[Federal Register Volume 76, Number 69 (Monday, April 11, 2011)]
[Notices]
[Pages 20020-20025]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-8546]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Glenn D. Krieger, M.D.; Denial of Application
On August 31, 2009, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Glenn D. Krieger, M.D. (``Applicant''), of West
Bloomfield, Michigan. The Show Cause Order proposed the denial of
Applicant's application for a DEA Certificate of Registration on the
ground that his ``registration would be inconsistent with the public
interest as defined by 21 U.S.C. Sec. Sec. 823(f) and 824(a)(4).''
Show Cause Order, at 1.
More specifically, the Show Cause Order alleged that Applicant
filed an
[[Page 20021]]
application for a DEA registration on October 9, 2008. Id. The Order
further alleged that on ``June 28, 2007, July 19, 2007, and August 1,
2007,'' Applicant was subjected to random urine drug tests and tested
positive for fentanyl, a Schedule II controlled substance,\1\ although
the drug had never been prescribed to him. Id. Relatedly, the Order
alleged that on November 7, 2008, Applicant told DEA Investigators that
he ``obtained the fentanyl from patients who returned unused fentanyl
to [him], because [he] was collecting pain medication to give as a
donation to the Oakpointe Church's missionary project in Zambia,
Africa.'' Id. The Order further alleged that DEA Investigators were
subsequently ``informed by Oakpointe Church executives that the church
did not conduct any Zambian missionary projects in 2007, that the
Zambian missionary projects of previous years did not collect donated
controlled substances, and that [Applicant] did not participate in any
of the Zambian missionary projects.'' Id. at 1-2. The Order then
alleged that Applicant's ``false statements to DEA investigators
constituted both conduct which may threaten the public health and
safety pursuant to 21 U.S.C. Sec. 823(f)(5) and criminal acts pursuant
to 18 U.S.C. 1001. Id. at 2.
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\1\ See 21 CFR 1308.12(c)(9).
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Next, the Show Cause Order alleged that Applicant had previously
held a DEA Certificate of Registration, BK4918528, which he
``surrendered for cause on March 7, 2008.'' Id. The Order then alleged
that ``[b]etween March 7, 2008 and November 1, 2008,'' Applicant
``issued approximately 435 prescriptions for controlled substances
despite not having a valid DEA Certificate of Registration, in
violation of 21 U.S.C. Sec. 841(a).'' Id. Finally, the Order alleged
that Applicant's ``violation[s] of Federal laws and regulations are
inconsistent with the public interest.'' Id. (citing 21 U.S.C. 823(f)
and 824(a)(4)).
The Show Cause Order also explained that Respondent had the right
to request a hearing on the allegations or to submit a written
statement in lieu of a hearing, the procedures for doing either, and
the consequences for failing do so. Id. (citing 21 CFR 1301.43(c), (d),
& (e)). On or about September 2, 2009, the Government attempted to
serve Applicant with the Order by certified mail addressed to him at
the address he provided in his application for a new registration.
However, on or about September 11, 2009, the Post Office returned the
Order as ``not deliverable as addressed.''
On or about September 25, 2009, DEA made a second attempt to serve
Applicant with the Order by certified mail addressed to him at the
address given on his application. Again, however, the Post Office
returned the mailing as ``not deliverable as addressed.''
On or about September 16, 2009, DEA mailed a copy of the Show Cause
Order to Applicant's counsel.\2\ As evidenced by a signed return
receipt card, Applicant's counsel received the letter on September 18,
2009.
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\2\ Applicant's counsel had represented him during an interview
with DEA Investigators on November 7, 2008.
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On February 2, 2010, the Office of Administrative Law Judges
received a letter from Applicant (dated Jan. 28, 2010). Therein,
Applicant stated that ``[a]round mid-October 2009, I received a letter
from my attorney * * * that was supposed to contain a complete copy of
the letter he received only a few days earlier. Due to several
different miscommunications and difficulty with traveling due to
expenses, I did not appear for the scheduled show cause on December 1,
2009. In spite of my absence, I am very interested in scheduling a show
cause.''
Upon receipt of this letter, the ALJ ordered that the Government
provide evidence of the date of service of the Show Cause Order upon
Applicant by February 19, 2010 and to file any motion to terminate
based on his failure to timely request a hearing by the same date.
Order Granting the Government's Motion to Terminate Proceedings, at 1.
