[Federal Register Volume 80, Number 15 (Friday, January 23, 2015)]
[Notices]
[Pages 3630-3653]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-01219]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 13-37]
Samuel Mintlow, M.D.; Decision and Order
On July 2, 2013, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Samuel Mintlow, M.D. (hereinafter, Respondent), of
Conyers, Georgia. ALJ Ex. 1. The Show Cause Order proposed the
revocation of Respondent's DEA Certificate of Registration BM0288983,
which authorizes him to dispense controlled substances in schedules II
through V, and the denial of any pending applications to renew or
modify his registration, on the ground that his ``registration is
inconsistent with the public interest.'' Id. (citing 21 U.S.C. 823(f)
and 824(a)(4)).
The Show Cause Order specifically alleged that around January 2011,
one Charles Thomas Laing, a resident of Tennessee, and one Mark Del
Percio, a resident of South Florida, neither of whom is a licensed
medical professional, decided to open a pain management clinic which
was named Liberty Wellness Center (hereinafter, Liberty or LWC) in
Norcross, Georgia. Id. at 2. The Order alleged that in January 2011,
Respondent was hired to treat Liberty's patients and to distribute
controlled substances, and that through April 2012, Liberty
``unlawfully distributed controlled substances through prescriptions
issued under [Respondent's] registration for no legitimate medical
purpose'' including highly abused drugs such as oxycodone, hydrocodone,
alprazolam, and carisoprodol. Id.
The Order further alleged that the majority of Liberty's patients
(687) were from Tennessee (while 54 were from Georgia), and that 50 of
the Tennessee patients lived in the same town (Rogersville) as Charles
Laing (with sixteen living on the same road), and that this town was
located 254 miles from Liberty. Id. The Show Cause Order then alleged
that between January and June 2011, ``Laing recruited approximately 20-
25 [persons] to travel to [Liberty] and obtain'' prescriptions for
oxycodone 30mg from Respondent, and that they provided the oxycodone to
Laing who then sold the drugs. Id. The Order alleged that Laing
subsequently pled guilty in federal district court to conspiracy to
distribute and possess with the intent to distribute oxycodone, in
violation of 21 U.S.C. 846 and 841(b)(1)(c). Id. at 3.
Next, the Show Cause Order alleged that ``between February 2011 and
April 2012, [Respondent] unlawfully distributed approximately 1,950
oxycodone'' 30mg tablets, ``by issuing prescriptions'' to one Terrance
Q. Williams, an alleged associate of Laing, who also sponsored various
other individuals from Greenville, Tennessee. Id. The Order alleged
that Williams would pay the costs of a sponsored person's trip,
including the amount charged by Liberty and by the pharmacy which
filled the prescriptions, and that
[[Page 3631]]
the latter would provide a percentage of the oxycodone to Williams, who
sold the drugs to persons including Del Percio. Id. The Order then
alleged that while Williams and the persons he sponsored complained of
pain, Respondent did little or nothing to verify their complaints and
that Respondent ``repeatedly and deliberately ignored red flags that
could or did indicate likely paths of diversion while prescribing
controlled substances to Williams.'' Id. The Order also alleged that on
February 8, 2013, Williams pled guilty in federal district court to one
count of conspiracy to distribute and possess with the intent to
distribute oxycodone, in violation of 21 U.S.C. 846 and 841(b)(1)(c).
Id.
The Show Cause Order next alleged that ``[b]etween March 2011 and
April 2012, [Respondent] unlawfully distributed 1,560 oxycodone [30mg]
tablets by issuing prescriptions to Jessica R. Bernard,'' who resided
in Rogersville, Tennessee and was an acquaintance of Williams and
Laing. Id. The Show Cause Order alleged that Bernard also sponsored
persons from Tennessee, and that she would ``bring groups of people''
to Liberty, ``sometimes two to three times a week to obtain
prescriptions for oxycodone and other controlled substances'' from
Respondent, which she would then distribute in Tennessee, and that
Respondent ``repeatedly and deliberately ignored red flags that could
or did indicate likely paths of diversion while prescribing controlled
substances to Bernard.'' Id. The Show Cause Order then alleged that
``on August 28, 2012,'' Bernard pled guilty in federal district court
to one count of conspiracy to distribute and possess with the intent to
distribute oxycodone, in violation of 21 U.S.C. 846 and 841(b)(1)(c).
Id. at 3-4.
Finally, the Show Cause Order alleged that between August 2 and
December 1, 2011, DEA conducted seven undercover visits, during which
Respondent issued controlled substance prescriptions to three
undercover officers (UC), ``for other than a legitimate medical purpose
or outside the usual course of professional practice.'' Id. at 4
(citing 21 CFR 1306.04(a); Ga. Code Ann. 16-13-41(f)). The Show Cause
Order also alleged that Respondent ``violated Georgia medical practice
standards'' by failing ``to maintain appropriate patient records that
supported the prescribing of controlled substances and'' by failing
``to conduct an appropriate physical examination or maintain
substantial supporting documentation to support large doses of narcotic
medication.'' Id. (citing Ga. Comp. R. & Regs. 360-3-.02(7) and 360-
3-.02(14)). Id.\1\ Finally, with respect to UC3, the Show Cause Order
alleged that Respondent further violated Agency regulations by
prescribing oxycodone to him knowing that he was dependent on
narcotics. Id. at 6 (citing 21 CFR 1306.04(c) and 1306.07).
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\1\ The Order then set forth various factual allegations related
to each of the seven undercover visits. ALJ Ex. 4-6.
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On August 5, 2013, Respondent requested an extension of time to
respond to the Order to Show Cause. ALJ Ex. 2. Therein, Respondent
stated that he received the Order to Show Cause on July 23, 2013. Id.
The case was then placed on the docket of the Office of Administrative
Law Judges and assigned to ALJ Christopher B. McNeil. The next day, the
ALJ found that Respondent's request ``should be treated as a request
for a hearing,'' and issued an Order for Prehearing Statements and
Setting the Matter for Hearing. ALJ Ex. 3.
Following pre-hearing procedures, the ALJ conducted an evidentiary
hearing in Atlanta, Georgia on October 8-9, 2013, at which both parties
called witnesses to testify and submitted various exhibits for the
record. Following the hearing, both parties submitted briefs containing
their proposed findings of fact, conclusions of law, and argument.
On December 18, 2013, the ALJ issued his recommended decision
(hereinafter, R.D.). Therein, the ALJ found that ``the Government has
established its prima facie case by at least a preponderance of the
evidence, and [that] Respondent had failed to rebut that case through a
demonstration of sufficient remediation.'' R.D. 108. The ALJ thus
recommended that Respondent's registration be revoked and that any
pending application be denied. Id.
Most significantly, the ALJ found that ``between January 2011 and
April 2012 . . . Respondent issued prescriptions . . . for controlled
substances, including oxycodone and Xanax to [ten patients] and to
[three] undercover DEA agents . . . under conditions that were
inconsistent with the usual course of professional practice for [a]
physician in Georgia and that were not for a legitimate medical
purpose.'' R.D. at 102 (Finding of Fact Number 4).\2\ As support for
his conclusion, the ALJ found that Respondent prescribed controlled
substances ``based on a diagnosis of pain, without obtaining and
sufficiently verifying the patient's medical history including his or
her history of prescription medications,'' and ``without first
conducting a physical examination sufficient to determine the necessity
of opioid treatment.'' R.D. at 103. The ALJ also relied on his findings
that Respondent ``fail[ed] to use medication and other modalities of
treatment based on generally accepted or approved indications with
proper precautions to avoid adverse physical reactions, habituation, or
addiction''; that he prescribed controlled substances ``under
conditions where the medical records fail to contain sufficient indicia
to support diagnoses warranting narcotic pain therapy''; and that he
``prescrib[ed] controlled substances to patients who without
demonstrating legitimate medical reasons travelled from out of state
and from long distances.'' Id. The ALJ thus concluded that the evidence
supported a finding that Respondent's continued registration ``is
inconsistent with the public interest'' and supported the revocation of
his registration.'' Id. at 107.
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\2\ But see R.D. at 107 (Conclusion of Law Number Seven)
(stating that ``between December 2011 and April 2012 the Respondent
issued prescriptions . . . for controlled substances that were not
for a legitimate medical need and were not issued in the ordinary
course of a professional medical practice''). The Recommended
Decision contains no explanation for this inconsistency.
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The ALJ further found that ``Respondent has failed to affirmatively
acknowledge specific acts of improper prescribing . . . and failed to
establish by . . . substantial evidence effective steps taken in
remediation.'' Id. at 108. The ALJ thus concluded that ``the Government
has established cause to revoke Respondent's . . . registration and to
deny all pending applications,'' and recommended that I revoke
Respondent's registration and deny any pending application to renew or
modify his registration. Id.
Both parties filed exceptions to the ALJ's recommended decision.
Thereafter, the record was forwarded to me for final agency action.
Having considered the entire record, including the parties' exceptions,
I adopt the ALJ's ultimate conclusions that the Government has met its
prima facie burden of showing that Respondent's continued registration
is inconsistent with the public interest and that Respondent has not
produced sufficient evidence to rebut the Government's case.
Accordingly, I will order that Respondent's registration be revoked and
that any pending application be denied. I make the following findings.
Findings
Respondent's Registration Status
Respondent is a medical doctor who is apparently licensed by the
Georgia Composite State Board of Medical Examiners. Tr. 330. Respondent
also holds DEA Certificate of Registration
[[Page 3632]]
BM0288983, which authorizes him to dispense controlled substances in
schedules II through V as a practitioner, at a registered address in
Conyers, Georgia. GX 1. Respondent's registration was due to expire on
January 31, 2013. Id. However, on January 30, 2013, Respondent
submitted a renewal application. GX 2, at 1. While Respondent's
application has not been approved and remains pending until the
resolution of this proceeding, because the application was timely
filed, Respondent's registration remains in effect. 5 U.S.C. 558(c).
The Investigation of Respondent
In either October or November 2010, Respondent answered a newspaper
advertisement, which apparently sought a physician for a pain
management clinic. Tr. 279; GX 34, at 3. Thereafter, Respondent met one
Mark Del Percio at a restaurant; Del Percio told Respondent that he was
opening Liberty and that while he had interviewed another doctor, ``he
wanted somebody closer to his age.'' Id. at 280. Del Percio offered the
job to Respondent, who began working at Liberty in January 2011. Id.
Liberty was located in Norcross, Georgia, a suburb of Atlanta. GX 9, at
2; Tr. 238, 282.
Respondent admitted that Del Percio told him ``that he had a
partner named Charles,'' and ``that Charles would be working out of one
of the rooms in the office,'' but ``Charles never showed up.'' Tr. 280.
Respondent further testified that he ``never met Charles,'' ``never
talked to [him] on the phone,'' and ``didn't even know his last name.''
Id. Charles' last name was Laing. Id. at 282.
Respondent admitted that he knew Del Percio was from Florida and
that he did not have a background in pain management. Tr. 349. He also
testified that he did not ask Del Percio why he wanted to open a pain
clinic when Del Percio had no background in pain management. Id. at
348. Respondent nonetheless claimed that he did not find this unusual.
Id. at 349. Nor did Respondent ask Del Percio why he wanted to open a
pain clinic in Georgia, even though he acknowledged having read about
the pill mills in Florida and further testified that he knew ``they
were prescribing an excessive amount of oxycodone . . . 120--240 of the
30s, and 120 of the 15s.'' Id. at 350. Respondent further testified
that he did not ask Del Percio about his background and did not ``do a
criminal check on him.'' Id. at 349.
According to Respondent, during his first month, he saw ``maybe ten
people.'' Id. at 281. Because the business was slow, Del Percio hired
``a marketing person''; ``[t]he following month, more patients began to
come in, and the following month, even more patients began to come
in,'' with ``quite a few'' of the patients coming ``from Tennessee.''
Id.
Indeed, according to a Task Force Officer, Investigators executed a
search warrant at Liberty pursuant to which they seized 881 patient
files. Tr. 84, 226-7; GX 3, at 19. Upon reviewing the patient files,
the Investigators determined that 690 patients (or 78.3%) of Liberty's
patients came from Tennessee; by contrast, only 54 patients lived in
Georgia.\3\ GX 4, at 1. Moreover, the Investigators determined that 27
of the patients lived on Beech Creek Road in Tennessee (including
Charles Laing's mother) and in at least nine instances, two or three
patients lived at the same address.
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\3\ The Investigators found that the other Liberty patients came
from the following States in the following amounts: South Carolina
(21); Virginia (37); Kentucky (41); North Carolina (19), Florida
(11), West Virginia (7), and Arkansas (1). GX 4, at 1.
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Based on their review of the 881 patient files, the Investigators
determined that 875 patients received oxycodone, while six patients did
not. GX 3, at 19. However, of the six patients, four of them received
Percocet 10/325, a combination drug which contains ten (10) milligrams
of oxycodone.\4\ See id. at 4 (Pt. S.A.), 11 (Pt. J.I.), 12 (Pt. J.L.),
and 16 (Pt. J.S.). Thus, nearly every patient Respondent saw received
oxycodone, which according to a Task Force Officer, is ``the drug of
choice among pill seekers and diverters.'' Tr. 260.
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\4\ Of the remaining two patients, one (E.P.) received Lortab
10/500mg (a combination drug containing hydrocodone) and one (J.P.)
was never seen by Respondent. GX 3, at 1-2.
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In June 2011, Respondent came to the attention of DEA after the
Hawkins County, Tennessee Sheriff's Office (HCSO) executed a search
warrant at the home of Charles Laing in Rogersville, based on
information it obtained that Laing was involved in trafficking
oxycodone obtained by persons from Liberty. GX 40, at 2. According to a
DEA Task Force Officer, the HCSO seized oxycodone, Xanax and Suboxone
totaling approximately 300 tablets, as well as appointment cards for
Liberty. Id. at 2. The Investigators also determined that Laing co-
owned Liberty with Del Percio, and that Respondent was Liberty's
prescribing physician. Id.
Thereafter, DEA and the Norcross, Georgia Police Department
conducted surveillance operations at Liberty. According to several
Investigators, Liberty did not have any signage or other markings
outside the building in which it was located, Tr. 76, and when the
Investigators first went to the clinic, ``there was no way to know if
[they] were at the right location.'' Id. at 77. It was not until the
next morning when the Investigators returned and observed an
``abundance of'' cars with ``Tennessee tags parked in front of the''
clinic that they knew that they were at the right location. Id.
During their surveillance of the clinic, the Investigators observed
numerous cars arriving at the clinic that had out-of-state license
plates, including cars from Tennessee, Kentucky, North Carolina, and
Florida. GX 40, at 2. They also observed that in some instances, the
cars had multiple passengers who would then enter the clinic. Id. at 2-
3. Finding their observations to be consistent with drug diversion, the
Investigators decided to conduct undercover visits at the clinic to
determine if Respondent was issuing unlawful prescriptions. Id. at 3.
Between August and December 2011, three TFOs conducted a total of seven
visits.\5\
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\5\ Having reviewed the entire record, I deem it unnecessary to
make findings regarding the single visit of TFO Jones.
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The Visits of TFO Vickery
In his role as L.C., Officer Vickery made four visits to Liberty
Wellness Center, the first of which occurred on August 22, 2011. Tr.
158. Vickery explained that ``[m]ostly every time I was there, every
chair was full, so that [there] would probably be 30, 35 people sitting
there, all younger crowds . . . the majority of [the patients were]
under 40.'' Id. at 207. Vickery also testified that while in the
waiting room, he ``could overhear [the patients] talking back and forth
about what they're getting from different doctors, where they're
filling at, what pharmacy charges what. You would see that a lot of the
patients would travel in groups.'' Id. at 207-208.
Officer Vickery further testified during the time he spent in the
waiting room, he was able to identify persons acting as ``sponsors.''
Id. at 208. He described a sponsor as someone who ``takes care of
everything as far as financial, getting their MRIs, their prescriptions
filled,'' and the sponsor ``would deal with the owner of the clinic, up
until the point to where . . . the patient finally went back to see the
doctor.'' Id.
Officer Vickery testified that he observed that only two people
worked at the clinic, Del Percio and Respondent. Del Percio was
``actually
[[Page 3633]]
controlling everything that [was] going on out in the front area.'' Id.
at 209-212. According to Vickery, once a patient entered the waiting
room, Del Percio would not allow the patient to go outside to smoke or
go to the parking lot, such that if the patient had to leave the
waiting room before seeing the doctor, he or she would have to leave
the area. Id. at 210. Del Percio's duties included answering the
phones, arranging appointments, providing the patients with the intake
forms and receiving them back, collecting the patients' payment,
answering their questions, taking their blood pressure, and directing
them to provide urine samples. Id. at 212-14. Only after the initial
intake was completed would patients be escorted back to Respondent's
office.
Officer Vickery also stated that each time he received treatment at
Liberty Wellness Center he paid $300 in cash. Id. at 167. He testified
that the clinic required cash payments, that it ``didn't do
insurance,'' and was told, ``well, we're in the process of getting our
insurance accepted, but we haven't been approved for anything so
everything's got to be cash at the moment.'' Id. at 210-211.
According to Vickery, Respondent's office had a massage table that
served as the examination table. Id. at 215. Vickery testified that
while the table was used during the examination done by Respondent at
his first visit, he remained fully clothed. Id. Vickery further
testified that during his three subsequent visits, he remained seated
in an office chair for the entirety of each visit. Id. at 216.
Officer Vickery explained that he had obtained an MRI for another
investigation and that he presented the MRI to Del Percio, along with a
false Georgia driver's license showing a Newnan, Georgia address, which
was located approximately 60 miles from the clinic. Id. at 160-161.
Vickery testified that he brought the MRI to the August 22, 2011 visit
because he had been to the clinic twice before and that during those
visits, Del Percio told him he needed an MRI before he could be seen by
Respondent. Id. at 163, 165. Vickery also testified that the MRI was of
the lumbar spine, based on a complaint of ``LBP'' or lower back pain.
Id. at 164; GX 27, at 4.
The MRI Report states that ``[t]here is no significant disc disease
at L1 through L3.'' GX 27, at 4. However, at L3-L4, it states that
``[a] left far posterolateral asymmetrical disc protrusion with annular
tear is noted'' and that ``[d]isc material effaces the exiting left L3
nerve root.'' Id. At L4-L5, it notes a ``posterior disc bulging
effacing the thecal sac without nerve root impingement,'' and that at
L5-S1, ``[t]here is low-grade disc bulging without significant mass
effect.'' Id. The report then states that ``[t]here is no extruded disc
herniation identified. No central canal or neuroforaminal canal
stenosis is identified.'' Id.
However, on his medical intake form, Vickery listed his chief
complaint as shoulder pain, and reported that ``with medication'' his
pain level was a ``0'' (this ``being no pain''), and ``without
medication'' a ``5.'' Id. at 5. He explained that he did this
``basically to see if I could get into the clinic without an MRI, like
I was told I needed, on an ailment or an injury different than what I
gave them.'' Tr. 165. However, on the third page of the intake form,
which listed a large number of medical conditions, Vickery placed an
``x'' in the blanks corresponding to both his back and shoulders.\6\ GX
27, at 7.
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\6\ As part of the intake process, Vickery (as were the other
undercover officers) was required to review and sign a Pain
Management Agreement. GX 27, at 9-10. The Agreement contained
twenty-two paragraphs, including one which states that ``I will not
share, sell, or trade my medications with anyone.'' Id. at 10.
Moreover, at his subsequent visits, Vickery was required to complete
a Patient Comfort Assessment Guide, which included the statement and
question: ``To sell or divert and [sic] of my medication is illegal.
Do you give permission to this clinic to report any illegal
incident?'' Id. at 22. The same form also include the question: ``Do
you understand this clinic has reported a number of individuals to
authorities for illegal behavior?'' Id.
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There are video recordings of Officer Vickery's office visits with
Respondent, and three computer disc files containing recordings of
brief exchanges between Vickery and Del Percio during the first visit.
RX G, Disc N-29.
During the time Officer Vickery spent with Respondent, the two
discussed Vickery's physical condition and the likely reasons for his
pain. Respondent made no mention of the distance between Liberty and
Vickery's home address, nor did he ask why Vickery had come to Liberty.
When Respondent asked Vickery if he had a history of back injuries,
Vickery said no, but that he worked in construction and home
improvement, and that his age was ``starting to catch up to'' him. GX
28, at 2; RX G, Disc N-29.
