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Trinity Health Care Corp., D/B/A/ Oviedo Discount Pharmacy;
Affirmance of Immediate Suspension
FR Doc E7-10627 [Federal Register: June 4, 2007 (Volume 72, Number
106)] [Notices] [Page 30849-30855] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr04jn07-86]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 06-4]
Trinity Health Care Corp., D/B/A/ Oviedo Discount Pharmacy;
Affirmance of Immediate Suspension
On August 19, 2005, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Immediate
Suspension of Registration to Trinity Healthcare Corporation, d/b/a/
Oviedo Discount Pharmacy (Respondent) of Oviedo, Florida. The Order
immediately suspended Respondent's Certificate of Registration,
BT2863668, as a retail pharmacy, based on my preliminary finding that
Respondent was filling large quantities of prescriptions for controlled
substances that were issued through an internet site, iPharmacy.MD, by
physicians who did not have a legitimate doctor-patient relationship
with the individuals who ordered the drugs. See Show Cause Order at 5-
10. Based on my preliminary finding that Respondent was "responsible for
the diversion of large quantities of controlled substances,'' and that
its participation in this scheme "invites the fraudulent procurement of
controlled substances on a vast scale,'' I concluded that Respondent's
continued registration pending these proceedings "would constitute an
imminent danger to the public health and safety,'' and therefore
immediately suspended its registration. Id. at 10.
More specifically, the Show Cause Order alleged that Respondent was
filling prescriptions for phentermine, a schedule IV controlled
substance, which were issued to the customers of iPharmacy.MD by Richard
Carino, a physician located in Port Richey, Florida. Id. at 5. The Show
Cause Order alleged that Dr. Carino issued prescriptions for phentermine
to persons located "throughout the country'' based solely on a
questionnaire. Id. The Show Cause Order further alleged that DEA
investigators interviewed various individuals who had been prescribed
controlled substances by Dr. Carino; each of these persons stated that
they were not patients of Dr. Carino and had not provided him with their
medical records. Id. at 6.
The Show Cause Order also alleged that on May 6, 2004, DEA
investigators conducted an inspection of Respondent during which they
obtained its prescription records for the period January 1 through May
6, 2004. Id. at 7. The Show Cause Order alleged that between January and
May 5, 2004, Respondent had filled 2,196 internet prescriptions for
phentermine issued by Dr. Carino to persons located throughout the
United States. Id. at 7-8.
Finally, the Show Cause Order alleged that on April 15, 2005, a DEA
Special Agent (S/A) had accessed the iPharmacy.MD Web site, completed a
questionnaire, and ordered 90 tablets of phentermine. Id. at 9. The Show
Cause Order further alleged that on April 21, 2005, the S/A received a
bottle of phentermine which had been filled by Respondent.
Respondent, through its counsel, requested a hearing. The matter was
assigned to Administrative Law Judge (ALJ) Mary Ellen Bittner, who
conducted a hearing on May 30 through June 2, 2006, in Arlington,
Virginia. At the hearing, both parties called witnesses to testify and
introduced documentary and/or demonstrative evidence. Following the
hearing, both parties submitted briefs containing their proposed
findings of fact, conclusions of law, and argument.
On October 2, 2006, the ALJ issued her decision. In that decision,
the ALJ concluded that Respondent's continued registration would be
inconsistent with the public interest and recommended that I revoke
Respondent's registration and deny any pending applications for renewal
or modification. ALJ Dec. (hereinafter ALJ) at 32. Neither party filed
exceptions.
On November 13, 2006, the ALJ forwarded the record to me for final
agency action. Having carefully reviewed the record as a whole, I hereby
issued this decision and final order. I adopt the ALJ's findings of fact
and conclusions of law except as noted herein. Furthermore, while
Respondent's registration expired on November 30, 2006, and Respondent
did not submit a renewal application, I nonetheless conclude that this
case is not moot. See William R. Lockridge, 71 FR 77791, 77797 (2006).
Accordingly, while I do not adopt the ALJ's recommendation that
Respondent's registration be revoked, I will review the propriety of the
immediate suspension under section 304(a) of the Controlled Substances
Act, 21 U.S.C.
824(a), and make the following findings.
Findings of Fact
Respondent is a corporation, which is owned and operated by Mr. Obi
Enemchukwu, a pharmacist, and does business as Oviedo Discount Pharmacy
in Oviedo, Florida. ALJ at 2; ALJ Ex. at 3. Respondent held DEA
Certificate of Registration, BT2863668, which authorized it to dispense
controlled substances in Schedules II through V, from September 1991
until the expiration of its registration on November 30, 2006. ALJ Ex.
3, at 1. Respondent last renewed its registration on October 24, 2003.
Id. I take official notice of the fact that Respondent did not submit a
renewal application prior to the expiration of its registration.\1\
Accordingly, I find that Respondent is no longer registered with the
Agency. See 5 U.S.C. 558(c).
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\1\ Under the Administrative Procedure Act (APA), an
agency "may take official notice of facts at any stage in a
proceeding-- even in 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's 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 this
fact, Respondent may file a motion for reconsideration within fifteen
days of service of this order which shall commence with the mailing of
the order.
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DEA's 2001 Policy Statement on Internet Prescribing and Dispensing
In April 2001, several years before the events at issue here, DEA
published in the Federal Register a guidance document entitled "Dispensing
and Purchasing Controlled Substances over the Internet.'' 66 FR 21181
(2001); see also Gov. Ex. 18. DEA issued this document to advise "the
public concerning the application of current laws and regulations as
they relate to the use of the Internet for dispensing [and] purchasing *
* * controlled substances.'' 66 FR at 21181.
