Registrant Actions - 2012
[Federal Register Volume 77, Number 202 (Thursday, October 18, 2012)]
[Notices]
[Pages 64131-64142]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-25618]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11-34]
Zvi H. Perper, M.D., Decision and Order
On July 19, 2011, Administrative Law Judge (ALJ) Gail A. Randall
issued the attached recommended decision. The Respondent did not file
exceptions to the decision.
Having reviewed the entire record, I have decided to adopt the
ALJ's recommended rulings, findings of fact, conclusions of law, and
recommended Order except for her legal conclusions as to the initial
visits of the two undercover officers (UCs) and her discussion in the
first full paragraph at page 34 of her slip opinion.\1\ However, I need
not decide whether the prescriptions Respondent issued at the initial
visits of the two UCs violated 21 CFR 1306.04(a), because there is
substantial evidence to support the ALJ's legal conclusions that he
acted outside of the usual course of professional practice and lacked a
legitimate medical purpose in issuing prescriptions at the UCs'
subsequent visits.
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\1\ The ALJ noted that Respondent and his PA "were given direct
evidence of diversion and failed to act." Slip Op. at 34. More
specifically, the ALJ noted that UC1 had told the PA that his
girlfriend had used some of his controlled substances and that the
PA did nothing in response and that UC2 had told both Respondent and
his PA that he had bought controlled substances off the street and
that neither Respondent nor his PA took any action. Id. The ALJ thus
reasoned that "[a] practitioner who takes no 'precautions against *
* * misuse and diversion' exceeds the bound of professional practice
when he prescribes controlled substances[,]" and that "[s]uch
action violates the standard of diligence expected of a DEA
registrant." Id. (quoting United States v. Moore, 423 U.S. 122,
142-43 (1975)).
While purchasing drugs off the street may well be evidence that
a patient is a substance abuser, the record contains no evidence
establishing the appropriate course of professional practice when a
practitioner is confronted with such information. Likewise, while
UC1's statement to the PA that his girlfriend had gotten into his
medication supports a finding that diversion is occurring, here
again, the record contains no evidence establishing what precautions
were required to be taken under the standard of professional
practice. Thus, while I find this conduct extremely disturbing, I do
not rely on it.
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More specifically, one week after the initial visit of David Hays
(UC1), at which he was prescribed 150 Percocet, a drug which combines
10 mg of oxycodone with 325 mg of acetaminophen, Hays returned to
Respondent complaining that the drug was causing digestive problems.
Respondent then prescribed 150 Roxicodone (oxycodone) 30 mg, without
any inquiry into Hays' pain level. Tr. 54, GX 3a, at 13. Respondent
noted in the chart, however, that Hays "had no relief [from] pain."
GX 12, at 14.
With respect to this prescription, the Government's Expert
testified that the "[m]edication would not have been indicated given
the complaints of the patient, [and] certainly not that particular
agent and certainly not that dose or frequency." Tr. 54. Notably, this
[[Page 64132]]
testimony was unrefuted. I thus conclude that Respondent acted outside
of the usual course of professional practice and lacked a legitimate
purpose in issuing the prescription and thus violated federal law. 21
CFR 1306.04(a).
Hays returned three weeks later (May 19, 2010) and saw Respondent's
Physician Assistant (PA). While during the visit, the PA initially
confused Hays with a patient whose name was spelled Hayes, upon
recognizing his error he nonetheless noted that Hays was "too early."
GX 4, at 14. During the visit, Hays asked the PA if he could increase
the Roxicodone 30 mg prescription because he was probably going to be
gone for three or four months working on a tugboat. Id. at 23. The PA
instead offered to give Hays "the fifteen milligrams * * * strength."
Id. at 25. Hays asked the PA if he "[c]ould * * * increase the
thirties * * * just to whatever is reasonable and add some fifteens,"
to which the PA answered: "I have to ask." Id. The PA then told Hays
To "have a seat in the waiting room" and "[l]et me find out for
you." Id. Notably, during this visit, Hays did not tell the PA that he
was experiencing breakthrough pain.
Approximately fifteen minutes later, the PA spoke with Hays and
told him that Respondent "was very generous" but that the "the
deal" was that Hays could not see the PA again until after the fourth
of July. Id. at 31. The PA then told Hays that Respondent had given him
210 Roxicodone 30 mg and 90 Roxicodone 15 mg. Id. at 32; GX 12, at 23
(copies of prescriptions). On the prescription for the Roxicodone 15
mg, Respondent noted that it was for "breakthrough" pain, even though
Hays never complained of having breakthrough pain.\2\
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\2\ Under Federal law, a practitioner may issue a patient
"multiple prescriptions authorizing the patient to receive a total
of up to a 90-day supply of a schedule II controlled substance"
provided, inter alia, that the prescriptions otherwise comply with
21 CFR 1306.04(a) (as well as other provisions of the CSA and state
law), the prescriptions include the earliest date on which they can
be filled, and that they "do not create an undue risk of diversion
or abuse." 21 CFR 1306.12(b)(1).
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While the progress note for this visit stated "Earliest pt. can be
seen until 7/5/10," id. at 20; on June 16, Hays returned and saw
Respondent. GX 5, at 16. While Hays was nearly three weeks early,
Respondent did not raise this as an issue, see id. at 16-19, even
though according to the Government's Expert, this is a "red flag"
indicative of "[d]rug-seeking behavior" and either abuse or
diversion. Tr. 65, 67. Moreover, Hays told Respondent that he still had
not been on the tugboat assignment--the purported reason for why he
needed an increase in his prescriptions--and once again asked for an
increase. GX 5, at 16-19.
Respondent then noted that Hays' "pain level is only a two over
ten" and that this was "pretty good." Id. at 17. Respondent then
asked Hays if he was "having some breakthrough pain mostly at work."
Id. Hays answered: "Every now and then something feels * * * a little
bit hey-wire back there," that it was "mostly in the mornings," and
that he would "get all sore and stiff back there." Id. Respondent
noted that at the last visit, Hays had been "given a prescription for
breakthrough pain" and Hays was "going kind of rapidly with [his]
medicine." Id. Notwithstanding that Hays had reported his pain level
as only a two and was nearly three weeks early, Respondent gave him a
prescription for 210 tablets of Roxicodone 30 mg, a prescription for 90
Roxicodone 15 mg for breakthrough pain, and a prescription for a liver
function test, which Hays never obtained. GX 12, at 26.
Hays returned on July 20 and saw the PA. Hays told the PA that he
was doing "pretty good" and that his back had improved. GX 6, at 3-4.
During the visit, Hays told the PA that his girlfriend had gotten into
his medicine (which according to the Government's Expert was indicative
of "misuse and diversion," Tr. 65) and wanted to come to the clinic.
GX 6, at 5. The PA told Hays that "we could only see her with a valid
reason * * * like an MRI report" and "not just because [the drugs]
made her feel good." Id. at 6. The PA, however, then commented that
"she got that subtle euphoria and of course she liked it. But if she
doesn't have a true pain area * * * it's not appropriate." Id. The PA
then explained that the laws had changed and that the clinic would
never fill prescriptions again and that Hays would have to go to a
pharmacy to fill the prescriptions and that the clinic was going to
discuss with local pharmacies where they could "at least direct
patients to." Id. at 7.
The PA then discussed giving Hays "this new medicine called
Dilaudid, which is a morphine derivative" for his breakthrough pain.
After discussing how Dilaudid (hydromorphone) was different from
oxycodone, the PA and Hays resumed discussing where the latter could
fill his prescriptions with the PA stating that because of the number
of pills (210 Roxicodone), it was "extremely hard to believe that
[Hays would] be able to get" the Oxycodone 30s from big chain drug
stores such as CVS or Publix. Id. at 11. Hays then asked the PA to
recommend a pharmacy which would fill the prescriptions; the PA told
him he would give him a list and that the pills would cost four dollars
each. Id. at 12. In response, Hays stated that he could not afford to
fill 210 pills and asked if the PA could split his prescription; the PA
agreed. Id. at 12-13. The PA stated that a lot of the small pharmacies
were going to "require a non-narcotic, non-controlled medicine to go
with" the narcotic prescriptions and that "[t]hey wouldn't just take
* * * the Roxicodone, Dilaudid script from" him because there is "a
perception problem." Id. at 14-15. The PA then explained that he would
give Hays a prescription for thirty Motrin to put in his "back
pocket" which he could produce if the pharmacist questioned the
prescriptions. Id. at 15. However, the PA told Hays to "shred" the
script if the pharmacist did not question the prescriptions. Id.
Later, the PA asked Hays if he was "satisfactory in the sleep
department and in the anxiety department?" Id. at 18. Hays answered:
"You know, I never have anxiety, really. And I sleep pretty good."
Id. Following a discussion of a new state law prohibiting pain
management clinics from dispensing and a proposal to establish a state
prescription database, the PA left to have Respondent review and sign
the prescriptions. Id. at 23. Respondent issued Hays two prescriptions
totaling 210 tablets of Roxicodone 30 mg, as well as prescriptions for
60 Dilaudid 4 mg and 30 Motrin.
Hays returned on August 18 and again saw the PA. Notably, on the
Patient Comfort Assessment form, Hays indicated that the worst his pain
had been in the last month was a "3" on a "0" to "10" scale, that
his pain had averaged a "2" during the last month, and that it was
currently a "1." GX 12, at 33. Hays also wrote that his pain "was in
my lower back but feels better now" and circled that pain was
"occasional" and not "continuous."
Hays told the PA that the Dilaudid made him "kind of dizzy and
nauseous" and that he thought the oxycodone were "good for" him and
asked if Respondent ever prescribed the 80s. GX 7, at 22-23. The PA
stated that Respondent would "start out a little slower[,] like the
40's * * * but yes, we do, do the 80s." Id. at 23. Hays told the PA
that he did not have any problems getting the thirties and that his
"girlfriend knew [a] a place that has them * * * readily available."
Id. The PA then asked Hays whether he had "hand[ed] two split scripts
in in one time"; Hays said "No." Id. at 24. The PA then told
Respondent that he had to get his liver function tested and told him
where to get it and that it would cost $45. Id. at 24-25.
[[Page 64133]]
Next, the PA asked Hays if his "lower back [was] okay this
month?" Id. at 25. Hays answered: "You know, I think it really feels
pretty good." Id. The PA then asked: "Do you even need a breakthrough
* * * I mean * * * [y]ou're taking seven * * * a day, why don't you
just stick with them?" Id. Hays answered: "well, there might be that
occasion when I did need it but * * * I don't know." Id. at 26. The PA
replied: "I'll throw you a few Percocets then just to get on the safe
side but the 15s are very hard to come by and they're very expensive."
Id.
Hays asked if the stuff Michael Jackson had taken would work; the
PA stated that that drug was only indicated to "put people out with
and perform surgery." Id. at 27. Hays then asked "if there is some
other creative way that you could deal with me?" Id. at 28. In
response, the PA asked: "Are you having trouble sleeping? Is [that]
what you're getting at?" Id. Hays answered "I wonder * * * I do have
trouble sleeping. I don't sleep much." Id. The PA then asked Hays if
he had "ever tried Valium?" Id. After Hays answered that he had not,
the PA asked if he would like to. Id. Hays replied "You know I might,
because there are times when I * * * and it could be because * * * I've
got too much on my mind, with work and everything, and I wake up at
night and then I just stay awake." Id. The PA then told Hays to "try
it one hour before you want it to work," but not to drive on it and
not to take it every night.\3\ Id. at 29.
