Jack A. Danton, D.O.; Decision and Order, 60900-60922 [2011-25231]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 76, Number 190 (Friday, September 30, 2011)]
[Notices]
[Pages 60900-60922]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-25231]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 11-14]


Jack A. Danton, D.O.; Decision and Order

    On June 17, 2011, Administrative Law Judge (ALJ) Gail A. Randall 
issued the attached recommended decision.\1\ Thereafter, the Government 
filed exceptions to the ALJ's decision.
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    \1\ All citations to the ALJ's decision are to her slip opinion 
as originally issued.
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    Having considered the entire record and the Government's 
exceptions, I have decided to adopt the ALJ's decision except for her 
legal conclusions with respect to whether the Respondent issued 
prescriptions for controlled substances to several undercover officers 
and several of her findings under factor five. However, because I 
otherwise agree with the ALJ's findings as to the public interest 
factors, I adopt her ultimate conclusion that the Government has shown 
that ``Respondent's continued registration would not be in the public's 
interest'' and that the Respondent ``has not accepted responsibility 
for all of her wrongdoing, nor has she adequately assured this tribunal 
of future compliance.'' ALJ at 64. I will therefore order that 
Respondent's registration be revoked and that any pending application 
be denied.

The Government's Exceptions

    The ALJ concluded that the Government failed to establish that 
Respondent's prescriptions to three undercover officers (UC) lacked a 
legitimate medical purpose. ALJ at 42-51; see also 21 CFR 1306.04(a) 
(``A prescription for a controlled substance * * * must be issued for a 
legitimate medical purpose by an individual practitioner acting in the 
usual course of his professional practice.''). In so concluding, the 
ALJ explained that the Government ``provided no expert testimony to 
support this finding,'' and that while the Government ``introduced the 
transcripts and recordings of the undercover transactions, and a 
summary of those transactions via officer testimony[,] * * * the 
Government ha[d] provided no meaningful lodestar by which this court 
can measure the legitimacy of the Respondent's medical practice under 
Florida statutory and regulatory requirements.'' Id. at 43. The ALJ 
noted that ``while the [A]gency has considered over fifty cases 
concerning the legitimacy of a practitioner's prescriptions since 
[Gonzales v. Oregon, 546 U.S. 243 (2006)], the [A]gency has seldom 
found a violation of 21 CFR 1306.04(a) absent expert testimony[,]'' and 
that ``where the [A]gency has found such illegitimacy without an 
expert's testimony, that finding was based on patent violations, where 
diversion was either unrefuted or unquestionable.'' Id. at 43-44 
(citing cases).
    The ALJ also noted that ``expert testimony may not be required'' 
where the evidence shows that a registrant ``has acted in a manner that 
clearly contravened state law governing what constitutes a legitimate 
medical practice,'' such as where a physician

[[Page 60901]]

issues a prescription where ``no physical examination or face-to-face 
communication was conducted'' as through Internet or telephone 
consultations. Id. at 44-45. However, the ALJ then explained that 
``when the Government seeks to use a state law violation as a means of 
establishing a violation of Sec.  1306.04(a), the question remains to 
what extent that state law violation is so tethered to a finding of 
actual illegitimacy that, without expert testimony, it can be used as a 
predicate to a violation of the federal law.'' Id.; see also id. at 45-
46 (citing Gonzales, 546 U.S. at 70 (``the CSA `bars doctors from using 
their prescription-writing powers as a means to engage in illicit drug 
dealing and trafficking as conventionally understood' ''); and Laurence 
T. McKinney, 73 FR 43260, 43266 (2008) (rejecting Government's 
contention that physician's failure to listen to undercover officer's 
heart and lungs and take her blood pressure established a violation of 
21 CFR 1306.04(a); while physician's actions violated a state 
regulation, the officer had presented a medical complaint, identified a 
specific area of her body that was the cause of pain and complained of 
a relatively high pain level and at no point stated that she was not in 
pain, and physician had put her through several different range of 
motion tests'')).\2\
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    \2\ As McKinney explained, 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.' '' 73 FR at 
43266 (quoting United States v. McIver, 470 F.3d 550, 559 (4th Cir. 
2006)).
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    I agree with the ALJ that where the Government fails to provide 
expert testimony to support a finding that a practitioner acted outside 
of the usual course of professional practice and lacked a legitimate 
medical purpose, it can nonetheless prove a violation by: (1) Providing 
evidence that a practitioner committed a violation of a state medical 
practice standard which is sufficiently tied to a state law finding of 
illegitimacy to support a similar finding under Federal law,'' or (2) 
providing evidence showing that Respondent knowingly diverted drugs. 
However, I also conclude that a violation of a state medical practice 
standard which has a substantial relationship to the CSA's purpose of 
preventing substance abuse and diversion is also sufficient to support 
a violation of 21 CFR 1306.04(a). Moreover, I disagree with the ALJ's 
conclusion that the Government has not proved a violation of the CSA's 
prescription requirement.
    In its exceptions, the Government argues that it proved that 
Respondent did not perform a physical examination of either UC1 or UC2. 
Gov. Exc. at 3. The ALJ found otherwise, noting that Florida law does 
not define the term ``physical examination,'' and that at the time of 
the events at issue here, the meaning of the term under the State's law 
was ``nebulous.'' ALJ at 47 & n.25. The ALJ further explained that 
Respondent's ``interpretation, in light of the Government's failure to 
provide a contrary one, must be given considerable weight'' and that 
Respondent had explained that ``[a] physical examination does not 
necessarily entail touching the body'' as ``in the case of chronic 
injury `you can't see--whether you're putting your hands on the patient 
or not, you can't see that evidence of chronic inflammation and disease 
by visual inspection or palpation.'' Id. The ALJ also credited 
Respondent's testimony that she performed a physical examination 
through ``silent observation,'' i.e., by watching how the patients 
walked from the waiting room to the exam room and how they sat. Tr. 
413, 449; ALJ at 47-48. However, when questioned on cross-examination 
as to why Respondent had made no findings in the undercover officers' 
charts as to her observations, Respondent testified that she only 
recorded observations if the patient had complained of pain and then 
``done an inappropriate action'' such as ``complain[ing] of severe low 
back pain'' and then ``bent over and jumped in the air.'' Tr. 543.
    It is far from clear why Respondent's explanation should be 
entitled to ``considerable weight'' given the ALJ's acknowledgment that 
it ``has the potential for being self-serving,'' ALJ at 43 n.23; and 
appears to be patently disingenuous.\3\ Moreover, just as jurors are 
not required in criminal cases to disregard ``their own experiences in 
doctors' care over their lives'' in assessing evidence as to whether a 
physician performed a bona-fide physical exam and thus prescribed in 
the usual course of professional practice, United States v. Armstrong, 
550 F.3d 382, 389 (5th Cir. 2008), so too, an Agency adjudicator can 
call on her experiences with physicians and conclude that merely 
watching a patient walk to an office and sit down does not constitute a 
physical exam, let alone one sufficient to support prescribing 
narcotics.
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    \3\ Among the ALJ's findings which she then proceeded to ignore 
in giving ``considerable weight'' to Respondent's testimony as to 
the proper scope of a physical examination was Respondent's 
discussion of UC2's MRI. More specifically, the ALJ found that 
Respondent had ``explained that she would have `to take the clinical 
symptoms and * * * the exam, [and the] neurological examination' of 
the patient to determine if there was any significance to the 
bulging disc. She further explained that if `someone has a bulge but 
has no symptomatology, now, it's there * * * [but] it's not 
clinically significant.' '' ALJ at 25 (quoting Tr. 454-55). 
Respondent did not, however, perform a neurological exam on UC2 at 
any time. Tr. 289, 297, 300. In addition, as Respondent's testimony 
suggests, an MRI might well show that a person has a bulging disc 
but that the condition is asymptomatic. Yet as the evidence shows, 
Respondent prescribed oxycodone to UC1 and UC2, notwithstanding that 
neither complained of having pain at a level, which according to 
Respondent's own statement to UC3, warrants oxycodone.
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    However, I need not decide whether Respondent performed a 
legitimate physical exam of any of the undercover officers, or whether, 
as the Government argues, ``the plain meaning of the term `physical 
examination' is that a physician [must do] something more than watch 
the patient walk into her office.'' Gov. Exc. at 5. Here, the record 
contains sufficient other evidence to conclude that Respondent both: 1) 
knowingly diverted drugs, and 2) violated State medical practice 
standards that have a substantial relationship to the CSA's purpose of 
preventing drug abuse and diversion so as to support a finding that she 
acted outside of the usual course of professional practice and lacked a 
legitimate medical purpose in issuing the prescriptions. 21 CFR 
1306.04(a).
    As the ALJ recognized, the Florida Board of Osteopathic Medicine 
has, by regulation, promulgated ``Standards for the Use of Controlled 
Substances for Treatment of Pain.'' ALJ at 47 (citing Fla. Admin. Code 
Ann. r.64B15-14.005). The Board has explained that the standards 
``communicate what the Board considers to be within the boundaries of 
professional practice.'' Fla. Admin. Code Ann.r.64B15-14.005(1)(g).
    The first of these standards is the Board's standard for 
``Evaluation of the Patient.'' This provision states:

    A complete medical history and physical examination must be 
conducted and documented in the medical record. The medical record 
should document the nature and intensity of the pain, current and 
past treatments for pain, underlying or coexisting diseases or 
conditions, the effect of the pain on physical and psychological 
function, and history of substance abuse. The medical record also 
should document the presence of one or more recognized medical 
indications for the use of a controlled substance.

Id. r.64B15-14.005(3)(a). In addition, the standards state that 
``[a]fter treatment begins, the osteopathic physician should adjust 
drug therapy to the individual medical needs of each patient.'' Id. 
r.64B15-14.005(3)(b). As

[[Page 60902]]

the Board further explained in its discussion of pain management 
principles, ``[p]ain should be assessed and treated promptly, and the 
quantity and frequency of doses should be adjusted according to the 
intensity and duration of the pain.'' Id. 64B15-1.005(1)(c).
    Of note here, even if the Government has not proved that 
Respondent's physical examination was medically inadequate to support 
her diagnoses of UCs 1 and 2, the evidence shows that Respondent's 
evaluations of them failed to comply with the Board's standards in 
several other ways. Moreover, because these violations have a 
substantial relationship to the CSA's purpose of preventing drug abuse 
and diversion they support the conclusion that the prescriptions 
violated 21 CFR 1306.04(a).
    At her first visit, UC1 (Tanya Hall), who indicated that she was 
from Illinois, obtained a prescription for 180 oxycodone 15 mg, as well 
as 30 Xanax 2mg.\4\ RX1, at 1, 5. Yet on her intake form, UC1 rated her 
pain as a 3 on a scale of 1 to 10, and gave as her reason for visiting 
Respondent, ``soreness in neck and shoulder.'' RX 1, at 2, 6. While 
during her first meeting with Respondent, UC1 reported that two months 
earlier, she had been working in a school cafeteria and had some boxes 
of chicken nuggets fall on her as she was getting one of them out of a 
freezer and that she also had a slip and fall incident,\5\ UC1 did not 
make any statement to Respondent that she was currently in pain and 
Respondent did not conduct any further inquiry into the nature and 
intensity of her pain and what effect, if any, it had on her physical 
and psychological functioning. GX 14B. Moreover, during her visit with 
Respondent, UC1 never claimed to suffer from ``breakthrough pain.''
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    \4\ UC1 also obtained prescriptions for 30 Soma 350 mg 
(carisoprodol) and 90 Ibuprofen 800 mg.
    \5\ UC1 also reported auto accidents in 1999 and 2003. However, 
this did not prompt Respondent to ask UC1 about the extent of her 
injuries from these accidents and what treatment had been provided 
for any injuries.
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    Notably, during an encounter with UC3 (which occurred the same 
day), Respondent explained that under her pain scale, pain between 1 
and 3 was ``mild pain,'' that pain at level 4 was ``comfortable pain,'' 
and that at this level, ``I can do whatever I want to do because the 
pain is just not that bad.'' GX 13B, at 12 & 14. Respondent then asked 
rhetorically: ``Is that the time to take a break with narcotic, an 
opiate, a dangerous heroin related drug? No, it's not.'' Id. at 14. 
Shortly thereafter, Respondent added: ``So, if the worst pain is being 
tolerable pain [or level 5 according to Respondent] and it's never 
being as bad as bitching pain [level 6 according to Respondent], maybe 
you don't need a narcotic. Or may be some * * * Vicodin * * * You know, 
Hydrocodone, not an Oxycodone.'' Id. As this makes clear, under 
Respondent's own pain scale, the oxycodone prescriptions she issued to 
UC1 (and UC2) were not medically necessary to treated UC1's (or UC2's) 
reported pain level.
    Moreover, when Respondent asked UC1 ``what kind of medicine have 
you been on?,'' UC1 reported that she had been taking Vicodin and 
Tylenol III (a drug with codeine). GX 14B, at 10. However, Respondent 
did not ask her whether she had previously been (or was currently 
being) treated by another physician, and if so, what treatments had 
been tried. Id. Finally, when Respondent offered to prescribe a drug 
combining oxycodone with acetaminophen, UC1 complained that drugs with 
acetaminophen hurt her stomach. However, when Respondent then asked: 
``Does it make[] you nauseous or bother your stomach? Tell the truth,'' 
UC1 replied: ``No, not really.'' Id. at 12. UC1 persisted in not 
wanting a drug with acetaminophen, and asked Respondent if she could 
try oxycodone 15 mg. Id. at 13. Respondent then agreed, stating: 
``Alright, no big deal,'' and added ``Lucky, I love my patients.'' Id. 
While at this point, Respondent had reason to know that UC1 was not a 
legitimate patient, but rather a drug seeker, she nevertheless 
prescribed 180 tablets of Oxycodone 15 mg to UC1, with the dosing 
instruction to take one tablet every 6 hours and \1/2\; tablet for 
level 6 breakthrough pain.\6\ RX 1, at 5. Notably, at no point did 
Respondent--even though she had reason to know that UC1 was a drug 
abuser--question her about her past drug abuse.
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    \6\ Respondent also prescribed 30 Xanax 2 mg.
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    At UC1's second visit (Mar. 22, 2010), Respondent indicated on the 
progress note that UC1 had pain levels of 6-7/10 and 2-3/10. Id. at 15. 
While UC1 had circled her left shoulder on a pain assessment form, she 
indicated on the form that the worst her pain got was a 3. Id. at 16; 
Tr. 220. Moreover, during the visit, Respondent did not ask UC1 about 
her condition. Tr. 220-21. Respondent, however, issued UC1 a 
prescription for 360 Oxycodone 15 mg, double the amount of the original 
prescription, with the dosing instruction to take two tablets every six 
hours and one tablet for level six breakthrough pain,\7\ as well as 30 
Xanax 2mg. RX1, at 19. Moreover, on this day, Respondent saw UC1 and 
UC2 (Pedro Castillo) together.
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    \7\ The actual prescription was issued on a script bearing the 
name Daniel M. Jacobs, M.D., and apparently signed by Dr. Jacobs. 
See RX 1, at 19. However, UCI did not see Dr. Jacobs that day, and 
received the prescription from Respondent. Tr. 222.
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    On April 20, 2010, UC1 and UC2 returned to Respondent. Once again, 
they saw Respondent together. While at this visit, UC1 indicated that 2 
was her ``acceptable level of pain,'' she left blank the entries on the 
pain assessment form for indicating the ``[p]resent'' intensity, the 
``[w]orst pain gets,'' and ``[b]est pain gets.'' RX1, at 21. Moreover, 
during the visit, Respondent did not ask her any questions regarding 
her pain levels and asked her only if she was getting in the pool and 
the frequency of her doing so, and whether the dosing of the Xanax was 
working well for her. GX 17C, at 7; 17D, at 6. Respondent, however, 
issued UC1 more prescriptions, including one for 180 Oxycodone 15 mg 
and 30 Xanax 2mg. RX1, at 22.
    As for UC2, who also represented that he was from Illinois, at his 
first visit he listed ``stiffness in neck'' as the reason for his 
visit; however, he left the form for indicating his general health 
history entirely blank. RX 2, at 5, 12. Moreover, on his pain 
assessment form, UC2 rated his pain intensity as a 2 on a scale of 1 to 
10 and left the rest of the form blank including the entries for 
describing the ``quality,'' ``onset'', ``manner of expressing,'' ``what 
relieves your pain,'' and ``what causes or increases your pain.'' Id. 
at 15.
    When Respondent asked UC2 what medicine he had been on, UC2 stated 
that he had not ``gotten anything from a doctor'' and he ``was just 
getting some Oxys from a friend * * * because that was the only thing 
that was helping my neck.'' GX 15B, at 34. Respondent noted that UC2 
had ``one * * * mild bulging disc * * * which is basically what Tanya 
has.'' Id. Respondent added that he would ``normally say, `You know 
what, I have four herniated discs, in fact bulging discs, and I get 
fine on Percocet' '' 10/325. Id. Respondent then said he would 
prescribe oxycodone 15 mg, but not oxycodone 30s, which UC2 had stated 
were the ones he was getting from his friend. Id. at 35.
    Subsequently, Respondent noted that UC2 had one bulging disc, which 
was neither torn nor herniated, and was ``not even pressing'' on a 
nerve; Respondent advised that this condition did not warrant oxycodone 
30 mg and required only 10/325. Id. at 39. Respondent further explained 
that oxycodone 10/325s cost only twenty-five cents more

