substances.
    (5) Such other conduct which may threaten the public health and 
safety.

Id.
     ``[T]hese factors are * * * considered in the disjunctive.'' 
Robert A. Leslie, M.D., 68 FR 15227, 15230 (2003). I ``may rely on any 
one or a combination of factors, and may give each factor the weight 
[I] deem[] appropriate in determining whether a registration should be 
revoked.'' Id. Moreover, I am ``not required to make findings as to all 
of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005); see 
also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005). In this 
case, I am unpersuaded by Respondent's defense of identity theft and 
her denial of involvement in the scheme. Rather, I conclude that 
Factors Two and Four establish that allowing Respondent to continue to 
dispense controlled substances would be inconsistent with the public 
interest. Accordingly, I will order that Respondent's registration be 
revoked and that any pending renewal application be denied.

Factors Two and Four--Respondent's Experience in Dispensing Controlled 
Substances and Respondent's Compliance with Applicable Laws

    The central issue in this case is whether the prescriptions 
Respondent issued through Web sites associated with CHS/ISG complied 
with Federal law. As explained below, the evidence conclusively 
demonstrates that Respondent used her prescribing authority to act as a 
drug pusher; the only difference between her and a street dealer was 
that she did not physically distribute the drugs to the customers of 
CHS/ISG.
    Under DEA regulations, a prescription for a controlled substance is 
not ``effective'' unless it is ``issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of 
[her] professional practice.'' 21 CFR 1306.04(a). This regulation 
further provides that ``an order purporting to be a prescription issued 
not in the usual course of professional treatment * * * is not a 
prescription within the meaning and intent of [21 U.S.C. 829] and * * * 
the person issuing it, shall be subject to the penalties provided for 
violations of the provisions of law related to controlled substances.'' 
Id. As the Supreme Court recently explained, ``the prescription 
requirement * * * ensures patients use controlled substances under the 
supervision of a doctor so as to prevent addiction and recreational 
abuse. As a corollary, [it] also bars doctors from peddling to patients 
who crave the drugs for those prohibited uses.'' Gonzales v. Oregon, 
126 S.Ct. 904, 925 (2006) (citing Moore, 423 U.S. 122, 135, 143 
(1975)).
    It is fundamental that a practitioner must establish a bonafide 
doctor-patient relationship in order to be acting ``in the usual course 
of * * * professional practice'' and to issue a prescription for a 
``legitimate medical purpose.'' See United States v. Moore, 423 U.S. 
122 (1975). Under numerous state standards of medical practice, before 
issuing a treatment recommendation, a physician must, inter alia, 
physically examine a patient to establish a bona-fide doctor-patient 
relationship and properly diagnose her patient. See, e.g., Cal. Bus. & 
Prof. Code 2242.1; Colo. Bd. of Med. Exam'rs, Policy 40-9; Mass. Bd. of 
Reg. in Med., Policy 03-06; Ohio Admin. Code 4731-11-09; Okla. Bd. of 
Med. Lic. & Supervision, Policy on Internet Prescribing; Va. Code 54.1-
3303.
    Relatedly, the American Medical Association has explained that to 
establish a bonafide doctor-patient relationship, a ``physician 
shall'':

    i. obtain a reliable medical history and perform a physical 
examination of the patient, adequate to establish the diagnosis for 
which the drug is being prescribed and to identify underlying 
conditions and/or contraindications to the treatment recommended/
provided; ii. have sufficient dialogue with the patient regarding 
treatment options and the risks and benefits of treatment(s); iii. 
as appropriate, follow up with the patient to assess the therapeutic 
outcome; iv. maintain a contemporaneous medical record that is 
readily available to the patient and * * * to his * * * other health 
care professionals; and v. include the electronic prescription 
information as part of the patient medical record.

American Medical Association, Guidance for Physicians on Internet 
Prescribing; see also William R. Lockridge, 71 FR 77791, 77798 (2006).

