FR Doc E8-16948[Federal Register: July 24, 2008 (Volume 73,
Number 143)] [Notices] [Page 43260-43269] From the Federal
Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr24jy08-96]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 08-29]
Laurence T. McKinney; Revocation of Registration
On February 5, 2008, I, the Deputy Administrator of the Drug
Enforcement Administration, issued an Order to Show Cause and
Immediate Suspension of Registration to Laurence T. McKinney,
M.D. (Respondent), of Philadelphia, Pennsylvania. The Order
immediately suspended and proposed the revocation of
Respondent's DEA Certificate of Registration, BM7201267, as a
practitioner, on the grounds that his continued registration was
"inconsistent with the public interest'' and "constitute[d]
an imminent danger to public health and safety.'' Show Cause
Order at 1 (citing 21
U.S.C. 824(a)(4) & 824(d)).
More specifically, the Show Cause Order alleged that
Respondent was "one of the largest prescribers of schedule
II controlled substances in the Philadelphia area[,]'' and that
"[f]rom October 5, 2004 to November 30, 2007 [had written]
3,101 prescriptions for schedule II narcotics.'' Id. Next, the
Show Cause Order alleged that Respondent sold prescriptions for
narcotics for $100 per prescription, that he had issued
prescriptions to undercover law enforcement officers on five
separate dates between December 14, 2007, and January 30, 2008,
that he had either failed to perform a physical examination or
had conducted only a "cursory physical examination'' on the
Officers, and that he had also written a prescription for one of
the undercover Officer's fictitious wife. Id. at 1-2. The Show
Cause Order further alleged that these "prescriptions were
not issued for a legitimate medical purpose or in the normal
course of professional practice'' and thus violated both Federal
and state laws and regulations. Id. at 2 (citing 21
U.S.C. 841(a); 21
CFR 1306.04(a)).
Based on the above, I also made the preliminary finding that
Respondent had "deliberately diverted controlled
substances'' and that his "continued registration during
the pendency of these proceedings would constitute an imminent
danger to the public health or safety because of the substantial
likelihood that [he would] continue to divert controlled
substances.'' Id. at 2. I therefore also ordered the immediate
suspension of Respondent's registration. Id.
On February 15, 2008, Respondent, through his counsel,
requested a hearing on the allegations. ALJ Ex. 2. The matter
was assigned to Administrative Law Judge (ALJ) Mary Ellen
Bittner. Following pre- hearing procedures, a hearing was held
on April 7, 2008 in Arlington, Virginia, at which both parties
introduced testimonial and documentary evidence.\1\ Upon
conclusion of the hearing, both parties submitted briefs
containing their proposed findings, conclusions of law and
argument.
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\1\ The Government also introduced
recordings of several undercover visits.
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On May 5, 2008, the ALJ issued her recommended decision (ALJ).
In her decision, the ALJ specifically rejected Respondent's
testimony regarding his prescribing to the undercover patients
finding that he was not credible. ALJ at 29. With respect to
factor two (Respondent's experience in dispensing controlled
substances), the ALJ concluded that "the record establishes
* * * that Respondent issued prescriptions to the undercover
Officers for controlled substances without any meaningful
physical examination or gathering sufficient information from
the patients to arrive at a reasoned diagnosis or * * * to
determine whether they had any condition at all warranting
treatment with the drugs he prescribed to them.'' Id. at 29-30.
The ALJ thus found "that all the prescriptions Respondent
issued to the undercover officers were not issued for a
legitimate medical purpose.'' Id. at 30.
The ALJ further noted that various patient files introduced
into evidence by the Government demonstrated that Respondent had
not provided "individualized attention'' to other patients.
Id. Relatedly, while noting that Respondent had "introduced
into evidence patient files containing considerably more
detailed information than those the Government offered,'' the
ALJ reasoned that even if these files showed that Respondent had
"legitimately treated'' some patients, the files predated
November 26, 2007, the date on which the Philadelphia Police
Department had received a complaint about Respondent and did not
"diminish the weight of the evidence that he improperly
prescribed controlled substances after it.'' Id.
With respect to factor four (Respondent's compliance with
applicable laws), the ALJ concluded that Respondent had failed
to comply with Pennsylvania law because he had issued
prescriptions for controlled substances without doing proper
physical examinations, taking adequate medical histories,
documenting the patient's symptoms, his diagnosis and treatment
recommendations, and that he had failed to counsel his patients
regarding how the drugs should be taken, the appropriate dosage,
and their side effects. Id. at 31. The ALJ thus concluded that
"Respondent violated applicable Pennsylvania law and also
violated 21
CFR 1306.04, and thereby 21
U.S.C. 829(b).'' Id.
With respect to factor five (other conduct), the ALJ rejected
Respondent's contention that he had prescribed pursuant to a
good-faith belief that the undercover patients were in pain. Id.
More specifically, the ALJ expressed her disbelief "that
Respondent did not know that the undercover Officers were not in
pain but were trying to obtain controlled substances for other
than a legitimate medical reason.'' Id. at 31. The ALJ further
found that Respondent had "refus[ed] to acknowledge his
wrongdoing,'' and that there was "little hope'' that
"he will act more responsibly in the future.'' Id.\2\
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\2\ The ALJ also found that Respondent had
retained his state medical license and that this factor
supported a finding "that his continued registration
would be in the public interest.'' ALJ at 29. The ALJ
explained, however, that this factor was not dispositive
because "state licensure is a necessary but not
sufficient condition for DEA registration.'' Id. The ALJ
further found that while Respondent had been convicted of a
felony, his offense did not involve an offense related to
controlled substances. Id. at 30-31. The ALJ thus found that
this factor supported his continued registration although it
too was not dispositive.
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Based on her findings with respect to three of the factors,
the ALJ concluded "that Respondent is unwilling or unable
to accept the responsibilities inherent in a DEA registration.''
Id. at 32. The ALJ thus recommended the revocation of
Respondent's registration and the denial of any pending
applications. Id. Respondent filed exceptions to the ALJ's
recommended decision. In this filing, Respondent raised
thirty-three exceptions to the ALJ's decision.\3\
[[Page 43261]]
Thereafter, the record was forwarded to me for final agency
action.
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\3\ Respondent's Exceptions did not,
however, comply with DEA's regulation which requires citation
to evidence of record which supports the exception. 21
CFR 1316.66(a).
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Having considered the record as a whole, as well as
Respondent's exceptions, I hereby issue this Decision and Final
Order. While I do not adopt the ALJ's factual findings in their
entirety, I adopt the ALJ's ultimate conclusions of law with
respect to each of the statutory factors and her recommended
sanction. I make the following findings of fact.
Findings
Respondent is a medical doctor who treats injury and trauma
patients, as well as weight loss patients, at a clinic he
operates in Philadelphia, Pennsylvania. Tr. 19-21. While
Respondent previously held board certification in obstetrics and
gynecology, he is no longer "board certified in anything.''
Id. at 21. In February 1998, Respondent pled guilty in Federal
Court to two counts of mail fraud based on fraudulent billing
practices. Id. at 48. Respondent was sentenced to a term of
imprisonment of twelve months and one day which he served at the
Federal Correctional Institution at Loretto, Pennsylvania, and
in a halfway house.\4\ Id. at 48-49; 266-67.
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\4\ In March 2000, the State of Pennsylvania
suspended Respondent's medical license for a period of four
years based on his mail fraud convictions. Tr. 267. The State,
however, stayed the suspension after nine months. Id. Shortly
thereafter, Respondent was granted a new DEA registration. GX
1, at 2.
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Respondent currently holds DEA Certificate of Registration,
BM7201267, which before I suspended it, authorized him to handle
controlled substances in schedules II through V as a
practitioner at his registered location of 7514 Frankford
Avenue, Philadelphia, Pa. GX 1, at 1. Respondent's registration
does not expire until January 31, 2010. Id.