The Order further directed Applicant to file a responsive pleading by
February 26, 2010. Id.
Thereafter, the Government timely filed a Motion to Terminate.
Therein, it asserted that it ``effected service of the OSC on
Respondent's counsel via certified mail on or around September 18,
2009,'' that the Show Cause Order clearly set forth the procedures for
requesting a hearing and the consequences for failing to do so, and
that he did not request a hearing within 30 days of receiving the Order
as required by DEA regulations. Id. at 2. Applicant did not file a
response to the Government's motion.
The ALJ granted the Government's motion noting that Applicant did
not contest the Government's representation that the Show Cause Order
had been served on his legal counsel/agent on or about September 18,
2009, and that, in his letter requesting a hearing, Applicant had
acknowledged that in mid-October 2009, he had received a document from
his attorney ``related to this proceeding and `did not appear for the
scheduled show cause hearing on December 1, 2009,''' which information
was contained on the front page of the Show Cause Order. Id. at 2-3.
Because Applicant did not request a hearing until ``several months
after effective service of the'' Order, and did not offer good cause
for his failure to do so, the ALJ concluded that he had waived his
right to a hearing and terminated the proceeding. Id. at 3 (citing 21
CFR 1301.43). I adopt this finding.\3\
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\3\ Respondent did not challenge whether the Government's
mailing of the Show Cause Order to the lawyer who previously
represented him constituted sufficient service. See 21 U.S.C. 824(c)
(``Before taking action pursuant * * * to a denial of registration
under section 823 of this title, the Attorney General shall serve
upon the applicant * * * an order to show cause. * * * .''); see
also United States v. Ziegler Boat and Parts Co., 111 F.3d 878, 881
(Fed. Cir. 1997) (``The mere relationship between a defendant and
his attorney does not, in itself, convey authority to accept
service. * * * Even where an attorney exercises broad powers to
represent a client in litigation, these powers of representation
alone do not create a specific authority to receive service.'')
(citing numerous authorities). However, a challenge to the
sufficiency of service is deemed waived if it is not raised in a
party's first responsive pleading. See Hemisphere X Biopharma, Inc.,
v. Johannesburg Consol. Investments, 553 F.3d 1351, 1360 (11th Cir.
2008). Accordingly, I hold that Respondent has waived any challenge
to the sufficiency of service.
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Thereafter, the investigative record was forwarded to me for final
agency action. Based on relevant evidence contained in the record, I
conclude that granting Respondent's application would be ``inconsistent
with the public interest.'' 21 U.S.C. 823(f). Accordingly, his
application will be denied. I make the following findings of fact.
Findings
On October 9, 2008, Applicant filed an application for a DEA
Certificate of Registration through DEA's Web site. The application is
the subject of this proceeding.
Applicant previously held DEA Certificate of Registration
BK4918528. On March 7, 2008, Respondent voluntarily surrendered this
registration and executed a DEA Form 104, Voluntary Surrender of
Controlled Substances Privileges (which his counsel signed as a
witness). The form clearly stated that it provided ``authority for the
Administrator * * * to terminate and revoke my registration without an
order to show cause, a hearing, or any other proceedings.'' In
addition, the form stated: ``I understand that I will not be permitted
to * * * prescribe, or engage in any other controlled substance
activities whatsoever, until such time as I am again properly
registered.''
According to a report obtained by an Agency Investigator from the
Michigan
[[Page 20022]]
Automated Prescription System (MAPS), within less than three weeks of
the surrender, Applicant issued prescriptions to two patients for 60
and 90 tablets of OxyContin 80 mg. The report further showed that by
the end of July, Applicant had resumed prescribing controlled
substances full-bore.
The investigative record establishes that Applicant voluntarily
surrendered his registration in connection with an Administrative
Complaint (``Complaint'') filed by the Michigan State Bureau of Health
Professionals (BHP) on December 20, 2007. The Complaint alleged two
counts. Administrative Complaint, In re Glenn D. Krieger, M.D., No. 43-
07-106420.
