Registrant Actions - 2012
[Federal Register Volume 77, Number 234 (Wednesday, December 5, 2012)]
[Notices]
[Pages 72387-72408]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29333]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 11-73]
Jeffery J. Becker, D.D.S., and Jeffery J. Becker, D.D.S.,
Affordable Care Decision and Order
On December 22, 2011, Chief Administrative Law Judge John J.
Mulrooney, II, (hereinafter, ALJ), issued the attached Recommended
Decision.\1\ Respondent filed Exceptions to the ALJ's Decision, and the
Government filed a Response to Respondent's Exceptions.
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\1\ All citations to the ALJ's Recommended Decision are to the
slip opinion as originally issued.
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Having reviewed the record in its entirety, including Respondent's
Exceptions, I have decided to adopt the ALJ's recommended rulings,
factual findings, legal conclusions and decision except as discussed
below. A discussion of Respondent's Exceptions follows.
Respondent's Exceptions
In his Exceptions, Respondent raises five main contentions. Having
considered his Exceptions, and finding one of them to be of merit, I
nonetheless conclude that the record supports the ALJ's recommended
order of revocation.
Exception 1--Respondent's Violation of the Separate Registration
Requirement Does Not Support the Revocation of His Registration
The evidence shows that Respondent maintains a dental practice at
two offices, which are located in Norwalk and Avon, Ohio, each of which
is open two days a week. However, Respondent holds a registration only
for the Norwalk office, even though the evidence shows that he
routinely performs procedures, which require that he administer
controlled substances to his patients, at both offices.
Under 21 U.S.C. 822(e), "[a] separate registration shall be
required at each principal place of business or professional practice
where the applicant manufactures, distributes, or dispenses controlled
substances or list I chemicals." See also 21 CFR 1301.12(a). While, by
regulation, DEA has exempted several categories of locations from the
registration requirement, with respect to practitioners, the exemption
is limited to "[a]n office used by a practitioner * * * where
controlled substances are prescribed but neither administered nor
otherwise dispensed as a regular part of the professional practice of
the practitioner at such office, and where no supplies of controlled
substances are maintained." 21 CFR 1301.12(b)(3) (emphasis added).
Respondent does not dispute that "he dispensed controlled
substances at his unregistered Avon office," Resp. Exc. at 11, and he
admitted in his testimony that he had continued to do so up until the
date of the hearing. Tr. 764-65. Respondent maintains, however, that
upon being informed during the December 2009 DEA inspection that he
could not store controlled substances at the Avon office, he
discontinued storing controlled substances there. Resp. Exc. at 11. As
for why he did not cease administering controlled substances at his
Avon office, Respondent contends that he "believed that the critical
issue was where the controlled substances were 'stored' as opposed to
'administered.' " Id. (quoting Tr. 764-65).
To buttress the latter contention, Respondent cites the testimony
of the Government's Expert witness, a D.D.S., whose practice is limited
to providing intravenous (IV) sedation services for the patients of
other dentists "throughout the Dayton-Cincinnati area," as well as at
a local hospital. GX 14; Tr. 23-24. In particular, Respondent notes
that the Government's Expert testified that he has only one
registration, and that he does not obtain registrations for the
numerous offices of other dentists at which he provides anesthesia to
patients. Tr. 103. Citing the Government's Expert testimony that he is
an expert on the state and federal regulations pertaining to controlled
substances, as well as that he also teaches IV sedation and the
standards of the dental profession to other dental practitioners in
Ohio, Respondent asserts that revoking his registration cannot be
reconciled with the Expert's testimony that a registration is only
necessary "where you order your drugs, store your drugs and keep the
records of disposal and usage." Tr. 103; Resp. Exc. at 13.
While Respondent now concedes that both his belief and that of the
Expert were mistaken, he contends that the Expert's testimony
"support[s] the reasonableness of [his] mistake in fact relating to
the regulatory requirements." \2\ Resp. Exc. at 13. According to
Respondent, his violations of the CSA were the "result of his
confusion and apparent misunderstanding of the law." Id. However,
Respondent then contends that "it is difficult to comprehend a
situation that would be more confusing to a respondent than to sit in a
courtroom and hear testimony of the Government's expert advocating the
very position for which [his] registration is in jeopardy." Id. at 13-
14. Thus, Respondent argues that the ALJ's findings that he
"flagrantly" violated the law and that he has failed to acknowledge
wrongdoing and establish his future compliance are unsupported by the
record and that the recommended sanction of revocation is unwarranted.
Id. at 14.
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\2\ Of course, this is not a mistake of fact at all as
Respondent then states that his violations were caused in part by
his "apparent misunderstanding of the law." Resp. Exc. 13.
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The argument is not persuasive because the determination of the
meaning of the CSA and Agency regulations is not within the proper role
of expert witnesses. Rather, it is a function vested in the Agency and
the Federal Courts. See Chevron v. NRDC, 467 U.S. 837 (1984). Most
importantly, Respondent cannot credibly claim to have been confused as
to the requirement that he obtain a separate registration for his Avon
practice as both the Act itself and its implementing regulations
provide clear notice as to what is required. See United States v.
Clinical Leasing Serv., Inc., 925 F.2d 120, 123 (5th Cir. 1991) ("A
physician of ordinary means and intelligence would understand that the
federal registration provisions apply to each important or
consequential place of business where the physician distribute
controlled substances. It is sufficiently clear that the application of
the provisions is not limited to a single important or consequential
place of business where controlled substances are distributed.").