On November 26, 2007, the Philadelphia Police Department
received a citizen's complaint which alleged that Respondent was
prescribing controlled substances such as Xanax (alprazolam),
and Percocet, a drug which contains oxycodone and
acetaminophen.\5\ GX 48. More specifically, the caller alleged
that "all the neighborhood kids know about'' Respondent,
that all one had to do to get an appointment was to call his
office and possibly tell him that "you were referred by a
neighbor,'' that "the Doctor will tell you to come in and
tell you to bring $100,'' and that "[t]ell the doctor you
have some type of aliment [sic] and he will write you a
prescription for Xanax, Percocet, Oxycodone etc.'' Id.
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\5\ Oxycodone is a schedule II controlled
substance and derivative of opium.
21 CFR 1308.12(b)(1). Xanax is the brand name of
alprazolam, a schedule IV controlled substance. See id. Sec.
1308.14(c).
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Upon receipt of this tip, the Philadelphia Police
Department's Intensive Drug Investigation Squad (IDIS) contacted
DEA's Philadelphia Diversion Group, which had also received
complaints about Respondent from local pharmacists. Tr. 154. As
part of their investigation, the decision was made to have
several IDIS members attempt to obtain prescriptions from
Respondent. Id. at 83-84.
The First Undercover Visit
On December 6, 2007, an undercover Officer using the name of
Nicole Hodge went to Respondent's office. Id. at 130. The
Officer paid Respondent $100 in cash and told him that she had
not been in an accident and did not have an injury but wanted a
prescription for Percocet. Id. Respondent attempted to get the
Officer to talk about an injury but she refused to. Id.
Respondent refused to issue the prescription and told her to
leave his office. Id. at 131. Respondent subsequently noted in
Nicole Hodge's patient file that "Pt. lied, Ask for
Percocet. Patient is not injured.'' GX 23.
The Second Undercover Visit
On December 14, 2007, another IDIS Officer, who used the
named Anthony Wilson, visited Respondent. After paying $100 in
cash, Respondent asked the Officer whether he had been in an
accident.\6\ Tr. 86. The Officer stated that he had been. Id.
Respondent then asked the Officer some unspecified question
about pain; the latter answered that he "hurt all over.''
Id. at 86-87. Moreover, the evidence includes a medical history
form on which the Officer indicated as his complaint: "Hurt
All Over,'' that the location of his condition was "all
over,'' and that its severity was "bad pain.'' GX 22, at 7.
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\6\ According to the record, Respondent
would instruct his "patients'' when they called for an
appointment that they should have cash. Tr. 92.
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According to the DEA Special Agent who debriefed the Officer,
the latter did not exhibit any signs of injury and Respondent
did not ask him to rate his pain level on a scale of one to ten.
Tr. 87. The Officer reported that Respondent's physical
examination was limited to touching him lightly on the shoulder
and back; moreover, Respondent did not listen to his heart and
lungs, and no one took his blood pressure. Id. at 88.
Respondent did not order any diagnostic tests such as an
x-ray or mri. Id. at 198. Respondent nonetheless diagnosed the
Officer as having back and neck contusions and prescribed to him
90 Percocet (10 mg.), 60 Xanax (1 mg.), and 60 Cataflam, a
non-controlled substance. Id. at 89; GX 16. The prescription
indicated that the Percocet should be taken every eight hours as
needed for pain and that the Xanax should be taken every twelve
hours as need for muscle spasms or anxiety. GX 16, at 2.
Respondent did not, however, counsel the Officer regarding the
dosing and frequency of taking the drugs, the drug's potential
side effects and its interactions with other drugs. Tr. at 92.
Another form in the patient file indicates that the Officer's
blood pressure was 120/82, as well as a height and weight. GX
22, at 5. Under the heading of "history of pertinent
facts,'' the form appears to state: "Passenger in MVA
driver side'' and "\8/10\ pain scale.'' Id. Finally,
another form entitled "ROM--AMA Guides'' has a notation of
"+2'' in the blocks for "Cervical Spine,''
"Dorsal Spine'' and Lumbar/Sacral.'' Id. at 6.
While Respondent testified that either he or a nurse had
taken the Officer's blood pressure, Tr. 312-13, the ALJ
specifically credited the testimony of the DEA agent \7\
regarding the various undercover visits and rejected
Respondent's testimony pertaining to them. More specifically,
the ALJ found that "Respondent did not impress [her] as
credible and appeared to try to tailor his testimony to suit his
own purposes, particularly with respect to his insistence that
he complied with Pennsylvania's requirements for prescribing
controlled substances.'' ALJ at 29. I adopt the ALJ's
credibility findings noting that she was in the best position to
observe the demeanor of the respective witnesses. I therefore
find that neither Respondent nor a nurse took the Officer's
blood pressure during the visit. I further find that the history
form for this visit contains no notation in the blocks for the
patient's "heart'' and "lungs'' (nor in any of the
other blocks save one in which findings pertaining to various
bodily functions are recorded). I therefore further find that
Respondent did not listen to Respondent's heart or lungs on this
date.
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\7\ As the ALJ explained, the Agent, in
contrast to Respondent, "appeared to be straightforward
and candid.'' ALJ at 29.
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The Third Undercover Visit
On January 3, 2008, the Officer returned to Respondent's
office and again presented himself as Anthony Wilson and paid
$100 for the visit. Tr.
[[Page 43262]]
97, 103. The same DEA Special Agent conducted surveillance of
the visit. ALJ at 12.
Apparently while the Officer was in the waiting room,
Respondent started calling out the names of patients. When
Respondent called the Officer's undercover name, he asked him
whether he was there for physical therapy. GX 3, at 2. At some
point, the Officer was taken back to an exam room and was told
by Respondent to take off his jacket. Id. The Officer stated to
Respondent: "last time you said I had neck and back
contusions.'' Id. Respondent told the Officer to have a seat and
asked him his first name. Id. The Officer answered:
"Anthony.'' Id. Following an unintelligible statement of
Respondent, the Officer offered to come back for physical
therapy. Id. After Respondent was interrupted by several phone
calls, the Officer offered to come back on Sunday for therapy
and Respondent agreed. Id. The Officer then stated that the
"the first time I was here you didn't have therapy,'' and
asked whether he had "to fill out the paperwork again, or
did she find my file?'' Id. Respondent answered: "No that's
all right, I saw it the other day, that's alright.'' Id. The
Officer then asked whether if "when I have the therapy and
the medicine it's the same price or is it?'' Id. Respondent
answered that it was the "[s]ame price if you come in for
just the prescription its 100 dollars, if you come in for the
prescription and exam and therapy its 100 dollars, if you come
in for just therapy its 100 dollars, o.k.'' Id.
During the visit, Respondent gave the Officer prescriptions
for 90 Percocet (10/325 mg.) and 60 Xanax (1 mg.). Id. at 3; GX
17. While Respondent asked the Officer how he had been doing,
Respondent limited his physical exam to pressing on the
Officer's back and shoulder and did not listen to the Officer's
heart and lungs or take his blood pressure. Tr. 99-100.
Moreover, while it was less than three weeks since the Officer's
previous visit (at which Respondent had also given him
prescriptions for 90 Percocet and 60 Xanax, each of which should
have lasted thirty days), Respondent did not question him about
why he needed new prescriptions so soon. Id. at 102.
Furthermore, once again, Respondent did not counsel the Officer
about the two drugs. Id. Finally, the patient file for
"Anthony Wilson'' contains no documentation of this visit.
See GX 22.
The Fourth and Fifth Undercover Visits
On January 18, at approximately 4:10 p.m., the Officer
returned to Respondent's office and was accompanied by another
Officer who used the name of Richard Johnson. Tr. 104.
Respondent called for Johnson first, and asked him if it was his
first visit. GX 5, at 1. Although the Officer had not previously
been to Respondent's office, the Officer responded: "No, I
was here December 14th.'' \8\ Id. Respondent then collected $100
from the Officer. Id.
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\8\ The DEA Agent testified that Respondent
attempted to find the Officer's patient file. Tr. 110-11.
