[Federal Register Volume 71, Number 248 (Wednesday, December 27, 2006)]
[Notices]
[Pages 77791-77800]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-22105]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 04-48]
William R. Lockridge, M.D. Affirmance of Immediate Suspension of
Registration
Introduction and Procedural History
On May 17, 2004, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and Notice of
Immediate Suspension of the practitioner's Certificate of Registration,
BL6779005, held by William R. Lockridge, M.D. (Respondent), of Wayne,
N.J. The Notice of Immediate Suspension was based upon my preliminary
finding that Respondent was ``responsible for the diversion of large
quantities of controlled substances'' by writing prescriptions for
controlled substances that were issued on behalf of persons he never
physically examined and which thus lacked a ``legitimate medical
purpose.'' Order to Show Cause at 9. Based on this finding, I concluded
that Respondent's continued registration ``constitute[d] an imminent
danger to the public health and safety because of
[[Page 77792]]
the substantial likelihood that [he] would continue to divert
controlled substances.'' Id. at 10.
More specifically, the Show Cause Order alleged that a Pennsylvania
State Pharmacy Inspector had conducted an inspection of an Internet
pharmacy, CMC Pharmacy (CMC), and determined that a ``significant
portion of'' the controlled substances prescriptions dispensed by CMC
were issued by Respondent. Id. at 5. The Show Cause Order alleged that
a DEA Diversion Investigator (DI) had interviewed a drug-dependent
person who informed the DI that he had obtained prescriptions for
Schedule III and IV controlled substances such as Lortab and Xanax from
Respondent based on a telephone interview and a falsified medical
record. See id. at 5-6. The Order further alleged that this person told
the DI that several of his acquaintances had also obtained
prescriptions for controlled substances from Respondent and CMC
although they had no legitimate medical need for the drugs. See id. at
6.
The Show Cause Order also alleged that the DI subsequently
contacted CMC regarding the purchase of controlled substances from it,
and was told that in order to do so, he was required to register as a
patient of the Southwest Medical Group (SMG). See id. The Show Cause
Order alleged that the DI, using an undercover persona, registered as a
patient with SMG and faxed to it a fabricated medical record which
stated that he had shoulder pain but did not indicate that he had ever
been prescribed controlled substances for the condition. See id. at 7.
The Show Cause Order next alleged that the DI subsequently
completed an online questionnaire and obtained an appointment for a
telephonic consultation with Respondent. See id. at 8. The Show Cause
Order alleged that the DI called Respondent and that during the
conversation Respondent asked him why he was requesting Vicodin. See
id. The Show Cause Order alleged that the DI told Respondent that he
had bought the drug from a friend and that he needed it because he was
a truck driver and had to turn his truck's steering wheel. See id. The
Show Cause Order alleged that Respondent then suggested a prescription
for 120 ten mg. tablets of Vicodin with two refills, and ultimately
prescribed the drug. See id.
The Show Cause Order further alleged that Respondent then asked the
DI whether there was anything else he could do for him. See id.
According to the Show Cause Order, after the DI informed Respondent
that he was nervous because he had just been given a contract to haul
dynamite, Respondent prescribed 120 two mg. tablets of alprazolam with
two refills. See id. The Show Cause Order thus alleged that both
prescriptions were issued without a legitimate medical purpose and
without a legitimate medical examination. See id. at 8-9.
Next, the Show Cause Order alleged that Respondent told the DI that
the prescription had been forwarded to CMC. See id. at 9. The Show
Cause Order also alleged that the DI was charged $ 115 for Respondent's
services, which was payable to SMG. See id. The Show Cause Order
alleged that the DI subsequently received 120 tablets of 10 mg.
hydrocodone and 120 tablets of 2 mg. alprazolam, for which he paid $
261. See id.
Finally, the Show Cause Order alleged that ``nearly all'' of the
controlled substance prescriptions that were filled by CMC were issued
by Respondent through the SMG. See id. The Show Cause further alleged
that over a one year period, Respondent was responsible for dispensing
more than 2,316,300 dosage units of hydrocodone-based drugs ``via the
Internet, for no legitimate medical purpose and without the benefit of
a * * * legitimate medical examination.'' See id.
DEA DIs initially attempted to serve the Show Cause Order and
Immediate Suspension on Respondent at his registered location of 1777
Hamburg Turnpike, Suite 202, Wayne, N.J. However, upon their arrival at
this address, the DIs were told that Respondent had not practiced there
for the past four years. See ALJ at 4. Thereafter, DI Conlon, who had
conducted the investigation, contacted Respondent using a phone number
from SMG's Web site which was for a Florida address. See id. The DI
instructed Respondent that his registration had been immediately
suspended and subsequently, DIs from Florida served Respondent with the
Order to Show Cause and Immediate Suspension. See id.
Thereafter, Respondent timely requested a hearing. The matter was
assigned to Administrative Law Judge (ALJ) Gail Randall, who conducted
a hearing in Pittsburgh, Pa., on October 26 and 27, 2004. At the
hearing, the Government elicited the testimony of six witnesses and
introduced numerous exhibits. Respondent rested without putting on a
case. Thereafter, both parties submitted post-hearing briefs.
On November 18, 2005, the ALJ issued her decision. The ALJ
concluded that the Government had proved by a preponderance of the
evidence that the revocation of Respondent's registration was in the
public interest and recommended that I revoke Respondent's
registration. See ALJ at 42-43. Neither party filed exceptions.
Having carefully reviewed the record as a whole, I hereby issue
this decision and final order. I adopt the ALJ's findings of fact and
conclusions of law in their entirety. Because Respondent's registration
has since expired and Respondent did not submit a renewal application,
I do not adopt the ALJ's recommendation that Respondent's registration
be revoked. I do, however, affirm the immediate suspension of
Respondent's registration and make the following findings.
Findings of Fact
Respondent is a medical doctor who at the time of the hearing held
medical licenses in the States of New Jersey and New York. See ALJ at
4. Respondent did not, however, hold a medical license in the State of
Florida. See id.
At the time of the hearing, Respondent held DEA Certificate of
Registration, BL6779005, with an expiration date of March 31, 2006. I
take official notice of the fact that Respondent has not submitted an
application to renew his Certificate of Registration.
Respondent's registered location was: Associates in Women's Health,
1777 Hamburg Turnpike, Suite 202, Wayne, N.J. See Gov. Ex. 1.
Respondent had not, however, practiced at this location for at least
four years prior to the May 2004 service of the Order to Show Cause.