First, the Complaint alleged that Applicant had self-reported that
he was abusing fentanyl, a schedule II controlled substance, to the
Michigan Health Professional Recovery Program (HPRP) and had undergone
a substance abuse evaluation and been diagnosed as abusing opioids. Id.
at 5-6. The Complaint alleged that he had tested positive for fentanyl
during urine drug screens conducted on June 28, July 19, and August 1,
2007, and that thereafter, HPRP advised him that ``he was not safe to
practice'' medicine and recommended that he admit himself into an
inpatient rehabilitation program. Id. at 6. The Complaint further
alleged that he had failed to enter an inpatient drug rehabilitation
program or enter into a monitoring agreement with HPRP. The BHP charged
that his conduct ``constitute[d] a mental or physical inability
reasonably related to and adversely affecting Respondent's ability to
practice in a safe and competent manner,'' ``constitute[d] a conduct
that impairs or may impair his ability to safely and skillfully
practice medicine,'' and ``constitute[d] substance abuse,'' all in
violation of state law. Id. at 6-7.
Second, the Complaint alleged that, in treating S.S. for chronic
back pain, TMJ,\4\ fibromyalgia and depression, Applicant's ``chart for
S.S. [was] devoid of physical exams or clinical findings to support his
long term prescribing of high doses of opioids, benzodiazepines, and
stimulants'' and that he had ``failed to recognize that his prescribing
of escalating doses of opioids was detrimental to S.S.'s overall
functioning and quality of life.'' Id. at 10. The BHP charged that his
conduct ``constitute[d] negligence,'' ``incompetence,'' and the
``prescribing, giving away or administering [of] drugs for other than
lawful diagnostic or therapeutic purposes,'' all in violation of
Michigan law. Id.
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\4\ Temporo-mandibular joint dysfunction.
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The investigative file contains copies of the results from the
urine drop assessments of June 28, July 19, and August 1, 2007. These
documents establish that Applicant tested positive for fentanyl on each
occasion.
On December 28, 2007, the BHP's Board of Medicine's Disciplinary
Subcommittee (DS) summarily suspended Applicant's state medical license
effective on service of the order. Order of Summary Suspension, at 1.
On May 30, 2008, Applicant entered into a Consent Order with the State.
Consent Order, at 6. The Consent Order provided that the DS found
``that the allegations of fact contained in the complaint are true''
and that Applicant had violated sections 16221(a),\5\ (b)(i),\6\
(b)(ii),\7\ (b)(iii),\8\ and (c)(iv)\9\ of the Michigan Public Health
Code. Id. at 2. The DS thus ordered that Applicant's license be
``LIMITED for a minimum period of two years'' such that he ``shall not
obtain, possess, dispense, administer, or have access to any drug
designated as a controlled substance under the Public Health Code or
its counterpart in federal law unless the controlled substance is
prescribed or dispensed by a licensed physician for [Applicant] as a
patient.'' Id. The Consent Order also placed him ``on PROBATION for a
period of two years.'' Id.
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\5\ Section 16221(a) ``provides the [DS] with the authority to
take disciplinary action against [Applicant] for a violation of
general duty, consisting of negligence or failure to exercise due
care . . . or any conduct, practice, or condition which impairs or
may impair, the ability to safely and skillfully practice
medicine.'' Administrative Complaint, at 2.
\6\ Section 16221(b)(i) provides the DS with authority to take
disciplinary action against a licensee for ``incompetence,'' defined
as ``[a] departure from, or failure to conform to, minimal standards
of acceptable and prevailing practice for a health profession
whether or not actual injury to an individual occurs.''
Administrative Complaint, at 2.
\7\ Section 16221(b)(ii) provides the DS with authority to take
disciplinary action against a licensee for ``substance abuse,''
defined as ``the taking of alcohol or other drugs at dosages that
place an individual's social, economic, psychological, and physical
welfare in potential hazard or to the extent that an individual
loses the power of self-control as a result of the use of alcohol or
drugs, or while habitually under the influence of alcohol or drugs,
endangers public health, morals, safety, or welfare, or a
combination thereof.'' Administrative Complaint, at 2.
\8\ Section 16221(b)(iii) provides the DS with authority to take
disciplinary action against a licensee ``for a mental or physical
inability reasonably related to and adversely affecting the
licensee's ability to practice in a safe and competent manner.''
Administrative Complaint, at 2.
\9\ Section 16221(c)(iv) provides the DS with authority to take
disciplinary action against a licensee for ``obtaining, possessing,
or attempting to obtain or possess a controlled substance[] * * *
without lawful authority; or selling, prescribing, giving away, or
administering drugs for other than lawful diagnostic or therapeutic
purposes.'' Administrative Complaint, at 3.
