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