ALJ at 4. Moreover, pursuant to 5 U.S.C. 557(e), I take official notice
of the records of the New Jersey Division of Consumer Affairs, which
indicate that Respondent's N.J. medical license expired on June 30,
2005.\1\
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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 the final decision.'' U.S. Dept. of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). In accordance with the APA and
DEA'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 the
facts of which I am taking official notice, publication of this
final order shall be withheld for fifteen days, which shall begin on
the date of service by placing this order in the mail.
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Respondent did not hold a DEA Certificate of Registration for
either of the two Florida addresses he used during the 2003 through
2004 time frame. See Tr. 236; Gov. Ex. 2 (printout of registration
status); Gov. Ex. 8 (N.J. and N.Y. medical licenses listing
Respondent's address as 2555 PGA Blvd., 157, Palm Beach
Gardens, Fl. 33410); Gov. Ex. 10 (Letter of June 28, 2003, from
Respondent to Mr. Dave
[[Page 77793]]
Schwartzenberger of SMG, using 2555 PGA Blvd. address); Gov. Ex. 24 (Rx
forms listing Respondent's address as 461 Surfside Lane, Juno, Fl.).
Respondent was living in Juno Beach, Florida, when he was finally
served with the Order to Show Cause and Immediate Suspension. See Gov.
Ex. 6 (Return Receipt Card signed by Respondent on June 2, 2004, using
Juno Beach address).
In October 2003, a DI assigned to the Pittsburgh field office
received information that CMC and Respondent were using the Internet to
distribute controlled substances. ALJ at 5. While CMC was the initial
focus of the investigation, at some point thereafter, a Pennsylvania
State Pharmacy Inspector informed the DI that a high volume of CMC's
prescriptions were for hydrocodone combination drugs (which are
Schedule III controlled substances, see 21 CFR 1308.13(e)), and various
benzodiazepines such as diazepam and alprazolam (which are Schedule IV
controlled substances, see 21 CFR 1308.14(c)), and that ``the vast
majority of the prescriptions'' filled by CMC were written by
Respondent. Tr. 343, 359.
On March 25, 2004, the DI phoned CMC to find out how the ``scheme
worked.'' Tr. 238. During that conversation, the DI was told by an
unidentified person at CMC that the pharmacy worked with SMG and that
SMG ``set up the doctor consults.'' Tr. 240; see also Gov. Ex. 3. The
DI was then given SMG's phone number. See Tr. 240.
Later that day, the DI called SMG and spoke with a person named Sam
about obtaining prescriptions from CMC. Id. at 241. Sam told the DI to
go to SMG's Web site and follow the posted instructions to register
with it. Id. at 241-42.
Thereafter, the DI, using the undercover persona of John Dearing,
went to SMG's ``New Patient Registration'' webpage and completed the
form. On the form, the DI gave both e-mail and street addresses, his
date of birth, phone number and indicated that his medical condition
was a ``problem with shoulder.'' Gov. Ex. 12. The webpage stated:
``Before completing this form please make sure you have your medical
records or release form and a legible copy of your government issued
identification ready to fax upon completion of this registration
form.'' Id.
To comply with this requirement, the DI created a false medical
record which indicated that he had been treated for neck pain and flu-
like symptoms with over-the-counter drugs such as Tylenol and Motrin
during several office visits. See Gov. Ex. 14; Tr. 246. The document
also contained a reference to spasms and exterior and lateral
extension. See Gov. Ex. 14; Tr. 246. Finally, the document did not
include the name, address and phone number of a physician. See Gov.
Exh. 14. The DI also created a fictitious photo identification by
altering his driver's license. Tr. 243. The DI subsequently faxed both
items to SMG. See Gov. Ex. 16.
Several hours later, the DI received an e-mail from SMG which
congratulated him on his registration and provided him with a patient
identification number. See Gov. Ex. 17. The e-mail also instructed the
DI to visit the southwestmedicalgroup.com webpage to ``to secure an
appointment for a physician consultation.'' Id.
Thereafter, on April 7, 2004, the DI returned to the SMG Web site
and completed a ``repeat patient medical history form'' even though
``he was a new customer.'' ALJ at 8, Gov. Ex. 18, at 50. On this form,
the DI was asked whether he was ``requesting a specific
Medication(s)?.'' Gov. Ex. 18, at 50. The DI indicated ``yes,'' and
that he was requesting ``Vicodin 10 mg'' for a ``shoulder'' condition.
See id. The DI further indicated that he had ``taken Vikes before with
no side effects.'' Id. Vikes is a street name for Vicodin. ALJ at 8.
The DI also selected a time for a ``consultation'' with Respondent;
the DI was subsequently instructed to call Respondent at 11:10 AM the
next day and was given Respondent's name and a Florida phone number.
See Gov. Ex. 18, at 60.
At the appointed time, the DI called Respondent. During this
conversation, Respondent asked the DI what he wanted; the DI told
Respondent that he wanted Vicodin. While Respondent was aware that the
DI had indicated that he had a shoulder problem, he did not ask the DI
whether he was in pain and the DI did not say that he ``had any pain.''
Tr. 255-56. The DI also told Respondent that he had been getting
Vicodin from friends but had just found out that it was illegal to do
so. Gov. Ex. 4. Respondent replied that it was illegal to obtain the
drug from friends and that a doctor had to prescribe it. See Tr. 300.
Respondent then asked the DI ``how many [he] wish[ed] to purchase?'';
the DI replied ``120.'' Id. Respondent then agreed to prescribe 120
Vicodin tablets with two refills. See id.
Respondent then asked whether there was ``anything else [he] could
do'' for the DI. Id. at 301. The DI told Respondent that he was
``nervous'' because he was going through a divorce and had just gotten
a contract to haul dynamite. Id. Respondent then asked the DI ``[w]hat
would you like for your nerves?,'' and offered to prescribe ``either
Xanax or Valium.'' Id. The DI eventually asked for Valium and requested
that the prescription coincide with the Vicodin so that they would
``run out at the same time.'' Id. at 302. Respondent then told the DI
that he would authorize a prescription for 120 Valium tablets with two
refills. Id.\2\
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\2\ The DI attempted to record this conversation, but the
recording device did not pick up Respondent's voice. The DI
subsequently called Respondent again to recapture the substance of
the first conversation. See Tr. 303. The transcript of that
conversation confirms that Respondent prescribed 120 tablets of both
Vicodin and diazepam, with two refills for each drug, for the DI.
See Gov. Ex. 4, at 9-10. In that conversation, Respondent also told
the DI that the fee for the consultation (which was $ 115) should be
paid to SMG. Id. at 9. The DI subsequently sent a postal money order
to SMG. See Gov. Ex. 20, at 66 & 68. Respondent also informed the DI
that CMC would bill him separately for the drugs. Tr. 302.
