[Federal Register Volume 76, Number 168 (Tuesday, August 30, 2011)]
[Notices]
[Pages 53961-53964]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-22090]


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 DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Harold Edward Smith, M.D.; Revocation Of Registration

    On April 17, 2009, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, issued an Order to 
Show Cause to Harold Edward Smith, M.D. (Respondent), of Mt. Dora, 
Florida. The Show Cause Order proposed the revocation of Respondent's 
DEA Certificate of Registration, BS4681979, and the denial of any 
pending applications to renew or modify the registration, on the 
grounds that Respondent had materially falsified various applications 
for his DEA registration and had committed acts which render his 
registration inconsistent with the public interest. Show Cause Order at 
1 (citing 21 U.S.C. 824(a)(1) & (4)).
    The Show Cause Order alleged that Respondent has ``a documented 
substance abuse history dating back as far as 1982,'' when he ``entered 
treatment for alcohol and controlled substance abuse.'' Id. The Order 
alleged that on April 3, 1985, Respondent entered into a consent order 
with the Georgia Board of Medical Examiners (Georgia Board) based on 
his ``chemical dependency,'' which placed him on probation for four 
years and imposed various conditions including that he ``abstain from 
the consumption of alcohol or controlled substances,'' undergo random 
drug testing, and ``relinquish'' his controlled substance privileges. 
Id. The Order then alleged that in June 1990, Respondent tested 
positive for cocaine and that on October 10, 1990, he ``entered into an 
Interim Consent Order'' with the Georgia Board under which his medical 
license was suspended and he was ordered (1) Not to practice medicine, 
(2) not to use his DEA registration, and (3) ``to participate in a 
program for impaired physicians.'' Id. at 2.
    Next, the Show Cause Order alleged that during 1999 and 2000, 
Respondent issued prescriptions for hydrocodone to J.R.S. and L.L.S., 
and had failed to maintain the ``records of any examinations, 
diagnoses, treatment[s] or * * * drugs prescribed to these individuals 
as required by Section 458.331(1)(q) of the Florida statutes.'' Id. The 
Order further alleged that based on this conduct, Respondent ``entered 
into a Consent Agreement with the'' Florida Board of Medicine, which 
required him to pay a fine of $5,000, desist ``from prescribing to 
family members'' and to

[[Page 53962]]

take ``a course on the proper prescribing of [a]busable [d]rugs.'' Id. 
(int. quotations omitted).
    The Show Cause Order further alleged that on February 16, 2007, the 
Florida Board indefinitely suspended Respondent's medical license 
``based in part'' on his ``admission of'' having ``relapse[d] on crack 
cocaine'' and ``failure to submit to a urine screen while under 
contract with the Board's impaired physicians' program.'' Id. The Order 
then alleged that on June 26, 2007, the Florida Board reinstated 
Respondent's medical license ``subject to several probationary terms.'' 
Id.
    Finally, the Show Cause Order alleged that ``[o]n April 22, 2002, 
February 28, 2005, and again on January 31, 2008,'' Respondent had 
``submitted applications for renewal'' of his DEA registration. Id. The 
Order alleged that each of these applications was materially false 
because Respondent failed to disclose the various sanctions imposed on 
his state licenses by the Georgia and Florida Boards, as well as the 
previous ``surrenders'' of his DEA registration. Id.
    On May 8, 2009, the Show Cause Order, which also notified 
Respondent of his right to request a hearing on the allegations (or to 
submit a written statement in lieu of a hearing) and the consequences 
if he failed to do so, Id. at 2, was served on Respondent by certified 
mail to him at the address given on his most recent application as his 
registered location. Since that date, neither Respondent, nor any 
person purporting to represent him, has filed a request for a hearing 
or submitted a written statement in lieu of a hearing. As thirty days 
have now passed since Respondent was served with the Order to Show 
Cause, I find that Respondent has waived his right to a hearing. See 21 
CFR 1301.43(d). I therefore enter this Final Order without a hearing 
based on relevant evidence contained in the Investigative Record. See 
Id. at 1301.43(e). I make the following findings.