As set forth above, the CSA's registration provision states in
relevant part that "[a] separate registration shall be required at
each principal place of business or professional practice where the
applicant manufactures, distributes, or dispenses controlled
substances." 21 U.S.C. 822(e) (emphasis added). Likewise, the CSA
defines the term dispense to "mean[] to deliver a controlled
substances to an ultimate user * * * by * * * a practitioner, including
the * * * administering of a controlled substance." Id. Sec. 802(10).
Thus, the statute provides clear notice that it is the activity of
dispensing, which includes the administration of controlled substances,
itself, which triggers the requirement, in the case of a practitioner,
of obtaining a separate registration for a principal place of
professional practice. See 21 U.S.C. 822(e). And to similar effect, the
text of 21 CFR 1301.12(b)(3), which uses the conjunction "and," makes
clear that the exemption from registration for a practitioner's office
obtains only when
[[Page 72388]]
two conditions are met: (1) That the practitioner only engages in the
prescribing of controlled substances and "neither administer[s] nor
otherwise dispense[s]" at the office, and (2) that the practitioner
does not maintain any supplies of controlled substances at the office.
To the extent Respondent suggests that the Expert's testimony
establishes that there is widespread confusion among practitioners as
to the scope of the registration requirements, the argument is
unavailing. The clarity of the Act and the Agency's regulations is not
determined by whether there are even a substantial number of members of
the dental profession in Ohio who are confused as to the scope of the
registration requirements. Rather, it is determined by assessing
whether the text of the Act and regulations provide fair notice such
that a person of ordinary intelligence can understand when a separate
registration is required. See FCC v. Fox Television Stations, Inc., 132
S.Ct. 2307, 2310 (2012) (quoting United States v. Williams, 553 U.S.
285, 304 (2008)). The Act and regulations pass this test with flying
colors.
There is likewise no merit to Respondent's contention that the
Government's position is "irreconcilable" with the Expert's
acknowledgement that he does not hold registrations at each of the
numerous offices where he administers controlled substances. Resp. Exc.
at 12-13. The CSA's registration requirement applies only to "each
principal place of * * * professional practice * * * where controlled
substances are * * * dispensed by a person." 21 CFR 1301.12(a)
(emphasis added). While the record establishes that the Government's
Expert travels to numerous offices of other dentists to provide
anesthesia services for their patients, he does so on an apparently as-
needed and random basis, and there is no evidence that he maintains a
place of professional practice, let alone a principal one, at any of
these locations. Nor is there any evidence as to whether the dentists
who call on him to provide anesthesia to their patients themselves have
DEA registrations. See 21 CFR 1301.22(b).
By contrast, the evidence shows that Respondent maintains two
offices, at which he regularly both sees and administers controlled
substances in the course of treating patients. Notwithstanding that the
word "principal" ordinarily means the "most important,
consequential, or influential," Webster's Third New International
Dictionary 1802 (1993), or the "main, prominent" or "leading," see
Hertz Corp. v. Friend, 130 S.Ct. 1181, 1192 (2010) (quoting 12 Oxford
English Dictionary 495 (2d ed. 1989)), by inserting the word "each"
into the statutory text, Congress clearly was aware that practitioners
frequently maintain multiple places of professional practice and
manifested its intent that such an office be registered if the
practitioner administers controlled substances at the location. Any
other interpretation would undermine Congress' purpose of requiring
registration to ensure that those locations at which controlled
substance activities take place have adequate security and procedures
in place to prevent the diversion of drugs from their legitimate use.
Nor is there any merit to Respondent's contention that the ALJ
erred in finding that he "flagrantly" violated the registration
provision. Resp. Exc. at 14. Even if at the time of the December 2009
inspection, the Agency's Investigator told him only that he could not
store controlled substances at his Avon office and did not mention that
he was also prohibited from administering drugs at this location
because it was not registered, subsequently, the Show Cause Order
specifically cited 21 CFR 1301.12, the provision which makes plain that
he was required to hold a registration at this Office. ALJ Ex. 1, at 2.
Moreover, in its Pre-Hearing Statement, the Government provided notice
that it intended to establish that Respondent's Avon office "is not
registered with DEA to handle controlled substances[,]" and that "DEA
learned that Respondent administered controlled substances to patients
from his Avon dental practice." ALJ Ex. 5, at 7. Yet even after being
provided with notice that the Government was alleging that he was in
violation of the registration provision, Respondent acknowledged that
he had administered controlled substances at his Avon office as
recently as the week before the hearing. Tr. 764-65. This is more than
enough to establish that Respondent flagrantly violated the statute,
and in the absence of mitigating evidence, it is sufficiently egregious
to support the revocation of his registration.
Exception 2--Respondent's Violation of 21 CFR 1301.75(b) Does Not
Support the Revocation of His Registration
Respondent also argues that the evidence pertaining to the storage
of controlled substances at his Avon location in violation of 21 CFR
1301.75 does not "reflect an intentional disregard for security," and
that the ALJ ignored evidence of steps he took to comply when the
adequacy of security was questioned by a State Board Inspector. Resp.
