[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53942-53961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22093]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

[Docket No. 09-33]


Richard A. Herbert, M.D.; Decision and Order

    On June 15, 2010, Administrative Law Judge (ALJ) Mary Ellen Bittner 
issued the attached recommended decision. Thereafter, Respondent filed 
Exceptions to the ALJ's decision.
    Having reviewed the entire record including Respondent's 
Exceptions, I have decided to adopt the ALJ's rulings, findings of 
fact, conclusions of law, and recommended Order except as expressly set 
forth below.\1\
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    \1\ Pursuant to 5 U.S.C. 552(a)(2), the ALJ's recommended 
decision has been edited to eliminate the names of various persons 
who were either witnesses or were referred to in the proceeding. All 
citations to the ALJ's decision are to the slip opinion attached to 
this Decision and Order.
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    In his Exceptions, Respondent raises several issues. First, 
Respondent argues that he ``was irreparably harmed'' because he was 
forced to represent himself ``pro se'' after the ALJ granted his 
previous attorney's motion to withdraw but did not grant his motion for 
a continuance of the hearing to allow him to obtain new counsel.\2\ 
Exc. at 6-7. Respondent argues that his previous attorney had requested 
that he ``be given leave of 21 days to obtain new counsel,'' and that 
``[t]he ALJ mistakenly assumed that the attorney and Respondent were 
not asking for a delay of the hearing'' and did not grant a continuance 
in her October 13, 2009 order. Id. at 7. Respondent further asserts 
that the ALJ ``unfairly denied a continuance'' and that he ``must be 
given a fair hearing with representation for a proper outcome in this 
matter.'' Id. at 10.
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    \2\ Respondent does not, however, contend that the ALJ erred in 
granting the motion to withdraw. See Resp. Exc. at 6-10.
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    The record establishes that on October 9, 2009, Respondent's prior 
counsel filed a motion for leave to withdraw; in his motion, 
Respondent's prior counsel ``further requested that Respondent be given 
leave of twenty-one (21) days to secure new counsel.'' ALJ Ex. 5. On 
October 13, 2009, the ALJ granted the motion to withdraw. Id. However, 
the ALJ found ``it unnecessary to provide leave of twenty-one (21) days 
for Respondent to secure new counsel * * * as Respondent is free to 
retain counsel at any time.'' Id. The ALJ further ordered that ``the 
hearing in this matter, scheduled to begin on November 3, 2009, shall 
proceed as scheduled.'' Id. A copy of this ruling was served on 
Respondent by Federal Express. Id. In addition, the following day, the 
ALJ's law clerk wrote Respondent noting that it appeared that he was no 
longer represented by counsel and calling his attention to his ``right 
to be represented by an attorney''; the letter also included verbatim 
the language of 21 CFR 1316.50, which addresses a party's right to 
representation. ALJ Ex. 6. The letter further advised Respondent that 
he could contact the ALJ's law clerk if he had any questions. Id.
    At the hearing, Respondent argued that his prior counsel had sought 
a continuance of twenty-one days. Tr. 11. However, the ALJ noted that 
Respondent's prior attorney ``did not ask for a postponement of the 
hearing'' and that he had simply requested that Respondent ``be given 
leave of 21 days to secure new counsel.'' Id. at 12-13. Respondent 
replied that his prior lawyer's intent was ``to get [him] time'' 
because ``we have blocked out four days'' for the hearing, and no 
``major league attorney is going to have four days [open] on his 
calendar,'' having been notified approximately three weeks before the 
hearing date. Id. at 13. The ALJ responded that she did not

[[Page 53943]]

know what Respondent's prior lawyer had ``intended,'' but only ``what 
he asked for.'' Id. Respondent then stated that he understood, and that 
ALJ ``ha[d] made [her] ruling.'' Id. The ALJ then proceeded to conduct 
the hearing.
    I conclude that the ALJ did not abuse her discretion in proceeding 
to conduct the hearing. Whatever the intent of Respondent's counsel was 
in asking for ``leave * * * to secure new counsel,'' Respondent had at 
least three weeks between his prior attorney's moving to withdraw and 
the commencement of the hearing to find new counsel. While it may be 
the case that most capable attorneys would not have four days clear on 
their calendar on three weeks' notice, it is not as if Respondent had 
secured new counsel who, because his calendar was not clear, sought a 
continuance, which was denied. Indeed, it is notable that at the 
hearing, Respondent made no claim that he had actually contacted any 
attorney, let alone that an attorney had declined to represent him 
because the attorney had a scheduling conflict. I therefore reject 
Respondent's exception and conclude that he is not entitled to a new 
hearing.
    Respondent takes further exception to the ALJ's conclusion that the 
OxyContin prescriptions he issued to E.M. lacked ``a legitimate medical 
purpose'' and that he ``was at least reckless or negligent in ignoring 
the warning signs of diversion.'' Exc. at 10-16. Respondent raises a 
number of contentions regarding the weight the ALJ gave to the 
testimony of various witnesses and exhibits; Respondent also notes that 
after the Agency's hearing, the Illinois Department of Financial and 
Professional Regulation (IDFPR) held a hearing on the same allegations 
and ``found that the State did not prove that any diversion occurred.'' 
Id. at 15.
    Having reviewed each of these contentions, I concluded that a 
preponderance of the evidence supports the ALJ's conclusions that the 
OxyContin prescriptions which Respondent issued in the name of E.M. 
were issued outside of the ``usual course of * * * professional 
practice'' and lacked ``a legitimate medical purpose'' and therefore 
violated the CSA. 21 CFR 1306.04(a). The evidence shows that beginning 
in September 2003, Respondent prescribed 60 tablets of Oxycontin 80 mg. 
(BID, twice a day), to E.M., who was then 93 years old, on a monthly 
basis through May 2009, one month before her death. RX 16. Yet on 
various occasions throughout this period, E.M. was an in-patient in 
either a hospital or nursing home. See GX 42. Moreover, E.M. was under 
hospice care from June 9 through October 11, 2006; December 8, 2006 
through June 1, 2007; and from July 11, 2007 through the date of her 
death.
    According to the testimony of a hospice nurse who treated E.M. for 
between eight months to a year, under the hospice agreement, E.M.'s 
family was required to disclose whether any other physicians were 
treating her. Tr. 35, 38. In addition, the testimony established that 
the hospice was required to know what medications E.M. was taking. Id. 
at 35. As the hospice nurse explained, a doctor would need to 
communicate with hospice what drugs he was prescribing so that 
contraindicated drugs were not prescribed by another doctor. Id. at 65.
    Yet E.M.'s family, including her son I.S., who was a long-standing 
friend of Respondent and who also received the same monthly 
prescriptions for 60 tablets of OxyContin 80 mg (see id. at 686) and 
filled his mother's prescriptions (id. at 690), did not disclose to the 
hospice either that E.M. was being treated by Respondent or that she 
was taking OxyContin 80 mg. Id. at 66. According to the hospice nurse, 
the only controlled substance she was aware of being prescribed to E.M. 
was Valium. Id. at 35. Moreover, on those occasions when the hospice 
nurse determined that E.M. needed some medicine for her arm or knee 
pain, I.S. told the hospice nurse that Tylenol (acetaminophen, a non-
controlled drug) worked for his mother and that his mother could not 
handle stronger medicine. Id. at 65.
    The Government also called as a witness Dr. S.D., a specialist in 
internal medicine who was E.M.'s primary care physician for the last 
four years of her life, including when she was in hospice. Id. at 72, 
76. According to Dr. S.D., E.M. had lower back pain, shoulder and knee 
pain, for which he prescribed Tylenol or Darvocet. Id. at 89-90. 
However, she did not require constant medication, and he never 
prescribed OxyContin 80 mg, which he considered to be ``too strong for 
her.'' Id. at 91-92. While Dr. S.D. once prescribed Vicodin to E.M. 
upon her discharge from the hospital, GX 21, at 31; he did not 
prescribe Vicodin to her on a monthly basis. Tr. 143.
    While Dr. S.D. talked with I.S.'s live-in girlfriend regarding 
E.M.'s condition, he further testified that he was never told that 
Respondent was prescribing OxyContin to her. Id. at 92, 95, 109, 141-
42. Moreover, the hospice nurse never told him that E.M. was seeing 
another doctor and never listed OxyContin as one of her medications. 
Id. at 96, 102. Dr. S.D. further testified that if E.M. had, in fact, 
been taking two OxyContin 80 mg each day and had stopped (as when she 
was in the hospital), she would have undergone ``severe withdrawal,'' 
including such symptoms as abdominal pain, diarrhea, and vomiting. Id. 
at 105-06. Dr. S.D. also testified that when a patient is hospitalized, 
a family member is not allowed to give the patient medication. Id. at 
107. There was, however, no evidence that E.M. underwent withdrawal 
during any of the various occasions when she was hospitalized. Id. at 
106, 143-44.
    Dr. S.D. further testified that because he was E.M.'s primary care 
physician, Respondent had ``the legal responsibility to send [him] a 
consult that [Respondent was] treating her for pain and prescribing'' 
OxyContin 80 mg to her. Id. at 140. Dr. S.D. testified that if doctors 
do not coordinate their prescribing to a patient, the patient could 
overdose. Id. at 144. Dr. S.D. then testified that it is outside of the 
normal course of medical practice for a physician, who is aware that a 
patient is being treated by another physician, to prescribe drugs and 
fail to consult with the other physician.\3\ Id.
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    \3\ Respondent acknowledged that he was aware that E.M. was 
being treated by other doctors, and the chart he maintained on her 
shows that he was aware at various points that she was a patient in 
a rehab facility and a nursing home. RX 16, at 5-6. Yet he never 
notified either her physicians or these facilities that he was 
prescribing OxyContin to her. While Respondent maintained he did not 
notify E.M.'s physicians and the facilities regarding the OxyContin 
prescriptions because E.M's family did not want him to, Respondent 
offered no credible explanation for why he continued to prescribe to 
E.M. when he knew she was under the care of other physicians.
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    As noted above, during the period in which Respondent issued the 
OxyContin prescriptions in E.M.'s name, E.M. was admitted as an in-
patient to a hospital on approximately twenty occasions.\4\ See GX 42. 
Yet there is no evidence that she ever underwent withdrawal. Moreover, 
in the voluminous medical records entered into evidence, Respondent 
points to only a single instance (involving a January 18, 2006 
emergency room visit for a potential stroke (CVA)), in which the 
medical records listed her medications as including OxyContin. GX 21, 
at 29. If E.M. was actually taking the OxyContin, this begs the 
question of why her family was so reluctant to disclose this 
information (as well as Respondent's) name to the hospitals where she 
was treated.
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    \4\ She was also taken to the Emergency Room approximately ten 
times.
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    There is further evidence establishing that Respondent's 
prescriptions were unlawful. The evidence shows that on November 10, 
2004, E.M. was discharged from the hospital to the

[[Page 53944]]

Heritage Village Nursing Home, and that at 9:30 a.m., she was admitted 
to the latter. GX 11, at 1; GX 25, at 3; GX 27A, at 70. Yet Respondent 
noted in her chart that on the same day, he performed a physical exam 
at which he took her blood pressure, palpated her deformities and found 
that they were ``not as painful,'' and found that her ``hand grip 
good,'' RX 16, at 4; the same day, he also issued her a prescription 
for sixty OxyContin 80 mg. See GX 28, at 10. Respondent did not, 
however, offer any testimony explaining how he could have performed a 
physical exam on E.M. on this day.
    Likewise, Respondent noted in E.M.'s chart that on November 17, 
2006, her blood pressure was 138/94, she was ``[d]oing surprisingly 
well today,'' she ``spoke my 1st name,'' and was ``oriented,'' RX 16, 
at 5; he also issued a prescription in her name for sixty OxyContin 80 
mg. See GX 14, at 5. However, between October 12 and December 8, 2006, 
E.M. was a patient in the Manor Care Nursing Home. GX 21, at 203; GX 
27B, at 17, 956. Yet the record (including Respondent's testimony) 
establishes that Respondent did not travel to the facilities E.M. was 
in. Tr. 547.
    The ALJ found that there were ``numerous inconsistencies between 
the testimonies of [I.S.] and Respondent'' and that this led her ``to 
believe that neither is a credible witness with regard to [E.M.'s] 
medication and treatment.'' ALJ at 54. The ALJ further noted the 
extensive amount of time that E.M. was in either a hospital or nursing 
home/rehab facility (approximately 290 days during the course of 
Respondent's prescribing to her) and found ``it difficult to believe 
that [E.M.'s] family was able to administer [80 mgs of] OxyContin twice 
a day for such an expansive time without ever arousing the suspicion of 
the facility staff.\5\'' Id. I agree and find Respondent's and I.S.'s 
testimony implausible. I also agree with the ALJ's conclusion that the 
record supports the conclusion that the OxyContin prescriptions 
Respondent issued in the name of E.M. lacked a legitimate medical 
purpose and were issued outside of the usual course of professional 
practice and thus violated Federal law.\6\ 21 CFR 1306.04(a).
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    \5\ Among the implausible testimony I.S. gave was that he or a 
family member would take the OxyContin to his mother when she was 
institutionalized and give her the drug, which was prescribed to be 
taken twice a day. Tr. 685. I.S. also asserted that when he went to 
his mother's various institutions, and told them that he had 
``supplements [and] medications that I give my mother at home, and I 
would like you to administer them, * * * they said we won't do that 
* * * unless the doctor orders it. But if you want to come in 
yourself, or have somebody come in and give it to your mother, we 
haven't got a problem with that, and that's what I did.'' Id. at 
692-93. However, I.S. testified that he did not tell the facilities 
that he would be administering OxyContin. Id. Indeed, it seems 
strange that the facilities did not ask I.S. what medications he 
intended to bring into the facility, and as the ALJ found, this 
testimony is patently disingenuous.
    \6\ Respondent argues that DEA Investigators ``could have easily 
secured a blood test of [E.M.] to discern whether she was receiving 
OxyContin,'' and that ``[b]y the time Respondent realized the focus 
of the investigation centered around this patient and the severity 
of the charges against him, it was too late because the patient had 
passed away.'' Exceptions at 12. Respondent further argues that 
``even though OxyContin was listed as a home medication and there 
was evidence that she was taking the medicine s[u]rreptitiously, Dr. 
[S.D., her primary care physician,] never ordered a blood test for 
opioid levels.'' Id. at 13. As for DEA's obligation to secure a 
blood test, this is beside the point. Moreover, in his testimony, 
Respondent acknowledged that ``[i]n retrospect'' he should have done 
a blood test on E.M. to see if she was actually taking the 
OxyContin. Tr. 835. However, he then attempted to shift the blame to 
Dr. S.D., asking ``[w]hat is [his] excuse?'' Id.
    Respondent ignores that he was one who prescribed 60 tablets of 
OxyContin 80 mg to E.M.--which is the second strongest formulation 
available and which just happened to be the same prescription that 
he was giving her son--each month, and did this for a period of more 
than five and a half years and did so even when he knew she was 
being treated by other doctors. At a minimum, this evidence 
establishes that Respondent acted with deliberate ignorance as to 
the likelihood the drugs were being diverted. See Jeri Hassman, 
M.D., 75 FR 8194, 8228 (2010) (citing United States v. Katz, 445 
F.3d 1023, 1031 (8th Cir. 2006)).
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    Respondent further points to an IDFPR Inspector's Report of an 
interview he conducted with E.M. and her son on August 9, 2005. During 
this interview, E.M. identified two green tablets, which were 
reportedly OxyContin, and stated that they ``were to combat pain.'' RX 
10. However, earlier in the interview the Inspector had asked E.M. if 
she had pain when she initially went to see Respondent and she answered 
``no.'' Id. I.S. had objected that ``the question was unfair as he felt 
she did not recall.'' Id. Moreover, Respondent had previously diagnosed 
E.M. as having ``senile dementia'' nearly two years earlier, RX 16, at 
1; and Dr. P. (Dr. S.D.'s partner) had diagnosed E.M. as having 
Alzheimer's disease and dementia in June 2005, two months prior to the 
interview. Thus, there is ample reason to discount E.M.'s statement 
regarding the use of the OxyContin.
    Respondent also argues that after the instant hearing, the IDFPR 
held a hearing on the ``same underlying allegations,'' at which much of 
the same evidence was presented; however, at the state hearing, 
Respondent was also able to procure the testimony of C.S. (I.S.'s 
wife). Exceptions at 15. Respondent argues that the State ALJ ``found 
that the State did not prove that any diversion occurred.'' Id.
    Respondent does not, however, argue that C.S. was unavailable to 
testify in the DEA proceeding and her testimony does not constitute 
newly discovered evidence. Cf. ICC v. Brotherhood of Locomotive 
Engineers, 482 U.S. 270, 286 (1987). As for the state ALJ's findings, 
DEA was not a party to that proceeding. Moreover, this Agency has long 
held that it ``maintains a separate oversight responsibility [apart 
from that which exists in a state board] with respect to the handling 
of controlled substances and has a statutory obligation to make its 
independent determination as to whether the granting of [a 
registration] would be in the public interest.'' Mortimer B. Levin, 
D.O., 55 FR 8209, 8210 (1990). Accordingly, even if Respondent had 
submitted the state ALJ's decision, the state ALJ's finding would not 
be entitled to collateral estoppel effect in this proceeding.\7\ Cf. 
United States v. Mendoza, 464 U.S. 154 (1984). I therefore reject 
Respondent's exception that the evidence in the record of this 
proceeding does not demonstrate that he engaged in the diversion of 
controlled substances and agree with the ALJ's conclusion that he acted 
outside of the usual course of professional practice and lacked a 
legitimate medical purpose when he issued OxyContin prescriptions in 
E.M.'s name. 21 CFR 1306.04(a). See also George Mathew, M.D., 75 FR 
66138, 66146 (2010) (under Federal law, where a physician issues a 
prescription in violation of 21 CFR 1306.04(a), the drug is deemed 
diverted).
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    \7\ The Government also notes that in the IDFPR proceeding, the 
State's burden of proof was ``clear and convincing evidence,'' but 
in this proceeding the ``preponderance of the evidence'' standard 
applies. Gov. Resp. to Resp. Motion for Rehearing and Exceptions, at 
13 (citing Tit. 68, Cp. VII, Subchapter a, Admin. Rule, Part 
1110.190).
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    Finally, Respondent argues that the proven allegations do not 
support the revocation of his registration. Resp. Exc. at 16. Contrary 
to Respondent's understanding, DEA has held that proof of a single act 
of diversion is sufficient to support the revocation of a registration 
and the denial of an application. See Dewey C. MacKay, 75 FR 49956, 
49977 (2010); Alan H. Olefsky, 57 FR 928, 928-29 (1992) (revoking 
registration based on physician's act of presenting two fraudulent 
prescriptions to pharmacy for filling). The ALJ's finding that 
Respondent issued prescriptions which lacked a legitimate medical 
purpose is sufficient by itself to support the revocation of 
Respondent's registration, especially, where, as here, the ALJ