Findings

    Respondent currently holds DEA Certificate of Registration 
BS4681979, which authorizes him to dispense controlled substances in 
schedules II through V as a practitioner, at the registered address of 
2875 S. Orange Ave., Suite 500-600, Orlando, Florida. While 
Respondent's registration was to expire on February 29, 2008, on 
February 7, 2008, he submitted an application to renew his 
registration. In accordance with the Administrative Procedure Act, 
Respondent's registration remains in effect pending the issuance of 
this Final Order. See 5 U.S.C. 558(c).

The State Proceedings Against Respondent

    In April 1983, Respondent, who was then licensed in Arkansas and 
Tennessee, was discharged from an impaired physicians program. 
Thereafter, Respondent applied for a Georgia medical license. On April 
17, 1985, Respondent entered into a Consent Order with the Georgia 
Board, which noted that he had ``completed a treatment program for 
chemical dependency.'' Consent Order at 1, In re Harold Edward Smith, 
Jr., M.D., No. 91328-85 (Ga. Bd. Med. Exam'rs, April 17, 1985). 
Pursuant to the Consent Order, the Georgia Board issued Respondent a 
medical license and placed him on probation for four years subject to 
several conditions. Id. at 2-4. The conditions included that he 
``completely abstain from the consumption of alcohol or controlled 
substances, except as prescribed by a duly licensed practitioner for a 
legitimate purpose,'' that he ``undergo random alcohol/drug screening 
at his own expense,'' that he ``not possess a DEA permit or any 
triplicate prescription forms or Federal order forms,'' and that he 
relinquish his right (until further order by the Board) ``to prescribe, 
administer, dispense, order or possess (except as prescribed, 
administered or dispensed to [him] by another person authorized by law 
to do so) controlled substances.'' Id. Respondent was also required to 
``submit quarterly reports regarding his physical and mental condition 
to the Board * * * including a report on any medication being 
prescribed to'' him. Id. at 3. In April 1989, Respondent was 
``discharged from probation.'' Interim Consent Order for Suspension of 
License During Treatment at 1, In re Harold Edward Smith, Jr., M.D., 
No. 90-499 (Ga. Bd. Med. Exam'rs, Oct. 10, 1990).
    In June 1990, physicians at Respondent's place of employment 
requested that he provide a specimen for drug testing. Id. at 2. The 
specimen tested positive for cocaine. Id. Subsequently, the Georgia 
Board ordered Respondent to ``undergo a 72-hour inpatient mental/
physical examination evaluation'' and thereafter, Respondent entered 
``treatment for relapse of chemical dependence.'' Id.
    On October 10, 1990, Respondent entered into an Interim Consent 
Order with the Georgia Board pursuant to which he agreed that his 
license would be ``suspended until further order of the board''; that 
during the suspension, he would ``not engage in the practice of 
medicine or be authorized to utilize his DEA registration for 
controlled substances''; and that he would not resume practicing 
medicine or use his DEA registration ``without the prior written 
approval of the Board.'' Id. at 3 & 8. Respondent also agreed to 
``remain in treatment,'' to ``abide by all conditions of his treatment/
aftercare program,'' and to submit ``quarterly reports on his mental/
physical condition and progress in rehabilitation.'' Id. at 3. 
Moreover, as a condition of the Board's lifting of the suspension 
(after he completed treatment and executed an aftercare contract), 
Respondent was required to submit: (1) A certification by his 
monitoring physicians that he had ``successfully completed treatment'' 
and ``is able to resume the practice of medicine with reasonable skill 
and safety,'' (2) a plan to return to practice under a ``physician who 
would actively supervise [his] practice,'' and (3) ``a summary of 
continuing education activity in the last year.'' Id. at 4-5.
    At some point, Respondent moved to Florida and obtained a medical 
license from the Florida Department of Health (DOH). On October 18, 
2002, the DOH filed an Administrative Complaint against him. See 
Administrative Complaint, Department of Health v. Smith, No. 2000-12434 
(Fla. DOH). The Complaint alleged that ``[f]rom on or about July 24, 
1999 to on or about August 14, 2000,'' Respondent wrote hydrocodone 
prescriptions for J.R.S., and that ``[f]rom on or about January 14, 
2000 to on or about June 30, 2000,'' Respondent wrote hydrocodone 
prescription for L.L.S., both of whom were alleged to be related to 
him. Id. at 2. The Complaint further alleged that Respondent ``did not 
keep records of [his] examinations, diagnoses, treatment or * * * drugs 
prescribed'' for either person. Id.
    On June 18, 2003, Respondent entered into a Consent Agreement with 
the DOH. Consent Agreement at 6-7. Therein, Respondent neither admitted 
nor denied the allegations. Id. at 2. However, he agreed to pay a fine 
of $2,000, to reimburse the DOH for its costs in the amount of 
$4,776.58, and to complete a course entitled ``Protecting Your Medical 
Practice, Clinical, Legal and Ethical Issues in Prescribing Abusable 
Drugs.\1\ '' Id. at 2-4.
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    \1\ The Order further noted that ``[t]he terminal condition of 
Respondent's mother understandably contributed to poor judgment for 
the time he provided prescriptions for her.'' Consent Agreement at 
4.
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    On August 18, 2003, the Florida Board of Medicine rejected the 
Consent