More specifically, the guidance document advised that "[o]nly
practitioners acting in the usual course of their professional practice
may prescribe controlled substances. * * * A prescription not issued in
the usual course of professional practice * * * is not considered valid.
Both the practitioner and the pharmacy have a responsibility to ensure
that only legitimate prescriptions are written and filled.'' Id.
The guidance document also discussed the legality under existing law
of prescribing controlled substances based on an on-line questionnaire.
After noting DEA's regulation that a prescription for a controlled
substance is not effective unless it is " `issued for
[[Page 30850]]
a legitimate medical purpose by an individual practitioner acting in
the usual course of professional practice,'' ' the document further
explained that "[u]nder Federal and state law, for a doctor to be acting
in the usual course of professional practice, there must be a bona fide
doctor/patient relationship.'' Id. at 21182 (quoting 21 CFR 1306.04(a)).
The guidance document also explained that the factors typically
necessary under existing law to establish the existence of a legitimate
doctor-patient relationship include: That the "patient has a medical
complaint''; "[a] medical history has been taken [and a] physical
examination has been performed''; and that there must be "[s]ome logical
connection * * * between the medical complaint, the medical history, the
physical examination, and the drug prescribed.'' Id. at 21182-83.
Relatedly, the guidance document advised that "[c]ompleting 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.'' Id. at 21183
Finally, the guidance document advised that "[s]ome internet pharmacy
sites do not require that you have a prescription from your doctor[,]''
but rather, "require the customer to complete a medical questionnaire,''
which then "will be reviewed by a doctor, and the drug will be
prescribed and sent to you, if appropriate.'' Id. The guidance document
further stated that these types of internet pharmacy sites "operate in a
manner that is not consistent with state laws regarding standards of
medical practice and may be engaging in illegal sales of controlled
substances.'' Id.
The Investigation of Respondent
At some date not specified in the record, but likely in the fall of
2003, Mr. Terry Butler, the owner and president of iPharmacy.MD
(hereinafter iPharmacy) and Drug-storemd, called Mr. Enemchukwu to
recruit his pharmacy to fill prescriptions for his business. Tr. 807-
08, ALJ at 3. According to Mr. Enemchukwu, Mr. Butler told him that
iPharmacy had a Web site "which would screen patients, and if they
qualified * * * would refer them to physicians who wrote them
prescriptions,'' and "that he would like [him] to fill these
prescriptions and * * * send them to the patient.'' Tr. 808. In late
December 2003, Mr. Enemchukwu met with Mr. Butler to discuss the
proposed arrangement and asked him whether the physicians who would do
the prescribing were qualified. Id. at 810-11. Butler told him that the
doctors were qualified and would be "acting ethically.'' Id. at 811. Mr.
Enemchukwu further testified, however, that he did not do any research
into the background of iPharmacy. Id. at 818.
On January 7, 2004, Mr. Enemchukwu and Mr. Butler entered into a
contract through their respective entities (Oviedo Discount Pharmacy and
Drug-storemd). ALJ at 4, Gov. Ex. 95, at 1. Under the contract, Drug-storemd
engaged Respondent "to provide medicinal products to Drug-storemd's
customers.'' Gov. Ex. 95, at 1. Drug-storemd further agreed to provide
to Respondent "[a]n electronic * * * prescription for medication,
properly, legally, and ethically authorized by a licensed physician in
good standing in Florida or any other relevant state.'' Gov. Ex. 95, at
3. Drug-storemd also agreed to pay Respondent $8.00 for each order
filled and to reimburse Respondent for the cost of the drugs it
dispensed. Id. at 4.
The contract also included several provisions which Mr. Enemchukwu
proposed as an addendum. See id. at 7. These included a requirement that
the prescribing physicians supply Respondent "with copies of their
credentials including their location, address and other pertinent
information,'' that Respondent "be able to communicate with the
prescribing physician,'' and that it "reserve[d] the right to use [the]
professional judgment of the pharmacist according to law to deem a
prescription not to be filled.'' Id. 7-8. IPharmacy did not, however,
provide Respondent with copies of its physicians' credentials; Mr.
Enemchukwu did not insist that it do so because it provided him with
other information such as the numbers of the physicians' DEA
registrations and state medical licenses. Tr. 817, 820
According to the record, Respondent was given a password which
allowed it to access a webpage at the iPharmacy Web site and obtain a
list of the prescriptions it was to fill. Id. at 737-38, 757. According
to the testimony, Mr. Enemchukwu would print out both the prescriptions
and the shipping labels, which had been prepared in advance by
iPharmacy.MD. Id. at 738, 757, 768. Mr. Enemchukwu would then enter the
customer's name and information into a computer and perform a drug
utilization review. Id. at 763.
On January 6, 2004, (even before the contract was apparently signed),
Respondent began by filling fifteen prescriptions which were written by
Dr. Richard Carino--a physician based in Port Richey, Florida, Gov. Ex.
15--and allocated to it by iPharmacy. See Gov. Ex. 77, at 1. Of these
prescriptions, twelve of them were for either phentermine or Adipex-P.
Id.