Vickery explained that he had tried ibuprofen but that ``it just
didn't,'' and that he had got a few ``oxys'' and they worked.\7\ GX 28,
at 2. He then explained that he had seen a Dr. Chapman in Cartersville,
who treated him with Dilaudid and Xanax and ``sometimes Oxy 30s,
sometimes . . . Oxy 15s. It was just whatever I needed for the break
through.'' Id. at 2-3. Vickery further stated that his previous doctor
had written prescriptions for 100 Dilaudid 4mg (but did not keep him on
the drug for ``very long''), 120 oxy 30s, 90 oxy 15s for the
breakthrough, and 60 Xanax 2mg. Id.
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\7\ Officer Vickery also testified that when trying to obtain
oxycodone from Respondent, he referred to them as ``30s'' ``because
it's basically street lingo, drug lingo, and that's what most of the
addicts, drug dealers, whatever, refer to the oxycodone as . . . by
their milligrams.'' Tr. 173-74.
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When Respondent asked ``where are you hurting now,'' Officer
Vickery did not deny having pain, but replied: ``Well, sometimes it's
the shoulder, sometimes the lower back. It just comes in spurts.'' Id.
at 3. Respondent then asked him how bad his lower back pain was;
Vickery replied, ``Like today, it's not bad, because . . . I hadn't
been working because construction has been slow.'' Id. at 4. Respondent
then stated: ``when you're not working, you don't have much pain is
what you told me.'' Id. Vickery agreed with this characterization,
stating that he ``just kept going,'' adding that Dr. Chapman told him
to do so. Id. Vickery then told Respondent that he was returning to
work the next week, and he wanted ``to get on track so I . . . won't
miss work next time.'' Id. at 4-5.
When Respondent asked him about his pain levels, Officer Vickery
said that without medication, his pain was ``probably around a five''
on a ten-point scale, but with medication, it was ``almost down to
zero.'' Id. at 5. Respondent then asked whether Vickery had ever had
any treatment other than pain killers, including epidural injections,
chiropractic service, physical therapy or surgery. Id. He also engaged
in a lengthy discussion with Vickery about his consumption of caffeine,
learning that Vickery was drinking about four 24-ounce cups of coffee a
day. Id. at 6-8. After Vickery told him that he drank very little water
each day, Respondent stated ``we're in trouble,'' adding ``what if I
told you, you were on your way for a dialysis soon?'' Id. at 8.
Respondent recommended that Vickery cut back on his caffeine
consumption and increase his daily water intake, explaining that
caffeine can damage the kidneys and contribute to back pain. Id. at 9.
At this point, Respondent referred to a model of a spine, showing
those areas when the discs lose water and explaining that this can
cause pain. See RX G, Disc N-29. Respondent then reviewed Vickery's MRI
report, and explained that the MRI showed that he had bulging discs,
one effacing the thecal sac; one with material affecting the spinal
nerve roots; and still another, which had an annular tear resulting in
[[Page 3634]]
a bulge pressing on a nerve end. GX 28, at 10-11. Respondent warned
Vickery that drinking caffeinated coffee and not that much water would
cause more pain. Id. at 11. He then stated that ``the first thing we
need to do is work on these--getting rid of a lot of this caffeine and
get you up to maybe half a gallon of water. I think that's going to
make a big difference in your pain. It may get rid of all your pain.''
Id.
Respondent had Vickery sit on the exam table and then lie on his
back, at which point, he directed Vickery to lift his legs, one at a
time, ``straight up,'' and asked if this ``bothered [him] at all'';
Vickery answered ``no.'' Id. Respondent then directed Vickery to turn
over onto his stomach, palpated Vickery's back in several areas, asking
if it bothered him. Id. at 12. In response to the first palpation,
Vickery replied that ``It's a little tender right there, yeah.'' Id.
The next three times, Vickery denied any pain. Id. However, the fifth
time, Vickery replied ``Well, it's a little sore to me because I spent
[yesterday] washing my car.'' Id.
Respondent then asked Vickery if he had tried anti-inflammatories;
Vickery answered that he had quit taking them because they didn't do
anything for him and added that the only drug that worked for him were
the drugs he was getting from Chapman--the 30s and the ``15s every now
and then.'' Id. at 12-13. Respondent then asked if he had taken
Percocet, Vicodin, or Lortab; Vickery replied that he had tried Lortab
but that it didn't work for him. Id. at 13. Respondent stated that
Vickery's ``main thing'' was to get away from the caffeine and that he
also needed to use the anti-inflammatories for three to four months for
them to work. Id. Respondent also asked Vickery if he had tried muscle
relaxants such as Flexeril or Robaxin; Vickery said that he had tried
them but they ``just never worked.'' Id. at 13-14.
After Respondent told Vickery he was going to place him on an anti-
inflammatory, he asked Vickery when he had last taken oxycodone. Id. at
14. While this visit took place on a Monday, Vickery said that he had
probably taken three tablets late Thursday or early Friday morning. Id.
Respondent then asked Vickery if he took the oxycodone because he was
hurting or just to take them; Vickery did not answer directly, replying
that ``I could feel something coming on.'' Id.
Respondent suggested that this was because of Vickery's coffee
consumption and ``not having enough water in your system.''' Id. at 15.
While he then told Vickery that his ``x-rays do show that you have a
problem, but your exam is not showing a whole lot at all,'' Respondent
said: ``I'll try you on maybe two or three times a day and see how that
works for you.'' Id. He added, however:
I'm not even sure you need that much, because, I mean, your x-
ray--your x-ray shows that your nerves are being pinched on, but
[unintelligible] I just don't feel a whole lot. Okay. And what that
suggests to me is that if you get away from the caffeine and drink
more water, you're probably not going to have any pain at all.
Id.
Vickery then asked if could get some Xanax for ``the night.'' Id.
While Respondent told Vickery that Xanax and Oxycodone is not a real
good mixture, and that they both ``suppress your lungs'' and that he
``may not wake up,'' he agreed to prescribe 30 tablets of Xanax 1mg to
him. Id. at 15. Vickery asked if he could get 60 tablets, explaining
that ``my wife kind of uses them, too''; Respondent stated, ``No. She
can't use your medicine.'' Id. at 16. When Vickery persisted, saying
that ``she takes them every now and then, and it's like, come on,''
Respondent repeated his earlier answer, stating ``she's got to get her
own medicine,'' and ``[y]ou've got to hide your stuff, [s]he can't . .
. take your medicine.'' Id. After a further discussion of the Vickery's
caffeine use, the visit ended.
Officer Vickery paid $300 cash to Del Percio for the visit. Tr.
167. Respondent issued Vickery prescriptions for 90 tablets of
oxycodone 30mg, a schedule II narcotic; 30 tablets of Xanax 1mg, a
schedule IV benzodiazepine; and 60 tablets Naproxen, a non-controlled
drug. GX 27, at 2.
Officer Vickery testified that he not been taking oxycodone,
notwithstanding his representation during the visit. Tr. 171. He also
testified that contrary to what he wrote in his medical history, he was
not being treated by Dr. Chapman, and had not been prescribed Xanax or
Dilaudid. Id. at 172-73. Moreover, he had not been taking oxycodone or
any other prescription drugs. Id. at 171, 173. Vickery testified that
while he was required to provide a urine sample prior to his visit with
Respondent, he did not know what the test results were and they were
not discussed with him. Id. at 170.
On cross-examination, Officer Vickery testified that he believed
Dr. Chapman's medical office had been closed before his initial visit
to Liberty. Id. at 201. Respondent subsequently testified that while he
was working at Liberty, he ``had heard the word `pill mill.' Dr.
Chapman's office was shut down and they called it a pill mill.'' Id. at
346. However, Respondent otherwise denied knowing why Dr. Chapman's
office was shut down. Id. While the closure of Chapman's clinic may
have resulted in Respondent being unable to obtain medical records from
it, according to Officer Vickery, Respondent never attempted to obtain
his purported medical records from Chapman. Id. at 172.
On September 22, 2011, Officer Vickery returned to see Respondent.
Tr. 179; GX 27, at 20. Recordings were made of this visit,\8\ which
were also transcribed. See RX G, Disc N-42; GX 29. Prior to seeing
Respondent, Vickery completed a form entitled ``Patient Comfort
Assessment Guide'' on which he wrote that he had back pain and circled
the words ``aching,'' ``sharp,'' ``nagging,'' ``unbearable'' and
``continuous.'' GX 27, at 22. Asked by the form to rate his pain in the
last month ``with medication,'' he indicated that it was a ``6'' ``at
its worst,'' a ``2'' ``at its least, and a ``5'' on ``average.'' Id. He
also noted that ``right now,'' his pain was a ``3.'' Id. Finally, he
noted that oxycodone 30 provided a level of relief of ``3,'' where 0
was ``no relief'' and 10 was ``complete relief.'' Id.
---------------------------------------------------------------------------
\8\ There are seven video files on the disc, six of which depict
people sitting in the clinic's waiting room or Officer Vickery's
actions before or after the office visit, and have no probative
value. RX G, Disc N-42.
---------------------------------------------------------------------------
Officer Vickery's visit with Respondent lasted just under six
minutes. See generally RX G, Disc N-42. As was the case with the
initial visit, Vickery was required to provide a urine sample for drug
screening; however, Respondent did not discuss the results of either
the previous test or this test. Tr. 187. Nor did Respondent discuss
with Vickery his records from any prior treating physician. Id.
Upon being seated in Respondent's office, Officer Vickery commented
on the number of patients yet to be seen in the waiting room while
Respondent, who was seated at his desk, made notes on one of about a
dozen medical folders before him. GX 29, at 1. Twenty-two seconds into
the recording, Respondent rose from his chair and moved to where
Vickery was seated. Respondent asked Vickery to lean forward, and after
six seconds or so, during which time no one spoke, returned to the
chair behind his desk. RX G, Disc N-42, clip 7.
Officer Vickery testified that Respondent ``walked over to where I
was at, took his hand, r[a]n it down my back; then went back and sat
down at his desk.'' Tr. 181. Vickery stated that in running his hands
down his back, Respondent was ``kind of just like pushing down, as
you're going down from the top of your neck, down
[[Page 3635]]
towards your body with the tip of your fingers.'' Id.
At no time during this visit did Respondent inquire of Officer
Vickery's pain level, nor did Vickery raise the subject. See GX 29; RX
G, Disc N-42, clip 7. Nonetheless, in the Physical Exam section of the
Progress Notes for this visit, Respondent wrote ``Lumbar--severe
tenderness over paravertebral muscle with [two up arrows] muscle
tone.'' GX 27, at 20. Nothing in the recording, however, suggests that
Officer Vickery indicated either by word or physical response that he
was experiencing severe tenderness in any part of his body. See GX 29;
RX G, Disc N-42, clip 7.
Similarly, the progress note describes Officer Vickery's chief
complaint as ``pain is 5 with medication.'' GX 27, at 20. While on the
``Patient Comfort Assessment'' form for this visit, Vickery circled
``5'' as his average pain ``in the last month with medication,'' he
also circled ``3'' as his pain ``right now.'' Id. at 22. Moreover, at
no point in the various recordings of the visit, did Vickery assert to
either Del Percio or Respondent that his current pain level was a 5, or
even suggest that he was then in pain. See GX 29; RX G, Disc N-42, clip
7.
Upon Respondent's returning to his desk, he asked Vickery how the
medicine was working for him. GX 29, at 1. While Vickery said ``It's
fine,'' he then added that someone had told him that he was taking
Opana (oxymorphone) and that it ``was working out better for them.''
Id. at 2. Vickery then said that ``you gave me the 30's, but I . . .
think I still need some of those 15's during the in between the
times.'' Id. Respondent then asked Vickery if he was taking the anti-
inflammatory; the latter replied that he took some of them but ``I just
don't like it.'' Id.
After a discussion of Vickery's consumption of both coffee and
water, Vickery told Respondent that ``it just seems like in between my
30's, I need something in between there.'' Id. at 3. When Respondent
suggested that ``that's where the Naproxen comes in,'' Vickery replied
``that it just didn't do anything.'' Id. Respondent told Vickery that
while the Naproxen ``feel[s] like it's not doing anything, . . . it's
working for you.'' Id. Vickery took issue with Respondent, explaining
that ``[b]ut then I'm having to . . . put some beers on top of it to
kind of go through all that stuff.'' Id.
After asking Vickery if he was ``taking 90 of the Oxycodone'' and
Vickery asked if he could ``up them,'' Respondent agreed and added,
``[w]e'll take you up to 120'' and ``[s]ee if that works better for
you.'' Id. Vickery then asked Respondent if he thought that Opana was
``worth anything''; Respondent answered that different drugs work
differently on different persons and offered to prescribe Opana, while
rejecting Vickery's request to try Opana with the Oxy 30s. Id. at 3-4.
Respondent then told Vickery that he could ``go with just the plain
Opana by itself, or you can go with the Oxycodone.'' Id. at 4.
Officer Vickery then asked if he got the Opana, could he also ``get
some of the 15's just in case.'' Id. When Respondent said ``no,''
Vickery replied: ``Doc, you killing me, man. Even if I float you a
little bit extra on the side, maybe a couple hundred bucks on the side
to.'' Id. Respondent again said ``no,'' and then explained that Opana
came in 10, 20 and 40 milligram dosage units. Id. Vickery asked if he
could ``get the 40's''; Respondent replied: ``I would try it three
times a day'' and asked Vickery if he ``want[ed] to try that?'' Id.
Vickery agreed, notwithstanding that Respondent told him that Opana was
``pretty expensive,'' but then asked for some Lortabs for ``in between
them,'' adding that the Naproxen ``just doesn't work.'' Id. at 4-5.
Respondent insisted that the Naproxen would work with time. Id. at 5.
Apparently upon reviewing the prescriptions, Officer Vickery
complained that Respondent had decreased the amount of his Xanax
prescription. Id. When Respondent explained that he had gotten 30 last
time, Vickery complained that ``they didn't last me all month. . . .
They didn't last at all. You being stingy, Doc.'' Id. Vickery's visit
with Respondent then ended.
Respondent gave Vickery three prescriptions: one for 90 Opana ER
40mg, a schedule II controlled substance, one for 30 Xanax 1mg, and one
for 60 Naproxen. GX 27, at 21. Moreover, Respondent did not document in
the medical record Vickery's attempt to buy extra drugs from him. Id.
at 20.
Officer Vickery testified that his goal in this visit was to
determine whether he could get more Opana (oxymorphone) or oxycodone,
and he was ``just kind of bargaining to see what I could get . . .
prescribed to me, just by asking for whatever.'' Tr. 182-183. As
Vickery put it, the exchange recorded during this visit would best be
described as one between a ``drug dealer and a supplier.'' Id. at 184.
On October 24, 2011, Officer Vickery made a third office visit with
Respondent. GX 30, at 26. A video recording and transcript of the visit
were entered into evidence. One video file captures the office visit
from start to finish and provides a fairly steady view of Respondent
from across his office desk. RX G, Disc N-49, Clip 4.
As with the first and second visits, Del Percio had Officer Vickery
produce a urine sample for drug screening, but neither he nor
Respondent discussed the results of this screening with Vickery. Tr.
187. Thus, there was no discussion of any possible inconsistency
between what Vickery told Respondent about his current use of narcotics
and the results of his urine screen--although Vickery testified that he
was not taking any medications at the time of this office visit. Id. at
188.
Once again, Vickery completed a Patient Comfort Assessment form, in
which he complained of back pain that was ``aching,'' ``exhausting,
``nagging,'' and ``continuous.'' GX 27, at 28. Rating his various pain
levels ``in the last month with medication,'' Vickery circled ``O'' for
the ``worst'' his pain was, the ``least'' it was, and his ``average''
level. Id. However, he then circled ``3'' for his pain level ``right
now.'' Moreover, while he then wrote that ``meds'' made his pain
better, he also wrote that Opana 40mg provided no relief, oxycodone 30
provided relief at a level of 1 (where 0 was ``no relief'' and 10
``complete relief''), and that Xanax 1mg provided no relief. Id. at 28-
29.
The entire office visit with Respondent took approximately seven
minutes. RX G, Disc N-49, Clip 4. About two minutes elapsed at the
beginning of the visit, during which Respondent remained seated behind
his desk, apparently making notes in Vickery's medical record. Id.
During this time the dialogue between Respondent and Officer Vickery
focused almost exclusively on the medications that were prescribed,
with Respondent asking ``how's the medicine working for you,'' and
Vickery reporting that ``[i]t's good,'' but that he would ``like to get
something for'' break-through. GX 30, at 2. Respondent then asked
Vickery if he had ``taken Lortabs''; Vickery replied that ``I may have
before,'' and added that he thought ``the Percocets do better than the
Lortab.'' Id., See generally RX G, Disc N-49, Clip 4.
Vickery then explained that the Opanas ``went pretty quickly,''
asked Respondent if he could ``raise some of them or may be up the
Percocet,'' and added that ``the Oxy 15's worked perfect for me in
between . . . everything.'' Id. Notwithstanding that he had not
previously prescribed Percocet to Vickery, Respondent asked: ``you're
taking the Percocet also?'' Id. Vickery
[[Page 3636]]
answered that he had ``taken them before with the Oxy,'' at which point
Respondent left his chair and asked if he could press on Vickery's
back. Id.
The entire exam lasted less than thirteen seconds, and while the
video does not show what it involved, Officer Vickery testified that
this exam involved his ``just lean[ing] over in the chair. [Respondent]
would take his hands, both rub from the top to the bottom. . . .'' Tr.
189. As this occurred, Vickery stated that he ``was always the getting
the 30's . . . and then I'd take the 15's in between'' and that Chapman
``was giving me 180 of the 30's'' and ``90 or 120 of the 15's in
between, something like that . . . [a]nd those seemed to get me through
the whole 28-day cycle.'' GX 30, at 2-3. After Respondent said that
Liberty used a 30-day cycle and that Vickery was ``here a little
early,'' Vickery maintained that ``this is the appointment he gave me''
and Respondent conceded that it was not Vickery's fault. Id. at 3.
Vickery explained that he had a hard ``time getting a ride up
here'' and that he had been dropped off by his buddy. Id. Vickery then
told Respondent that his buddy liked Xanax and had asked him to give
Respondent ``200 bucks and see if he'' would write a prescription for
Xanax. Id. Respondent laughed; Vickery showed him the cash and said:
``I don't know if you can do that and put it in my name for an extra--
or up my Xanax some.'' Id. at 3-4. Respondent replied: ``No, we can't
do.'' Id. at 4. Vickery asked: ``Can we do that?''; Respondent answered
``no.'' Id.
Vickery then asked if he was getting 40 Percocet; Respondent said
``right.'' Id. Vickery then complained that Respondent was ``stingy,''
explained that he ``was used to what [he] was getting,'' and asked if
he could up the Xanax prescription because the 30 tablets ``didn't get
me through two, three weeks.'' Id. When Vickery further asserted that
he had been getting 60 of the two milligram Xanax, Respondent stated
that he had been ``doing 45.'' Id. Respondent then suggested that if
Vickery's friend had a problem with anxiety and needed Xanax, he could
go to a walk-in clinic. Id. Vickery then asked: ``so you can't do
nothing?''; Respondent said ``No.'' Id.
Respondent gave Vickery prescriptions for 90 tablets of Opana 40mg,
45 tablets of Xanax (an increase from 30), and 40 tablets of Percocet
10/325, which was an additional prescription.\9\ GX 27, at 27. On each
of the controlled substance prescriptions, Respondent wrote: ``an
emergency exists for Rx.'' Id.
---------------------------------------------------------------------------
\9\ He also wrote him a prescription for Naproxen.
---------------------------------------------------------------------------
Here again, Respondent did not document Vickery's attempt to
purchase additional controlled substances from him. See id. at 27.
Instead, he wrote that Vickery was ``having more problems [with]
anxiety.'' Id.
Officer Vickery returned for a fourth visit to Liberty Wellness
Center on December 1, 2011. GX 31; GX 27, at 32-37; RX G, Disc N-54.
Vickery testified that he was intentionally one week late for his
appointment so that ``I would have been out of my medication for over
seven days.'' Tr. 194. Before meeting Respondent, Officer Vickery was
required to produce a urine sample and complete another Patient Comfort
Assessment form. Tr. 191; GX 27.
On the form, Vickery noted that he had back pain which was aching,
exhausting, and tiring, but was only occasional. GX 27, at 34. Rating
his worst, least, and average pain level in the last month with
medication, Vickery circled 0, indicating no pain, for all three
levels. Id. However, he then claimed that his pain was a ``3'' ``right
now.'' Id. While he also wrote that ``meds'' made his pain better, he
then indicated that each of the three drugs (Opana 40, Percocet 10/325,
and Xanax 1mg) provided ``0'' relief. Id. at 34-35.