[[Page 53963]]

Agreement and offered a counter agreement, which the parties accepted. 
Final Order at 1. The Agreement increased the fine to $5,000, imposed a 
restriction on his license requiring him to ``remain in compliance with 
any and all terms of'' his contract with the Professional Resource 
Network (PRN), and prohibited him ``from writing prescriptions for 
controlled substances for any family member.'' Id. at 1-2.
    On May 31, 2006, the DOH filed another Administrative Complaint 
against Respondent. Administrative Complaint, Department of Health v. 
Harold Smith, M.D., No. 2005-67946. The Complaint alleged that on 
approximately August 9, 2005, Respondent had ceased complying with his 
PRN contract and that, on August 16, 2005, a PRN monitor had contact 
with him and ``recommended,'' based on his ``body language and general 
demeanor[,] * * * that [he] undergo a psychiatric evaluation.'' Id. at 
4-5. PRN then allegedly ``requested that Respondent submit to a 
psychiatric evaluation and drug screen''; however, Respondent failed to 
``present for his drug screen.'' Id. at 5. The Complaint further 
alleged that three weeks later, ``Respondent contacted PRN and admitted 
to a relapse on crack cocaine and agreed to be evaluated.'' Id.
    The Complaint alleged that on or about October 7, 2005, Respondent 
was evaluated and ``diagnosed with cocaine dependence'' and ``opioid 
dependence, in apparent relapse.'' Id. The Complaint further alleged 
that the evaluator found that ``Respondent was not safe to practice 
medicine'' and recommended that he enter a ``structured detoxification 
and stabilization unit and undergo intensive psychotherapy.'' Id. at 5-
6. The Complaint alleged that while Respondent completed this portion 
of his treatment, he subsequently refused to enter into a halfway 
house, did not have a phone, and had no money to pay for urine screens. 
Id. at 6. The State thus alleged that Respondent was ``unable to 
practice medicine with reasonable skill and safety to patients due to 
his substance abuse problems and his unwillingness to undergo 
additional treatment'' and monitoring by PRN. Id. at 7.
    In February 2007, the Florida Board of Medicine issued a Final 
Order adopting a settlement agreement which Respondent had entered into 
with the State. Final Order at 2, DOH v. Harold Smith, M.D., No. 2005-
67946 (Fla. Bd. Med., Feb. 15, 2007). Apparently (as the agreement is 
not part of the record), Respondent had agreed to the suspension of his 
medical license. See Order on Reinstatement, DOH v. Harold Smith, M.D., 
No. 2005-67946 (Fla. Bd. Med., June 26, 2007).
    On June 26, 2007, the Board reinstated Respondent's license and 
placed him ``on probation for a period to run concurrent with his [PRN] 
contract.'' Id. at 1. The Board imposed the following conditions: That 
he comply with his PRN contract; that he appear before the Board's 
``Probationer's Committee'' each quarter; that he submit a practice 
plan to the Committee; that he practice only ``under the indirect 
supervision'' of a ``monitoring physician'' approved by the Committee, 
who is required to submit quarterly reports to the Committee on 
Respondent's compliance and to ``[r]eview 25 percent of [his] patient 
records selected on a random basis at least once each month'' and who 
is also required to report any violations of applicable laws and 
regulations to the Board. Id. at 1-5. Finally, the Board prohibited 
Respondent ``from writing prescriptions for controlled substances until 
such time as he is authorized to do so by the * * * Probationer's 
Committee.'' Id. at 5.