The Government's evidence established that early on in the
arrangement (in early March 2004), it should have been obvious that many
of Dr. Carino's "patients'' resided in other States and thus were not
likely to be patients at all. More specifically, the Government produced
copies of controlled substance prescriptions, which showed that the "patients''
resided in such far-flung places as Houston, Texas (Rx 44122);
Martinsville, Indiana (Rx 44131); Dallas, Texas (Rx 43947); Corbin,
Kentucky (Rx 43948); Woodward, Oklahoma (Rx 43949); Cliffside Park, New
Jersey (Rx 43950); Cincinnati, Ohio (Rx 43951); Hanahan and Greenville,
South Carolina (Rxs 44012 & 44016); Carver, Massachusetts (Rx
44013); Pocono Lake, Pennsylvania (Rx 44015); and Berwyn, Illinois (Rx
43953).\2\ See Gov. Ex. 81.\3\
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\2\ The prescriptions also indicated the date and
time of approval. While these records are not complete, and represent
only a small portion of the prescriptions written by Dr. Carino, they
do suggest that he approved prescriptions in a rapid-fire manner. See,
e.g., id. at 4-9 (indicating that Dr. Carino approved six
prescriptions in a period of less than ninety seconds); see also Gov.
Ex. 76 (prescriptions issued by Drs. Duncan and Mercado- Francis).
\3\ See also Gov. Ex. 61 (providing copies of
prescriptions issued by Carino and filled by Respondent for persons
living in Tulsa, Oklahoma (Rx 45291); Seattle, Washington (Rx 45296);
Manchester, Kentucky (Rx 45297); New Orleans, Louisiana (Rx 45299);
Jacksonville, Florida (Rx 45302); Morrow, Ohio (Rx 45306); Prestonburg,
Kentucky (Rx 45311); Statesville, North Carolina (Rx 45314);
Westerville, Ohio (Rx 45315); Concord, Virginia (Rx 45317); Houston,
Texas (Rx 45318); and Cape May, NJ (Rx 45325)).
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Notwithstanding that many of the prescriptions were for persons who
resided at a great distance from Port Richey, Florida (the location of
Dr. Carino)--thus rendering it highly improbable that the patients were
ever physically examined by Carino--Respondent proceeded to fill an ever
increasing number of prescriptions issued by this physician. For
example, on March 9, 2004, Respondent filled 82 prescriptions for
controlled substances that were issued by Dr. Carino. See Gov. Ex. 77,
at 42-45. The prescriptions were for phendimetrazine and Didrex (benzphetamine),
both schedule III stimulants, see 21 CFR 1308.13(b), and phentermine, a
highly abused schedule IV controlled substance in both generic and
branded drugs such as Adipex-P. See id. at 21
CFR 1308.14(e); Tr. 583-844, 596. On May 26, 2004, Respondent filled
182 prescriptions issued by Dr. Carino for controlled substances
including Didrex, phendimetrazine, diethylpropion (another schedule IV
[[Page 30851]]
stimulant, see 21 CFR 1308.14(e)), and, of course, branded and
generic phentermine. See Gov. Ex. 77, at 174-79. And on July 30, 2004,
Respondent filled 337 prescriptions issued by Dr. Carino for controlled
substances including Didrex, phendimetrazine, diethylpropion, and
phentermine. Id. at 421-30.\4\
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\4\ The above are only representative samples to
show the growth and the extent of Respondent's dispensing pursuant to
its contract with iPharmacy. Respondent filled increasing and
frequently extraordinary quantities of controlled substance
prescriptions issued by Dr. Carino on numerous other days until August
27, 2004. See Gov. Ex. 77, at 1-554.
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For some reason not established by the record, in late August/early
September 2004, Respondent apparently stopped receiving prescriptions
that were issued by Dr. Carino. See Gov. Ex. 77, at 554; Tr. 856.
Respondent, however, began filling controlled substance prescription
issued by two other physicians retained by iPharmacy, Dr. Michael
Duncan, who was based in Nashville, Tennessee, and Dr. Jose Mercado-
Francis, who was based in Isla Verde, Puerto Rico. See Gov. Ex. 77, at
554, 641-42; Gov. Ex. 73.
On September 10, 2004, Respondent filled 134 controlled substance
prescriptions issued by Dr. Duncan for phentermine, phendimetrazine,
benzphetamine, and diethylpropion. See Gov. Ex. 77, at 554-557. Less
than a week later, on September 16, 2004, Respondent filled 272
controlled substance prescriptions issued by Dr. Duncan for these same
drugs. See id. at 574-81. And on September 29, 2004, Respondent filled
107 controlled substance prescriptions for these same drugs that were
issued by Dr. Mercado-Francis. Id. at 642-48. Respondent continued to
fill large quantities of controlled substances prescriptions issued by
both physicians until early May 2005. See generally id. at 582-1172.
With respect to these physicians, the Government introduced copies of
the controlled substance prescriptions issued by them during the period
April 20-26, 2005. See Gov. Ex. 76, at 1-404. Here, again, the
prescriptions were for persons in such far flung locations as Sherman
Oaks, California (Rx 84929); Westfield, Massachusetts (Rx 84932);
Beaumont, Texas (Rx 84933); Isanti, Minnesota (Rx 84938); Watertown,
South Dakota (Rx 84939); Lockport, Louisiana (Rx 84940) and Oklahoma
City, Oklahoma (Rx 84943). See id. at 2, 6, 7,10, 11, 12, 15. The ALJ
also found that between January 2004 and May 3, 2005, "Respondent filled
at least 43,203 prescriptions, the vast majority of them [being] for
controlled substances.'' ALJ at 22; see also Gov. Ex. 77. This finding
is supported by substantial evidence.
On July 19, 2005, DEA investigators executed a search warrant at Dr.