Upon meeting, Vickery told Respondent that the Opana was ``doing
good'' and was ``unbelievable,'' but that he had been ``talking to some
people'' who said he could get ``25 milligram caplets'' instead of the
oxy 30 pills. Id. at 3-4. Respondent asked Vickery where he would get
``those filled''; Vickery replied that someone told him he could go to
a pharmacy (Stacy's) that did compounding. Id. at 4. After Vickery said
that he had heard in the lobby ``that the pills are getting scarce,''
Respondent replied: ``yeah, yeah, yeah.'' Id. Respondent then advised
Vickery that he may want to check with the pharmacy ``to see if there's
any available because sometimes they have it and sometime they don't.''
Id.
After some small talk about Thanksgiving, Respondent asked Vickery
to rate his pain on the one to ten scale; Vickery replied that is was
``[a]round 3,4'' but that ``it comes and goes.'' Id. at 5. Respondent
then asked Vickery to rate his pain when he was ``on the medicine'';
Vickery replied that it was ``down around almost nothing really on the
medicine.'' Id.
Respondent then got up and asked Vickery to let him ``press on
[his] back a little bit''; Vickery agreed. Respondent asked Vickery to
lean forward, pressed on Vickery's back and asked, ``[d]oes that bother
you?'' Id. While Vickery's answer is unintelligible, Respondent then
asked, ``[b]ut not a lot of pain?'' Id. at 5-6. Vickery replied: ``I
guess today I'm having kind of a good day . . . but then again, I
didn't work today.'' Id. at 6.
Respondent said ``[t]hat a good thing'' and added that ``I don't
even think you need those 25's,'' a point which he then reiterated. Id.
Vickery stated that ``I really do, Doc. I need the 25's, especially
since I been taking all that other stuff. I been taking the Opanas, and
I had Percocets.'' Id.
Respondent then observed that Vickery was ``a week late'' and was
``still not having much pain.'' Id. Vickery replied, ``Okay, well, I'm
having a lot of pain Doc,'' to which Respondent said ``no'' and started
laughing. Id. Vickery insisted that he was ``in a lot of pain'' and
that ``Doc [your] kill [sic] me.'' Id. After Respondent replied, ``no,
no,'' Vickery asked him for ``something to hold me'' because ``it's
going to be a mess'' when he resumed working. Id.
At this point, Respondent, for the first and only time during
Vickery's four visits, discussed his urine test results, noting that
``you're doing good. I mean, your urine doesn't show any medicine in
your system. You're not having much pain. I mean, you're actually doing
pretty good.'' Id. After Vickery said ``okay,'' Respondent added: ``I'm
not sure if you need much of anything.'' Id. Vickery then asserted that
he needed ``at least my oxy's . . . and my Xanax,'' prompting laughter
from Respondent, who after an unintelligible comment by Vickery, asked:
``What, the anxiety's bothering you a bit.'' Id. at 6-7. Vickery
asserted that he knew ``I'll have to have it because . . . it may not
be going on right now, but . . . it will.'' Id. at 7. Respondent then
told Vickery that ``you may not need anything but the Xanax and the
Naproxen. Id.
After Vickery explained that he didn't take the Naproxen and did
not ``even like it,'' Respondent again asked Vickery ``so how much pain
are you having today?'' Id. Vickery said, ``well, I guess now I'm
having . . . up in the five, six, seven,'' and Respondent observed,
``That's not what you told me when you came in.'' Id. Vickery then
stated, ``I'll say around four, okay''; Respondent said: ``But that's
not what you told me.'' Id. After Vickery stated that ``I said three or
four,'' Respondent acknowledged that he ``did write down three.'' Id.
However, Respondent then stated that ``when I pressed, you're not
having much tender[ness],'' noted that there was ``no medicine in
[Vickery's] system,'' and added ``you don't need much of anything.''
Id. Vickery asserted that he was ``going to have to have something,''
[[Page 3637]]
and that he would find a different doctor ``to go to next month,''
prompting more laughter from Respondent. Id. at 7-8.
Vickery then explained that the Opanas ``were good'' but expensive;
Respondent reiterated that there was no medicine in his urine. Id. at
8. Vickery stated that he didn't know why, suggested that ``maybe the
urine screen is wrong,'' and added that he had taken ``one a couple
days ago.'' Id. Respondent subsequently asked Vickery how much pain he
felt when his back was pressed on; Vickery did not answer directly,
stating that he ``hadn't done anything today'' and that he worked ``for
the last couple of days'' and hadn't done anything ``to aggravate'' it,
but that he was going back to work the next day and that if his
``appointment had been tomorrow . . . it would probably be[] a whole
different story.'' Id. at 8-9.
Respondent said ``okay,'' and added: ``I think you can probably get
away with using maybe either some Percocet or some oxy 15's.'' Id. at
9. Vickery then said that he would ``really like to get some of the
25's, noting that there was ``not that much difference'' between the
15's and the 25's. Id. Respondent agreed, Vickery asked ``why can't we
do the 25's, and I can get the caplets,'' Respondent said ``okay,'' and
Vickery asked for ``some Percocets in between.'' Id.
Respondent then asked Vickery if he would check the pharmacy ``and
see if they have any 25's?'' Id. Vickery replied that he did not ``have
a number for them,'' and added that he was ``sure they can make them''
and ``can get the stuff.'' Id. Vickery added that ``they can fill my .
. . Xanax to hold me till they can make . . . the other stuff.'' Id. He
then complained that Respondent was ``getting hard to work with.'' Id.
Respondent replied, ``No. I'm easy, but . . . I don't need you
taking anything if you're not having any problem because that's not
good for you. And that's where the problem is.'' Id. at 10. Respondent
then observed that Vickery had almost no pain when he was on medication
and that his pain level was only a three when he was not taking
medication.\10\ Id. Vickery then insisted that his ``3 may be somebody
else's 7, 8,'' to which Respondent replied ``that's a good thing'' and
``that means you don't need as much medicine,'' and laughed. Id.
Vickery then said: ``yes I do, yes I do, Doc. Yes, I do.'' Id.
---------------------------------------------------------------------------
\10\ Having compared the transcript with the video recording, I
conclude that Respondent actually said: ``when you're not taking
any, your pain level is only at a 3.'' RX G Disc N-54.
---------------------------------------------------------------------------
Respondent reiterated that it was ``a good thing'' that Vickery did
not ``feel as much pain as someone else'' and did not ``need as much
medicine'' as other persons. Id. Vickery then stated: ``I like what I
take, Doc, so--I been--used to taking it[,] kind of where I'm at.'' Id.
Respondent replied that if ``you're used to taking it, then we're
talking about somewhat of a dependency here, okay,'' and laughed. After
an unintelligible remark from Vickery, Respondent stated that he was
going to ``try and wean'' Vickery ``down some,'' because he did not
``need as much as . . . what you've been taking.'' Id.
When Vickery asked what this involved, Respondent explained that:
``I can't just cold turkey you, either, because then you have some
withdrawal problems. But you haven't taken it in seven days, so I doubt
you would have that.'' Id. at 11. Respondent then laughed, and added,
``[t]here none in your system,'' and again laughed. Id.
Vickery complained that Respondent was being stingy; Respondent
replied that he was ``trying to keep [him] out of trouble,'' noting
that ``everything suggests to me that you don't need as much as you had
before.'' Id.
Vickery then asked ``how many 25's'' he could get''; Respondent
stated that he ``was on 90'' and if he ``got the 25 a couple of times a
day,'' that would keep Vickery ``out of trouble.'' Id. When Vickery
then sought some Percocets for ``in between,'' Respondent said ``no''
and that ``[y]ou're not hurting in between.'' Id. Vickery replied,
``Okay, my pain is higher now. Now since I sat here and talked to you,
my pain is higher.'' Id. Respondent laughed, and Vickery stated: ``You
really got to be a pain in my back Doc. Now, I'm getting higher.'' Id.
Respondent laughed, and said that he would prescribe the 25's
``maybe twice a day and see how that works for you.'' Id. Vickery then
sought more drugs for ``in between'' and asked if he could get Lortab.
Id. at 12. While Respondent initially agreed to prescribe ``maybe one
Lortab a day,'' Vickery then complained that he was only getting 60
oxycodone 25's, and asked if he could get 90. Id.
Respondent then asked if Vickery ``was on 90 of the Opanas,'' and
after Vickery confirmed this, Respondent agreed to prescribe 90
oxycodone 25s but not the Lortabs. Id. Vickery said ``that's fine'' and
asked ``What about Somas in between? What would those do?'' Id.
Respondent said that it was ``a muscle relaxer'' and agreed to
prescribe the drug, telling Vickery that he could take them at bedtime
and not at work. Id. Vickery said ``okay,'' and Respondent said that he
``did feel some tight muscles back there,'' to which Vickery replied,
``[s]ee, they've gotten tighter since I'm talking to you.'' Id.
Respondent laughed. Id. at 12-13.
Vickery then said he would have to ask Del Percio for the
pharmacy's phone number; Respondent said there were other places that
made compounds. Id. at 13. Respondent then reiterated his statement
that Vickery was ``doing better'' and that ``the medicine is working
for you,'' adding that ``you probably don't need as much as what you're
taking'' as he had not had medication for a whole week and was not
``bending over in pain or anything.'' Id. at 13-14. Respondent then
gave Vickery the prescriptions, after which Vickery said: ``I'll be in
more pain next time.'' Id. at 14. Respondent replied: ``No, no, no, no
no,'' and Vickery said: ``I know what you're saying. I'm just messing
with you.'' Id. Following an exchange of pleasantries, Vickery left
Respondent's office. Id.
Vickery then saw Del Percio and asked him about the name of the
pharmacy that did the caplets (oxy 25). Id. at 15. Del Percio told
Vickery that he could not ``get those today'' and asked ``why'd he give
you those.'' Id. Vickery explained that he could not afford the Opana
and that he had been told ``that there were no pills around.'' Id. Del
Percio told Vickery that Stacy's Pharmacy did not have any caplets
available today and that Vickery was to call him the next morning and
that he (Del Percio) would then call the pharmacy to check on whether
the caplets would be available. Id. Vickery agreed to ``do that,'' and
Del Percio explained, ``that's how it works over there.'' Id. Vickery
then left Liberty. Id.
Consistent with the recording and the transcript, Respondent
provided Vickery with prescriptions for three drugs. GX 27, at 33. The
prescriptions were for 90 oxycodone 25mg, 30 Xanax 1mg, and 30 Soma
(carisoprodol). Id.
As the ALJ found, this visit ``can only be described as a
negotiation over the quantity of narcotics Respondent would prescribe
for Officer Vickery.'' R.D. at 44. Officer Vickery summarized this
office visit in these terms: ``It appeared to me, because it was almost
like it was starting out, he didn't want to give me anything. And then
the further we went along and the more I kept changing my story here
and there, he just decided, well, okay, we'll just go with it.'' Tr.
196.
The Visits of TFO Lawson
In his role as C.F., TFO Lawson made two office visits to Liberty,
the first on
[[Page 3638]]
August 2, 2011, the second on September 2, 2011. Tr. 78; GX 40 at 3. He
stated that his objective was to investigate ``the general activity of
the clinic'' and ``to obtain prescriptions for controlled substances
for no legitimate purpose.'' Tr. 81; GX 40, at 3. To do this, he ``was
to make as minimal complaint as possible, provide as few indications of
pain as [he] reasonably could, and to try to show that [he] was
involved in diversion.'' Tr. 81.
TFO Lawson testified that Del Percio conducted the initial intake
on August 2, 2011. On intake, Del Percio asked Lawson if he had an
appointment (Lawson saying ``yeah''), where his MRI was (with Lawson
saying that ``it should have been faxed to you'' and ``when I called I
thought you had it''), and if all he was then taking was Endocet. GX
23, at 1. Lawson replied that this was the drug he got at an urgent
care center he went to and that his pain clinic (which he later
identified as Atlanta Medical Group in Cartersville) had been ``shut
down.'' Id. at 1-3. Del Percio then asked Lawson again about his MRI
and if he had gotten it done at Greater Georgia Imaging, with Lawson
answering ``yeah.'' After searching through various documents for the
MRI, Del Percio told Lawson that he would ``have them fax over a copy''
and not to ``worry about it.'' Id. at 2. See generally RX G, Disc N-13.
Next, Del Percio asked Lawson for his last name and date of birth
and had him sign and date a form, after which he gave him paperwork to
complete and asked him to clip his ID to the forms when he was done. GX
23, at 2-3. Included in the forms was one which solicited general
health information; on the form, Lawson listed his ``chief complaint''
as his back, wrote that the pain started ``3 years ago,'' and that it
was the result of an ``accident in military.'' He also indicated that
his pain was a 5 without medication and a 2 with medication on a scale
of 0 to 10, with ``0 being no pain and 10 being the worst pain
possible.'' GX 22, at 5.
Del Percio asked Lawson where he had previously gone and how he had
heard about Liberty; Lawson replied that a buddy had told him and that
``everybody else was giving me the runaround because my place was shut
down.'' Id. at 3. Del Percio then gave Lawson an additional form to
complete, again asked him to clip his ID to it when he was done, and
told Lawson that he would need to provide a urine sample.
After completing the interview, Del Percio collected $300 in cash
from Officer Lawson and brought him into Respondent's office, where
after exchanging pleasantries, Respondent stated that Lawson's x-rays
\11\ showed that he had ``a little bulging disc'' and asked if he had
``any injuries at all to [his] back.'' GX 23, at 4. Lawson said that
``ten years ago,'' while he was ``in the military,'' he was in a Humvee
that ``went off the road.'' Id. Respondent asked Lawson where he was
now hurting; Lawson said, ``about mid-back.'' Id.
---------------------------------------------------------------------------
\11\ Lawson's undercover patient file included an MRI report
which is dated July 22, 2011 and which lists the referring physician
as ``LIBERTY.'' GX 22, at 3. The report notes ``no significant disc
disease at L1-L2, L2-L3, and L3-4. Id. At L4-L5, the report notes
that ``[t]here is broad based low grade disc bulging abutting the
ventral thecal sac without significant mass effect or nerve root
impingement,'' and at L5-S1, it notes that ``[t]here is posterior
low grade disc bulging without significant mass effect identified.''
Id. The report further notes that ``[t]here is no extruded disc
herniation identified at any level'' and that ``[t]here is no
central canal or neural foraminal canal stenosis see.'' Id.
---------------------------------------------------------------------------
Respondent then asked, ``[d]oes the pain go anywhere?'' Lawson said
that it depended on what he was doing and that he hadn't ``been at work
today.'' Id. at 4-5. He then explained that on a normal day, ``it's
usually all in the same place.'' Id. at 5. However, Lawson denied
having ``any numbness or tingling in [his] legs.'' Id. Respondent then
asked Lawson to rate his usual pain level on a scale of one to ten;
Lawson said ``five.'' Id.
Next, Respondent asked if anyone had recommended that Lawson
receive injections or surgery and if he had seen either an orthopedic
surgeon or neurosurgeon. Id. Lawson answered ``no'' to both questions.
Id. Respondent also asked if this had been ``looked at in the
military,'' Lawson said that ``was so long ago,'' and after he ``got
out,'' he ``went to the VA,'' but ``they patch you up and send you
on.'' Id. Respondent then asked Lawson if he would want to undergo
surgery; Lawson answered ``[n]ot necessarily.'' Id.
Respondent asked Lawson about his fluid consumption. Id. Lawson
said that he usually drank three cans of Mountain Dew a day, a glass of
tea at both lunch and dinner, four bottles of water, and alcohol on the
weekends. Id. at 6-7.
Next, Respondent asked Lawson what medicines he had taken that had
helped. Id. at 7. Lawson stated that when he ``was going to Atlanta
Medical Group,'' he was taking oxycodone, Soma, and ``Xanax to help
with the jitters.'' Id. Lawson further stated that he was taking the
thirty milligram oxycodone, ``at most . . . 3 a day''; that he thought
he was supposed to take one Soma a day but that the clinic had ``been
shut down for two months''; and that he took the Xanax two milligram
tablets. Id. Respondent then noted that Lawson been ``taking something
in the past month''; Lawson explained that he had gone ``to an urgent
care place'' after his ``clinic got shut down,'' where he got ``two
weeks'' of Percocet, which ``hardly'' worked for him. Id.
Respondent then asked if Lawson had ever been prescribed the
oxycodone 15's; Lawson replied that it had ``been so long when they did
this,'' but ``at one point'' they gave him ``a few of the 15's to try
to cut down on taking the three 30's a day.'' Id. Lawson then denied
that the 15's had been prescribed in the place of the 30's, and when
Respondent suggested that they had been given to him ``for
breakthrough,'' he agreed. Id. at 8-9.
Respondent then told Lawson that he was drinking a half gallon of
caffeine a day, plus alcoholic beverages on the weekend, and that this
was causing his body to lose water, and that ``the less water you have
in your system, the more pain you're going to have.'' Id. at 9.
Continuing, Respondent stated that a muscle that is not ``well hydrated
goes into spasms'' and causes pain. Id. He also told Lawson that his
caffeine consumption was ``going to mess up [his] kidneys'' and that he
was surprised that Lawson was ``even sleeping at night drinking that
much caffeine.'' Id.
Respondent then showed Lawson a model of the spine and explained
that his discs lost ``water throughout the day'' and because he was
drinking lots of caffeine, the discs were not filling back up with
water at night while he was sleeping. Id. Respondent explained his ``x-
ray'' showed he had a bulging disc, pointed to where the disc was on
his spine model, and explained that he actually had two bulging discs,
one ``between L4 and L5,'' that was ``actually coming near or pressing
on the spinal cord a little bit,'' and one at ``L5-S1, where it's just
back here bulging.'' Id. at 9-10. Respondent then reiterated his
earlier advice that Lawson needed to reduce his caffeine consumption to
one can of Mountain Dew per day and to increase his water consumption
to six bottles per day. Id.
Respondent then asked Lawson to sit on the exam table and performed
a physical examination. Id. The video shows that the exam consisted of
Respondent testing Lawson's left and right patellar reflexes with a
hammer; having Lawson lie on his back and raise each leg and asking
whether each movement hurt, with Lawson saying no \12\; having Lawson
turn over on his
[[Page 3639]]
stomach and asking him whether this movement ``bother[ed]'' him, with
Lawson saying ``um, a bit''; followed by Respondent palpating Lawson in
several areas and asking ``[r]ight in here,'' with Lawson answering
``[r]ight in there''; upon which Respondent concluded that Lawson had
muscle spasms which he asserted were caused by Lawson's caffeine
consumption. See generally RX G, Disc N-13; see also GX 23, at 10-
11.\13\
---------------------------------------------------------------------------
\12\ In the progress note, Respondent noted that each straight
leg lift was ``unremarkable.'' GX 22, at 1. He also wrote that he
found moderate tenderness in the paravertebral muscles and muscle
spasms in both Lawson's thoracic and lumbar regions. Id.
\13\ Regarding the physical examination, Respondent testified
that the deep tendon reflex he observed in performing the patellar
examination was normal and the leg lifts were unremarkable for both
legs, suggesting that there was no nerve impingement in the area of
Lawson's lumbar spine. Tr. 321. According to Respondent, the MRI
presented by Officer Lawson ``was abnormal,'' and there was
``moderate tenderness of [the] paravertebral muscles . . . with
increased muscle tone.'' Id.
---------------------------------------------------------------------------
Respondent then told Lawson that he needed to do back exercises
(although Liberty was out of back-stretching sheets) and asked if he
had ever taken anti-inflammatories such as Naproxen or Motrin. Id. at
11. Lawson replied that he had gotten Naproxen ``along with the other
medicines.'' Id. Respondent then asked Lawson if he had ever taken
Flexeril; Lawson replied that he believed he did. Id. Respondent told
Lawson that it was a muscle relaxer and asked how it worked for him;
Lawson replied that he ``really couldn't say.'' Id. at 11-12.
Respondent then asked Lawson if ``the Soma work[ed] better for you;
Lawson said ``yeah.'' Id. at 12.
Respondent then asked whether the Percocet had helped him; Lawson
replied that ``it didn't seem like it was doing anything . . . it just
didn't touch.'' Id. Respondent then said he was going to try Lawson on
``the oxycodone, the 15's . . . maybe four times a day'' and ``we'll
see how well that works with you''; Lawson said ``all right.'' Id.