[[Page 53945]]

found that ``Respondent has repeatedly failed to accept responsibility 
for his misconduct.'' ALJ at 44. See also Jayam Krishna-Iyer, 74 FR 
459, 463 (2009) (quoting Medicine Shoppe--Jonesborough, 73 FR 364, 387 
(2008) (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.'')); see also Hoxie v. DEA, 419 F.3d 477, 
483 (6th Cir. 2005) (``admitting fault'' is ``properly consider[ed]'' 
by DEA to be an ``important factor[]'' in the public interest 
determination).\8\
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    \8\ In concluding that Respondent has not accepted 
responsibility for his misconduct, the ALJ noted that ``despite my 
previous rulings to the contrary, Respondent continues to assert 
that most of the evidence and testimony admitted in the instant 
hearing is inadmissible and should not be considered'' and that he 
``continues to assert that he was `not afforded a capable attorney' 
although he was at any time free to procure the assistance of 
counsel [and] was notified of such.'' ALJ at 44 (citing Resp. 
Closing Argument Br. at 10).
     To make clear, that Respondent continues to object to the 
admission of certain evidence and argues that he was not afforded a 
capable attorney is of no relevance in determining whether he 
accepts responsibility for his misconduct. I thus reject the ALJ's 
reliance on Respondent's legal arguments as a basis for concluding 
that he does not accept responsibility. However, the record contains 
an ample evidentiary basis for concluding that Respondent does not 
accept responsibility for most of his misconduct, and his 
explanation of his prescribing to E.M. is utterly implausible. Thus, 
I conclude that Respondent has not rebutted the Government's prima 
facie case. See Hoxie, 419 F.3d at 483 (upholding Agency's reliance 
on registrant's lack of candor in determining whether registration 
is consistent with the public interest).
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    Moreover, the ALJ found that Respondent had committed additional 
acts which support the revocation of his registration, including that 
he materially falsified his 2006 renewal application when he failed to 
disclose the 1998 probation imposed on his state medical license by the 
Illinois Department of Professional Regulation. ALJ at 43. As the ALJ 
found, this was a material falsification because the underlying conduct 
which gave rise to the State's order was Respondent's prescribing of 
Dilaudid, a schedule II controlled substance, to four patients ``under 
questionable circumstances, i.e., for pain related to old injuries or 
for pain in which surgery may have provided relief and that two (2) of 
the patients may have sold some of the Dilaudid back to Respondent.'' 
GX 7. This falsification was material because under the public interest 
standard, DEA is required to assess an applicant's experience in 
dispensing controlled substances and his record of compliance with 
state and federal laws related to controlled substances. 21 U.S.C. 
823(f) (2) & (4). Accordingly, Respondent's failure to disclose the 
1998 probation was capable of influencing the Agency's decision as to 
whether to grant his application and was a material falsification.\9\ 
See The Lawsons, Inc., 72 FR 74334, 74338-39 (2007) (other citations 
omitted). Under the CSA, material falsification provides a separate and 
independent ground for denying an application. 21 U.S.C. 824(a)(1).
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    \9\ In his Exceptions, Respondent also contends that the 
Agency's consideration of the 1998 Consent Order violates his right 
to due process because due process ``requires protection from a 
never-ending time limit for the DEA to bring an action.'' Exceptions 
at 3. Respondent, however, makes only a conclusory assertion of 
prejudice. Cf. United States v. Brockman, 183 F.3d 891, 895 (8th 
Cir. 1999). He likewise ignores that in making the public interest 
determination, Congress directed the Agency to consider his 
experience in dispensing controlled substances, an inquiry which 
necessarily entails review of prior incidents of misconduct.
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    Substantial evidence also supports the ALJ's findings that 
Respondent committed other acts of misconduct. These included his: (1) 
Obtaining Marinol, a schedule III controlled substance, from a patient, 
who had been dispensed the drug by another doctor, in violation of 21 
U.S.C. 844(a); and his (2) failing to document his receipt of the 
Marinol in violation of 21 U.S.C. 827(a)(3). ALJ at 48-49. In addition, 
Respondent prescribed controlled substances from a new location at 
which he did not hold a registration and did so even after he was told 
by DEA personnel to stop doing so. ALJ at 30-31, 52-53 (citing GXs 9, 
33, and 34). As the ALJ noted, ``Respondent's act of continuing to 
handle controlled substances after numerous warnings shows a flagrant 
disregard for the requirements of the law governing the handling of 
controlled substances.'' Id. at 53.
    Finally, based on a 2003 state proceeding, the ALJ found that 
Respondent failed to properly supervise an unlicensed person who 
distributed phentermine, a schedule IV controlled substance, to 
patients of a weight loss clinic where Respondent worked and which was 
owned by the unlicensed person who was a personal friend. ALJ at 46. 
According to the record, this occurred when Respondent left his medical 
bag (which contained the drugs) at the clinic and the clinic owner 
distributed the phentermine to its patients. Notably, five years 
earlier--as part of the 1998 Consent Order, which resolved the 
allegations pertaining to his handling of Dilaudid--Respondent was 
required to take a course in controlled substance management. GX 7, at 
3. Yet Respondent then committed additional violations of the CSA.
    The numerous acts of misconduct proved on this record, along with 
Respondent's unwillingness to accept responsibility for much of it, and 
his demonstrated inability to take heed of the laws and regulations 
pertaining to controlled substances even after being required to 
undergo remedial instruction, make clear that his continued 
registration ``would be inconsistent with the public interest.'' 21 
U.S.C. 823(f). I therefore reject Respondent's exception that the 
evidence does not support the revocation of his registration. 
Accordingly, I will adopt the ALJ's recommendation that his 
registration be revoked and that his applications to renew and modify 
his registration be denied.

Order

    Pursuant to the authority vested in me by 21 U.S.C. 823(f) & 
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificate of 
Registration, BH8738063, issued to Richard A. Herbert, M.D., be, and it 
hereby is, revoked. I further order that the applications of Richard A. 
Herbert, M.D., to renew and modify his registration be, and they hereby 
are, denied. This order is effective September 29, 2011.

    Dated: August 12, 2011.
Michele M. Leonhart,
Administrator.

Bryan Bayly, Esq., for the Government.
Richard A. Herbert, M.D., Pro Se, for the Respondent.

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

    Mary Ellen Bittner, Administrative Law Judge. This proceeding is an 
adjudication pursuant to the Administrative Procedure Act, 5 U.S.C. 551 
et seq., to determine whether the Drug Enforcement Administration (DEA) 
should revoke a physician's Certificate of Registration as a 
practitioner and deny any pending applications for renewal or 
modification of that registration. Without this registration the 
physician, Respondent Richard A. Herbert, M.D., of Riverside, Illinois, 
will be unable to lawfully handle controlled substances in the course 
of his practice.
    On March 11, 2009, the Deputy Assistant Administrator, Office of 
Diversion Control, of the DEA issued an Order to Show Cause to 
Respondent, giving Respondent notice to show cause why the DEA should 
not revoke his

[[Page 53946]]

DEA Certificate of Registration pursuant to 21 U.S.C. 824(a)(l) and 
(a)(4), and deny any pending applications for renewal or modification 
of such registration pursuant to 21 U.S.C. 823(f), on grounds that he 
materially falsified an application for renewal of his registration and 
that his continued registration would be inconsistent with the public 
interest as that term is used in 21 U.S.C. 824(a)(4) and 823(f).
    In substance, the Order to Show Cause alleges that Respondent holds 
a DEA Certificate of Registration that expired on October 31, 2006, and 
for which Respondent submitted a timely renewal application on 
September 26, 2006; that on that renewal application, Respondent was 
required to answer whether a state medical board had taken action 
against his state license; that on February 26, 1998, the Illinois 
then-Department of Professional Regulation had placed Respondent's 
medical license on probation for one year because Respondent issued 
unlawful prescriptions for Dilaudid, a brand name product containing 
the Schedule II narcotic controlled substance hydromorphone 
hydrochloride; that Respondent failed to disclose the 1998 probation on 
his September 2006 renewal application; that Respondent obtained 
dronabinol, a Schedule III hallucinogenic controlled substance, from a 
patient who had acquired it pursuant to a prescription from another 
physician but had no record of such receipt, and that on July 21, 2003, 
Respondent dispensed that dronabinol to another purported patient but 
had no record of such dispensing; that on August 15, 2003, the Illinois 
Department of Financial and Professional Regulation (IDFPR) placed 
Respondent's medical license on probation for three years because 
Respondent failed to supervise an unlicensed employee who illegally 
handled phentermine, a Schedule IV stimulant controlled substance; that 
Respondent disclosed the 2003 probation on his September 2006 renewal 
application; that on July 5, 2005, the Illinois Department of 
Professional Regulation served Respondent with an administrative 
subpoena seeking to obtain patient records and that Respondent did not 
fully comply with the subpoena in that he redacted patient 
identification information and all dates of treatment; that on July 28, 
2007, the administrative subpoena was re-issued to Respondent; and that 
from February 2006 through August 2007, Respondent diverted OxyContin, 
a brand name product containing the Schedule II narcotic controlled 
substance oxycodone, to a patient by giving the patient a prescription 
that Respondent wrote in the name of the patient's mother.
    Respondent, through counsel, timely requested a hearing on the 
allegations in the Order to Show Cause. On October 9, 2009, 
Respondent's counsel requested leave to withdraw as counsel because of 
a conflict of representation; I granted counsel's request on October 
13, 2009; and sent a copy of the memorandum granting that request to 
Respondent by Federal Express that same day. Following prehearing 
procedures, a hearing was held in Chicago, Illinois, from November 3 
through November 6, 2009, with the Government represented by counsel 
and Respondent appearing pro se. Both parties called witnesses to 
testify and introduced documentary evidence. After the hearing, both 
parties filed proposed findings of fact, conclusions of law, and 
argument. All of the evidence and posthearing submissions have been 
considered, and to the extent the parties' proposed findings of fact 
have been adopted, they are substantively incorporated into those set 
forth below.

Issue

    Whether a preponderance of the evidence establishes that, pursuant 
to 21 U.S.C. 824(a)(l) and (a)(4), Respondent's registration with the 
Drug Enforcement Administration should be revoked and any pending 
applications for renewal or modification of that registration denied, 
because Respondent made material misstatements on an application for 
registration and because his continued registration would be 
inconsistent with the public interest as that term is used in 21 U.S.C. 
823(f).

Findings of Fact

I. Background

    Respondent is a physician licensed to practice medicine and to 
handle controlled substances in Illinois. He has held a DEA 
registration since April 13, 2004, with a registered address at 
Oakbrook Center Mall in Oak Brook, Illinois. [GX 1]

II. The Illinois Department of Financial and Professional Regulation

    The Illinois Department of Financial and Professional Regulation 
(IDFPR) is a state agency that licenses physicians and investigates 
complaints regarding licensed physicians. Upon conclusion of an 
investigation, the information is forwarded to a medical coordinator, 
who is a physician, for review. That individual then determines whether 
to recommend the case to the Medical Disciplinary Board. [Tr. 151-152] 
D. M., a medical investigator and controlled substance inspector for 
the IDFPR, testified that the IDFPR was previously known as the 
Department of Professional Regulation but was merged with several 
stand-alone agencies to eventually become the IDFPR. [Tr. 155]

III. The Evidence Pertaining to Respondent

A. Respondent's Illinois Department of Professional Regulation 1998 
Consent Order
    Investigator D.M. testified that he and two representatives of the 
DEA were involved in a 1994 investigation of Respondent regarding the 
diversion of Dilaudid. [Tr. 154, 733] On February 26, 1998, Respondent 
entered into a Consent Order with the Illinois then-Department of 
Professional Regulation. The Consent Order stated that Respondent ``may 
have prescribed Dilaudid to four (4) patients under questionable 
circumstances, i.e. for pain related to old injuries or for pain in 
which surgery may have provided relief and that two (2) of the patients 
may have sold some of the Dilaudid back to Respondent.'' \10\ 
Respondent did not admit or deny the allegations but, for the purposes 
of the Consent Order only, agreed not to contest the allegations. 
Respondent testified in the instant hearing that he does not agree that 
his actions were unlawful and that his position is that he acted 
lawfully. [Tr.743, GX 2]
---------------------------------------------------------------------------

    \10\ GX 7.
---------------------------------------------------------------------------

    Under the terms of the Consent Order, Respondent's Illinois 
physician and surgeon and controlled substances licenses were both 
placed on probation for one year with several conditions, including 
completion of a course in controlled substances management and a 
requirement that Respondent make and submit controlled substance logs 
to the Department of Professional Regulation for a period of time. [GX 
7]
B. Respondent's Illinois Department of Financial and Professional 
Regulation 2003 Consent Order
    Investigator D.M. testified that another IDFPR investigation of 
Respondent began in 1999 and concerned the ``aiding and abetting in the 
unlicensed practice of medicine.'' \11\ According to Investigator D.M., 
an A.D. had ``dispensed'' \12\ to patients in Chicago phentermine that 
Respondent

[[Page 53947]]

had ordered and received at his Oakbrook office.
---------------------------------------------------------------------------

    \11\ Tr. 157.
    \12\ Agent D.M. testified that his use of the term ``dispense'' 
referred to ``providing the actual pills.'' Tr. 159.
---------------------------------------------------------------------------

    At the hearing in the instant case, Respondent testified that he 
had a ``deal for pay'' with his friend Mr. D., who owned a weight loss 
clinic in Chicago. Pursuant to this agreement, Respondent used his DEA 
registration to purchase phentermine at his registered Oakbrook 
location and then took the phentermine to Mr. D.'s clinic in a locked 
bag that Respondent would sometimes leave at the clinic; Respondent saw 
patients and created records at the clinic and sold the phentermine to 
Mr. D. who in turn sold the phentermine to the patients at a higher 
cost. Respondent testified that one day he left his bag filled with his 
stock of phentermine at the clinic although he was not there, and when 
patients came in Mr. D. provided them with phentermine from the bag and 
instructed them to come back in a few days to see Respondent.\13\ 
Respondent testified that once he was notified that some of those 
patients were state investigators, he immediately resigned from the 
clinic and offered to cooperate.
---------------------------------------------------------------------------

    \13\ Tr. 587.
---------------------------------------------------------------------------