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Respondent did not take a complete medical history from the DI, and
obviously did not perform a physical exam. See ALJ at 12 (citing Tr.
256-58). He did not order medical testing, and did not discuss with the
DI either the risks and benefits of taking the drugs he prescribed or
the availability of alternative treatments. See id. Moreover,
Respondent did not ask the DI whether he was seeing other physicians or
using other online pharmacies. See id. Finally, Respondent did not
discuss the contents of the ``medical record'' the DI had submitted and
did not establish a treatment plan or a timetable for taking the drugs.
See id.
On April 22, 2004, the DI faxed to SMG a copy of the postal money
order paying for the consultation. See Gov. Ex. 20. Later that day, SMG
sent an e-mail to the DI providing him with a United Parcel Service
tracking number and instructing him that the drugs were being shipped
COD and that the ``total for all pharmacy services (medication,
shipping and handling) [was] $ 261.'' See Gov. Ex. 21. The e-mail also
gave instructions for ordering refills and stated that: ``You will NOT
be able to refill your prescription at any local pharmacy. You must
order your refill through the Southwest Medical Group Web site only.''
Id. The ALJ also found that CMC ``did not accept any form of insurance
as payment for medications.'' ALJ at 9 (citing Tr. 335).
Thereafter, the DI obtained both drugs from CMC along with an
invoice that indicated the details of each prescription and listed
Respondent as the prescribing physician. See Gov. Ex. 22. Moreover, on
May 19, 2004, during the execution of a search warrant at CMC, copies
of the prescriptions which Respondent wrote for the DI were retrieved.
See Gov. Ex. 24; Tr. 325. The
[[Page 77794]]
heading of the forms gave Respondent's name and his address as his
Juno, Florida residence. See Gov. Ex. 24. The forms also listed
Respondent's New Jersey medical license number and the DEA number for
his former office in Wayne, N.J. See id., see also Gov. Ex. 8.
During the search of CMC, the Government seized the pharmacy's
computer database and retrieved from it patient and prescription
information. Tr. 328-29; Gov. Exs. 25-30. The ALJ specifically found
that Respondent wrote ``the vast majority of [the] prescriptions filled
by CMC.'' See ALJ at 10. This finding is supported by substantial
evidence. See Tr. 328; Gov. Exs. 27-30.
Moreover, the Government compiled a list of CMC's customers by
their State. CMC filled prescriptions for customers located ``in
virtually every [S]tate.'' ALJ at 11, see also Gov. Ex. 25. Indeed, CMC
filled prescriptions for customers in such far-off places as Alaska,
Hawaii and Washington State. See id. The Government also compiled a 467
page list of the prescriptions filled by CMC between July 1, 2003, and
May 11, 2004, which includes the patient's name, the prescribing
physician's name, the drug, and the quantity. See Gov. Exhs. 28 & 30;
see also Gov. Exhs. 27 & 29. Based on this evidence, I further find
that the overwhelming majority of the prescriptions Respondent issued
(and CMC dispensed) were for controlled substances.
The Government also submitted into evidence an analysis of the
prescriptions Respondent wrote and CMC dispensed for the drugs
alprazolam, diazepam, hydrocodone and Lortab (a branded drug that
combines acetaminophen and hydrocodone). See Gov. Ex. 65. During the
last six months of 2003, Respondent wrote 1,207 prescriptions for
alprazolam (for a total of 115,400 dosage units) and 1,140
prescriptions for diazepam (for a total of 71,811 dosage units). See
id. During the portion of 2004 in which CMC remained in business,\3\
Respondent wrote 2,519 prescriptions for alprazolam (for a total of
245,130 dosage units) and 1,806 prescriptions for diazepam (for a total
of 126,925 dosage units). See id.
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\3\ While the document states that the data covered the
``[f]irst 5 months of 2004,'' in fact, the last date that the data
was available for was May 11, 2004. See Gov. Ex. 65. CMC was shut
down following the execution of the search warrant.
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During the last six months of 2003, Respondent wrote 7,939
prescriptions for hydrocodone (for a total of 1,021,146 dosage units)
and 44 prescriptions for Lortab (for a total of 5,730 dosage units).
See id. During the period of 2004 in which CMC remained in business,
Respondent wrote 14,129 prescriptions for hydrocodone (for a total of
1,840,355 dosage units) and 97 prescriptions for Lortab (for a total of
12,330 dosage units). See id. Finally, the analysis found that on May
10, 2004, and May 11, 2004 (the last two days for which there was
data), CMC filled respectively 358 and 242 prescriptions for controlled
substances that were written by Respondent. Id.
On October 15, 2004, the Government also executed a search warrant
at Respondent's residence. The only documents found were scheduling
charts. No patient records were found. Tr. 407.
The Government also called three other persons who testified as to
the circumstances surrounding their obtaining prescriptions for
controlled substances from Respondent. Mr. A.W. testified that he
submitted a medical record, on which he altered the date; the record
had been prepared by a physician, who had since died, and contained the
physician's name, address and phone number. Id. at 24-26. A.W. gave
testimony consistent with that of the DI as to the process required to
register with SMG. Id. at 28-33. A.W. further testified that upon
receiving his identification number and password, he went to the
``repeat patient medical history form'' and requested a prescription
for Xanax (alprazolam) and Norco, a product containing hydrocodone and
acetaminophen. Id. at 33-34.
A.W. obtained a time for a phone consultation with Respondent and
called him. Id. at 40. As a result of the consultation, which lasted
``no more than four or five minutes,'' Respondent prescribed for A.W. a
month's supply of both hydrocodone and Xanax with two refills. Id. at
33-34, 41.
A.W. had several additional ``consultations'' with Respondent at
three month intervals, each of which lasted approximately four to five
minutes. Id. at 41. The conversations typically involved Respondent
asking A.W. how he was feeling, whether everything was o.k., whether he
wanted the same drugs, and if there was anything else Respondent could
do for him. Id. at 42. Respondent never required A.W. to submit any
other medical records to him. Id.
Moreover, Respondent never asked A.W. if he had previously been
addicted to drugs, never took a medical history, and never asked what
drugs he had previously taken or what other drugs he was then taking.
See ALJ at 23 (citing Tr. 42-43). Most significantly, Respondent never
performed a physical exam on A.W. and did not require that he obtain a
physical exam from another physician. Tr. 43. Furthermore, A.W. never
saw Respondent ``in person.'' Id. at 43. Respondent also never
suggested alternative treatments for A.W.'s condition, and other than
to mention that the drugs he prescribed could be addictive, never
discussed the benefits and risks of taking controlled substances. Id.
at 44.