Duncan's residence and interviewed him. Tr. 39-41. During the interview,
Dr. Duncan stated that in September 2004, he had entered into a contract
with iPharmacy.MD, under which he reviewed questionnaires submitted by
iPharmacy's customers and either approved or did not approve a
prescription for the drug (typically phentermine, but also including
other stimulants which are controlled substances) requested by its
customers. Tr. 45-47. More specifically, Duncan told investigators that
he would approve the prescriptions if the person indicated that they had
a Body Mass Index greater than thirty and indicated that they were in
good health. Id. at 47. Duncan would then e-mail the prescription to
either Respondent or another pharmacy that filled prescriptions for
iPharmacy. Id.
Duncan told investigators that he reviewed approximately 1100
questionnaires each week (for which he was paid $ 3.00 each). Id. at
47-48. Duncan further admitted that he never saw any of the "patients''
or talked with a patient, and that he did not review any document other
than the on-line questionnaire which was submitted by iPharmacy's
customers.\5\ Id. While Dr. Duncan held a DEA registration, it did not
authorize him to dispense schedule IV controlled substances such as
phentermine. See Gov. Ex. 16.
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\5\ Among the phentermine prescriptions which Duncan
issued were two obtained by a DEA Special Agent (acting in an
undercover capacity) on January 7, 2005, and April 14, 2005. See Tr.
at 128; Gov. Exs. 37, 47, 101, 102. Respondent filled the second of
these prescriptions. Gov. Exs. 62 & 102. With respect to this
prescription, Mr. Enemchukwu testified that he did not knowingly fill
a fraudulent prescription. Tr. 782.
The iPharmacy questionnaire expressly stated that "To
order weight loss products (i.e. Phentermine) your BMI (Body Mass
Index) must be over 30. Your body mass index is automatically
calculated to the right based on the values you enter above.'' Gov.
Ex. 40, at 2. Obviously, iPharmacy's customers could enter any values
they wanted because there was no verification of the information as
would occur in a physical exam. Indeed, the Special Agent testified
that to obtain the prescription she entered her height as 5'1'' and
her weight as 160 lbs. Tr. 93-94. While the Special Agent entered her
correct height, her actual weight was 130 lbs. Id.; see also Gov. Ex.
45.
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The ALJ found that between January 2004 and April 2005, Respondent
had purchased a total of 2,002,700 dosage units of phentermine which was
comprised of 58,700 (15 mg.) tablets, 374,200 (30 mg.) tablets, and
1,569,800 (37.5 mg.) tablets. Gov. Ex. 57 & 98; ALJ at 21. On a
monthly basis, Respondent thus purchased an average of approximately
125,168 tablets of the drug.
To demonstrate the excessiveness of these purchases, the Government
obtained data regarding the dispensing of phentermine by forty Walgreens'
stores in the metropolitan Orlando area during the period September 1,
2004, through July 30, 2005. See Gov. Ex. 65. This data showed that the
forty stores combined filled 6,317 phentermine prescriptions and
dispensed a total of 188,541 dosage units. Id. On a monthly basis, the
stores dispensed an average of 14.3 prescriptions per month and 428
tablets. In contrast, between January 2004 and May 2005, Respondent
dispensed approximately 43,200 prescriptions for various controlled
substances which predominately included phentermine for an average of
2700 prescriptions per month. See Gov. Ex. 77.
The Government also elicited testimony from several expert witnesses.
The first of these was Dr. Carmen Catizone, a registered pharmacist and
the Executive Director of the National Association of Boards of
Pharmacy. Gov. Ex. 89. Dr. Catizone testified that "[a] valid
prescription is one where the pharmacy or pharmacist has ascertained
that there is a bona fide patient/doctor relationship, and the
prescription is within the scope of practice * * * and * * * is
legitimate for the patient, and the patient's condition, and does not
contraindicate * * * with any other medications that the patient is
taking.'' Tr. 479. Dr. Catizone further testified as to the State of
Florida's regulations pertaining to the prescribing of weight loss drugs
which include reviewing the patient's body mass index, conducting a
physical examination,\6\ and the physician's obligation to personally
present the prescription to the \7\patient. Id. at 480. Dr. Catizone
also stated that while it is not illegal for a physician to prescribe
for a patient in another State,
[[Page 30852]]
"that patient would have had to have an in-person examination by that
physician''; in other words, a "face-to-face'' physical exam.\8\ Id. at
538-39.
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\6\ While the Florida rule pertaining to the
prescribing of anti-obesity drugs allows a physician to delegate the
performance of the physical exam to a trained licensed physician's
assistant or a licensed advanced registered nurse practitioner, the
rule requires that "the delegating physician must personally review
the resulting medical records prior to the issuance of an initial
prescription.'' Fla. Admin. Code R. 64B8-9.012(3), Respondent produced
no evidence to show that Dr. Carino practiced in this manner. Beyond
that, as found above, the raw number of prescriptions being issued by
Dr. Carino was staggering and should have at least triggered some
inquiry of Dr. Carino as to how he could issue so many prescriptions
on a daily basis.
\7\ Dr. Catizone further testified as to the dangers
posed by illegitimate Internet pharmacies including the ease in which
persons are able to obtain controlled substances without having to
undergo a physical examination and the potential for fraud. Tr.
485-91. \8\ Dr. Catizone acknowledged that a second physician could
rely on the medical records created by another physician who conducted
a physical exam or a physical exam conducted by another physician and
observed by video conferencing. Tr. 539-40. Respondent did not,
however, produce any evidence to show that the three iPharmacy
physicians issued prescriptions based on physical exams they observed
via video conferencing or their review of a medical record of an exam
performed by another physician.
