[Federal Register: December 31, 2007 (Volume 72, Number 249)]
[Notices]
[Page 74332-74334]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr31de07-76]
[[Page 74332]]
-----------------------------------------------------------------------
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Jon Karl Dively, D.D.S.; Denial of Application
On December 14, 2005, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Jon Karl Dively, D.D.S. (Respondent), of Macomb,
Illinois. The Show Cause Order proposed the denial of Respondent's
pending application for a DEA Certificate of Registration as a
practitioner, on the ground that he had committed acts which would
render his registration ``inconsistent with the public interest.'' Show
Cause Order at 1 (citing 21 U.S.C. 823(f)).
The Show Cause Order specifically alleged that Respondent, while
holding a DEA registration (which he had since surrendered), had
``prescribed large amounts of hydrocodone, a schedule III controlled
substance, to [his] wife, on many occasions,'' and did so ``with
knowledge that she was addicted to'' the drug. Id. The Show Cause Order
alleged that ``[t]he prescriptions were not written in the usual course
of medical practice,'' and thus violated Federal law and DEA
regulations. Id.
The Show Cause Order further alleged that ``[f]rom at least mid-
2003 to May 2005,'' Respondent had ``abused hydrocodone.'' Id.
Relatedly, the Show Cause Order alleged that Respondent had admitted to
DEA investigators that he was ``taking regularly Oxycontin and
oxycodone,'' notwithstanding that he was being treated for drug and
alcohol abuse. Id. at 1-2. The Show Cause Order also alleged that
during a December 6, 2005 interview with DEA investigators, Respondent
appeared to be impaired but denied using controlled substances and
refused to take a drug test. Id. at 2. Relatedly, the Show Cause Order
alleged that in January 2006, DEA received a letter from an individual
affiliated with Rush Behavioral Health, which indicated that Respondent
``needed counseling, close supervision of [his] medications, verified
attendance at Alcoholic Anonymous and monitoring by a physician's
monitoring program.'' Id.
On December 27, 2006, the Show Cause Order was served on Respondent
by certified mail as evidenced by the signed return-receipt card.
Thereafter, on January 16, 2007, Respondent submitted a letter in which
he expressly waived his right to a hearing. Respondent did, however,
offer a response to each of the allegations of the Show Cause Order.
See Ltr of Resp. to Hearing Clerk (dated Jan. 3, 2007).
Based on Respondent's letter, I find that he has waived his right
to a hearing. See 21 CFR 1301.43(c). However, in accordance with 21 CFR
1301.43(c), Respondent's letter is made a part of the record and will
``be considered in light of the lack of opportunity for cross-
examination in determining the weight to be attached to matters of fact
asserted therein.'' Id. Having considered the entire record, I issue
this Decision and Final Order and make the following findings.
Findings
On December 28, 2005, Respondent, an Illinois licensed dentist,
applied for a DEA registration to handle controlled substances in
schedules II through V. Respondent had surrendered his DEA registration
on December 6, 2005, upon the conclusion of an interview with a DEA
Special Agent (SA), a DEA Diversion Investigator (DI), and an Inspector
from the Illinois Department of Financial and Professional Regulation.
Respondent first came to the attention of this Agency on September
26, 2005, when the state Inspector notified a DI that he had received
information indicating that Respondent was prescribing schedule III
controlled substances containing hydrocodone to his wife. 21 CFR
1308.13(e). Upon receipt of this information, the DI determined that
several pharmacies had filled the prescriptions including DrugStore.com
(whose prescriptions are filled by Rite Aid Pharmacy), Osco Drug, and
Hy-Vee Pharmacy. The DI then contacted each entity and requested that
it provide a list of the prescriptions it had filled which had been
issued by Respondent.
Subsequently, Rite Aid provided a spreadsheet listing thirty-seven
controlled-substance prescriptions it filled which Respondent had
issued in his wife's name. The prescriptions covered the period
beginning on October 29, 2003, and ending on January 24, 2005. Osco
Drug also provided a list of Respondent's controlled-substance
prescriptions which it filled. This list included seven prescriptions
which Respondent issued between September 21 and December 26, 2003.