[[Page 60903]]

than oxycodone 15mg, and that when he had hurt his neck and had four 
herniated discs, he had used 10/325s with his pool program. Id. at 41-
42.
    Respondent noted that if UC2 used his pool program and stayed on 
the Ibuprofen, UC2 would not need to spend $200 on oxycodone ``which 
you don't need.'' Id. at 42. Continuing, Respondent asked: ``So, now 
that I've given you all the options which do you want?* * * Which 
medicine you want?'' Id. UC2 stated that he wanted the oxycodone 15s 
and not the oxycodone 10s, because he thought the 15s would be better 
and he knew his buddy had given him that. Id. Respondent then told UC2 
that he was out of oxycodone 15mg and that he would have to come back 
like his ``friend'' UC1. Id. at 43. UC2 then asked if ``I'll get the 
same other stuff that [UC2] got?'' Id. Respondent answered: ``Yes, yes, 
exactly the same.''
    Finally, Respondent got around to asking UC2 how he got hurt. Id. 
at 44. Initially, UC2 said that he ``had a little accident at home,'' 
but Respondent then asked if he had a ``car accident or what?'' Id. UC2 
said he had been in a motorcycle accident ``in the last year, some 
time'' and that was how he hurt his neck. Id. UC2 stated, however, that 
he did not hurt his lower back, that he did not have numbness or 
tingling in his hands, that he did not have pain radiating into his 
arms or hands, and that his pain was not constant but ``comes and goes 
sometimes.'' Id. at 44-45. Respondent explained that he was going to 
prescribe 180 oxycodone 15mg and that UC2 should take a half of a 15mg 
tablet ``[w]hen level five (5) tolerable pain become level six,'' or 
``very uncomfortable, miserable, bitching pain.'' Id. Respondent then 
asked UC2 whether he had difficulty sleeping, to which UC2 answered 
``sometimes.'' Id. at 47. Respondent said he would give him Xanax, even 
though he had already stated that he would give UC2 the same drugs he 
gave UC1.\8\
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    \8\ Respondent also asked UC2 if he got ``muscle spasms at 
night?'' GX 15B, at 48. UC2 answered, ``yeah.'' Id. Respondent then 
said he would prescribe Soma 350 mg as well, without any further 
inquiry as to how often UC2 has spasms and how debilitating they 
were. See id.
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    Here again, notwithstanding that UC2 never represented at this 
visit that he had pain higher than level 2, Respondent issued him 
prescriptions for 180 oxycodone 15 mg and 30 Xanax 2mg (as well as 
Ibuprofen and Soma). Moreover, on the progress note documenting the 
visit, Respondent wrote that UC2 had a neck injury and that his ``pain 
comes & goes,'' but did not document any pain level. RX 2, at 1.
    As noted above, on March 22, UC2 and UC1 saw Respondent together. 
This time Respondent indicated in the progress note that UC2 had 
``Chronic left shoulder pain'' and wrote pain levels of 6-7/10 and 2-3/
10. RX 2, at 17. UC2 testified, however, that during the second visit, 
there was no discussion of whether he had pain. Tr. 297. UC2 further 
stated that he complained of having only stiffness in his neck, and not 
chronic pain in his left shoulder. Id. at 313-14. Respondent gave UC2 
prescriptions (which, just as for UC1, were written on the script and 
DEA number of Dr. Jacobs \9\) for 360 Oxycodone 15mg (also double the 
previous dose), 30 Xanax 2mg, Ibuprofen and Soma. RX 2, at 19.
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    \9\ Here too, UC2 testified that he did not see Dr. Jacobs that 
day. Tr. 299.
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    Likewise, at the third visit, UC2 noted a pain level of three on a 
form, but again complained only of a stiff neck. RX2, at 16; Tr. 300-
01. On the progress note, however, Respondent noted that UC2 had pain 
levels of 6-7/10 and 2-3/10 and had ``chronic left shoulder pain.'' RX 
2, at 20. While Respondent asked UC2 how he was doing on ``the 180 
program,'' a reference to his oxycodone prescribing, to which UC2 
answered ``awesome,'' at no point during the visit did Respondent ask 
UC2 what his pain levels were. See GX 17C & 17D. Respondent then gave 
UC2 a prescription for 180 oxycodone 15 mg, as well as 30 Xanax, and 
the other two drugs.\10\
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    \10\ Respondent also asked UC2 if he was ``doing wonderful[ly] 
on'' the Xanax dosing; UC2 answered that ``[i]t's working for me.'' 
GX 17D, at 2-3.
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    UC2 testified that Respondent did not perform a physical 
examination of him at any of the three visits. Notwithstanding 
Respondent's testimony that she silently observed UC2, unexplained is 
the basis for her diagnosis that UC2 had ``chronic left shoulder pain'' 
when he never complained of anything other than a stiff neck.
    As the forgoing demonstrates, even assuming that Respondent's 
silent observation of UC1 and UC2 constitutes a valid physical 
exam,\11\ the evidence shows that in multiple other ways, Respondent 
did not comply with the State's standard for evaluating his patient and 
determining whether prescribing controlled substances was warranted. 
She failed to inquire as to whether the UCs had been, or were currently 
being, treated by other doctors for their purported conditions and what 
those treatments involved. Likewise, Respondent made no inquiry as to 
the effect of the UCs' pain on their physical and psychological 
functioning. Moreover, she did not ask either UC about their history of 
substance abuse even though Respondent had reason to know that both UC1 
and UC2 were drug seekers. Finally, at their second (joint) visit, 
Respondent doubled the amount and dosage of UC1's and UC2's oxycodone 
prescriptions even though she did not discuss with either of them their 
current pain levels and the efficacy of the prior prescriptions.
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    \11\ It is also noted that Respondent did not document the 
results of her silent observation.
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    The ALJ did not address whether these requirements, which 
Respondent clearly violated, have a substantial relationship to the 
CSA's core purpose of preventing drug abuse and diversion so as to 
support a finding that Respondent lacked a legitimate purpose and acted 
outside of the usual course of professional practice in prescribing 
controlled substances to UCs 1 & 2. I conclude that they do.
    For example, inquiry into whether a patient is currently being 
treated, or has previously been treated for pain, might reveal that the 
patient is engaged in, or has a history of, doctor shopping or other 
non-compliant behaviors consistent with self-abuse or diversion; such 
inquiry might also show that controlled substances were previously 
tried and not effective. Fla. Admin. Code r.64B15-14.005(3)(d)(noting 
important of reevaluating ``the appropriateness of continued 
treatment''). Inquiry into the effect of pain on a patient's physical 
and psychological functioning would seem to be an essential step in 
determining whether the patient's report of pain is consistent with his 
level of function, and whether prescribing controlled substances is 
even medically indicated to treat a patient's pain, as well as the 
appropriate drug and dosage level, another critical step in preventing 
diversion and self-abuse. Likewise, inquiry into whether a patient has 
a history of substance abuse has an obvious relationship to the CSA's 
purpose. Finally, the failure to adjust drug therapy based on a re-
evaluation of the patient could lead to a patient's becoming addicted 
or overdosing.\12\
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    \12\ It could also result in the patient having extra drugs 
which could be sold on the street.
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    Respondent's failure to comply with these requirements with respect 
to UC1 and UC2 is fundamentally different than the situation at issue 
in McKinney, where the practitioner clearly violated a state regulation 
by not listening to an undercover officer's heart and lungs and taking 
her blood pressure but otherwise