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Based upon his review of Respondent's prescription records, and more
specifically, the records pertaining to Dr. Carino's prescribing, see
Gov. Ex. 77, Dr. Catizone further testified that "as a pharmacist [it]
would be very unusual to see that many prescriptions sequentially for
this type of practice.'' Tr. 504. With respect to the prescriptions
issued by Dr. Duncan (who was in Tennessee) and filled by Respondent,
Dr. Catizone opined that "[t]he pattern there again does not follow
traditional practice.'' Id. at 505. Noting that "in this case, you have
a physician located in a completely different State, and the patient is
located in a completely different State than the pharmacy,'' Dr.
Catizone concluded that "[t]here appears to be no relationship between
the prescriber and the patient, and the pharmacy.'' Id. Dr. Catizone
concluded by testifying that Respondent's dispensing of controlled
substances to Internet customers was not in compliance with accepted
standards of pharmacy practice. Id. at 508.
On cross-examination, Dr. Catizone was asked a series of questions
regarding how a pharmacist would know whether a prescription was
suspicious and had not been issued for a legitimate medical purpose. Id.
at 516-17. More specifically, Respondent's counsel asked Dr. Catizone
how a pharmacist is "to know that the prescription was generated from an
on-line questionnaire or cyberspace evaluation?'' Id. at 517. Dr.
Catizone answered that if a pharmacist "received one prescription from a
physician, [he] probably wouldn't have a suspicion. But if [he]
receive[s] multiple prescriptions from a physician, and that physician
is writing for controlled substances, that would invoke a suspicious
relationship.'' Id. When pressed by Respondent's counsel as to what
number of prescriptions "would invoke a suspicion,''? Dr. Catizone
explained that "any more than 10 prescriptions per day for a physician
would invoke a suspicion.'' Id. at 517-18. I credit all of Dr.
Catizone's testimony.
The Government also called to testify Dr. George J. Van Komen, the
former President of The Federation of State Medical Boards of the United
States and former Chairman of the State of Utah's Physicians Licensing
Board. Gov. Ex. 88, at 3. Based upon his review of Respondent's
prescription records, (compiled in Government Ex. 77), Dr. Van Komen
concluded that Dr. Carino was engaged in "a rogue practice, because
there is no way that a physician in a normal setting could see anywhere
from fifty to a hundred patients, and appropriately and properly manage
their weight.'' Tr. 602-03. After noting that Carino was writing
prescriptions for patients located all over the country, Dr. Van Komen
further testified that:
The prescribing behavior and practices for Dr. Carino and Dr. Duncan
were identical. Both of them wrote large numbers of prescriptions, far
larger than one would expect anyone to be able to take care of [in the]
normal appropriate safe practice of medicine. And his [Dr. Duncan's]
behavior also shows that his prescriptions were going to patients all
over the United States as well.
Id. at 604.
Finally, Dr. Van Komen testified that the manner in which Drs. Carino
and Duncan were prescribing controlled substances over the Internet "was
totally against any conceivable standard'' of medical practice. Id. at
605. On cross-examination, however, Dr. Van Komen acknowledged that it
was possible that a physician who had four physician assistants working
for him could write over one hundred valid prescriptions a day. Id. at
612-13.
Mr. Enemchukwu testified that he stopped filling controlled substance
prescriptions from iPharmacy in May 2005, after receiving various
materials regarding Internet prescribing which were sent by the DEA
Miami office in April 2005 including the 2001 guidance document. Id. at
732; Gov. Ex. 18. Mr. Enemchukwu stated, however, that he had no
knowledge that iPharmacy was engaged in improper activity. Tr. 733. Mr.
Enemchukwu further testified that "the reason why [he] decided to stop
filling those controlled substance prescriptions was not because [he]
knew that the doctor was not doing what he was supposed to do,'' i.e.,
enter into a valid patient-doctor relationship with iPharmacy's
customers. Id. at 736. Rather, the reason was that if "the DEA might in
any way frown on this, I [didn't] want to be a part of it.'' Id.
Mr. Enemchukwu further claimed that he did not obtain knowledge that
the iPharmacy prescriptions were not issued in the course of a
legitimate patient-doctor relationship until "[i]n these proceedings.''
Id. Mr. Enemchukwu also claimed that he never went to the iPharmacy
webpages that were used by its customers and thus "did not know'' that
its customers could select their drugs, the dosage, and count, before
submitting their requests to the physicians. Id. at 739- 40.
Mr. Enemchukwu further testified that he was not familiar with
regulations issued by the State of Florida governing the prescribing of
obesity drugs. Id. at 782; see also Gov. Ex. 86. Under these
regulations, an initial evaluation must "be conducted prior to the
prescribing, * * * dispensing, or administering of any drug * * * and
such evaluation shall include an appropriate physical and complete
history; appropriate tests related to medical treatment for weight loss;
* * * all in accordance with general medical standards of care.'' Fla.
Admin. Code Ann. R.64B8-9.012(3) (reproduced at Gov. Ex. 86, at 2).
Moreover, while an initial evaluation can be "delegated to either a
physician's assistant or to an advanced registered nurse practitioner, *
* * the delegating physician must personally review the resulting
medical records prior to the issuance of an initial prescription.'' Id.
Furthermore, under the Florida rule, "[a]t the time of delivering the
initial prescription or providing the initial supply of such drugs to a
patient, the prescribing physician must personally meet with the patient
and personally obtain an appropriate written informed consent from the
patient.'' Id. R64B8-9.012(5).
