Richard A. Herbert, M.D.; Decision and Order, 53942-53961 [2011-22093]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53942-53961]
From the Federal Register Online via the Government Printing 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