Respondent then stated that he thought that ``a lot of the problems
we're seeing is just these tight muscles'' and ``you got some pain in
the lower back, where you showed the disc problem, but I think a lot of
it's just the muscle spasm.'' Id. Continuing, Respondent explained that
``then we're talking about stretching the muscles, take the muscle
relaxer, and then the anti-inflammatory, something for pain, then
stretching those muscles. But if you . . . don't decrease your
caffeine, they're going to stay tight. And they're going to continue to
bother your body.'' Id. Respondent reiterated his earlier advice on
fluid intake, provided Lawson with prescriptions for 120 oxycodone 15mg
and 30 Soma 350mg, (as well as Naproxen), told him he would see him in
a month, and the visit ended. Id.; GX 22, at 2.
On September 2, 2011, TFO Lawson returned to Liberty. GX 22, at 21;
GX 24. Prior to seeing Respondent, Lawson completed a form entitled
``Patient Comfort Assessment Guide,'' on which he identified his pain
as being in his ``lower back'' and circled that it was ``aching,''
``sharp'' and ``continuous.'' GX 22, at 23. He also rated his ``worst''
pain in the last month as a ``9,'' his ``least'' pain as a ``6,'' his
``average'' pain as a ``7,'' and his pain ``right now'' as an ``8.''
Id. He also noted that ``medication'' made his pain better, but then
indicated that oxycodone 15 provided ``No Relief.'' Id. at 23-24.
Lawson's visit with Respondent lasted under six minutes, with the
physical exam lasting approximately fifteen seconds. See generally RXG,
Disc N-34.
Upon meeting, Respondent and Lawson exchanged pleasantries, and
Respondent asked Lawson how the medicine was working for him. GX 24, at
1-2. Lawson replied: ``Well, the clinic I was going to before--I was
taking 30 milligram and the 15's aren't as affective [sic] as the 30's
were.'' Id. at 2. Respondent then asked Lawson to rate his pain on a
one to ten scale; Lawson replied: ``it has gotten worse than last time.
It was--it's about an eight or a nine.'' Id. Respondent said ``okay''
and asked: ``and with the 30's you were--where were you running?'' Id.
Lawson then stated that ``on the medicine,'' he was ``[u]nder five.''
Id.
Respondent replied: ``Okay. So we need you under five,'' and asked
if Lawson was ``taking the anti-inflammatories?'' Id. Lawson asked ``is
that what the Naproxen is,'' and after Respondent confirmed this,
Lawson said: ``Yeah. You gave me that.'' Id. Respondent then asked,
``[w]hat about those Mountain Dews?''; Lawson answered that it was
``harder to give up'' caffeine than smoking, but added that he had been
``drinking more water though.'' Id. After Lawson promised to do better,
Respondent asked how many Mountain Dews he was drinking a day; Lawson
answered: ``maybe three. Is that still too much?'' Id. at 3. Respondent
said it was ``too much'' and that if Lawson would ``give up the
Mountain Dews, [he] probably wouldn't have that much pain now'' and
that he needed him ``on like one Mountain Dew a day.'' Id.
Respondent then asked Lawson if he was ``taking the 30's three
times a day before?''; Lawson answered ``correct.'' Id. Respondent then
asked Lawson to lean forward in his chair, palpated his back, and noted
that ``you've got all these muscles spasms here'' and ``[w]ith that
caffeine they're not going anywhere.'' Id. at 3-4. Respondent and
Lawson engaged in further discussion of the latter's caffeine
consumption, followed by a discussion of Lawson's fortuitousness in
arriving at the clinic before it closed for the weekend. Id. at 4-5.
Respondent provided Lawson with prescriptions for 90 oxycodone
30mg, 30 Soma 350mg, and Naproxen. Id. at 5; GX 22, at 22. The visit
then ended. GX 24, at 5.\14\
---------------------------------------------------------------------------
\14\ At the hearing, Respondent contended that various portions
of the transcripts were inconsistent with the recordings. See Tr.
314-16. The ALJ carefully reviewed the recordings in light of
Respondent's testimony and found that the transcripts were
``substantially accurate reports of what the parties said during
these visits.'' R.D. at 8-9. The staff of this Office has also
watched the videos and agrees with the ALJ's conclusion that the
transcriptions are substantially accurate and notes that any errors
are not material.
---------------------------------------------------------------------------
Regarding the visits, TFO Lawson testified that at no time did
Respondent ask why he traveled from Thomaston to Norcross, a distance
of 84 miles (GX 40, at 3), in order to receive treatment. Tr. 91-92. He
also testified that Respondent never asked the names of his prior
treating physicians, and although he did require Lawson to produce a
urine sample, he never discussed the results of the sample, even though
Lawson testified that to his knowledge he had no drugs in his system at
the time this sample was taken. Id. at 92. TFO Lawson added that at the
start of the initial office visit at Liberty, he told Del Percio that
he was currently taking Endocet, a drug combining oxycodone and
acetaminophen. Id. at 93. While Lawson told Respondent he had also been
treated at a Veterans Administration hospital and at a clinic in
Cartersville, to the best of his knowledge Respondent never attempted
to confirm any of these statements. Id. at 94-96.
Respondent testified that when TFO Lawson reported his medical
history, the latter told him that he was using an existing prescription
for oxycodone 30 mg, which Respondent noted on the progress note. Tr.
323; GX 22, at 1. However, the recording and the transcript establish
that Lawson said that the pain clinic he had previously gone to had
been shut down two months earlier and that he had since gone to an
urgent care center from which he received only Percocet. GX 23, at 1,
8; RX G, Disc N-13.
Respondent further testified that he would normally take steps to
confirm a prior prescription, but acknowledged that he did not do so in
this case and offered no explanation for failing to do so. Tr. 325.
While Respondent also
[[Page 3640]]
testified that the clinic Lawson identified as his prior treating
source had closed, and then asserted that this was why he would not be
able to obtain records from it, he gave no explanation for why he could
not obtain the same information by contacting Lawson's pharmacy. Id. at
325-326. Nor did he explain why he did not contact the urgent care
clinic which Lawson claimed he had recently gone to. Id.
The Visit of TFO Manning
On or about October 24, 2011, a fourth TFO also went to Liberty in
an attempt to see Respondent. According to the video recording, the TFO
did not have an MRI report and instead provided Del Percio with a
letter from a doctor. See RX G, Disc N-51. On reviewing the letter, Del
Percio observed that ``if you read his comments there's nothing on
there. This is like his examination. Where is the MRI report? . . . if
you read his comments, there's nothing there. This is his review'' [and
it says there] is ``no evidence of lumbar disk herniation, no nothing,
MRI was unremarkable.'' Id. Del Percio then reiterated that he needed
an MRI report and not the films because the doctor's letter did not
show him anything and told the TFO to have the report faxed. Id.
A short while later, the TFO placed a phone call to Del Percio, in
which he stated that he was going to New York the next day and that he
hoped to get his prescription filled. Id. Del Percio explained that he
could not use the letter the TFO had provided and that ``the doctor
would laugh at me if I tried to hand that'' to him. Id. The TFO then
told the Del Percio if he could get in to see Respondent, he would
``get another one while'' he was in New York and that he would ``take
care of'' Del Percio. Id. Del Percio replied that ``[i]t's not about
that man, we cannot do that. We cannot risk anything like that . . .
the Dr. is not going to risk his license. He's just not going to [ ] He
can't see a patient without one.'' Id. After the TFO again promised
that he would ``take care'' of Del Percio, the latter stated that ``he
couldn't do it'' and ``that he had to have something to show because
otherwise any person could walk in off the street and say Oh hey, I got
pain.'' Id. The TFO then stated that there were a lot places that do
that, to which Del Percio replied that they were shut down. Id.
Regarding TFO Manning's attempt to see him, Respondent testified
that ``there's only one agent that really came into the office for no
legitimate medical reason'' for a prescription. Tr. 292-93. Continuing,
Respondent testified that ``[i]f you come in and you complain of pain,
you have a positive MRI, you have findings on your exam, it suggests
that your pain is real and your MRI is real. Whether you are a good
actor or a bad actor, that suggestion is still there.'' Id. at 293-94.
The Expert Testimony
Both the Government and Respondent elicited testimony from an
expert witness, the Government calling Thomas E. Hurd, M.D., and
Respondent calling Carol Anastasia Warfield, M.D. GX 37; RX F2. Dr.
Hurd holds a doctor of medicine degree from Northwestern University
Medical School, held a fellowship in critical care medicine at the
Department of Anesthesia, University of Florida, and is a diplomate of
the American Board of Anesthesiology, the American Board of Pain
Medicine, and the American Board of Interventional Pain Physicians. GX
37, at 1; Tr. 434. He further testified that in 2005, he did a
Fellowship in Interventional Pain Practice and is certified by the
World Institute of Pain. Tr. 434.
Dr. Hurd is licensed in four States, including Georgia, and has
been president of Pain Solutions Treatment Centers, a multi-clinic
interventional pain practice located in Georgia. GX 37, at 1-2. He has
testified as an expert in pain management and chronic regional pain
syndrome in other proceedings. Tr. 440. Dr. Hurd further testified that
he currently practices only interventional pain medicine and that fifty
to seventy percent of his practice involves treating chronic pain
patients. Id. at 449.
Dr. Warfield holds a Doctor of Medicine degree from Tufts
University Medical School, did a fellowship in anesthesia, and is a
diplomate of the American Board of Anesthesiology and a Fellow of the
American Board of Pain Medicine. RX F2, at 1. Between 1980 and 1986,
she was an Instructor in Anesthesia at Harvard Medical School, after
which she became a Professor of Anesthesia at Harvard Medical School.
Id. at 2. Between 1980 and 2000, she was the Director of the Pain
Management Center, at Beth Israel Hospital in Boston, Mass., and
between 2000 and 2007, she was the Chairman, Department of Anesthesia,
Critical Care and Pain Medicine. Id. She has also served on the
editorial boards of various professional journals. Id. at 6.
Dr. Hurd testified that he had reviewed the Georgia statutes
governing controlled substance prescriptions, the Georgia Board of
Medical Examiners' regulation defining unprofessional conduct,\15\ the
Board's guidelines for using controlled substances to treat pain, and
the Board's ``recommendations and guidelines'' for identifying pill
mills and drug-seeking patients. Tr. 435-36. Dr. Hurd testified that at
the initial visit, the patient's history must be obtained from both the
patient orally and by obtaining documentation from other sources who
treated the patient, after which a physical exam is performed based on
the history to arrive at a preliminary diagnosis and a treatment plan
is then begun. Id. at 441. While Dr. Hurd acknowledged the role of
opioids in giving pain relief, he further explained that it ``is
incumbent upon the physician to go ahead and engage in other more
conservative measures and make sure those have been taken out, such as
physical therapy, maybe injection therapy, [and] different kinds of
medication modalities.'' Id. at 442.
---------------------------------------------------------------------------
\15\ Dr. Hurd specifically identified that he had reviewed the
provisions defining ``unprofessional conduct'' to include ``failing
to maintain appropriate patient records whenever'' controlled
substances are prescribed, ``failing to use such means as history,
physical examination, laboratory, or radiographic studies, when
applicable, to diagnose a medical problem,'' and ``failing to use
medication and other modalities based on generally accepted and
approved indications, with proper precautions to avoid adverse
physical reactions, habituation, or addiction.'' Tr. 438-39
(discussing Ga. Comp. R. & Regs. R. 3603.02(5), (14), & (15)).
---------------------------------------------------------------------------
Asked to describe what information he needed to establish a
diagnosis of chronic pain, Dr. Hurd stated that he would first perform
a physical examination. Id. at 450. Second, he would want to see if the
patient had any records from other physicians because he did not ``want
to repeat failed treatments,'' and if the patient claimed he was on
opioids, he would ``want to know that another physician has treated
them already'' so that he would not be ``giving the patient a medicine
that they're not taking.'' Id. at 450-51. Later, Dr. Hurd explained
that ``if a patient is telling you that they took a bunch of
medications for legitimate reasons, you'd like to see [that
physician's] reasoning, because otherwise, you're basing your entire
treatment plan [on] the patient' statement, and . . . not everybody
always tells the truth.'' Id. at 468-69.
Dr. Hurd then added that ``almost every patient within the first
two visits is going to have an MRI.'' Id. at 451. Dr. Hurd explained,
however, that half of the patients whose MRIs show an abnormality do
not ``have any pain.'' Id. Dr. Hurd then testified that an MRI alone
``is not sufficient'' to form a diagnosis of chronic pain and the MRI's
findings must be correlated to the
[[Page 3641]]
patient's pain complaint ``by doing a physical exam . . . that's
usually a neurological physical exam,'' and that during the exam, the
patient's motor function, sensory function and reflexes are checked.
Tr. 452; see also id. at 484-86 (discussing use of sensory testing to
correlate MRI findings with patient's pain complaint and how different
nerve roots correspond to various areas of the body). Dr. Hurd also
discussed the importance of testing the strength of a patient's
muscles. Id. at 484.
Dr. Hurd testified that ``[t]here are several classes of pain
medication,'' which vary from lower-risk drugs which include anti-
inflammatories, anti-depressants, and ``nerve medications,'' to higher-
risk drugs including opioids and benzodiazepines. Id. at 453-54. He
also testified that ``[t]here are many'' non-drug therapies for chronic
pain, including physical therapy, aqua therapy, stretching or exercise
programs, trigger point injections, and spinal injections. Id. at 455.
When then asked by the Government whether, aside from an emergency or
acute situation, there was any situation in which he would prescribe
opioids at a patient's first visit without having obtained the
patient's records from his previous treating physician, Dr. Hurd
testified that if he
judge[d] their pain to be severe enough that I would think they
needed some help, if I could find on physical exam, their history
that they were clearly weak or impaired, I would consider using that
as a modality. However, I would also consider using other drugs as a
modality as well. Now--and the ones I just talked about: anti-
inflammatory medications, antidepressant medications, et cetera.
. . . I'll give you an example. Suppose somebody just had an acute
fall. They saw me two weeks later. They were not getting better.
Then I might consider a low dose of opioid therapy, in addition to
the other things I've already mentioned.
Id. at 456. Later, Dr. Hurd testified that where he had determined that
it was appropriate to treat a patient with opioids, he would not
normally start a patient on oxycodone 30mg. Id. at 558. Rather, he
would usually start a patient on a combination of oxycodone and Tylenol
(acetaminophen), such as Percocet 5/325 or 7.5/325. Id.
Dr. Hurd then explained that he would ``absolutely try[ ] to seek
prior treatment records of any other physician that's treated this
patient'' and that while ``I don't want to say that a physician doesn't
have latitude to ever use a narcotic . . . it would be a lower dose
narcotic, if you thought that . . . there was some reason that the
patient couldn't take or tolerate a different medication,'' such as an
anti-inflammatory because of ``kidney problems.'' Id. at 457.
As for how he would address the situation where a patient's prior
practice had closed and the patient's records were not available, Dr.
Hurd testified that he would determine where the patient filled their
prescriptions and obtain a pharmacy record. Id. at 458. Dr. Hurd noted,
however, that under Georgia law, ``[e]very legitimate practice is
required . . . to maintain records,'' and every physician who retires
from practice is required to notify their patients and must keep
patient records so that they can be retrieved. Id. at 458-59.
Next, Dr. Hurd testified as to the use of urine drug screens in
monitoring pain patients. Dr. Hurd explained that the tests serve two
purposes: (1) Determining if the patient has been taking the drugs that
were prescribed to him, and (2) determining if the patient is taking
illegal drugs. Id. at 459-60. He further testified that the use of
these tests is ``imperative'' at a patient's first visit if a patient
has already been on opioids or is asking for them, id. at 461; he also
explained that if a patient tests negative for a prescribed medication,
``then that means they didn't take the medicine'' and ``that usually
means [they] don't need it.'' Id. at 462.\16\
---------------------------------------------------------------------------
\16\ Dr. Hurd also testified regarding the Georgia's Board
January 2011 Newsletter (GX 39), which contained a two page
discussion of the characteristics of ``pill mills,'' or illegitimate
pain management practices, as well as various ``red flags''
associated with drug-seeking patients. Tr. 463-69. Of relevance
here, the Newsletter identified the following red-flags: ``[t]he
patient is from another state,'' ``[t]he patient requests a specific
drug,'' ``[t]he patient states that an alternative drug does not
work,'' ``[t]he patient states that their[sic] previous physician
closed their practice,'' ``[p]rior treatment records cannot be
obtained,'' ``[t]he patient presents to an appointment with an
MRI,'' ``[t]he patient(s) carpool,'' ``[t]he patient's pain level
remains the same,'' ``[t]he patient is non-compliant with the
physician's treatment plan.'' GX 39, at 7.
The Newsletter also made a variety of suggestions to
prescribers, including that they ``[r]equire patients to submit
treatment records from previous providers,'' and verify the
authenticity of MRIs and prior treatment records. Id.
---------------------------------------------------------------------------
Regarding the large number of out-of-state patients who obtained
drugs from Respondent, Dr. Hurd testified that this ``just seems
unusual and unwarranted.'' Id. at 513. While not denying that patients
might travel out of state to see a specialist, Dr. Hurd observed that:
[t]here is nothing about the ultimate prescription . . . of 30
milligrams of oxycodone several times a day, repeated over and over
again, in case after case that is anything unique, except perhaps in
the willingness of the physician to prescribe it. So . . . there's
no reason for somebody to pass 120 pain doctors on the road from
Tennessee to Georgia to select the one who will write that medicine,
except for a non-legitimate purpose.
Id.
Dr. Hurd also testified that in his chart review, he noted that
``over and over again,'' the patients were given an order from Liberty
for an MRI ``without a previous exam.'' Id. at 514. Dr. Hurd explained
that ``[t]here is no reason to order an MRI . . . in the absence of an
emergency, without examining a patient.'' Id. While Dr. Hurd
acknowledged that he ``get[s] patients all the time with MRIs . . .
they've been ordered by a referring physician.'' Id. at 514-15.
Dr. Warfield took issue with much of Dr. Hurd's testimony. She
testified that she had reviewed the reports of the investigation, the
videos of the undercover visits, Dr. Hurd's report, and a number of
patient files. Id. at 570. She disputed Dr. Hurd's testimony regarding
the use of urine drug screens, explaining that ``there are lots of pain
centers that don't use a lot of urine drug testing, because the people
who want to obviate the urine drug test know how to do it. . . . So
many folks feel that they're not particularly useful.'' Id. at 573. She
also testified that while ``Dr. Hurd was saying . . . that this is the
way he does it . . . I've been on many . . . national boards across the
country. This isn't the way everybody does it, and by no means does
everybody have to do it the way he does it.'' Id. at 573-74.
Dr. Warfield also took issue with Dr. Hurd's testimony regarding
the need to obtain a patient's medical records. Tr. 590-91. She
testified: ``[w]e don't do that in our practice. I think it's a rare
medical practice that does that.'' Id. at 591. Dr. Warfield then
testified that:
[t]ypically . . . when you go to a physician, you walk in the door
without any medical records. You see the physician. They ask you
questions. You tell them about your medical history, and they take
what you say as the truth. There has to be a certain amount of trust
between the patient and the physician, so if the patient says to me,
I had back surgery in 1995, and they removed my L5 disc, I believe
the patient. I don't say . . . I'm going to need the medical records
from that hospital where you say you had that surgery.
Id. at 591. She then asserted that ``[m]ost physicians do not ask for
old medical records.'' Id. at 591-92.
The ALJ then asked Dr. Warfield what verification process she
recommended her students use when a patient presents with no records,
but has an MRI showing some degenerative disc disease or other disease
impacting the spine, and tells the student that he has an existing
prescription for oxycodone. Id. at 592. Dr. Warfield answered: ``what
we teach our residents is if a patient
[[Page 3642]]
comes in, you do a history and you do a physical exam, and you make up
your own mind as to what the diagnosis is and what the treatment is for
that particular diagnosis.'' Id. at 593. While Dr. Warfield testified
that there are a variety of situations which would prompt further
investigation of a patient's story (i.e., slurred speech, being very
sleepy, changing their story, erratic behavior, shaking hands, track
marks on physical exam, id. at 595), she then explained:
But I think a patient who comes in and tells me they have pain,
and their pain is consistent with what I know from my experience is
a real medical condition--in other words, someone comes in and says,
you know, I was in an accident; I hurt my right lower back, and I
subsequently have pain going down my leg, and it goes into my toes,
and I know that's consistent with a real medical entity, and I look
at their MRI and they have findings that are consistent with that,
and their physical examination is consistent with that, I don't go
and get old medical records or further verify what they have.