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About twenty minutes later, Respondent again asked the
Officer his name. Upon being told "Richard Johnson,''
Respondent asked the Officer: "You said you been here
before * * * you do construction right?'' Id. The Officer
answered: "Yes, sir.'' Id. After discussing the Officer's
age and taking a phone call, Respondent asked the Officer:
"How you been doing since you [were] put on pain
medication?'' Id. at 2. The Officer answered: "pretty
good.'' Id. When Respondent asked: "Did it work real
well?''; the Officer answered: "Yes.''
Respondent next asked: "you['ve] been taking the yellow
ones three times a day?'' Id.\9\ The Officer answered:
"Yes.'' Id. Respondent then stated: "I had you on the
blue ones at night''; the Officer commented: "Yeah, at
night.'' Id. Respondent then asked the Officer to "stand
up,'' and stated: "7:05 p.m. Ok, what I'm going to do is
refill your medication * * * we can finally get you out of
here.'' Id. After taking a phone call, and commenting about
people stealing pens from his office, Respondent noted that it
was "7:08 p.m.'' and stated: "60 of the Xanax, 90 of
the Percocet.'' Id. As evidenced by the actual prescriptions,
Respondent prescribed 90 Percocet (10/325), which was to be
taken every eight hours, and 60 Xanax 1 mg., which was to be
taken every 12 hours. GX 18, at 2.
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\9\ I take official notice of the Product
Identification Guide found in the Physician's Desk Reference
(2005). According to the Guide, Percocet 10/325 mg. tablets
are yellow, id. at 311, and Xanax 1 mg. tablets are blue. Id.
at 330. Based on this and the prescriptions Respondent wrote,
I conclude that Respondent's references to the yellows ones
and the blue ones were references to Percocet and Xanax
respectively. In accordance with the Administrative Procedure
Act and DEA regulations, Respondent is entitled to an
opportunity to refute the facts which I have taken official
notice by filing a motion for reconsideration within fifteen
days of service of this Order, which shall begin on the date
of mailing. See 5 U.S.C. 556(e); 21
CFR 1316.59(e).
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Respondent's physical exam was limited to tapping the Officer
lightly on the back and shoulder. Tr. 112 Moreover, Respondent
did not order any diagnostic tests. Id. at 113. During a
subsequent search of Respondent's office, no patient file was
found for Richard Johnson. Id. at 215. Approximately 45 minutes
later, Respondent saw the other Officer (Anthony Wilson) who was
waiting in an exam room. GX 5, at 4. Respondent asked him
"how are you doing?,'' to which the Officer responded:
"I'll pay you now.'' \10\ Id. About a minute later,
Respondent entered the exam room and stated: "I am going
crazy right now, turn around this way.'' Id. In response, the
Officer stated: "I know it's been a long day.'' Id.
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\10\ It is unclear whether Respondent had
actually entered the exam room at this point or just stuck his
head in it.
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Respondent replied: "You have no idea.'' Id. Respondent
then stated: "stand up facing me, try to bend down knees
and touch your toes, come back up, alright, have a seat, look[s]
like your doing a little better.'' Id. The Officer replied:
"Yes sir, yes sir.'' Id. Respondent then stated: "Last
time I gave you Percocet 10's and Xanax right?'' Id. The Officer
responded: "Yes sir.'' Id. Respondent then stated: "So
that seems it gotta be working.'' Id. The Officer agreed, and
added that "the last time I didn't have any problems
cashing the [unintelligible].'' Id. Respondent then stated
"script.'' Id. The Officer again commented to the effect
that he had not had any problems filling his prescriptions. Id.
at 5.\11\ Respondent did not ask Wilson why he had returned only
fifteen days after the previous visit. See generally GX 5, at
4-5.
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\11\ Most of the remaining conversation
between Respondent and the Officer centered on the Officer's
problems with his ex-wife, although at one point the Officer
stated: "You said lower back and neck,'' and Respondent
agreed. GX 5, at 5.
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During the visit, Respondent issued the Officer additional
prescriptions for 90 Percocet (10/325 mg.) and 60 Xanax (1 mg.).
GX 18, at 1. The prescriptions called for the Percocet to be
taken every eight hours and for the Xanax to be taken every
twelve hours. Id.
The Sixth and Seventh Undercover Visits
On the night of January 22, 2008, at 8:07 p.m., the Officer
who had previously presented herself as Nicole Hodge went back
to Respondent's office. Tr. 131. The Officer was accompanied by
another Officer, who used the name "John Rio,'' and
apparently posed as her boyfriend. See GX 6, at 1.\12\
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\12\ According to GX 6, the Officers entered
Respondent's office together. GX 6, at 1. It is unclear,
however, whether they arrived in the same vehicle.
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Shortly after her arrival, Respondent called her name and
asked: "Why are you here dear?'' GX 6, at 1. The Officer
stated that she had been in an accident two days earlier. Id.
Respondent asked: "Nicole the last time you were here you
[[Page 43263]]
didn't have an injury remember?'' Id. The Officer answered:
"I know.'' Id. Respondent then asked the Officer whether
she swore that she was injured this time. Id. The Officer
answered that she had been "out with my boyfriend and got
hit by a car the other day.'' Id. The Officer then explained
that "I ran out before him * * * he pisses me off a lot.''
Id. Respondent laughed and asked: "Well I'm sure you don't
have anything to do with that at all, right?'' Id. The Officer
then asked the Officer posing as her boyfriend: "Did you
push me in front of that car?''; the latter answered:
"No.'' Id.
Respondent then told "John Rio'' to have a seat in an
exam room and asked him: "You been here before right?'' Id.
The Officer answered "Yeah,'' Id. although he had not been.
Tr. 123. The female Officer then stated: "I can hear you.''
GX 6, at 1. Respondent replied: "I'm sure you can hear us,
that's the point, we want you to hear us''; the female Officer
responded: "Oh.'' Id.
Respondent then asked the male Officer if he was having back
pain. Id. The Officer answered affirmatively. Id. at 2. After
some extraneous comments about his ex-wife, either Respondent or
an assistant hooked the male Officer up to a physical therapy
machine, recommended twenty minutes of treatment and started the
machine. Tr. 126. The Officer then complained that the treatment
"hurts too much, man.'' GX 6, at 2. Respondent then told an
assistant to "cut it back to the minimum level''; the
assistant acknowledged Respondent's order. Id. Several minutes
later, the Officer disconnected himself from the machine and
told Respondent's staff that he was doing so. Tr. 126-27. The
record does not, however, establish whether Respondent was
advised that the Officer had disconnected the machine.\13\ Id.
at 127.
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\13\ The ALJ further found that during the
visit, Respondent did not take a medical history or order any
diagnostic tests. Tr. 126.
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At some point during the visit, Respondent issued to the
Officer prescriptions for 90 Percocet (5/325 mg.); 30 Xanax (1
mg); and for Flexeril, a non-controlled muscle relaxant. GX 19,
at 1-2. During the visit, while Respondent put two fingers on
the Officer's back, he did not check the Officer's heart or
lungs. Tr. 125. Nor did he counsel the Officer regarding the
controlled substances he prescribed. Id. at 128- 29. Moreover,
during the subsequent search of Respondent's office, the
authorities did not find a patient file for the Officer. Id. at
125. In his testimony, Respondent asserted that he maintained a
file on the Officer and that this visit was probably the
Officer's third visit with him. Id. at 313. I find, however,
that it was the first visit.
Respondent then turned his attention to the female Officer
and asked her if she had been driving. GX 6, at 2. The Officer
answered: "No, we were walking.'' Id. Respondent then asked
her if she had gone to the hospital; Respondent answered:
"No.''
Respondent then asked her: "What areas are hurting?''
Id. The video indicates that the Officer answered that her knee,
left hip, and lower back were. GX 14. Next, Respondent asked her
to numerically rank her pain level with one "being no pain
and ten being the worst possible pain.'' GX 6, at 2. The Officer
stated that her pain level was "a six.'' Id. Respondent
then told her to "let me take your pulse.'' Id.\14\
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\14\ In his testimony, Respondent maintained
that he listened to the Officer's heart and lungs and that a
nurse took her blood pressure. Tr. 310, 312, 334.