Exc. at 17. However, while the ALJ found that Respondent violated 21
CFR 1301.75(b) by leaving controlled substances (unattended) in open
storage bins in the sterilization room at the Avon office (rather than
keeping them in a securely-locked and substantially-constructed
cabinet), there is also credible evidence that Respondent had changed
his storage practices at the time of the December 2009 DEA inspection
and that he was then in compliance with the above regulation. See Tr.
595. The ALJ did not, however, discuss this evidence in his decision.
Had Respondent's violations of 21 CFR 1301.75 been the only allegations
sustained on the record, they would not support the sanction
recommended by the ALJ. However, as explained above, they are not the
only violations proved.
Exception 3--The Provisions of 21 CFR 1307.21(a) Are Not Mandatory, Are
Void for Vagueness, and Are Inapplicable in Light of State Regulation
As noted above, the record shows that Respondent administered
controlled substances intravenously to patients and that he disposed of
the excess drug by squirting it down the sink. Respondent did not,
however, notify the Agency of this practice and did not complete DEA
Form 41 for these disposals.\3\ The Government thus alleges that
Respondent violated 21 CFR 1307.21(a), because he "did not provide
prior notification to DEA of such disposal as required by" this
regulation. ALJ Ex. 1, at 2.
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\3\ Other evidence of record relevant to the issue includes an
affidavit of Dr. Joel Weaver, a dentist anesthesiologist and
Professor Emeritus at The Ohio State University Medical Center, who
has practiced for thirty-five years. RX J, at 1. In his affidavit,
Dr. Weaver stated that "[t]he standard practice among dentists in
Ohio and most likely in most states is for the dentist to log the
dose of the drug taken from his inventory, record the dose given to
the patient in the patient sedation/anesthesia record and record any
'wasted' dose in either the drug log, the patient's record or both
as soon as the case is concluded." Id. at 2. He also explained that
"[t]he 'wasted' drug is typically squirted into the sink * * *,
into the trash or sharps container, or into the soil of potted
plants as a source of nitrogen-containing fertilizer." Id.
According to Dr. Weaver, in titrating the dose of sedation for
each patient, "there is often some amount of drug remaining in
syringes since the dose is individualized for each patient and [the]
length of the operation[,] and cannot be predicted." Id. He then
explained that "[t]he safest and most convenient method of
disposing of these drugs is immediate disposal and then placing the
contaminated syringes in a sharps container." Id. Dr. Weaver
further stated that in Ohio alone, there are approximately 500
dentists who are licensed to perform intravenous sedation and that
each of these physicians could perform twenty sedation procedures
each day for a total of 10,000 procedures each day. Id.
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[[Page 72389]]
While Respondent admits that he disposed of controlled substances
in this manner, he argues that the regulation does not set forth
mandatory procedures for disposing of controlled substances. Resp. Exc.
at 18-19. Alternatively, he argues that the regulation "is void for
vagueness," id. at 19, and that the regulation, when coupled with the
instructions provided on DEA Form 41, create "an alarming morass of
confusion" as to what it requires. Id. at 21. As support for his
contention, Respondent points to the testimony of the Government's
Expert that, he too, disposes of a drug, in excess of what he
administered to a patient, by squirting it down the sink, and does so
without obtaining permission from the Agency. Id. at 22-23. Respondent
further points to the testimony of an Agency Investigator that "a
large portion" of the practices he has inspected dispose of excess
drugs by squirting them into either the sink or toilet.\4\ Id. at 24
(quoting Tr. 631).
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\4\ Respondent also contends that the regulation "is
inapplicable in light of" an Ohio Board of Pharmacy regulation
governing the disposal of controlled substances. Id. at 24-25. In
light of my disposition of this Exception, I conclude that it is not
necessary to address this contention.
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Responding to Respondent's contention that the regulation does not
provide fair notice, the Government argues that the various cases he
relies on "are applicable to criminal or civil proceeding[s], but
inapplicable to regulated persons subject to the licensing requirement
set forth by an administrative agency or provision of the
Administrative Procedures [sic] Act." Gov. Resp. to Exceptions, at 6-
7. However, contrary to the Government's understanding, just last term
the Supreme Court invalidated an FCC order finding various broadcasters
liable for violating that Agency's indecency policy, because the FCC
failed to provide fair notice that their conduct would be deemed a
violation. FCC v. Fox Television Stations, Inc., 132 S.Ct. 2307 (2012).
In FCC v. Fox, the Court reiterated that the "requirement of clarity
in regulation is essential to the protections provided by the Due
Process Clause," and that a "punishment fails to comply with due
process if the statute or regulation under which it is obtained 'fails
to provide a person of ordinary intelligence fair notice of what is
prohibited, or is so standardless that it authorizes or encourages
seriously discriminatory enforcement.' " Id. (quoting United States v.
Williams, 553 U.S. 285, 304 (2008)).
While FCC v. Fox involved the imposition of a monetary penalty, it
hardly broke new ground. See General Electric Co. v. EPA, 53 F.3d 1324,
1328-29 (D.C. Cir. 1995); Diamond Roofing Co. v. OSHRC, 528 F.2d 645,
649 (5th Cir. 1976) Nor is there any no doubt that the Government's
obligation to provide "fair notice" of what conduct is prohibited
applies to licensing proceedings as well. Indeed, this has been the law
for more than forty years. See Trinity Broadcasting of Florida, Inc.,
v. FCC, 211 F.3d 618, 628 (D.C. Cir. 2000); Radio Athens, Inc., v. FCC,
401 F.2d 398, 404 (D.C. Cir. 1968). Thus, in Trinity Broadcasting, the
D.C. Circuit recognized that the denial of an application to renew a
license is "a severe penalty," and "held that 'in the absence of
notice--for example, where the regulation is not sufficiently clear to
warn a party about what is expected of it--an agency may not deprive a
party of property by imposing civil or criminal liability.' " Id.