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\3\ Under DEA precedent, a registrant is strictly liable for the
misconduct of those employees that he has authorized to act on his
behalf with respect to the registrant's handling of controlled
substances. See Anthony L. Capelli, 59 FR 42288 (1994) (holding
registrant strictly liable for unauthorized prescriptions issued
under his registrant by unlicensed persons). See also Scott C.
Bickman, 76 FR 17694, 17703 (2011); Harrell Robinson, 74 FR 61370,
61377-78 2009, Paul Volkman, 73 FR 30630, 30644 n.42 (2008). While
in this case the PA did not have authority to issue controlled
substance prescriptions under Florida law, it is clear that
Respondent authorized the PA to act on his behalf in evaluating his
patients and relied on the PA's evaluation to issue controlled
substances prescriptions. Accordingly, Respondent is strictly liable
for issuing the prescriptions.
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Hays and the PA returned to discussing his use of Dilaudid, with
the PA stating that he was going to discontinue it. Id. at 30. The PA
then asked Hays to move each leg up to his hand, and whether doing so
bothered his back; Hays indicated that it did not. Id. at 31; see also
GX 20 (audio recording of visit). The PA asked Hays if he needed the
prescriptions split again; Hays answered that he did not. GX 7, at 31.
The PA then said he was going to give Hays "a couple [of] Percocet for
the day" for "breakthrough" pain and advised him to "eat with
them." Id. at 31-32. The PA added that "hopefully the seven thirties
a day will be enough pain relief for you and you don't need anything
else" and advised Hays to fill the Percocet prescription only if he
needed it. Id. Following a discussion of doctor shopping, the PA went
to Respondent to obtain his approval for the prescriptions. Id. at 39.
Thereafter, Hays was provided with prescriptions for 210 Roxicodone 30
mg, 60 Percocet 10/325mg, 30 Valium 10mg, and Motrin. GX 12, at 35.
With respect to the Dilaudid prescription Respondent issued to
Hays, the Government's Expert testified that there was no evidence that
Hays was experiencing break-through pain "of any significant degree."
Tr. 60. The Expert further explained that "[t]here was no history
consistent with severe break-through pain and it appeared that [Hays']
pain was adequately--more than adequately managed, even based on the
subjective history." Id. The Expert thus concluded that Dilaudid
prescription was "not justified." Id. This testimony stands
unrefuted.
I therefore conclude that substantial evidence supports the
conclusion that Respondent acted outside of the usual course of
professional practice and lacked a legitimate medical purpose in
issuing the Dilaudid prescription to Hays. 21 CFR 1306.04(a). Moreover,
for the same reasons that the Expert concluded that the Dilaudid
prescription was not medically justified, I also conclude that
Respondent acted outside of the usual course of professional practice
and lacked a legitimate medical purpose in issuing the May 15 and June
16 prescriptions for Roxicodone 15mg, as well as the August 18
prescription for Percocet 10, all of which were purportedly issued for
breakthrough pain.
As for the Valium prescription, the Government's Expert observed
that the progress note "indicated that the patient had insomnia for
the past month" but that Respondent did not explain "in his note why
Valium [was] being added, although the prescription is to be taken one
at bedtime only." Id. at 61. Continuing, the Expert testified that
while he could "hypothesize why [Valium] may have been chosen * * *
there was nothing that would justify that dose * * * for this
individual." Id.
The Government's Expert further explained that before prescribing
Valium for insomnia, "[t]he first reasonably standard thing to do
would be to ensure that the patient wasn't doing anything that may be
promoting insomnia" such as having "caffeine at night or excessive
meals right before bedtime." Id. at 62. Once this was addressed, the
Expert stated that if "medications were indicated there are [other]
agents that are appropriate for insomnia, rather than a benzodiazepine
like Valium, [which is available in 2, 5 and 10 mg tablets], at its
highest dose." Id. at 63. Finally, the Expert noted that Valium's
"primary purpose is not [to treat] insomnia." Id.
Here too, the testimony of the Government's Expert was unrefuted. I
therefore conclude that substantial evidence supports the conclusion
that Respondent acted outside of the usual course of professional
practice and lacked a legitimate medical purpose in issuing the Valium
prescription to Hays. 21 CFR 1306.04(a).\4\
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\4\ Noting that Hays had asked the PA "if there is some other
creative way that you could deal with me?" and the PA's response
that: "Are you having trouble sleeping? Is [that] what you're
getting at?," the ALJ reasoned that the circumstances surrounding
the prescription "nearly equate[] to outright drug dealing." ALJ
at 31. I go one step further and conclude that it was an outright
drug deal, noting not only unusual nature of Hays' statement, but
also that Hays had denied a sleep problem just one month earlier, as
well as the Expert's testimony that: (1) the PA's evaluation of
Hays' sleep problem was inadequate, Tr. 62; (2) that there are other
drugs which are indicated for insomnia and that Valium's "primary
purpose is not [to treat] insomnia"; and (3) that the prescribed
dose was "very high." Id. at 63.
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As for the prescriptions issued to Eddie Martinez, the evidence
showed that Respondent increased his prescription from 120 Percocet 10/
325 at the initial visit (for a total daily dose of 40 mg of oxycodone)
to 90 Oxycodone 30 mg (for a total daily dose of 90 mg of oxycodone) at
the second visit. GX 13, at 16, 20. The Government's Expert opined that
Martinez's complained-of pain level did not justify a prescription for
Roxicodone 30, which was more than double the dosing of the previous
prescription, as "[t]here wasn't any physical examination abnormality
or focal neurological deficit * * * consistent with his MRI finding or
even his complaints that * * * would have warranted those medications
at that dose[]." Tr. 85. This testimony was unrefuted.
At the third visit, Martinez told Respondent that he had run out a
week early and bought drugs on the street even though in Respondent's
words "[y]ou changed from Percocet to Oxycodone, that's a much
stronger medicine than what you were using" and "there's a
significant increase in the total amount of medicine you're getting
daily." GX 11, at 20; see also id. at 22. At the visit, Respondent
wrote Martinez
[[Page 64134]]
prescriptions for 90 Roxicodone 30 mg, as well as 60 Percocet 10 mg,
the latter being for "breakthrough pain." GX 13, at 24. Notably, on
the Patient Comfort Assessment Guide for this visit, Martinez noted
that at its worst, his pain was a "5" on a scale of 0 to 10, a
decrease from the level of 7-8 which he reported the previous month. GX
13, at 17, 21. Moreover, at no point did Martinez complain of having
breakthrough pain. See GX 11, at 20-24.
According to the Government's Expert, that Martinez said he had run
out early and complained of unrelieved pain was not a legitimate
medical justification for increasing the dosing of oxycodone because it
was "[n]ot based on the history, physical, and objective information
available in this patient's file." Tr. 87. The Expert further opined
that while it would be within the course of professional practice to
prescribe analgesic medications "if the clinical justification
existed," Martinez's "history and physical" did not meet the
criteria for prescribing. Id. at 90.
Here again, this testimony was unrefuted. Accordingly, I hold that
substantial evidence supports the conclusion that Respondent acted
outside of the usual course of professional practice and lacked a
legitimate medical purpose in issuing oxycodone prescriptions to
Martinez at both his second and third visits. 21 CFR 1306.04(a). I thus
conclude that Respondent violated Federal law in issuing numerous
controlled substance prescriptions to both UCs.
This finding provides reason alone to conclude that Respondent has
committed acts which render his registration inconsistent with the
public interest. See 21 U.S.C. 824(a)(4). However, this conclusion is
buttressed by the ALJ's additional findings and legal conclusions,
including those regarding the shortages of controlled substances
ordered under Respondent's registration (nearly 24,000 dosage units of
oxycodone 30 and 2,565 dosage of Endocet 10/325), his failure to take
initial inventories after moving his practice, 21 CFR 1304.11, and his
failure "to provide any explanation for his conduct or any assurances
regarding his future conduct." ALJ at 37. See also Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008).\5\
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\5\ As explained in Medicine Shoppe-Jonesborough, 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.'" 73 FR at 387 (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).
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Accordingly, I adopt the ALJ's recommended order that Respondent's
registrations be revoked and any pending applications be denied. For
the same reasons which led me to order the Immediate Suspension of
Respondent's registrations, I conclude that the public interest
requires that this Order be made effective immediately. See 21 CFR
1316.67.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificates of
Registration Nos. FP1312406, BP8477639, and BP3429835, issued to Zvi H.
Perper, M.D., be, and they hereby are revoked. I further order that any
pending applications of Zvi H. Perper, M.D., to renew or modify any of
his registrations, be, and they hereby are denied. This Order is
effective immediately.
Dated: October 8, 2012.
Michele M. Leonhart,
Administrator.
Frank Mann, Esq., for the Government
Richard G. Lubin, Esq. & Anthony Vitale, 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 Administrator,
Drug Enforcement Administration ("DEA" or "Government"), issued
an Order to Show Cause and Immediate Suspension of Registration
("Order I") dated February 18, 2011, proposing to revoke the DEA
Certificate of Registration, Number FP1312406, of Zvi H. Perper,
M.D., ("Respondent" or "Dr. Perper"), as a practitioner,
pursuant to 21 U.S.C. Sec. 824(a)(4) (2006), and deny any pending
applications for renewal or modification of such registration
pursuant to 21 U.S.C. Sec. 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. Sec. Sec. 823(f) and
824(a)(4). Order I also immediately suspended the registration
pursuant to 21 U.S.C. Sec. 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 Administrator, Drug Enforcement Administration, issued a
second Order to Show Cause and Immediate Suspension of Registration
("Order II") dated March 4, 2011, proposing to revoke the DEA
Certificates of Registration, Numbers BP7732349,\6\ BP7622764,\7\
BP7622752,\8\ BP3429835, and BP8477639, of Dr. Perper, as a
practitioner, pursuant to 21 U.S.C. Sec. 824(a)(4) (2006), and deny
any pending applications for renewal or modification of such
registrations pursuant to 21 U.S.C. Sec. 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. Sec. Sec.
823(f) and 824(a)(4). Order II also immediately suspended these
registrations pursuant to 21 U.S.C. Sec. 824(d), because the
Respondent's continued registration constituted an imminent danger
to the public health or safety. [ALJ Exh. 3].
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\6\ This registration expired by its own terms on March 31,
2011, and the Respondent did not file an application to renew it.
[Tr.293-94, 323; Govt. Exh. 1].
\7\ This registration expired by its own terms on March 31,
2011, and the Respondent did not file an application to renew it.
[Tr. 297, 323-324; Govt. Exh. 1].
\8\ This registration expired by its own terms on March 31,
2011, and the Respondent did not file an application to renew it.
[Tr. 297, 324; Govt. Exh. 1].
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The Respondent was served with the Order II on March 7, 2011.
[ALJ Exh. 2].