    Respondent testified that at a state hearing regarding the matter, 
he admitted that he had guilt because he technically aided in Mr. D.'s 
``practice of medicine by not securing my controlled substances'' \14\ 
but that he ``didn't actually aid and abet.'' \15\ On August 15, 2003, 
Respondent entered into a Consent Order with the IDFPR with regard to 
Mr. D.'s provision of phentermine from the Chicago clinic. The Consent 
Order stated that Respondent failed to supervise an unlicensed employee 
and Respondent admitted that the allegations were true. As a result of 
the Consent Order, Respondent's Illinois physician and surgeon and 
controlled substances licenses were placed on probation for a period of 
three years with several conditions, including completion of continuing 
medical education in the area of prescribing and dispensing controlled 
substances and allowing the IDFPR to inspect Respondent's controlled 
substance log book and inventory record book upon request. [GX 8]
---------------------------------------------------------------------------

    \14\ Tr. 589.
    \15\ Tr. 589.
---------------------------------------------------------------------------

C. Respondent's Activity During the 2003-2006 Probation Period
    The IDFPR filed a complaint against Respondent on April 5, 2007, 
alleging that he violated the terms of his probation as set forth in 
the 2003 Consent Order by failing to make available for inspection his 
controlled substance log and inventory records; receiving dronabinol, a 
Schedule III controlled substance, from a purported patient and re-
dispensing it to another purported patient, and failing to keep any 
records of the receipt and dispensing of the dronabinol; providing 
incomplete records in response to an IDFPR subpoena issued by the 
IDFPR; aiding and abetting the unlicensed practice of medicine relating 
to a June 2005 incident; and issuing prescriptions for OxyContin to 
patients without examining them and failing to keep and maintain 
records of those patients and the controlled substances.
1. The IDFPR Inspection of Respondent's Controlled Substances Log
    Investigator D.M. testified that in April 2005 he interviewed 
Respondent regarding his controlled substances logs and that Respondent 
stated that he did not have any logs for the years 2003, 2004, or 2005 
because he had not ordered any controlled substance medications and 
therefore had no occasion to dispense \16\ them or maintain a log of 
them. [Tr. 194] Investigator D.M. further testified that when he again 
met with Respondent in May 2005, Respondent iterated that he did not 
have a log because he had not dispensed any controlled substances in 
2003, 2004, or 2005. Investigator D.M., however, was aware from the 
transcript of a Chicago Police Board hearing held on August 10 and 
October 13, 2004, that Respondent had testified in that proceeding 
about dispensing dronabinol to a patient on July 21, 2003; this 
incident is further discussed below. [Tr. 165] Respondent testified in 
the instant hearing that ``my assumption when D.M. was in there was 
that I knew that I had not ordered anything for years, and not 
recalling these three patients, I simply filled out a handwritten log 
and zero.'' \17\
---------------------------------------------------------------------------

    \16\ Investigator D.M. stated that in this instance, 
``dispensing'' means providing or prescribing. Tr. 194. But see 
supra note 3. The Illinois Compiled Statutes defines ``dispense'' as 
``the interpretation, evaluation, and implementation of a 
prescription drug order, including the preparation and delivery of a 
drug or device to a patient or patient's agent in a suitable 
container appropriately labeled for subsequent administration to or 
use by a patient in accordance with applicable State and federal 
laws and regulations.'' 225 ILCS 85/3.
    \17\ Tr. 622.
---------------------------------------------------------------------------

    Respondent further stated that at the time he knew that he had not 
ordered anything from drug wholesalers for many years and therefore had 
not dispensed anything, and that he did not recall that he had made a 
controlled substances log for 2003, which included three entries and 
had been stored in his sample cabinet; later that evening he realized 
his error and notified his attorney, who in turn notified Investigator 
D.M. and produced the log that included three entries for 2003. [Tr. 
622, RX 2]
2. Respondent's Dispensing of Dronabinol
    D.S. was a Chicago police officer who tested positive for 
tetrahydrocannabinol \18\ (THC) after a random drug test performed by 
the Chicago Police Department on July 24, 2003. [Tr. 163] At Officer 
D.S.'s subsequent police board hearing on August 10, 2004, Respondent 
testified that he treated Officer D.S. on July 21, 2003, at 
Respondent's office and gave him eight 10-milligram gelatin capsules of 
Marinol \19\ to control nausea and vomiting; that he did not write a 
prescription for Marinol for Officer D.S. but gave him ``samples'' of 
the drug that he had in his office; \20\ [GX 5 at 98] that it is his 
practice to ask patients to give him their unused medications, so that 
he can ``recycle'' them ``as much as I possibly can''; \21\ [GX 6 at 
146] and that when he receives medications from patients, he puts the 
medication in a bottle, labels it, and stores it, but does not keep a 
record of which patient provided the medication. [GX 6 at145]
---------------------------------------------------------------------------

    \18\ THC is a Schedule I controlled substance.
    \19\ Marinol is a brand name product containing dronabinol, a 
Schedule III controlled substance, the active ingredient of which is 
a synthetic form of tetrahydrocannabinol, which naturally occurs in 
the Schedule I controlled substance marijuana.
    \20\ See GX 5 at 98.
    \21\ GX 6 at 146.
---------------------------------------------------------------------------

    In a continuation of the police board hearing on October 13, 2004, 
Respondent testified that the Marinol he gave to Officer D.S. was not a 
manufacturing sample but came from another of Respondent's patients, 
although Respondent had no record of who that patient was; [GX 6 at 
144] when asked at the police board hearing which patient provided the 
Marinol, Respondent replied that ``[i]t could be anyone of a number of 
patients''; \22\ and that the Marinol ``probably came from either a 
leukemia or lymphoma treatment patient * * * the other possibility is 
this could have come from an AIDS patient.'' \23\ In response to a 
question regarding the frequency with which he had prescribed or given 
Marinol to patients, Respondent said: ``I have a number of patients 
that use chemotherapeutic agents for lymphomas and malignancies, 
leukemias. I also have a large number of AIDS patients

[[Page 53948]]

that I use Marinol for.'' \24\ Respondent then testified, however, that 
he had prescribed or given samples of Marinol only a few times in the 
last several years and that he had the Marinol in his office because it 
might have come from a patient who obtained it pursuant to a 
prescription from another doctor.
---------------------------------------------------------------------------

    \22\ GX 6 at 144-145.
    \23\ Id.
    \24\ GX 6 at 146.
---------------------------------------------------------------------------

    In the instant hearing, the Government entered into evidence 
Respondent's medical record for Officer D.S., which indicates that 
Respondent ``sampled'' Marinol 10 mg to Officer D.S. [GX 4] Respondent 
testified that he both received and dispensed the Marinol in a plastic 
pill case without a label but that he recognized the pills as Marinol 
and used a picture in the Physician's Desk Reference (PDR) to verify 
what the pill was. Respondent further testified that he remembered the 
patient from whom he had received the Marinol because he had never 
received Marinol from a patient before. [Tr. 767] Respondent entered 
into evidence an affidavit dated May 2, 2008, and signed by a J.W.; 
Respondent testified that Mr. J.W. was a former patient of his who had 
AIDS.\25\ Mr. J.W.'s affidavit states that he was HIV positive; that 
Respondent was one of several physicians who treated him; and that he 
took Marinol to stimulate his appetite but because he did not like the 
way it made him feel and he could not control its effects, he stopped 
taking the Marinol and gave the remaining pills to Respondent. The 
affidavit does not identify Mr. J.W.'s source for the Marinol but 
states that the cost is high and that Mr. J.W. did not want to dispose 
of the pills by flushing them down the toilet or putting them in the 
garbage. [RX 17]
---------------------------------------------------------------------------

    \25\ The affidavit is signed by a J.W.; there is no witness 
signature and the document is not notarized.
---------------------------------------------------------------------------

    Respondent testified that as of the date of the hearing he 
understood that he was not authorized to acquire Marinol from a 
patient, although he had not thought about it before, and that he was 
not authorized to provide that Marinol to Officer D.S.. Respondent 
further testified that he did not tell Officer D.S. that he had 
acquired the Marinol from another patient rather than as a 
manufacturing drug sample. [Tr. 765] Respondent further testified that 
he did not keep any record of receipt of the Marinol because at the 
time he thought that he was only required to maintain records of drugs 
that he purchased.
3. Respondent's Response to the IDFPR Subpoenas
    Investigator D.M. testified that the IDFPR Medical Disciplinary 
Board issued to Respondent a Subpoena Duces Tecum dated June 15, 2005, 
pursuant to the Illinois Medical Practice Act of 1997. [GX 10] The 
subpoena commanded Respondent to surrender certain documents and 
records concerning his treatment of ten individuals, identified on the 
subpoena by name and date of birth. The documents were to be 
surrendered on or before June 30, 2005, to one of two identified 
individuals for inspection by the medical disciplinary board.
    Investigator D.M. prepared and attached to the subpoena an 
affidavit advising that, according to a profile received from the 
Illinois Department of Human Services, [GX 28] Respondent issued 
multiple prescriptions of OxyContin 80 mg to the ten individuals whose 
records were requested, and that some of those individuals also were 
identified as having received Dilaudid from Respondent in the 1994 
investigation. The affidavit states that Respondent issued the 
prescriptions in question between January 1, 2004, and April 2005, and, 
specifically, that during this period Respondent issued 124 
prescriptions for Schedule II controlled substances, 123 of which were 
for 60 dosage units each of OxyContin 80 mg.
    Investigator D.M. testified that in response to the subpoena, 
Respondent's attorney provided records from which the names of the 
individuals and the dates of treatment were redacted. [GX 3] Further, 
Investigator D.M. stated that the documents provided indicated that one 
patient had her records sent to a family doctor who agreed to continue 
OxyContin and that Respondent did not have copies of those records, and 
that after Respondent advised another patient that the Medical 
Disciplinary Board had asked to review the patient's records, the 
patient strongly objected to such a review and took the records, and 
Respondent did not have copies of them. [Tr. 170]
    Investigator D.M. further testified that on June 20, 2007, the 
Medical Disciplinary Board issued a second subpoena to Respondent, 
again requesting the medical records for the ten previously identified 
individuals and requiring that no information other than the patient 
identity be removed. [Tr. 171] Investigator D.M. testified that he did 
not know whether Respondent had provided that information, [Tr. 311] 
but that he had seen documents in the possession of an IDFPR attorney 
that appeared to include the dates of treatment and other information 
that had been previously redacted. [Tr. 175] Respondent testified that 
he eventually complied with the subpoena after the remaining patients 
gave him permission to provide copies of their records.\26\
---------------------------------------------------------------------------

    \26\ As evidence of his compliance with the subpoena, Respondent 
admitted into evidence Respondent Ex. 1, which includes the first 
page of multiple patient files that appear to have the patients' 
names and dates of birth and dates of treatment redacted, although a 
name is handwritten at the top of each page.
---------------------------------------------------------------------------

4. Respondent's Issuance of OxyContin Prescriptions
    Investigator D.M. testified that he met with Respondent in June 
2005 at Respondent's office and that during that interview Respondent 
said that he issued to chronic pain patients prescriptions for 60 
OxyContin 80 mg and for Tylenol 3 or Tylenol 4,\27\ and that he 
instructed the patients to take a half tablet of OxyContin twice a day. 
Respondent further said that he used to prescribe Dilaudid 2 or 4 mg. 
[Tr. 198] Investigator D.M. further testified that, at that meeting, 
Respondent indicated that a number of his patients were employed at 
Balmoral horse racing track and, when Investigator D.M. asked 
Respondent whether any of the ten patients listed on the subpoena 
discussed above knew one another, Respondent stated that two of the 
patients, S.P. and C.G., worked at Balmoral. Respondent did not, 
however, mention the relationships among I.S., E.M., and C.G., all of 
whom were also identified on the subpoena and who, as discussed below, 
shared a household. [Tr. 202] Respondent testified in the instant 
hearing that he had a personal relationship with Ms. E.M. and went to 
high school with her son, Mr. I.S.; Ms. C.G. was identified as Mr. 
I.S.'s girlfriend. [Tr. 485]
---------------------------------------------------------------------------

    \27\ I take official notice from the 2007 edition of the 
Physicians' Desk Reference that Tylenol 3 and Tylenol 4 are brand 
names for products containing acetaminophen with codeine, a Schedule 
III controlled substance.
---------------------------------------------------------------------------

    Investigator D.M. testified that he and Diversion Investigator C.R. 
of the DEA's Chicago office interviewed Mr. I.S. in July 2005. Mr. I.S. 
told them that he was on the board of directors for harness racing at 
Balmoral Park; that approximately sixty percent of the employees there 
had drug abuse and/or dependency problems; that he had sustained some 
injuries from horse racing accidents; that he had been friends with 
Respondent for about 25 or 30 years; that Respondent issued him 
OxyContin prescriptions either at Respondent's office or when they met 
for lunch; and that Respondent also

[[Page 53949]]

prescribed OxyContin for Mr. I.S.'s girlfriend, C.G., and his mother, 
E.M., who both lived with him. [Tr. 212]
    Investigator D.M. testified that at the July 2005 interview, Mr. 
I.S. showed him OxyContin vials for Ms. E.M., Ms. C.G., and himself, 
all of which indicated that they had contained 60 dosage units of 80 mg 
strength and that Respondent issued the prescriptions. The label had 
been removed from Mr. I.S.'s vial; he explained that it could be 
embarrassing for anyone, particularly at the race track, to know that 
he was taking OxyContin inasmuch as he was promoting a program to help 
people at the track who might have addiction problems. Mr. I.S. further 
told the investigators that he had helped to create rules regarding 
drug use in both humans and horses; and that he did not think that he 
was abusing the medication because he was able to function and he did 
not have needle marks, which he said would be a sign of an addict. [Tr. 
224]
    Mr. I.S. testified in the instant hearing, however, that he removed 
the label from his OxyContin bottle so that ``the kids wouldn't know 
what was in the bottles''; \28\ [Tr. 721] he received his pain 
medication from Respondent, whose office was one hour and 25 minutes 
away from Mr. I.S.'s residence, [Tr. 722] and that ``if I couldn't get 
my pain medication from [Respondent], then I would get medication 
wherever I could if I had to, but I don't recall even having to.'' \29\ 
Mr. I.S. then testified that ``there was a time when [Respondent] was 
having a problem with the DEA, and I couldn't get my medication, and at 
that time when I was getting medication whatever way I could, and I 
went to another doctor once''; \30\ and before Ms. E.M. began getting 
the OxyContin prescriptions, he ``would take her to the doctors and I 
would take her to a clinic'' and ``[y]ou only had to look at my mother 
and write her something right away, because she was crippled.'' \31\
---------------------------------------------------------------------------

    \28\ Tr. 720
    \29\ Tr. 715.
    \30\ Tr. 715.
    \31\ Tr. 716.
---------------------------------------------------------------------------

D. E.M.
1. E.M.'s Medical Conditions
    Investigator D.M. testified that he interviewed Mr. I.S. again in 
August 2005 at Mr. I.S.'s home. Investigator D.M. testified that Mr. 
I.S. advised him that Ms. E.M. had recently suffered a stroke and had 
been hospitalized at St. Mary's Hospital and treated by V.P., M.D.; 
[Tr. 226] that Respondent was Ms. E.M.'s primary physician prior to her 
admission to St. Mary's Hospital and that S.D., M.D., treated Ms. E.M. 
while she was at a senior care center. [Tr. 312] Mr. I.S. showed 
Investigator D.M. prescriptions that Respondent had issued to Ms. E.M. 
for various medications, including Plavix, Micardis, Prevacid, aspirin, 
Lipitor, nitroglycerin patches, Remeron, Toprol, and Vicodin \32\ which 
Mr. I.S. typically filled near his home at a pharmacy called Doc's 
Drugs. Mr. I.S. stated that after the stroke Ms. E.M. had difficulty 
getting around and was responding to stimuli differently than before 
and was no longer doing household chores.
---------------------------------------------------------------------------

    \32\ Lipitor is a brand name product containing atorvastatin 
calcium, a non-controlled substance and synthetic lipid-lowering 
agent. I take official notice of the following information from the 
2007 edition of the Physicians' Desk Reference: Plavix is a brand 
name product containing clopidogrel bisulfate, a non-controlled 
substance and inhibitor of platelet aggregation that helps protect 
against future heart attack or stroke; Micardis is a brand name 
product containing telmisartan, a non-controlled substance that is a 
nonpeptide name product containing lansoprazole, a non-controlled 
substance, the active ingredient of which is a compound that 
inhibits gastric acid secretion, typically prescribed to treat and 
prevent stomach and intestinal ulcers; nitroglycerin patches contain 
an organic nitrate, a non-controlled substance, that helps prevent 
chronic chest pain caused by heart disease; Remeron is a brand name 
product containing mirtazapine, a non-controlled substance and 
tetracyclic antidepressant used primarily in the treatment of 
depression; Toprol is a brand name product containing metoprolol 
succinate, a noncontrolled substance that is indicated for the 
treatment of hypertension; and Vicodin is a brand name drug 
containing hydrocodone bitartrate, a Schedule III controlled 
substance, and acetaminophen, and is indicated for the relief of 
moderate to moderately severe pain.
---------------------------------------------------------------------------