[[Page 60904]]

performed a physical exam. To make clear, this is not a case where a 
physician made some attempt to comply with various state medical 
practice standards and the adequacy of those efforts is at issue.\13\ 
Rather, it is a case where a physician has utterly failed to comply 
with multiple requirements of state law for evaluating her patients and 
determining whether controlled substances are medically indicated and 
thus has ```completely betrayed any semblance of legitimate medical 
treatment.''' McKinney, 73 FR at 43266 (quoting United States v. 
Feingold, 454 F.3d 1001, 1010 (9th Cir. 2006)). Indeed, the State 
Board's statement that its standards ``communicate what the Board 
considers to be within the boundaries of professional practice,'' Fla. 
Admin. Code r.64B15-14.005(1)(g), provides further support for the 
conclusion that Respondent, by failing to comply with them, acted 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose in prescribing oxycodone to UC1 and UC2 \14\ 
and thus violated Federal law. 21 CFR 1306.04(a); see also Fla. Stat. 
Ann. Sec.  893.05(1) (``A practitioner, in good faith and in the course 
of his or her professional practice only, may prescribe * * * a 
controlled substance'').\15\
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    \13\ Such a case would likely require expert testimony to show 
that a physician did not merely commit malpractice, but rather, 
acted outside the boundaries of professional practice.
    \14\ The Government takes exception to the ALJ's finding of fact 
116, in which she credited Respondent's testimony that she ``was 
willing to make a small salary so that people could afford to come 
and learn'' and that ``if I could dispense the pills at a reasonable 
price, it would be an incentive for them * * * to come and stay with 
the program. If they kept with the program and they got used to the 
program, eventually they would be able to get off of narcotics.'' 
ALJ at 33-34 (FoF 33-34); Exceptions at 6-7.
    That this testimony is patently self-serving and disingenuous is 
made clear by the undercover visits of UC1 and UC2, in which 
Respondent prescribed oxycodone to them notwithstanding that the UCs 
reported low pain levels (which were also well below the levels 
Respondent stated warranted oxycodone), and Respondent made no 
inquiry into how each of the UCs' respective pain levels were 
affecting their physical and psychological function, made no inquiry 
into whether they had a history of substance abuse, and made no 
inquiry into whether the UCs had previously been or were currently 
being treated for pain. In any event, having concluded that 
Respondent violated 21 CFR 1306.04(a) with respect to UC1 and UC2 
and thus unlawfully distributed controlled substances to them, 
whether Respondent charged the highest price she could or discounted 
the drugs does not make the distributions any less unlawful.
    The Government also takes exception to the ALJ's having given no 
weight to the testimony of a Diversion Investigator that Respondent 
had stated that she did not dispense controlled substances at a 
patient's first visit. Exceptions at 8 (citing FoF 30 & n.5). It is 
acknowledged that the ALJ stated that she gave ``this testimony no 
weight.'' ALJ at 10 n.5. However, it is not clear whether the ALJ 
was referring to the DI's testimony or the statement Respondent made 
to the DI as the ALJ also noted that Respondent's statement to the 
DI ``is inconsistent with her conduct regarding the undercover 
visits.'' ALJ at 10 n.5. However, because it is clear that 
Respondent issued prescriptions to the UCs at their first visits, I 
conclude that it is not necessary to resolve what the ALJ meant and 
whether she improperly gave no weight to the DI's testimony.
    \15\ In her discussion of factor five--such other conduct which 
may threaten public health and safety--the ALJ found that many 
characteristics of Respondent's practice increased the risk of 
diversion. ALJ at 60-62. More specifically, the ALJ noted that 
Respondent did not conduct urine drugs screens on the undercover 
patients, operated a cash-only dispensary thus foreclosing third-
party review, did not verify the MRIs that were presented by the 
UCs, and failed to obtain past treatment records. Id.
    In contrast to the requirements imposed under the State's 
standard for ``Evaluation of the Patient,'' the Florida standards 
then in effect did not explicitly require that a doctor perform 
urine drug screens or verify the authenticity of an MRI. Moreover, 
while the State's standard required documenting a patient's past 
treatments for pain, it says nothing about obtaining past treatment 
records. Given that these requirements were not explicitly imposed 
by the State's rules, either expert testimony or perhaps medical 
treatises (or articles in peer-reviewed medical journals) was 
necessary to establish that each of these is required as part of the 
accepted standard of professional practice. Because there is no such 
evidence, the ALJ's conclusions that each of these omissions 
constitutes conduct which may threaten public health and safety must 
be rejected.
    As for Respondent's operation of a cash-only clinic, while this 
may be probative evidence of illegal activity when considered with 
the other evidence in the case, by itself, operating a cash-only 
clinic does not constitute conduct which may threaten public health 
and safety.
---------------------------------------------------------------------------