Id. at 595-96.\17\ See also id. at 628 (Dr. Warfield's testimony:
``occasionally there are patients who it's very obvious that they don't
need the drug. Their physical exam is inconsistent with their MRI.'').
---------------------------------------------------------------------------
\17\ See also id. at 594 (asserting that if a patient with high
blood pressure came to see her and said she was on a particular
medication, she doesn't ``do verification . . . we make our own mind
up as to whether that's the appropriate drug . . . or should they be
on a different drug or a different treatment''). Id.
---------------------------------------------------------------------------
The ALJ then asked Dr. Warfield whether ``she would expect a
Georgia doctor to be mindful'' of the Guidelines published in the
Georgia's Board January 2011 newsletter ``when evaluating patients who
present [with] chronic pain?'' Id. at 597. She answered:
Yes. I mean, I would expect the physician to be mindful of it,
but I would expect a physician to individually decide which of those
is appropriate for their particular patient and which are not. I
don't see guidelines as being laws. They're--you know, certainly
everybody should have a history; certainly a physical examination
should be done. And, you, I think the way those things are done and
how they're documented in the record and how extensive a physical
examination is and such is really up to the individual physician to
decide for an individual patient.
Id. Dr. Warfield then asserted that while she gives lectures on opiate
prescribing ``around the country,'' the guidelines have not been well
publicized and most physicians ``don't even know they exist.'' Id. at
598. And on follow-up questioning by the ALJ, Dr. Warfield agreed that
physicians ``should make themselves familiar with those guidelines''
but then maintained that ``most reasonable physicians in the same
situation don't know about those state guidelines.'' Id. at 599-
600.\18\
---------------------------------------------------------------------------
\18\ Asked by the ALJ what she would instruct her students to do
if they were presented with an employment opportunity at a clinic
which was ``run on a cash-only basis; where patients drive long
distances, often from other states; and where all the patient MRIs
come from the same imaging facility,'' Dr. Warfield testified that
``taking each of those individually, I don't think any of these
things would make me tell my particular doctors to sway one or the
other.'' Tr. 610-11. She then explained that ``none of those things
are illegal per se,'' and that there are ``very outstanding,
legitimate pain centers that take only cash'' because they don't
want to deal with insurance companies. Id. at 611. As for patients
travelling a long distance, she asserted that there are states where
legitimate pain patients cannot get medication because ``doctors are
just unwilling to prescribe these drugs'' and ``don't care what the
patient has,'' ``[s]o there is some legitimacy to patients coming
from other states to states where they can get these drugs.'' Id. at
611-12. As for the MRIs coming from the same place, Dr. Warfield
testified that if ``you're in a small town, there may be one place
where patients get their MRIs.'' Id. at 613.
When then asked what she would advise her students if all three
of these issues were present, Dr. Warfield testified that ``if
you're in a practice like that . . . you better make darn sure that
you're treating your patients in an appropriate way, that you are .
. . seeing your patients, treating them individually, doing
histories, doing physical exams, doing, you know, an appropriate
medical practice, is what I might tell them.'' Tr. 614-15.
---------------------------------------------------------------------------
Dr. Warfield further asserted that there are ``no national
guidelines'' and ``no standards in terms of exactly how one needs to
treat a particular patient with pain when dealing with opiates,'' and
that she had ``seen time and again with these kind of cases'' that
experts testify as to the ``best possible practice, that in the perfect
world, this is the way we should practice when we deal with these
opiate patients.'' Id. at 621. While Dr. Warfield testified that she
``would agree with that,'' she maintained that people do not practice
that way. Id. She then explained:
And unfortunately, I see a lot of experts who come forward and
say that, you know, this is he [sic] best possible practice, and
this is the way I do it. Therefore, anybody who doesn't do this is
practicing below the standard of care. And I think that's what we're
really talking about here. We're talking about the fact that . . .
we all agree that there probably is a best possible practice out
there, but the fact that someone is not practicing the best possible
practice or not practicing the way a particular individual thinks is
the law or standard doesn't meant that they're not practicing
legitimate medicine.
Id. at 622.
On questioning by Respondent, Dr. Warfield then testified that she
had reviewed ``in detail'' the charts for patients she identified by
the initials of V.S., L.C., T.W., C.P., A.C., L.L., S.G., J.L., A.B.,
H.W., and J.B. and that she did not ``see . . . any evidence . . . that
this was not a legitimate medical practice or that these drugs were not
prescribed . . . in the usual course of practice or were not
appropriate.'' Id. at 623-24. While these initials apparently
correspond to the patients other than the undercover officers whose
medical records were reviewed by Dr. Hurd,\19\ Respondent also
introduced a letter which Dr. Warfield had written on his behalf,
apparently in connection with a criminal proceeding. RX F2. Therein,
Dr. Warfield noted that she had reviewed various items of evidence
related to the visits of the three undercover officers. Id. at 1. She
then wrote:
---------------------------------------------------------------------------
\19\ The initials of two of these individuals T.W. and J.B.
correspond with those of Terrance Williams and Jessica Bernard, both
of whom were eventually criminally charged and pled guilty to
violations of 21 U.S.C. 846 and 841(b)(1)(C). See GXs 10 & 12.
I do not see any evidence that the medications prescribed by
[Respondent] were not prescribed in the usual course of care in a
legitimate medical practice. Histories and physical examinations
were conducted, a diagnosis was made and a plan was formulated. The
patients underwent urine drug screens and follow-up visits with a
review of the drug effects. And while I agree that the examinations
were brief, I do not believe that this in any way indicated that the
practice was not legitimate. F
Id. at 3.
Dr. Warfield further suggested that Respondent had been deceived by
the undercover officers who, in her view, ``were clearly very good
actors'' who ``knew what to say and how to argue their case for needing
pain medicine.'' Id. at 4. She then suggested ``[t]here is no way any
physician can ever be correct all the time about who is fooling them
and who is not. They can only try to treat these patients in the best
way they can without denying other patients the pain-relieving drugs
they need and deserve.'' Id.
Finally, Dr. Warfield pointed to the two ``occasions when
[Respondent] was specifically offered cash for a prescriptions,''
noting that ``he quickly and adamantly refuse[d].'' Id. Dr. Warfield
maintained that ``[t]his clearly demonstrates that this is not a cash
for drugs business but rather a legitimate medical practice intent on
providing relief to patients with chronic pain.'' Id. Dr. Warfield then
concluded that it was her belief that Respondent's ``treatment of these
patients was part of a legitimate medical practice and that the drugs
that were prescribed were done so in the course of usual medical
practice.'' Id.
On questioning by the ALJ as to whether she would document a
patient's attempt to bribe her to obtain
[[Page 3643]]
additional drugs, Dr. Warfield offered a lengthy and evasive answer.
She stated:
I may or may not make a note of that. . . . I would certainly .
. . you know, if I'm the only doctor seeing that patient, I may or
may not write that down. What I would do is I would keep it in mind.
. . . [Y]ou're asking me what I would say to a doctor in training. I
would say, you know. This is . . . someone who has some suspicious
activity here, so you have to keep this in mind when you--you know,
when you subsequently see the patient.
Tr. 583-84. After then explaining that the appropriate thing is ``to
not take the bribe and know that this patient . . . possibly has been
involved in some suspicious activity,'' Dr. Warfield contended that
just because the patient ``might be involved in some suspicious act or
asking you to do something that isn't legal doesn't mean that the
person does not have pain.'' Id. at 584. Continuing with her answer,
Dr. Warfield testified:
I mean, you can believe that patient, that they still have pain
and that they were honestly trying to get medication for a friend of
theirs. You could discharge that patient. . . . You could send that
patient off for a consultation with someone, or you could continue
to treat the patient. I think all of those, depending on the
situation, are reasonable at one time or another.
I don't think there are any guidelines or anything that says
that if a patient comes in and offers you money to get a
prescription for their sister and you refuse to do that, that you
should automatically discharge that patient.
Id. at 585. When asked a further time by the ALJ what a physician
should note in the patient's record regarding an ``offer to bribe,''
Dr. Warfield asserted:
Again, I don't think there are any guidelines that say you
should write that . . . in the record. I mean, would I argue if
somebody wrote it in the record? No. Would I think that if somebody
didn't write it in the record, they didn't have a legitimate medical
practice? No. . . .
We don't write down everything that the patient tells us and
says to us every time we see them in an office, and the fact that
somebody doesn't write down something that the patient says . . . I
don't think indicates that it's below the standard of care or not a
legitimate medical practice. It's just in a busy practice, one can
never, you know, write down everything the patient tells you. I
think that if that's a patient you're going to be seeing again and
again, that you keep that in mind when you're seeing the patient.
Id. at 586-87. However, unexplained by Dr. Warfield is how a doctor in
a busy practice, such as Respondent's which had nearly 900 patients,
would be able to remember which of his patients had attempted to buy
extra drugs if he only kept a mental note of the incidents.
Dr. Hurd came to the exact opposite conclusion as to the lawfulness
of the controlled substances prescriptions Respondent issued to both
the undercover officers and multiple other patients whose charts he
reviewed, including those persons who pled guilty to conspiring to
unlawfully distribute controlled substances. In both his testimony and
report, Dr. Hurd identified multiple deficiencies in the manner in
which Respondent made prescribing decisions.
For example, in his report, Dr. Hurd observed that Respondent
performed ``inappropriate or minimal exams'' and that ``[i]n case after
case, patients presented with complaints suggestive of spine disease
with low back pain and leg pain, which would suggest . . . disc disease
and potential neurologic comprise.'' GX 35, at 4. He also noted that
Respondent ``used borderline [MRI] results in many cases to support the
need for narcotic medication'' and that ``[i]n other cases,
signific[an]t findings were noted but no appropriate physical exam was
performed to see if this was a danger or risk to the patient.'' Id. Dr.
Hurd then explained that:
A diligent and responsible approach to patients like this is to do a
direct and appropriate neurologic examination, in this case, to the
low back and lower extremities. An appropriate focused exam would
include testing of muscle strength for each nerve root in the lumbar
spine, testing reflexes at the patella and Achilles tendons[,] as
well as conducting a sensory exam which would at minimum consist of
lightly touching or scratching the patient's skin either with or
without clothing to ascertain if there were sensory abnormalities
such as decreased sensation, numbness, increased sensations or
tingling when the skin is touched. It is not medically necessary to
do a complete comprehensive exam at every visit depending on the
period between visits but it certainly should be done at least once
during a patient's tenure with the physician.
Id. Continuing, Dr. Hurd observed that:
In virtually every case, including the ones with video surveillance,
[Respondent] only documented an attempt at testing reflexes at the
patella and a gross spontaneous motor exam when he asked the patient
to lift their legs. This is not specific to each nerve root in the
lumbar spine as would be expected in a comprehensive exam. No
patient underwent a sensory exam that was either documented in the
chart or demonstrated in video recordings that I reviewed.
Id.
Dr. Hurd then specifically addressed Respondent's treatment of each
of the undercover officers. With respect to Officer Lawson, Dr. Hurd
observed that Lawson's MRI report ``demonstrated minor changes at L4-5
and L5-S1.'' Id. at 7. He explained that while Respondent told Lawson
that ``the discs were pressing on his spinal cord[,] [t]hey were not .
. . as the spinal cord ends several levels above L4-5 in the spine.''
Id. Dr. Hurd then noted that while Lawson told Respondent that he had
been in a Humvee accident, he asked no further questions about the
accident. Id. Moreover, while Respondent asked Lawson if he had
numbness or tingling in his legs, Lawson denied having either symptom.
Id.
Dr. Hurd characterized Respondent's physical exam on Lawson as
``cursory'' as it was limited to three tests: (1) Testing Lawson's
patellar reflexes with a hammer, (2) having Lawson lie on his back on
the exam table and lift each leg without Respondent resisting the
movements to determine Lawson's muscle strength, and (3) having Lawson
lie in the prone position and palpating his back muscles. Id.; see also
Tr. 491-92. Dr. Hurd then identified four important tests that were not
performed, including: (1) Testing Lawson's leg strength against
resistance to ``either rule out or . . . in a more serious problem'';
(2) performing sensory testing of the skin dermatomes of Lawson's legs
to determine whether any abnormal MRI finding was either ``minor'' or
``something that was clinically significant''; (3) testing Lawson's
Achilles reflexes; and 4) testing the range of motion of Lawson's
spine. GX 35, at 7.
Dr. Hurd also explained that ``[t]he performance of a routine
neurological exam'' is warranted ``on almost every patient's initial
visit'' even if the patient did not present with ``a strictly
neurologic complaint.'' Id. Dr. Hurd also explained that Respondent had
at one point been board certified in internal medicine and would have
known how to perform a neurologic exam. Id.
Regarding the visit, Dr. Hurd further observed that Respondent did
not discuss with Lawson his ``activities of daily living,'' or ``any
restrictions to be placed upon him during work or leisure.'' Id. at 7-
8. Dr. Hurd also faulted Respondent for failing to discuss the risks
and benefits of using controlled substances. Id. at 8. While Dr. Hurd
found that Respondent did document in the medical record that Lawson
had told him that neither Lortab nor Percocet had helped him, Dr. Hurd
observed that Respondent ``offered no other rationale for the narcotic
prescription'' which included 120 oxycodone 15mg for the month. Id.
With respect to Lawson's second visit, Dr. Hurd noted that while
Lawson said he had better pain relief on the ``oxy 30s,'' Respondent
failed to perform a physical exam. Id. He also noted that
[[Page 3644]]
Respondent increased the prescription to 90 oxycodone 30mg. Id.
Dr. Hurd noted that Lawson had been referred for an MRI before he
was seen by Respondent. Id. Dr. Hurd stated that it was ``unclear'' why
this ``would occur'' as apparently there was no medical indication for
ordering an MRI (Respondent having yet to see Lawson) and there was
``no emergency.'' Id.
Applying the Georgia Board's Guidelines on using controlled
substances to treat pain, Dr. Hurd opined that Respondent did not
comply with step one because he did not perform an appropriate history
and physical. GX 35, at 8. He also noted that Respondent failed to
comply with other provisions of the Guidelines by failing to refer
Lawson to a specialist; failing to document his rationale for
prescribing opiates; failing to review Lawson's prescription record and
obtain his medical records; and failing to discuss the risks and
benefits of narcotics. Id.; see also Tr. 494 (testimony of Dr. Hurd
that ``the first thing you need to do is . . . see if you can get any
notes from the practice. Failing that, certainly you'd want to get some
pharmacy records that showed what the patient was given.'').
In his testimony, Dr. Hurd also explained that it was a ``red
flag'' that Lawson had told Respondent that his previous physician's
practice had been shut down. Tr. 494. Dr. Hurd further noted that
Respondent did not take appropriate steps to verify Lawson's claims.
Id.
Dr. Hurd thus concluded that the oxycodone prescriptions Respondent
issued TFO Lawson were not for a legitimate medical purpose. Id. at
492.
Regarding the visits of TFO Vickery, Dr. Hurd explained that his
MRI report stated that he had ``a ruptured disc that shoots out to the
side of the spinal canal and pinches a nerve as it goes from the spine
to the leg'' and that ``[t]his would be expected to cause pain in the
left thigh and potentially some weakness'' either extending or raising
the leg. GX 35, at 9. Dr. Hurd observed that ``[t]his would normally be
tested for by having the patient either sit or lay down and have them
extend (straighten) their leg while the examiner has [his] hand on the
patient's ankle to see if [the patient] ha[s] enough strength to
straighten their leg against some resistance.'' Id. Dr. Hurd also
explained that ``[a]nother test that would be performed would be a
sensory exam which would involve touching, scratching or using a sharp
pin to poke the skin to see if there was any numbness or increased
sensitivity.'' Id. According to Dr. Hurd, a physician would use these
tests to determine whether a herniated disc has resulted in significant
nerve damage. Id.
Dr. Hurd observed that Respondent's physical of TFO Vickery was
limited to checking his patellar reflexes, having him lay on his back
and raise his legs, followed by having Vickery lay on his stomach and
palpating his back. Id. While Dr. Hurd noted that it ``was
appropriate'' to test Vickery's patellar reflexes, he did not do an
appropriate exam to test Vickery's leg strength. Id. Dr. Hurd also
explained that ``[t]here was no examination of the patient's peripheral
nerves or his muscular strength to determine if the MRI finding might
be valid.'' Id. Dr. Hurd then opined that Respondent ``prescribed
without . . . a legitimate medical indication'' both 90 oxycodone 30mg
and 30 Xanax 1mg. Id.; see also Tr. 539-40 (Dr. Hurd's testimony that
the tests Respondent performed during the physical exam ``are gross
tests that don't discriminate between nerve levels''); id. at 549
(Explaining that ``usually a straight leg raise'' is performed by the
doctor picking up the patient's leg to see if the ``nerve back there is
irritated, so it sends the pain down their leg. Having [the patient]
pick it up by [himself] does not give you that same thing, because they
can actively guard when they pick it up.'').
With respect to Vickery's second visit, Dr. Hurd noted that ``[n]o
significant exam was performed [and] yet [Respondent] prescribed'' 90
pills of Opana ER 40mg. GX 35, at 9. Dr. Hurd then observed that Opana
ER is ``to be taken every 12 hours and is not known to be given
legitimately [at] 90 per month'' as a prescription for sixty tablets
``would suffice for its correct dosing.'' Id. As found previously, the
Opana prescriptions Respondent wrote called for the drug to be taken
TID, or three times a day, and not twice per day. Dr. Hurd also
observed that while Respondent again prescribed Xanax to Vickery, ``no
discussion of the [TFO's] anxiety had taken place.'' Id.
In his testimony, Dr. Hurd further explained that ``[i]t is
important and incumbent upon a physician to document that there is some
evidence of anxiety, and [that] you've reached a medical diagnosis''
that ``justif[ies] the treatment.'' Tr. 495. Dr. Hurd then opined that
the Xanax prescription was not issued for a legitimate medical
purpose.\20\ Id. And when asked if the opioid prescriptions that
Respondent wrote at this visit were issued for a legitimate medical
purpose, Dr. Hurd opined that ``[t]hey were not.'' Id. at 495-96.
---------------------------------------------------------------------------
\20\ On cross-examination, Respondent asked Dr. Hurd whether
Vickery's ``yes'' answers to questions on an intake form regarding
whether his pain made him ``irritable'' and ``angry'' suggested the
presence of ``some anxiety.'' Tr. 534. Dr. Hurd answered that it
``[s]uggests there's anger and irritability present, not necessarily
anxiety.'' Id. at 535. Respondent then asked Dr. Hurd whether
Vickery's ``yes'' answer to ``[d]oes this pain interfere with
sleep?'' suggested ``anxiety or a need for Xanax.'' Id. Dr. Hurd
replied: ``not specifically. If your pain interferes with sleep, it
may just indicate the need to relieve the pain, as opposed to taking
away anxiety.'' Id. Of further note, on one of the intake forms, TFO
Vickery provide a ``No'' answer to the question: ``does the pain
give you feelings of anxiety?'' GX 27, at 24.
---------------------------------------------------------------------------
The Government also asked Dr. Hurd about TFO's Vickery offer during
this visit of additional cash for extra drugs. Tr. 497. While Dr. Hurd
explained that ``it's good that [Respondent] did not accept money,''
TFO Vickery was ``absolutely telling'' Respondent that he was ``going
to traffic in drugs.'' Id. at 498. Dr. Hurd then explained that a
patient such as Vickery ``should not be in any legitimate
practitioner's office.'' Id.
As for Vickery's third visit, in his report, Dr. Hurd observed that
Respondent had documented in the progress note that the TFO was
``[h]aving more problems with anxiety,'' that he ``continued to
[complain of] severe back pain,'' and that he was ``requesting
additional pain meds.'' Id. at 9. Dr. Hurd again found that ``no
significant physical exam was done,'' noting that there was ``[n]o
motor testing, no sensory testing, and no testing of reflexes.'' Id.
Dr. Hurd then noted that Respondent again prescribed Vickery 90 tablets
of Opana ER 40mg, ``which was outside the regular prescribing
parameters of this drug,'' and that he had also given Vickery 40
tablets of Percocet 10, as well as increased the Xanax prescription
from 30 to 45 tablets. Id.
Regarding this visit, Dr. Hurd testified that TFO Vickery's attempt
to purchase Xanax for a friend should have resulted in Respondent
terminating the doctor-patient relationship. Tr. 499-500. He further
explained ``that this is different than a patient . . . whom you
suspect has addiction'' and should be referred to ``addiction
treatment'' and not given ``more medicine.'' Id. at 500. Instead, it
``represented drug trafficking'' on Vickery's part. Id. Dr. Hurd then
added that given Vickery's attempt ``to bribe'' him, it was not
appropriate for Respondent ``to increase the medicine that the patient
just asked for,'' i.e., the Xanax. Id. at 501. Moreover, according to
Dr. Hurd, this incident should have been documented in the patient
record. Id. at 560. Yet it wasn't. See GX 27, at 26.