Thereafter, on December 6, 2005, DEA and State investigators
visited Respondent and interviewed him. When asked about the
prescriptions he had written for his wife, Respondent asserted that he
had done so because she had herniated cervical discs. Respondent
acknowledged, however, that he issued the prescriptions outside of the
course of his professional practice as a dentist; he then admitted that
he had supplied his wife because she was addicted to hydrocodone.
Respondent further asserted that he had stopped writing the
prescriptions six months earlier.
Moreover, during the interview, Respondent's speech was slow and
slurred, his thought process was disjointed, and he appeared to have
trouble completing his thoughts. When the investigators expressed to
Respondent their concern that he was then impaired, Respondent denied
that this was so. The State Inspector then suggested that Respondent
obtain a drug test to prove that he was not impaired.
Respondent then told investigators that he had herniated lumbar
discs and had been prescribed fentanyl patches, Ultracet, and Lidoderm
for the condition by his prior physician. He further related that his
new physician, whom he met at an Alcoholic Anonymous meeting, was
prescribing Oxycontin for him. Respondent then agreed to voluntarily
surrender his DEA registration.
Two days later, Respondent telephoned the DI and left a voice mail
message. In the message, Respondent questioned the need for a drug
test, as well as why the DI could not have allowed Respondent to
continue with his registration and watch him ``like a hawk.'' In the
message, Respondent's speech was still slow and slurred.
On January 9, 2006, Respondent again contacted the DI asking how
long it would take to regain his DEA registration. In that
conversation, Respondent asked the DI whether he had received a letter
from Rush Behavioral Health, a Chicago-based clinic which treats drug
and alcohol addiction. The DI related to Respondent that he had not
received the letter.
On January 17, 2006, the DI received a letter from an Intake
Coordinator at Rush. According to the investigative report, in the
letter, the Intake Coordinator noted that she had evaluated Respondent
and had found that from mid-2003 through May 2005, Respondent had
written Vicodin prescriptions in his wife's name for his personal
use.\1\ According to the report, the Intake Coordinator noted that
Respondent ``seem[ed] impaired,'' and ``very anxious.'' The letter
added,
[[Page 74333]]
however, that ``this could have been from this high dosage'' of
Provigil. The letter added that Respondent needed counseling, close
supervision of his medications, accountable attendance at AA, and
monitoring by a physician's monitoring program to get his controlled-
substance prescribing authority back.
---------------------------------------------------------------------------
\1\ The letter was not submitted into the record. Rather, its
contents were summarized in an investigative report. The report does
not, however, establish what the Intake Coordinator's qualifications
and duties are, the date she evaluated Respondent, and what the
basis for this finding was.
---------------------------------------------------------------------------
On February 6, 2006, Respondent again called the DI and asked
whether he had received the letter from Rush. Respondent also told the
DI that he was seeing a new psychiatrist. Finally, Respondent stated
that while his wife's physician had attempted to get her off of
narcotics, it just made matters worse. Respondent added that his wife
had quit ``cold turkey'' and that ``it was rough.''
In his letter responding to the Show Cause Order, Respondent
admitted that he had prescribed large amounts of schedule III drugs
containing hydrocodone to his wife knowing that she was addicted to the
drug, and that the prescriptions were not issued in the usual course of
his professional practice. Resp. Ltr. at 2. Respondent denied, however,
that he had abused hydrocodone between mid-2003 and May 2005. Id. He
also denied that he was under treatment for drug and alcohol abuse
during this period. Id. Respondent also asserted that he had been sober
for twenty-five years. Id.
Respondent further admitted that he appeared to be impaired during
the December 6, 2005 interview. Id. Respondent asserted, however, that
this was because of his use of Provigil pursuant to a prescription. Id.
Respondent further admitted that during the interview, he denied
abusing controlled substances and refused to take a drug test. Id.