Respondent's DEA Applications

    On April 22, 2002, Respondent submitted an application to renew his 
DEA registration. In section 3 of the application, Respondent was 
required to answer four questions regarding whether he had ever been 
convicted of a controlled substance offense, and whether sanctions had 
ever been imposed against his DEA registration, any state medical 
license, or any state controlled substance registration.
    More specifically, question 3(d) asked: ``Has the applicant ever 
surrendered or had a state professional license or controlled substance 
registration revoked, suspended, denied, restricted, or placed on 
probation? Is any such action pending?'' Respondent circled ``no.''
    On February 28, 2005, Respondent submitted another application to 
renew his registration. Respondent was required to answer the same four 
questions as on the previous application. Once again, in answering 
question 3(d), Respondent circled ``no.''
    On January 31, 2008, Respondent submitted another application to 
renew his DEA registration. While there were some minor changes to the 
application, Respondent was required to answer the same four questions 
as on the previous applications. This time, however, Respondent 
answered ``yes'' to the question: ``Has the applicant ever surrendered 
(for cause) or had a state professional license or controlled substance 
registration revoked, suspended, denied, restricted, or placed on 
probation, or is any such action pending?'' In the application's block 
for explaining the ``nature of incident'' and the ``result of 
incident,'' Respondent wrote ``see attached.'' Respondent attached a 
copy of the Florida Board of Medicine's June 2007 Order on 
Reinstatement and a letter to him from a DOH Compliance Officer 
relating the minutes of a September 7, 2007 meeting of the Board's 
Probation Committee. The letter related that the Committee had lifted 
the restriction on his prescribing authority. Respondent did not, 
however, disclose the two Georgia proceedings or the 2003 Florida 
proceeding.

Discussion

    Section 304(a)(1) of the Controlled Substances Act (CSA) provides 
that a registration ``may be suspended or revoked by the Attorney 
General upon a finding that the registrant * * * has materially 
falsified any application pursuant to or required by this subchapter.'' 
21 U.S.C. 824(a)(1). Section 304(a)(4) also provides that a 
registration to ``dispense a controlled substance * * * may be 
suspended or revoked by the Attorney General upon a finding that the 
registrant * * * has committed such acts as would render his 
registration under section 823 of this title inconsistent with the 
public interest as determined under such section.'' 21 U.S.C. 
824(a)(4). With respect to a practitioner, the CSA requires that the 
following factors be considered in making the public interest 
determination:

    (1) The recommendation of the appropriate State licensing board 
or professional disciplinary authority.
    (2) The [registrant's] experience in dispensing * * * controlled 
substances.
    (3) The [registrant'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.

21 U.S.C. 823(f).
    ``[T]hese factors * * * are considered in the disjunctive.'' Robert 
A. Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a 
combination of factors and give each factor the weight I deem 
appropriate in determining whether to revoke an existing registration 
or to deny an application to renew a registration. Id. Moreover, I am 
``not required to make findings as to all of the factors.'' Morall v. 
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005); see also

[[Page 53964]]

Volkman v. DEA, 567 F.3d 215, 222 (6th Cir. 2009).
    Having considered the evidence, I conclude that the record 
establishes that Respondent materially falsified his 2002, 2005, and 
2008 applications for DEA registrations. While there is evidence 
suggesting that Respondent is still abusing controlled substances, in 
light of my conclusion with respect to the material falsification 
allegations, I deem it unnecessary to rule on the Government's 
alternative ground for seeking the revocation of Respondent's 
registration.\2\
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    \2\ As found above, while the DOH 2006 complaint makes the 
allegations that Respondent had admitted to t relapse on crack 
cocaine and had been diagnosed as being dependent on cocaine and 
opioids, neither the Board's Final Order nor the Order on 
Reinstatement contain factual findings establishing the validity of 
these allegations.
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The Material Falsification Allegations