A.W. further testified that all of the prescriptions written for
him by Respondent were filled by CMC, id. at 52, that he was not
allowed to have the prescriptions filled at another pharmacy, and that
he could not use his insurance to pay for the drugs and instead had to
pay with cash. Id. at 97-98. According to the data obtained during the
search of CMC, A.W. received from CMC prescriptions for 140 hydrocodone
tablets and 60 alprazolam tablets, which were authorized by Respondent
on a monthly basis from October 2003 through April 2004. See Govt. Ex.
27, at 5-6. A.W. further testified that the 140 hydrocodone tablets he
received each month ``was more than any doctor ever gave'' him in his
entire life. Tr. 44. A.W. also testified that he was addicted to drugs
when he became a ``patient'' of SMG. Id. at 84. I credit A.W.'s
testimony.
The Government also called as a witness Ms. B.B. I, like the ALJ,
credit her testimony.
Consistent with the testimony of the DI and A.W., B.B. testified
that she registered with SMG by going to its Web site and completing
its new patient registration form and submitting a copy of her driver's
license and medical records. See ALJ at 25-26. B.B.'s medical record
indicated that she had been treated by a chiropractor for ``tennis
elbow'' with heat therapy and ``electrolysis.'' Tr. 123, 132. The
medical record did not indicate that B.B. had been treated with
controlled substances, and the chiropractor had not prescribed
controlled substances for her condition. See ALJ at 26 (citing Tr. 131-
32).
In completing SMG's ``repeat patient medical history form,'' B.B.
requested a prescription for hydrocodone 10/500 to treat her condition.
See id. (citing Tr. 135-36). B.B. then selected a time for her
consultation with Respondent. See id. (citing Tr. 137). After the first
consultation, Respondent prescribed 90 hydrocodone tablets for B.B. See
id. at 27 (citing Tr. 140 & 142).\4\ B.B. had three
[[Page 77795]]
consultations with Respondent, each of which lasted for two to ``three
minutes tops.'' Tr. 139. According to B.B., the consultations involved
Respondent asking her ``what can I do for you, what do you need?'' Id.
While Respondent and B.B. did discuss her condition, id. at 144, after
B.B. told Respondent what she wanted, Respondent ``always ask[ed] is
there anything else I can do for you or get for you?'' Id. at 139. The
ALJ further found that ``B.B. credibly testified that every time she
talked to the Respondent, she got the controlled substances she
requested.'' ALJ at 27 (citing Tr. 147).
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\4\ TDI Pharmacy initially filled the prescriptions B.B.
obtained from Respondent. ALJ at 28 (citing Tr. 147-48). At some
point thereafter, CMC started filling the prescriptions B.B.
obtained from Respondent. See id. (citing Tr. 147-48).
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B.B. testified that following the first consultation she found out
from an Internet message board that Respondent was giving other persons
prescriptions for 120 hydrocodone tablets. Id. (citing Tr. 142-43).
B.B. subsequently asked Respondent to increase her prescription and
Respondent did so. Id. (citing Tr. 142-43).
B.B. testified that she never saw Respondent ``face to face,'' that
Respondent never performed a physical exam on her, and never took a
complete medical history. Tr. 125. Moreover, Respondent never ordered
any medical tests (such as an x-ray or mri) or asked her to submit any
previous test results. Id. at 125-26. Respondent also did not discuss
with B.B. alternative treatments or the benefits and risks of taking
controlled substances. Id. at 126. Nor did Respondent discuss with B.B.
a timetable for her use of controlled substances. Id. Respondent also
never asked B.B. if she was obtaining prescriptions from another doctor
or using other Internet pharmacies. Id. at 180. Finally, Respondent
never asked B.B. whether she had previously been addicted. Id.
B.B. paid SMG a fee of $ 120.00 for these consultations. Id. at
133. B.B. further testified that Respondent never gave her a paper
prescription that she could take to another pharmacy. Id. at 148-49.
B.B. testified that at the same time that she was obtaining
prescriptions from Respondent, she was able to obtain hydrocodone from
ten other Internet pharmacies and was taking ``up to 40'' hydrocodone
tablets a day. Id. at 145. B.B. became addicted, ``contemplate[ed]
suicide,'' and could not function without the drug. Id. at 145-46. She
also lost her house and means of transportation and did not have money
to care for her children. Id.
The Government also called as a witness Mr. B.H., who at the time
was incarcerated for possession of a forged instrument and was about to
plead guilty to this offense. Tr. 215-16. B.H. also admitted that he
had been convicted of two misdemeanor theft offenses, one misdemeanor
drug offense, and one felony drug offense for which he was given
youthful offender status. Id. at 216-17. Moreover, B.H. testified that
in exchange for his testimony in this proceeding, local law enforcement
officials had promised not to prosecute him for conduct related to his
obtaining controlled substances over the Internet. Id. at 207. B.H.
also testified that he had been drug dependent since 1998. Id. at 188.
The ALJ credited B.H.'s testimony and I find no reason to disturb this
finding. See Universal Camera Corp. v. NLRB, 340 U.S. 474, 494-96
(1951).
B.H. testified that in 2002, he found SMG's Web site while
searching the Internet. Tr. 189. B.H. ``filled out the paperwork'' and
faxed to SMG a copy of his driver's license and a medical record that
he had obtained from another person. Id. at 189-90. B.H. altered the
medical record, which indicated that he had a problem with his L-4 & L-
5 disk and suffered from severe anxiety, by placing his name, date of
birth and social security number on it. Id. at 190. The record also
indicated that B.H. had previously been prescribed Lortab and Xanax.
Id. at 191.
After obtaining his ``patient ID,'' B.H. logged on to SMG's Web
site and requested hydrocodone and Xanax. Id. at 191-92. He also
obtained an appointment for a telephone consultation with Respondent.
Id. at 192. SMG did not provide B.H. with a choice of physicians, and
throughout his association with SMG, B.H. always dealt with Respondent.
Id.
B.H. testified that all of his consultations with Respondent
followed the same pattern and took ``about three or four minutes,
maybe, if that.'' Id. at 194. According to B.H., Respondent would state
that ``it says here you need hydrocodone and it said here you need
this. He'd write the prescription and you hang up.'' Id. B.H. further
testified that ``I would call up at my certain time and tell
[Respondent] what I wanted, and he would say okay. That would be it.''