(quoting G.E. v. EPA, 53 F.3d at 1328-29). Accordingly, if the
regulation (or other pronouncements interpreting it) do not provide
"fair notice" of what is required, Respondent cannot be deemed to
have violated it.
The starting point for resolving these contentions is, of course,
the language of the regulation. The regulation, which was one of the
original regulations promulgated by DEA's predecessor, the Bureau of
Narcotics and Dangerous Drugs, see 36 FR 7802 (1971) (then codified at
21 CFR 307.21), provides, in relevant part, that:
(a) Any person in possession of any controlled substance and
desiring or required to dispose of such substance may request
assistance from the Special Agent in Charge of the Administration in
the area in which the person is located for authority and
instructions to dispose of such substance. The request should be
made as follows:
(1) If the person is a registrant, he/she shall list the
controlled substance or substances which he/she desires to dispose
of on DEA Form 41, and submit three copies of that form to the
Special Agent in Charge in his/her area[.]
21 CFR 1307.21(a) (emphasis added).\5\
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\5\ The regulation also provides that:
(b) The Special Agent in Charge shall authorize and instruct the
applicant to dispose of the controlled substance in one of the
following manners:
(1) By transfer to person registered under the Act and
authorized to possess the substance;
(2) By delivery to an agent of the Administration or to the
nearest office of the Administration;
(3) By destruction in the presence of an agent of the
Administration or other authorized person; or
(4) By such other means as the Special Agent in Charge may
determine to assure that the substance does not become available to
unauthorized persons.
21 CFR 1307.21(b). In addition, subsection c of the regulation
provides that:
[i]n the event that a registrant is regularly required to
dispose of controlled substances, the Special Agent in Charge may
authorize the registrant to dispose of such substances, in
accordance with paragraph (b) of this section, without prior
approval of the Administration in each instance, on the condition
that the registrant keep records of such disposals and file periodic
reports with the Special Agent In Charge summarizing the disposals
made by the registrant.
Id. Sec. 1307.21(c).
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The ALJ rejected Respondent's contention that the regulation does
not impose a mandatory requirement of notification, reasoning that its
language "[n]ecessarily * * * implies that a person who does not
request assistance to dispose of a controlled substance does not have
authority to dispose of such substance. This is a classic example of
permissive language which 'plainly carr[ies] a restrictive meaning.' "
Order Regarding Respondent's Multiple Motions For Appropriate Relief
(ALJ Ex. 25), at 10 (quoting Forest Grove School Dist. v. T.A., 557
U.S. 230, 254 n.1 (2009) (Souter, J., dissenting)). The ALJ further
reasoned that "[u]nder a plain reading of the regulation, a registrant
is not required to dispose of controlled substances, but once he or she
elects to do so, such disposal may not be made without authorization
from the specified DEA official." Id. at 11.
I conclude, however, that the regulation's text does not provide
sufficient clarity to conclude that it provides a mandatory procedure
which must be followed in all instances in which a person seeks to
dispose of a controlled substance rather than simply a mechanism by
which a person who requires assistance to dispose of a controlled
substance can obtain such assistance. Moreover, while the ALJ's
interpretation might be permissible, it rests on the unsupported
premise that authority must always be obtained to lawfully dispose of a
controlled substance. However, neither the Government, nor the ALJ,
undertook to analyze the CSA and explain why this conclusion is
required.
Significantly, unlike most (if not all) other DEA regulations which
are indisputably mandatory, the relevant text uses the word "may"
rather than "shall" to modify the words "request assistance." As
the Supreme Court has explained, "[t]he word 'may' customarily
connotes discretion," and this is particularly true where, as here, an
enactment also uses the word "shall." Jama v. ICE, 543 U.S. 335, 346
(2005). Likewise, the phrase's use of the words "request assistance"
rather than "request authority," notwithstanding that obtaining
authority may well be the ultimate purpose of the procedure provided in
the regulation (at least in
[[Page 72390]]
some cases), is hardly the language of a mandatory requirement or
command.
Thus, while on its face, section 1307.21(a) is broad in scope as it
applies to all persons (and not only registrants) as well as all means
of disposal, it is far from clear why a person, like Respondent, who
disposes of a controlled substance by squirting or flushing it down the
drain, would necessarily need any assistance to do so. Nor, even
assuming that there are circumstances in which a person is required to
obtain authority from DEA to dispose of a controlled substance (i.e.,
because the person lacks authority to distribute the drug to another),
is it clear why a person, who disposes of a controlled substance in the
manner Respondent did, requires authority from DEA to do so. Thus,
while it is clearly reasonable to construe the regulation as providing
a mandatory procedure for disposing of controlled substances where a
person must distribute the controlled substances to another person--
because other provisions of the CSA make clear that a person cannot
lawfully distribute a controlled substance without the required
registration--that does not mean that the regulation provides fair
notice that it is mandatory when applied to other circumstances.