    Dr. S.D., an internal medicine physician experienced in treating 
geriatric patients and in the medical use of controlled substances, 
testified that Ms. E.M. suffered from medical problems such as 
tachycardia (an irregular heartbeat), lower back pain, arthritis in 
multiple joints, and dementia; [Tr. 79] he also noted that Ms. E.M. had 
kyphoscoliosis, which he said was not uncommon for a patient of Ms. 
E.M.'s age, and often occurs after a person develops osteoporosis; and 
that she had been admitted to the hospital at various times for such 
ailments as urinary tract infection, pneumonia, chest pain, and 
possible seizure disorder. C.K., a licensed practical nurse 
specializing in geriatrics and end-of-life care and employed by Hospice 
of Kankakee Valley (Kankakee Hospice), testified that when Ms. E.M. was 
admitted to Kankakee Hospice, she suffered from ``adult failure to 
thrive,'' \33\ arthritis, a steel rod in her right arm, a hump in her 
back, and some dementia, as indicated by her difficulty remembering 
people, including her son whom she confused with her husband.
---------------------------------------------------------------------------

    \33\ Tr. 34.
---------------------------------------------------------------------------

    Respondent testified that Ms. E.M. suffered from vascular dementia, 
known as Binswanger's disease, which he characterized as a small vessel 
disease of the white matter; and benign myalgic encephalomyelitis, 
which causes fatigue, bowel disorders, and cognitive deficits. 
Respondent testified that because of the dysfunction of the white 
matter in the brain, Ms. E.M. found it difficult to walk and perform 
organizational tasks. [Tr. 480] Mr. I.S. testified that Ms. E.M.'s 
problems of loss of memory and failure to recognize her family were 
caused by and occurred only when Ms. E.M. was taking certain 
medication. [Tr. 725]
    Respondent testified that he treated Ms. E.M. ``in concert with the 
whole patient''; \34\ that diabetes affects every organ in the body and 
causes kidney failure, high blood pressure, coronary disease, 
peripheral artery disease, and cerebral vascular disease; [Tr. 472] and 
that Ms. E.M. suffered a series of transient ischemic attacks (TIAs), a 
closing of a small blood vessel in the brain, around 2004, and had 
elevated blood sugar levels. Respondent testified that all of these 
factors taken together led him to ``try everything that I could to 
reverse the arterial sclerosis in the carotid arteries.'' \35\
---------------------------------------------------------------------------

    \34\ Tr. 472.
    \35\ Tr. 486.
---------------------------------------------------------------------------

    Respondent testified that he prescribed to Ms. E.M. a combination 
of high-dosage drugs, including Actos \36\ and Metformin,\37\ to shut 
down her body's glucose production and to re-sensitize the peripheral 
resistance to insulin, Lipitor to reverse the arterial sclerotic 
changes in the neck, and Lycinapro, Morvasc, and Zetia [Tr. 477] with 
Metformin to open up her arteries, all of which was part of an anti-
inflammatory treatment to stop the progression of her carotid artery 
disease. [Tr. 600] Dr. S.D., however, testified that if Ms. E.M. had 
the blood sugar and glycosulated hemoglobin levels Respondent 
described, it would not have been necessary to medicate her for 
diabetes, and that the proper treatment would have been to try to 
control the condition with diet. Dr. S.D. testified that he has never 
prescribed Actos or Metformin for ``off-label'' use; and that in his 
opinion, Actos and Metformin

[[Page 53950]]

have no use other than to treat diabetes. [Tr. 133]
---------------------------------------------------------------------------

    \36\ See RX 22. Actos is a brand name product containing 
pioglitazone hydrochloride, a non-controlled substance, and is an 
oral antidiabetic agent that acts primarily by decreasing insulin 
resistance. [GX 40]
    \37\ I take official notice that Metformin is a non-controlled 
substance.
---------------------------------------------------------------------------

    Investigator R. testified that she visited the Kankakee Hospice 
central office on April 30, 2009, [Tr. 354] where she spoke to 
Executive Director D.L., Patient Care Coordinator P.L., C.K., and C.D., 
another nurse who treated Ms. E.M. Investigator R. testified that none 
of the people she interviewed had any knowledge of Ms. E.M. ever having 
diabetes [Tr. 355] and there was no record of Ms. E.M. receiving 
medication such as Actos and Metformin. [Tr. 356] Investigator R. also 
obtained from Doc's Drugs pharmacist E.U. a prescription profile 
listing all the prescriptions issued to Ms. E.M. and filled at that 
pharmacy from January 1, 2006, through August 29, 2008, [Tr. 347] that 
indicates that Respondent wrote prescriptions for Ms. E.M. for Actos, 
Metformin, Lipitor, Plavix, and Zetia.\38\ Dr. S.D. testified that a 
home health nurse caring for Ms. E.M. once asked him about giving Ms. 
E.M. Coumadin and Plavix, both blood thinners, but he advised that Ms. 
E.M. should not take either drug because she had suffered multiple 
falls and those medications increased the danger of bleeding in the 
brain.
---------------------------------------------------------------------------

    \38\ Zetia is a brand name product containing ezetimibe, a non-
controlled substance that inhibits the intestinal absorption of 
cholesterol. [RX 36]
---------------------------------------------------------------------------

    Dr. S.D. testified that he told the nurse that Ms. E.M. should just 
continue taking aspirin. [Tr. 87]
2. E.M.'s Treating Physicians
    Respondent testified that he began treating Ms. E.M. around 2003, 
when she was approximately 92 years old, and that he had ``a lot 
invested in E.M.,'' \39\ with whom he had had a personal relationship 
since he attended high school with Mr. I.S. [Tr. 485] Mr. I.S. 
testified that the hospice to which Ms. E.M. was admitted only allowed 
patients to use the hospice doctors; that hospice personnel told him 
that the only doctor Ms. E.M. could have was Dr. S.D.,\40\ [Tr. 661] 
and that he nonetheless admitted his mother to hospice care because he 
needed someone to care for her and he could not afford financially to 
provide that care himself. Mr. I.S. further testified that Dr. S.D. was 
``strictly a hospice doctor that she saw whenever she was admitted to 
the hospital, and he helped her get into hospice''; that Respondent was 
Ms. E.M.'s primary doctor, [Tr. 677] and that if another physician 
prescribed something for Ms. E.M., Mr. I.S. would discuss the issue 
with Respondent and follow his advice as to what medication Ms. E.M. 
should be prescribed. [Tr. 730] Mr. I.S. testified that he would have 
Ms. C.G. ``ask Dr. S.D. to write it, and most of the time he would.'' 
\41\ Mr. I.S. also testified that he took Ms. E.M. to see G.M., M.D., 
or T.M., M.D.\42\ ``on an emergency basis, and because we didn't want 
to see Dr. S.D.''; \43\ and if Ms. E.M. was sick, which, according to 
Mr. I.S., occurred ``maybe once or twice in her life,'' \44\ he took 
her to see Dr. M. Mr. I.S. initially testified that he believed Dr. M. 
was aware that Respondent was treating Ms. E.M., [Tr. 698] but later 
said that he did not think that either Dr. T.M. or Dr. G.M. knew that 
Respondent was treating Ms. E.M. [Tr. 699]
---------------------------------------------------------------------------

    \39\ Tr. 487.
    \40\ In his brief, Respondent asserts that the hospice 
requirement was to use a doctor located in Kankakee. See 
Respondent's Closing Argument Brief at 11.
    \41\ Tr. 673.
    \42\ G.M. and T.M. are physicians who practice together and 
appear to have each treated Ms. M. The testimony is not always clear 
as to which Dr. M. the witnesses are referencing.
    \43\ Tr. 698.
    \44\ Tr. 698.
---------------------------------------------------------------------------

    Dr. S.D. testified that he, along with Dr. V.P., B.D., M.D., and 
M.S., M.D., all treated Ms. E.M. for approximately four years prior to 
her death in 2009. Dr. S.D. further testified that Ms. E.M. was 
admitted to St. Mary's Hospital in Kankakee, Illinois, several times 
and also was a patient at Manor Care Nursing Home in Kankakee and at 
times had hospice care and home health care; that he was listed as Ms. 
E.M.'s primary care physician at each of those institutions; and that 
he does not know Respondent and was never informed that Respondent was 
treating Ms. E.M. [Tr. 98] Dr. S.D. further testified that Ms. E.M. was 
under hospice care for the last two-and-a-half to three years of her 
life, during which time he was her primary care physician; that 
although he only saw Ms. E.M. a few times in his office and in the 
hospital, he gave telephone orders and communicated with the hospice 
nurse regarding Ms. E.M.'s condition; he had no reason to believe that 
Ms. E.M. was seen by any other doctor or was taking medications not 
included on the medication list that he approved; [Tr. 102] and that 
any other physician who was treating Ms. E.M. should have informed him 
that he or she was prescribing OxyContin to her. [Tr. 140] Dr. S.D. 
testified that it is out of the range of normal practice for a 
physician to prescribe medications to a patient without consulting with 
other treating physicians of which he is aware. [Tr. 144]
    Ms. E.M. was first admitted to Kankakee Hospice, which provides 
care in the patient's home, on June 9, 2006.\45\ Ms. C.K. testified 
that she cared for Ms. E.M. in her home in late 2007 and early 2008, 
seeing her twice per week for approximately one hour per visit. [Tr. 
30] At each visit Ms. C.K. performed a physical assessment of Ms. E.M. 
(taking her blood pressure, heart and respiration rate; listening for 
lung sounds, bowel sounds; assessing her skin, cognition, etc.). [Tr. 
32] Ms. C.K. testified that every visit from and telephone call or 
other conversation with Kankakee Hospice personnel was recorded and 
that the hospice also kept hospital records, laboratory test results, 
and records received from the doctor.
---------------------------------------------------------------------------

    \45\ See GX 17.
---------------------------------------------------------------------------

    Ms. C.K. further testified that Kankakee Hospice needs to know of 
every physician ``who is on board to treat the patient''; \46\ that 
there is a primary physician and usually a secondary physician; and 
that Kankakee Hospice prefers to have its personnel accompany the 
patient to doctor appointments. Ms. C.K. testified that while she cared 
for Ms. E.M., none of her family members ever mentioned that Respondent 
was treating her, but the family did mention that Ms. E.M. saw Dr. S.D. 
and Dr. M. Ms. C.K. also was not aware of any physicians making home 
visits to Ms. E.M., although that information should have been 
disclosed to Kankakee Hospice.
---------------------------------------------------------------------------

    \46\ Tr. 35.
---------------------------------------------------------------------------

3. Ms. E.M.'s Prescriptions and Treatment
    Respondent testified that when he began treating Ms. E.M. in 2003, 
she was taking multiple pain medications, such as Tylenol No. 4, 
Lorcet,\47\ and Vicodin; that she sometimes took as many as 10 or 12 
pills per day; and that he changed her regimen to a more potent and 
controlled dosage on a regular schedule. [Tr. 498] Respondent testified 
that Ms. E.M. suffered from low back pain; that treatment with 
medication on an as-needed basis was not sufficient to relieve her 
pain; and that the appropriate treatment was to increase the amount of 
opioid medication until either the pain went away or the side effects 
became too drastic to continue. [Tr. 514] According to Respondent, 
instead of tapering a patient off a drug while he still has symptoms, a 
doctor should increase the level of the drug in order to extinguish the 
symptoms; tolerance with regard to symptoms requires an increased 
dosage that relieves the pain, which is different from increasing 
dosage to extinguish pain. [Tr. 517] Respondent testified that all 
patients develop dependence, which

[[Page 53951]]

means that if the medicine is abruptly withdrawn, the patients will 
become antsy, shaky, and complain of nervousness, and that although 
some anti-anxiety agents or antihistamines may be used to treat the 
withdrawal symptoms, the best option is to withdraw the medication 
slowly over a period of time. Respondent testified that addiction ``is 
the unworkable lifestyle that is created by a person that escalates the 
intake of narcotics and opioids,'' \48\ and is always exhibited by 
anti-social behavior.
---------------------------------------------------------------------------

    \47\ I take official notice that Lorcet is a brand name product 
containing hydrocodone bitartrate and acetaminophen.
    \48\ Tr. 519.
---------------------------------------------------------------------------

    Dr. S.D. testified that he never prescribed OxyContin to Ms. E.M. 
because he was afraid that she could not handle a strong pain 
medication, but that he prescribed Aricept for dementia, Toprol XL and 
Micardis for cardiac issues, [Tr. 83] and Tylenol, and that he maybe 
prescribed Darvocet, and occasionally Vicodin for pain.\49\ Dr. S.D. 
testified that Ms. E.M.'s pain, although chronic, was not so severe 
that she needed constant pain medication. [Tr. 89]
---------------------------------------------------------------------------

    \49\ I take official notice of the following information from 
the 2007 edition of the Physicians' Desk Reference: Aricept is a 
brand name product containing donepezil hydrochloride, a non-
controlled substance, indicated for the treatment of mild to 
moderate dementia; Tylenol is a brand name over-the-counter 
medication containing acetaminophen and is indicated for the 
temporary relief of minor aches and pains; propoxyphene and 
acetaminophen and is used to relieve mild to moderate pain.
---------------------------------------------------------------------------

    Mr. I.S. testified that OxyContin seemed to work better than the 
other medications Ms. E.M. had tried, and that before she started 
taking OxyContin, Ms. E.M. sometimes took as many as four or five pills 
per day'' \50\ of Vicodin, Lorcet, or ``whatever I had.'' \51\ Mr. I.S. 
testified that Respondent started prescribing OxyContin 80 mg to Ms. 
E.M. in 2003, and that Mr. I.S. was not surprised by the high dosage 
because he ``didn't know much about it.'' \52\ Mr. I.S. further 
testified that Respondent never changed the strength or quantity of 
OxyContin he prescribed to Ms. E.M. [Tr. 708]
---------------------------------------------------------------------------

    \50\ Mr. I.S. later testified that Ms. E.M.s took ``[a]t least 
three pills a day,'' in the range of three to seven pills, 
``whatever it took to kill her pain, that is as many pills as I gave 
her for the day.'' Tr. 717.
    \51\ Tr. 669.
    \52\ Tr. 668.
---------------------------------------------------------------------------

    Mr. I.S. testified that he initially filled Ms. E.M.'s OxyContin 
prescriptions with the brand name drug but because it was very 
expensive, he then tried the generic form. According to Mr. I.S., 
however, Ms. E.M. insisted that she wanted the brand name product'' 
\53\ and the pharmacist had told him that the ``deliver[y] mechanism of 
oxycodone was that it delivers all at once, and that the OxyContin was 
more of a time release thing over 12 hours.'' \54\ Mr. I.S. further 
testified that because the generic drug was not a time release product 
and Ms. E.M. insisted that she wanted ``the other one,'' \55\ [Tr. 695] 
he thereafter filled the prescriptions with OxyContin. [Tr. 672]
---------------------------------------------------------------------------

    \53\ Investigator D.M. testified that in the August 2005 
interview, Mr. I.S. had stated that he filled his mother's 
prescriptions with generic drugs because his mother had suffered a 
stroke and would not recognize the difference between generic and 
brand name drugs. Tr. 244.
    \54\ Tr. 671.
    \55\ Tr. 671.
---------------------------------------------------------------------------

    Investigator R., however, testified that she spoke with Mr. E., the 
pharmacist from Doc's Drugs, who informed her that if a patient 
presents a prescription written for a brand name drug and requests a 
generic, or the prescription allows a generic to be substituted for the 
brand name product, then the pharmacist must provide the patient with a 
generic medication that has the same properties as the brand name drug, 
including any time release effect; and that oxycodone 80 mg is not 
available as an immediate release tablet because it could be fatal. 
[Tr. 840] The Government offered into evidence copies of prescriptions 
Respondent issued to Ms. E.M. that investigators obtained from Doc's 
Drugs; [Tr. 340; Tr. 412; Tr. 231] each prescription was written for 
OxyContin with substitution permitted. Respondent testified that 
breaking an OxyContin tablet in half only somewhat obviates the time 
release effect and that the active ingredient may release more quickly. 
[Tr. 797]
    According to a Physician's Desk Reference excerpt for OxyContin 
that the Government offered into evidence, ``OxyContin tablets are to 
be swallowed whole and are not to be broken, chewed, or crushed. Taking 
Broken, Chewed, or Crushed OxyContin tablets leads to rapid release and 
absorption of a potentially fatal dose of oxycodone.'' \56\
---------------------------------------------------------------------------