    Moreover, Respondent's testimony makes clear that she does not 
accept responsibility for her misconduct in prescribing to the UCs. 
When asked by her own counsel whether her oxycodone prescriptions were 
medically appropriate, she asserted that they were because ``the PDR 
allows up to 30-milligrams, which is twice the 15 that I recommended 
for these patients,'' Tr. 484, ignoring that UC1 and UC2 never 
complained of pain warranting prescriptions at this level of drug. 
Likewise, in addressing why she gave UC3 an extra twenty oxycodone 
pills after he requested them so that he could repay a friend, 
Respondent offered the disingenuous testimony that she did so so that 
UC3 would ``have those twenty extra pills as a parachute'' and she 
``didn't want him to worry.'' Id. at 512. While in her testimony 
Respondent maintained that this was ``an error of judgment,'' in fact, 
it was a criminal act. 21 U.S.C. 841(a)(1).
    It is true that at UC3's third visit, Respondent refused to give 
UC3 additional pills. However, here again Respondent gave false 
testimony, stating that she had told UC3 that ``[i]f you know you're 
going to be short, you break and take half pills so you won't go into 
withdrawal.'' Tr. 513. However, as the transcript of the undercover 
visit makes clear, there was no discussion of withdrawal. Instead, she 
advised UC3 that if he owed people, he could break the pills and ``take 
a fifteen instead of a thirty and that way'' he could save the extras 
and ``give the money back.'' GX 16B, at 22.\16\
---------------------------------------------------------------------------

    \16\ The evidence shows that UC3 was given a prescription for 
180 Oxycodone 30 mg at his third visit by Dr. Jacobs. See RX 3, at 
11-12.
---------------------------------------------------------------------------

    Respondent's advice to UC3 is fundamentally inconsistent with a 
registrant's obligation to prevent drug abuse; her giving of false 
testimony on this and other issues, as well as the numerous violations 
of the CSA which have been proved on this record make clear that she 
cannot be entrusted with a registration. Accordingly, I will adopt the 
ALJ's ultimate conclusion that Respondent's continued registration 
would be inconsistent with the public interest and her recommendation 
that I revoke her registration and deny any pending applications to 
renew or modify her registration.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration FD1749057, issued to Jack A. Danton, D.O., a/k/a/Jacalyn 
A. Danton, D.O., be, and it hereby is, revoked. I further order that 
any pending application of Jack A. Danton, D.O., a/k/a Jacalyn A. 
Danton, D.O., to renew or modify her registration, be, and it hereby is 
denied. This Order is effective October 31, 2011.

    Dated: September 19, 2011.
Michele M. Leonhart,
Administrator.
Carrie Bland, Esq., for the Government.
Brian Y. Silber, Esq., for the Respondent.

Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision 
of the Administrative Law Judge

I. Procedural Background

    Gail A. Randall, Administrative Law Judge. The then Deputy 
Administrator, Drug Enforcement Administration (``DEA'' or 
``Government''), issued an Order to Show Cause and Immediate Suspension 
of Registration (``Order'') dated November 19, 2010, proposing to 
revoke the DEA Certificate of Registration, Number FD1749057, of Jack 
A. Danton, D.O., (``Respondent'' or ``Dr. Danton ''), as a 
practitioner, pursuant to 21 U.S.C. 824(a)(4) (2006), and deny any 
pending applications for renewal or modification of such

[[Page 60905]]

registration pursuant to 21 U.S.C. 823(f), because the continued 
registration of the Respondent would be inconsistent with the public 
interest, as that term is used in 21 U.S.C. 823(f) and 824(a)(4). The 
Order also immediately suspended the registration pursuant to 21 U.S.C. 
824(d), because the Respondent's continued registration constituted an 
imminent danger to the public health or safety. [Administrative Law 
Judge Exhibit (``ALJ Exh.'') 1]. The Respondent was served with the 
Order on November 23, 2010. [ALJ Exh. 2].
    The Order asserted that the Respondent dispensed ``inordinate 
amounts'' of controlled substances, primarily oxycodone and alprazolam, 
under circumstances where the Respondent knew or should have known 
``that such prescribing and dispensing are for other than legitimate 
medical purposes and are outside the usual course of professional 
practice.'' [ALJ Exh. 1 at 2].
    Next the Order asserted that many of the patients are from out of 
state, and that they have indicated that the Respondent failed to 
perform physical examinations and only accepted payment in cash. [Id.].
    Next, the Order asserted that between February and April of 2010, 
the Respondent treated three law enforcement personnel, operating in an 
undercover capacity. At each of at least eight visits the Respondent 
issued prescriptions for other than legitimate medical purposes and 
outside the usual course of professional practice. The Respondent's 
prescribing of controlled substances to these individuals violated both 
State and Federal law, per the Order. [Id.].
    By letter dated December 14, 2010, the Respondent, through counsel, 
timely filed a request for a hearing in the above-captioned matter. 
[ALJ Exh. 3].
    At the Respondent's request, the hearing was held in Fort 
Lauderdale, Florida, on April 5-7, 2011. [ALJ Exh. 5-8; Transcript 
(``Tr.'') Volume I-III]. At the hearing, Counsel for the DEA and 
Counsel for the Respondent called witnesses to testify and introduced 
documentary evidence. After the hearing, the Government \17\ submitted 
Proposed Findings of Fact, Conclusions of Law and Argument.
---------------------------------------------------------------------------

    \17\ The Respondent attempted to submit her post-hearing brief 
late. Her request for permission to submit it late was denied. The 
Government timely submitted its brief.
---------------------------------------------------------------------------

II. Issue

    The issue in this proceeding is whether or not the record as a 
whole establishes by a preponderance of the evidence that the Drug 
Enforcement Administration should revoke the DEA Certificate of 
Registration Number FD1749057of Jack A. Danton, D.O., as a practitioner 
pursuant to 21 U.S.C. 824(a), and deny any pending applications to 
renew or modify this registration under 21 U.S.C. 823(f), because to 
continue Respondent's registration would be inconsistent with the 
public interest as that term is used in 21 U.S.C. 823(f). [Transcript 
(``Tr.'') at 6].

III. Findings of Fact

    I find, by a preponderance of the evidence, the following facts:

A. Stipulated Facts

    1. Respondent is registered with DEA as a practitioner in Schedules 
II-V under DEA registration number FD1749057.
    2. Respondent's DEA registration expires by its terms on June 30, 
2012.