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As one of the probationary conditions, the State ordered that
Applicant ``shall comply with the terms of the monitoring agreement''
which he had entered into with the HPRP on May 15, 2008. Id. at 3. The
Monitoring Agreement provided, inter alia, that he ``will not obtain,
possess, dispense, or administer controlled substances,'' that he
``will practice total abstention from alcohol, controlled substances,
and other mood-altering substances,'' and that he ``will submit to drug
screens as requested by HPRP.'' Monitoring Agreement, at 1-2. In the
Consent Order, the parties stipulated that Applicant ``does not contest
the allegations of fact and law contained in the complaint'' but that
``by pleading no contest * * * does not admit the truth of the
allegations [and] agrees that the Disciplinary Subcommittee may treat
the allegations as true for the resolution of the complaint.'' Consent
Order, at 4-5.\10\
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\10\ On June 4, 2008, a State ALJ dissolved the summary
suspension of his medical license. Order Dissolving Suspension, at
1.
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On September 26, 2008, a Diversion Investigator (DI) with the DEA
Detroit Division Office received information that Applicant was issuing
prescriptions using the DEA registration number which he had previously
surrendered. That day he contacted Applicant's attorney and left a
phone message advising him that Applicant could not issue controlled
substance prescriptions without a valid DEA registration.
On October 3, 2008, a pharmacist phoned the DI and told him that
Applicant had issued a prescription for Vicotussin, a controlled
substance. The pharmacist further stated that he had determined that
Applicant did not have a valid registration, and therefore, did not
fill the prescription. The DI again left a phone message with
Applicant's attorney advising that Applicant could not issue controlled
substance prescriptions without a valid registration. The DI also
attempted to contact Applicant directly; the DI left a phone message
advising him that he was not legally authorized to write controlled
substance prescriptions unless and until he obtained a new
registration.
The same day, Applicant's attorney contacted the DI and informed
him that Applicant's Michigan medical license had been reinstated; the
attorney further stated that he had advised Applicant that all of his
licensure had been restored upon the reinstatement of his medical
license such that Applicant had issued controlled substance
[[Page 20023]]
prescriptions based on the attorney's erroneous advice. The DI informed
the attorney that Applicant would have to apply for a new registration
in order to prescribe controlled substances.
On October 5, 2008, the DI received a letter from Applicant's
attorney, dated October 1, 2008. The letter requested the reinstatement
of Applicant's controlled substances privileges, based on the
reinstatement of his medical license.
The following day, on October 6, 2008, the DI received a telephone
call from a second pharmacist regarding a controlled substance
prescription (for 120 tablets of Oxycontin 80 mg.) issued by Applicant
on September 10, 2008. The pharmacist had also checked Applicant's
registration, found that he lacked a valid registration, and did not
fill the prescription.
On October 9, 2008, Applicant filed an application for a new
registration. Six days later, the DI received a telephone call from a
third pharmacist. The pharmacist reported that the day before, a person
had presented to him controlled substance prescriptions (for OxyContin,
Roxicodone, Norco and Xanax) issued by Applicant on October 3, 2008.
However, the pharmacy had experienced a delay in ordering the
prescribed medications.\11\
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\11\ The record contains copies of various controlled substance
prescriptions issued by Applicant on which he used the DEA
registration number he had previously surrendered.
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On October 15, the pharmacist called the customer to advise her of
the delay. Within fifteen minutes, he received a phone call from
Applicant about the delay. Finding this suspicious, the pharmacist
contacted the DI, who advised him that Applicant did not have a valid
registration.
On November 7, 2008, the DI and his Group Supervisor interviewed
Applicant in the presence of his attorney. During the interview,
Applicant's attorney stated that he had ``fumbled the ball'' by
advising Applicant that he could resume his customary practice,
including prescribing controlled substances, upon the reinstatement of
his medical license.\12\ During the interview, Applicant stated that he
had stopped issuing controlled substance prescriptions on October 3,
2008, when the DI had notified him that he could not do so without
first obtaining a new registration. He further acknowledged that he had
previously executed a Voluntary Surrender Form.
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\12\ The attorney also stated that he was unaware that Applicant
was required to apply for a new registration, despite his having
witnessed the Voluntary Surrender Form previously executed by
Applicant which had clearly stated that ``I will not be permitted to
* * * dispense, administer, prescribe, or engage in any other
controlled substance activities * * * until such time as I am again
properly registered.'' DEA Form 104.