    \56\ GX 40 at 17.
---------------------------------------------------------------------------

    Investigator D.M. testified that there is a large price 
differential between the brand drug and the generic, and that the 
OxyContin brand can sell on the street for approximately one dollar per 
milligram. [Tr. 297] Investigator R. testified that Mr. E. told her 
that Mr. I.S. always picked up Ms. E.M.'s prescriptions and that 
although insurance covered the prescriptions, Mr. I.S. paid the co-pay, 
which was sometimes as much as $400 for the brand name drug, in cash. 
Mr. E. further told Investigator R. that it was unusual for a customer 
to request a brand name with such a high co-pay when a generic 
alternative was available; [Tr. 414] and that the time release generic 
of OxyContin had been available at relevant times except for a period 
of approximately six months around 2007. [Tr. 840] Mr. I.S. testified 
that he submitted the insurance claims for the OxyContin prescriptions 
to Ms. E.M.'s insurance carrier and that he paid Respondent in cash for 
his services to Ms. E.M. [Tr. 695]
4. Administering OxyContin to E.M.
    On January 18, 2006, Ms. E.M. was admitted to St. Mary's Hospital; 
at that time, a home medication list indicated that she received 
OxyContin 80 mg every 12 hours. [GX 21 at 9] Respondent testified that 
he arranged to have a family member see that OxyContin was included on 
Ms. E.M.'s home medication list because he ``wanted somebody to figure 
out that she was on pain medication.'' \57\ Dr. S.D. testified that he 
ordered that the OxyContin not be continued and that he was not aware 
of OxyContin ever again being listed on Ms. E.M.'s medication lists, 
[Tr. 90] but that if Ms. E.M. had been on OxyContin and it was stopped, 
she would suffer from withdrawal symptoms such as abdominal pain, 
diarrhea, and vomiting. [Tr. 106]
---------------------------------------------------------------------------

    \57\ Tr. 821.
---------------------------------------------------------------------------

    Dr. S.D. also testified that Ms. E.M. did not receive OxyContin 
while in the hospital because family members are not permitted to give 
medication to patients, that patients receive only those medications 
prescribed by the attending physician, and that he was Ms. E.M.'s 
attending physician and did not prescribe OxyContin to her. [Tr. 107]
    Dr. S.D. testified that he never spoke with Mr. I.S. but would call 
his home and leave messages regarding Ms. E.M.'s condition. Dr. S.D. 
testified that Mr. I.S. did not return calls, but that he did speak 
with Mr. I.S.'s girlfriend. [Tr. 109] Mr. I.S. testified that although 
Dr. S.D. issued prescriptions to Ms. E.M. for Vicodin, he did not fill 
those prescriptions because his mother was already taking OxyContin.
    Investigator R. testified that on October 23, 2006, she met with 
Kankakee Hospice's executive director, D.L., who told her that the 
Hospice's policy requires that the nurses be informed of all of a 
patient's medications and treating physicians. Investigator R. further 
testified that at that meeting she also spoke with other Hospice 
personnel who told her that OxyContin did not appear on Ms. E.M.'s 
medication list and her Kankakee Hospice records did not mention that 
she was in pain or that Respondent

[[Page 53952]]

treated her. [Tr. 352] Ms. C.K. testified that Ms. E.M. complained of 
pain in her knees and arm and sometimes had difficulty standing and 
some stiffness, but that Mr. I.S. or Ms. C.G. gave her Tylenol to 
alleviate the pain and that Mr. I.S. said that the Tylenol worked and 
he did not want his mother to have anything else. Ms. C.K. testified 
that it seemed unusual for the caregivers to insist that only they 
would administer certain medications. [Tr. 40, Tr. 45] Ms. C.K. further 
testified that as far as she knew, the only controlled substance that 
Ms. E.M. took was Valium \58\ for seizures; and that Ms. E.M.'s family 
never mentioned that she was taking OxyContin. Ms. C.K. testified that 
she was not aware of any controlled substances that were prescribed to 
Ms. E.M. on a chronic or recurring basis; that she never saw any 
medications prescribed by Respondent or any OxyContin vials or pills at 
Ms. E.M.'s home; and that the only medication that the hospice team 
attempted to count was Valium, which they had difficulty accessing from 
Ms. E.M.'s family. [Tr. 35; Tr. 42] Mr. I.S. testified that he did not 
want to tell the Kankakee Hospice personnel about his mother having 
OxyContin because Kankakee Hospice had told him that it must have 
control over any controlled substances Ms. E.M. took and thus hospice 
personnel must have access to those drugs, but that he did not want to 
leave the OxyContin ``in a cabinet for some punk or something that may 
be coming in my house after school to take or whatever.'' \59\ Mr. I.S. 
also testified that Ms. E.M. did not want anyone to know that she was 
on pain medication because ``she was very old-fashioned, and * * * she 
just didn't think it was anybody else's business.'' \60\
---------------------------------------------------------------------------

    \58\ I take official notice of information in the 2007 edition 
of the Physicians' Desk Reference that Valium is a brand name 
product containing diazepam, a Schedule IV controlled substance.
    \59\ Tr. 697.
    \60\ Tr. 680.
---------------------------------------------------------------------------

    Investigator R. testified that on October 23, 2008, she interviewed 
Ms. D., who had treated Ms. E.M. in her home in 2006-2007. Ms. D. told 
Investigator R. that Ms. E.M. complained of mild arthritic pain; that 
Ms. D. asked Mr. I.S. whether they should look into getting something 
stronger to alleviate the pain; and that Mr. I.S. said that he had 
previously given Ms. E.M. one-half tablet of Vicodin, but that that 
medicine was too strong for her and she should continue to take 
Aleve.\61\ [Tr. 448]
---------------------------------------------------------------------------

    \61\ I take official notice from the 2007 edition of the 
Physicians' Desk Reference that Aleve is a brand name product 
containing naproxen sodium, a non-controlled substance.
---------------------------------------------------------------------------

    Mr. I.S. testified that Kankakee Hospice only allowed patients to 
use the hospice ``system for drugs,'' \62\ and therefore either he or 
someone in his family gave Ms. E.M. OxyContin while she was admitted to 
Kankakee Hospice and when she was in St. Mary's Hospital, at Manor Care 
Nursing Home, at Heritage Village Nursing Home, and at St. James 
Hospital. [Tr. 680] Mr. I.S. testified that Ms. E.M. received one 
OxyContin pill in the morning and one at night but for the two weeks 
before his mother died he gave her only the nighttime dose because he 
worried that she may have been too weak to receive more; [Tr. 682] 
OxyContin was the only prescription medication that the family gave to 
Ms. E.M.; \63\ and to his knowledge, the hospital never gave Ms. E.M. 
any pain medication, not even Aleve, and that he did not know why she 
should need Aleve.\64\ [Tr. 668]
---------------------------------------------------------------------------

    \62\ Tr. 661.
    \63\ But see Section D.1. supra: Respondent prescribed Ms. 
E.M.'s Actos, Metformin, Lipitor, Plavix, and Zetia, all of which 
appeared on Ms. E.M.'s prescription profile from Doc's Drugs but not 
always on her home medication lists. GX 27.
    \64\ Ms. E.M. did receive pain medication such as Aleve and 
Tylenol.
---------------------------------------------------------------------------

    Respondent's patient chart for Ms. E.M. includes treatment notes 
for at least one day each month beginning September 15, 2003, and 
ending on the date of her death, June 13, 2009, [RX 16] but indicates 
that Ms. E.M. ``missed appointments'' with Respondent on both February 
28 and March 28, 2006.\65\ Respondent explained that ``at this point in 
time when I write missed appointment, that will mean that I did not 
give her a prescription for pain medication.'' \66\ Respondent later 
testified that ``I may have issued it at their home at a later 
appointment, at a later point in time, but I don't think I issued it.'' 
\67\ The Government offered into evidence [GX 14] photocopies of 
prescriptions Respondent issued to Ms. E.M. for 80 mg OxyContin and 
dated February 28 and March 28, 2006. Respondent's patient chart for 
Ms. E.M. indicates, and Respondent testified, that he saw her on 
October 20 and November 17, 2006, but records from St. Mary's Hospital 
in evidence as a Government exhibit show that Ms. E.M. was admitted to 
that hospital on October 7, 2006, that she was discharged on October 
12, 2006, [GX 21 at 203] and immediately admitted into Manor Care 
Nursing Home, where she remained until December 8, 2006. [GX 21 at 203, 
GX 27B at 956, GX 43 at 108]
---------------------------------------------------------------------------

    \65\ RX 16 at 5.
    \66\ Tr. 787.
    \67\ Tr. 787.
---------------------------------------------------------------------------

    Respondent testified that he completed the continuing medical 
education course required under his 2003 Consent Order and that during 
that course he learned that it is unlawful ``for a pharmacist to refill 
a blank and give two dispenses on the same single blank'' \68\ for a 
Schedule II controlled substance. Respondent further testified that he 
believes that a physician can authorize another prescription without 
seeing the patient and that it is ``even legal under the information 
that I go by that you can even predate a controlled substance 
prescription''; \69\ [Tr. 739] but that he has never predated 
prescriptions and has never written refills although he has written new 
prescriptions without seeing the patient. Respondent testified that he 
also learned that a physician should ensure that patients to whom he 
prescribes a controlled substance do not obtain controlled substances 
from another source and that such patients should be tested to verify 
that they are actually taking that medication. [Tr. 740] Respondent had 
earlier testified that if the Government suspected diversion of 
OxyContin with regard to E.M. then either the Government or Dr. S.D. 
should have tested her for it. [Tr. 577]
---------------------------------------------------------------------------

    \68\ Tr. 738.
    \69\ Tr. 739.
---------------------------------------------------------------------------

    Mr. I.S. testified that he discussed with Respondent the concern 
that Ms. E.M. receive ``her proper pain medicine'' \70\ when she was in 
a nursing home or hospital. [Tr. 674] Mr. I.S. further testified that 
Dr. S.D. prescribed Vicodin for Ms. E.M. but that she never asked for 
it because she did not need it; and that when Ms. E.M. was in the 
nursing home or hospital he hired his girlfriend's daughter to visit 
her twice a day and to give her medication and food and to sit with 
her. [Tr. 675] Respondent testified that he had instructed ``him'' \71\ 
to be aware of other depressants, sleeping pills, narcotics, and 
opioids given Ms. E.M. so as to avoid an overdose. [Tr. 656] Mr. I.S. 
testified that in the three or four weeks before his mother died, he 
met with the St. Mary's Hospital administrator and asked that no new 
medications be given to Ms. E.M. without his knowledge. Mr. I.S. 
further testified that prior to that time, the hospital had no 
directions not to give pain medication to Ms. E.M. and that he reviewed 
her medication charts every day to make sure that she did not receive 
pain medication. [Tr. 711] Mr. I.S. testified that he never saw any 
pain medication listed in Ms. E.M.'s hospital

[[Page 53953]]

charts, not even over-the-counter medications. [Tr. 714]
---------------------------------------------------------------------------

    \70\ Tr. 674.
    \71\ Presumably he is referring to Mr. I.S. See Tr. 656.
---------------------------------------------------------------------------

    Mr. I.S. later testified that in the thirty days before Ms. E.M. 
died, he reviewed the charts as many times as he went to the hospital 
and that he ``left orders with them to not introduce any new 
medications to my mother. * * *'' \72\ Mr. I.S. then testified that he 
always gave directions to the hospital to not give Ms. E.M. any new 
medications, and that he had previously told the DEA that both he and 
Ms. E.M. were receiving OxyContin. Mr. I.S. testified that he knew that 
DEA personnel could go to the hospital to see whether Ms. E.M. received 
any other pain medication, so he made sure that she did not get any. 
[Tr. 719] Mr. I.S. also testified that if an emergency arose when Ms. 
E.M. was in a hospital or nursing home, such as if she were to fall, 
then the hospital or nursing home would call him and he would issue 
instructions not to give her any pain medication. [Tr. 728]
---------------------------------------------------------------------------

    \72\ Tr. 712.
---------------------------------------------------------------------------

    Respondent testified that at times, depending on the conditions, he 
would omit or reduce the amount of OxyContin he prescribed to Ms. E.M. 
or change the dosing schedule based on her clinical situation, and that 
if she was suffering certain symptoms, such as from a stroke, he would 
have ``them'' \73\ withhold the pain medication for up to 24 hours. Mr. 
I.S. testified that he did not recall whether Respondent ever asked him 
to delay the dosage or to hold back Ms. E.M.'s pain medication when she 
was hospitalized.
---------------------------------------------------------------------------

    \73\ Tr. 656. Presumably Respondent was referring to Ms. E.M.'s 
family.
---------------------------------------------------------------------------

E. Respondent's 2006 DEA Renewal Application and Registered Location
    On September 25, 2006, Respondent submitted to the DEA an 
application to renew his registration. [Tr. 318; GX 31] Respondent's 
registered location on that renewal application was listed as 120 
Oakbrook Center Mall, Oakbrook, Illinois.\74\ In response to question 
number three of the application, ``Has the applicant ever had a state 
professional license or controlled substance registration revoked, 
suspended, denied, restricted, or placed on probation, or is any such 
action pending?'', Respondent provided an affirmative answer. In his 
explanation for that answer, submitted with the application, Respondent 
identified and explained the 2003 IDFPR Consent Order but did not refer 
to the 1998 Consent Order. [GX 31] Respondent testified that his 
omission of the 1998 order was inadvertent and that he had included the 
1998 incident on previous renewal applications. [Tr. 618, GX 18]
---------------------------------------------------------------------------

    \74\ GX 31.
---------------------------------------------------------------------------

    Investigator R. testified that on March 13, 2009, she and another 
diversion investigator served upon Respondent the DEA Order to Show 
Cause that gave rise to this proceeding. [Tr. 323] Investigator R. 
testified that she served the Order to Show Cause at Respondent's 
residence in Riverside, Illinois, because the investigators had not 
succeeded in serving it at his registered location, and that when the 
investigators went to Respondent's residence and ``before we had the 
opportunity to identify ourselves, [Respondent] slammed the door in our 
face when I said, `Dr. Herbert, I have something for you,' and he said 
that `I am not Dr. Herbert. I am R.S.' '' \75\ Investigator R. further 
testified that a few minutes later Respondent telephoned her, 
indicating that he was returning one of her earlier calls.
---------------------------------------------------------------------------

    \75\ Tr. 327.
---------------------------------------------------------------------------

    Investigator R. testified that during that telephone conversation 
she arranged to serve the Order to Show Cause through Respondent's 
attorney the next day; that Respondent informed her that he had moved 
his registered location to 2910 South Harlem Avenue, Riverside, 
Illinois; [Tr. 324] that she then advised Respondent that in order to 
modify his registered location he needed to submit a modification 
request along with a copy of his Illinois controlled substance license 
showing the new location; and that she provided him a fax number to use 
to send the documents. Investigator R. further advised Respondent that 
he needed to wait until his modification was approved before he could 
handle controlled substances at the new location. [Tr. 327]
    Investigator R. testified that prior to March 13, 2009, the DEA had 
not received any notification from Respondent or anyone else that he 
had moved his medical practice from his DEA registered location in 
Oakbrook to Riverside; [Tr. 326] that she had previously made several 
failed attempts to contact Respondent at his registered address (she 
went to 120 Oakbrook Center and knocked on Suite 711; telephoned 
Respondent's office and left messages requesting a call back; and 
identified herself in those messages and indicated that she needed to 
deliver something); but that she had never been able to locate 
Respondent at his registered location except when she arranged to do so 
by appointment. [Tr. 325] Investigator R. testified that on March 26, 
2009, the leasing office at the Oakbrook Center Mall informed her that 
as of July 31, 2008, the locks had been changed on Respondent's 
Oakbrook office because he had abandoned the location. [Tr. 324]
    Respondent testified that in July 2008 he moved his office to 2910 
Harlem Avenue; [Tr. 577] that the DEA would not send him any address 
modification forms; that he could not access the forms on-line; and 
that he called the DEA office in Chicago multiple times and left 
messages in an attempt to get a change of address form.
    Investigator R. testified that Respondent's attorney filed with the 
DEA a request dated April 7, 2009, to modify Respondent's registered 
location. [RX 15] That same day, counsel for the Government sent a 
letter to Respondent indicating that since he had already moved his 
office, he was not authorized to handle controlled substances at the 
new location until the DEA approved the modification of his address. 
[GX 9] Investigator R. testified that she served that letter in person 
to Respondent's attorney and left for Respondent a telephone message 
summarizing the contents of the letter. [Tr. 331] On June 8, 2009, 
counsel for the Government sent another letter to Respondent's attorney 
indicating that the registered location modification request had not 
yet been approved and that, until it was approved, any controlled 
substance prescriptions issued by Respondent would be unlawful. [GX 33] 
Investigator R. testified that the letter was personally delivered to 
Respondent and was faxed to Respondent's attorney. [Tr. 333]
    Investigator R. further testified that she obtained from the 
Illinois Department of Human Services Prescription Monitoring Program, 
to which Illinois pharmacies are required to report information 
pertaining to controlled substance prescriptions, a prescription 
profile identifying controlled substance prescriptions that Respondent 
issued from June through August 2009. [GX 34] During that period, 
according to the prescription profile, Respondent issued 29 controlled 
substance prescriptions to 13 different people: 60 dosage units of 
OxyContin 80 mg to each of seven different people, one of whom also 
received 30 diazepam 10 mg; 40 oxycodone 5 mg and 30 Adderal 30 mg to 
one person; 90 hydrocodone 7.5 mg to one person; 10 hydrocodone 5 mg to 
one person; 30 phentermine 37.5 mg (via two separate prescriptions 
written on the same day) to one person; and 14 phentermine 37.5 mg to 
one person. [GX 34]
    Respondent testified that Investigator R. had told him on March 13, 
2009, that he could not handle controlled

