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William R. Lockridge, M.D. Affirmance of Immediate Suspension
of Registration
FR Doc E6-22105 [Federal Register: December 27, 2006 (Volume 71,
Number 248)] [Notices] [Page 77791-77800] From the Federal Register
Online via GPO Access [wais.access.gpo.gov] [DOCID:fr27de06-95]
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
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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