[Federal Register Volume 73, Number 143 (Thursday, July 24, 2008)]
[Notices]
[Pages 43260-43269]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-16948]


-----------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \1\ The Government also introduced recordings of several 
undercover visits.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \6\ According to the record, Respondent would instruct his 
``patients'' when they called for an appointment that they should 
have cash. Tr. 92.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \7\ As the ALJ explained, the Agent, in contrast to Respondent, 
``appeared to be straightforward and candid.'' ALJ at 29.
---------------------------------------------------------------------------

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.
---------------------------------------------------------------------------

    \8\ The DEA Agent testified that Respondent attempted to find 
the Officer's patient file. Tr. 110-11.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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).
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \10\ It is unclear whether Respondent had actually entered the 
exam room at this point or just stuck his head in it.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \13\ The ALJ further found that during the visit, Respondent did 
not take a medical history or order any diagnostic tests. Tr. 126.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \30\ See 49 Pa. Code Sec.  16.92(a)(1).
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \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.''
---------------------------------------------------------------------------

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\
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

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