[[Page 53954]]

subscriptions but he ``didn't take it all that seriously with the word 
handling, because I had not ordered any prescriptions, and I had no 
samples'' \76\ but he did not ask her what she meant by ``handling.'' 
Respondent further testified that he did not see anything about 
prescribing until he saw the letters from Government counsel, and that 
his attorney reviewed the letters and told him that it appeared that 
the DEA did ``have the power to withhold the registration'' \77\ but he 
nonetheless continued to issue original controlled substances 
prescriptions until October 2009, ``when the gravity of what was going 
on here became absolutely clear.'' \78\ [Tr. 778]
---------------------------------------------------------------------------

    \76\ Tr. 779.
    \77\ Tr. 777.
    \78\ Tr. 778.
---------------------------------------------------------------------------

The Parties' Contentions

I. The Government

    The Government contends, in substance, that the Deputy 
Administrator should revoke Respondent's DEA registration and that any 
pending applications for renewal or modification of that registration 
should be denied, ``because Respondent made material misstatements on 
an application for registration and because his continued registration 
would be inconsistent with the public interest as that term is used in 
21 U.S.C. 823(f).'' \79\
---------------------------------------------------------------------------

    \79\ Government's Proposed Findings of Fact, Conclusions of Law 
and Argument at 3.
---------------------------------------------------------------------------

    The Government contends that Respondent has had controlled 
substances violations dating back to 1994 and resulting in consent 
orders with the Illinois Medical Board in 1998 and 2003. The 1998 
consent order involved the unlawful prescribing of Dilaudid and 
required Respondent to complete a course pertaining to the handling of 
controlled substances. The Government contends that this course had 
little effect on Respondent's prescribing, that he continues to violate 
applicable law, and that he is evading the allegations rather than 
responding to them candidly.
    The Government next asserts that Respondent unlawfully received 
dronabinol from a patient's prescription, failed to properly record 
that receipt, and maintained a misleading and inaccurate record of his 
subsequent dispensing of the dronabinol. Further, the Government argues 
that Respondent's 2003 Consent Order with the IDFPR arose because the 
unlawful dispensing was inevitable based on the arrangement between 
Respondent and the clinic owner and Respondent's conduct therefore 
enabled and abetted the clinic owner. As with the 1998 Consent Order, 
Respondent was again required to complete a course on proper 
prescribing and dispensing of controlled substances but, according to 
the Government, Respondent ignored this education and continued to 
collect violations.
    The Government goes on to contend that Respondent violated state 
law when he failed to disclose records demanded in an IDFPR subpoena. 
The Government argues that the Illinois Medical Practice Act provides 
the IDFPR with the authority to serve an administrative subpoena duces 
tecum pursuant to a Medical Board investigation and that the Health 
Insurance Portability and Accountability Act (HIPAA) provides an 
exception for the disclosure of information that is requested by an 
order of an administrative tribunal.
    The Government further asserts that Respondent's omission of his 
1998 Consent Order from his DEA controlled substances registration 
renewal application was a material omission because it involved the 
diversion of a Schedule II controlled substance and because Respondent 
was conversant with the facts of the Consent Order at the immediate 
hearing.
    The Government argues that Respondent participated in a scheme that 
involved the diversion of OxyContin. It argues that there is a lack of 
medical history to justify issuing prescriptions for 80 mg OxyContin to 
Ms. E.M. and that Respondent's attempts to provide justification for 
prescribing to her are essentially post hoc rationalizations. 
Additionally, the Government contends, it is unlikely that someone from 
Ms. E.M.'s family was able to secretly administer OxyContin twice per 
day during the approximately 290 days that she was in a hospital or in-
patient nursing home. According to the Government, Respondent's 
arguments are further diminished by not only the conflicts in testimony 
between Respondent and Mr. I.S. but also between the testimony and 
institutional records, as well as Respondent's questionable patient 
chart for Ms. E.M., which includes dates of Respondent's purported 
treatment of her when she was confined to a hospital or nursing home. 
The Government contends that if Ms. E.M. had received the OxyContin 
that Respondent prescribed, she would likely suffer withdrawal symptoms 
when institutionalized, but there is no such record. Also, the 
Government contends, Respondent's and Mr. I.S.'s claims regarding the 
time release properties of generic oxycodone are not credible because 
they were refuted by both the Physician's Desk Reference and a 
pharmacist.
    The Government also argues that Respondent prescribed other drugs, 
in addition to OxyContin, in Ms. E.M.'s name but that these drugs were 
never administered to her and were likely diverted. The Government 
points out that, although Respondent claims that he prescribed Actos 
and Metformin to Ms. E.M. to treat diabetes, her other treating 
physicians and hospital records indicate that she did not have diabetes 
and Mr. I.S.'s testimony is again in conflict with Respondent's because 
he testified that the only prescription drug he or his family 
administered to Ms. E.M. was OxyContin. The Government further contends 
that Plavix was also diverted, relying again on the conflicting 
testimony of Respondent and Mr. I.S. and on the evidence that for some 
time both Dr. S.D. and Respondent prescribed Plavix but, although Dr. 
S.D. discontinued it because of injury risks, Respondent continued to 
prescribe it; and Respondent's patient chart for Ms. E.M. provided no 
information regarding such prescriptions.
    Finally, the Government asserts that Respondent unlawfully 
prescribed controlled substances from an unregistered location because 
Respondent failed to timely request a modification of his registered 
address and continued to issue controlled substances prescriptions at 
his new location even after receiving numerous warnings against such 
action.

II. Respondent

    Respondent contends that the omission of his 1998 state probation 
from his renewal application was not a material falsification because 
the omission was inadvertent. Respondent asserts that inasmuch as he 
accepted the 1998 state probation related to phentermine dispensing, 
the DEA should not ``seek additional retribution'' \80\ for the 
incident. Respondent argues his disclosure of the 1998 probation on 
previous DEA applications, the DEA and state investigators' awareness 
of both the 1998 and 2003 disclosures, and the previous disclosures' 
existence ``permanently on the D.E.A. computerized files,'' ``clearly 
[indicate] no subterfuge motive.'' \81\
---------------------------------------------------------------------------

    \80\ Respondent's Closing Argument Brief at 8.
    \81\ Respondent's Closing Argument Brief at 3.
---------------------------------------------------------------------------

    Respondent argues that in mid-August 2003, because of his 2003 
state probation, he ``purposely discontinued all ordering of 
medications from wholesale suppliers for the purpose of

[[Page 53955]]

dispensing medications;'' \82\ that, in the spring of 2005, when 
Investigator D.M. asked to inspect Respondent's controlled substance 
logs, Respondent did not recall any ordering or dispensing of 
controlled substances in 2003 and created a handwritten log indicating 
such; that later that same day, he found a controlled substance log 
from the first seven months of 2003 that showed three instances in 
which he had dispensed a controlled substance; and that Respondent's 
attorney contacted Investigator D.M. to notify him of that log and that 
Investigator D.M. was given a copy.
---------------------------------------------------------------------------

    \82\ Respondent's Closing Argument Brief at 4.
---------------------------------------------------------------------------

    Respondent further contends that his dispensing of dronabinol did 
not violate 21 U.S.C. 844(a) because he was ``acting in the course of 
his professional practice.'' \83\ Respondent argues that he had a 
patient who obtained dronabinol via a prescription issued by another 
physician; that the patient ``lawfully transferred the medication to me 
* * * to be used for the benefit of another patient * * *;'' and that 
he dispensed the dronabinol to another patient and recorded that action 
in the patient's chart and in his 2003 controlled substance log. 
Respondent argues that his actions fall under the exception in Sec.  
844(a) permitting a physician to possess or obtain a controlled 
substance when ``acting in the course of his professional practice'' 
\84\ and that there is no prohibition against obtaining medication from 
a patient to use for another patient.
---------------------------------------------------------------------------

    \83\ Respondent's Closing Argument Brief at 5.
    \84\ Respondent's Closing Argument Brief at 5.
---------------------------------------------------------------------------

    Respondent then asserts that this entire proceeding was initiated 
against him as a form of revenge by the City of Chicago because 
Respondent testified on behalf of Officer D.S. at the Chicago Police 
Board hearing. Respondent asserts that his right to due process has 
been violated because Illinois and the DEA have violated the Illinois 
Medical Practice Act and because he was not represented by counsel at 
the instant hearing. Respondent argues that any evidence that was not 
``generated by [Investigator] R. alone or directly subpoenaed by D.E.A. 
has no place in evidence at this hearing.'' \85\
---------------------------------------------------------------------------

    \85\ Respondent's Closing Argument Brief at 9.
---------------------------------------------------------------------------

    Respondent contends that the DEA has failed to meet its burden of 
proof of showing that he failed to comply with the IDFPR administrative 
subpoenas issued in 2005 and 2007; Respondent asserts that he provided 
the requested records but redacted all identifying information as 
required by 225 ILCS 60/22(A)(38). Respondent argues that because the 
statute provides that ``all information indicating the identity of the 
patient shall be removed and deleted'' and that because records of 
prescriptions he issued and to which Illinois and the DEA have access 
include patient names and the date the prescriptions were issued, he 
was required to redact the names and treatment dates in order to allow 
Illinois to ``review the records without tying a specific chart to a 
patient.'' \86\ Respondent further argues that he complied with the 
subpoena prior to March 2009 because his attorney supplied codes 
revealing the names and Respondent obtained permission from his 
patients to provide the relevant medical charts. Respondent contends 
that the allegation that he failed to comply with the subpoenas is 
another example of revenge-seeking by Chicago because of Respondent's 
testimony in the Police Board hearing; that the DEA and Illinois are 
``doing the bidding of the City of Chicago;'' \87\ that the records 
that were the subject of the subpoenas should not have been available 
to the DEA because 225 ILCS 36 bars the DEA from having or using 
information compiled by Illinois; that Respondent was not represented 
by counsel at the instant hearing; and that Respondent relied on the 
advice of his previous counsel with regard to the redacted information 
provided in response to the subpoenas.
---------------------------------------------------------------------------

    \86\ Respondent's Closing Argument Brief at 9.
    \87\ Respondent's Closing Argument Brief at 10.
---------------------------------------------------------------------------

    Respondent asserts that there is no evidence of diversion with 
regard to his prescribing OxyContin to Ms. E.M.; that he treated her 
for more than five and a half years prior to her death; that Ms. E.M. 
suffered from multiple medical problems (including severe 
kyphoscoliosis, cerebral vascular disease, Binswanger's Disease, and 
diabetes); that Ms. E.M. and seven other patients required the 
prescriptions he issued them for OxyContin 80 mg because that strength 
was not a high dose for them because of the form of chronic pain from 
which they suffered; and that he properly treated Ms. E.M. for diabetes 
and inflammatory vascular disease by prescribing Actos and Metformin. 
Respondent also asserts that Actos and Metformin are not controlled 
substances and are therefore outside the DEA's jurisdiction.
    Respondent argues that it is not plausible that the OxyContin he 
prescribed to Ms. E.M. was diverted because: Respondent and his 
patients were aware of the DEA investigation and the patients produced 
their current medications when interviewed; the DEA and Dr. S.D. failed 
to perform opioid level tests on Ms. E.M., even though they were free 
to do so and she showed signs of clinical opioid usage and rarely 
complained of pain despite the presence of ``multiple and obvious pain 
sources;'' \88\ if Respondent performed an opioid test on Ms. E.M. it 
would not disprove diversion; Mr. I.S. never filled the prescriptions 
that Drs. S.D. and V.P. issued to Ms. E.M. for Vicodin; and Respondent 
had previously prescribed OxyContin 80 mg to Ms. C.G. and, after 
Respondent stopped treating her, a Dr. M. continued the same 
prescriptions. Respondent further claims that the failure of the DEA, 
Dr. S.D., Dr. V.P., and Dr. M.\89\ to test Ms. E.M. for opioids and 
thereby exonerate Respondent, cannot be used against him because, if 
they had suspicions of diversion, they should have ``[acted] to clear 
up this charge.'' \90\ Respondent contends that Investigator R. 
conducted her investigation with ``obvious prejudice'' \91\ to cast 
Respondent in an unfavorable light. Respondent asserts that Drs. S.D., 
P., and M. were aware that Ms. E.M. had pain because they prescribed 
pain medicines such as Vicodin and morphine; that Ms. E.M.'s not taking 
the pain medication should have alerted these doctors that her family 
was medicating her; that Ms. E.M.'s family asked Respondent not to 
communicate with her other doctors and he complied to avoid discharge 
as her physician; and that Respondent ``placed OxyContin on the 
record.'' \92\
---------------------------------------------------------------------------

    \88\ Respondent's Closing Argument Brief at 14.
    \89\ Although he refers to a ``Dr. M.'' in his brief, I presume 
that Respondent actually intended to refer to either Dr. G.M. or Dr. 
T.M. because there was no evidence presented that Ms. E.M. was ever 
treated by a Dr. M.
    \90\ Respondent's Closing Argument Brief at 15.
    \91\ Respondent's Closing Argument Brief at 15.
    \92\ Respondent's Closing Argument Brief at 17.
---------------------------------------------------------------------------

    Respondent contends that the DEA acted ``capriciously and in bad 
faith'' \93\ by invalidating his DEA registration when he moved his 
office from his registered location and by refusing to reinstate his 
license pending the instant proceedings. Respondent argues that he was 
not permitted access to forms or other communication methods on the DEA 
Web site and that none of his calls to Investigator R. and the DEA's 
Chicago office were returned; that the DEA refused to transfer 
Respondent's registration to his new office after ``the D.E.A. finally 
figured out I moved''; \94\ that Respondent sent a letter to the DEA 
advising it of his move in lieu of the forms he ``was not allowed to 
fill

[[Page 53956]]

out''; \95\ that Respondent ``essentially stopped practicing medicine'' 
\96\ after he received a second letter from Government counsel; and 
that the DEA allowed his registration to remain active on its website 
even though it had the power to ``shut off [his] registration by 
pulling it from the active list on their pharmacy access Web site,'' 
\97\ thereby creating ``an incident and another charge against me'' 
\98\ that occurred for no reason other than harassment. Respondent 
further claims that the cases counsel for the Government cited in his 
letter to Respondent regarding his change of address are not applicable 
in this situation because those cases involved ``two meth suppliers to 
convenience stores, a pharmacy, and a doctor whose state license had 
already been revoked'' \99\ and Respondent,\100\ as a ``practicing MD 
with no criminal complaint'' \101\ does not fit into any of those 
categories. Respondent further argues that the DEA had the power to 
deactivate his controlled substance license on the DEA Web site, 
thereby ``shutting down [his] ability to issue any controlled 
substances'' \102\ and that because the DEA's failure to do so was more 
harassment which was ``clearly unethical if not illegal,'' \103\ 
Respondent should not be held responsible.
---------------------------------------------------------------------------

    \93\ Respondent's Closing Argument Brief at 17.
    \94\ Respondent's Closing Argument Brief at 17.
    \95\ Respondent's Closing Argument Brief at 17.
    \96\ Respondent's Closing Argument Brief at 17.
    \97\ Respondent's Closing Argument Brief at 17.
    \98\ Respondent's Closing Argument Brief at 18.
    \99\ Respondent's Closing Argument Brief at 18.
    \100\ Respondent's Closing Argument Brief at 18.
    \101\ Respondent's Closing Argument Brief at 18.
    \102\ Respondent's Closing Argument Brief at 18.
    \103\ Respondent's Closing Argument Brief at 18.
---------------------------------------------------------------------------