Id. at 196-97.\5\
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\5\ B.H. acknowledged on cross-examination that he ``probably''
asked Respondent to prescribe Oxycontin and Percodan (which contain
oxycodone, a Schedule II controlled substance, 21 CFR 1308.12(b)),
but Respondent told him he could not prescribe these drugs. Tr. 214-
15.
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Indeed, the ALJ specifically found that ``during the initial call,
the Respondent and B.H. never discussed B.H.'s medical condition.'' ALJ
at 31 (citing Tr. 197). During the first consultation, Respondent gave
B.H. a prescription for 150 hydrocodone tablets and either 120 Xanax or
its generic equivalent alprazolam; B.H. subsequently received these
drugs on a monthly basis. Tr. 193.
Throughout this period, Respondent never took B.H.'s complete
medical history, never met with B.H. and performed a physical exam,
never asked B.H. about prior medical tests, and never ordered any
medical tests. Id. at 194-95. Respondent also never discussed a
treatment plan or alternative treatments. Id. at 195. Nor did he ever
discuss with B.H. the benefits and risks of taking controlled
substances, or a time table for taking the drugs. Id. at 195-96.
Finally, Respondent never asked B.H. whether he was seeing any other
doctors, if he was obtaining prescriptions from any other online
pharmacies, or asked whether he had ever been addicted to controlled
substances. Id. at 196. Other than when B.H. asked for a Schedule II
drug, Respondent never refused a request by B.H. for a controlled
substance. Id. at 195.
B.H. was obtaining controlled substances from other online
pharmacies at the same time he was obtaining prescriptions from
Respondent. Id. at 208. B.H. sold the hydrocodone he received from
Respondent's prescriptions to buy Oxycontin, but took the Xanax. Id. at
207.
B.H. never received from Respondent a prescription form that he
could take to a pharmacy. Id. at 209. He also showed several other
persons how to obtain prescriptions from SMG; these individuals then
obtained controlled substances which were prescribed to them by
Respondent. Id. at 198-200. B.H. testified that these individuals had
not previously obtained controlled substances from a physician for a
medical condition. Id. at 202.
The Government also called Dr. Richard Weinberg, a physician who is
board certified in internal medicine, as well as hospice and palliative
medicine. Tr. at 383. Dr. Weinberg testified as an expert in internal
medicine. See ALJ at 16. I credit all of his testimony which is
summarized as follows.
Dr. Weinberg reviewed a list of the prescriptions Respondent issued
and that were filled by CMC. See Tr. 386, Gov. Exhs. 28 & 30. He also
reviewed various documents related to the DEA DI's obtaining controlled
substances prescriptions from Respondent including transcripts of the
telephone conversations, the medical ``documentation'' the DI
submitted, and the various SMG Web pages that the DI filled out in
order to obtain the prescriptions. Tr. 386.
[[Page 77796]]
Dr. Weinberg testified that based on the above, Respondent did not
establish a valid doctor-patient relationship with the DI and did not
conduct an ``adequate assessment'' or ``evaluation'' to justify
Respondent's prescribing the controlled substances (hydrocodone and
Valium) which he did for the DI. Tr. 389. Dr. Weinberg further
testified that to establish a valid doctor-patient relationship, ``[a]
physician must have a direct and immediate observation of the
patient,'' which ``should be person-to-person.'' Id. at 393.
Dr. Weinberg testified that in treating pain, a physician must
obtain a medical history which includes ``what the origin of the pain
was, the history of it, previous treatments, attempts at physical
therapy, and other modalities for treatment of pain.'' Id. The
physician must further do ``a direct physical exam'' and create ``a
plan for further evaluation and treatment [with] reassessment at an
appropriate interval.'' Id. Moreover, a physician must ``inquire as to
whether there is a risk of chemical dependency before initiating the
use of drugs that are commonly associated with addiction, including all
opiates and benzodiazepines.'' Id. at 400.
As for treating anxiety, Dr. Weinberg testified that the physician
must take ``an extensive history to understand the appropriate
background, whether the patient is experiencing any depression, any
psycho-social stresses, [has] a history of panic disorder, et cetera.''
Id. at 393. According to Dr. Weinberg, this ``can only be done on a
face-to-face basis and, again, requires that a patient be followed over
time.'' Id.
Dr. Weinberg further testified that he has ``been involved with
addiction medicine throughout [his] career,'' id. at 403, that he was
currently ``the head of the addiction task force'' at a hospital and
that he is familiar with some of the street terminology used by drug
dependent persons. Id. at 403-04. More specifically, Dr. Weinberg
testified that ``Vikes'' is street talk for Vicodin, id. at 402, and
that if he received a questionnaire which indicated that a patient had
been taking ``Vikes'' and was told by the patient that he got the drug
from a friend (as the DI did in obtaining prescriptions from
Respondent), he would not prescribe the drug. Id. at 404. Dr. Weinberg
added that ``obtaining controlled substances from acquaintances [or]
friends [is] a warning sign that this is someone who is chemically
dependent or certainly involved with illicit use.'' Id. Dr. Weinberg
further added that a sedating medication such as Valium should not be
prescribed to a person who reports that he has anxiety from hauling
dynamite. Id. at 405.
Dr. Weinberg also reviewed the prescription data seized from CMC.
While acknowledging that there was ``a scattering of other
prescriptions,'' Dr. Weinberg noted that ``[i]n every instance in this
database, patients [were] prescribed substantial quantities of short-
acting opiates * * * and, in most cases, patients are also prescribed
benzodiazepine[s], either diazepam or alprazolam.'' Id. at 393-94.
According to Dr. Weinberg, ``[i]t would be a highly unusual
relationship with a set of patients that every single patient with whom
you have an encounter would be prescribed these agents.'' Id. at 394.
Moreover, it would also be ``extraordinary to have up to 120 patients
receive prescriptions in a single day.'' Id. According to Dr. Weinberg,
``[i]t's impossible for any clinician to have an appropriate evaluation
of that volume of patients in any short period of time.'' Id.
The Government also called as a witness Dr. James M. Tolliver, a
DEA employee who holds a Ph.D. in Pharmacology. See Gov. Ex. 34. Dr.
Tolliver has also served as a scientific advisor to the World Health
Organization (WHO) and has been involved in the preparation of various
documents used by the WHO in recommending that various drugs of abuse
be controlled under international conventions. See id. at 2.
Specific to this case, Dr. Tolliver explained that hydrocodone is
``a narcotic drug similar to morphine,'' which produces euphoria and
``has a potency similar to morphine.'' Tr. 275. Hydrocodone is ``a
substitute for heroin'' and ``heroin users like'' the drug. Id. at 275-
76. Moreover, over time hydrocodone users develop a tolerance to the
drug and thus require increased doses ``to produce the same effect.''