    As found above, on both April 22, 2002 and February 28, 2005, 
Respondent submitted an application to renew his DEA registration on 
which he answered ``no'' to the question: ``Has the applicant ever 
surrendered or had a state professional license or controlled substance 
registration revoked, suspended, denied, restricted, or placed on 
probation?'' In both instances, Respondent's answer was false because 
he failed to disclose (1) The Georgia Board's 1985 consent order which 
placed him on probation for four years, and (2) the Georgia Board's 
1990 Consent Order which suspended his license. Moreover, Respondent's 
statement on his 2005 application was false for the further reason that 
in 2003, the Florida Board had imposed restrictions on his license 
which included that he remain in compliance with the PRN contract and 
was prohibited from writing controlled substance prescriptions ``for 
any family member.''
    As for his January 31, 2008 application, it is true that Respondent 
gave a ``yes'' answer to the question regarding his state license and 
included a copy of the Florida Board's June 2007 reinstatement order. 
However, the statement was still false because Respondent failed to 
disclose the Georgia Board's 1985 and 1990 consent orders, as well as 
the 2003 Florida consent agreement.
    It is likewise clear that Respondent's failure to disclose the 
various state proceedings on each of the three applications was a 
materially false statement under the CSA. 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.'' Kungys v. United States, 485 U.S. 759, 770 (1988) (int. 
quotation and other citations omitted). While the evidence must be 
``clear, unequivocal, and convincing,'' the ``ultimate finding of 
materiality turns on a substantive interpretation of the law.'' Id. at 
772 (int. quotations and citations omitted). See also Craig H. Bammer, 
73 FR 34327, 34328 (2008).
    Respondent's false statements were material because, under the 
public interest standard, the Agency is required to consider, inter 
alia, the applicant's experience in dispensing controlled substances, 
his compliance with applicable state and federal laws related to 
controlled substances, and whether his conduct threatens public health 
and safety. See 21 U.S.C. 823(f). Disclosure of each of the state 
orders would have provided significant information to the Agency 
showing that Respondent has a significant problem with drug abuse; DEA 
has long held that a practitioner's self-abuse of a controlled 
substance is a relevant consideration under factor five of the public 
interest standard and is grounds for the revocation of an existing 
registration or the denial of an application for registration even 
where there is no evidence that a practitioner has abused his 
prescription-writing authority.\3\ See Kenneth Wayne Green, Jr., M.D., 
59 FR 51453, 51454 (1994) (registrant's ``continued drug usage and 
relapses lead[ ] to the conclusion that he cannot be entrusted with the 
responsibilities of a DEA registrant and that his continued possession 
of a registration would be contrary to the public interest''); David E. 
Trawick, 53 FR 5326, 5327 (1988) (``offenses or wrongful acts committed 
by a registrant outside of his professional practice, but which relate 
to controlled substances may constitute sufficient grounds for the 
revocation of a'' registration).
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    \3\ It is also relevant in assessing Respondent's compliance 
with applicable laws related to controlled substances. See 21 U.S.C. 
823(f)(4).
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    Disclosure of the 2003 Florida proceeding (on the 2005 and 2008 
applications) would have also provided information that Respondent had 
been accused of writing unlawful prescriptions for hydrocodone, a 
schedule III controlled substance. 21 CFR 1308.13(e). This information 
is material to the Agency's investigation and assessment of 
Respondent's experience in dispensing controlled substances and his 
compliance with applicable laws related to the dispensing of controlled 
substances.\4\ See 21 U.S.C. 823(f)(2) & (4).
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    \4\ That the State did not require Respondent to admit to the 
allegations in the consent agreement does not make his failure to 
disclose the proceeding any less material.
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    I thus conclude that Respondent materially falsified his 2002, 2005 
and 2008 applications to renew his DEA registration.\5\ Only one of 
these material falsifications is necessary to support the revocation of 
Respondent's registration; that there are three such instances 
manifests a shocking level of dishonesty on his part. 21 U.S.C. 
824(a)(1). Accordingly, Respondent's registration will be revoked and 
his pending application will be denied.
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    \5\ While the Agency did not grant Respondent's 2008 
application, ``[i]t makes no difference that a specific 
falsification did not exert influence so long as it had the capacity 
to do so.'' United States v. Alemany Rivera, 781 F.2d 229, 234 (1st 
Cir. 1985). Moreover, Respondent's false statements on his 2002 and 
2005 applications obviously did influence the Agency's decision to 
grant them.
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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, BS4681979, issued to Harold Edward Smith, M.D., be, and 
it hereby is, revoked. I further order that the pending application of 
Harold Edward Smith, M.D., to renew his registration, be, and it hereby 
is, denied. This Order is effective September 29, 2011.

    Dated: August 17, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-22090 Filed 8-29-11; 8:45 am]
BILLING CODE 4410-09-P