Indeed, the regulation's use of the word "may" rather than
"shall" itself suggests that there are circumstances in which
authority from DEA is not required to dispose of a controlled
substance.\6\ So too, that the regulation "shall not be construed as
affecting or altering in any way the disposal of controlled substances
through procedures provided in laws and regulations adopted by any
State," 21 CFR 1307.21(d), raises the question of whether its
procedures are still mandatory if one disposes of controlled substance
in compliance with state law (and thus has authority) without engaging
in a distribution.
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\6\ The regulation's use of the permissive word "may" cannot
be reasonably attributed to the fact that the regulation provides a
procedure that applies whether a person is merely "desiring * * *
to dispose of a controlled substance," or is "required to dispose
of a controlled substance." 21 CFR 1307.21(a) (emphasis added).
Surely, no one "desiring * * * to dispose of a controlled
substance" would object if the regulation stated that he "shall
request assistance" to do so. Id.
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In its pleadings, the Government acknowledges that "the
administrative case law is relatively silent on the requirements of a
registrant under 21 CFR 1307.21." Gov. Resp. to Respondent's Motion to
Exclude Paragraph 7 of the Order to Show Cause (ALJ Ex. 17), at 2.
Indeed, while this regulation has been in existence for more than forty
years, the Government points to no case in which a person, whether a
practitioner or ultimate user, has been either criminally or
administratively prosecuted for destroying a controlled substance,
without notifying the Agency, which he/she lawfully possessed and
retained possession of during the destruction process.\7\ Nor does the
Government cite to either an interpretive rule or guidance document it
has issued explaining that this regulation requires all persons,
including practitioners, to first obtain authority from the Agency
before they destroy a controlled substance of which they retain
possession.\8\ Finally, even in this litigation, the Government does
not explain why a person, who destroys controlled substances which they
lawfully possess and which they do not distribute to another,
nonetheless requires either "assistance" or "authority" to do so.
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\7\ The only case cited by the Government involved an entity,
which was "in the business of receiving salvage or undeliverable
merchandise from common carriers," and which sought a DEA
registration as a distributor. Associated Pharmaceutical Group,
Inc., 58 FR 58181 (1993). Notably, the entity was unregistered and
could not lawfully possess controlled substances. Id. at 58183. The
Order's brief discussion of 21 CFR 1307.21 simply recounted the
advice given the entity by a DEA Investigator that the regulation
"requires that it seek DEA authorization for disposal or
destruction of controlled substances that it was retaining in its
possession," id. at 58181, as well as in a letter which advised it
"that all unclaimed controlled substances in [its] possession would
have to be disposed of according to 21 CFR 1307.21." Id. at 58182.
\8\ At the time of the regulation's promulgation, DEA did not
recognize reverse distributors as a category of registrant and the
regulations only authorized a person to distribute (without being
registered to distribute) "that substance to the person from whom
he obtained it or to the manufacturer of the substance." 21 CFR
307.12 (1971).
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Notably, the CSA itself contains no provision explicitly
prohibiting or regulating (other than through recordkeeping) the
destruction of controlled substances. Moreover, in enacting the Secure
and Responsible Drug Disposal Act of 2010, which amended the CSA,
Congress found that "take-back programs often cannot dispose of the *
* * controlled substance medications * * * because Federal law does not
permit take-back programs to accept controlled substances unless they
get specific permission from [DEA] and arrange for full-time law
enforcement officers to receive the controlled substances directly from
the member of the public who seeks to dispose of them." Secure and
Responsible Drug Disposal Act of 2010, Public Law 111-273, Sec.
2(4)(B), 124 Stat. 2858, 2859 (2010). Yet Congress further found that:
Individuals seeking to reduce the amount of unwanted controlled
substances in their household consequently have few disposal options
beyond discarding or flushing the substances which may not be
appropriate means of disposing of such substances. Drug take-back
programs are also a convenient and effective means for individuals
in various communities to reduce the introduction of some
potentially harmful substances into the environment, particularly
into water.
Id. Sec. 2(4)(C). Of significance, while Congress noted the lack of
legal authority for take-back programs to accept controlled substances
without Agency permission, it made no similar observation that those
individuals who dispose of their controlled substances by discarding or
flushing them also lack legal authority to do so.\9\
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\9\ Consistent with this understanding, in several other
pronouncements, including guidelines developed by the FDA in
conjunction with the Office of National Drug Control Policy (ONDCP),
which discuss the proper method of disposing of prescription drugs
including controlled substances, not once has the Federal Government
explained that a person must first obtain permission from DEA to
dispose of a controlled substance if he destroys it himself. See
ONDCP, Epidemic: Responding to America's Prescription Drug Abuse
Crisis 7-8 (2011). Moreover, while the Guidelines instruct that
drugs should be flushed "down the toilet only if the accompanying
patient information specifically instructs it is safe to do so,"
ONDCP, Press Release, Federal Government Issues New Guidelines For
Proper Disposal of Prescription Drugs (Feb. 20, 2007), the FDA has
determined, with respect to a number of controlled substances, that
flushing them down the toilet or sink is appropriate and that "any
potential risk to people and the environment from flushing [these
drugs] is outweighed by the real possibility of life-threatening
risks from accidental ingestion of these medicines." U.S. Food and
Drug Administration, Disposal of Unused Medicines: What You Should
Know 1 (Jan. 2012). See also U.S. Food and Drug Administration, How
to Dispose of Unused Medicines 2 (April 2011) (noting that the
disposal instructions on some drugs may contain "instructions to
flush down the toilet, * * * because FDA * * * has determined this
method to be the most appropriate route of disposal that presents
the least risk to safety" and that "[d]rugs such as powerful
narcotic pain relievers and other controlled substances carry
instruction for flushing to reduce the danger of unintentional use
or overdose and illegal abuse").
