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/ Thursday, July 24, 2008
[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]
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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.
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\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).
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\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]
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