[[Page 3645]]
With respect to Vickery's fourth and final visit, Dr. Hurd noted
that while Respondent changed his narcotic prescription from Opana 40mg
to oxycodone 25mg and decreased the Xanax from 45 to 30 tablets, ``he
added [30] Soma, a potent muscle relaxant, to be taken at bed time.''
Id. at 10. Thus, Dr. Hurd found that Respondent ``bumped up his
sedative effect by giv[ing] him'' the Soma. Id.
In his testimony, Dr. Hurd further noted the discussion between
Vickery and Respondent during which Vickery changed his story regarding
his pain level and Respondent observed that he did not think that
Vickery was ``that bad off'' and that his urine drug screen ``showed
nothing in [his] system.'' Tr. 503. After explaining that Opana ER is
an extended release medicine, which is supposed to last twelve hours
between doses and that there is no reference in the literature to
prescribing it three times a day, Id. at 503-4, Dr. Hurd also observed
that Vickery was prescribed ``a ton of medicine'' and that he could not
have run out of medicine ``without going through withdrawal,'' and yet
there was ``no evidence this patient was in withdrawal.'' Id. at 504.
Dr. Hurd thus concluded that ``similar to the previous patient,''
Respondent's ``care fell short according to the guidelines'' in that
``he did not perform an appropriate history and physical'' and ``did
not do any physical exam of significance.'' GX 35, at 10. Dr. Hurd
further faulted Respondent because ``he did not refer [TFO Vickery] to
an outside specialist'' and ``did not obtain any old records.'' Id.
The Government also entered into evidence Dr. Hurd's findings based
on his review of the patient charts of J.L., A.B., J.B., K.C., S.P.,
L.C., S.G., V.S., L.L., H.W., and T.W. See GX 35, at 12-13; GX 36a.
While these findings were not the principal focus of the Government's
case, Dr. Hurd's findings with respect to these patients provides, in
some respects, a more complete picture of Respondent's prescribing
practices than the undercover visits because several of the patients
made an extensive number of visits to Liberty.
For example, A.B., who was from Greeneville, Tennessee, made twelve
visits to Liberty. GX 36a. At her first visit, A.B. said that she had
been in a ``severe'' motor vehicle accident two years earlier and that
her current prescriptions were 210 oxycodone 30mg, 120 oxycodone 15 mg,
and 30 Xanax .25mg. Id. at 1. A.B. obtained an MRI at Greater Georgia
Imaging the same day as her initial visit, which Respondent noted as
being abnormal in his physical exam note. Id. Respondent diagnosed A.B.
has having thoracic spasm, lumbar radiculopathy, and four bulging
discs, with three of them (L5-S1, L3-4, L2-3) ``involving'' their
respective nerve root. Respondent prescribed 180 oxycodone 30mg to A.B.
at this visit. Id.
However, according to Dr. Hurd, A.B.'s MRI report presented
``minimal findings'' and Respondent's physical exam did not note a
``neurologic abnormality.'' Id. at 2. Moreover, Respondent repeatedly
provided A.B. with prescriptions for 180 oxycodone 30mg, although he
did decrease the prescription twice (to 165 oxy 30mg and then to 180
oxy 20mg \21\) before he again prescribed 180 oxycodone 30mg at her
eleventh monthly visit, when she reported her pain as a ``seven.'' Id.
---------------------------------------------------------------------------
\21\ According to Dr. Hurd, A.B. had reported that her pain with
medication was a ``three'' at the visit during which Respondent
reduced her medication to 165 tablets of oxycodone 30mg, and she
reported that her pain with medication was a ``two'' at the visit
where he reduced her medication to 180 oxycodone 20mg. GX 36a, at 2.
---------------------------------------------------------------------------
However, Dr. Hurd observed that at this visit, ``[t]here was no
change in her exam findings,'' and ``to this date,'' Respondent had not
done ``a neurologic exam.'' Id. He further noted that ``[t]his is the
11th monthly visit in a row that this patient has been treated with
large doses of oxycodone . . . with minimal findings on MRI'' and that
A.B. had not been referred ``for spinal injections, spinal surgery
consultation, physical therapy, acupuncture, psychological evaluations,
or any second opinion.'' Id.
Regarding Respondent's physical exams of A.B., Dr. Hurd identified
seven items which were not documented as having been performed. More
specifically, Dr. Hurd observed that there was no documentation of: (1)
``an analysis of the patient's gait''; (2) an examination of the range
of motion of A.B.'s lumbar spine; (3) a sensory examination of A.B.'s
arms and legs; (4) strength testing of A.B.'s arms and legs; (5) which
``deep tendon reflexes were tested''; (6) a pupil examination to
determine if narcosis existed; and 7) a mental status examination. Id.
at 3. Dr. Hurd explained that ``all of these exam techniques are
designed to determine the clinical significance of the MRI findings''
and ``is a standard of care in determining the cause of pain and
dysfunction in the back and lower extremities.'' Id.
Also, notwithstanding that A.B. made twelve visits to Respondent
between April 12, 2011 and March 14, 2012, Dr. Hurd found that neither
``old [medical] records'' nor ``pharmacy records were referenced in the
chart.'' Id. at 2. Based on Respondent's failure to obtain A.B.'s
records, his failure to perform adequate physical examinations, his
failure to use any treatments other than medication, Dr. Hurd concluded
that Respondent lacked a legitimate medical purpose when he prescribed
to A.B. Id. at 3-4.
J.B., who was from Rogersville, Tennessee, made twelve visits to
Liberty which began on March 3, 2011. GX 36b, at 1. She complained of
severe lower back pain caused by motorcycle and motor vehicle
accidents. Id. She too obtained an MRI at Greater Georgia Imaging on
the morning of her initial visit. Id. She received 120 oxycodone 30mg
at each visit. Id. at 2.
Here again, Dr. Hurd observed that Respondent did not review J.B.'s
prior medical or pharmacy records (and there are no such records in her
patient file, see GX 11), notwithstanding that at her initial visit,
she wrote on one of the intake forms that her current medication
included ``7-8 Roxycodone 30mg, 5-6 Roxycodone 15mg (breakthrough
pain),'' and ``Xanax to sleep 2mg (2 day).'' GX 11, at 70; GX 36B, at
2. Moreover, Dr. Hurd found that there was no documentation that
Respondent had performed the seven tests he identified as required by
the standard of care in his review of A.B. GX 36B, at 2. He then
observed that ``[t]he MRI and physical findings do not . . . warrant
treatment with that level of narcotic'' and that the lack of exam
findings with respect to these seven tests ``suggests that there is no
correlation between the patient's MRI and her physical findings.'' Id.
He also noted that Respondent did not offer conservative therapy to
J.B. including physical therapy, trigger point injections, epidural
injections or a surgical referral. Id. Dr. Hurd thus concluded that
Respondent's prescribing to J.B. did not meet ``the standard of care
for treating with opioids'' and that he lacked a legitimate medical
purpose. Id.
L.L., who was from Kingsport, Tennessee, made sixteen visits
between January 14, 2011 and April 11, 2012. GX 36h. At his initial
visit, L.L., who worked as a horsebreaker, complained that he had been
having severe back pain for three years following a work related
incident but denied ``any numbness or tingling.'' Id. at 1. He also
claimed that he had taken oxycodone 30mg, Dilaudid and Xanax 1mg. Id.
L.L. presented an MRI, which had been done a year and a half earlier in
Florida; the MRI found that he had a moderate size disc protrusion at
L5-S1 with bulging of the annulus and bilateral nerve root effacement
and a small disc protrusion at L4-5 with no effacement of the nerve
root. Id. at 2. The MRI Report explicitly ``[r]ecommended correlation
with the
[[Page 3646]]
clinical symptoms and neurologic exam to assess the significance of the
above findings.'' Id.
Here again, Dr. Hurd found that Respondent did not document, with
respect to any of the physical exams, the performance of any of the
seven tests he previously identified (in discussing A.B.) as being part
of the ``standard of care in determining the causation of pain and
dysfunction in the back and lower extremities.'' Id. Yet Respondent
prescribed 120 oxycodone 30mg (as well as 30 Xanax 1mg) which, at the
next visit, he increased to 150 oxycodone 30mg (and 30 more Xanax 1mg),
notwithstanding that the note for the second visit contained ``no
further delineation of the physical exam to corroborate the MRI
findings and there [was] no mention of'' an anxiety diagnosis (which
was not listed until two months later). Id.
According to Dr. Hurd, L.L. requested more medication at his May
2011 visit, and Respondent increased his oxycodone prescription to 160
tablets, even though he again noted that ``[t]here was no more
delineation of the physical exam to demonstrate a diagnosis consistent
with the MRI.'' Id. at 3.
Dr. Hurd then found that at L.L.'s June 2011 visit, Respondent
added a diagnosis of lumbar radiculopathy. Id. Dr. Hurd found, however,
that Respondent had at no point ``done a neuromuscular exam to
delineate the reason for'' this diagnosis. Id. He also noted that while
at this visit, Respondent had decreased the amount of oxycodone 30mg by
twenty pills, he then added a prescription for 60 Percocet 10/325, thus
providing the same amount of oxycodone to L.L. Id. Dr. Hurd opined that
there was ``no medical rationale for this prescribing.'' Id.
Dr. Hurd further found that Respondent maintained the same
medication regimen through April 2012, even though L.L. continued to
complain of pain at a level of 5 to 6 out of 10. Id. at 3. Respondent,
however, never offered to refer L.L. for a spinal injection or a
surgical consultation. Id. Nor did he ever offer to refer L.L. for
``more conservative'' treatment such as acupuncture or physical
therapy. Id. at 3-4. Dr. Hurd also found that there was no evidence
that Respondent had reviewed L.L.'s previous medical records. Based on
his findings, Dr. Hurd found that Respondent's prescribing to L.L. did
not meet ``the standard of care for treating with opioids'' and that he
lacked a legitimate medical purpose. Id.
H.W., who was from Midway, Tennessee, made twenty-three visits to
Liberty beginning on April 28, 2011. GX 36I. She reported a history
which included three motor vehicle accidents, a fall, and a fractured
pelvis. Id. at 1. She complained of ``severe lower back pain radiating
down [her] right leg,'' as well as ``neck pain radiating down [her]
right arm,'' and reported that she was currently on 180 oxycodone 30mg,
90 oxycodone 15mg, and 60 Xanax 2mg. Id., see also GX 13, at 13. She
also provided an MRI, which was done by a facility in Florida fifteen
months earlier and which listed the patient's date of birth as being
``4/12/78.'' GX 36I, at 2. However, H.W.'s driver's license lists her
date of birth as ``11/26/88.'' Id.
Respondent performed a physical exam and documented that he found
severe tenderness over H.W.'s cervical trapezius muscle, her lumbar
paravertebral muscles, and her sacrum, and tenderness over her
sciatica. Id. His physical exam findings also included ``DTR + 2,'' and
an abnormal straight leg lift and cross straight leg lift. Id.
Respondent diagnosed H.W. as having herniated discs at L5-S1and L4-5
and a bulging of the annulus fibrosis at L3-4 (each of which were
listed as MRI findings), as well as having lumbar radiculopathy and
cervical radiculitis. Id. at 1-2. He then prescribed 120 oxycodone 30mg
and Xanax 1mg at this visit. Id. at 1.
Dr. Hurd again found that Respondent did not document having
performed any of the seven tests (discussed above) at any of H.W.'s
twenty-three visits. Id. at 2. While at her second visit, Respondent
noted that he would consider performing a trigger point injection, at
H.W.'s third visit, he documented that she ``was afraid'' to have one
done but would reconsider at her next visit. Id. According to Dr. Hurd,
a trigger point injection was never done on H.W. Id.
At this visit, Respondent prescribed 130 oxycodone 30mg and 45
Xanax 1mg to H.W. Id. Dr. Hurd found that Respondent ``continued to
prescribe those same dosages and quantities at every visit that [he]
reviewed.'' Id. He also observed that notwithstanding Respondent's
``diagnoses of lumbar radiculopathy[,] cervical radiculitis[,] and [a]
labral tear left hip[,] no treatment other than medications was
noted.'' Id.
Dr. Hurd found that there were no prior medical records or pharmacy
records for H.W. Id. He explained that ``[i]n the absence of
independent evidence . . . that she was prescribed and consumed
[o]xycodone 30mg four to six times a day, [Respondent] [was] risking
either an acute narcotic overdose, or, if not consumed by the patient,
possible diversion.'' Id. at 3. He then observed that a positive urine
drug screen ``may indicate the patient has consumed some narcotic, but
it does not indicate the dosage or total quantity'' the patient has
been prescribed or consumed. Id.
Noting that Respondent did not review H.W.'s prior medical records,
and based on Respondent's failure to perform the seven tests listed
above, Dr. Hurd opined ``that there [was] no correlation between the
patient's MRI and his physical findings.'' Id. at 2-3. He also opined
that ``[t]he MRI and physical findings [did] not . . . warrant
treatment with that level of narcotic.'' Id. at 2. He thus concluded
that ``the standard of care for treating [with] opioids has not been
met.'' Id. He further concluded that the prescriptions lacked a
legitimate medical purpose. Id. at 3.
V.S., a 48-year old female from Coral Springs, Florida, saw
Respondent eleven times between January 25, 2011 and March 5, 2012. GX
36G, at 1-2. She reported having been ``in several bad car accidents''
and having ``recently . . . broken [her] right arm'' which apparently
was in a cast.'' Id. at 1. She also complained of ``severe low back
pain'' which made it ``very difficult for her to perform any activities
that [cause] pain'' and reported that she had been taking oxycodone
30mg six times a day, Dilaudid 8mg for breakthrough pain, and Xanax
2mg, twice a day, ``for two years.'' Id.
V.S. presented an MRI, which had been done more than a year
earlier, at a facility located in Boca Raton, Florida. Id. While the
MRI report listed findings of three bulging discs, one of which (L5-S1)
was causing narrowing of the right neuroforamen and another (L4-5)
which causing encroachment of both neuroforamen, Dr. Hurd explained
that this was a ``mild to moderately abnormal MRI.'' Id. at 1-2.
Notably, in the physical exam section of the progress note, Dr.
Hurd found that Respondent documented only that he had palpated her
paravertebral muscles in the area of V.S.'s lumbar spine (finding
``severe tenderness'') and that he had V.S. perform a straight leg lift
(which was ``abnormal''). Id. at 1. Here again, Respondent did not
perform any of the seven tests Dr. Hurd previously identified as
necessary ``to determine the clinical significance of the MRI
findings,'' which Dr. Hurd explained was ``a standard of care in
determining the causation of pain and dysfunction in the back and lower
extremities.'' Id. at 2-3.
Respondent nonetheless diagnosed V.S. as having chronic back pain
(along with the three bulging discs). Id. at 1. Respondent prescribed
to V.S. 180
[[Page 3647]]
tablets of oxycodone 30mg, 80 Dilaudid 8mg (one tablet every eight
hours), and 60 Xanax 2mg (one tablet twice a day). Id.
At V.S.'s second visit, she again complained of ``severe'' back
pain ``when not on medication'' and ``severe pain'' in her right arm
which had screws in it. Id. at 2. She further reported that her pain
was worse when she was not taking Xanax ``because of her anxiety.'' Id.
Yet the only test Respondent documented as having performed was
palpating V.S.'s paravertebral muscles in her lumbar region. Id.
Respondent diagnosed V.S. as having a ``disc bulge L4-5 with
neuroforaminal encroachment,'' and added a diagnosis of ``lumbar
radiculopathy.'' Id. He issued her prescriptions for 180 oxycodone
30mg, 50 Dilaudid 8mg, 60 Xanax 2mg, and 30 Flexeril, a non-controlled
muscle relaxant. Id.
According to Dr. Hurd, Respondent issued V.S. the exact same three
controlled substance prescriptions through her last visit of March 5,
2012. Id. Dr. Hurd found that there were ``no new exam findings to
corroborate the findings on MRI,'' further noting that Respondent never
documented the performance of the seven tests he previously identified
as the standard of care. Id. at 2-3. He also observed that there were
no old medical records, nor pharmacy records ``referenced in the
chart.'' Id. at 2.
Based on the chart review, Dr. Hurd further observed that
Respondent never considered offering trigger point injections or
referral to specialists such as ``an interventional spine physician who
could perform an epidural steroid injection or . . . a spine surgeon to
assess'' whether surgery would reduce V.S.'s pain. Id. at 3. Dr. Hurd
also noted that Respondent did not offer to refer V.S. for physical
therapy, acupuncture, biofeedback therapy, a psychological assessment,
or a second opinion. Id.
Dr. Hurd thus concluded that Respondent did not meet the standards
for prescribing opioids with respect to V.S. Id. He further concluded
that Respondent lacked a legitimate medical purpose when he prescribed
controlled substances to V.S. Id.
T.W., a thirty-six year old male, saw Respondent fifteen times
between February 4, 2011 and March 20, 2012. GX 9, at 2-16. T.W.
presented with a history of a gunshot wound to his abdomen (fifteen
years earlier) and a car accident (three years earlier) and complained
of lower back pain, which according to the progress note, had gotten
progressively worse, as well as ``numbness and tingling down [his] left
leg.'' GX 36J; GX 9, at 83. He further reported that his pain was a 10
without medication and a 5 with medication. GX 9, at 83.
T.W. reported having seen a chiropractor, as well as having
received decompression therapy and an injection of some sort. Id.; GX
36J. He also reported having seen other doctors for this pain and that
oxycodone 30mg had provided him with relief and that he had obtain some
relief on Percocet, but none from Lortab. GX 9, at 83; id. at 16. Yet
T.W.'s file does not contain records from his prior doctors or pharmacy
records. See generally GX 9.
T.W. presented an MRI report which he obtained from Greater Georgia
Imaging on the same day as the day of his initial visit with
Respondent. The MRI report (which did not include the name of the
reading radiologist and was unsigned) found that T.W. had a left
paracentral disc protrusion at L4-5 and a right far posterolateral disc
protrusion at L3-4. GX 9, at 82. In the physical exam section of the
progress note, Respondent documented four findings: (1) The existence
of moderate to severe tenderness in the paravertebral muscles in the
lumbar region; (2) the existence of severe tenderness in the left
sciatic area; (3) that the straight leg lift was abnormal on the right
side; (4) and that test of the Deep Tendon Reflexes was ``+1.'' GX 9,
at 16.
With the exception of the latter test which did not specify which
reflexes (knee or ankle) were tested, Respondent did not document
having examined any of the other six items which Dr. Hurd explained are
required to meet the standard of care. Id. Respondent diagnosed T.W. as
having ``lumbar radiculopathy,'' ``lumbar spasm,'' and disc protrusions
at L4-5 and L3-4. GX 9, at 16. He then provided T.W. with a
prescription for 30 oxycodone 30mg qd (one tablet per day), as well as
Flexeril and Naproxen. Id. He also recommended that T.W. obtain an
inversion table. Id.
T.W. returned on March 3, 2011, and claimed that the medication had
lasted only six days. GX 9, at 15. Respondent documented his physical
exam findings as ``severe tenderness paravertebral muscles lumbar
spine'' and ``moderate tenderness lumbar spine.'' Id. He then increased
T.W.'s oxycodone 30mg prescription to 120 tablets. Id. Respondent
continued prescribing this quantity until T.W.'s visit on July 28, when
the latter complained of ``having more severe pain'' and Respondent
increased the prescription to 140 tablets. Id. at 10-14; GX 36J, at 2.
Respondent continued to prescribe 140 tablets at each visit until his
last visit on March 20, 2012, when T.W. again complained of ``having
more pain'' and that the medication was ``not lasting long enough.'' GX
9, at 2-9; GX 36J, at 2. Respondent then increased the prescriptions to
155 tablets of oxycodone 30mg. GX 9, at 2.
Throughout this period, Respondent never documented findings on a
physical exam other than that he found varying degrees of tenderness
over T.W.'s paravertebral muscles in the lumbar region. GX 9, at 2-9.
As Dr. Hurd found, the progress notes for the remaining 14 visits
contain no documentation that Respondent examined any of the seven
items he identified as part of the standard of care after T.W.'s first
visit. GX 36J, at 2-3. Dr. Hurd thus opined that there was ``no
correlation between the patient's MRI'' and the physical exam findings
and that ``the MRI and physical findings'' did not ``warrant treatment
with that level of narcotic. Id. at 3.