To make clear, whether flushing the drugs which Respondent used
in the procedures he performed creates environmental harms is an
issue for other agencies.
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To be sure, because of their role in the closed system of
distribution, the CSA imposes requirements on registrants which are not
imposed on ultimate users, and the Act generally limits the authorized
activities of practitioners to the dispensing of controlled substances
and prohibits them from distributing a controlled substance. Yet the
Government offers no argument that squirting the small amount of excess
medication, which has been drawn into a syringe but not administered to
a patient, into a sink or toilet and flushing it, constitutes a
distribution within the
[[Page 72391]]
meaning of the CSA, or is otherwise prohibited by the Act.\10\ Indeed,
disposing of the excess amount of a controlled substance, pursuant to
the administration of the drug to a patient in the course of
professional practice and in this manner, would seem to be a necessary
incident of administering the drug and within the scope of a
practitioner's authorized activities.
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\10\ To further demonstrate the lack of clear notice provided by
the Government's proposed reading of the regulations, apparently
even if a registrant wants to distribute a controlled substance to a
reverse distributor, it must request authority to do so under 21 CFR
1307.21(a). Yet under a separate regulation, a practitioner is
authorized to "distribute (without being registered to
distribute)" a controlled substance to "[a] reverse distributor
who is registered to receive such controlled substances." 21 CFR
1307.11(a). Thus, this provision would seem to grant authority to a
practitioner to dispose of his excess controlled substances by
shipping them to a reverse distributor who destroys them. However,
no guidance from the Agency explains whether a practitioner who
disposes of his controlled substances in this manner (and who
seemingly has been granted authority by this regulation to do so) is
nonetheless required to comply with section 1307.21.
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I therefore conclude that the use of the phrase "may request
assistance" in the relevant language of the regulation creates an
ambiguity as to whether it is permissive or mandatory in all instances
in which a person disposes of a controlled substance. Because the
Government points to no provision of the CSA which prohibits this
method of disposal or otherwise requires that a practitioner obtain
authority to dispose of controlled substances in all circumstances, and
because notwithstanding that the regulation has been in existence for
more than forty years, the Government has not published any
administrative interpretation holding that disposal in this manner
violates the Act or requires authority from the Agency, I hold that the
Government has not provided fair notice that Respondent's conduct was
prohibited.\11\ Accordingly, this conduct cannot be used as a basis for
finding a violation of the CSA.\12\
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\11\ My holding that the regulation is ambiguous as applied to
practitioners engaged in this manner of disposal does not preclude
the Agency from issuing an interpretative rule clearly explaining
the scope of the regulation and attempting to provide a reasoned
basis for applying the regulation to this conduct.
\12\ The ALJ also noted that even after Respondent was advised
by the Agency's Investigator that he was in violation of 21 CFR
1307.21, he continued to engage in the same conduct. While this
conduct is disturbing, I do not rely on it given the absence of any
published order, interpretive rule, or guidance document holding or
explaining that the Agency deems such conduct to be a violation. In
any event, given the evidence that Respondent continued to violate
the registration requirement and did so even after being served with
the Show Cause Order, this conduct is, by itself, sufficiently
egregious to support the revocation of his registration.
The Government also argues that Respondent's contention that
the regulation does not provide fair notice should be rejected
because he did not seek "agency guidance regarding the issue."
Gov. Resp. to Exceptions at 7. Contrary to the Government's
understanding, the Due Process Clause places the burden on the
Government to provide fair notice of what its regulation requires
and not on Respondent to seek clarification of the regulation's
ambiguity.
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Exception 4--The ALJ's Recommended Decision Is Arbitrary and Capricious
and Unsupported By Law
Respondent also takes exception to the ALJ's factual findings,
legal conclusions, and recommended sanction, contending that they are
"arbitrary, capricious and unsupported by law." Resp. Exc. at 27.
However, with the exception of the ALJ's legal conclusions pertaining
to the alleged violations of 21 CFR 1307.21, I find that the ALJ's
findings of fact and legal conclusions are supported by substantial
evidence. Based on the ALJ's findings that: (1) Respondent violated the
separate registration requirement by failing to register his Avon
practice, notwithstanding that he regularly administered controlled
substances at this office, see ALJ at 37; (2) even after he was on
notice that he was in violation of this provision, he continued to
violate the Act and was still doing so the week before the hearing, see
id. (citing Tr. 660 & 764); (3) Respondent failed to maintain proper
records in that he was missing purchase records as well as order forms
(DEA 222) for the schedule II controlled substances he purchased, see
id. at 39-40; and (4) Respondent failed to properly secure the
controlled substance he took to his Avon office, see id. at 38-39; I
conclude that the ALJ's finding that Respondent has committed acts
which render his registration inconsistent with the public interest is
supported by substantial evidence and that the Government has satisfied
its prima facie burden. See id.