Id. at 277. In 2002, the abuse of hydrocodone combination products
resulted in ``over 27,000 emergency room episodes.'' Id. at 279.
Hydrocodone was thus among ``the top six to seven controlled
substances'' found in persons seeking treatment for drug abuse in
emergency rooms. Id.
Dr. Tolliver also testified regarding the abuse of benzodiazepines
such as alprazolam (Xanax) and diazepam (Valium). According to Dr.
Tolliver, ``[a]lprazolam is the number one prescription drug that is
abused by our youth in the United States.'' Id. at 283. Alprazolam was
number five on the list of drugs most frequently abused by persons who
require treatment in emergency rooms. Id. at 284. Moreover, other
benzodiazepines such as diazepam also rank in the top twenty of drugs
abused by persons requiring treatment in emergency rooms. Id.
Furthermore, benzodiazepines ``severely impact[]'' a user's psychomotor
control, thus affecting the ability to drive or operate machinery.\6\
Id. at 285.
---------------------------------------------------------------------------
\6\ Respondent neither testified on his own behalf nor put on
any witnesses.
---------------------------------------------------------------------------
Discussion
At the outset, this case presents a substantial question as to
whether this proceeding is moot. Respondent's registration expired on
March 31, 2006, after the hearing in this case and the ALJ's issuance
of her decision. Moreover, Respondent apparently has not submitted a
renewal application.
Under DEA precedent, ``[i]f a registrant has not submitted a timely
renewal application prior to the expiration date, then the registration
number expires and there is nothing to revoke.'' Ronald J. Riegel, 63
FR 67132, 67133 (1998). In Riegel, the registrant sought a hearing upon
being served with a Show Cause Order; his registration, however,
expired several months before the hearing was held and the registrant
did not submit a renewal application. Id. at 67132.
Following the hearing in Riegel, the Government discovered that the
respondent's registration had expired and moved to either order the
respondent to submit a renewal application or to terminate the
proceeding as moot. Id. The respondent did not respond to the motion.
Id. The ALJ, however, denied the motion concluding that the proceeding
was not moot under existing agency precedent. Id. While my predecessor
concluded that the matter was ``moot because there [was] no viable
registration to revoke,'' he nonetheless reasoned that ``it would be
unfair to * * * terminate the proceedings without resolution'' because
the Government's position was based on a ``deviation'' from agency
precedent and was not raised until after the hearing was held. Id. at
67133. He thus decided the case on the merits and ordered the
revocation of the respondent's registration. See id. at 67133-35.
Having carefully considered this precedent, as well as authorities
discussing the mootness doctrine in both the judicial and
administrative settings, I conclude that Riegel is not controlling. ``
`[A]n administrative agency is not bound by the constitutional
requirement of a ``case or controversy'' that limits the authority of
article III courts to rule on moot issues.' '' RT Communications, Inc.
v.
[[Page 77797]]
FCC, 201 F.3d 1264, 1267 (10th Cir. 2000) (quoting Climax Molybdenum
Co. v. Secretary of Labor, 703 F.2d 447, 451 (10th Cir. 1983)); see
also Metropolitan Council of NAACP Branches v.FCC, 46 F.3d 1154, 1161
(D.C. Cir. 1995) (``case or controversy requirement'' does not apply to
an agency). As the Tenth Circuit has explained, ``an agency has
`substantial discretion' to decide whether to hear issues which might
be precluded by mootness'' if litigated in an Article III court. RT
Communications, 201 F.3d at 1267 (quoting Climax Molybdenum, 703 F.2d
at 451).
Moreover, my decision to issue a final order in this matter finds
ample support in the mootness doctrine applied by the courts. Under
long settled principles, `` `a defendant's voluntary cessation of a
challenged practice does not deprive a federal court of its power to
determine the legality of the practice,' '' because `` `if it did, the
courts would be compelled to leave ``[t]he defendant * * * free to
return to his old ways.' '' Friends of the Earth, Inc., v. Laidlaw Env.
Servs., Inc., 528 U.S. 167, 189 (2000) (quoting City of Mesquite v.
Aladdin's Castle, Inc., 455 U.S. 283, 289 & n.10 (1982) (quoting United
States v. W.T. Grant Co., 345 U.S. 629, 632 (1953))). Most
significantly, the standard ``for determining whether a case has been
mooted by the defendant's voluntary conduct is stringent: `A case might
become moot if subsequent events made it absolutely clear that the
allegedly wrongful behavior could not reasonably be expected to recur.'
'' Friends of the Earth, 528 U.S. at 189 (quoting United States v.
Concentrated Phosphate Export Assn., 393 U.S. 199, 203 (1968)).
Finally, a case remains a live dispute when ``collateral
consequences'' attach to a proceeding which otherwise would be moot. In
re Surrick, 338 F.3d 224, 230 (3d Cir. 2003). As several courts have
noted in cases involving sanctions against licensed professionals such
as attorneys, 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.' '' Id. (quoting Dailey v. Vought
Aircraft Co., 141 F.3d 224, 228 (5th Cir. 1998)). See also id. (quoting
Kirklandv. 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 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' '').
Relying on these cases for guidance, I hold that this case is not
moot. As an initial matter, I note that neither party has moved to
dismiss the proceeding on mootness grounds. Moreover, while Respondent
has not submitted a renewal application, he has submitted no evidence
(such as a declaration) establishing that he intends to permanently
cease the practice of medicine. Cf. 21 CFR 1301.52(a) (``Any registrant
who * * * discontinues business or professional practice shall notify
the Administrator promptly of such fact.''). Indeed, under DEA's
regulations, Respondent can apply for a new registration at any time
and could re-engage in the practice at issue here. It is thus not ``
`absolutely clear that [Respondent's] allegedly wrongful behavior could
not reasonably be expected to recur.' '' See, e.g., Friends of the
Earth, 528 U.S. at 189 (quoting Concentrated Phosphate, 393 U.S. at
203).
Moreover, the Government (as did Respondent) expended substantial
resources in litigating this case; the ALJ also committed an extensive
amount of time to preparing her decision. To dismiss this proceeding
without making the findings which the evidence in this case compels
would prejudice the public interest. I thus conclude that Respondent's
failure to submit a renewal application does not preclude the entry of
a final order in this matter.