The Orders asserted that the Respondent dispensed controlled
substances to undercover law enforcement officers for other than a
legitimate medical purpose and/or outside the usual course of
professional practice. [ALJ Exh. 1]. Further, the Orders also
alleged that Respondent's Physician's Assistant coached an
undercover law enforcement person on how to procure large amounts of
narcotics from pharmacies without "arousing suspicions that the
prescriptions were being issued for other than legitimate medical
purposes." [ALJ Exh. 1 at 2].
By letter dated March 15, 2011, the Respondent, through counsel,
timely filed a request for a hearing in the above-captioned matter.
[ALJ Exh. 4].
At the Respondent's request, the hearing was held in St. Lucie,
Florida, on May 18-19, 2011. [ALJ Exh. 6; Transcript ("Tr.")
Volume I-II]. At the hearing, Counsel for the DEA called witnesses
to testify and introduced documentary evidence. The Respondent,
through Counsel, elected not to present any evidence. [Tr. 346].
After the hearing, both Counsel submitted Proposed Findings of Fact,
Conclusions of Law and Argument.
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
Registrations, Numbers FP1312406, BP7732349, BP7622764, BP7622752,
BP3429835, BP8477639, of Zvi H. Perper, M.D., ("Respondent"), as a
practitioner, pursuant to 21 U.S.C. Sec. 824(a),
[[Page 64135]]
and deny any pending applications for renewal or modification of
such registrations, pursuant to 21 U.S.C. Sec. 823(f), because his
continued registrations would be inconsistent with the public
interest, as that term is defined in 21 U.S.C. Sec. 823(f). [Tr. 8;
ALJ Exh. 5].
III. FINDINGS OF FACT
I find, by a preponderance of the evidence, the following facts:
A. Stipulated Facts
The parties have jointly agreed to the following stipulated
facts:
1. Respondent is registered with DEA as a practitioner in
Schedules II-V under DEA registration numbers FP1312406, BP7732349,
BP7622764, BP7622752, BP3429835, and BP8477639 at the following
locations, respectively: (1) Delray Pain Management, 102 N. Swinton
Avenue, Delray Beach, Florida 33444; (2) Women's Center of Hyde
Park, LLC, 502 S. Magnolia Avenue, Tampa, Florida 33606-2257; (3)
1103 Lucerne Terrace, Orlando, Florida 32806; (4) 609 Virginia
Drive, Orlando, Florida 32803; (5) 3025 Andrews Place, Boca Raton,
Florida 33234; and (6) Ocala Womens Center, 108 NW Pine Avenue,
Ocala, Florida 34475. [ALJ Exh. 5].
2. DEA registration Nos. BP7732349, BP7622764, and BP7622752
expire by their terms on March 31, 2011; DEA registration Nos.
FP1312406 and BP8477639 expire by their terms on March 31, 2012; and
DEA registration No. BP3429835 expires by its terms on March 31,
2013. [Id.{.
3. Respondent is currently licensed in the State of Florida as a
Medical Doctor (Dispensing Practitioner), Lic. No. ME 65525,
expiration date: 1/31/2013. [Id.].
B. Background Facts
4. The Respondent works at Delray Pain Management ("clinic").
The clinic disqualified some patients because of the distance they
had to travel to get to the clinic. [Tr.183].
5. In 2009, the Respondent ordered 321,600 dosage units of
oxycodone. [Tr. 318; Government Exhibit ("Govt. Exh.") 14 at 3].
From January 1 to June 30 of 2010, the Respondent ordered 387,248
dosage units of oxycodone. [Tr. 318-19; Govt. Exh. 14 at 4]. Based
on these purchases, the Respondent ranked 22nd in the nation
regarding practitioners purchasing oxycodone. [Tr. 319].
6. The Respondent accepted cash for office visits and
prescriptions. [Tr. 320-323; Govt. Exh. 34].
7. The record does not contain any legal documents indicating
the ownership of Delray Pain Management. Mr. Kent Murray appears to
have been the owner of the pain clinic for some time, but the
Respondent acted as either the general manager or also the owner of
the clinic. [Tr. 326-329].
8. The clinic requires a valid Florida identification for the
patients seen there. [Tr. 332].
9. The clinic also requires each patient to provide an MRI. [Tr.
332-33]. The MRIs of Mr. Hays and Mr. Martinez were verified by an
individual named Lynette or Lynn. [Tr. 334-35; Govt. Exh. 12 at 16;
Govt. Exh. 13 at 12].
10. Both undercover agents were required to take a urinalysis
examination on their first visit. [Tr. 335].
11. Each new patient at the clinic was required to give a
medical history with an emphasis on their pain complaint. [Tr. 336].
The undercover agents, on their first visits, had a face-to-face
meeting with the Respondent. [Tr. 336].
C. Dr. Rubenstein's Testimony
12. Dr. Rubenstein, a medical doctor, is board certified in
Physical Medicine in Rehabilitation, in Pain Medicine, and in
Electrodiagnostic Medicine. [Tr. 20; Govt. Exh. 25 at 1]. Dr.
Rubenstein has a private practice focused on his specialties, and he
is licensed to practice medicine in Florida and Virginia. [Tr. 23].
Approximately 90 percent of his patients have some type of pain
complaint. [Tr. 24].
13. He also has two certificates, one as a Diplomate of the
American Academy of Pain Management, and Board Certification through
the American Board of Medical Specialties, with a sub-specialty in
Pain Medicine. [Tr. 21]. He has been practicing pain medicine since
1993. [Id.].
14. Dr. Rubenstein holds four academic appointments and teaches
pain medicine at each one. [Tr. 22].
15. Dr. Rubenstein was qualified as an expert in pain management
and pain medicine. [Tr. 24].
16. Prior to rendering his opinion concerning the Respondent's
prescribing of controlled substances, Dr. Rubenstein reviewed the
medical records reporting the treatment of two individuals, David
Hays \9\ and Eddie Martinez.\10\ Dr. Rubenstein also reviewed the
transcripts of their visits with the Respondent. [Tr. 29-30, 34;
Govt. Exhs. 12 and 13, 2-11].
---------------------------------------------------------------------------
\9\ David Hays is the undercover name used by Special Agent Jack
Lunsford. For consistency with the documentary exhibits, I will
refer to this individual as Mr. Hayes. Since this investigation, SA
Lunsford has retired from the DEA. [Tr. 118, 179, 308].
\10\ Eddie Martinez is the undercover name used by Special Agent
Eddie Brigantty. [Tr. 308].
---------------------------------------------------------------------------
D. Treatment of David Hays
17. David Hays first visited the Respondent on April 21, 2010.
[Govt. Exh. 12 at 5; Govt. Exh. 15]. On that date, Mr. Hays' chart
\11\ notes a drug screen was taken with negative results for all
tested substances, to include opiates. [Tr. 123-24; Govt. Exh. 12 at
8]. At none of the other visits, after controlled substances were
prescribed, did the Respondent require a urinalysis screen. [Govt.
Exhs. 3-7, 9-11].
---------------------------------------------------------------------------
\11\ The Respondent maintained a medical record for Mr. Hays.
[Govt. Exh. 12].
---------------------------------------------------------------------------
18. In his medical history forms, Mr. Hays reported taking over-
the-counter anti-inflammatories such as Advil or Motrin. [Govt. Exh.
12 at 9-10]. From the medical history, Dr. Rubenstein concluded that
he had not taken opiates in the past. [Tr. 40-41]. The urinalysis
results corroborated this conclusion as to the immediate past. [Tr.
96].
19. The medical history form also indicated that Mr. Hays did
not have a primary physician, and that his last physical examination
was in August 1980. [Govt. Exh. 12 at 4].
Mr. Hays also wrote that he had never taken opiates before.
[Govt. Exh. 12 at 11].
20. Mr. Hays also signed an agreement regarding his
responsibilities in taking medications that may be prescribed
("Agreement"). The Agreement informed Mr. Hays of his agreement to
random drug testing, to only receiving pain medications from the
Respondent, to understanding that lost medications will not be
refilled, and to keeping referral appointments should the Respondent
make such a referral. The Agreement also defines actions Mr. Hays
may take that would result in his being discharged from the
practice. Such actions include selling or distributing prescribed
medications, obtaining pain medication from a source other than "my
doctor," forging or altering a prescription, or failing to receive
any therapeutic benefit from the pain medication. Mr. Hays and the
Respondent signed this Agreement on April 21, 2010. [Tr. 41-42;
Govt. Exh. 12 at 12].
21. At the initial visit there was no evidence that Mr. Hays was
doctor shopping. [Tr. 97].
22. Mr. Hays' medical history also disclosed, in response to
questions asked on the form, that his pain was sharp and had been
with him for three years, and that his pain interfered with work,
sleep, and daily activities. [Tr. 190-93; Govt. Exh. 12 at 10].
However, the form did not provide space for Mr. Hays to discuss the
basis for his answers to these questions, and nowhere else in the
medical record are these concerns addressed. [Tr. 42-43; Govt. Exh.
12 at 10-11].
23. When asked on the intake form if Mr. Hays had provided
honest and valid medical records to the clinic, he answered "Yes."
[Tr. 193]. As for his treatment goals, Mr. Hays wrote that he wanted
to "work better". [Tr. 193]. Mr. Hays also wrote and told the
Respondent that the pain interfered with his self-esteem, his
overall energy, and his ability to perform physical activities. [Tr.
193-94, 198; Govt. Exh. 12 at 11]. Mr. Hays also told the Respondent
that his back "hurt." [Tr. 200]. However, none of these
complaints, other than pain, was discussed with Mr. Hays. [Govt.
Exh. 2].
24. Mr. Hays' magnetic resonance imaging ("MRI") report noted
that there was "L4/5 and L5/S1, small protrusions with annular
bulge and no nerve effacement." [Tr. 44; Govt. Exh. 12 at 16]. Per
Dr. Rubenstein, the MRI report, alone, does not justify prescribing
of narcotics on April 21, 2010. [Tr. 46]. This MRI, "in and of
itself, (doesn't) define necessarily a pain generator, maybe a
potential pain generator, that needs to be related to the patient's
history and physical examination." [Tr. 46].
25. Mr. Hays' basic complaint was low back stiffness, having
never said pain during the physical examination. [Tr. 129, 189]. Low
back pain is a diagnosis, however. [Tr. 47]. Mr. Hays explained that
he restored BMW motorcycles, and his back was "stiff and jammed up
and all." [Govt. Exh. 2 at 22]. He agreed, however, that his pain
had worsened over the last three years. [Govt. Exh. 2 at 23]. He
managed his pain with over-the-counter
[[Page 64136]]
medications like Aleve. He denied currently taking any medications
or having taken medications in the past year. [Govt. Exh. 2 at 23,
27]. The Respondent then instructed Mr. Hays that he only gives
prescriptions for one month and that Mr. Hays must only be seen by
him. [Id. at 25].
26. Next, the Respondent physically examined the patient. [See
id. at 27]. The Respondent noted that Mr. Hays experienced "no pain
with straight leg raising bilaterally and normal motor and
sensory." [Govt. Exh. 12 at 14]. Dr. Rubenstein opined that this
would represent a limited neurologic exam for this patient. [Tr.
47]. But the results were "normal," and Dr. Rubenstein opined that
he did not see "what the justification is, then, to even treat
(him) if the exam is normal." [Tr. 98].