B. Background Facts

    3. The Respondent is a doctor of osteopathic medicine who practices 
in cosmetic dermatology, cosmetic surgery, and some family practice. 
[Tr. 378]. She has practiced in those areas for thirty-five years. [Tr. 
379]. A greater percentage of her practice was ``dealing with 
musculoskeletal injury.'' [Tr. 384]. In 2009, after the demand for 
cosmetic surgery declined, the Respondent added pain management to her 
area of practice. [Tr. 385-87].
    4. Dr. Danton is a veteran of the United States Army and the Viet 
Nam war. [Tr. 379-80].
    5. ``Palliative care'' means that ``once the acute injury heals, 
that there's still something going on from either pinched nerves or 
some kind of pressure or spinal problems that cause the pain nerve to 
remain in active pain, even though the initial injury might heal.'' 
[Tr. 386]. Up to the time of the hearing, the Respondent treated from 
five to ten-thousand pain management patients seeking treatment for 
acute injuries all the way to chronic palliative care. [Tr. 390]. 
However, the Respondent is not Board certified in pain management. [Tr. 
391].
    6. At the hearing, Dr. Danton was recognized as an expert in the 
field of osteopathic medicine with extensive experience in pain 
management assessment and treatment. [Tr. 392].
    7. Dr. Danton described how the human body becomes dependent on 
pain medications and how the body grows to tolerate pain medication. 
[Tr. 395-399]. The Respondent testified that she restricted her 
patients to taking four 15 mg oxycodone tablets a day. [Tr. 400].
    8. In diagnosing muscular-skeletal injuries, the more important 
part of the diagnostic tools would be the MRI, for it is objective 
evidence of such an injury. [Tr. 558].
    9. Prior to opening her own practice, the Respondent worked at a 
pain clinic called the Pain Center of Broward. [Tr. 554]. She also 
supervised a physician assistant, signing all the controlled substance 
prescriptions herself. The role of the physician assistant is to 
examine patients and to either continue or follow the physician's 
treatment plan, or if the physician assistant sees any noted change in 
the patient's condition based on the examination, to inform the 
physician of the change. The physician would write the prescription 
appropriately. [Tr. 570].
    10. The Respondent testified that, although over 400,000 dosage 
units of oxycodone were attributable to her per the ARCOS reports, she 
in fact did not see all of the patients represented by this dosage 
number. The physician assistant saw multiple patients per day as well. 
[Tr. 526, 554]. Another physician was hired, and the Respondent does 
not know whether controlled substances purchased using the Respondent's 
DEA registration were actually dispensed by this physician as well. 
[Tr. 555]. The Respondent left that practice when her ``180 program'' 
was not being followed. [Tr. 526]. She left her DEA Form 222s at the 
Pain Center of Broward when she left the practice. [Tr. 556].
    11. When asked if ``any time an order was placed using your DEA 
number, was that an order done appropriately and legitimately or for 
other purposes,'' the Respondent replied that she was not sure. 
Specifically, she stated that the DEA Form 222s she signed ``were done 
appropriately and legitimately, but if my former employer went and 
ordered stuff and signed my name to it, I had no knowledge or concept 
that it was being done.'' [Tr. 574-75]. It's possible that some of the 
over 400,000 dosage units were ordered without the Respondent's 
knowledge. [Tr. 575].
    12. The Respondent primarily wrote prescriptions using a computer. 
However, she did have prescription pads, and it was possible that such 
a pad was outside her control on the day the search and seizure warrant 
was executed, although she did not intentionally leave such a pad 
outside her control. [Tr. 557]. The Respondent was a dispensing 
physician. [Tr. 210, 237, 341, 346-47, 362].
    13. A pain management clinic would dispense a large number of 
oxycodone

[[Page 60906]]

because the clinic's patients are being seen regularly for chronic pain 
problems and obtaining controlled substances every month. [Tr. 527]. 
The Respondent also believed this over 400,000 dosage units figure 
reported in ARCOS actually corresponds to the number of chronic pain 
patients she and Dr. Jacobs treated. [Tr. 528].
    14. Dr. Danton developed a treatment program she described as the 
``180 program.'' [Tr. 402]. The essential point of the 180 program was 
to help patients control their pain without developing tolerance to the 
pain medication and to keep the patient safe from a drug overdose. [Tr. 
402]. To her knowledge, Dr. Danton is the only physician who limits 
oxycodone prescriptions to 180 dosage units of 15 mg oxycodone. [Tr. 
403]. However, depending on the patient's pain level and the diagnosis, 
the Respondent would sometimes prescribe 30 mg oxycodone. [Tr. 403].
    15. Dr. Danton described a bulging disc as a disc between vertebrae 
in the back that acts as a gel-filled shock absorber. After a high 
velocity injury, the gel begins to thin out and form a bulge of the 
disc material outward, pressing on the nerve roots, causing pain. [Tr. 
406-09].
    16. Dr. Danton described a herniated disc as a disc where the gel 
actually cracked out of the disc and escapes into a very small space in 
the spine, causing more pressure on the nerve roots, thus causing more 
pain. [Tr. 410]. The added pressure can also cause inflammation, which 
causes swelling around the nerve roots, making the pain worse as well. 
[Tr. 410-11].
    17. Scoliosis is an abnormal curvature of the spine and can cause 
pain. [Tr. 417-19]. The nerve roots in the back become impinged and 
inflammation around the nerve roots results which causes the pain. [Tr. 
419]. Scoliosis comes in degrees, and the severity of the scoliosis 
impacts upon the severity of the pain. [Tr. 419-20]. If a patient 
elects not to have surgery, then the appropriate treatment is pain 
management with analgesics. [Tr. 420].
    18. To diagnose and treat scoliosis, Dr. Danton would ask about the 
patient's history, to determine whether the scoliosis was developmental 
and to find out what kind of past treatment the patient has 
experienced. [Tr. 421]. A prior physician would have prescribed an MRI, 
and the patient would bring that MRI report for Dr. Danton to review. 
[Tr. 421-23]. Unlike an X-ray, an MRI shows soft tissue changes such as 
impingement of nerves caused by a herniation of a disc. [Tr. 423-24].
    19. To determine if a patient has either a bulging disc or a 
herniated disc, the Respondent listens to the level of the patient's 
complaint, looks at the medical history forms, and evaluates how the 
patient moves into the treatment room, watching how the patient walks 
and sits as part of the physical examination. [Tr. 412-13]. Next, Dr. 
Danton would look at a purely objective evaluation, such as an MRI. 
[Tr. 414]. She is also evaluating the consistencies of the MRI with the 
patient's complaint, and looking to see if the patient is honest and 
truthful. [Tr. 414]. Patients who are not honest and truthful tend to 
exaggerate their pain levels, so that their complaints do not match up 
with their MRI results. [Tr. 415-16]. The Respondent also testified 
that when patients subjectively rated their pain level, she interpreted 
that rating to mean their pain level with medication. Therefore, if a 
patient rated his pain at 2, then she interpreted the patient's pain to 
be at a level 7 without pain medication. [Tr. 469-70].
    20. According to Dr. Danton, a physical examination does not 
necessarily ``entail touching the body.'' [Tr. 425]. For example, in 
the chronic injury ``you can't see--whether you're putting your hands 
on the patient or not, you can't see that evidence of chronic 
inflammation and disease by visual inspection or palpation.'' [Tr. 
428]. But the physician can inspect the painful area, can get an idea 
of the pain by watching the patient move the body, which is also a part 
of the physical examination. [Tr. 428-29]. Although different now, in 
early 2010, the physician also needed to get a urinalysis test within 
the first four to six months of treatment with oxycodone. [Tr. 429].
    21. The Respondent prescribed 2 mg tablets of Xanax or alprazolam. 
She described this as a moderate dose, and she instructed her patients 
to take .5 mg during the day, .5 mg in the evening, and 1 mg at night. 
If the patient stops taking Xanax in these quantities, there would be 
no adverse side effects. [Tr. 535].
    22. The Respondent was aware that a complete medical history and 
physical examination must be conducted and noted in a patient's medical 
file. [Tr. 557].
    23. The Respondent has been convicted of four counts of mail fraud, 
but the record contains no information that this conviction entailed 
the handling of controlled substances. [Tr. 560].