Furthermore, this case is not moot because of the collateral
consequences that attach to the immediate suspension of Respondent's
registration. As explained above, the immediate suspension was imposed
based on my preliminary finding that Respondent's continued
registration ``would constitute an imminent danger to the public health
and safety'' because he was diverting large amounts of controlled
substances. Show Cause Order at 10. It is indisputable that when the
Agency is forced to take this extraordinary step to protect public
health and safety, a registrant's reputation is harmed. Moreover, it is
likely that Respondent would be required to report the Immediate
Suspension were he to apply for a renewal of his state medical
licenses. Finally, were Respondent to apply for a new DEA registration
at some point in the future, he would be required to disclose the
suspension that is at issue here. See DEA Form-224, Section 5; DEA
Form-224A, Section 4.\7\
---------------------------------------------------------------------------
\7\ Furthermore, pursuant to 21 U.S.C. 824(f), DEA personnel who
serve an immediate suspension are directed to seize and place under
seal all controlled substances possessed by a registrant. See, e.g.,
Show Cause Order at 10. Under federal law, title to any such
property is dependent upon the outcome of the proceeding. 21 U.S.C.
824(f). Thus, while there is no evidence in the record as to whether
DEA investigators seized any controlled substances when they served
the order on Respondent, most cases which begin with the issuance of
an immediate suspension present this additional collateral
consequence.
---------------------------------------------------------------------------
As the forgoing demonstrates, the issuance of an immediate
suspension creates collateral consequences beyond those that are
present when the Government serves a Show Cause Order but allows a
registrant to continue to handle controlled substances throughout the
litigation. Therefore, I conclude that Riegel is not controlling and
that this case is not moot. I thus proceed to analyze the merits of
this case under the standards of section 304.
The Statutory Factors
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 his
registration under section 823 of this title inconsistent with the
public interest as determined under such section.'' 21 U.S.C.
824(a)(4). In making the public interest determination, the Act
requires the consideration of the following factors:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id.
``[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).
[[Page 77798]]
Finally, section 304(d) provides that ``[t]he Attorney General may,
in his discretion, suspend any registration simultaneously with the
institution of proceedings under this section, in cases where he finds
that there is an imminent danger to the public health or safety.'' 21
U.S.C. 824(d). In this case I conclude that Factors Two, Four and Five
establish that allowing Respondent to handle controlled substances
would be inconsistent with the public interest. Analyzing these
factors, I also conclude that Respondent's conduct created ``an
imminent danger to public health or safety,'' id., and thus sustain the
immediate suspension of his registration.
Factors Two and Four--Respondent's Experience In Dispensing Controlled
Substances and Respondent's Compliance With Applicable Laws
As the ALJ noted, the key issue in this case is whether the
prescriptions Respondent issued to the persons who were referred to him
through the SMG Web site complied with Federal law. As explained below,
the evidence conclusively demonstrates that Respondent used his
prescribing authority to act as a drug pusher; the only difference
between him and a street dealer was that he did not physically
distribute the drugs to SMG's clients.
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 his
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 (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.'' As Doctor Weinberg, the Government's
expert explained, existing professional standards require that to
establish a bonafide doctor-patient relationship, a physician must
first obtain a medical history which establishes the origin of the
patient's complaint, its history and previous attempts to treat the
condition. Tr. 393, 400. Moreover, the physician must conduct a
physical examination which involves the ``direct and immediate
observation of the patient'' and should be on an in-person basis. Id.
at 393. Furthermore, before prescribing controlled substances, the
physician must determine whether there is a risk of chemical dependency
or the patient is engaged in the illicit use of drugs. Id. at 400. The
physician should also develop ``a plan for further evaluation and
treatment [with] reassessment at an appropriate interval.'' Id. at 393.
The American Medical Association's Guidance for Physicians on
Internet Prescribing explains the ``components'' of a bonafide doctor-
patient relationship. Gov. Ex. 48. The AMA instructs that 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.
Id .
To similar effect are the guidelines issued by the Federation of
State Medical Boards of the United States, Inc. See Gov. Ex. 50 (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.'').\8\
---------------------------------------------------------------------------
\8\ 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.
---------------------------------------------------------------------------
Under the standards of the medical profession, it is clear that
Respondent did not establish a bonafide doctor-patient relationship
with any of the four material witnesses in this case and thus, none of
the prescriptions he issued to them complied with federal law.
Respondent never obtained a reliable medical history from these
persons--indeed, in this case there is substantial evidence that he
simply accepted whatever documents were provided by these individuals
without verifying their validity. In doing so, he ignored the potential
for fraud inherent in the scheme, which was obvious in light of the
fact that SMG allowed its ``patients'' to request a particular drug.
Most significantly, he did not physically examine any of these four
persons, direct that they be examined by another physician, or order
medical testing to verify their reported medical complaints.
Furthermore, he did not discuss with any of these persons the existence
of alternative treatments, generally failed to discuss the risks/
benefits of taking the various controlled substances he prescribed,
never developed a timetable for using controlled substances or a
treatment plan, and never attempted to determine whether any of these
persons had a history of addiction to the drugs or were obtaining them
from other sources. It is thus indisputable that none of the
prescriptions Respondent issued for these four persons were for a
legitimate medical purpose.
Indeed, there is ample evidence suggesting that Respondent knew
that his ``patients'' were seeking the drugs to abuse them. Several
witnesses testified that they requested specific drugs. Moreover, at
least three of the witnesses stated that during their conversations
with Respondent, he would ask them whether there was anything else he
could do for them. This is not the type of question that a physician
normally asks a patient during the course of providing medical
treatment. Indeed, several of the witnesses testified that they
interpreted Respondent's question as an offer to supply additional
controlled substances. See Tr. 301 (testimony of DI); id. at 140
(testimony of B.B.).
The evidence in this case further demonstrates the danger to public
health and safety created by Respondent
[[Page 77799]]
and other Internet prescribers. B.B. testified that while she was
obtaining controlled substances from Respondent and CMC, she was also
able to obtain them from ten other Internet pharmacies. B.B.
acknowledged that she was taking as many as 40 hydrocodone tablets a
day, that she became addicted, and that she considered suicide.
Relatedly, B.H. testified that he sold the hydrocodone he obtained from
Respondent's prescriptions in order to buy Oxycontin, a stronger and
more addictive controlled substance. He also related that he showed
several acquaintances how to obtain controlled substances from SMG,
which were prescribed to them by Respondent. B.H. further testified
that these persons had not previously been prescribed controlled
substances for a medical condition. He (along with the DI) also
testified to the ease of obtaining their prescriptions by submitting
fraudulent medical records. Obviously, Respondent's prescribing
practices invited fraud. Cf. 66 FR at 21183 (``A consumer can more
easily provide false information in a questionnaire than in a face-to-
face meeting with a doctor.'').