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The DI also questioned Applicant about his abuse of fentanyl.
Noting that he had obtained a report from the Michigan Automated
Prescription System (MAPS) \13\ showing the prescriptions Applicant had
received as a patient and that no fentanyl prescriptions were listed,
the DI asked Applicant how he had obtained the fentanyl. Applicant
stated that he obtained the fentanyl by collecting unused pain
medication from his patients, which he was collecting to give as a
donation to his church's missionary project in Zambia. He further
denied that he had issued fentanyl prescriptions to patients in order
to have them fill the prescriptions and return the drugs to him for his
personal use.
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\13\ MAPS is part of a mandatory system in Michigan through
which pharmacies and dispensing physicians report their controlled
substance dispensings twice a month.
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The DI subsequently interviewed several individuals associated with
the church's missionary project. The church's senior pastor stated that
while he knew Applicant through the church, he was not a member of it,
and that while the church did conduct missionary projects in Zambia,
Applicant had not participated in any of them. Subsequently, the DI
interviewed a physician, who had run the project in 2003 and 2008, and
a physician assistant, who had run the project in 2004 and 2005. Both
individuals stated that there had been no missionary projects in 2006
and 2007, when Respondent tested positive for fentanyl. Moreover, the
physician had never met Applicant and the physician assistant had not
spoken to him since 2005. Finally, according to the church's Executive
Pastor, the 2008 project did not use controlled substances and any
drugs that were used had been bought and not donated.
On November 19, 2008, the DI ran another MAPS inquiry, this time
for controlled substance prescriptions written by Applicant between
March 1 and November 1, 2008. The report shows that between March 7,
the date on which he surrendered his registration, and November 1,
Applicant issued approximately 438 controlled substance prescriptions.
The report also shows that he issued three controlled substance
prescriptions prior to June 4, the date on which his Michigan medical
license was reinstated,\14\ and that he issued eight controlled
substance prescriptions after October 3, 2008,\15\ the date he received
the DI's phone message to stop writing prescriptions and the date he
claimed that he had ceased doing so.
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\14\ Two of the prescriptions, dated March 19 and April 11,
2008, were issued to patient A.F. and were for first 60 tablets and
then 90 tablets of OxyContin 80 mg. The third prescription, issued
March 26, 2008, was for patient D.P. and was for 90 tablets of
OxyContin 80 mg.
\15\ On October 4, 2008, Applicant issued two prescriptions to
patient L.V.: One for hydrocodone/APAP 10 mg./325 mg. (90 tablets)
and one for OxyContin 40 mg. (180 tablets). On October 8, 2008,
Applicant wrote five prescriptions for patient K.B.: For clonazepam
1 mg. (30 tablets), for Endocet 325 mg./10 mg. (90 tablets), for
Methadone Hcl 10 mg. (90 tablets), for Methylin 20 mg. (90 tablets),
and for OxyContin 80 mg. (75 tablets). On October 9, 2008, he issued
a prescription to patient D.P. for alprazolam 1 mg. (75 tablets).
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Discussion
Section 303(f) of the Controlled Substances Act (CSA) provides that
the Attorney General ``shall register practitioners * * * to dispense *
* * controlled substances in schedule II, III, IV, or V, if the
applicant is authorized to dispense * * * controlled substances under
the laws of the State in which he practices.'' 21 U.S.C. 823(f).
However, the statute also provides that the Attorney General ``may deny
an application for such registration if he determines that the issuance
of such a registration is inconsistent with the public interest.'' Id.
In determining the public interest, Congress directed that the
following factors be considered:
(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, 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 to revoke an existing registration
or to deny an application. 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).
In this matter, I have considered all of the factors. While
Applicant's state medical license has been re-instated (factor one) and
there is no evidence
[[Page 20024]]
that he has been convicted of an offense related to the distribution or
dispensing of controlled substances,\16\ I conclude that the evidence
relevant to Respondent's experience in dispensing controlled substances
(factor two) and his compliance with applicable laws related to
controlled substances (factor four), conclusively establishes that
granting his application would be ``inconsistent with the public
interest.'' 21 U.S.C. 823(f).
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\16\ Putting aside that the State of Michigan has made no
recommendation as to whether Respondent's application should be
granted, this Agency has repeatedly held that the possession of a
valid state license is not dispositive of the public interest
inquiry. See Patrick W. Stodola, 74 FR 20727, 20730 n.16 (2009);
Robert A. Leslie, 68 FR at 15230. As DEA has long recognized, ``the
Controlled Substances Act requires that the Administrator * * * make
an independent determination as to whether the granting of
controlled substances privileges would be in the public interest.''