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Following this, Respondent told the Officer: "turn
towards me, no turn, turn back and back up, back up, back up,
that's good * * * within your comfort zone, if I ask you to do
anything that causes severe pain don't do it.'' Id. The Officer
acknowledged this by stating: "OK.'' Id. at 3.
Respondent then directed the Officer to "Put your head
back, down to your chest, back to normal position, ok head to
the side, the other side, back to normal position, rotate, to
the right, back to normal position, bring your shoulders up.''
Id. The Officer then stated: "like that hurts, down the
center of my back.'' Id. Continuing, Respondent stated to the
Officer: "Side, other side, back to the normal position,
backward and now touch your toes, turn around, relax your
arms,'' and asked if there was "no pain where [he was]
pressing.'' Id. In response, the Officer answered: "naw.''
Id.
Next, Respondent told the Officer to "bring [your] right
leg up as high as you can.'' Id. The Officer laughed. Respondent
then told the Officer to "bring [your] left leg up as high
as you can.'' Id. He then told the Officer to "have a seat
up here''; the Officer responded: "OK.'' Id.
Continuing, Respondent instructed the Officer to "hold
your hands together for me, relax, unpress them,'' and remarked
"that's tender.'' Id. Next, he told the Officer to
"lay on your back, cross your legs, raise your legs up,''
and then asked "where's the pain?'' Id. The Officer
answered: "my lower back.'' Respondent then told the
Officer to "sit up,'' and asked her several questions
regarding whether she had filed a report with her insurance
company, and whether she was planning any legal action. Id.
Respondent then left the room to get another form. Id. When
he returned, Respondent explained to the Officer that she had
mild sprains of her neck, middle lower back, left hip and both
knees. Id. He further noted that her injuries would take four to
six weeks to heal and asked if she was paying cash for her
prescription. Id. After the Officer stated "Yep,''
Respondent told her that he was going to prescribe a drug that
was a mild anti-inflammatory and pain medication, as well as a
mild muscle relaxant to help her sleep. Id. With respect to the
first drug, Respondent told the officer to "only take one
twice a day.'' Id. Respondent also told the Officer to take the
muscle relaxant "every 12 hours if you have [a] muscle
spasm,'' and to ice her knees three times a day for fifteen
minutes. Id. at 4. Respondent further told the Officer to come
back "in a few weeks'' and that she could come back without
making an appointment. Id. Respondent prescribed sixty tablets
of Vicoprofen, a schedule III controlled substance which
contains hydrocodone and ibuprofen, and Soma (carisoprodol), a
non-controlled substance. GX 19, at 3.
The Eighth and Ninth Undercover Visits
On January 30, 2008, at 6:45 p.m., the Officers who had
previously posed as Anthony Wilson and Richard Johnson returned
to Respondent's office. GX 7, at 1. At 7:49 p.m., Respondent
asked: "Who's for prescription refills?'' GX 7, at 1. The
Officer posing as Anthony Wilson answered: "Right here.''
Id.
Seven minutes later, the Officer told Respondent that the
"last time I have my wife with me, but she couldn't make it
today, can I pick up her script for her?'' Id. Respondent
replied: "your wife, yeah, you can do that one time.'' Id.
The Officer then stated: "thank you, that's for her and
that's for me.'' Id. Respondent then said: "OK, you gotta
tell me who the wife is.'' Id. The Officer stated that his
wife's name was "Shania Wilson.'' \15\ Id. Respondent
subsequently gave the Officer prescriptions issued in the name
of T. Wilson for 60 Xanax (1 mg.), and 90 Percocet (5/325 mg.).
See GX 20, at 1-2; GX 7, at 2.\16\
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\15\ As was the Officer's undercover
identity, Shania Wilson was also a fictitious name. \16\ While
Shania Wilson was not a real person, the DEA Agent testified
that he believed that Respondent had a patient with the name
that Respondent used on the prescriptions. Tr. 144, 229. To
protect her privacy, her first name will not be used.
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Shortly thereafter, Respondent asked the Officer: "Which
Percocet are you getting--either yellow or the greens
[[Page 43264]]
ones?'' GX 7, at 2. The Officer answered: "the yellow.''
Id. Respondent then gave the Officer prescriptions issued in the
name of Anthony Wilson for 60 Xanax (1 mg.) and 90 Percocet
(10/325 mg.). Id. Respondent also issued to the Officer posing
as Richard Johnson prescriptions for 90 Percocet (10/325 mg.)
and 60 Xanax (1 mg.). GX 20, at 3. During these visits,
Respondent did not perform any type of examination on either of
the Officers and did not even discuss with them their
conditions. Tr. 144-45.
Regarding his issuance of the prescription to the first
Officer's fictitious wife, Respondent testified that he told the
Officer that he normally did not do this but that the Officer
had stated that his wife "was in such severe pain that she
couldn't get out of bed, and she really needed a refill.'' Id.
at 317. Respondent further asserted that the Officer had given
him the name "T ------,'' so he "pulled her chart,''
and "verified that,'' and "wrote the prescription.''
Id. at 318. Respondent further maintained that he based his
decision on when Ms. Wilson "had her last refill.'' Id.
Respondent, however, produced no evidence from this patient's
chart establishing that he had previously diagnosed her with a
condition that warranted the prescribing of Percocet and Xanax.
Moreover, the only evidence on this issue indicated that the
real Ms. Wilson had last been prescribed Percocet more than four
months earlier. See GX 45, at 95.
The ALJ specifically found incredible Respondent's testimony
regard his filling of the prescription for the fictional Ms.
Wilson. ALJ at 18. While Respondent may have pulled a chart for
the real Ms. Wilson, see GX 7, at 2 (Officer stating
"that's my wife there''); neither the transcript nor the
video contain any evidence that the Officer had represented that
his wife was in such severe pain that she could not get out of
bed. Accordingly, I adopt the ALJ's credibility finding to the
extent she rejected Respondent's testimony that the Officer
represented that his wife was in severe pain and could not get
out of bed and his testimony that he based his decision on when
Ms. Wilson had her last refill.\17\
---------------------------------------------------------------------------
\17\ In his testimony, Respondent did not
identify when he had last seen the patient or the medical
condition which justified the prescribing of Percocet and
Xanax.
---------------------------------------------------------------------------
Respondent also testified regarding his having issued
prescriptions before previous prescriptions which were for a
thirty-day supply should have run out. As found above,
Respondent issued prescriptions for both 60 Xanax and 90
Percocet to the Officer who posed as Anthony Wilson on December
14, 2007, and on January 3, 18, and 30, 2008. Moreover,
Respondent issued prescriptions for Xanax and Percocet to
Richard Johnson on both January 18 and 30, 2008.
Regarding these prescriptions, Respondent testified that
"[i]n one case the person indicated that they were going to
be away during that particular week, and [asked] could they get
their prescriptions a week early.'' Tr. 318-19. Respondent
further explained that with respect to the other patient,
"it was a matter of not being able to locate that
individual's chart, and because I couldn't locate the chart, at
that particular time, which was I think the 18th of January or
so, I took him at his word and good faith.'' Id. at 319.
Continuing, Respondent testified: "I asked him, I said,
'Are you sure that it has been 30 days since you had your last
prescription?' And he said, 'Yes, it was.' So, then, I wrote out
his prescription.'' Id. Respondent also maintained that
"what happened was that [the] copy that was made did not
get back into his chart, so when he came back on the 30th, it
looked as though * * * he was * * * last here on around the 30th
of December, so he was issued another prescription.'' Id.
Respondent further attempted to justify his issuance of early
prescriptions by contending that there were "safeguards''
in place against the early filling of his prescriptions. Id.
More specifically, Respondent testified that if the patient
"either takes it to the same pharmacy or tries to use his
insurance, they will notify me that the prescription has been
filled less than 30 days, and then I can reject it.'' Id.