27. As part of the physical examination, the Respondent noted
that there was a "positive, moderate tenderness at L5/S1." [Tr.
48]. In response to the question of whether his pain was in his
lower back, Mr. Hays responded "yes." [Tr. 203]. However, Dr.
Rubenstein noted that Mr. Hays did not complain of pain or
tenderness during the physical examination, and such a complaint
would need to be made for the Respondent to make such a legitimate
observation. [Tr. 49].
28. The Respondent diagnosed Mr. Hays with "chronic lumbar pain
with bulge L4-5 and L5/S1 with protrusions. No radiculopathy." [Tr.
48; Govt. Exh. 12 at 14]. During the visit, the Respondent discussed
a back brace that Mr. Hays could use, and he even showed Mr. Hays
how to wear the belt. [Tr. 204; Govt. Exh. 2 at 32-40].
29. Mr. Hays paid $250.00 cash for an examination fee at this
first visit. He was a "walk-in patient" without an appointment.
[Tr. 121, 178].
30. On April 21, 2010, the Respondent prescribed Percocet 10/325
in a quantity of 150, to be taken every four to six hours. [Govt.
Exh. 12 at 17]. Dr. Rubenstein opined that the "doses and frequency
of the medication were excessive. . . Percocet 10 milligrams would
be excessive for an opioid na[iuml]ve patient . . . and that
quantity of medication would be excessive given the patient's pain
complaints and lack of any objective pathology on physical
examination." [Tr. 52]. Although muscle spasm may be expected given
this diagnosis, opiates are not often given as a result of this
observation. [Tr. 55-56].
31. Mr. Hays purchased 150 Percocet tablets and paid $195.00
cash for them. [Tr. 130, 178].
32. Mr. Hays next visited the Respondent, unscheduled, on April
28, 2010. On that date the Respondent wrote in Mr. Hays' medical
records that the patient had complained of severe stomach upset and
that the Percocet did not relieve his pain. The Respondent then
prescribed Roxycodone, 30 milligrams, 150 dosage units to be taken
as needed for pain. [Tr. 52, 150; Govt. Exh. 12 at 14, 18].
33. Yet Mr. Hays told the Respondent that the prior medication
"doesn't seem to be having the total effect I expected. And another
side thing it does is it, it's giving me some kinda like-digestive-
anxiety or something. I'm always feeling kinda unsettled." Later in
the conversation, Mr. Hays stated that the medication "[k]inda
makes me not want to eat." [Govt. Exh. 3A at 11-12; see also Tr.
312; Govt. Exh. 16 ]. When asked about the Flexeril, Mr. Hays
responded that "I don't know that it does anything at all." [Govt.
Exh. 3A at 13]. He was not asked if the Percocet relieved his pain,
and he did not comment about the Percocet and pain. [Tr. 145; Govt.
Exh. 3A]. Yet Mr. Hays medical chart contained the statement that
the prior prescription had provided "no relief (from) pain."
[Govt. Exh. 12 at 14. Mr. Hays denied making such a statement, and
no such statement appears on the recording or in the transcript.
[Tr. 145; see also Govt. Exh. 3A and 16A]. Dr. Perper did not ask
Mr. Hays whether he still had pills from the earlier script for
Percocet, nor did he instruct him what to do with those remaining
pills, if they existed. [Govt. Exh. 3A at 12, 16].
34. Dr. Rubenstein disagreed with this prescription, noting that
the medication "would have not been indicated given the complaints
of the patient, certainly not that particular agent and certainly
not that dose or frequency." [Tr. 54].
35. Mr. Hays did not pay anything for this visit. [Tr. 178].
36. On May 19, 2010, Mr. Hays visited with Mitchell Cohen, a
physician's assistant at the Respondent's clinic. [Tr. 151, 312;
Govt. Exh. 17 and 17A]. Mr. Hays reported that his pain was between
zero to five on a ten point scale, and it was completely alleviated
by taking the prescribed medication of six Roxycodone 30 milligram
tablets per day. [Tr. 56; Govt. Exh. 12 at 21-22]. Mr. Hays rated
his average pain as a "2" for the prior month, and rated his
current pain level as "no pain". [Tr. 152; Govt. Exh. 12 at 22].
He also wrote "was in lower back; gone now." [Id.]. Mr. Hays told
Mr. Cohen that his lower back was "no problem at all" and denied
having any side effects from the medication. [Govt. Exhs. 4 at 18,
17A]. He did state, however, that his symptoms "might come back if
(he) didn't have medication." [Govt. Exh. 4 at 19; Govt. Exh. 17A].
37. Mr. Cohen performed a cursory physical examination, asking
him to raise and lower his legs, declaring that Mr. Hays' back felt
"a little tight" but not "horribly bad." [Govt. Exh. 4 at 21;
Govt. Exh. 17A]. During this examination, Mr. Hays expressed no pain
or discomfort. He also denied any anxiety or sleep problems. [Govt.
Exh. 17A]. Here, Mr. Cohen asked about Mr. Hays'earlier prescription
for Percocet, which Mr. Hays stated he still had. Mr. Cohen then
instructed him to flush those pills and not to give them to anyone.
[Govt. Exh. 4 at 22].
38. Mr. Hays requested a larger amount of pain medication,
because he was joining a tugboat crew and would be gone for three
months. [Tr. 156; Govt. Exh. 17A]. Mr. Cohen refused to approve this
request and advised Mr. Hays to "stretch out" his medication by
breaking it in half and "tak(ing) some Advil in between." [Govt.
Exhs. 4 at 24, 17A]. Mr. Cohen then offered to give Mr. Hays some 15
mg. strength oxycodone tablets instead of increasing the number of
30 mg. strength tablets prescribed to Mr. Hays. Mr. Hays again
requested a greater quantity of Roxicodone (30 mg pills) as well as
the 15 mg. oxycodone pills. [Govt. Exh. 4 at 24; Govt. Exh. 17A].
Mr. Cohen agreed to speak to the Respondent, whom Mr. Cohen later
stated had been "very generous" in his prescribing to Mr. Hays.
[Govt. Exh. 4 at 31-32; Govt. Exh. 12 at 23; Govt. Exh. 17A].
Ultimately, the Respondent added a prescription for 15 mg. strength
oxycodone to Mr. Hays' 30 mg. prescription. [Govt. Exh. 12 at 20].
39. On this date, Mr. Hays received two prescriptions signed by
the Respondent; one for Roxycodone 30 mg, 210 tablets, and one for
Roxycodone 15 mg., 90 tablets. [Tr. 164; Govt. Exh. 12 at 23]. Mr.
Cohen told Mr. Hays not to return to the clinic until after July 4.
[Tr. 157; Govt. Exh. 4 at 31].
40. Mr. Hays paid $175.00 for this visit and $510.00 for the
medication. [Tr. 178].
41. On June 16, 2010, Mr. Hays reported, and the Respondent
acknowledged that Mr. Hays' lower back pain ranged from zero to four
out of ten, with an average pain level of two, and a current pain
level of one. [Tr. 58; Govt. Exh. 12 at 24, Govt. Exh. 5]. Mr. Hays
circled on his intake form that his pain was "gnawing" and
"nagging." [Tr. 209; Govt. Exh. 12 at 24].
42. There was no discussion about Mr. Hays returning to the
clinic before July 4. [Tr. 165].
43. During this visit, the Respondent again remarked that he was
due to set out on a three month tug boat excursion, and asked for
additional pills to tide him over. The Respondent noted that Mr.
Hays was going through his medication rather quickly. [Govt. Exh. 5
at 17]. The Respondent asked Mr. Hays whether his break-through pain
was mostly with work. Mr. Hays had not complained of break-through
pain, however. [Tr. 166; Govt. Exh. 5 at 17]. Yet, at this visit he
received a prescription for 210 Roxycodone 30 mg and 90 Roxycodone
15 mg., with "break through pain" written on the bottom. [Govt.
Exh. 12 at 26].
44. Mr. Hays was prescribed a liver function test. [Tr. 210;
Govt. Exh. 12 at 26]. However, Mr. Hays did not get such a test.
[Tr. 210].
45. Mr. Hays paid $175.00 for this visit and $638.00 for his
medication. [Tr. 178].
46. On July 20, 2010, Mr. Hays returned to the clinic. [Tr. 169;
Govt. Exh. 6]. He met with Mitchell Cohen on that date. [Tr. 170].
Mr. Hays reported that his lower back pain ranged from zero to three
out of ten, with complete relief after taking seven oxycodone \12\
30 milligram tablets and three oxycodone 15 milligram tablets per
day. [Tr. 57; Govt. Exh. 12 at 29-30]. When asked if his lower back
had improved with the medicine, Mr. Hays said that he thought it had
improved. [Govt. Exh. 6 at 4].
---------------------------------------------------------------------------
\12\ Roxycodone is a medication containing oxycodone. [Tr. 83].
---------------------------------------------------------------------------
47. On this date, the Respondent \13\ prescribed Dilaudid four
milligrams, 60 tablets to be taken one, twice daily, as needed for
breakthrough pain. [Tr. 59; Govt. Exh. 12
[[Page 64137]]
at 31]. He also signed two prescriptions \14\ for Roxycodone 30 mg.,
one for 120 tablets and one for 90 tablets. [Govt. Exh. 12 at 31].
However, after reviewing the medical records for this date, there
was no evidence that Mr. Hays was experiencing any breakthrough
pain. [Tr. 60].
---------------------------------------------------------------------------
\13\ Although Mr. Cohen saw Mr. Hays, the prescriptions bore the
Respondent's signature. [Govt. Exh. 12 at 3].
\14\ Instead of writing one prescription for 210 Roxicodone
tablets, the prescriptions were divided into two separate
prescriptions, one for 120 tablets and one for 90 tablets. Mr. Cohen
advised Mr. Hays to hand in one of the prescriptions, then "wait a
couple of days or a week and go hand in the other one." [Govt. Exh.
6 at 13; Govt. Exh. 19 and 19A]. In this way Mr. Cohen advised Mr.
Hays in how to avoid arousing suspicion when presenting his
prescriptions to a pharmacy. Further, Mr. Cohen gave Mr. Hays a
prescription for ibuprofen, saying that by providing a prescription
for a non-controlled substance, he could waylay such suspicion, if
needed. If the ibuprofen prescription was not needed in this way,
Mr. Hays was to shred the prescription. [Govt. Exh. 6 at 15].
---------------------------------------------------------------------------
48. This shift of medication to Dilaudid was not justified
according to Dr. Rubenstein. [Tr. 60]. Further, Dr. Rubenstein noted
that no neurological musculoskeletal exam had been performed, and
that Mr. Hays had violated his pain contract by allowing his
girlfriend to share his medications. [Tr. 39-41; Govt. Exh. 12 at
12]. Dr. Rubenstein agreed that sharing medication with a girlfriend
would be a violation of the Agreement. [Tr. 42]. In reviewing Mr.
Hays' medical chart, Dr. Rubenstein found that "drug-seeking
behavior is suspected." [Tr. 95].
49. On this date, Mr. Hays told Mr. Cohen that his girlfriend
"got into [his] medication" and "liked it." [Tr. 170-71; Govt.