Respondent asserted, however, that ``on December 7, 2005, I did submit
to a drug analysis of urine.'' Id. Finally, Respondent admitted that
during the interview, he had admitted that he ``was regularly taking
Oxycontin and Oxycodone for a back injury'' as prescribed by his
physician. Id. Respondent further stated that he could neither admit
nor deny the allegation regarding the letter from Rush Behavioral
Health because he had not seen the letter.
The record also contains a copy of a consent order which Respondent
entered into with the Illinois Department of Financial and Professional
Regulation. The consent order noted that ``[t]he Department alleges
that Respondent engaged in improper medication prescribing practice.''
Consent Order at 1. Respondent pled no contest and agreed to various
sanctions including the suspension of his dental license for two weeks
followed by twenty-four months of probation. During the probation,
Respondent is required to submit to monthly alcohol-drug testing on
twenty-four hours notice, to complete ten hours of continuing education
in jurisprudence, and to file quarterly reports with the State
regarding his activities. Respondent was also fined $1,000.
Discussion
Section 303(f) provides that ``[t]he Attorney General may deny an
application for such registration if he determines that the issuance of
such registration would be inconsistent with the public interest.'' 21
U.S.C. 823(f). In making the public interest determination, the Act
requires the consideration of the following factors:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id.
``[T]hese factors are considered in the disjunctive.'' Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003). I may rely on any one or a
combination of factors, and may give each factor the weight I deem
appropriate in determining whether an application for a registration
should be denied. Id. Moreover, I am ``not required to make findings as
to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir.
2005); see also Morall v. DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).
While I have considered all of the factors, I conclude that the
Government has made out a prima facie case under Factors Two and Four
to deny Respondent's application based on his prescribing of controlled
substances to his wife. While I am mindful that the State has allowed
Respondent to maintain his dental license, Respondent has not presented
sufficient evidence to establish that he should be entrusted with a new
DEA registration. I therefore conclude that Respondent's application
should be denied.
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Record of Compliance With Applicable Laws
Under DEA regulations, ``[a] prescription for a controlled
substance * * * must be issued for a legitimate medical purpose by an
individual practitioner acting in the usual course of his professional
practice* * * . An order purporting to be a prescription issued not in
the usual course of professional treatment * * * is not a prescription
within the meaning and intent of [the CSA] and * * * the person issuing
it, shall be subject to the penalties provided for violations of the
provisions of law related to controlled substances.'' 21 CFR
1306.04(a). As the Supreme Court recently explained, ``the prescription
requirement * * * ensures patients use controlled substances under the
supervision of a doctor so as to prevent addiction and recreational
abuse.'' Gonzales v. Oregon, 126 S.Ct. 904, 925 (2006) (citing United
States v. Moore, 423 U.S. 122, 135 (1975)).
The record in this case establishes that Respondent issued numerous
prescriptions for controlled substances in the name of his wife. While
Respondent initially maintained that he wrote the prescriptions because
his wife had herniated cervical discs, Respondent subsequently admitted
that in doing so, he acted outside of the course of his professional
practice as a dentist. Respondent later admitted that he had written
the prescriptions because his wife was addicted to hydrocodone.
Respondent thus violated Federal law.
The Government also alleged that Respondent was personally abusing
controlled substances. More specifically, the Government alleged that
Respondent was impaired during the December 2005 interview and that he
had admitted to taking Oxycontin and oxycodone ``despite the fact that
[he was] under treatment for addiction.'' Show Cause Order at 2.
It is true that the evidence indicates that Respondent slurred his
speech during the interview (and in phone calls thereafter) and that he
had trouble completing his thoughts. The Government, however, has not
proved that Respondent's symptoms were caused by his abuse of a
controlled substance or that either of the controlled substances he was
then taking was not lawfully prescribed to him to treat a legitimate
medical condition. Indeed, the letter from the Intake Coordinator at
Rush supported Respondent's contention that his symptoms could have
been caused by the Provigil, and the Government produced no evidence
establishing that this drug was not lawfully prescribed to him, or that
he was taking in excess of the dosage prescribed by his physician.