It is unclear whether the ALJ credited Respondent's testimony
regarding his issuance of the early prescriptions to Anthony
Wilson and Richard Johnson. See ALJ at 17-18.\18\ In any event,
as ultimate factfinder, I reject Respondent's testimony.
Respondent's testimony was vague in that he did not identify
which of the two undercover Officers had stated that he was
going to be away and needed the new prescription/early
refill.\19\ Moreover, there is no credible evidence to support
Respondent's claim that either Officer (Anthony Wilson or
Richard Johnson) had ever represented that they were going to be
away when their prescriptions ran out. As for Respondent's
assertion that he asked the other patient whether it had been
thirty days since the last prescription, there is likewise no
credible evidence of his having done so.
---------------------------------------------------------------------------
\18\ In contrast to the testimony regarding
Respondent's issuance of a prescription to Ms. Wilson which
she specifically rejected, the ALJ did not expressly address
whether she found this testimony credible. ALJ at 17-18.
\19\ Under Federal law, a prescription for a
schedule II controlled substance cannot be refilled. 21
U.S.C. Sec. 829(a).
---------------------------------------------------------------------------
I also reject Respondent's testimony regarding the safeguards
to protect against the early filling of prescriptions. As for
his contention that an insurance company would notify him if a
patient attempted an early refill, notably the undercover
officers did not use insurance, but rather, paid cash for their
visits. As for Respondent's contention that the pharmacy would
notify him that a patient was attempting an early refill, this
would be true only if the patient used the same pharmacy. Drug
abusers typically know better than to take an early refill to
the same pharmacy (unless the pharmacy is in cahoots with the
prescriber).
Other Evidence
Both parties also submitted into evidence additional patient
records. The Government introduced sixteen patient files; nearly
all of the patients received prescriptions for Percocet and
Xanax. See GXs 24- 39. Moreover, some of the files lack
documentation of a physical exam and/or a medical history. See
GX 25 (J.L.); GX 26 (E.L.); GX 27 (J.L.); GX 31 (A.L.); GX 32 (B.L.);
GX 33 (O.G.); GX 34 (B.G.); GX 35 (J.L.); GX 36 (M.K.); GX 38 (R.K.);
GX 39 (M.G.).
Respondent submitted four patient files into evidence.
Notably, and in contrast to the patient files cited above, three
of these files contain extensive documentation of the findings
of an initial physical exam, Respondent's assessment/diagnosis,
and his treatment recommendations. See RX 13A, at 670-72; RX
13B, at 764; RX 13D, at 4740-42. Moreover, each of the files
contains documentation of the physical exams performed, the
assessments made, and treatment recommendations given on
followup visits. See RX 13A, at 677-78, 681- 82, 694; 702, 703;
RX 13B, at 774, 781, 788, 814; RX 13C, at 4024, 4035; RX 13D, at
4727-28, 4731, 4746, 4753, 4754, 4757, 4759-61, 4762, 4775.
Respondent also introduced into evidence copies of four
different notices he had posted in his office. Two of these
warned his patients that it was a felony offense to obtain
prescription drugs by fraud or "for other than prescribed
reasons,'' as well as to resell them. RXs 1 & 2. Another
notice listed numerous excuses used by drug-abusing patients to
obtain early refills and which Respondent deemed to be
"unacceptable.'' RX 3.
In the fourth of the notices, Respondent stated that it had
recently come to his attention that several of his
[[Page 43265]]
patients were "faking their illnesses, injuring
themselves intentionally an [sic] lying to [him] for the purpose
of obtained controlled III prescriptions (I.E. Perococet [sic])
and controlled II prescriptions (Xanax).'' RX 4. Respondent
further asserted that "I am sickened by you individuals,''
and that "I am not a 'dirty doctor.' '' Id. Respondent then
maintained that he was going to discharge "[a]ll patient
[sic] referred by the individual who have not been in auto
accidents who are not treating three times per week.'' Id.
Respondent further stated that he would "no longer
prescribe Controlled III [and] Controlled II medications to
anyone,'' and while he would continue to treat all of his
legitimate patients, he would so "without Controlled II or
III medications.'' Id.\20\
---------------------------------------------------------------------------
\20\ Respondent also introduced into
evidence copies of various prescriptions which he maintained
had been written by patients who had stolen his prescription
pads. See RXs 5-10.
---------------------------------------------------------------------------
Discussion
Section 304(a) of the Controlled Substances Act (CSA)
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). With respect to a practitioner, the Act
requires the consideration of the following factors in making
the public interest determination:
(1) The recommendation of the appropriate State licensing
board or professional disciplinary authority.
(2) The applicant's experience in dispensing * * *
controlled substances.
(3) The applicant's conviction record under Federal or
State laws relating to the manufacture, distribution, or
dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local
laws relating to controlled substances.
(5) Such other conduct which may threaten the public health
and safety.
Id.
"[T]hese factors are * * * considered in the
disjunctive.'' Robert A. Leslie, M.D., 68 FR 15227, 15230
(2003). I "may rely on any one or a combination of factors,
and may give each factor the weight [I] deem[] appropriate in
determining whether a registration should be revoked.'' Id.
Moreover, I am "not required to make findings as to all of
the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005);
see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).
Having considered all of the statutory factors, I conclude
that on balance, the evidence pertaining to Respondent's
experience in dispensing controlled substances (factor two) and
his record of compliance with applicable laws related to the
prescribing of controlled substances (factor four) establish
that his continued registration would be "inconsistent with
the public interest.'' \21\ 21
U.S.C. 823(f). Moreover, while I do not find that all of the
prescriptions he issued were illegal under Federal law, I agree
with the ALJ's finding under factor five that Respondent has
failed acknowledge his wrongdoing and therefore cannot be
entrusted with a registration.
---------------------------------------------------------------------------
\21\ I acknowledge that there is no evidence
that the Pennsylvania Board has taken action against
Respondent's medical license (factor one). There is also no
evidence that Respondent has been convicted of an offense
related to controlled substances under Federal or State law
(factor three).
---------------------------------------------------------------------------
Factor Two and Four--Respondent's Experience in Dispensing
Controlled Substances and Record of Compliance With Applicable
Controlled Substance Laws
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. Sec. 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. See
also 21
U.S.C. 802(10) (defining the term "dispense'' as
meaning "to deliver a controlled substance to an ultimate
user * * * pursuant to the lawful order of * * * a practitioner,
including the prescribing and administering of a controlled
substance'') (emphasis added).
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, 546 U.S. 243, 274 (2006)
(citing Moore, 423 U.S. 122, 135 (1975)).\22\
---------------------------------------------------------------------------
\22\ 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.'' 21 CFR 1306.04(a); see also United States
v. Moore, 423 U.S. 122, 142-43 (1975). The CSA, however,
generally looks to state law to determine whether a doctor and
patient have established a bonafide doctor- patient
relationship. See Kamir Garces-Mejias, 72 FR 54931, 54935
(2007); United Prescription Services, Inc., 72 FR 50397,
50407-08 (2007); Dispensing and Purchasing Controlled
Substances Over the Internet, 66 FR 21181, 21182-83 (2001).
---------------------------------------------------------------------------
Consistent with the standards of Federal law, Pennsylvania
law prohibits "[t]he * * * prescription of any controlled
substance by any practitioner * * * unless done (i) in good
faith in the course of his professional practice; (ii) within
the scope of the patient relationship; (iii) in accordance with
treatment principles accepted by a responsible segment of the
medical profession.'' 35 Pa. Stat. Sec. 780-113(a)(14).
Moreover, under the Pennsylvania Administrative Code, a
practitioner must meet certain "minimum standards'' \23\
before prescribing a controlled substance including taking an
initial medical history and conducting "an initial physical
examination * * * unless emergency circumstances justify
otherwise.'' \24\ 49 Pa. Code Sec. 16.92(a)(1). Furthermore,
"[t]he physical examination shall include an evaluation of
the heart, lungs, blood pressure and body functions that relate
to the patient's specific complaint.'' Id. (emphasis added).