Exh. 6 at 5; Govt. Exh. 19 and 19A]. Next, Mr. Hays said that his
girlfriend wanted to come to the Respondent's clinic, but he was
unsure whether she had a "valid reason" for requesting medication.
[Govt. Exh. 6 at 5-6]. Mr. Hays also admitted that his own
medication made him euphoric. [Govt. Exh. 6 at 6]. Mr. Cohen took no
action in response to these comments except to tell Mr. Hays that
the Respondent would not see his girlfriend unless she had a "valid
reason." [Govt. Exh. 6 at 6]. Mr. Cohen further stated that if Mr.
Hays' girlfriend "has a legitimate area of pain" that is "proven
with an objective test . . . like an MRI, then no problem." [Govt.
Exh. 6 at 6-7]. Mr. Cohen made no response to the news that Mr.
Hays' girlfriend had gotten into his medication or that Mr. Hays
experienced euphoria from his controlled substances. [Id.]. During
this visit, Mr. Cohen also had a long conversation with Mr. Hays
about the price of medication and where to have his prescriptions
filled. Mr. Cohen advised Mr. Hays that "at this level," he should
not go to large chain pharmacies and that the clinic would provide
him with a list of places to go. [Govt. Exh. 6 at 7-14]. Mr. Cohen
then indicated that he would give him a script for Motrin, even
though he already had two refills, because otherwise the script for
controlled substances would not be filled by the pharmacy. [Govt.
Exh. 6 at 14-15]. Then Mr. Cohen asked Mr. Hays how he would like
his "pills split." [Govt. Exh. 6 at 16].
50. Mr. Hays spent $200.00 cash for this visit. [Tr. 178].
51. On August 18, 2010, Mr. Hays returned to the clinic and met
with Mitchell Cohen. [Tr. 174-75; Govt. Exh. 7; see also Tr. 314;
Govt. Exh. 20]. Mr. Hays spent $200.00 for this visit. [Tr. 178].
52. Mr. Hays reported that his back pain "feels better now,"
with a pain level from zero to three out of ten, averaging two, and
a present rating of one. [Tr. 59; Govt. Exh. 12 at 33-34]. Further,
during a physical exam where Mr. Cohen told Mr. Hays to move his
legs up against Mr. Cohen's hand, Mr. Hays indicated that neither
action caused him any discomfort or pain. [Govt. Exh. 7 at 30-31;
Govt. Exh. 20]. He told Mr. Cohen that his girlfriend knew of a
place for him to get prescriptions filled.
53. On this date, Mr. Hays asked Mr. Cohen whether there was
some other "creative way that he could deal with him." [Govt. Exh.
7 at 28]. To this Mr. Cohen responded, "Are you having trouble
sleeping? Is that what you're getting at?" [Id.]. Mr. Hays replied,
"ummm[hellip].you know. I wonder . . . I do have trouble sleeping.
I don't sleep much . . ." [Id.]. Mr Cohen then asked if Mr. Hays
had ever tried Valium and if he'd like to this month. [Id.]. The
Respondent prescribed Roxycodone 30 mg, 210 tablets, Percocet 10
mg., 60 tablets for break-through pain, and Valium 10 mg., 30
tablets. [Tr. 177; Govt. Exh. 12 at 35]. Although the treatment note
documented Mr. Hays' insomnia and noted that he was to take one
Valium at bedtime only, Dr. Rubenstein opined that "there was
nothing that would justify that dose . . . for this individual."
[Tr. 61-62; see also Govt. Exh. 7 at 28]. Rather, Dr. Rubenstein
stated that the "first reasonably standard thing to do would be to
ensure that the patient wasn't doing anything or taking anything
that may be promoting insomnia . . ." [Tr. 62]. Dr. Rubenstein
objected to the fact that the Respondent prescribed Valium at the
highest available dose, which would be a very high dose, and "its
primary purpose is not for insomnia." [Tr. 63].
54. The Respondent had told Mr. Hays to obtain a liver function
test, yet the medical records fail to indicate that such a test was
taken. [Tr. 68]. Mr. Cohen also emphasized at this visit that the
Respondent should get the test, and he told the Respondent where he
could go and the cost of the test. [ Govt. Exh. 7 at 24-25]. Dr.
Rubenstein opined that he would be concerned about Mr. Hays' lack of
compliance with the test recommendation, as well as being concerned
about the possible liver toxicity that results from the medications
being prescribed to Mr. Hays. [Tr. 68, 102-03].
55. Mr. Hays also told Mr. Cohen that he was not experiencing
any side effects from the medication and that he felt "real good"
now and was able to work better. [Tr. 212].
56. Dr. Rubenstein ultimately opined that, after reviewing the
transcripts of the visits, the medical records, and the recording of
the first visit, he did not believe the prescribing of controlled
substances was within the acceptable standard of care, given the
quantities and frequency of such prescriptions. [Tr. 68-69]. There
was also a problem with patient safety because of the large dose of
controlled substances prescribed at the initial visit. [Tr. 52, 69].
He also opined that the prescribing of controlled substances to Mr.
Hays was not based on sound clinical grounds. [Tr. 69]. Dr.
Rubenstein would not consider the prescribing appropriate, given
"the history and physical examination and objective information."
[Tr. 69-70]. Thus, this prescribing of these controlled substances
was outside the usual course of professional practice and without a
legitimate medical purpose. [Tr. 70].
57. Further, Dr. Rubenstein did not find any evidence that the
Respondent discussed the risk and benefits of the use of controlled
substances with Mr. Hays. [Tr. 70].
58. Lastly, Dr. Rubenstein identified numerous "red flags"
indicating potential diversion and/or abuse of controlled
substances. [Tr. 65]. The Respondent seemed to ignore these red
flags, for there was no reaction to Mr. Hays' constant requests for
more narcotic medication or his sharing of medication with a
girlfriend. [Tr. 65; see also Govt. Exhs. 3A at 7]. Also, no mention
was made of Mr. Hays' visit before July 5, 2010. [Tr. 68].
E. Treatment of Eddie Martinez \15\
---------------------------------------------------------------------------
\15\ Eddie Martinez is the undercover name of Special Agent Ed
Brigantty. [Tr. 218, 221 308].
---------------------------------------------------------------------------
59. Mr. Martinez was first treated by the Respondent on June 10,
2010. He did not have an appointment. [Tr. 73, 226; Govt. Exh. 13;
see also Tr. 314; Govt. Exh. 21 and 21A]. Digital audio and video
recordings were made of the visit. [Govt. Exh. 21 and 21A]. A
transcript of the audio recording was also made. [Govt. Exh. 8].
60. On the intake documentation,\16\ Mr. Martinez answered
"yes" to several of the questions asked in reference to his pain
information. [Govt. Exh. 13 at 4]. However, the form did not provide
space for Mr. Martinez to discuss his "yes" answers, and nothing
in the medical record indicates that the Respondent discussed these
questions with Mr. Martinez. [Tr. 73; Govt. Exh. 13]. The Respondent
did not discuss the lack of information in Mr. Martinez
documentation, for he did not list an emergency contact or a
previous doctor. [Govt. Exh. 13 at 1]. When asked to note how long
he had been on opiates, Mr. Martinez left that question blank. He
also left blank the questions asking if he had taken a list of
controlled substances. [Govt. Exh. 13 at 4]. He never described the
duration of his pain or whether it was constant. [Govt. Exh. 13 at
2]. On the intake documents, Mr. Martinez denied taking Motrin,
Advil, Aleve, or Naproxyn [Govt. Exh. 13 at 4], but then told the
Respondent that he had tried taking at least some of those drugs.
[Govt. Exh. 8 at 13-14]. Mr. Martinez even admitted that over-the-
counter medications provided "temporary" relief. [Tr. 228; Govt.
Exh. 13 at 14].
---------------------------------------------------------------------------
\16\ The Respondent maintained a medical record for Mr.
Martinez. [Govt. Exh. 13].
---------------------------------------------------------------------------
61. Yet the Respondent did enter into a physician-patient
relationship with Mr. Martinez. [Tr. 92]. He had a face-to-face
meeting with Mr. Martinez, and he kept medical records and evidence
of the prescriptions he wrote to Mr. Martinez. [Tr. 92; Govt. Exh.
13].
[[Page 64138]]
62. Mr. Martinez told the Respondent that he had pain in his leg
and his back, and that the pain is worse in the morning. [Tr. 259].
On the pain assessment form, Mr. Martinez had circled his neck and
upper spine as the locations for his pain. [Tr. 229-30, 259; Govt.
Exh. 13 at 4]. Mr. Martinez told the Respondent that when he would
lay down flat on a hard surface, that helped his pain. [Tr. 259].
63. Mr. Martinez signed a pain management agreement. [Govt. Exh.
13 at 5]. Mr. Martinez agreed not to obtain pain medications from
any other sources other than the Respondent. [Tr. 74]. Dr.
Rubenstein agreed that, if a patient stated that he had purchased
illegally pain medications on the street, the patient would have
violated this provision of the pain agreement. [Id.].
64. Mr. Martinez's urinalysis report was negative for all
substances tested, to include opiates. [Tr. 96; Govt. Exh. 13 at 6].
After controlled substances were prescribed, at follow-up visits,
the Respondent did not require any other urinalysis tests. [Tr. 112,
231, 249].
65. Mr. Martinez told the Respondent that his pain started ten
years ago and "slowly and surely got worse." [Govt. Exh. 8 at 11].
The Respondent asked him about his work, his other medications, and
symptoms, and whether he saw any other physicians. [Id. at 12-14].
The Respondent conducted a physical examination of Mr. Martinez,
which consisted of his raising his arm and leg and the Respondent
asking if it hurt in various places on his body. [Tr. 227]. At no
time did Mr. Martinez indicate he was experiencing any significant
pain. [Govt. Exh. 8 at 16-17; see also Govt. Exhs. 21 and 21A]. Yet,
compared to his MRI, Mr. Martinez's statements were contradictory.
Though he circled areas on a diagram that corresponded to his center
back and neck, he told the Respondent he was feeling pain "[m]ore
on my left." [Govt. Exh. 8 at 15; Govt. Exh. 13 at 4]. In the
written documentation, Mr. Martinez had denied any "lower back
problems." [Govt. Exh. 13 at 2]. The Respondent did not address
these inconsistencies.
66. The radiologist, interpreting an MRI of Mr. Martinez dated
May 27, 2010, found a disc bulge at L3-4 which approached the canal
where the nerve leaves at that level, but there was no evidence that
the spinal cord was encroached. [Tr. 75; Govt. Exh. 13 at 12]. The
radiologist also noted that at L4-5, there was a disc bulge that
touched the front of the region where the spinal cord sat. The disc
bulge "was narrowing the canals where the nerves would leave on
either side between the fourth and fifth vertebrae of the lumbar
spine." [Tr. 75-76]. Also, at L5/S1 there were similar findings of
enchroachment on both sides. [Tr. 76]. Dr. Rubenstein credibly
opined that an MRI, alone, does not justify the prescribing of
controlled substances. [Tr. 76]. However, these MRI results could
lead a doctor to believe that "there were some significant changes
in the lower back that could be a pain generator." [Tr. 104]. Dr.
Rubenstein also found a significant disconnect between Mr.