Dr. Hurd also observed that while the progress notes repeatedly
listed diagnoses of ``lumbar radiculopathy'' and a bulging disc at L3
involving the nerve root, as well as that T.W. repeatedly rated his
pain with medication at a 7-8, Respondent ``never offered standard
treatment such as lumbar epidural steroid injections or [a] surgical
referral.'' Id. at 2. Dr. Hurd thus concluded that Respondent did not
``meet the standard'' for prescribing opioids and that the
prescriptions he issued T.W. lacked a legitimate medical purpose. Id.
at 3.
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)
(emphasis added). 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.
[[Page 3648]]
Id. Sec. 823(f).
``[T]hese factors are . . . considered in the disjunctive.'' Robert
A. Leslie, M.D., 68 FR 15227, 15230 (2003). It is well settled that 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.; see also MacKay v. DEA, 664 F.3d
808, 816 (10th Cir. 2011); Volkman v. DEA, 567 F.3d 215, 222 (6th Cir.
2009); Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005). Moreover, while
I am required to consider each of the factors, I ``need not make
explicit findings as to each one.'' MacKay, 664 F.3d at 816 (quoting
Volkman, 567 F.3d at 222 (quoting Hoxie, 419 F.3d at 482)).\22\
---------------------------------------------------------------------------
\22\ In short, this is not a contest in which score is kept; the
Agency is not required to mechanically count up the factors and
determine how many favor the Government and how many favor the
registrant. Rather, it is an inquiry which focuses on protecting the
public interest; what matters is the seriousness of the registrant's
misconduct. Jayam Krishna-Iyer, 74 FR 459, 462 (2009). Accordingly,
as the Tenth Circuit has recognized, findings under a single factor
can support the revocation of a registration. MacKay, 664 F.3d at
821.
---------------------------------------------------------------------------
The Government has the burden of proving, by a preponderance of the
evidence, that the requirements for revocation or suspension pursuant
to 21 U.S.C. 824(a) are met. 21 CFR 1301.44(e). However, ``once the
[G]overnment establishes a prima facie case showing a practitioner has
committed acts which render his registration inconsistent with the
public interest, the burden shifts to the practitioner to show why his
continued registration would be consistent with the public interest.''
MacKay, 664 F.3d at 817 (citing Medicine Shoppe-Jonesborough, 73 FR
364, 387 (2008) (citing cases)).
Having considered all of the factors, I agree with the ALJ's
conclusion that the Government's evidence with respect to factors two
(Respondent's experience in dispensing controlled substances) and four
(Respondent's compliance with applicable controlled substance laws),
establishes that Respondent has committed acts which render his
registration inconsistent with the public interest.\23\ 21 U.S.C.
824(a)(4).
---------------------------------------------------------------------------
\23\ As for factor one, the recommendation of the state
licensing authority, the ALJ found that Georgia Composite Medical
Board has not made an ``express recommendation'' in this matter.
R.D. at 82. The ALJ further noted, however, Respondent's testimony
that the Board had subpoenaed some 46 patient files including five
files which were presented to Dr. Hurd and that the Board declined
to take any action against his medical license. Id. (citing Tr.
309). Respondent did not, however, identify the names of the
patients whose files were reviewed by the Board. See Tr. 309.
Moreover, while Respondent testified, in essence, that the Board had
found no reason to act, he did not produce any official document
from the Board setting forth its reasons for not pursuing sanctions
against his license.
Although Respondent retains his state license, DEA has
repeatedly held that while a practitioner's possession of state
authority constitutes an essential condition for maintaining a
registration, see 21 U.S.C. 802(21) & 823(f), it ```is not
dispositive of the public interest inquiry.''' George Mathew, 75 FR
66138, 66145 (2010), pet. for rev. denied Mathew v. DEA, 472
Fed.Appx. 453, 455 (9th Cir. 2012); see also Patrick W. Stodola, 74
FR 20727, 20730 n.16 (2009); Robert A. Leslie, 68 FR 15227, 15230
(2003). As the Agency has long held, ``the Controlled Substances Act
requires that the Administrator . . . make an independent
determination [from that made by state officials] as to whether the
granting of controlled substance privileges would be in the public
interest.'' Mortimer Levin, 57 FR 8680, 8681 (1992). Thus, while
Respondent satisfies the CSA's requirement that he be currently
authorized to dispense controlled substances under the laws of the
State in which he practices medicine, this factor is not dispositive
either for, or against, the continuation of Respondent's
registration. Paul Weir Battershell, 76 FR 44359, 44366 (2011)
(citing Edmund Chein, 72 FR 6580, 6590 (2007), pet. for rev. denied
Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008)).
Regarding factor three, there is no evidence in the record that
Respondent has been convicted of an offense related to the
manufacture, distribution or dispensing of controlled substances.
However, as there are a number of reasons why a person may never be
convicted of an offense falling under this factor, let alone be
prosecuted for one, ``the absence of such a conviction is of
considerably less consequence in the public interest inquiry'' and
is thus not dispositive. Dewey C. MacKay, 75 FR 49956, 49973 (2010),
pet. for rev. denied MacKay v. DEA, 664 F.3d 808 (10th Cir. 2011).
---------------------------------------------------------------------------
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Controlled
Substance Laws
To effectuate the dual goals of conquering drug abuse and
controlling both the legitimate and illegitimate traffic in controlled
substances, ``Congress devised a closed regulatory system making it
unlawful to manufacture, distribute, dispense, or possess any
controlled substance except in a manner authorized by the CSA.''
Gonzales v. Raich, 545 U.S. 1, 13 (2005). Consistent with the
maintenance of the closed regulatory system, a controlled substance may
only be dispensed upon a lawful prescription issued by a practitioner.
Carlos Gonzalez, M.D., 76 FR 63118, 63141 (2011).
Under a longstanding DEA regulation, 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). Under
the CSA, it is fundamental that a practitioner must establish a
bonafide doctor-patient relationship in order to act ``in the usual
course of . . . professional practice'' and to issue a prescription for
a ``legitimate medical purpose.'' See United States v. Moore, 423 U.S.
122, 142-43 (1975); United States v. Lovern, 590 F.3d 1095, 1100-01
(10th Cir. 2009); United States v. Smith, 573 F.3d 639, 657 (8th Cir.
2009); see also 21 CFR 1306.04(a) (``an order purporting to be a
prescription issued not in the usual course of professional treatment .
. . is not a prescription within the meaning and intent of [21 U.S.C.
829] and . . . the person issuing it, shall be subject to the penalties
provided for violations of the provisions of law related to controlled
substances'').
As the Supreme Court has 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, 143 (1975)).
Both this Agency and the federal courts have held that
``establishing a violation of the prescription requirement `requires
proof that the practitioner's conduct went ``beyond the bounds of any
legitimate medical practice, including that which would constitute
civil negligence.'' ' Laurence T. McKinney, 73 FR 43260, 43266 (2008)
(quoting 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.'').\24\
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\24\ However, as the Agency has held in multiple cases, ``the
Agency's authority to deny an application [and] to revoke an
existing registration . . . is not limited to those instances in
which a practitioner intentionally diverts a controlled substance.''
Bienvenido Tan, 76 FR 17673, 17689 (2011) (citing Paul J. Caragine,
Jr., 63 FR 51592, 51601 (1998)); see also Dewey C. MacKay, 75 FR, at
49974. As Caragine explained: ``[j]ust because misconduct is
unintentional, innocent, or devoid of improper motive, [it] does not
preclude revocation or denial. Careless or negligent handling of
controlled substances creates the opportunity for diversion and
[can] justify'' the revocation of an existing registration or the
denial of an application for a registration. 63 FR at 51601.
``Accordingly, under the public interest standard, DEA has
authority to consider those prescribing practices of a physician,
which, while not rising to the level of intentional or knowing
misconduct, nonetheless create a substantial risk of diversion.''
MacKay, 75 FR, at 49974; see also Patrick K. Chau, 77 FR 36003,
36007 (2012). Likewise, ``[a] practitioner who ignores the warning
signs that [his] patients are either personally abusing or diverting
controlled substances commits `acts inconsistent with the public
interest,' 21 U.S.C. 824(a)(4), even if [he] is merely gullible or
na[iuml]ve.'' Jayam Krishna-Iyer, 74 FR 459, 460 n.3 (2009); see
also Chau, 77 FR, at 36007 (holding that even if physician ``did not
intentionally divert controlled substances,'' State Board Order
``identified numerous instances in which [physician] recklessly
prescribed controlled substances to persons who were likely engaged
in either self-abuse or diversion'' and that physician's ``repeated
failure to obtain medical records for his patients, as well as to
otherwise verify their treatment histories and other claims, created
a substantial risk of diversion and abuse'') (citing MacKay, 75 FR,
at 49974).
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[[Page 3649]]
As found above, both parties elicited the testimony of expert
witnesses, who came to diametrically opposite conclusions regarding the
lawfulness of the prescriptions. The ALJ ultimately resolved this
issue, concluding that Dr. Hurd's opinion testimony was entitled to
more weight than that of Dr. Warfield because of his greater
familiarity with the standards of medical practice that exist in
Georgia. I agree, and while I am mindful of Dr. Warfield's professional
accomplishments and her testimony suggesting that Dr. Hurd was applying
a ``best possible practices'' standard in evaluating Respondent's
prescribing practices, rather than the actual standard of care as
generally practiced by pain management physicians, I find that the
evidence supports a finding that Respondent repeatedly breached the
standard of care (applicable in Georgia) and did so in a manner which
establishes that he acted outside of the usual course of professional
practice and lacked a legitimate medical purpose in issuing many (if
not all) of the prescriptions.
Notably, Dr. Warfield did not dispute Dr. Hurd's contentions that
half of the patients whose MRIs show an abnormality do not have any
pain and that an MRI alone ``is not sufficient'' to form a diagnosis of
chronic pain. Tr. 452. Indeed, Dr. Warfield agreed with Dr. Hurd that a
physical examination must be done and that a physician must determine
whether the examination's findings are consistent with the MRI's
findings and then correlate those findings with the patient's pain
complaint. Compare Tr. 595-96 & 628 with id. at 452-54 and 485-86.
Moreover, even Respondent acknowledged that ``sometimes you can have an
abnormal MRI, and a person is not having pain. That's why we do those
exams . . . to check the nerve roots, to see if it's consistent with
the MRI report. Id. at 287.
Dr. Hurd also specifically identified multiple tests (including
examinations of the patient's gait, range of motion, sensory, strength,
mental status, and pupils) that Respondent did not perform in examining
both the undercover officers and the chart-review patients that he
maintained were required by the standard of care to properly diagnose
the patients; he also explained why the straight leg lift was not an
adequate test because it was not specific to each nerve root.
Notwithstanding that Dr. Warfield reviewed Dr. Hurd's report in
preparation for her testimony, she did not identify a single test among
those which Dr. Hurd testified were required by the standard of care as
being unnecessary to properly diagnose a patient.\25\ Thus, I reject
her testimony in which, while she agreed with Dr. Hurd ``that the
examinations were brief,'' she offered the conclusory assertion that
she did ``not believe that this in any way indicated that
[Respondent's] practice was not legitimate.'' RX F2, at 3.
---------------------------------------------------------------------------
\25\ Dr. Warfield also asserted that ``how extensive a physical
examination is and such is really up to the individual physician to
decide for an individual patient.'' Tr. 597. Undoubtedly, the scope
of an appropriate physical exam is based on the nature of a
patient's pain complaint and symptoms. To the extent Dr. Warfield's
statement suggests that there is no standard of care which governs
the scope of an appropriate physical exam, it is refuted by numerous
judicial decisions in both medical malpractice and criminal cases,
medical board decisions involving allegations of unprofessional
conduct, and Agency decisions involving allegations of unlawful
prescribing.
---------------------------------------------------------------------------
I therefore give substantial weight to Dr. Hurd's testimony and
report in which he concluded that Respondent repeatedly failed to
conduct adequate physical exams for diagnosing the undercover officers
and various patients as having chronic pain which warranted the
prescribing of oxycodone. So too, I give substantial weight to Dr.
Hurd's conclusion that Respondent also prescribed Xanax without a
legitimate medical purpose, because there was no evidence that he had
properly evaluated whether the patients had anxiety. Moreover, given
that for each of the patients, Dr. Hurd identified multiple tests
(indeed, as many as seven different tests which should have been done
but were not), I conclude that Respondent's breaches of the standard of
care were not merely malpractice, but rather, establish that the
prescriptions lacked a legitimate medical purpose and that he knowingly
diverted controlled substances. 21 CFR 1306.04(a).
This conclusion is buttressed by Dr. Hurd's testimony and report
which identified multiple other ways in which Respondent failed to
comply with the Georgia Board's Guidelines for the Use of Controlled
Substances for the Treatment of Pain: Ten Steps. See RX A. It is also
supported by the evidence of TFO's Vickery's undercover visits.
To be sure, Dr. Warfield took issue with Dr. Hurd's reliance on the
Guidelines. More specifically, Dr. Warfield testified that she does not
``see guidelines as being laws'' and that ``most reasonable physicians
in the same situation don't know about those state guidelines.'' Tr.
597, 599-600. To similar effect, in a document which appears to be
Respondent's post-hearing brief, Respondent writes that the Guidelines
are not a statute or rule, but ``are simply a guide to help
physicians.'' Resp. Post-Hrng. Br., at 2. However, Respondent also
argues that ``[a]dherence to [the] guidelines improves quality medical
practice and helps distinguish legitimate practice from foul play.''
Id.
The Government does not, however, argue that the Guidelines have
the force and effect of law. Rather, the Guidelines are--as Respondent
himself recognizes--probative evidence of the standards of professional
practice that are applicable in Georgia to the use of controlled
substances for treating chronic pain.\26\ And as Dr. Hurd testified and
documented in his report, measured against the Guidelines, Respondent's
prescribing practices were deficient in other respects.
---------------------------------------------------------------------------
\26\ Based on her experiences lecturing throughout the country,
Dr. Warfield asserted that most physicians are unaware of the
existence of the controlled substance prescribing guidelines that
have been published by numerous States. However, many of the States
have long published policy statements on the use of controlled
substances to treat pain and it is not as if Dr. Warfield has
conducted polling on the issue.
Moreover, even if knowledge of guidelines applicable to one's
profession cannot be presumed in the same manner as is knowledge of
duly promulgated laws and regulations, in his Exceptions, Respondent
asserted that ``[b]efore working at liberty center, [in] December
2010 I went online reviewing information regarding pain management
on [the] Georgia composite medical board site.'' Resp. Exceptions,
at 4. Of note, the Georgia Board adopted the Guidelines in January
2008.
---------------------------------------------------------------------------
First, Step Two of the Guidelines instructs the physician to
``[c]reate a treatment plan'' and to ``consider referrals to
appropriate specialists, such as neurologists, orthopedists . . .
addictionologists, and psychiatrists.'' Step Two also instructs that
``[t]he written treatment plan should state objectives that will be
used to determine treatment success,'' as well as whether ``any further
diagnostic evaluations or treatments are planned.'' Yet with the
exception of a single patient to whom he offered a trigger point
injection, the treatment plans documented in the patient charts, which
were submitted for the record, provided only for the use of controlled
substances. Moreover, Dr. Hurd found that Respondent never referred any
of the patients whose files he reviewed to specialists, nor for other
treatments such as physical therapy.
[[Page 3650]]
Notably, this point was unchallenged by Dr. Warfield.
Step Four of the Guidelines instructs the physician to ``[r]eview
the patient's prescription records and discuss the patient's chemical
history before prescribing a controlled drug.'' Continuing, Step Four
states that ``[i]f the patient is new or otherwise unknown to you, at a
minimum obtain an oral drug history and medication allergies, and
discuss chemical use and family chemical history with the patient and
obtain old records which may include pharmacy records.''
As to whether a physician is required to obtain a new patient's old
records prior to the initial prescribing of a controlled substance, the
Guideline is not a model of clarity. In any event, it is unnecessary to
decide whether Respondent breached the standard of care because he
failed to obtain (or even attempt to obtain) the old records which
purportedly existed for TFO Lawson (who made but two visits) because
the evidence otherwise shows that he did breach the standard. As the
evidence shows, TFO Vickery made four visits between August 22 and
December 1, 2011, and yet Respondent made no effort to obtain the
records which purportedly existed for him. Most significantly, Dr. Hurd
identified multiple patients who saw Respondent for a year or more and
to whom he repeatedly prescribed controlled substances, and yet he did
not obtain (or attempt to obtain) their records. Moreover, Respondent
failed to obtain the records even when the patients claimed that they
had previously been prescribed large doses of oxycodone, as well as
other controlled substances such as Xanax, and were travelling long
distances to see him.
Dr. Warfield unconvincingly defended Respondent's failure to obtain
records. She asserted that ``[m]ost physicians do not ask for old
medical records'' and that ``[w]e don't do that in our practice.'' She
also asserted that ``[t]here has to be a certain amount of trust
between the patient and the physician'' so that if a patient tells her
she had ``back surgery in 1995,'' she doesn't ``need the medical
records from that hospital where you say you had that surgery.''
Dr. Hurd did not, however, testify, and the Government makes no
contention, that Dr. Mintlow was required to obtain medical records of
such vintage. Moreover, while Dr. Warfield may deem it unnecessary to
obtain patient records of any sort, including those establishing what
medications have been previously and recently prescribed to a patient,
this does not establish what the standard of care requires in any
State, let alone Georgia, where the Medical Board has concluded
otherwise. See RX A (Georgia Guidelines Step 4). And even if it is her
practice not to obtain records, Liberty nonetheless required its
patients to execute a form authorizing the release of their medical
records including prescription profiles, progress notes,
hospitalization reports, and diagnostic reports, and yet did not even
attempt to obtain those records (such as prescription profiles) which
would be available even if a patient's previous clinic had been shut
down. See GX 27, at 18. So too, Respondent testified that the clinic he
previously worked at would attempt to obtain prior records to verify
the patients' treatment histories. Tr. 343-44. As for why no attempts
were made to obtain the records of the patients identified by Dr. Hurd,
Respondent blamed this on Del Percio, even though he acknowledged that
it was his responsibility. Id. at 344-45.
Nor does this Agency dispute Dr. Warfield's statement that there
has to be a certain amount of trust between the patient and physician.
However, when a patient represents that he/she has previously been
prescribed large doses of powerful narcotics such as oxycodone 30mg (as
well as other controlled substances such as benzodiazepines), which are
highly abused and diverted, and may also have travelled a long distance
bypassing numerous other potential treating physicians with no
plausible explanation for doing so, there is ample reason to verify the
patient's claim. Indeed, requiring verification of a patient's claims
that he/she had previously received large doses of narcotics is fully
supported by the CSA's prescription requirement, one purpose of which
is to prevent the recreational abuse of controlled substances by
``bar[ring] doctors from peddling to patients who crave the drugs for
those prohibited uses'' or to sell the drugs to others who seek to
abuse them. Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing Moore,
423 U.S. 122, 135, 143 (1975)).
There is additional evidence which supports the conclusion that
Respondent prescribed controlled substances outside of the usual course
of professional practice and lacked a legitimate medical purpose. In
contrast to his failure to obtain the prior records of his patients,
the evidence shows that Respondent would not see a patient unless that
patient had already obtained an MRI. As found above, TFO Vickery
testified that prior to his first visit, he twice attempted to see
Respondent and was told by Del Percio that he needed an MRI before he
could be seen by Respondent. Tr. 162-63. So too, TFO Manning attempted
to see Respondent without an MRI and was turned down by Del Percio, who
told him that Respondent was ``not going to risk his license.'' RX G,
Disc N-51.
Notably, there is no evidence that the undercovers were referred by
another physician and thus would already have obtained their MRIs. So
too, Dr. Hurd noted that in reviewing the patient files, he found
``over and over again'' that the patients were given an order by
Liberty for an MRI before they were ever examined by Respondent. Tr.
514. Regarding this practice, Dr. Hurd explained that ``[t]here is no
reason to order an MRI . . . in the absence of an emergency, without
examining a patient.'' Id. This testimony was unchallenged by both
Respondent and Dr. Warfield.