Mr. Enemchukwu further maintained that "[p]harmacists are not
mini-doctors,'' and what a pharmacist does "is completely separate from
what the doctor does.'' Tr. 796. When asked on cross-examination how he
would know that iPharmacy was "not a fly-by-night operation that [was]
only interested in getting money?,'' Mr. Enemchukwu answered: "I was
filling prescriptions that I believed were valid prescriptions, and
prescribed by qualified physicians.'' Id. at 819-20. When asked,
however, whether as a pharmacist he had a corresponding obligation "to
ensure that the prescriptions are filled properly?,'' Mr. Enemchukwu
answered: "[t]hat the prescriptions are filled properly and prescribed
properly, yes.'' Id. at 820. Later, when asked whether a pharmacist is "just
as responsible if they filled an unlawful prescription'' as the
physician who issued it?, Mr. Enemchukwu answered: "No.'' Id. at 824.
Mr. Enemchukwu further maintained that "[it] would not be fair to hold
[a pharmacist] responsible for what somebody else did if they did not
know that the prescription was not authorized.'' Id. at 824-25.
[[Page 30853]]
Notwithstanding that he was filling numerous prescriptions for
phentermine which were issued by Dr. Carino, Mr. Enemchukwu admitted
that he never spoke with Carino and never inquired in to whether he ran
a diet practice. Id. at 829-30. Mr. Enemchukwu further maintained that
it was his understanding that Carino could prescribe to patients in
different parts of the country but admitted that he did not inquire as
to whether Carino actually could. Id. at 830-31. Mr. Enemchukwu
justified this stating that he did not know "what the medical boards of
other States are allowing. I don't know what doctors are authorized to
do * * * as far as prescribing outside Florida.'' Id. at 831.
Later, the Government asked Mr. Enemchukwu whether a physician could
issue a legitimate prescription based solely on a questionnaire and
without performing a physical examination. Id. at 843-44. Mr. Enemchukwu
answered: "I would not approve that, and if I know that as a pharmacist,
I would not fill the prescription.'' Id. at 844. When asked whether he
was "aware that Dr. Carino was doing examinations on a patient prior to
your pharmacy dispensing or issuing a prescription?,'' Mr. Enemchukwu
stated: "[i]t was my impression that he was doing these examinations
himself or doing what a physician practicing good medicine would do.''
Id. at 844. Mr. Enemchukwu then tried to justify his filling the Carino
prescriptions on the grounds that the "patients'' could have been
physically examined by physician assistants or other physicians, or
Carino could have "had offices in multiple States.'' Id. at 844-45. Mr.
Enemchukwu admitted, however, that he never inquired with Carino as to
whether the latter had persons in other parts of the country who were
doing physical examinations for him. Id. at 849.
Relatedly, Mr. Enemchukwu testified that the frequency of the
prescriptions he was filling did not raise his suspicion even though
none of the local physicians whose prescriptions he filled for walk-in
customers prescribed at the rate of Dr. Carino. Id. at 850. When pressed
by the Government as to how Carino's rate of prescribing compared to
that of local physicians, Mr. Enemchukwu asserted that "everything we
are looking at now is from hindsight.'' Id. Mr. Enemchukwu further
testified that "[t]here were questions that I did not ask because I
thought everything was okay.'' Id. at 852.
Likewise, Mr. Enemchukwu testified that he had had only one
conversation with Dr. Duncan, which was about a particular prescription,
and that he never asked Duncan about his practice because it was "obvious''
that he operated a diet practice. Id. at 858. When asked whether he had
assumed that Duncan had authority "to practice in different parts of the
country,'' Mr. Enemchukwu answered: "I did not know what his prescribing
rights was [sic].'' Id. at 858-59. Mr. Enemchukwu then added that "[i]n
Florida, we are allowed to fill prescriptions prescribed by out-of-state
doctors.'' Id. at 859. Here, too, Mr. Enemchukwu insisted that he "had
no reason to believe that'' the prescriptions issued by Drs. Duncan and
Carino were unlawful. Id. at 864.
The ALJ specifically declined to credit Mr. Enemchukwu's testimony
that he believed that the prescriptions he filled for iPharmacy were
issued by its physicians pursuant to a legitimate doctor-patient
relationship and that he had no reason to believe to the contrary. See
ALJ at 29. As the ALJ reasoned, "it defies [the] imagination to believe
that [Mr. Enemchukwu] did not think that something might be wrong when a
physician in one state issued prescriptions--thousand of them--to
purported patients in other states.'' Id. at 30. As the ALJ further
explained, "between January 2004 and May 2005, Respondent filled more
than 43,000 prescriptions, or more than 2,700 prescriptions per month,
the vast majority of which were for controlled substances and issued by
only [three] \9\ physicians to individuals all over the United States.''
Id. The ALJ thus further found that "Mr. Enemchukwu knew but refused to
acknowledge that the prescriptions he filled were not issued pursuant to
a legitimate physician-patient relationship.'' Id.
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\9\ As found above, in fact, Respondent filled
prescriptions written by three iPharmacy physicians (Carino, Duncan,
and Mercado- Francis).
---------------------------------------------------------------------------
I adopt both of the ALJ's findings. With respect to the finding that
Mr. Enemchukwu's testimony (that he had no reason to believe that the
iPharmacy prescriptions were invalid) was disingenuous, the ALJ
personally observed Mr. Enemchukwu's testimony and was in the best
position to evaluate his credibility on this issue of historical fact.
See Universal Camera Corp. v. NLRB, 340 U.S. 474, 496 (1951).
Indeed, Mr. Enemchukwu's testimony is implausible. As found above,
early on in Trinity's relationship with iPharmacy it was apparent that
the prescriptions were illegal. Even under Respondent's theory that it
would be possible for a physician using four physician assistants to
write over one hundred valid prescriptions a day, as early as May 26,
2004, Respondent filled, on a single day, 182 prescriptions for
controlled substances issued by Carino. And by July 30, 2004, Respondent
filled, on a single day, 337 prescriptions issued by this same doctor.