---------------------------------------------------------------------------
\23\ The regulation further states that it
"establishes minimum standards for the prescription,
administration and dispensation of controlled substances by
persons licensed to practice medicine and surgery in''
Pennsylvania. 49 Pa. Code Sec. 16.92(b).
\24\ Respondent does not contend that any of
the undercover patients presented a medical emergency.
---------------------------------------------------------------------------
This regulation also requires that a physician provide
"[a]ppropriate counseling * * * to the patient regarding
the condition diagnosed and the controlled substance
prescribed.'' Id. Sec. 16.92(a)(3). Furthermore, "[u]nless
the patient is in an inpatient care setting, the patient shall
be specifically counseled about dosage levels, instructions for
use, frequency and duration of use and possible side effects.''
Id.
Finally, the regulation requires that the physician record
"certain information * * * in the patient's medical record
on each occasion when a controlled substance is prescribed,''
which "shall include the name of the controlled substance,
its strength, the
[[Page 43266]]
quantity and the date it was prescribed.'' Id. Sec.
16.92(a)(4). The regulation further mandates that "[o]n the
initial occasion when a controlled substance is prescribed * * *
to a patient, the medical record shall * * * include a
specification of the symptoms observed and reported, the
diagnosis of the condition for which the controlled substance is
being given and the directions given to the patient for the use
of the controlled substance.'' Id.
Applying these standards, I do not find that the Government
has proved that each of the prescriptions issued to the
undercover officers violated Federal law. The evidence
nonetheless establishes that on several occasions, Respondent
issued prescriptions to the undercover officers for Percocet and
Xanax--both of which are highly abused drugs--that did not
comply with Federal law. I further find--based on the lack of
any supporting documentation of a physical exam in various
files--that Respondent issued numerous other prescriptions for
controlled substances in violation of Pennsylvania's regulation.
The Visits of Nicole Hodge
At the outset, I note that Respondent did not commit any
illegal acts when he was first approached by "Nicole
Hodge.'' Rather, when the Officer asked for Percocet and made
clear that she was not injured, Respondent told her to leave his
office, and did not issue her any prescription.
Respondent's interaction with "Nicole Hodge'' during the
second visit is more problematic. The evidence shows that
Respondent specifically questioned her about what areas were
hurting and asked her to rank her pain level. The Officer
unambiguously presented a medical complaint by stating that her
"lower back'' was hurting and that her pain level was
"six'' on a scale of one to ten. Respondent then put the
Officer through several different range-of-motion tests.
Moreover, Respondent took her pulse. Finally, Respondent
diagnosed her injuries, explained his diagnosis and treatment
recommendations, and provided the Officer with instructions on
how to take the medicines he prescribed.
The ALJ did not credit Respondent's testimony that he
listened to the Officer's heart and lungs and had a nurse take
her blood pressure. Tr. 310 & 312. Moreover, there is no
documentation in the patient file that he did so. See GX 23, at
7. That being said, as the Supreme Court explained in Gonzalez,
"the [CSA] and our case law amply support the conclusion
that Congress regulates medical practice insofar as it bars
doctors from using their prescription-writing powers as a means
to engage in illicit drug dealing and trafficking as
conventionally understood.'' 546 U.S. at 270.
Likewise, numerous court decisions make plain that the
offense of unlawful distribution requires proof that the
practitioner's conduct went "beyond the bounds of any
legitimate medical practice, including that which would
constitute civil negligence.'' United States v. McIver, 470 F.3d
550, 559 (4th Cir. 2006); see also United States v. Feingold,
454 F.3d 1001, 1010 (9th Cir. 2006) ("[T]he Moore Court
based its decision not merely on the fact that the doctor had
committed malpractice, or even intentional malpractice, but
rather on the fact that his actions completely betrayed any
semblance of legitimate medical treatment.''). As the Fourth
Circuit has further explained, "the scope of unlawful
conduct under Sec. 841(a)(1) [requires proof that a physician]
used his authority to prescribe controlled substances * * * not
for treatment of a patient, but for the purpose of assisting
another in the maintenance of a drug habit or some other
illegitimate purposes, such as his own personal profit.'' 470
F.3d at 559 (int. quotations and citation omitted).
Accordingly, while Respondent's failure to listen to the
Officer's heart and lungs and take her blood pressure violated
Pennsylvania's regulation, the totality of the evidence
surrounding this visit does not establish that he, in issuing
the Vicoprofen prescription to Ms. Hodge, lacked a legitimate
medical purpose and acted outside of the course of professional
practice. The Officer presented a medical complaint, identified
specific areas of her body as the cause of her pain, and
complained of a relatively high pain level. Moreover, at no
point did the Officer convey to Respondent that she was not in
pain. Notwithstanding that Respondent failed to perform several
steps required by Pennsylvania law, the physical exam he
conducted cannot be characterized as deficient or cursory in the
absence of expert testimony establishing as much.
At most, the evidence suggests that Respondent committed
malpractice. It does not, however, support the conclusion that
Respondent used his prescription writing authority to engage in
illicit drug dealing when he issued the Vicoprofen prescription
to Ms. Hodge.\25\ See McIver, 470 F.3d at 559.
---------------------------------------------------------------------------
\25\ The Government does not cite to any
decision in which the Pennsylvania Courts or Medical Board
have held that a physician's failure to comply with this
regulation in all respects establishes a violation of the
Pennsylvania Controlled Substances Act.
---------------------------------------------------------------------------
The Visits of Anthony Wilson
At his first visit, Anthony Wilson presented as his medical
complaint that he "Hurt All Over,'' that the location of
his condition was "all over,'' and its severity was
"bad pain.'' While Respondent did not ask the Officer to
rate his pain level on a numerical scale, the Government offered
no evidence to show that a practitioner must do so when the
patient has already indicated that he has "bad pain.''
The evidence further establishes that Respondent's physical
exam was limited to touching him lightly on the shoulder and
back, that Respondent did not listen to his heart and lungs, and
that neither Respondent nor anyone else took his blood pressure.
Based on this physical exam, and without ordering any diagnostic
testing, Respondent diagnosed the Officer as having back and
neck contusions and issued him prescriptions for 90 Percocet (10
mg.), 60 Xanax (1 mg.), as well as Cataflam, a non-controlled
drug.\26\ Respondent did not, however, counsel the patient
regarding the taking of the drugs. At a minimum, Respondent's
conduct violated Pennsylvania's Administrative Regulation
pertaining to the prescribing of controlled substances.\27\
---------------------------------------------------------------------------
\26\ Based on the dosing instructions, both
the Percocet and Xanax should have lasted thirty days.
\27\ Respondent's conduct creates a strong
suspicion that his prescribing exceeded the course of
professional practice as this term is used in Federal law and
was also not "in accordance with treatment principles
accepted by a responsible segment of the medical profession''
as required by Pennsylvania law. 35 P.S. Sec. 780-113(a)(14).
But while the Government cited several cases which upheld the
convictions of physicians who engaged in similar conduct to
Respondent, in all but one of the cases there was expert
testimony establishing that the physician's conduct exceeded
the bounds of professional practice. See United States v. Bek,
493 F.3d 790, 799-800 (7th Cir. 790); McIver, 470 F.3d at 556;
Feingold, 454 F.3d at 1005; United States v. Alerre, 430 F.3d
681, 686 (4th Cir. 2005).
Moreover, in the only case cited by the
Government in which there was no expert testimony, the
undercover officer made clear that he was seeking Percocet to
party and would share the drugs with others. United States v.
Celio, 230 Fed. Appx. 818, 822 (10th Cir. 2007). By contrast,
in this case, with the exception of the first visit of Nicole
Hodge, the undercover officers frequently complained of pain
and made no statements which indicated that they were seeking
the drugs for non-medical purposes.