Martinez's complaints and the actual diagnosis. Dr. Rubenstein found
that Mr. Martinez's complaints of pain in his middle back and neck
were not consistent with the MRI. [Tr. 77].
67. The Respondent made a diagnosis of Mr. Martinez, finding
"chronic lumbar pain with stenosis, and in parentheses, spasm,
multiple bulges with spondylosis with neural foraminal
enchroachment, which is the NFE, canal stenosis and lumbosacral
stenosis, which is the LSS. No radicular pain." [Tr. 77; Govt. Exh.
13 at 15]. Yet Dr. Rubenstein opined that this is a radiologic
diagnosis based on the MRI, not on the complaint of Mr. Martinez,
for he complained of pain in his cervical and thoracic region, not
the lumbar region. [Tr. 77-78, 106; Govt. Exh. 13 at 4]. Such an
inconsistency raised a "pink" flag for Dr. Rubenstein. [Tr. 79].
Neither the medical record nor the transcript of the patient visit
contain evidence that the Respondent explored this inconsistency
with Mr. Martinez. [Tr. 79; Govt. Exhs. 13, 8]. Dr. Rubenstein
pointed out that the Respondent seemed only to treat the pathology
included in the MRI, while ignoring the fact that Mr. Martinez had
identified pain in his middle back and neck. [Tr. 106-07; Govt. Exh.
13 at 4].
68. Mr. Martinez had indicated on his intake forms that he had
only taken over-the-counter medications and that they provided
temporary relief. [Tr. 79, 228; Govt. Exhs. 8 at 13-14, 13 at 4]. He
also told the Respondent that he had taken some "blues" \17\ and
that he had purchased them from someone that he knew had them. [Tr.
228; Govt. Exh. 8 at 12-13; Govt. Exh. 21 and 21A].
---------------------------------------------------------------------------
\17\ "Blues" are street slang for Roxicodone which contains
oxycodone. [See Tr. 75].
---------------------------------------------------------------------------
69. However, the Respondent prescribed controlled substances to
Mr. Martinez on his first visit, Percocet 10mg, 120 tablets,
totaling 1200 mg of oxycodone. [Tr. 81; Govt. Exh. 13 at 15-16]. Dr.
Rubenstein thought such prescribing would not be appropriate. [Tr.
80]. Specifically, he credibly testified that "I think the
prescription was excessive and not warranted based on the history
and physical examination presented." [Tr. 81].
70. Mr. Martinez paid $250.00 in cash for this visit and $156.00
for his medication. [Tr. 226, 232-33]. There was no explanation of
his diagnosis and no discussion about physical therapy or any other
modalities. [Govt. Exh. 8].
71. Next, Mr. Martinez saw Mr. Cohen on June 17, 2010. [Tr. 314;
Govt. Exhs. 9, 22, 22A]. Mr. Martinez told Mr. Cohen that the
medication did not agree with him and that he wanted a different
prescription. [Tr. 233-34]. Mr. Cohen refused to prescribe another
medication. He offered to give Mr. Martinez a shot of pain
medication, but he refused the offer. [Tr. 234-35]. In answer to a
question concerning how he had managed his pain prior to coming to
the clinic, Mr. Martinez told Mr. Cohen that he bought "stuff" off
the street. [Tr. 235-36]. Mr. Cohen advised Mr. Martinez that he
would have to "go back to" purchasing controlled substances on the
street. [Tr. 236; Govt. Exh. 9 at 4-5]. He insisted that Dr. Perper
would not change a prescsription for a patient who came back a week
later. [Govt. Exh. 9 at 3].\18\
---------------------------------------------------------------------------
\18\ Although this is inconsistent with Dr. Perper's treatment
of David Hays. [See FOF 30-33].
---------------------------------------------------------------------------
72. Next, the Respondent treated Mr. Martinez on July 28, 2010.
[Tr. 82, 238, 314; Govt. Exh. 13 at 19, Govt. Exhs. 10, 23]. Again,
Mr. Martinez told the Respondent that he had gotten meds off of the
street. [Govt. Exh. 10 at 13]. The Respondent prescribed Roxicodone
30 mg, 90 tablets, a total of 2700 mg of oxycodone. [Tr. 82; Govt.
Exh. 13 at 19-20]. This prescription was an increase in the dosage
strength of the oxycodone prescribed at the initial visit. [Tr. 83-
84]. Again, Dr. Rubenstein found that such prescribing was not
warranted, given the lack of any physical examination noting an
abnormality "or focal neurologic deficit to be consistent with his
MRI finding or even his complaints." [Tr. 85]. Dr. Rubenstein would
have expected the Respondent to 're-examine strengths, sensation and
reflexes; or at a minimum strength and reflexes at subsequent visits
with those types of complaints. And gait would be something I would
expect him to assess, too, at least to a degree." [Tr. 114]. Yet
the medical record fails to indicate that any of these tests were
performed at subsequent visits. [Govt. Exh. 13].
73. Lastly, the Respondent saw Mr. Martinez on August 25, 2010.
[Tr. 85, 314; Govt. Exhs. 13 at 23-24, Govt. Exhs. 11, 24, 24A].
Again, the Respondent increased the amount of oxycodone given to Mr.
Martinez by prescribing Percocet 10mg, 60 tablets for break-through
pain, Roxycodone, also an oxycodone containing medication, 30mg, 90
tablets, with a total of 3300 mg of oxycodone. [Tr. 85-86; Govt.
Exh. 13 at 24]. The only justification given for increasing the
dosage was that Mr. Martinez ran out of his medication early, had
purchased controlled substances illegally,\19\ and was still
complaining of unrelieved pain. [Tr. 86; Govt. Exh. 11 at 20-21;
Govt. Exh. 13 at 23]. The Respondent was clearly suspicious of Mr.
Martinez, for when Mr. Martinez attempted to argue that the
Respondent had decreased his medications, the Respondent urged him
to "do the math." [Govt. Exh. 11 at 21]. Yet, in response to Mr.
Martinez's statement that he had to get more, the Respondent issued
him another prescription for Percocet, the same medication that Mr.
Martinez had told Mr. Cohen had made him ill. [Govt. Exh. 11 at 22;
Govt. Exhs. 24 and 24A; Govt. Exh. 9 at 3-4].
---------------------------------------------------------------------------
\19\ The Respondent made no comment regarding this break of the
pain management agreement. [Tr. 245-46].
---------------------------------------------------------------------------
74. Dr. Rubenstein opined that "[j]ust simply his complaint of
pain without a physical exam that would correlate with the need for
same, wouldn't be a reason to titrate the medications." [Tr. 86].
Dr. Rubenstein concluded that, based on the history, physical, and
objective information available in Mr. Martinez's file, the increase
in medication was not a legitimate medical justification. [Tr. 86-
87].
75. Dr. Rubenstein did not believe that the Respondent's
prescribing of controlled substances to Mr. Martinez was within the
acceptable standard of care. [Tr. 87]. The
[[Page 64139]]
Respondent's prescribing demonstrated a lack of reasonable safety
given Mr. Martinez's complaints. [Tr. 87-88].
76. Further, Mr. Martinez had also told the Respondent that he
had purchased controlled substances on the street. [Tr. 88-89, 245-
46; Govt. Exh. 11 at 20]. Per Dr. Rubenstein, the Respondent's
prescribing of controlled substances did not evidence the diligence
needed to prevent the risk of diversion or to monitor for such risk.
[Tr. 88-89].
77. The Respondent told Mr. Martinez to get a liver function
test, but Mr. Martinez did not do that. [Tr. 249-50]. Dr. Rubenstein
was concerned that the Respondent failed to consider any treatment
options other than prescribing controlled substances. For instance,
Mr. Martinez had stated that over-the-counter medications provided
"temporary" relief, yet no such approach was attempted. [Tr. 79-
80].
78. In total, Dr. Rubenstein concluded that "I don't believe
that this patient's history and physical met that criteria for those
prescriptions." [Tr. 90].
F. The Respondent
79. The Government called the Respondent as a witness, and he
asserted his Fifth Amendment rights against self-incrimination and
refused to answer any questions beyond stating his name and business
address. [Tr. 116-117].
G. Audit
80. Diversion Investigator Janice Barnes ("DI Barnes")
conducted an accountability audit based on the Respondent's records.
[Tr. 280-81]. Specifically, she reviewed the Respondent's inventory
records of controlled substances on hand, receiving records to
include DEA Form 222 for Schedule II controlled substances, and
dispensing records, to include prescriptions. [Tr. 281-82].
81. The audit covered the timeframe of March 2, 2010, to
February 23, 2011. The beginning inventory came from the
Respondent's computerized inventory. The beginning inventory and the
amount of controlled substances received during the audit period are
added together to reflect the total number of controlled substances
for which the Respondent would be accountable. [Tr. 283]. For
oxycodone 30 mg. that total number accountable was 199,752. [Tr.
283; Govt. Exh. 32]. On the date of the closing inventory, February
23, 2011, the Respondent had no controlled substances on hand. [Tr.
284; Govt. Exh. 32]. The Respondent was able to account for, using
his prescriptions, 180,559 tablets of oxycodone 30 mg. [Tr. 284;
Govt. Exh. 32]. Thus, he did not have records showing the dispensing
of 19,193 tablets of oxycodone 30 mg. [Tr. 284; Govt. Exh. 32].
However, after verifying the receiving documents with the
Respondent's suppliers, in fact the Respondent should have received
an additional 4800 tablets of oxycodone 30 mg. [Tr. 285; Govt. Exh.
32 at 2]. Thus, the Respondent was actually responsible for 202,980,
and the total accountable is now 204,552 tablets. The Respondent's
records still only showed his dispensing of 180,559 tablets,
resulting in his being unable to account for 23,993 tablets of
oxycodone 30 mg. [Tr. 286-87; Govt. Exh. 32 at 2].
82. Using the same computation method and the Respondent's
records, the DEA's audit disclosed that the Respondent had an
overage, and therefore, was unable to account for 4808 tablets of
oxycodone 15 mg. [Tr. 288; Govt. Exh. 32 at 1]. However, using the
suppliers' records, the Respondent was only unable to account for 8
tablets of oxycodone 15 mg. [Tr. 288; Govt. Exh. 32 at 2].
83. Using the same computation method and the Respondent's
records, the DEA's audit disclosed that the Respondent was unable to
account for 38 tablets of oxycodone 40 mg., 71 tablets of oxycodone
80 mg., 2,565 Endocet 10/325 mg. and 365 tablets of Endocet 10/650
mg. [Tr. 289-293; Govt. Exh. 32 at 1]. Although DEA personnel
searched for records disclosing controlled substances returned from
customers, returns to suppliers, thefts, or surrenders of controlled
substances, no such records were found. [Tr. 291; Govt. Exh. 32 at
1].
84. Lastly, the DEA personnel were unable to find an initial
inventory which should have been taken on the date the Respondent
moved to the North Swinton Avenue address. [Tr. 294]. Even if the
Respondent had no controlled substances on hand, he needed to take
an initial, written inventory reflecting this zero balance. [Tr.
294].