Moreover, the prescriptions were for "patients'' located throughout the
United States. Notwithstanding this information, Mr. Enemchukwu made no
inquiry as to the legitimacy of Carino's prescriptions. Nor did Mr.
Enemchukwu inquire as to the legitimacy of Dr. Duncan's prescriptions.
Substantial evidence thus supports the conclusion that Mr. Enemchukwu
knew early on in his company's relationship with iPharmacy that the
prescriptions were not the result of a legitimate doctor- patient
relationship. I therefore also adopt the ALJ's further finding that Mr.
Enemchukwu knew that the iPharmacy prescriptions were invalid. Relatedly,
I reject as disingenuous Mr. Enemchukwu's testimony that he did not
recognize that the prescriptions were illegal until this proceeding.
Discussion
Mootness
At the outset, this case presents the question as to whether this
proceeding is now moot. As found above, Respondent's registration
expired on November 30, 2006 (shortly after the record was forwarded to
me), and Respondent has not submitted a renewal application. Therefore,
Respondent no longer has a registration and there is no application to
either grant or deny. See Lockridge, 71 FR at 77796; Ronald J. Riegel,
63 FR 67132, 67133 (1998).
This proceeding began, however, with the immediate suspension of
Respondent's registration. As Lockridge noted, the issuance of an order
of immediate suspension may impose collateral consequences which
preclude a finding of mootness. As several courts have noted in cases
involving licensed professionals, "even a temporary suspension followed
by a reinstatement does not moot a challenge to the initial suspension
because the action `is harmful to a [professional's] reputation, and the
mere possibility of adverse collateral consequences is sufficient to
preclude a finding of mootness.' '' Lockridge, 71 FR at 77797 (quoting
In re Surrick, 338 F.3d 224, 230 (3d Cir. 2003) (quoting Dailey v.
Vought Aircraft Co., 141 F.3d 224, 228 (5th Cir. 1998))). See also
Kirkland v. National Mortgage Network, Inc., 884 F.2d 1367, 1370 (11th
Cir. 1989) (attorney's appeal of the revocation of his pro hac vice
status was not moot following dismissal of the
[[Page 30854]]
underlying case because "the brand of disqualification on grounds of
dishonesty and bad faith could well hang over his name and career for
years to come'').
It is indisputable that an immediate suspension harms a registrant's
reputation. Moreover, were Respondent to apply for a new DEA
registration in the future, it would be required to disclose the
suspension. See DEA Form-224, at Section 5. And Respondent may also be
required to report this suspension to state authorities. Given that
Respondent remains in business,\10\ and under DEA's regulations, can
apply for a new registration at any time, it is not pure speculation to
conclude that Respondent may be impacted by the collateral consequences
that attached with the issuance of the immediate suspension order.
Moreover, under federal law, title to any controlled substances seized
when the immediate suspension was served is dependent upon the outcome
of this proceeding. 21 U.S.C. 824(f).
---------------------------------------------------------------------------
\10\ The case thus stands in contrast to one where a
registrant has either gone out of business or ceased professional
practice.
---------------------------------------------------------------------------
Besides these collateral consequences, I note that neither party has
moved to dismiss the proceeding as moot. Moreover, given the resources
that both the Government and Respondent have invested in this
proceeding, it makes little sense to dismiss this case without issuing a
ruling on the merits even if that ruling is limited to assessing whether
the suspension of Respondent's registration was warranted under section
304(a), 21 U.S.C. 824(a). I therefore conclude that this case is not
moot.
The Statutory Factors
Section 304(a) of the Controlled Substance 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 his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21
U.S.C. 824(a). Section 304(d) further provides that "[t]he Attorney
General may, in his discretion, suspend any registration simultaneously
with the institution of proceedings under this section, in cases where
he finds that there is an imminent danger to the public health or
safety.'' 21 U.S.C. 824(d).
In determining the public interest, the Act directs that the Attorney
General consider 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). In this case, I conclude that the suspension of Respondent's
registration was justified under factors two and four.
Factors Two and Four--Respondent's Experience in Dispensing
Controlled Substances and Its Compliance With Applicable Federal, State,
and Local Laws
As explained above, under DEA's regulation, a prescription for a
controlled substance is unlawful unless it has been "issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice.'' 21 CFR 1306.04(a). While
''[t]he responsibility for the proper prescribing and dispensing of
controlled substances is upon the prescribing practitioner, * * * a
corresponding responsibility rests with the pharmacist who fills the
prescription.'' Id. "[T]he person knowingly filling such a purported
prescription, as well as the person issuing it, [is] subject to the
penalties provided for violations of the provisions of law relating to
controlled substances.'' Id.
DEA has consistently interpreted this provision as prohibiting a
pharmacist from filling a prescription for controlled substances when he
either "knows or has reason to know that the prescription was not
written for a legitimate medical purpose.'' Medic-Aid Pharmacy, 55 FR
30043, 30044 (1990); see also Frank's Corner Pharmacy, 60 FR 17574,
17576 (1995); Ralph J. Bertolino, 55 FR 4729, 4730 (1990). See also
United States v. Seelig, 622 F.2d 207, 213 (6th Cir. 1980). This Agency
has further held that "[w]hen prescriptions are clearly not issued for
legitimate medical purposes, a pharmacist may not intentionally close
his eyes and thereby avoid [actual] knowledge of the real purpose of the
prescription.'' Bertolino, 55 FR at 4730 (citations omitted). This is
also apparently the standard applicable under Florida law. See Fla.