The prescription data further supports the conclusion that
Respondent was engaged in drug dealing rather than the legitimate
practice of medicine. Among other things, the evidence suggests that in
a single day (on or about May 10, 2004), Respondent issued as many as
358 prescriptions for controlled substances. The assembly line nature
of this activity refutes any suggestion that Respondent was engaged in
the legitimate practice of medicine. See Tr. 394 (testimony of
Dr.Weinberg) (noting that it would be ``extraordinary to have up to 120
patients receive prescriptions in a single day'').
The ALJ also reasoned that ``the sheer volume of the Respondent's
prescriptions also puts into question his medical practices.'' ALJ at
40-41. As found above, during the first four and half months of 2004
(before CMC was shut down), Respondent issued and CMC filled 14,219
prescriptions for hydrocodone, 2,519 prescriptions for alprazolam, and
1,806 prescriptions for diazepam. According to the ALJ, this Agency has
previously held ``that the numbers of prescriptions for controlled
substances, alone, do not create a regulatory violation.'' See ALJ at
41 (citing Paul W. Saxton, 64 FR 25073 (1999)). I need not decide,
however, whether Saxton supports this broad proposition. As the ALJ
also noted, there the respondent justified his prescribing by
presenting evidence as to the medical needs of his patients. See 64 FR
25075-76.
Here, by contrast, Respondent presented no such evidence. Moreover,
the geographical location of SMG's customers demonstrates the
substantial likelihood that most, if not all, of the prescriptions were
issued by Respondent without the establishment of a bonafide doctor-
patient relationship and while acting outside of the usual course of
professional practice. Indeed, one of the Government's exhibits
( 25) shows that Respondent prescribed to persons in every
State as well as the District of Columbia. Perhaps some of these
patients actually visited Respondent at his Florida residence, but
given his lack of licensure in that state, as well as the cost and time
involved for patients to travel there, the nature of SMG's scheme
(which offered the ability to obtain prescriptions based on a short
telephone conversation), and the absence of any medical records during
the search of his residence, it is most improbable that any
``patients'' did.
Respondent also violated the CSA for the additional reason that he
did not possess lawful authority to prescribe controlled substance in
Florida, the State in which he was practicing medicine. He also did not
hold a DEA registration authorizing him to dispense from his Florida
address.
The CSA defines the term ``practitioner'' as ``a physician . . .
licensed, registered, or otherwise permitted, by the United States or
the jurisdiction in which he practices . ., to distribute, dispense . .
. [or] administer . . . a controlled substance in the course of
professional practice.'' 21 U.S.C. 802(21) (emphasis added). Under the
CSA, the term ``dispense'' includes the act of ``prescribing'' a
controlled substance. Id. Sec. 802(10).
As the ALJ noted, this Agency has consistently interpreted the CSA
as prohibiting a practitioner from handling controlled substances
unless authorized to do so under the law of the state in which he
engages in professional practice. See ALJ at 37-38 (collecting cases).
See also Sheran Arden Yeates, 71 FR 39130, 39131 (2006). Also relevant
to this case is section 302 of the CSA, which expressly provides that
``[a] separate registration shall be required at each principal place
of business or professional practice where the applicant . . .
distributes, or dispenses controlled substances.'' 21 U.S.C. 822(e).
Here, there is substantial evidence that Respondent issued the
prescriptions from his residence in Florida. This includes the
addresses Respondent used in renewing his N.J. and N.Y. medical
licenses, the address Respondent used in his June 28, 2003
correspondence to SMG's head, the address used on the Rx forms found
during the search of CMC, the Florida phone number which the DI used
for his consultation, and the address at which Respondent was living
when the Show Cause Order and Immediate Suspension was served on him.
Finally, there is also the evidence that Respondent had not practiced
at the address of his DEA registered location for at least four years
prior to the service of the Show Cause Order. Respondent did not,
however, hold a Florida medical license and did not possess a DEA
registration for his Florida address. See Tr. 236; Gov. Ex. 1 & 2. His
prescribing thus violated the CSA for these reasons as well.
I thus conclude that Respondent's experience in dispensing
controlled substances and his history of non-compliance with applicable
laws amply demonstrate that Respondent could not be entrusted with a
DEA registration. I further affirm the preliminary finding that
Respondent's conduct constituted an ``imminent danger to the public
health or safety,'' 21 U.S.C. 824(d), and justified the immediate
suspension of his registration.
Factor Five--Other Conduct Which Threatens Public Health and Safety
The ALJ also found this factor applicable because Respondent
``failed to maintain adequate patient records.'' ALJ at 41. As the ALJ
explained, when the Government executed the search warrant at
Respondent's residence, no patient records were found notwithstanding
that he issued a substantial number of prescriptions from this address.
Id. at 42. I agree with the ALJ's conclusion.
As explained above under Factor Two, under existing professional
guidelines, a physician should ``maintain a contemporaneous medical
record.'' Gov. Ex. 48. Documenting the prescribing of controlled
substances would seem to be essential to a physician's effective
monitoring of a patient to ensure that the patient is not abusing the
drugs or has become addicted to them. Furthermore, it seems clear that
when a patient with a legitimate medical complaint needs to see a
specialist, the specialist needs accurate information pertaining to the
patient's use of controlled substances before recommending treatment
options. Finally, if a person engages in ``doctor shopping,'' accurate
records could help the new doctor assess the legitimacy of the person's
medical complaint. I thus conclude that Respondent's failure to
maintain patient records constitutes conduct that threatens public
health and
[[Page 77800]]
safety. See James S. Bischoff, 70 FR 12734 (2005).
It is not surprising that Respondent did not maintain patient
records because he was not engaged in anything remotely bordering on
the legitimate practice of medicine. Rather, Respondent was a drug
dealer. As I have previously noted, ``[l]egally, 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.'' Mario Avello, M.D., 70 FR 11695, 11697 (2005) (citing
Floyd A. Santner, M.D., 55 FR 37581 (1990)). The use of a DEA
registration to engage in such conduct manifestly creates ``an imminent
danger to the public health or safety'' and justifies the immediate
suspension of a registration. 21 U.S.C. 824(d).
Order
Pursuant to the authority vested in me by 21 U.S.C. 824, as well as
28 CFR 0.100 & 0.104, the order of immediate suspension of DEA
Certificate of Registration, BL6779005, issued to William R. Lockridge,
M.D., is hereby affirmed. The Office of Diversion Control is further
directed to cancel Respondent's DEA number. This order is effective
January 26, 2007.
Dated: December 8, 2006.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E6-22105 Filed 12-26-06; 8:45 am]
BILLING CODE 4410-09-P