Nor did the Government offer any evidence rebutting Respondent's
contention that the Oxycontin that he
[[Page 74334]]
admitted to ``regularly taking'' had been lawfully prescribed to him.
Finally, while the Government alleged in the Show Cause Order that
Respondent had refused to take a drug test upon being challenged to do
so by the State inspector, Respondent asserts that he did so.
Here again, the Government offered no evidence to rebut
Respondent's contention. Indeed, the Government produced no evidence
showing that it demanded that Respondent produce the test results and
that he failed to do so. I therefore conclude that the allegations that
Respondent was personally abusing controlled substances at the time of
the December 2005 interview and thereafter are not proved by
substantial evidence.\2\
---------------------------------------------------------------------------
\2\ There is also some evidence suggesting that Respondent
admitted to the Intake Coordinator at Rush that some of the
prescriptions he wrote for his wife were for his personal use. This
conduct would also violate Federal law. See 21 U.S.C. 843(a)(3)
(``It shall be unlawful for any person knowingly or intentionally *
* * to acquire or obtain possession of a controlled substance by
misrepresentation, fraud, forgery, deception, or subterfuge.''). The
letter which reports these admissions was not included in the
record. Moreover, this evidence does not establish that Respondent
was abusing controlled substances at the time of the December 2005
interview and thereafter.
---------------------------------------------------------------------------
While I reject the allegations of personal abuse, Respondent's
numerous violations of Federal law in prescribing controlled substances
to his wife make out a prima facie case for the denial of his
application. Where the Government has made out a prima facie case, the
burden shifts to the applicant to show why granting the application
would nonetheless be in the public interest. See Gregory D. Owens, 67
FR 50461, 50464 (2002).
As this Agency has repeatedly held, a proceeding under section 303
`` `is a remedial measure, based upon the public interest and the
necessity to protect the public from those individuals who have misused
* * * their DEA Certificate of Registration, and who have not presented
sufficient mitigating evidence to assure the Administrator that they
can be entrusted with the responsibility carried by such a
registration.' '' Samuel S. Jackson, 72 FR 23848, 23853 (2007) (quoting
Leo R. Miller, 53 FR 21931, 21932 (1988)). In short, Respondent must
prove by a preponderance of the evidence that he can be entrusted with
the authority that a registration provides by demonstrating that he
accepts responsibility for his misconduct and that the misconduct will
not re-occur.
While Respondent admitted in response to Show Cause Order that he
violated Federal law by prescribing controlled substances to his wife,
he has offered no evidence to establish that he will not engage in
similar acts in the future.\3\ Respondent has therefore failed to rebut
the Government's prima facie showing that granting him a new
registration ``would be inconsistent with the public interest.'' 21
U.S.C. 823(f). Accordingly, Respondent's application will be denied.
---------------------------------------------------------------------------
\3\ I acknowledge that the State has allowed Respondent to
retain his dental license and placed him on probation. The consent
order, however, merely recites that ``[t]he Department alleges that
Respondent engaged in improper medication prescribing practice,''
and does not contain the specific allegations that were made against
Respondent. Consent Order at 1. It is thus not even clear what
evidence the State had obtained and, in any event, there are a
number of reasons why the State may have decided to settle the case.
I thus decline to defer to the State's decision. See John Kennedy,
71 FR 35708 (2006) (declining to defer to State board's restoration
of medical license; a ``state license is a necessary, but not [a]
sufficient condition for [a DEA] registration'').
---------------------------------------------------------------------------
Order
Pursuant to the authority vested in me by 21 U.S.C. Sec. 823(f),
as well as 28 CFR 0.100(b) and 0.104, I order that the application of
Jon K. Dively, D.D.S., for a DEA Certificate of Registration as a
practitioner be, and it hereby is, denied. This order is effective
January 30, 2008.
Dated: December 13, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-25347 Filed 12-28-07; 8:45 am]
BILLING CODE 4410-09-P