IV. STATEMENT OF LAW AND DISCUSSION
A. Position of the Parties
1. Position of the Government
The Government asserts that the Respondent's DEA Certificates of
Registration should be revoked. As a basis for that assertion, the
Government argues that the Respondent prescribed controlled
substances to patients without a legitimate medical purpose and
outside the course of professional practice, in violation of DEA
regulations and precedent. Further, the Respondent violated Florida
law when he prescribed controlled substances after an inadequate
physical examination and history which failed to justify such
prescribing. [Government's Proposed Findings of Fact, Conclusions of
Law and Argument ("Government's Brief") at 26-28]. The medical
records actually contained inaccuracies and possibly false
statements, the Government argues. [Id.]. Further, the Respondent
failed to discuss the risks and benefits of using controlled
substances, and he failed to refer Mr. Hays and Mr. Martinez for
"additional evaluation and treatment." [Government's Brief at 26-
27].
Next the Government asserts that the Respondent issued
controlled substance prescriptions knowing that his patients could
be drug abusers or diverters. [Government's Brief at 27].
Prescribing under such circumstances "constitutes prescribing
outside the usual course of professional practice" and is contrary
to DEA regulations. [Government's Brief at 27]. Further, the
Respondent increased the amount of controlled substances without a
legitimate medical reason. The Respondent also prescribed additional
types of controlled substances without medical justification. The
Respondent "demonstrated no skill when issuing prescriptions to the
obviously opiate na[iuml]ve DEA officers and issued those
prescriptions without regard for their safety." [Government's Brief
at 27-28].
The Government further asserts that the Respondent failed to
follow the steps outlined in the Florida Administrative Code prior
to prescribing pain medication. [Government's Brief at 28].
The Government also asserts that the Respondent violated DEA
regulations when he failed to guard against diversion of controlled
substances. The Respondent overlooked numerous instances of drug
seeking behavior and prescribed controlled substances to such
patients anyway. [Government's Brief at 28]. The Respondent's
decision to keep providing those patients with controlled substance
prescriptions increased the risk of illegal diversion. [Government's
Brief at 29].
As for the actions taken by the physician assistant, Mr. Cohen,
under both Florida law and DEA precedent, the Respondent is liable
for Mr. Cohen's conduct. Mr. Cohen issued prescriptions for
controlled substances signed by the Respondent, instructed Mr. Hays
in ways to ensure pharmacists would fill controlled substances
prescriptions, and he advised Mr. Martinez to go back to purchasing
controlled substances on the street. The fact that Mr. Cohen
performed these actions does not absolve the Respondent from his
responsibilities in supervising Mr. Cohen. [Government's Brief at
29].
The Government argues that the Respondent's failure to maintain
accurate medical records threatens the public health and safety.
"Moreover, Respondent's employment of a physician assistant who
provides advice to patients to assist them in obtaining drugs for
abuse and/or diversion is both troubling and inconsistent with the
public interest." [Government's Brief at 30].
Lastly, the Respondent's failure to admit fault or to accept
responsibility for his misconduct also weighs heavily in the public
interest determination under DEA precedent. The fact that the
Respondent neither testified nor presented any evidence to rebut the
Government's prima facie case weighs in favor of revocation. The
Government argues that an adverse inference should be taken from the
Respondent's refusal to testify, and the record clearly lacks any
evidence of mitigating circumstances to consider on the Respondent's
behalf. In conclusion, the Government requests revocation of the
Respondent's DEA Certificates of Registration. [Government's Brief
at 30-32].
2. Position of the Respondent
The Respondent requests that his DEA Certificate of Registration
be reinstated. He argues that the Government has failed to meet its
burden of proof regarding his prescribing of pain medication; for he
prescribed controlled substances for a legitimate medical purpose
and in compliance with the standards set forth by the Florida
Medical Board Guidelines. [Respondent Zvi H. Perper, M.D.'s Post-
Hearing Brief (Resp. Brief) at 2,4,6]. Further, the Government has
not met its burden of proof that the Respondent's registration is
inconsistent with the public interest. [Resp. Brief at 6].
[[Page 64140]]
The Respondent next argues that the Court lacked subject matter
jurisdiction of Certificate of Registration numbers BP7732349,
BP7622752, BP7622764, BP3429835, and BP8477639 because the Order to
Show Cause only addressed Certificate of Registration number
FP1312406. He asserts that the DEA did not issue an Order to Show
Cause for the remaining DEA registration numbers. [Resp. Brief at 2-
3, 5].\20\
---------------------------------------------------------------------------
\20\ But see ALJ Exhibit 2 which shows that Order II had been
served on the Respondent.
---------------------------------------------------------------------------
B. Statement of Law
Pursuant to 21 U.S.C. Sec. 824(a)(4), the Deputy Administrator
\21\ may revoke a DEA Certificate of Registration if she determines
that the continuance of such registration would be "inconsistent
with the public interest" as determined pursuant to 21 U.S.C. Sec.
823(f). Section 823(f) requires that the following factors be
considered:
---------------------------------------------------------------------------
\21\ The Deputy Administrator has the authority to make such
determinations pursuant to 28 C.F.R. Sec. Sec. 0.100(b) and 0.104
(2011).
---------------------------------------------------------------------------
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to 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.
These factors may be considered in the disjunctive: The Deputy
Administrator may properly rely on any one or a combination of these
factors, and may give each factor the weight she deems appropriate,
in determining whether a registration should be revoked or an
application for registration denied. Marvin L. Gibbs, Jr., M.D., 69
Fed. Reg. 18299, 18302 (DEA 2004) (citing Henry J. Schwarz, Jr.,
M.D., 54 Fed. Reg. 16,422 (DEA 1989)).
Also, in an action to revoke a registrant's certificate, the DEA
has the burden of proving that the requirements for revocation are
satisfied. [21 C.F.R. Sec. 1301.44(e)]. The burden of proof shifts
to the Respondent once the Government has made its prima facie case.
[Medicine Shoppe, 73 Fed. Reg. 364, 387 (DEA 2008); Thomas Johnston,
45 Fed. Reg. 72,311 (DEA 1980)].
As the Supreme Court recently explained, "the prescription
requirement * * * ensures patients use controlled substances under
the supervision of a doctor so as to prevent addiction and
recreational abuse. As a corollary, [it] also bars doctors from
peddling to patients who crave the drugs for those prohibited
uses." [Gonzales v. Oregon, 546 U.S. 243, 274 (2006) (citing United
States v. Moore, 423 U.S. 122, 135, 143 (1975))]. When an
administrative tribunal elects to disregard the uncontradicted
opinion of an expert, it runs the risk of improperly declaring
itself as an interpreter of medical knowledge. [Ross v. Gardner, 365
F.2d 554 (6th Cir. 1966)].
DEA precedent has also held that "past performance is the best
predictor of future performance." [ALRA Labs, Inc. v. DEA, 54 F.3d
450, 452 (7th Cir. 1995)]. Further, 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 Fed. Reg. at 387; see also Samuel S. Jackson,
72 Fed. Reg. 23,848, 23,853 (DEA 2007)].
In this matter, factors two, four and five are relevant in
determining the appropriate resolution.
C. Discussion
1. Factors 2 and 4: The applicant's experience in dispensing, or
conducting research with respect to controlled substances; Compliance
with applicable State, Federal, or local laws relating to controlled
substances
a. Patient Care
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 C.F.R. Sec.
1306.04(a); George C. Aycock, M.D., 74 Fed. Reg. 17529, 17541 (DEA
2009)]. This regulation further provides that "an order purporting
to be a prescription issued not in the usual course of professional
treatment . . . is not a prescription within the meaning and intent
of [21 U.S.C. Sec. 829] and . . . the person issuing it, shall be
subject to the penalties provided for violations of the provisions
of law related to controlled substances." [Id. See also 21 U.S.C.
Sec. 802(10) (defining the term "dispense" as meaning "to
deliver a controlled substance to an ultimate user by, or pursuant
to the lawful order of, a practitioner, including the prescribing
and administering of a controlled substance")].
Likewise, under Florida law, grounds for disciplinary action or
denial of state licensure include "prescribing . . . any controlled
substance, other than in the course of the physician's professional
practice," and prescribing such substances "inappropriately or in
excessive or inappropriate quantities is not in the best interest of
the patient and is not in the course of the physician's professional
practice, without regard to his or her intent." [Fla. Stat. Sec.
458.331(q)(2009)].
Rulemaking authority regarding the practice of medicine within
the state of Florida has been delegated to the Florida Board of
Medicine (Florida Board). [Fla. Stat. Sec. 458.326 (2009)]. Florida
has promulgated a regulation, "Standards for the Use of Controlled
Substances for Treatment of Pain," Fla. Admin. Code r 64B8-9.013
(2009) ("Florida Standards"), which recognize that "inappropriate
prescribing of controlled substances . . . may lead to drug
diversion and abuse by individuals who seek them for other than
legitimate medical use." [Id. at Sec. 9.013(d)]. The language
employed by the regulation under the preamble section entitled
"Pain Management Principles" makes clear that the standards "are
not intended to define complete or best practice, but rather to
communicate what the [Florida Board] considers to be within the
boundaries of professional practice." Id. at 9.013(1)(g). Thus, the
plain text supports an inference that the standards provide the
minimum requirements for establishing conduct that meets the
professional practice of controlled substance-based pain management
within the state. Likewise, the range of acceptable practice that is
built into the regulation underscores the importance of seeking an
expert opinion in reaching a correct adjudication of whether a
registrant has met the applicable Florida standard.
Here, Dr. Rubenstein found that the Respondent issued
prescriptions that were not for a legitimate medical purpose or in
the course of usual medical practice. Specifically, he found that
the prescriptions issued to Mr. Hays were not within the acceptable
standard of care, given the quantities and frequency of such
prescriptions. [FOF 56]. Also, given the medical history, the
physical examination, and other objective information, Dr.
Rubenstein opined that the prescriptions were not based on sound
clinical grounds. Thus, he concluded that the prescriptions issued
to Mr. Hays were issued outside the usual course of professional
practice and were not issued for a legitimate medical purpose. [FOF
56].
Likewise, Dr. Rubenstein found that the Respondent issued
prescriptions to Mr. Martinez outside the acceptable standard of
care. [FOF 74-75]. Specifically, he found that the Respondent
demonstrated a lack of reasonable safety in his prescribing, given
Mr. Martinez's complaints. As he credibly concluded, "I don't
believe that this patient's history and physical met the criteria
for those prescriptions." [FOF 78].
For both Mr. Hays and Mr. Martinez, the Respondent shifted
medications, either increasing the dosages or adding Dilaudid and
Valium without medical justification. [FOF 48, 53, 72, 73, 74]. In
addition, the circumstances surrounding the Respondent's
prescription of Valium nearly equates to outright drug dealing. [See
FOF 53 (suggesting patient had trouble sleeping in response to his
request that Mr. Cohen find a "creative way to deal with him.")].
Dr. Rubenstein found that the Respondent's physical examinations
failed to provide an adequate basis for his prescribing of
controlled substances. [See FOF 26, 27, 52]. Likewise, relying upon
the MRI interpretation as a sole basis for prescribing controlled
substances is not appropriate. [FOF 24]. However, it appears that
the Respondent did so rely. For example, while Mr. Hays experienced
no pain during the neurological examination, the Respondent
prescribed controlled substances for him. [FOF 24, 26, 28, 52]. In
addition, when treating Mr. Martinez, the Respondent, per Dr.