C. Respondent's Practice

    24. The Respondent is neither a DATA-waived physician nor 
registered as a Narcotics Treatment Program. [Tr. at 533]. The 
Respondent denied providing her patients with detoxification services. 
[Tr. 533]. However, she did see her role as ``to educate patients how 
to take medicine safely and how to safely get off, away from the 
narcotics. That was my goal.'' [Tr. 581]. She also stated her goal was 
to have patients functioning at ``100%.'' [Tr. 500]. The Respondent is 
also not registered as a pain management clinic with the Florida 
Department of Health. [Tr. 185].
    25. Mr. Gordon Berman worked with the Respondent as the primary 
administrator of her practice. He owned the building. [Tr. 163].\18\ He 
ordered the medications, maintained the records, and ensured the 
practice's procedures were consistent with the legal requirements. [Tr. 
505]. He was also responsible for dispensing the medications and for 
conducting the inventories. [Tr. 163]. As of November of 2010, no 
inventories had been conducted. [Tr. 178, 183]. Mr. Berman is not a 
licensed pharmacist, and has had no previous experience dispensing 
drugs or controlled substances. [Tr. 190].
---------------------------------------------------------------------------

    \18\ Mr. Berman did not testify at the evidentiary hearing. 
Therefore, to the extent that the conversation he had with DI McRae 
constitutes hearsay, I will analyze the weight to give such evidence 
accordingly.
---------------------------------------------------------------------------

    26. Mr. Berman told DEA personnel that he was aware of the State 
law which had come into effect on October 1, 2010, providing that only 
a 72 hour supply of medication could be dispensed. [Tr. 185]. However, 
in November of 2010, he had dispensed 180 oxycodone 30 mg., a one-month 
supply. [Govt. Exh. 2 at 4-6; Tr. 185]. He stated that he knew of the 
limitations, but that he had just dispensed the entire amount. [Tr. 
185].
    27. Mr. Berman had told DEA personnel that every patient basically 
received the same thing; 180 oxycodone 30 mg., Xanax, Ibuprofen, and 
Soma. [Tr. 185-86; see also Govt. Exh. 2-5]. The medication was 
purchased in pre-measured volumes of 90 oxycodone, and the physician 
would issue an order sheet showing the amount to be dispensed. Mr. 
Berman would receive the order sheet, he would hand an employee the 
requisite amount of medication, and the employee would take the 
medication to the physician for review, the physician would sign the 
order sheet and either hand the medication to the patient or instruct 
the employee to do so. [Tr. 190]. The Respondent did not have access to 
the computers, and when questioned about them, she referred DI McRae to 
Mr. Berman. [Tr. 170].

[[Page 60907]]

    28. The Respondent accepted cash as a form of payment. It is 
unclear whether this was the sole form of payment accepted. The 
Respondent stated to DI McRae that to accept insurance would require a 
billing department, and that would cost a lot. [Tr. 165-66]. Further, a 
Diversion Investigator overheard the receptionist tell a patient that 
the clinic only accepted cash. [Tr. 226-7]. However, Mr. Berman stated 
that the practice also accepted Medicaid and Medicare. [Tr. 184]. The 
office visit cost $200.00,\19\ and the medication cost $600.00 per 
patient. [Tr. 170].
---------------------------------------------------------------------------

    \19\ However, I note that the undercover officers paid $150.00 
for their office visits. [Tr. 288, 337].
---------------------------------------------------------------------------

    29. Mr. Berman had a nine-year-old daughter who would sometimes 
come to the office after school. When Ms. Hall saw Mr. Berman and his 
daughter walking in the hallway, Mr. Berman said that his daughter was 
a good little helper, and that he had her counting pills.\20\ [Tr. 215; 
Govt. Exh. 14B at 27]. However, Ms. Hall did not observe the child 
handling pills and the Respondent credibly testified that she never saw 
the daughter touch any pills. [Tr. 259, 589].
---------------------------------------------------------------------------

    \20\ As Mr. Berman did not testify at this proceeding, I am 
unable to determine the credibility or sincerity of this comment. 
Therefore, I give this exchange no weight.
---------------------------------------------------------------------------

    30. The Respondent's job was patient care, making sure the patients 
were appropriately treated. The Respondent also managed the front 
office. [Tr. 505]. The Respondent told DI McRae that she saw between 25 
and 50 patients a day. [Tr. 166]. She had told DI McRae that she did 
not dispense controlled substances on the first visit of a patient. 
[Tr. 167].\21\
---------------------------------------------------------------------------

    \21\ This is inconsistent with her conduct regarding the 
undercover visits. Therefore, I give this testimony no weight.
---------------------------------------------------------------------------

    31. Another physician in the practice, Dr. Jacobs, is also 
practicing the Respondent's ``180 program.'' [Tr. 592].
    32. The Respondent acknowledged that the medications were ordered 
under her DEA registration number and that she took full responsibility 
for them. [Tr. 506, 516]. Yet she acknowledged that she gave people 
authority to take certain actions using her registration. [Tr. 507]. 
She stated that to the best of her knowledge ``we were doing everything 
that we thought'' was within the law. [Tr. 507]. There was no power of 
attorney on file affording Mr. Berman with the authority to sign the 
order forms for the controlled substances. [Tr. 163].
    33. When the Respondent became aware of discrepancies, she made 
corrections. She learned that her pain patients could be manipulative, 
and she ``became a little harder and a little more careful in how'' she 
responded to her pain patients. [Tr. 508-09].
    34. The Respondent's office was burglarized four times, and her 
computer systems with all the backups were stolen. [Tr. 515]. The 
computers the Respondent had on November 23, ``were basically only a 
month old, and the information on them was basically information from a 
month or two.'' [Tr. 515]. Three of the four break-ins occurred when 
the Respondent had no oxycodone on the premises. But in the instances 
that drugs were stolen, the Respondent did not handle informing the 
DEA. The thefts were reported to the Sheriff's Department but not to 
the DEA. [Tr. 122-23, 125, 549]. The Sherrif's Department made no 
mention of the Respondent's obligation to inform the DEA. [Tr. 514]. 
The Respondent credibly testified that she believed the Sherrif's 
Department would handle that responsibility. [Tr. 550]. No DEA theft 
and loss reports were found. [Tr. 125].
    35. For security measures, the Respondent had an alarm system, 
video camera system, and security doors as required between the 
treatment area and the medication room. [Tr. 518]. The oxycodone was 
stored in the medication room. [Tr. 518]. Mr. Berman told the 
Respondent that the facility had been inspected and found to be in 
compliance. However, the Respondent did not know who had inspected the 
facility, and the record does not contain any inspection reports 
indicating such compliance. [Tr. 550].
    36. Ms. Danielle Demers, an employee of the Respondent's, would 
bring her Rottweiler to the office wearing a police service dog vest. 
The dog was a deterrent and stayed in the administrative area of the 
office. [Tr. 516-17]. Ms. Demers wore a police belt with a tazer and a 
baton, but she did not carry a firearm in the clinic. [Tr. 517-18]. Ms. 
Demers was subsequently terminated from her employment. She worked for 
the Respondent approximately five months. [Tr. 520].
    37. Ms. Demers had access to all the records in the practice, to 
include inventory records, DEA Form 222s, and invoices. She also had 
access to the computer systems. [Tr. 520-21]. She knew what security 
measures were in place. [Tr. 521].
    38. The Respondent used two large safes behind the secured medicine 
room doors. One safe was for the Respondent's medications, and the 
other safe held the medications of Dr. Jacob.\22\ [Tr. 521-522, 592]. A 
pharmacy tech, Ms. Teresa Way, had access to the medication, Mr. Berman 
had access, and Ms. Demers had access. Ms. Terry Friedman, an employee 
who worked with the Respondent since she started this practice, may 
also have had access to the medications. [Tr. 522].
---------------------------------------------------------------------------