While I acknowledge that Respondent produced evidence that he has
changed his storage practices at his Avon office, he has offered no
evidence that he has applied for a registration for the Avon office,
nor provided any evidence to support a finding that he has addressed
the serious recordkeeping violations proven on this record. Moreover,
even to this day, Respondent does not accept responsibility for his
violations of the registration requirement; instead, he argues--
notwithstanding that the Agency's regulation is clear on its face--that
because others violate the same regulation, his violations should be
excused. Exacerbating this violation, Respondent continued to
administer controlled substance at his Avon office in violation of the
registration requirement even after being told by the DI that he was in
violation and even after being served with the Show Cause Order.
Accordingly, I agree with the ALJ's conclusion that Respondent has not
rebutted the Government's prima facie case and will order that
Respondent's registration be revoked and that any pending applications
be denied.\13\
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\13\ I have considered Respondent's contention that the
recommended sanction "is a significant departure from prior agency
decisions and * * * is without justification in fact." Resp. Exc.
at 29. However, as the ALJ explained, in Daniel Koller, 71 FR 66975
(2006), I revoked the registration of a practitioner who engaged in
similar misconduct. ALJ at 44. In his Exceptions, Respondent totally
ignores Koller. Accordingly, I reject Respondent's Exception.
Respondent also contends that because an Agency Investigator
approved his application for a Milwaukee registration when she knew
that another Agency Investigator had requested the issuance of an
Order to Show Cause, the Agency has "voluntarily and
intentionally" waived its right to revoke his Milwaukee
registration. Resp. Exc., at 25-26. Respondent, however, produced no
evidence that he entered into an agreement with the Agency pursuant
to which the Agency agreed that it would not seek to revoke this
registration. In addition, even if the Investigator's decision to
approve his registration was deemed to constitute a voluntary and
intentional act of waiver (itself a dubious conclusion), DEA has not
delegated the authority to waive prosecution to field investigators.
See 28 CFR 0.104. Rather, that authority remains vested in the
Deputy Assistant Administrator of the Office of Diversion Control. I
thus reject the contention. It is further noted that Respondent does
not claim that the Government is estopped from proceeding against
his Milwaukee registration.
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Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and
824(a), as well as 28 CFR 0.100(b), I order that DEA Certificates of
Registration Numbers FB2238865 and BB0569775, issued to Jeffery J.
Becker, D.D.S., be, and they hereby are, revoked. I further order that
any pending application of Jeffery J. Becker, D.D.S., to renew or
modify any of the above registrations, be, and it hereby is, denied.
This Order is effective January 4, 2013.
Dated: November 16, 2012.
Michele M. Leonhart,
Administrator.
Robert Walker, Esq., for the Government
Frank Recker, Esq., & Todd Newkirk, Esq., for the Respondent
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
Chief Administrative Law Judge John J. Mulrooney, II. On July 28,
2011, the Deputy Assistant Administrator of the Drug Enforcement
Administration (DEA or Government), issued an Order to Show Cause (OSC)
seeking the revocation of DEA Certificates of
[[Page 72392]]
Registration (COR), Number BB0569775,\1\ and Number FB2238865,\2\ of
Jeffrey J. Becker, D.D.S. (Respondent), as a practitioner, pursuant to
21 U.S.C. 824(a) (2006 & Supp. III 2010), and denial of a pending
application for renewal of Respondent's DEA COR, Number BB0569775,
pursuant to 21 U.S.C. 823(f) (2006). The OSC alleges that the
Respondent's continued enjoyment of the privileges vested in his COR
registrations is inconsistent with the public interest, as that term is
used in 21 U.S.C. 823(f). On August 25, 2011, the Respondent, through
counsel, timely requested a hearing, which was conducted in Arlington,
Virginia on November 8-9, 2011.
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\1\ The registered address under this registration is in
Norwalk, Ohio. Gov't Ex. 1.
\2\ The registered address under this registration is in
Milwaukee, Wisconsin. Gov't Ex. 2.
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The issue ultimately to be adjudicated by the Administrator, with
the assistance of this recommended decision, is whether the record as a
whole establishes, by substantial evidence, that the Respondent's CORs
should be revoked \3\ as inconsistent with the public interest, as that
term is used in 21 U.S.C. 823(f) and 824(a).
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\3\ The Respondent has timely submitted an application for
renewal of COR BB0569775 (Norwalk) which was scheduled to
expire under its own terms on July 31, 2011. Thus, by operation of
law, this COR has been extended and remains in full force and effect
until a final Agency order is issued in this case. 5 U.S.C. 558(c);
21 CFR 1301.36(i).
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After carefully considering the testimony elicited at the hearing,
the admitted exhibits, the arguments of counsel, and the record as a
whole, I have set forth my recommended findings of fact and conclusions
of law below.
The Allegations
The OSC issued by the Government contends that revocation of the
Respondent's CORs is appropriate because: (1) The Respondent has
practiced dentistry from a location in Avon, Ohio without obtaining a
DEA COR to handle controlled substances at that location; \4\ (2) the
Respondent "maintained * * * controlled substances at an unregistered
[location] in violation [of] 21 U.S.C. 822(e);" (3) the Respondent
"maintained controlled substances in an unsecured area in violation of
21 CFR Sec. 1301.75(b);" (4) "sometime in 2009 [the Respondent]
distributed controlled substances * * * to an unregistered location in
violation of 21 CFR Sec. 1307.11;" (5) an accountability audit of the
Respondent's "handling of fentanyl, diazepam and midazolam * * *
revealed shortages of fentanyl and midazolam and an overage of
diazepam;" and (6) the Respondent disposed of controlled substances
but "did not provide prior notification to DEA of such disposal as
required by 21 CFR Sec. 1307.21(a)." ALJ Ex. 1 at 1-2.