The Government also cites a state case to
contend that "expert testimony is not always necessary to
determine whether a practitioner may be convicted under'' the
Pennsylvania statute. Gov. Prop. Findings at 11 n.2 (citing
Commonwealth v. Manuel, 844 A.2d 1 (Pa. Super. Ct. 2004).
Notwithstanding the court's statement in Manuel, there, the
State presented expert testimony as to the appropriateness of
the physician's prescribing practices. See 844 A.2d at 11.
---------------------------------------------------------------------------
On January 3, 2008--less than three weeks later--the Officer
returned. While Respondent asked the Officer how he was doing
and pressed on his back and
[[Page 43267]]
shoulder, he proceeded to issue him more prescriptions for 90
Percocet and 60 Xanax even though the prescription he had
previously issued should not have been exhausted. Respondent did
not ask the Officer why he needed his prescription refilled ten
days early. Furthermore, the Respondent did not document the
prescribing in the Officer's patient file as required by the
Pennsylvania regulation.
On January 18, 2008--only fifteen days after the previous
visit-- the Officer saw Respondent again. Respondent asked the
Officer how we was doing, and performed a physical exam which
was limited to having the Officer attempt to bend his knees and
try to touch his toes. While Respondent asked whether he had
previously given the Officer Percocet 10s and Xanax, once again
he did not question the Officer as to why he had returned when
the second prescription should have lasted another fifteen days.
Respondent nonetheless gave the Officer another prescription for
90 Percocet (10/325) and 60 Xanax (1 mg.).
On January 30, 2008--which was only twelve days since the
previous visit--the Officer returned to Respondent's clinic for
a fourth time. Approximately one hour after his arrival,
Respondent appeared in the waiting area and asked: "Who's
for prescription refills?,'' to which the Officer said:
"right here.''
A few minutes later, the Officer told Respondent that the
"last time I have my wife with me, but she couldn't make it
today, can I pick up her script for her?'' Respondent replied
that the Officer could "do that one time.'' The Officer
subsequently told Respondent that his wife's name was "Shania
Wilson.'' Subsequently, Respondent issued prescriptions to
Anthony Wilson for 90 Percocet (10/325 mg.) and 60 Xanax (1
mg.). He also issued prescriptions for a T. Wilson for 90
Percocet (5/325 mg.) and 60 Xanax (1 mg.), which he gave to the
Officer.
Notably, Respondent did not even ask the Officer how he was
doing and issued the prescriptions to him without even the
pretense of conducting a physical exam. Indeed, the only
question he asked the Officer was which color Percocet tablet he
was getting, thus giving the "patient'' the right to decide
what strength of drug he wanted. Moreover, it was the third time
in less than a month that the Officer had sought prescriptions
for these drugs well before the previously issued prescriptions
should have run out. Yet again, Respondent did not question the
Officer as to why he had returned so soon.
Given these circumstances, expert testimony is not required
to conclude that in issuing these prescriptions, Respondent
exceeded the bounds of professional practice and that the
prescriptions lacked a legitimate medical purpose because
Respondent failed to take any steps to determine whether there
was a continuing medical need for the prescriptions. See 21 CFR
1306.04. Beyond that, he issued the prescriptions
notwithstanding that even a cursory review of the Officer's file
would have indicated that he had issued prescriptions to the
Officer only twelve days earlier. Likewise, the decision as to
what strength of drug a patient should take is the physician's
responsibility and is not the province of the patient. In short,
Respondent's issuance of the prescriptions on this date does not
remotely resemble the legitimate practice of medicine or even
the negligent practice of legitimate medicine. Rather, it is
out-and-out drug pushing.
Likewise, expert testimony is not required to conclude that
Respondent lacked a legitimate medical purpose and exceeded the
bounds of professional practice in issuing the prescriptions for
the Officer's fictitious wife. Notably, the Officer had
repeatedly sought and obtained new prescriptions well before
previous prescriptions would have run out and had thus
demonstrated a clear and obvious pattern of drug-seeking
behavior. Moreover, Respondent issued the prescriptions to a
patient who was not physically present and thus could neither be
questioned as to whether she had a medical condition that
required controlled substances nor physically examined. And he
did so notwithstanding that the Officer made no representation
that his "wife'' had a medical need for the prescriptions.
Furthermore, Respondent did not even attempt to contact
"her'' to determine whether there was a medical
justification for the prescriptions. Cf. 49 Pa. Code Sec.
16.92(a)(5) (authorizing the issuance of a "a prudent,
short-term prescription'' based on "an emergency phone call
by a known patient''). Finally, both the Percocet and Xanax
prescriptions were for a thirty-day supply and appear to be well
beyond what Pennsylvania authorizes on an emergency basis.\28\
---------------------------------------------------------------------------
\28\ Even if the Officer pointed to the
patient file for a real Ms. Wilson, the fact remains that the
Officer did not identify any medical reason for why his
"wife'' needed a prescription. Moreover, Respondent made
no attempt to contact Ms. Wilson to determine whether she had
a continuing medical need for the prescription and whether the
requirements were met for issuing an emergency prescription
under Pennsylvania's regulation.
---------------------------------------------------------------------------
I thus conclude that Respondent exceeded the bound of
professional practice in issuing the prescriptions to Ms. Wilson
and that these prescriptions were not supported by a legitimate
medical purpose. 21 CFR 1306.04. In short, Respondent's issuance
of these prescriptions was not simply the negligent practice of
medicine but rather drug pushing.
The Visits of Richard Johnson
On January 18, 2008, another undercover officer, who used the
name Richard Johnson, visited Respondent. When asked by
Respondent whether it was his first visit, the Officer
represented that he had previously seen Respondent on December
14th although he had not. Later, and apparently while in the
exam room, Respondent asked the Officer how he had been doing
since he was put on pain medication; the Officer answered
"pretty good.'' Respondent asked a followup question as to
whether the medication worked well; the Officer answered
"yes.''
The evidence establishes that Respondent performed a limited
physical examination by lightly tapping the Officer on the back
and shoulder. Moreover, Respondent acknowledged that he had been
taking the yellow ones (a reference to Percocet) and the blue
ones (a reference to Xanax). Respondent then stated that he was
going to refill the Officer's prescriptions and issued him
prescriptions for 90 Percocet and 60 Xanax. During the
subsequent search of Respondent's office, no file was found for
Richard Johnson.
While it is clear that the Officer misrepresented his status
as a prior patient, there is no evidence establishing that
Respondent knew this to be false. Moreover, the Government
produced no evidence regarding the proper course of professional
practice when a patient represents that he has recently been
treated and the physician cannot find the patient's medical
records. At most then, the evidence establishes that Respondent
violated Pennsylvania's regulation because he failed to document
the issuance of the prescriptions.\29\ See 49 Pa. Code Sec.
16.92(a)(4).
---------------------------------------------------------------------------
\29\ While the Pennsylvania regulation
clearly requires that a practitioner perform a physical
examination (or that one has been performed by another
practitioner within the "immediately preceding 30 days,''
49 Pa. Code Sec. 16.92(a)(1)), before commencing treatment
with a controlled substance, the Government produced no
evidence establishing that a physical examination is required
at every follow-up visit at which a controlled substance is
prescribed.
---------------------------------------------------------------------------
Twelve days later, Richard Johnson returned to Respondent's
office. Respondent issued him prescriptions for 90 Percocet
(10/325 mg.) and 60 Xanax (1mg.) without even asking him about
[[Page 43268]]
his condition. Moreover, Respondent did not ask the Officer
as to why he needed new prescriptions after only twelve days.
Given the circumstances of this visit, it is clear that there
was no legitimate medical purpose for the prescriptions and that
Respondent exceeded the bounds of professional practice in
issuing them. See 21
CFR 1306.04(a). As was the case with the prescriptions
issued to the Officer on January 18, Respondent did not document
the prescriptions and violated the Pennsylvania regulation for
this reason as well. 49 Pa. Code Sec. 16.92(a)(4).