In his Exceptions, Respondent argues that ``[i]n Georgia[,] [an]
MRI is not required to make a diagnosis.'' Resp. Exceptions, at 6. That
is undoubtedly true. Yet Respondent was obviously aware that the
Liberty patients could not see him without having previously obtained
an MRI. Respondent, however, offered no explanation as to why Liberty's
patients were required to have had an MRI done before he even examined
them and determined that an MRI was warranted. Here, the evidence
supports the inference that the MRIs were required--as Del Percio
explained to TFO Manning--to justify Respondent's issuance of unlawful
controlled substance prescriptions in the event law enforcement or
regulators became aware of Liberty and investigated it.\27\
---------------------------------------------------------------------------
\27\ Indeed, DEA has encountered this practice in investigating
numerous other rogue pain clinics. See Cynthia M. Cadet, 76 FR
19450, 19455 (2011); Jacobo Dreszer, 76 FR 19386, 19388 & n.8
(2011).
---------------------------------------------------------------------------
Still more evidence that Respondent knowingly diverted controlled
substances is provided by the undercover visits of TFO Vickery. On two
occasions, Vickery attempted to purchase additional controlled
substances for both himself and a friend and yet Respondent continued
to prescribe controlled substances to him. More specifically, at
Vickery's second visit, after Respondent agreed to prescribe Opana to
him, Vickery asked if he could also get some ``15s,'' a reference to
oxycodone 15; while Respondent said no, Vickery then offered ``to
float'' Respondent ``a couple hundred bucks on the side.'' While
Respondent again said no, he nonetheless issued him prescriptions for
[[Page 3651]]
90 Opana ER 40mg (oxymorphone), a drug which is also a schedule II
controlled substance (and more potent than oxycodone), as well as 30
Xanax 1mg. Moreover, upon receiving the prescriptions, Vickery
complained that the previous Xanax prescriptions ``did not last at
all'' and Respondent was ``being stingy.''
Similarly, at the third visit, Vickery complained that the Opana
``went pretty quickly'' and asked for something for breakthrough pain.
Moreover, Vickery then attempted to buy extra Xanax (actually showing
him the cash), asserting that his buddy had asked him to see if
Respondent would write him a prescription. While Respondent declined to
write a Xanax prescription for Vickery's purported buddy, he
nonetheless increased the Xanax prescription to forty-five tablets.
As found above, Dr. Hurd testified that these incidents should have
resulted in the Respondent's termination of Vickery as a patient. Dr.
Warfield disputed this. While she acknowledged that they were red
flags, she asserted that they did not constitute a contraindication to
providing drugs ``to this patient for [his] pain.'' Tr. 636. She then
reasoned that:
Does this patient understand that you can't just walk into a
doctor's office and say, you know, I have a friend who needs some
medication; here's some money? Does the patient just totally not
understand that that's illegal. I don't know the answer to that
question. What I understand here is that [Respondent] was offered
money and outright refused it, and I think that's what's important
to me when I read these records.
Id.
Notwithstanding Dr. Warfield's assertion, I conclude that patients
are generally well familiar with why a prescription is required for
certain drugs, especially controlled substances, and that a doctor must
examine a patient before issuing prescription, and in any event,
patients are also charged with knowledge of the law. Indeed, as found
above, at each visit, Vickery was required to review and sign documents
which warned that he could not sell, trade, or share medications, GX
27, at 10 (initial visit); or that selling or diverting medication is
illegal. Id. at 22 & 24 (2nd visit); 28 & 30 (3rd visit); 34 & 36 (4th
visit).
Beyond this, Respondent never testified that he continued to
prescribe to Officer Vickery because he believed that this was simply a
case of Vickery not knowing the law. Moreover, Vickery's statement to
Respondent--after telling Respondent he had $200 and showing him the
cash--that ``I don't know if you can do that,'' hardly suggests a
degree of na[iuml]vet[eacute] on Vickery's part as to the legal
requirements for obtaining prescriptions.
I also find unpersuasive Dr. Warfield's further contention that
because Respondent refused Vickery's offer, this establishes that he
was legitimately practicing medicine. Contrary to Dr. Warfield's
understanding, both the courts and the Agency have long recognized that
the wink and a nod manner in which Respondent prescribed to Officer
Vickery violates the CSA.\28\ See United States v. Moore, 423 U.S. 122,
142-43 (1975); United States v. Hooker, 541 F.2d 300, 305 (1st Cir.
1976) (holding that where physician ``carried out little more than
cursory physical examinations, if any, frequently neglected to inquire
as to past medical history, and made little or no exploration of the
type of problem a patient allegedly had, . . . the jury could
reasonably have inferred that the minimal `professional' procedures
followed were designed only to give an appearance of propriety to
appellant's unlawful distributions'').\29\
---------------------------------------------------------------------------
\28\ I also find entirely unpersuasive Dr. Warfield's testimony
justifying Respondent's failure to document Vickery's attempts to
purchase additional drugs. In the absence of documentation of such
an incident in the patient's medical record, a doctor with a busy
practice who merely kept a mental note could well fail to remember
the incident. Moreover, as Dr. Hurd explained, one of the purposes
of the medical record is to enable any subsequent treating physician
to properly evaluate the patient, the effectiveness of previous
treatments, and where a patient represents that they had previously
been treated with controlled substances, the prior physician's
reasoning and the patient's truthfulness. Tr. 451, 469. Furthermore,
the Guidelines explain that a patient's ``history of substance
abuse'' should be documented in the medical record. RX A, at 2.
Given that physicians are expected to assess the risks (and
benefits) of various treatments (including the risk of misuse, abuse
and diversion, see id. at 3-4 (steps four, five and seven)), it is
beyond dispute that documentation of a patient's prior attempts to
bribe a doctor and obtain drugs is essential information for any
subsequent physician who treats the patient and considers
prescribing controlled substances.
\29\ See also United States v. Joseph, 709 F.3d 1082, 1104 (11th
Cir. 2013) (holding physician ``acted without a legitimate medical
purpose and outside the usual course of professional practice''
where the evidence showed he ``prescribed an inordinate amount of
certain controlled substances, that he did so after conducting no
physical examinations or only a cursory physical examination, [and]
knew or should have known that his patients were misusing their
prescriptions'').
---------------------------------------------------------------------------
Furthermore, Dr. Warfield's assertion that Respondent was engaged
in the legitimate practice of medicine simply ignores TFO Vickery's
fourth visit. Indeed, in neither her report nor her testimony did Dr.
Warfield even address Respondent's prescribing to TFO Vickery at this
visit, which resulted in prescriptions for 90 oxycodone 25mg, 30 Xanax
1mg, and 30 Soma.
However, as the evidence shows, Respondent knew that Vickery was
not a legitimate pain patient as Vickery had been a week late for his
appointment and did not have drugs in his system. Moreover, Respondent
expressed his belief that Vickery was not having much pain and that he
did not need anything other than Naproxen (a non-controlled drug) for
his pain, prompting Vickery to change his pain level (and prompting
laughter from Respondent), and then going so far as to claim that his
``three'' was somebody else's ``seven or eight.''
Moreover, when Vickery explained that he did not even like Naproxen
and that he liked the oxycodone and was used to taking it, Respondent
remarked that Vickery was dependent on narcotics and laughed.
Respondent then said that he would try to wean him down to avoid
``withdrawal problems,'' but then expressed doubt that Vickery ``would
have that'' as there was no oxycodone in his system, and laughed again.
Indeed, at multiple points in the video, Vickery attempted to
explain why he needed more drugs notwithstanding that he was a week
late for the visit and his urine was clear, prompting laughter from
Respondent. Having viewed the video, I reject Respondent's testimony
that he was laughing because ``I smile all the time'' or that his
laughter was the result of his being ``frustrated with'' Vickery
because he was trying to reduce Vickery's medication and ``it looked
like [Vickery] was trying to change it to something different.'' Tr.
372-73.
Contrary to Respondent's understanding, he--not Vickery--held the
authority to prescribe controlled substances. Yet he continued to
prescribe more controlled substances to Vickery, including more
narcotics, notwithstanding the latter's statements that ``I like what I
take'' and that he was ``used to taking it,'' prompting Respondent to
acknowledge that ``we're talking about somewhat of a dependency here.''
Indeed, Respondent even agreed to increase the quantity of the
oxycodone 25mg from 60 to 90 tablets after Vickery complained about the
size of the prescription, and while he refused Vickery's request for
Lortab, he then added a prescription for Soma after Vickery asked for
the drug. And following this, Vickery promised that he would ``be in
more pain next time.''
Respondent thus knew that Vickery was not a legitimate pain
patient. In short, as the ALJ found, this visit ``can only be described
as a negotiation over
[[Page 3652]]
the quantity of narcotics\30\ Respondent would prescribe for Officer
Vickery.'' R.D. at 44.
---------------------------------------------------------------------------
\30\ Soma is not a narcotic. However, the drug was controlled
under the CSA because of its use by narcotic abusers to enhance the
effects of narcotics. See Placement of Carisoprodol Into Schedule
IV, 76 FR 77330, 77356 (2011).
---------------------------------------------------------------------------
I therefore conclude that Respondent acted outside of the usual
course of professional practice and lacked a legitimate medical purpose
when he issued prescriptions to TFO Vickery and Lawson, as well as the
patients A.B., J.B., L.L., H.W., V.S., and T.W. 21 CFR 1306.04(a). I
further conclude that the Government's evidence with respect to factors
two and four establishes a prima facie showing that Respondent ``has
committed such acts as would render his registration . . . inconsistent
with public interest.'' 21 U.S.C. 824(a)(4). I further hold that
Respondent's prescribing violations are egregious and warrant the
revocation of his registration.
The ALJ also found that Respondent engaged in actionable misconduct
because in December 2011, he became aware of a newsletter published by
the Georgia Board which identified various characteristics of both pill
mills and drug seeking patients. R.D. at 98. While Respondent admitted
to having reviewed only the former portion, as the ALJ explained:
The similarities between the clinical practice he was leading
and the features reported in the newsletter that are common to pill
mills were striking, and were undeniable. [Respondent] knew his
patient base was largely from out of state, and that many patients
travelled a great distance to be treated there. He knew the owners
had no medical background and that no other medically-trained
persons worked at the clinic. He knew his patients were asking for
oxycodone by name and by dosage, and he was aware that they were
presenting MRIs from a common source--and that they arrived with the
MRIs in hand prior to an initial office visit. He knew also the
clinic was operating on a cash basis, and that he was directly
benefiting from a share of that cash in a three-way split.
Id. at 99. The ALJ also noted that per the Board's newsletter,
Respondent could have ``request[ed] an onsite `courtesy meeting' with a
Board agent,'' if he had any questions about Liberty's operations.\31\
R.D. at 100 (quoting GX 39, at 7).
---------------------------------------------------------------------------
\31\ While the Board spelled out these red flags in its
newsletter, the red flags presented by Liberty's operations were so
obvious that any physician who has practiced in legitimate settings
would have quickly recognized the problematic nature of Liberty's
operations without the need for a newsletter, and any responsible
physician--at least one holding a DEA registration--would have
ceased practicing at such a clinic. Thus, I reject as incredible,
Respondent's contention that he was unfamiliar with the concept of
red flags. Tr. 334.
---------------------------------------------------------------------------
Yet Respondent did not request a meeting with a Board agent and he
continued to prescribe controlled substances for Liberty until April
2012, when a search warrant was executed at the clinic. GX 34, at 2 &
6. Moreover, Dr. Hurd's report establishes that Respondent continued to
unlawfully prescribe controlled substances during this period. While
the ALJ discussed this evidence under factor five, it is more
appropriately viewed as evidence probative of Respondent's experience
in dispensing controlled substances. It is also evidence which is
probative of his compliance with the CSA's prescription requirement as
it refutes any suggestion that he was simply a physician who trusted
his patients too much and was duped.
Sanction
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 364, 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 [his] actions and demonstrate that [he]
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).
However, while a registrant must accept responsibility and
demonstrate that he will not engage in future misconduct in order to
establish that his/her continued registration is consistent with the
public interest, DEA has repeatedly held these are not the only factors
that are relevant in determining the appropriate sanction. See, e.g.,
Joseph Gaudio, 74 FR 10083, 10094 (2009); Southwood Pharmaceuticals,
Inc., 72 FR 36487, 36504 (2007). Obviously, the egregiousness and
extent of a registrant's misconduct are significant factors in
determining the appropriate sanction. See Jacobo Dreszer, 76 FR 19386,
19387-88 (2011) (explaining that a respondent can ``argue that even
though the Government has made out a prima facie case, his conduct was
not so egregious as to warrant revocation''); Paul H. Volkman, 73 FR
30630, 30644 (2008); see also Paul Weir Battershell, 76 FR 44359, 44369
(2011) (imposing six-month suspension, noting that the evidence was not
limited to security and recordkeeping violations found at first
inspection and ``manifested a disturbing pattern of indifference on the
part of [r]espondent to his obligations as a registrant''); Gregory D.
Owens, 74 FR 36751, 36757 n.22 (2009).
Moreover, as I have noted in several cases, ```[n]either Jackson,
nor any other agency decision, holds . . . that the Agency cannot
consider the deterrent value of a sanction in deciding whether a
registration should be [suspended or] revoked.' '' Gaudio, 74 FR at
10094 (quoting Southwood, 72 FR at 36504 (2007)); see also Robert
Raymond Reppy, 76 FR 61154, 61158 (2011); Michael S. Moore, 76 FR
45867, 45868 (2011). This is so, both with respect to the respondent in
a particular case and the community of registrants. See Gaudio, 74 FR
at 10095 (quoting Southwood, 71 FR at 36503). Cf. McCarthy v. SEC, 406
F.3d 179, 188-89 (2d Cir. 2005) (upholding SEC's express adoptions of
``deterrence, both specific and general, as a component in analyzing
the remedial efficacy of sanctions'').
Thus, in Gaudio, the Administrator ``explained that `even when a
proceeding serves a remedial purpose, an administrative agency can
properly consider the need to deter others from engaging in similar
acts.' '' 74 FR at 10094 (quoting Southwood, 72 FR at 36504) (citing
Butz v. Glover Livestock Commission Co., Inc., 411 U.S. 182, 187-88
(1973)); cf. McCarthy, 406 F.3d at 189 (``Although general deterrence
is not, by itself, sufficient justification for expulsion or
suspension, we recognize that it may be considered as part of the
overall remedial inquiry.''); Paz Securities, Inc., et al. v. SEC, 494
F.3d 1059, 1066 (D.C. Cir. 2007) (agreeing with McCarthy). In Gaudio,
the Administrator further noted that the ``[c]onsideration of the
deterrent effect of a potential sanction is supported by the CSA's
purpose of protecting the public interest, see 21 U.S.C. 801, and the
broad grant of authority conveyed in the statutory text, which
authorizes the [suspension or] revocation of a
[[Page 3653]]
registration when a registrant `has committed such acts as would render
[his] registration . . . inconsistent with the public interest,' id.
Sec. 824(a)(4), and [which] specifically directs the Attorney General
to consider [`such other conduct which may threaten public health and
safety,' id. Sec. 823(f)].'' 74 FR at 10094 (quoting Southwood, 72 FR
at 36504).\32\
---------------------------------------------------------------------------
\32\ Unlike factors two (``[t]he applicant's experience in
dispensing'') and three (``[t]he applicant's conviction record''),
neither factor four (``Compliance with applicable laws related to
controlled substances'') nor factor five (``Such other conduct which
may threaten public health and safety'') contain the limiting words
of ``[t]he applicant.'' As the Supreme Court has held, ``[w]here
Congress includes particular language in one section of a statute
but omits it in another section of the same Act, it is generally
presumed that Congress acts intentionally and purposely in the
disparate inclusion or exclusion.'' Russello v. United States, 464
U.S. 16, 23 (1983). Thus, the text of factors four and five suggest
that these factors are not limited to assessing the applicant's
compliance with applicable laws and whether he has engaged in ``such
other conduct,'' but rather authorize the Agency to also consider
the effect of a sanction on inducing compliance with federal law by
other practitioners.
---------------------------------------------------------------------------
I conclude that Respondent has not accepted responsibility for his
misconduct. Notably, at the hearing, Respondent continued to maintain
that he had lawfully prescribed to TFOs Lawson and Vickery. Indeed,
with respect to the latter, Respondent claimed that even his
prescribing at the fourth visit was legitimate because ``he [Vickery]
still had pain.'' Tr. 373. So too, with respect to the patients whose
charts were reviewed by Dr. Hurd, Respondent failed to acknowledge that
the prescriptions were unlawful. Moreover, when asked why he did not
obtain prior records, Respondent explained that ``I didn't do it,
because it was the understanding that Mark [Del Percio] was going to
take care of those things.'' Id. at 345. Respondent's failure to
acknowledge his misconduct is reason alone to find that he has not
produced sufficient evidence to refute the Government's showing that
his registration is inconsistent with the public interest.
Even had Respondent made a sufficient showing that he accepts
responsibility for his misconduct, he has failed to produce sufficient
evidence of remedial measures to refute the Government's prima facie
case. Indeed, the only evidence Respondent offered regarding remedial
measures was his assertion that he would take a course (on two Saturday
mornings) to become ``board certified in pain management.'' Tr. 354.
However, Respondent conceded that he ``never got around to'' doing it.
Id. at 355-56.\33\
---------------------------------------------------------------------------
\33\ In his Exceptions, Respondent lists some twenty-three
things that he promises to do in the future, which he hopes ``will
eliminate many loopholes and help with the problem of drug
diversion.'' Exceptions, at 2. These include, inter alia, that he
``will familiarize [him]self with all of Georgia's rules, statute,
law and regulations and follow them,'' he ``will follow the . . .
Georgia medical board pain management guidelines,'' ``stay up-to-
date with changes implemented by the Georgia medical board,''
``follow the board[']s advice from medical newsletters . . .
regarding red flags and pill mills,'' ``investigate [the] patient's
past history and past drug history,'' ``perform additional physical
exam techniques to help with the diagnosis,'' '' pay close attention
to urine drug test and perform the test myself,'' ``correlate
physical exam with radiological findings,'' ``avoid seeing patients
who travel long distance,'' discharge any patient ``offering any
kind of bribe,'' and ``verify all past medical records'' including
patient's MRIs. Id.
Respondent's list of promises is not evidence in the case, and
thus, I give it no weight. In any event, even if he had testified as
to these promises and been found credible, because he has failed to
acknowledge his misconduct, I would still hold that he has not
refuted the conclusion that his registration is inconsistent with
the public interest.
---------------------------------------------------------------------------
Moreover, I conclude that revocation of Respondent's registration
is warranted given the egregious nature of Respondent's misconduct and
the need to deter other registrants from using their registrations to
distribute controlled substances to those persons who seek the drugs to
either personally abuse them or sell them to others. Here, the evidence
shows that Respondent knowingly diverted controlled substances by
issuing prescriptions outside of the usual course of professional
practice and which lacked a legitimate medical purpose to numerous
persons. See David A. Ruben, 78 FR 38363 (2013). Moreover, there is
substantial evidence that Respondent prescribed controlled substances
to multiple persons who obtained them for redistribution to others.
Such conduct strikes at the CSA's core purpose of preventing the
abuse and diversion of controlled substances. See Jack A. Danton, 76 FR
60900, 60903 (2011); George Mathew, 75 FR 66138 (2010). Indeed, this
Agency has revoked a practitioner's registration upon proof of as few
as two acts of intentional diversion and has further explained that
proof of a single act of intentional diversion is sufficient to support
the revocation of a registration. See MacKay, 75 FR at 49977 (citing
Krishna-Iyer, 74 FR at 463 (citing Alan H. Olefsky, 57 FR 928, 928-29
(1992))).
While Respondent's misconduct would be egregious if it had been
confined to Officer Vickery, it was not. As found above, the
Government's Expert provided credible evidence that Respondent diverted
controlled substances to at least six patients, over the course of a
year or more. And even after Respondent became aware of the State
Board's newsletter which listed various red flags associated with pills
mills that were also present at Liberty, he continued to write unlawful
prescriptions to these patients until the clinic was shut down.
I therefore conclude that the public interest necessitates that
Respondent's registration be revoked and that any pending application
be denied. Given the egregiousness of his misconduct, I further
conclude that the public interest requires that this Order be effective
immediately.
Order
Pursuant to the authority vested in me by 21 U.S.C. 824(a)(4) and
823(f), as well as 28 CFR 0.100(b) and 0.104, I order that DEA
Certificate of Registration BM0288983, issued to Samuel Mintlow, M.D.,
be, and it hereby is, revoked. I further order that any application of
Samuel Mintlow, M.D., to renew or modify the above registration, be,
and it hereby is, denied. This Order is effective immediately.
Dated: December 30, 2014.
Thomas M. Harrigan,
Deputy Administrator.
[FR Doc. 2015-01219 Filed 1-22-15; 8:45 am]
BILLING CODE 4410-09-P