Discussion and Conclusions

I. The Applicable Statutory and Regulatory Provisions

    The Controlled Substances Act provides that any person who 
dispenses (including prescribing) a controlled substance must obtain a 
registration issued by the DEA in accordance with applicable rules and 
regulations.\104\ ``A separate registration shall be required at each 
principal place of business or professional practice where the 
applicant * * * dispenses controlled substances.'' \105\ DEA 
regulations provide that any registrant may apply to modify his 
registration to change his address but such modification shall be 
handled in the same manner as an application for registration.'' \106\
---------------------------------------------------------------------------

    \104\ 21 U.S.C. 822(a)(2).
    \105\ 21 U.S.C. 822(e).
    \106\ 21 CFR 1301.51.
---------------------------------------------------------------------------

    It is unlawful for any person to possess a controlled substance 
unless that substance was obtained pursuant to a valid prescription 
from a practitioner acting in the course of his professional 
practice.\107\ A registered individual practitioner is required to 
maintain records of controlled substances in Schedules II through V 
that are dispensed and received, including the number of dosage units, 
the date of receipt or disposal, and the name, address, and 
registration number of the distributor.\108\
---------------------------------------------------------------------------

    \107\ 21 U.S.C. 844(a).
    \108\ 21 CFR 1304.03(b), 1304.22(a)(2)(ix), 1304.21(a), 
1304.22(c), and 1304.22(a)(2)(iv).
---------------------------------------------------------------------------

A. Revocation of DEA Registrations
    The Controlled Substances Act, at 21 U.S.C. 824(a), provides, 
insofar as pertinent to this proceeding, that the Deputy Administrator 
may revoke a registration if she finds that the registrant has 
materially falsified an application for registration or renewal of 
registration \109\ and/or if she finds that the continued registration 
would be inconsistent with the public interest as that term is used in 
21 U.S.C. 823(f).\110\
---------------------------------------------------------------------------

    \109\ 21 U.S.C. 824(a)(1).
    \110\ 21 U.S.C. 824(a)(4).
---------------------------------------------------------------------------

B. The Public Interest Standard
    Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may deny an 
application for a DEA Certificate of Registration if she determines 
that such registration would be inconsistent with the public interest. 
In determining the public interest, the Deputy Administrator is 
required to consider the following factors:
    (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.
    As a threshold matter, it should be noted that the factors 
specified in section 823(f) are to be considered in the disjunctive: 
The Deputy Administrator may properly rely on any one or a combination 
of those factors, and give each factor the weight she deems 
appropriate, in determining whether a registration should be revoked or 
an application for registration denied.\111\
---------------------------------------------------------------------------

    \111\ See Henry J. Schwarz, Jr. M.D., 54 FR 16,422 (DEA 1989).
---------------------------------------------------------------------------

II. The Factors To Be Considered

A. Renewal of Respondent's DEA Registration
1. Material Falsification of a Renewal Application
    Respondent materially falsified his 2006 renewal application for a 
DEA registration when he failed to disclose any information regarding 
his 1998 state probation, even though he did disclose his 2003 state 
probation. I find unpersuasive Respondent's argument that the omission 
is irrelevant due to the DEA's awareness of and Respondent's previous 
disclosure of the 1998 probation: The DEA has repeatedly held that `` 
`[t]he provision of truthful information on applications is absolutely 
essential to effectuating [the] statutory purpose' of determining 
whether the granting of an application is consistent with the public 
interest.'' \112\ A false statement is material if it ``has a natural 
tendency to influence, or was capable of influencing, the decision of 
the decisionmaking body to which it was addressed.'' \113\ While the 
evidence must be ``clear, unequivocal, and convincing,'' the ``ultimate 
finding of materiality turns on an interpretation of the substantive 
law.'' \114\ The Deputy Administrator has also previously held that 
``[t]he explanation given by an applicant who has affirmatively 
answered a liability question is * * * material because the public 
interest inquiry under section 303(f) requires, inter alia, that the 
Agency examine `[t]he applicant's experience in dispensing * * * 
controlled substances,' and its [c]ompliance with applicable State, 
Federal, or local laws relating to controlled substances.' '' \115\
---------------------------------------------------------------------------

    \112\ The Lawsons, 72 FR at 74338 (quoting Peter H. Ahles, 71 FR 
50097, 50098 (2006)). See also Hoxie v. DEA, 419 F.3d 477, 483 (6th 
Cir. 2005) (``Candor * * * is considered by the DEA to be an 
important factor when assessing whether a * * * registration is 
consistent with the public interest.'').
    \113\ Kungys v. United States, 485 U.S. 759, 770 (1988) (int. 
quotation and other citations omitted).
    \114\ Id. at 772 (int. quotation and other citations omitted).
    \115\ The Lawsons, 72 FR at 74338 (citing 21 U.S.C. 823(f)).
---------------------------------------------------------------------------

    Although Respondent claims that his omission of the 1998 probation 
from his registration renewal application was inadvertent, that is 
irrelevant because the Government only needs to show that the applicant 
``knew or should have known that the response given to the liability 
question was false,'' not that the material falsification was 
intentional.\116\ It is apparent that Respondent was aware of his 1998 
probation because he

[[Page 53957]]

admittedly disclosed it on previous DEA registration applications and 
because he entered into a consent order with the IDFPR and purportedly 
completed the required conditions. Respondent therefore knew or should 
have known that his response to the liability question was false.
---------------------------------------------------------------------------

    \116\ The Lawsons, 72 FR at 74339; Samuel Arnold, 63 FR 8687 at 
8688 (1998).
---------------------------------------------------------------------------

    Respondent's omitted 1998 probation was related to Respondent's 
handling of Dilaudid, which is directly related to the second and 
fourth factors listed in 21 U.S.C. 823(f). Regardless of whether DEA 
and Illinois had prior knowledge of that probation, the omission of an 
offense related to the handling of a schedule II controlled substance 
would certainly have a natural tendency to influence the decision of 
whether to grant Respondent's application when considering the 
applicant's experience in handling controlled substances and compliance 
with applicable State, Federal, and local laws relating to controlled 
substances. I thus conclude that Respondent's failure to disclose the 
1998 state probation was a material misrepresentation because it 
``ha[d] a natural tendency to influence the * * * decision'' of the DEA 
as to whether to grant his application for a new registration. Under 
DEA precedent, a material falsification ``provides an independent and 
adequate ground for denying'' Respondent's application.\117\
---------------------------------------------------------------------------

    \117\ The Lawsons, 72 FR at 74338; Cf Bobby Watts, 58 FR 46997 
(1993).
---------------------------------------------------------------------------

2. Candor and Admission of Fault
    The DEA properly considers the candor of the physician and his 
forthrightness in assisting in the investigation and admitting fault 
important factors in determining whether the physician's registration 
should be revoked.\118\ I find that Respondent has repeatedly failed to 
accept responsibility for his misconduct. This failure is evidenced by 
Respondent's consistent denial of any wrongdoing: Respondent asserts 
that his actions leading to his 1998 state probations were lawful even 
after he agreed to enter into a consent order with the IDFPR; with 
regard to his 2003 state probation, Respondent asserts (1) that his 
only blame was in leaving his bag, without a secure lock, at the clinic 
when he was not present and that he clearly ``could not prevent the 
owner's actions once I left medicine (Phentermine) in my locked bag'' 
and (2) that the DEA should not ``seek additional retribution'' with 
regard to the incident because he accepted the state probation; 
Respondent repeatedly claims that the immediate hearing is the result 
of a ``vendetta'' against him instigated by the City of Chicago; 
despite my previous rulings to the contrary, Respondent continues to 
assert that most of the evidence and testimony admitted in the instant 
hearing is inadmissible and should not be considered; and Respondent 
continues to assert that he was ``not afforded a capable attorney'' 
\119\ although he was at any time free to procure the assistance of 
counsel, was notified of such, and he did not request a postponement of 
the instant hearing prior to its commencement in order to do so.\110\
---------------------------------------------------------------------------

    \118\ Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005).
    \119\ Respondent's Closing Argument Brief at 10.
---------------------------------------------------------------------------

B. The Public Interest Standard
    As noted above, Respondent submitted a request to modify his 
registration, which is still pending. Pursuant to 21 CFR 1301.51, a 
request for a modification shall be handled in the same manner as an 
application for registration. Pursuant to 21 U.S.C. 823(f), the Deputy 
Administrator may deny an application for a DEA Certificate of 
Registration if she determines that such registration would be 
inconsistent with the public interest, consistent with the five factors 
described above.
    In light of the circumstances of this case, I will consider 
Respondent's compliance with applicable law and experience in handling 
controlled substances together below.
1. The Recommendation of the Appropriate State Licensing Board
    It is undisputed that Respondent is currently licensed as a 
physician and to handle controlled substances in Illinois. Inasmuch as 
Respondent is currently authorized to handle controlled substances in 
Illinois, I find that this factor weighs in favor of a finding that 
Respondent's registration would not be inconsistent with the public 
interest. However, I note that state licensure is a necessary but not 
sufficient condition for DEA registration, and I therefore find that 
this factor is not dispositive.
2. Respondent's Experience in Handling Controlled Substances and 
Compliance With Applicable State, Federal, or Local Laws Relating to 
Controlled Substances
    I conclude that Respondent's experience in handling controlled 
substances and Respondent's compliance with applicable State, Federal, 
or local laws relating to controlled substances weighs in favor of a 
finding that his registration would not be consistent with the public 
interest.
(a) Respondent's Prior State Disciplinary Actions
    In the previously discussed 1998 Consent Order, the then IDPR 
alleged that Respondent ``may have prescribed Dilaudid to four (4) 
patients under questionable circumstances''; \120\ Respondent did not 
admit or deny the allegations but did agree not to contest them. As a 
condition of his probation, Respondent was required to complete a 
remedial education course in controlled substance management. In his 
Closing Argument Brief, Respondent asserts that there was never any 
finding that the probation came about as a result of unlawful 
prescribing of Dilaudid, and in the instant hearing Respondent 
testified that his actions related to the incident were lawful.
---------------------------------------------------------------------------

    \120\ GX 7 at 2.
---------------------------------------------------------------------------

    In the 2003 Consent Order the IDFPR alleged, and Respondent 
admitted, that he failed to supervise an unlicensed employee. In the 
instant hearing and in his Closing Argument Brief, however, Respondent 
asserts that he was the employee and that he was unable to prevent the 
clinic owner from removing the phentermine from Respondent's locked 
bag, but that he accepted the probation because he should not have left 
the bag at the clinic when he was not there. As a condition of his 
probation, Respondent was required to complete ten hours of continuing 
education in the area of prescribing and dispensing controlled 
substances. I find that Respondent's conduct leading to the 2003 
Consent Order and his apparent lack of understanding of proper methods, 
even after completing several hours of controlled substance handling 
education, weigh in favor of a finding that his continued registration 
would be inconsistent with the public interest.
(b) Respondent's Receipt and Dispensing of Marinol
    I find no merit to Respondent's assertions that he lawfully 
received Marinol from a patient and also lawfully provided it to 
another patient. Pursuant to 21 U.S.C. 844(a), ``[i]t shall be unlawful 
for any person knowingly or intentionally to possess a controlled 
substance unless such substance was obtained directly, or pursuant to a 
valid prescription or order, from a practitioner, while acting in the 
course of his professional practice * * *'' except as otherwise 
authorized by the Controlled Substances Act.
    Respondent's interpretation of 21 U.S.C. 844(a) is mistaken; 
Respondent apparently believes that, because he is

[[Page 53958]]

a practitioner who was purportedly acting in the course of his 
professional practice at the time he received the Marinol, this section 
permitted him to receive the Marinol from a patient. Respondent, 
however, fails to recognize that 21 U.S.C. 844(a) requires that the 
controlled substance be obtained directly or pursuant to a prescription 
from a practitioner, not provided to a practitioner acting in the 
course of his professional practice. Respondent has made no assertion 
and provided no evidence that Mr. J.W., from whom Respondent admittedly 
obtained the Marinol, was a practitioner \121\ acting in the course of 
his professional practice or that Mr. J.W. possessed the proper DEA 
registration to dispense or distribute controlled substances, as 
required by 21 U.S.C. 822(a)(1) and 21 CFR 1307.11(a)(1),\122\ when he 
provided Respondent with the Marinol. Pursuant to 21 CFR 1307.12, 
however, a person in lawful possession of a controlled substance may, 
without a registration to do so, distribute such substance to the 
person from whom it was obtained or to the manufacturer of the 
substance. Respondent, however, testified at a police board hearing 
that the Marinol likely came from the prescription of another doctor, 
not Respondent. Mr. J.W., therefore, did not obtain the Marinol 
directly from or pursuant to a prescription from Respondent and there 
is no evidence indicating that Mr. J.W. possessed a DEA registration to 
distribute or dispense controlled substances so Respondent was 
subsequently not authorized to receive the Marinol from Mr. J.W. under 
21 CFR 1307.12.
---------------------------------------------------------------------------

    \121\ ``Practitioner'' is defined in 21 U.S.C. 802(21) as: ``a 
physician, dentist, veterinarian, scientific investigator, pharmacy, 
hospital, or other person licensed, registered, or otherwise 
permitted, by the United States or the jurisdiction in which he 
practices or does research, to distribute, dispense, conduct 
research with respect to, administer, or use in teaching or chemical 
analysis, a controlled substance in the course of professional 
practice or research.''
    \122\ 21 CFR 1307.11(a)(1) generally provides that a 
practitioner who is registered to dispense a controlled substance 
may distribute a quantity of such substance to another practitioner 
for the purpose of general dispensing to patients provided that both 
the distributing and the receiving practitioners record the 
distribution in accordance with 21 CFR 1304.22(c).
---------------------------------------------------------------------------

    Respondent apparently recognizes, as indicated in his Closing 
Argument Brief, that he is required to record the receipt and 
subsequent dispensing of controlled substances. Pursuant to 21 CFR 
1304.03(b), 1304.22(a)(2)(ix), 1304.21(a), 1304.22(c), and 
1304.22(a)(2)(iv), a registered individual practitioner is required to 
maintain records of controlled substances in Schedules II-V that are 
dispensed and received, including the number of dosage units, the date 
of receipt or disposal, and the name, address, and registration number 
of the distributor. In his brief, Respondent asserts that he has a `` 
`non monetary' receipt supplied by Mr. J.W.'' \123\ The only document 
admitted into evidence that relates to the receipt of the Marinol, 
however, is an affidavit \124\ with a signature reading ``J.W.'' and 
dated May 2, 2008, nearly five years after Respondent purportedly 
received and subsequently dispensed the Marinol. Not only is the 
general authenticity of that document suspect, but it also can not 
reasonably be viewed as a proper record of receipt, particularly 
considering that it was prepared nearly five years after the event and 
that Respondent previously claimed to have no recollection of the 
details of obtaining the Marinol. Respondent also entered into evidence 
a controlled substances log dated January 2003 through August 14, 2004, 
indicating that on July 21, Respondent dispensed 8 Marinol 10mg to 
Officer D.S., which, despite the questionable circumstances under which 
it was presented to the IDFPR investigator, may arguably be considered 
a record of dispensing.
---------------------------------------------------------------------------

    \123\ Respondent's Closing Argument Brief at 5.
    \124\ Although the document is signed, it is neither witnessed 
nor notarized, and when the document was admitted, no witness was 
presented to verify the document's authenticity.
---------------------------------------------------------------------------

    Accordingly, I find that Respondent's receipt of the Marinol was 
unlawful under 21 U.S.C. 844(a) and 21 CFR 1304.03(b), 1304.21(a), 
1304.22(c), 1304.22(a)(iv), 1304.22(a)(2)(ix), 1307.11, and 1307.12 
because Respondent did not receive the Marinol directly from or 
pursuant to a prescription or order from a practitioner acting in the 
course of his professional practice or from a person who was in lawful 
possession of and originally obtained the Marinol from Respondent, or 
as otherwise authorized by the Controlled Substances Act, and because 
the receipt of the Marinol was not properly recorded. Additionally, as 
the Government points out, Respondent testified in the instant hearing 
that he has also in the past provided to patients Tylenol III and 
Tylenol IV that he had obtained from other patients to whom it had been 
prescribed by other physicians. I find that Respondent's unlawful 
receipt of a Schedule III controlled substance and failure to properly 
record such receipt weigh in favor of a finding that Respondent's 
continued registration would be inconsistent with the public interest.
(c) IDFPR Administrative Subpoenas
    I find that the Government has not provided sufficient evidence to 
indicate that Respondent violated state law when he failed to comply 
with a subpoena duces tecum issued by the IDFPR requesting copies of 
patient records.
    The Government correctly asserts that the IDFPR has the authority 
to ``subpoena the medical and hospital records of individual patients 
of'' \125\ licensed physicians. Respondent, however, is essentially 
correct in his assertion that all information provided pursuant to such 
a subpoena and which indicates the identity of the patient, shall be 
removed and deleted prior to submission to the disciplinary board or 
department. Respondent further correctly asserts that the term ``all 
information indicating the identity of the patient'' includes patient 
names and dates of treatment because the IDFPR and the DEA have the 
ability to match that information with prescription records. Respondent 
also testified at the instant hearing that disclosure of the requested 
information, without first obtaining patient permission, would violate 
the federal Health Insurance Portability and Accountability Act 
(HIPAA).
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    \125\ 225 ILCS 60/38.
---------------------------------------------------------------------------