The Visit of John Rio
On the night that "Nicole Hodge'' made her second visit,
an Officer posing as "John Rio'' accompanied her. Although
the Officer had not previously been to Respondent's office, he
told Respondent that he had been. Moreover, when asked by
Respondent if he had back pain, the Officer answered
affirmatively. Respondent then recommended that the Officer
receive twenty minutes of physical therapy and either Respondent
or an assistant proceeded to set up the machine and started the
treatment. After the Officer complained that the treatment hurt
too much, Respondent told an assistant to cut back the level of
the treatment. While the Officer subsequently disconnected the
machine and told Respondent's staff that he was doing so, there
is no evidence that Respondent was advised of this. During the
visit, Respondent gave the Officer prescriptions for 90 Percocet,
30 Xanax, and a muscle relaxant which is not controlled.
Moreover, during the subsequent search of Respondent's office,
the authorities did not find a patient file for him.
As was the case with the first visit of "Richard
Johnson,'' the evidence does not establish that Respondent
violated Federal law in issuing the prescriptions. Here again,
there is no evidence as to the proper course of professional
practice when a patient represents that he has previously been
treated by a physician. At most, the evidence establishes a
violation of the Pennsylvania regulation requiring that each
issuance of a controlled-substance prescription be documented in
the patient's medical record. See 49 Pa. Code Sec. 16.92(a)(4).
Other Violations
As found above, the record includes numerous patient files
which show that Respondent prescribed controlled substances and
yet lack any documentation that he (or another physician \30\)
took a medical history, performed a physical examination and
diagnosed a medical condition which warranted the various
prescribings. Indeed, the documentation contained in these files
is charitably described as threadbare and stands in stark
contrast to the level of thoroughness and detail found in the
four patient files which Respondent submitted as evidence of the
appropriateness of his recordkeeping practices. Compare, e.g.,
GXs 25-27, 31-36, 38-39, with RXs 13A-D; see also Tr. 302-306
(Respondent's testimony that RXs 13A-D were "representative
of how [he] maintained a patient file''). At a minimum, this
evidence establishes numerous additional instances in which
Respondent violated the Pennsylvania regulation.
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\30\ See 49 Pa. Code Sec. 16.92(a)(1).
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In any event, while the Government's proof does not establish
that each of Respondent's prescribings to the undercover
officers violated the prescription requirement of Federal law
and were thus unlawful distributions under 21
U.S.C. 841(a), it has shown that several of them did. See 21
CFR 1306.04(a).\31\ Moreover, the record clearly establishes
that Respondent repeatedly failed to properly document the
necessity for prescribing controlled substances to numerous
patients and to properly counsel his patients regarding the
taking of the drugs. See 49 Pa. Code Sec. 16.92(a). I thus
conclude that Respondent's experience in dispensing controlled
substances and his record of compliance with applicable laws and
regulations amply demonstrates that his continued registration
"is inconsistent with the public interest.'' 21
U.S.C. 823(f).
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\31\ I have also considered the evidence
regarding the first undercover visit during which the Officer
told Respondent that she was not injured and brazenly asked
for a prescription for Percocet. While I acknowledge that
Respondent threw the Officer out of his office, the mitigating
character of this evidence is outweighed by the incidents in
which Respondent wrote prescriptions without inquiring as to
why the Officers were prematurely seeking new prescriptions,
the incident in which Respondent provided the Officers with
the prescriptions without even inquiring as to whether there
was a continuing medical need for them, and the issuance of
the prescriptions to the Officer's fictitious wife. Indeed, it
may well be that Respondent believed the first incident to be
a set-up or that he would only issue prescriptions to those
who claimed to be injured as alleged by the caller who
reported him to the police.
I further conclude that the various signs
Respondent posted in his office are entitled to no weight in
determining whether he is a responsible dispenser of
controlled substances. See Resp. Ex. 2 ("Obtaining
controlled prescriptions (Percocet and or Xanax) by deception
(faking injuries or lying about pain) is a Class B Felony.'');
Resp. Ex. 4 (noting that patients were intentionally lying to
Respondent "about the nature of their injuries for the
purpose of obtaining'' Percocet and Xanax). Indeed, it is
strange that Respondent would expressly refer to Percocet and
Xanax in the notices as if these are the only drugs available
to treat pain and other medical conditions. I further note
that with the exception of Ms. Hodge, each of the Officers was
prescribed the same drugs-- Percocet and Xanax.
As for RX 3, which catalogued a list of
"unacceptable excuses'' used by persons seeking early
refills, and stated that patients should "not ask [him]
for anymore medication until it is your time to get
refilled,'' Respondent did not ask either of the undercover
officers who sought new prescriptions prematurely why they
were doing so. This suggests that notwithstanding this
document, Respondent's policy was "don't ask, don't
tell.''
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Factor Five--Such Other Factors
Under Agency precedent, where, as here, "the Government
has proved that a registrant has committed acts inconsistent
with the public interest, a registrant must 'present sufficient
mitigating evidence to assure the Administrator that [he] can be
entrusted with the responsibility carried by such a
registration.' '' Medicine Shoppe- Jonesborough, 73 FR 363, 387
(2008) (quoting Samuel S. Jackson, 72 FR 23848, 23853 (2007)
(quoting Leo R. Miller, 53 FR 21931, 21932 (1988)). Moreover,
because "past performance is the best predictor of future
performance, ALRA Labs, Inc. v. DEA, 54 F.3d 450, 452 (7th Cir.
1995), [DEA] has repeatedly held that where a registrant has
committed acts inconsistent with the public interest, the
registrant must accept responsibility for its actions and
demonstrate that it will not engage in future misconduct.''
Medicine Shoppe, 73 FR at 387; see also Jackson, 72 FR at 23853;
John H. Kennedy, 71 FR 35705, 35709 (2006); Prince George
Daniels, 60 FR 62884, 62887 (1995). See also Hoxie v. DEA, 419
F.3d at 483 ("admitting fault'' is "properly
consider[ed]'' by DEA to be an "important factor[]'' in the
public interest determination).
The record supports the conclusion that Respondent has not
accepted responsibility for his misconduct. As found above,
Respondent's testimony regarding both his issuance of the
prescriptions for the Officer's fictitious wife and the early
prescriptions was not credible. Moreover, Respondent's testimony
that "it was never my intent to give more medication'' than
a thirty-day supply, Tr. 322-23, is belied by his failure to
ever ask the two Officers (on their subsequent visits) why they
had returned so soon and were in need of additional drugs.
Indeed, when Anthony Wilson returned for the fourth and final
time, Respondent did not even ask him about his condition.
Respondent nonetheless failed to offer any explanation as to why
he issued him two more prescriptions (and did so only twelve
days after having issued other prescriptions).
[[Page 43269]]
Respondent likewise offered no explanation as to why he
failed to properly document his prescribings to the various
undercover officers or counsel his patients regarding the proper
taking of the drugs. Because Respondent has failed to
acknowledge his wrongdoing, he has not rebutted the Government's
prima facie case. I therefore conclude that his continued
registration would be "inconsistent with the public
interest,'' 21
U.S.C. 823(f), and that his registration should be
revoked.\32\
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\32\ Respondent argues that the ALJ erred in
recommending revocation rather than a lesser sanction. DEA
has, however, repeatedly held that revocation is the
appropriate sanction in cases in which it has been shown that
a practitioner has used his prescription-writing authority to
deal drugs. See, e.g., Randi M. Germaine, 72 FR 51665 (2007);
Peter A. Ahles, 71 FR 50097 (2006). Moreover, as explained
above, Respondent has offered no evidence that he acknowledges
his misconduct.
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Order
Pursuant to the authority vested in me by 21
U.S.C. 823(f) & 824(a),
as well as 28 CFR 0.100(b) & 0.104, I hereby order that DEA
Certificate of Registration, BM7201267, issued to Laurence T.
McKinney, M.D., be, and it hereby is revoked. I further order
that any pending application to renew or modify the registration
be, and it hereby is, denied. This Order is effective August 25,
2008.
Dated: July 17, 2008.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E8-16948 Filed 7-23-08; 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).