Stat. Sec. 465.016(s) (dispensing drug when "pharmacist knows or has
reason to believe that the purported prescription is not based upon a
valid practitioner-patient relationship'' is grounds for discipline).
Respondent concedes that the iPharmacy prescriptions were not
legitimate. See Resp. Br. at 13. Respondent contends, however, that the
Government did not meet its burden of proof because various government
witnesses "testified that it was possible for these prescriptions to
have been legally and properly issued (although they were not) through
the use of physician assistants or referring physicians.'' Id. According
to Respondent, the Government failed to show "that Respondent knew or
had reason to believe that the prescriptions were improper.'' Id.
The Government did, however, prove that it was more likely than not
that Respondent knew that these prescriptions were illegitimate.\11\
While it is true that one of the Government's witnesses acknowledged
that it would be possible for a physician using four physician
assistants to write over one hundred valid prescriptions a day, the
dispensing records showed that Respondent was filling prescriptions far
in excess of this figure. As found above, on May 26, 2004, Respondent
filled 182 controlled substance prescriptions issued by Dr. Carino, and
on July 30, 2004, Respondent filled 337 controlled substance
prescriptions issued by Carino. Moreover, on September 16, 2004, shortly
after Dr. Duncan began issuing prescriptions, Respondent filled 272 of
them on a single day. These are only representative examples; the
dispensing log is replete with evidence showing that through May 2005,
Respondent dispensed a similar volume of prescriptions issued by
iPharmacy's
[[Page 30855]]
physicians on almost every other day it was open for business.
---------------------------------------------------------------------------
\11\ See Metropolitan Stevedore Co. v. Rambo, 521
U.S. 121, 137 n.9 (1997) (other citation omitted) (preponderance
standard requires only that the ultimate factfinder "believe that the
existence of a fact is more probable than its nonexistence before * *
* find[ing] in favor of the party who has the burden to persuade the [factfinder]
of the fact's existence'').
---------------------------------------------------------------------------
As recognized in other cases, the sheer volume of prescriptions thus
establishes that it more likely than not that Respondent's owner knew
that the prescriptions were illegitimate and intentionally ignored this.
See, e.g., Bertolino, 55 FR 4729, 4730. Beyond that, the prescriptions
were being sent to persons in every part of the country. Moreover, there
is also some evidence that the iPharmacy physicians performed their
reviews in rapid-fire fashion. Yet none of this prompted Respondent's
owner to question the legality of the prescriptions. Contrary to Mr.
Enemchukwu's assertion that "everything we are looking at now is from
hindsight,'' Tr. 850, shortly into the relationship with iPharmacy, Mr.
Enemchukwu was receiving abundant evidence--on a nearly daily basis--to
know that iPharmacy (and its doctors) were engaged in illegal
activity.\12\
---------------------------------------------------------------------------
\12\ Respondent's owner makes no claim that it was
reasonable for him to rely on the representations made by Mr. Butler
both orally and in the contract regarding the legality of internet
prescribing and dispensing. This is rightly so for three reasons: (1)
Mr. Enemchukwu is a licensed professional and is responsible for
knowing the rules applicable to the practice of his profession, (2) in
April 2001, nearly three years before he entered into the contract
with Mr. Butler, DEA published guidance which explained the
application of existing federal laws and regulations to the proposed
arrangement, and (3) other bodies such as the AMA and Federation of
State Medical Boards had published information regarding the
invalidity of internet prescribing under both ethical and legal
standards. See Gov. Exs. 3 & 4.
---------------------------------------------------------------------------
I thus conclude that Respondent is responsible for the dispensing of
more than 43,000 illegal prescriptions and the diversion of more than
two million dosage units of various controlled substances. Not only is
this a violation of federal law, see 21
U.S.C. 841(a), and appears to be a violation of Florida law,\13\ see
Fla. Stat. 465.016(s), it is manifest that diversion on this scale
creates an extraordinary threat to the public health and safety.
Respondent's experience in dispensing controlled substances and its
record of compliance with applicable laws thus provide abundant reason
to conclude that Respondent committed acts which rendered its
registration "inconsistent with the public interest'' and thus warranted
the suspension of its registration under section 304(a). 21
U.S.C. 824(a)(4).\14\
---------------------------------------------------------------------------
\13\ The Government also argues that Respondent
violated various state laws by dispensing to persons in States where
it was not licensed to do so. See Gov. Br. at 48. In its brief, the
Government did not, however, cite to specific laws establishing the
licensure requirements of various States. Moreover, the Government's
proof was largely confined to an e-mail in which Respondent sought
reimbursement for the fees it paid to obtain the permits. The
Government's evidence did not cite to specific instances in which
Respondent dispensed in violation of a particular State's law. See Tr.
361-62.Therefore, I conclude that this allegation had not been proved
with substantial evidence.
\14\ Based on Mr. Enemchukwu's insistence that he
did not know and had no reason to believe that the iPharmacy
prescriptions were unlawful, the ALJ further concluded that he had
failed to acknowledge his wrongdoing and thus was not "willing to
accept the responsibilities inherent in a DEA registration.'' ALJ at
31. While I agree with the ALJ's view of the evidence, there is
neither an existing registration to revoke nor a pending application
to deny. As this case is now limited to a review of the validity of
the suspension, there is no need to considerer this finding and weigh
it against the slight mitigating evidence in the case.
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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, BT2863668,
issued to Trinity Health Care Corporation, d/b/a/ Oviedo Discount
Pharmacy, is hereby affirmed.
Dated: May 21, 2007,
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-10627 Filed 6-1-07; 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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