Mortimer Levin, 57 FR 8680, 8681 (1992).
Nor is the lack of any criminal convictions related to the
distribution or dispensing of controlled substances dispositive.
Edmund Chein, 72 FR 6580, 6593 n.22 (2007), aff'd, Chein v. DEA, 533
F.3d 828 (D.C. Cir. 2008). Thus, the facts that Respondent holds a
Michigan medical license (assuming that he is actually authorized to
dispense controlled substances under the Consent Order) and has not
been convicted of a relevant criminal offense are not dispositive.
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Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substance and Compliance With Applicable Laws Related to Controlled
Substances
Under Federal law, it is unlawful ``for any person [to] knowingly
or intentionally * * * dispense a controlled substance'' ``except as
authorized by'' the CSA. 21 U.S.C. 841(a)(1). It is ``unlawful for any
person knowingly or intentionally * * * to use in the course of the * *
* dispensing of a controlled substance * * * a registration number
which is * * * revoked.'' Id. Sec. 843(a)(3). Moreover, ``[e]very
person who dispenses, or propose to dispense, any controlled substance,
shall obtain from the Attorney General a registration issued in
accordance with the rules and regulations promulgated by him.'' Id.
Sec. 822(a)(2); see also 21 CFR 1301.11(a) (same). Also relevant here
is 21 CFR 1301.13(a), which provides that ``[n]o person required to be
registered shall engage in any activity for which registration is
required until the application for registration is granted and a
Certificate of Registration is issued by the Administrator to such
person.''
As found above, Applicant issued more than 400 controlled substance
prescriptions even after he had surrendered his registration and had no
authority to lawfully do so. Moreover, upon surrendering his
registration, Respondent acknowledged his understanding that his
registration was being revoked and that he could not engage in any
controlled substance activities including the dispensing of drugs
``until such time as I am again properly registered.'' Yet within three
weeks of surrendering his registration, Applicant issued two
prescriptions for OxyContin 80 mg. Moreover, in late July, he escalated
his prescribing activities.
During the November 7, 2008 interview, Applicant's lawyer stated
that he had erroneously advised Applicant that upon the restoration of
his state medical license, he could resume prescribing controlled
substances. However, both the Voluntary Surrender Form and Federal law
clearly stated that he could not issue controlled substances
prescriptions until he obtained a new DEA registration. Moreover, the
evidence shows that Applicant issued controlled substance prescriptions
two months before his medical license was reinstated \17\ and that he
issued controlled substances prescriptions even after he was told to
stop doing so by the DI. Thus, it is clear that Applicant knowingly and
intentionally issued prescriptions in violation of Federal law. See 21
U.S.C. 822(a)(2), 841(a)(1), 843(a)(3). These violations were extensive
and provide reason alone to deny his application.
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\17\ Given the terms of the Consent Order, which prohibited him
from dispensing controlled substances, it also appears that his
issuance of the prescriptions violated that order. However, the
Government did not allege this in the Show Cause Order and thus I do
not consider this conduct.
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In addition, on at least three occasions during the summer of 2007,
Respondent tested positive for fentanyl, a schedule II controlled
substance. See 21 CFR 13087.12(c). According to a MAPS report obtained
by the DI which listed the prescriptions Applicant had obtained between
September 20, 2004 and November 20, 2007, Respondent was never
prescribed fentanyl by any physician. Moreover, as found above,
Respondent told the DI that he obtained unused fentanyl from his
patients to donate to his church's missionary project.
At a minimum, the evidence establishes a violation of 21 U.S.C.
844(a), which makes it ``unlawful for any person knowingly or
intentionally to possess a controlled substance unless such substance
was obtained directly, or pursuant to a valid prescription or order,
from a practitioner acting in the usual course of his professional
practice, or except as otherwise authorized by'' the CSA or the
Controlled Substances Import and Export Act. Moreover, while Applicant
still held a practitioner's registration during the period in which he
tested positive for fentanyl, such a registration authorizes its holder
only to dispense, i.e., ``to deliver a controlled substance to an
ultimate user.'' 21 U.S.C. 802(10). A practitioner's obtaining of a
controlled substance from a patient is not dispensing and thus is not
an authorized activity under a practitioner's registration. See 21 CFR
1301.13(e). Thus, even if Applicant had not engaged in the self-abuse
of fentanyl, he was not lawfully authorized to obtain possession of the
drug in this manner.\18\ This conduct further supports the conclusion
that granting Respondent's application would be ``inconsistent with the
public interest.'' 21 U.S.C. 823(f).