    To similar effect are the guidelines issued by the Federation of 
State Medical Boards of the United States, Inc. See Model Guidelines 
for the Appropriate Use of the Internet in Medical Practice. According 
to the Guidelines, ``[t]reatment and consultation recommendations made 
in an online setting, including issuing a prescription via electronic 
means, will be held to the same standards of appropriate practice as 
those in traditional (face-to-face) settings. Treatment, including 
issuing a prescription, based solely on an online questionnaire or 
consultation does not constitute an acceptable standard of care.'' Id. 
at 4 (emphasis added). Cf. DEA, Dispensing and Purchasing Controlled 
Substances over the Internet, 66 FR 21181, 21183 (2001) (guidance 
document) (``Completing a questionnaire that is then reviewed by a 
doctor hired by the Internet pharmacy could not be considered the basis 
for a doctor/patient relationship.'').\4\
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    \4\ The guidance document reflects this Agency's understanding 
of what constitutes a bonafide doctor-patient relationship under 
state laws and existing professional standards. 66 FR 21182-83.
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    The investigative file establishes that on four separate days in 
May 2005, Respondent, who was then practicing in Puerto Rico, issued at 
least 188 prescriptions for controlled substances to persons located in 
at least thirty-three different States including, but not limited to, 
Alaska (2 Rxs), California (21 Rxs), Colorado (3 Rxs), Washington (5 
Rxs), Massachusetts (7 Rxs), New Jersey (11 Rxs), New York (7 Rxs), 
Ohio (7 Rxs), Oklahoma (2 Rxs), Texas (9 Rxs), Virginia (13 Rxs) and 
Maryland (5 Rxs).\5\ The prescriptions were for highly abused drugs 
including hydrocodone (161 Rxs), Xanax (19 Rxs), phentermine (5 Rxs), 
acetaminophen with codeine (2 Rxs), and diazepam (1 Rx).
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    \5\ Under numerous state laws, a physician must typically be 
licensed in the State where the patient resides in order to 
prescribe to the patient. See, e.g., Cal. Bus. & Prof. Code section 
2052; Cal. Health & Safety Code section 11352(a). Respondent was, 
however, licensed only in Michigan and Puerto Rico. As I recently 
noted, ``[a] physician who engages in the unauthorized practice of 
medicine is not a `practitioner acting in the usual course of * * * 
professional practice,' '' and ``[a] controlled-substance 
prescription issued by a physician who lacks the license necessary 
to practice medicine within a State is therefore unlawful under the 
CSA.'' United Prescription Services, Inc., 72 FR 50397, 50407 (2007) 
(quoting 21 CFR 1306.04(a) and citing 21 CFR 1306.03(a)(1)). The 
prescriptions Respondent issued were thus illegal under Federal law 
for this reason as well.
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    Moreover, the evidence further shows that in June 2005, Respondent 
issued two hydrocodone prescriptions to persons located in 
Pennsylvania, and that in July 2005, Respondent issued a hydrocodone 
prescription to J.S., a person located in Vermont. In both cases, the 
evidence established that the prescriptions were issued on the basis of 
an online medical ``evaluation'' and were not based on a face-to-face 
encounter which included a physical exam. Given the far flung locations 
of the ``patients,'' which render it most unlikely that Respondent ever 
physically examined them; the evidence

[[Page 54936]]

pertaining to the Pennsylvania and Vermont customers; as well as 
evidence regarding the manner in which the CHS/ISG scheme operated 
including the statements of Mr. Almeida in both his telephone 
conversations with the TFO and in his e-mail; I conclude that 
Respondent issued controlled-substance prescriptions to numerous 
persons without establishing a valid physician/patient relationship 
with them and that the prescriptions were not issued for a legitimate 
medical purpose. See 21 CFR 1306.04(a); 21 U.S.C. Sec.  841(a). 
Respondent thus repeatedly violated federal law. See Gonzales v. 
Oregon, 126 S.Ct. at 925; Moore, 423 U.S. at 135.
    I further reject Respondent's defense of identity theft and her 
denial of involvement in the scheme. In this regard, I note that an 
employee of the Avatar pharmacy twice implicated Respondent in the 
scheme. Moreover, after the TFO spoke with Respondent he was called by 
Mr. Almeida, who informed the TFO that he was Respondent's co-worker 
and had been given the TFO's phone number by her. Respondent's act in 
giving the TFO's phone number to Mr. Almeida begs the question of why 
she did so if she was not involved in the scheme.
    Mr. Almeida admitted to the TFO that he managed a Web site where 
persons could obtain medications and stated that Respondent reviewed 
the applications and determined whether to issue the prescriptions. 
Furthermore, when told by the TFO that Respondent had denied issuing 
prescription through a Web site, Mr. Almeida stated that she certainly 
did so. Finally, Mr. Almeida's e-mail to Mr. Saran further implicated 
Respondent in the scheme. I therefore conclude that there is no merit 
to Respondent's assertions that she was the victim of identity theft 
and was not involved in the scheme.
    As recognized in Lockridge and other agency orders, `` `[le]gally 
there is absolutely no difference between the sale of an illicit drug 
on the street and the illicit dispensing of a licit drug by means of a 
physician's prescription.' '' 71 FR at 77800 (quoting Mario Avello, 
M.D., 70 FR 11695, 11697 (2005)). See also Floyd A. Santner, M.D., 55 
FR 37581 (1990). In short, Respondent's involvement in this scheme did 
not constitute the legitimate practice of medicine, but rather, drug 
dealing.
    Accordingly, Respondent's experience in dispensing controlled 
substances and her record of compliance with applicable laws makes 
plain that her continued registration would ``be inconsistent with the 
public interest.'' 21 U.S.C. 824(a)(4). Moreover, for the same reasons 
which led me to initially find that Respondent posed ``an imminent 
danger to the public health or safety,'' id. 824(d), I conclude that 
the public interest requires that her registration be revoked effective 
immediately. See 21 CFR 1316.67.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 
824(a), as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA 
Certificate Registration, BG2453075, issued to Kamir Garces-Mejias, 
M.D., be, and it hereby is, revoked. I further order that any pending 
application of Respondent for renewal of her registration be, and it 
hereby is, denied. This order is effective immediately.

    Dated: September 19, 2007.
Michele M. Leonhart,
Deputy Administrator. .
 [FR Doc. E7-19042 Filed 9-26-07; 8:45 am]
BILLING CODE 4410-09-P