Rubenstein, seemed only to treat the pathology included in the MRI,
while ignoring the fact that Mr. Martinez had identified pain in his
middle back and neck. [FOF 67]. [See Laurence T. McKinney, 73 Fed.
Reg. 43260, 43265 n. 22 (DEA 2008)]. Further, the Respondent
prescribed controlled substances to Mr. Hays too often, and in one
instance prescribed controlled
[[Page 64141]]
substances prior to the date he had told Mr. Hays to return without
even discussing the early dispensing of controlled substances. [FOF
39, 41, 42]. This occurred despite the Respondent's assertion that
he only gives out pills for one month, and Mr. Cohen's statement
that Dr. Perper would not change a prescription for a patient that
came back a week later. [FOF 25, 71]. Thus, based on the foregoing,
it is clear that the Respondent issued prescriptions for excessive
amounts without an adequate basis. Therefore, his prescriptions were
for an illegitimate medical purpose in violation of both Federal and
Florida law.
Subsequent to the initiation of treatment, "the physician
should adjust drug therapy to the individual medical needs of each
patient. Other treatment modalities or a rehabilitation program may
be necessary depending on the etiology of the pain and the extent to
which the pain is associated with physical and psychosocial
impairment." Fla. Admin. Code r 64B8-9.013(3)(b). Here, the
Respondent failed to meet this standard. The Respondent failed to
discuss other treatment modalities or physical therapy with Mr.
Martinez, despite an indication in his case, that non-controlled
substances had been utilized to control his pain in the past. [FOF
70, 77]. Although he ordered liver function tests, the Respondent
failed to take action when the patients refused to comply other than
to discuss their non-compliance. Both this failure to comply and
decision not to discuss other treatment options concerned Dr.
Rubenstein. [FOF 44, 54, 58, 77].
Further, the Respondent failed to adjust his drug therapy to the
individual medical needs of each patient. Dr. Rubenstein found that
the doses and frequency of prescribing to Mr. Hays were excessive
given the medical indications. [FOF 30, 34, 53]. Subsequently, the
Respondent \22\ prescribed controlled substances at the patient's
request, without medical justification for the increase in
controlled substances. [FOF 38, 39].
---------------------------------------------------------------------------
\22\ The Respondent remains liable for Mr. Cohen's actions.
Florida law states that "[e]ach physician . . . supervising a
licensed physician assistant must be qualified in the medical areas
in which the physician assistant is to perform and shall be
individually . . . responsible and liable for the performance and
the acts and omissions of [the] physician assistant." Fla. Stat.
Ann. Sec. 458.347(3) (2009).
---------------------------------------------------------------------------
Likewise, Dr. Rubenstein found that the Respondent's prescribing
to Mr. Martinez on the first visit "was excessive and not warranted
based on the history and physical examination presented." [FOF 69].
Another standard adopted by the Medical Board, under the
subheading "Informed Consent and Agreement for Treatment," is the
directive that "[t]he physician should discuss the risks and
benefits of the use of controlled substances with the patient,
persons designated by the patient, or with the patient's surrogate
or guardian if the patient is incompetent." [Fla. Admin. Code r
64B8-9.003(3)(c)]. Here the Respondent failed to discuss the risks
associated with the use of controlled substances. [FOF 57].
The Florida Standards also state that, "if the patient is
determined to be at high risk for medication abuse or have a history
of substance abuse, the physician should employ the use of a written
agreement between the physician and patient outlining patient
responsibilities, including, but not limited to: "1. Urine/serum
medication levels screening when requested; 2. Number and frequency
of all prescription refills; and 3. Reasons for which drug therapy
may be discontinued (i.e. violation of agreement.)" Yet the
Respondent was provided with information from the patients that
clearly showed a violation of the agreement, and the Respondent
failed to take any action in response. [FOF 48, 73]. [Fla. Admin.
Code r 64B8-9.003(3)(c)]. In addition, despite these red flags of
diversion, the Respondent failed to follow up with urine screens
beyond the first visit, to ensure the prescribed controlled
substances were being consumed by the patient and not diverted. [FOF
64]. Yet, the Respondent utilized pain management agreements. [FOF
20, 63].
The Florida Standards direct that "[p]hysicians should be
diligent in preventing the diversion of drugs for illegitimate
purposes." [Id. at 9.013(1)(d). Here, the Respondent and Mr. Cohen
were given direct evidence of diversion and failed to act. Mr.
Martinez clearly told the Respondent and Mr. Cohen that he had
purchased controlled substances off the street. [FOF 68, 71, 76].
Yet neither one took any action in response to this information. Mr.
Hays told Mr. Cohen that he had shared his controlled substances
with his girlfriend, and again, Mr. Cohen failed to take any action.
[FOF 49]. A practitioner who takes no "precautions against . . .
misuse and diversion" exceeds the bounds of professional practice
when he prescribes controlled substances. [United States v. Moore,
423 U.S. 122, 142-43 (1975)]. Such inaction violates the standard of
diligence expected of a DEA registrant.
Florida law further provides that grounds for such disciplinary
action also include:
Failing to keep legible, as defined by department rule in
consultation with the board, medical records that identify the
licensed physician . . . and that justify the course of treatment of
the patient, including, but not limited to, patient histories;
examination results; test results; records of drugs prescribed,
dispensed, or administered; and reports of consultations and
hospitalizations.
[Id. Sec. 458.331(m)].
Inherent in this law is the requirement that the medical records
accurately report the required data. [See Fla. Admin. Code r. 64B8-
9.013(3)]. Here, Mr. Martinez failed to complete his intake
documentation, leaving critical portions, such as his level of pain,
blank. [FOF 60]. The Respondent did not discuss the missing data
with Mr. Martinez and made no effort to complete the medical
history. [Id.].
Further, the Respondent charted inaccurately. For example,
despite no discussion about the relief of pain Mr. Hays experienced
from the Percocet, the Respondent wrote that Mr. Hays had
experienced "no relief (from) pain." [FOF 33]. Likewise, the
Respondent charted "break-through pain" and utilized this
information to justify increasing the amount of controlled
substances dispensed to Mr. Hays. Yet Mr. Hays had not complained of
break-through pain. [FOF 43, 47].
b. Inventory and Audit
Under Florida law, a dispensing physician is required to abide
by the statutory and regulatory recordkeeping provisions identical
to those levied against a pharmacy. [Fla. Stat. Ann. Sec.
465.0276(2)(b) (2009)]. That includes compliance with 21 C.F.R.
Sec. 1304.04, which requires dispensed prescriptions to be
maintained in a readily retrievable manner for two years after
dispensing. [ See Fla. Admin. Code r. 64B16-28.140 (2009) (stating a
pharmacy must comply with Sec. 1304.04)].
In addition, under federal law, a dispensing physician is
required to keep certain records similar to those kept by retail
pharmacies. For example, 21 C.F.R Sec. 1304.03(d) requires a
registered practitioner who regularly dispenses to keep records of
Schedule II-V controlled substances that he dispenses. Specifically,
the registrant is required to keep inventories of schedules I and II
controlled substances. In addition, the registrant is required to
keep inventories of schedules III through V controlled substances
either separate from all other records of the registrant or in a
manner that is readily retrievable. [Sec. 1304.04 (f)(1) and (2);
See also Sec. 1304.04(g) (imposing this requirement on registered
practitioners required to maintain records)]. Federal regulations
also set out in detail the requirements of those inventories. [See
Sec. 1304.11(e)(3) (specifying that a dispensing practitioner's
inventory of Schedules I and II must be conducted by hand count but
that Schedules III through V can be estimated provided the container
holds less than 1000 tablets and requiring the practitioner to
maintain records identical to those maintained by manufacturers
under Sec. 1304.11(e)(1)(iii) and (iv))].
Here, the Respondent failed to meet such requirements.
Specifically, the Respondent failed to conduct the required initial
inventory after moving to a new practice location. [FOF 84]. Next,
when conducting an accountability audit, the DEA found that the
Respondent was unable to account for, among other discrepancies,
23,993 dosage units of oxycodone 30 mg tablets, [FOF 81], and 2,565
dosage units of Endocet 10/325, [FOF 83].
Factor Five: Such other conduct which may threaten the public
health and safety.
Although factor five is quite broad, the Deputy Administrator
has qualified its breadth by limiting the considerations made under
that factor to those where there is "a substantial relationship
between the conduct and the CSA's purpose of preventing drug abuse
and diversion." [Tony T. Bui, 75 Fed. Reg. 49,979, 49,988 (DEA
2010)].
Here, I find that Mr. Cohen advised Mr. Hays on ways to present
prescriptions so that the pharmacy would not be "suspicious."
Specifically, Mr. Hays was to hand in one of the controlled
substances prescriptions and then wait to hand in the other one.
[FOF 49]. Further, Mr. Cohen gave Mr. Hays a prescription for
ibuprofen, to be used to waylay the pharmacist's suspicion. If the
pharmacist was not suspicious, Mr. Hays was to destroy the ibuprofen
prescription. [FOF 49]. Such deception in handling
[[Page 64142]]
prescriptions for controlled substances threatens the public health
and safety, for it circumvents the checks and balances available in
the pharmacist's corresponding liability for the dispensing of
controlled substances. [See 21 C.F.R. 1306.04].
Next Mr. Cohen advised Mr. Martinez to go back to buying
controlled substances on the street if he needed more drugs than the
ones already prescribed. [FOF 71]. Advising Mr. Martinez to engage
in illegal activity in purchasing controlled substances in this
manner promotes diversion and therefore, directly threatens the
public health and safety.
Lastly, Dr. Rubenstein found that the Respondent lacked concern
for patient safety. He prescribed large amounts of controlled
substances to opioid na[iuml]ve patients. [FOF 30, 53, 56]. He also
increased the amounts of controlled substances he prescribed, and
such increases were unjustified and reflect a lack of concern for
patient safety. [FOF 69, 72-74]. Dr. Rubenstein concluded that the
increase in medication was not medically justified. [FOF 74].
The Respondent did not testify in this proceeding.\23\
Therefore, he neither took responsibility for his misconduct nor
provided any assurances that he has implemented remedial measures to
ensure such conduct is not repeated. Such silence weighs against the
Respondent's continued registration. [Medicine Shoppe, 73 Fed. Reg.
at 387; see also Samuel S. Jackson, 72 Fed. Reg. 23,848, 23,853 (DEA
2007)].
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\23\ The Government asks me to take an adverse inference from
the Respondent's failure to testify. However, the Government does
not assert what adverse inference it believes such silence
establishes. Although I agree that the Government is entitled to
such an inference as established by the cited case law, without a
requested inference, I am at a loss in granting the Government's
request.
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V. CONCLUSION AND RECOMMENDATION
Consistent with the analysis in this matter, I conclude that the
Government has met its burden and established its prima facie case
for revocation. The Respondent has failed to provide any explanation
for his conduct or any assurances regarding his future conduct.
Therefore, I recommend that the Respondent's viable DEA
registrations FP1312406, BP3429835, and BP8477639, be revoked and
any pending applications for renewal or modification of such
registrations be denied.
Dated: July 19, 2011
Gail A. Randall,
Administrative Law Judge
[FR Doc. 2012-25618 Filed 10-17-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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