    \22\ It is unclear when these safes were added to the premises. 
The Government did not see any safes when personnel conducted a 
search of the offices in November of 2010. [Tr. 63, 115] In 
addition, it is similarly unclear whether a safe is depicted in 
Government Exhibit 9.
---------------------------------------------------------------------------

    39. The physician would prepare a charge sheet, noting the 
prescriptions authorized for the patient. The charge sheet would go to 
the pharmacy technician for filling. [Tr. 590]. [See Resp. Exh. 1-3]. 
For her patients, the Respondent would then sign the prescriptions. 
[Tr. 590].
    40. The Respondent has interpreted approximately four or five 
thousand MRI written reports in the course of her medical practice. 
[Tr. 561]. In reviewing the MRI reports pertaining to the undercover 
individuals, the Respondent saw nothing that led her to believe the 
reports were fraudulent, modified or illegitimate. [Tr. 561].
    41. The Respondent tried to ``correspond the patient's history and 
their presentation with the MRI report, and in those three (undercover) 
cases they seem to match.'' [Tr. 561]. Later in her practice, the 
Respondent instructed her front office personnel to call and verify the 
MRI report. If the office staff was unable to do so, they were 
instructed to require the patient to take another MRI locally. [Tr. 
586]. ``We didn't do that in the first three months because at that 
point in time I was, and I accept responsibility for it, I was 
na[iuml]ve. And I believed if somebody brought in an MRI that had their 
name on it and the doctor's signature, that it was a real MRI. I found 
information to the contrary. I changed.'' [Tr. 586].

D. DEA's Investigation

    42. On November 23, 2010, the DEA served a Federal search warrant 
at the Respondent's office, as well as the Immediate Suspension Order. 
[Tr. 19]. The clinic had the name posted as J.A. Danton. [Tr. 47]. 
During the search, Group Supervisor Susan Langston discovered a closet 
containing video equipment and several bottles of oxycodone 30 mg, 100 
count each. [Tr. 21, 112-13; see also Tr. 111; Govt Exh. 9]. This 
closet was located in Mr. Berman's office on the second floor of the 
clinic. [Tr. 22]. GS Langston testified that the closet was not a 
securely locked, substantially constructed cabinet suitable for the 
storage of controlled substances, however could not testify as to why 
it did not meet this requirement. [Tr. 22]. The pill bottles

[[Page 60908]]

were all sealed. [Tr. 112]. GS Langston did not know whether the closet 
was locked, and did not inspect the closet. [Tr. 48, 55]. In addition, 
DI Milan, who also saw the closet, stated she did not know whether the 
closet was locked or could be locked, she was not the first to see the 
closet, it was already open when she saw it, and that she did not 
otherwise investigate whether the Respondent had security on the 
premises. [Tr. 109-111].
    43. Also during the search, GS Langston located an empty 
prescription bottle with a label showing that the bottle had contained 
360 Oxycodone 30 mg tablets. The bottle was found in the Respondent's 
office on the first floor of the facility, and the label indicated that 
the medication was prescribed by Dr. Jack Danton to patient Jacqueline 
Danton, a name the Respondent also used. [Tr. 23, 377].
    44. During an interview with a local reporter, the Respondent 
asserted that she was not providing her patients with large quantities 
of oxycodone, she was weaning them off the drug. [Govt. Exh. 19].
    45. GS Langston identified ``red flags'' from the Respondent's 
practice. First, she received telephone calls from pharmacists 
inquiring as to whether prescriptions written by the Respondent were 
legitimate. [Tr. 36-37, 45]. GS Langston also thought it significant 
that the Respondent saw a large number of people from out of state. 
[Tr. 45-46; see also Tr. 93-95; Govt. Exh. 4].
1. The Audit
    46. DI Marjorie Milan also participated in the serving of the 
Immediate Suspension Order. [Tr. 68]. Her assignment was to collect any 
controlled substances that were on the premises. [Tr. 69]. DI Milan 
found bottles of oxycodone 30 mg. She found a total of 4,000 pills. 
[Tr. 69-70].
    47. DI Milan ran an ARCOS \23\ report, searching for the oxycodone 
purchases made using the Respondent's DEA registration number from 
January 1, 2009, through March 31, 2011. [Tr. 70-71]. The first 
transaction date was December 28, 2009, and the last transaction date 
was November 15, 2010. [Tr. 72; Govt. Exh. 18]. To order oxycodone, the 
purchaser would need to use a DEA Form 222. [Tr. 72]. The Respondent 
was ranked in the top 100 practitioners purchasing oxycodone throughout 
the United States. [Tr. 151].
---------------------------------------------------------------------------

    \23\ARCOS stands for automation of reports and consolidated 
ordering system. [Tr. 70; see also 99-101].
---------------------------------------------------------------------------

    48. DI Milan used the ARCOS information to identify the suppliers 
of oxycodone to the Respondent. [Tr. 73]. She then contacted the 
suppliers and received copies of the DEA Form 222 and invoices for the 
purchases made to the Respondent from Paragon Enterprises, Inc., 
Dispensing Solutions, Sunrise Wholesale, Inc., and Anda, Inc.. [Tr. 74-
80; Govt. Exh. 6]. The DEA Form 222 indicates the drug shipped, the 
date shipped, and the quantities shipped. [Tr. 77]. The DEA Form 222s 
were those issued to the Respondent. [Tr. 108].
    49. DI Milan also reviewed the purchase orders that were seized 
from the Respondent during the execution of the search warrant. [Tr. 
81-82; Govt. Exh. 7].
    50. DI Milan conducted an audit of oxycodone products from the 
beginning of business on December 1, 2009, through the close of 
business on November 23, 2010. [Tr. 87-88; Govt. Exh. 1]. DI Milan did 
not find an initial inventory in the records that were seized, so the 
beginning inventory amounts were recorded as ``0''. The computation 
chart is as follows:

                                                         Controlled Substances Computation Chart
-----------------------