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\18\ The record does not conclusively establish whether he told
this story to the persons from whom he obtained the fentanyl. Were
this shown to be the case, Respondent would have violated 21 U.S.C.
843(a)(3), which renders it ``unlawful for any person knowingly or
intentionally * * * to acquire or obtain possession of a controlled
substance by misrepresentation, fraud, * * * deception, or
subterfuge[.]''
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Factor Five--Such Other Conduct As May Threaten Public Health and
Safety
The Government further alleged that Applicant made a false
statement to an Agency Investigator when he stated that he had obtained
the fentanyl he self-abused because he collected the drugs ``to give as
a donation to the Oakpointe Church's missionary project in Zambia.''
Show Cause Order at 1 (para.2) (citing 18 U.S.C. 1001). The evidence
clearly shows that Applicant's statement to the DI was false in that he
did not participate in the missionary project, let alone collect drugs
for it.
That his statement was false does not, however, establish a
violation by 18 U.S.C. 1001, because this provision requires that the
statement be material to the matter being investigated by the
Government. See 18 U.S.C. 1001(a) (``whoever, in any matter within the
jurisdiction of the executive * * * branch of the Government of the
United States, knowingly and willfully * * * (2) makes any materially
false, fictitious, or fraudulent statement or representation * * *
shall be fined under this title, imprisoned not more than five years *
* * or both''). The Supreme Court has held that for a statement to be
``material'' for purposes of section 1001, it ``must have a `natural
tendency to influence, or [be] capable of
[[Page 20025]]
influencing, the decisionmaking body to which it is addressed.' ''
United States v. Gaudin, 515 U.S. 506, 509 (1995) (quoting Kungys v.
United States, 485 U.S. 759, 770 (1988)). The Court has further
explained:
Deciding whether a statement is ``material'' requires the
determination of at least two subsidiary questions: (a) ``What
statement was made?'' and (b) ``what decision was the agency trying
to make?'' The ultimate question: (c) ``Whether the statement was
material to the decision,'' requires applying the legal standard of
materiality (quoted above) to these historical facts.
Gaudin, 515 U.S. at 512. The ``evidence must be clear, unequivocal, and
convincing.'' Kungys, 485 U.S. at 772.
While the DI's affidavit establishes the falsity of Applicant's
statements, the Government does not explain what decision the statement
had ``the natural tendency'' to influence or ``was capable of
influencing.'' Gaudin, 515 U.S. at 509 (quoting Kungys, 485 U.S. at
770). Among the possibilities are whether to grant or deny his
application for registration, to pursue criminal charges against him,
or to conduct further investigation to determine whether he had
committed additional crimes or whether individuals (other than
na[iuml]ve patients \19\) were involved in supplying him with fentanyl.
However, because the DI's affidavit does not offer any explanation as
to why the false statement was ``capable of influencing'' any of the
possible agency decisions, let alone identify which decision(s) the
false statement was capable of influencing, I decline to address
whether the statement was material.
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\19\ During the interview, Applicant also denied that he had
ever issued prescriptions to patients to have them obtain drugs for
himself. There is, however, no evidence that this statement was
false.
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In any event, given the extensive evidence under factors two and
four establishing that Respondent knowingly wrote hundreds of
controlled substance prescriptions even though he had surrendered his
registration, that he wrote prescriptions within weeks of having
surrendered his registration, that he wrote prescriptions even after
being told to stop and that he could not do so until he obtained a new
registration, as well as the evidence that he abused fentanyl, it is
clear that issuing him a new registration would ``be inconsistent with
the public interest.'' 21 U.S.C. 823(f). Accordingly, Respondent's
application will be denied.
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as by 28 CFR 0.100(b) & 0.104, I order that the application of Glenn D.
Krieger for a DEA Certificate of Registration as a practitioner be, and
it hereby is, denied. This Order is effective immediately.
Dated: April 1, 2011.
Michele M. Leonhart,
Administrator.
[FR Doc. 2011-8546 Filed 4-8-11; 8:45 am]
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