    Although neither party has submitted any relevant case law on the 
topic, the Illinois Supreme Court has provided some guidance regarding 
the disclosure of confidential patient information pursuant to an 
administrative subpoena. In People v. Manos, the court held that the 
Illinois legislature did not expressly provide for the investigatory 
power provided to the IDFPR to override the physician-patient privilege 
as codified in 735 ILCS 5/8-802. The IDFPR, therefore, cannot require a 
physician under an administrative investigation to produce confidential 
patient medical records unless one of the statutory exceptions set 
forth in 735 ILCS 5/8-802 applies.\126\ Additionally, the court adopted 
a finding that the mere deletion of patient names and identifying 
information does not remove the records from protection under the 
physician-patient privilege when the department that issued the 
subpoena knows the names of the patients whose records were sought, 
those patients are not parties to the investigatory proceedings, and 
matching the records to the names would not be difficult even if the 
names and other identifying information were redacted.\127\ I note that 
at the time that

[[Page 53959]]

the IDFPR issued the subpoenas to Respondent on June 15, 2005, and June 
20, 2007, no applicable exception applied under 735 ILCS 5/8-802.\128\ 
An exception for subpoenas issued pursuant to the Medical Practice Act 
is now included in 735 ILCS 5/8-802,\129\ however, that exception did 
not become effective until August 27, 2007 and is therefore not 
applicable.
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    \126\ People v. Manos, 202 Ill. 2d 563 (2002).
    \127\ People v. Manos, 202 Ill. 2d 563 (2002) (citing Parkson v. 
Central DuPage Hospital, 105 Ill. App. 3d 850 (1982)).
    \128\ The exceptions in effect during the applicable period are 
as follows: ``* * * (1) in trials for homicide when the disclosure 
relates directly to the fact or immediate circumstances of the 
homicide, (2) in actions, civil or criminal, against the healthcare 
practitioner for malpractice * * *, (3) with the expressed consent 
of the patient * * *, (4) in all actions brought by the patient, his 
or her personal representative, a beneficiary under a policy of 
insurance, or the executor or administrator of his or her estate 
wherein the patient's physical or mental condition is an issue * * 
*, (4.1) in all actions brought against the patient, his or her 
personal representative, a beneficiary under a policy of insurance, 
or the executor or administrator of his or her estate wherein the 
patient's physical or mental condition is an issue, (5) upon an 
issue as to the validity of a document as a will of the patient, (6) 
in any criminal action where the charge is either first degree 
murder by abortion, attempted abortion or abortion, (7) in actions, 
civil or criminal, arising from the filing of a report in compliance 
with the Abused and Neglected Child Reporting Act [325 ILCS 5/1 et 
seq.], (8) to any department, agency, institution or facility which 
has custody of the patient pursuant to State statute or any court 
order of commitment, (9) in prosecutions where written results of 
blood alcohol tests are admissible pursuant to Section 11-501.4 of 
the Illinois Vehicle Code [625 ILCS 5111-501.4], (10) in 
prosecutions where written results of blood alcohol tests are 
admissible under Section 5-lla of the Boat Registration and Safety 
Act [625 ILCS 45/5-11a], or (11) in criminal actions arising from 
the filing of a report of suspected terrorist offense in compliance 
with Section 29D-10(p)(7) of the Criminal Code of 1961 [720 ILCS 5/
29D-l0].
    \129\ ``No physician or surgeon shall be permitted to disclose 
any information he or she may have acquired in attending any patient 
in a professional character, necessary to enable him or her 
professionally to serve the patient, except only * * * (12) upon the 
issuance of a subpoena pursuant to Section 38 of the Medical 
Practice Act of 1987 [225 ILCS 60/38]. * * *'' 735 ILCS 5/8-802.
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    I agree with the Government's assertion that Respondent's argument 
that compliance with the subpoenas would violate HIPAA is baseless 
because the subpoena was issued as an order of an administrative 
tribunal.\130\ Nonetheless, I further find that because of the Illinois 
Supreme Court decision in Manos, it does not matter whether the 
disclosure would violate HIP AA because it was not disclosable under 
the physician-patient privilege law in effect in Illinois at the time 
of the issuance of the subpoena.\131\ Accordingly, I find that the 
Government has not met its burden of proof that Respondent violated 
state law in failing to comply with a subpoena duces tecum issued by an 
administrative tribunal.
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    \130\ See 45 CFR 164.512(e)(1), (2), and (3).
    \131\ I also find no merit to Respondent's argument that he 
relied on the advice of counsel when he provided the redacted 
patient files to the IDFPR. Respondent has cited no relevant law to 
indicate that reliance on counsel would relieve him of 
responsibility for failing to comply with a subpoena.
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    I note that I have already found no merit to Respondent's argument 
that the patient files and the testimony of Investigator D.M. in the 
immediate hearing are inadmissible in this proceeding and should not be 
available to the DEA.\132\ Because Respondent is likely to present this 
argument again, however, I will add that, in addition to the reasons 
previously stated in my Memorandum to Parties and Rulings, dated 
February 12, 2010 and Memorandum to Parties and Ruling, dated April 9, 
2010, the section of this opinion regarding the IDFPR subpoena duces 
tecum cannot provide the basis for an argument that the relevant 
patient files are inadmissible because Respondent obtained permission 
to provide the files, thereby waiving the physician-patient privilege.
---------------------------------------------------------------------------

    \132\ See Memorandum to Parties and Rulings, dated February 12, 
2010 and Memorandum to Parties and Ruling, dated April 9, 2010. 
(Respondent relied on 225 ILCS 60/22(A)(5) and 60/23(B) to exclude 
the testimony of IDFPR Investigator D.M. and to exclude all evidence 
relating to Respondent's dispensing of Marinol to D.S. I denied 
Respondent's request and found that Section 60/23(B)'s constraint on 
the Medical Disciplinary Board's ability to further disclose 
reported information is limited to the confidentiality of medical 
reports and committee reports as otherwise protected by law.)
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(d) Prescribing From an Unregistered Location
    I find that Respondent violated federal law by prescribing 
controlled substances from his new location without a valid 
registration. As provided in 21 U.S.C. 822(e), ``[a] separate 
registration shall be required at each principal place of business or 
professional practice where the applicant * * * dispenses controlled 
substances.'' Additionally, pursuant to 21 CFR 1301.51, any registrant 
may apply to modify his registration to change his address but such 
modification shall be handled in the same manner as an application for 
registration. Unlike a renewal application, which, when timely filed, 
remains in effect past the registration expiration date while the DEA 
makes a final determination on the application,\133\ a request for a 
modification is treated as a new application; a registrant, therefore, 
is not authorized to dispense or prescribe controlled substances at his 
new location pending approval of a modification request to change a DEA 
registered address.\134\
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    \133\ See 5 U.S.C. 558(c).
    \134\ See John J. Fotinopoulos, 72 FR 24602 (2007).
---------------------------------------------------------------------------

    The record demonstrates that even though Respondent moved from his 
registered address to a new location in July 2008, he failed to notify 
the DEA of this change until at least April 7, 2009,\135\ after a DEA 
diversion investigator was unable to locate Respondent at his 
registered address and eventually located him at his residence. 
Additionally, Respondent admittedly continued to handle controlled 
substances not only while that modification was pending but after the 
DEA had notified him in writing at least two times, and Respondent's 
own attorney confirmed at least once, that he was not permitted to do 
so. Respondent's argument that the DEA actively prevented him from 
submitting a request for modification of his registered location is 
unconvincing, particularly considering that Respondent failed to 
provide any evidence indicating he ever attempted to submit the 
request.\136\
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    \135\ RX 15.
    \136\ Respondent submitted several documents with his brief, 
marked as ``Brief Exhibits.'' I have not considered these documents 
in reaching my findings and conclusions, however, because they were 
not offered or admitted into evidence. See 21 CFR 1316.57. 
Respondent also makes several references to testimony that was 
offered in related state proceedings; that information also will not 
be considered here for the same reason.
---------------------------------------------------------------------------

    Respondent's act of continuing to handle controlled substances 
after numerous warnings shows a flagrant disregard for the requirements 
of the law governing the handling of controlled substances. 
Additionally, Respondent not only refuses to accept any blame 
whatsoever for failing to properly notify the DEA of his change of 
address but also claims that the DEA is responsible for him continuing 
to issue prescriptions for controlled substances and for pharmacies 
continuing to fill those prescriptions. I therefore find that 
Respondent's failure to comply with federal law regarding modification 
of his controlled substances registration and his additional refusal to 
accept responsibility for his actions strongly support a finding that 
Respondent's continued registration would be inconsistent with the 
public interest.
(e) Diversion of OxyContin
    I find that the Government has met its burden in establishing 
diversion by a preponderance of the evidence and the Government has 
also shown that even if Respondent was unaware of the diversion, 
Respondent was involved in a scheme that created the opportunity for 
diversion of a Schedule II controlled substance.

[[Page 53960]]

    The DEA has held that a finding that a practitioner is reckless or 
negligent in ignoring the warning signs that a patient is either 
personally abusing controlled substances or diverting them to others is 
an indication that the practitioner's registration would be 
inconsistent with the public interest; misconduct that is 
``unintentional, innocent or devoid of improper motivation * * * 
creates the opportunity for diversion and could justify revocation or 
denial.'' \137\
---------------------------------------------------------------------------

    \137\ See Paul J. Caragine, Jr., 63 FR 51592 (DEA 1998).
---------------------------------------------------------------------------

    The evidence in this case clearly demonstrates that Respondent 
knowingly and willingly participated in a scheme to deceive other 
healthcare providers with regard to Ms. E.M.'s use of a Schedule II 
controlled substance and was at the very least reckless or negligent in 
ignoring the possibility of diversion and thereby created the 
opportunity for diversion of OxyContin. The record establishes that 
Respondent willingly agreed to continue to treat and to prescribe 
controlled substances to Ms. E.M. and to refrain from revealing his 
involvement to anyone other than Ms. E.M.'s family, even while Ms. E.M. 
was institutionalized and while she was being treated by other 
physicians. The numerous inconsistencies between the testimonies of Mr. 
I.S. and Respondent lead me to believe that neither is a credible 
witness with regard to Ms. E.M.'s medication and treatment and raises 
the questions of whether Respondent actually even treated Ms. E.M. and 
whether she received OxyContin.
    The evidence shows that each month for several years, Respondent 
provided prescriptions for 60 OxyContin 80 mg tablets to three members 
of the same household, including Ms. E.M., who was over 90 years old 
and purportedly frail. As the Government points out, Ms. E.M. was 
confined to a hospital or nursing home for a total of approximately 290 
days during that period.
    I first find it difficult to believe that Ms. E.M.'s family was 
able to administer OxyContin twice a day for such an expansive time 
without ever arousing the suspicion of the facility staff. I also find 
it difficult to believe that for each of those approximately 290 days, 
although Ms. E.M. was purportedly receiving a total of 160 mg of 
OxyContin per day, two doses of 80 mg each,\138\ Ms. E.M.'s family was 
able to prevent the possibility of an overdose simply by reviewing her 
daily charts (with the exception of the last three or so weeks of Ms. 
E.M.'s life when Mr. I.S. claims that he prohibited the facility from 
providing any type of pain medication to her).
---------------------------------------------------------------------------

    \138\ According to the Physician's Desk Reference, 80 mg is the 
second-highest dosage of OxyContin available in a single pill.
---------------------------------------------------------------------------

    Respondent ignored the warning signs of diversion by assisting in 
the family's scheme to conceal Ms. E.M.'s OxyContin prescriptions and 
by failing to test Ms. E.M.'s opioid levels to ensure that she actually 
received the drug. I find that Respondent was at least reckless or 
negligent in ignoring the warning signs of diversion with regard to the 
OxyContin he prescribed to Ms. E.M. and his conduct, intentional or 
not, thereby created the opportunity for diversion.
    I find that Respondent did not issue OxyContin prescriptions for a 
legitimate medical purpose while acting in the scope of his 
professional practice. While I agree with Respondent that the DEA's 
governing regulations do not require him to perform a physical 
examination of a patient before providing each prescription, 21 CFR 
1306.04(a), requires that controlled substance prescriptions be issued 
for a legitimate medical purpose by a practitioner acting in the scope 
of his professional practice.
    The evidence also does not support a finding that Respondent issued 
OxyContin prescriptions to Ms. E.M. pursuant to 21 CFR 1306.12(b)(1), 
1306.05, or 1306.04(a). What constitutes bona fide ``medical practice'' 
by a physician dispensing narcotic drugs must be determined upon 
consideration of the evidence and attending circumstances.\139\ The 
Supreme Court of the United States clarified this issue in Gonzales v. 
Oregon: \140\
---------------------------------------------------------------------------

    \139\ Moore v. U.S., 128 F.2d 887 (1942).
    \140\ 126 S.Ct. 904, 925 (2006) (citing Moore, 423 U.S. 122, 135 
(1975)).

    Under DEA regulations, a prescription for a controlled substance 
is not ``effective'' unless it is ``issued for a legitimate medical 
purpose by an individual practitioner acting in the usual course of 
his professional practice.'' 21 CFR 1306.04(a). This regulation 
further provides that ``an order purporting to be a prescription 
issued not in the usual course of professional treatment * * * is 
not a prescription within the meaning and intent of [21 U.S.C. 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. As the Supreme Court 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.'' (Emphasis added).

    Contrary to Respondent's assertions, the evidence does not support 
a finding that Respondent regularly saw Ms. E.M. as a patient; she 
therefore did not use controlled substances under his supervision. Mr. 
I.S.'s testimony combined with the discrepancies between Respondent's 
own records for Ms. E.M. and the admission and treatment dates for Ms. 
E.M. from hospice and treating hospitals indicate that it is unlikely 
that Respondent saw Ms. E.M. as a patient as frequently as he claims. 
Respondent even admitted that he relied on reports from Ms. E.M.'s 
family to determine the course of her treatment. Additionally, 
Respondent knowingly participated in a scheme to conceal Ms. E.M.'s 
alleged use of OxyContin from her treating physicians and other 
caregivers. Such actions certainly do not ``ensure patients use 
controlled substances under the supervision of a doctor,'' as explained 
by the Supreme Court. Because Ms. E.M. was not using OxyContin under 
the supervision of Respondent and Respondent's actions contributed to 
the prevention of her other physicians to supervise her use, Respondent 
did not issue OxyContin prescriptions to Ms. E.M. for a legitimate 
medical purpose while acting in the scope of his professional practice. 
I therefore find that the prescriptions that Respondent issued to E.M. 
for OxyContin were not issued for a legitimate medical purpose.
    Accordingly, I find that Respondent was at least reckless or 
negligent in ignoring the warning signs of diversion and issued 
prescriptions for other than a legitimate medical purpose and that this 
conduct weighs in favor of a finding that Respondent's registration 
would not be consistent with the public interest.
3. Respondent's Conviction Record
    There is no evidence that Respondent has ever been convicted under 
any federal or state laws relating to the manufacture, distribution, or 
dispensing of controlled substances. I therefore find that this factor, 
although not dispositive, weighs against a finding that his continued 
registration would be inconsistent with the public interest.
4. Other Conduct
    In light of my findings discussed above, I find it unnecessary to 
determine whether Respondent's prescribing of various noncontrolled 
substances to Ms. E.M. should weigh in favor of a finding that his 
continued registration would be inconsistent with the public interest.

[[Page 53961]]

Conclusion

    I conclude that Respondent's registration with the DEA would be 
inconsistent with the public interest.

Recommended Decision

    I recommend that Respondent's controlled substances registration be 
revoked and his application for renewal and modification of his DEA 
registration be denied.

    Dated: June 15, 2010.
Mary Ellen Bittner,
Administrative Law Judge.
[FR Doc. 2011-22093 Filed 8-29-11; 8:45 am]
BILLING CODE 4410-09-P