[Federal Register Volume 72, Number 249 (Monday, December 31, 2007)]
[Notices]
[Pages 74332-74334]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-25347]



[[Page 74332]]

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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.
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    \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.
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    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\
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    \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.
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    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.
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    \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'').
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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]
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