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\4\ This allegation does not aver that controlled substances are
maintained, administered or dispensed at the Avon office. See 21 CFR
1301.12.
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The Stipulations of Fact
The Government and the Respondent, through counsel, have entered
into stipulations regarding the following matters:
(1) The Respondent is registered with DEA as a practitioner in
Schedules II-V under DEA registration number BB0569775 at 282 Benedict
Avenue, Suite C, Box 22, Norwalk, Ohio 44857. While this registration
reflects an expiration date of July 31, 2011, the Respondent timely
submitted an application for renewal of registration on June 3, 2011.
(2) The Respondent is also registered with DEA as a practitioner in
Schedules II-V under DEA registration number FB2238865 at Affordable
Care, 6015 West Forest Home Avenue, Milwaukee, Wisconsin 53220. This
registration expires by its terms on July 31, 2013.\5\
(3) Fentanyl is a Schedule II controlled substance pursuant to 21
CFR 1308.12(c)(9) (2011).
(4) Diazepam is a Schedule IV controlled substance pursuant to 21
CFR 1308.14(c)(14) (2011).
(5) Lorazepam is a Schedule IV controlled substance pursuant to 21
CFR 1308.14(c)(28) (2011).
(6) Versed is a brand name for a product containing midazolam, a
Schedule IV controlled substance pursuant to 21 CFR 1308.14(c)(35)
(2011).
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\5\ The Respondent makes much of the granting of the Milwaukee
registration, arguing that "[i]f the DEA felt that the Respondent's
continued registration was inconsistent with the public interest,
they could have * * * at least denied the Respondent's application
for his Wisconsin registration." Resp't Posth'g Brf., at 18. It is
unclear on what legal authority this contention rests, but the DEA
has considered the application of waiver in situations where, as
here, the agency granted and then sought to revoke a license based
on information available at the time the license was granted. James
Dell Potter, M.D., 49 FR 9970, 9971 (1984). In Potter, the DEA
granted a license to the Respondent, notwithstanding information on
the application referencing a felony conviction. Sometime later, the
Agency rejected the respondent's argument that the granting of the
application waived the Agency's right to seek revocation, holding
that the doctrine of waiver requires a "voluntary and intentional
abandonment of known right." Thus, where the granting of a license
is "inadvertent and * * * unintentional[,]" there can be no
waiver. Here, as in Potter, there is no evidence that would support
an election by the Agency to voluntarily and intentionally abandon a
known right. Accordingly, application of waiver is unwarranted.
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The Evidence
The Government presented the testimony of Diversion Investigator
(DI) Scott Brinks. Tr 428. DI Brinks testified that he has been
employed as a DI in the Cleveland, Ohio, field office for just over ten
years, Tr. 429, and that, during this time, he has been a part of at
least a hundred investigations relating to practitioners. Tr. 431.
DI Brinks testified that, sometime prior to December of 2009, he
was contacted by Investigator Flugge of the Ohio Dental Board (Board),
who informed DI Brinks that "he had some drug related problems with
[Respondent]." Tr. 433. After the conversation with Investigator
Flugge, DI Brinks ran a query on the Respondent in the ARCOS \6\ and
RICS \7\ databases. Tr. 433-436. Although Brinks ascertained from the
Internet that the Respondent maintained a practice in Avon, Ohio, the
RICS database query did not indicate that the Respondent had a COR for
the Avon location. Tr. 435-36.
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\6\ The Automation of Reports and Consolidated Orders System
(ARCOS) database tracks the course of distributions of controlled
substances "from the manufacturer down to the final seller." Tr.
434.
\7\ DI Brinks explained the RICS system maintains a wide variety
of information on DEA registrants. Tr. 436.
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On the morning of December 21, 2009, DI Brinks met Investigator
Flugge at a McDonalds across the street from the Respondent's practice
in Norwalk, Ohio. Tr. 432. At this meeting, Investigator Flugge gave DI
Brinks the Board's investigative file on the Respondent, including "an
anonymous complaint [and] a complaint by Rebecca Crockett." Tr. 433.
Investigator Flugge also "gave * * * a brief overview of the [the
Board's] investigation and why he was referring [the matter]." Tr.
433. However, "Investigator Flugge said he did not want to come along
because of [the Respondent's] relationship with the [B]oard." Tr. 438.
When asked to clarify this remark, DI Brinks explained Investigator
Flugge's reluctance to join the investigation "had to do with some
hearing that [the] Respondent had went to." Tr. 438-40.\8\
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\8\ DI Brinks reasonably explained that the motivation for the
referral by Investigator Flugge did not matter to him because he
"ha[d] an allegation of a controlled-substance-related problem, so
[he was] required to investigate that." Tr. 439.
---------------------------------------------------------------------------
After meeting with Investigator Flugge, DI Brinks and a second DI
drove across the street to the Respondent's office. Tr. 438. Upon
entering the office, the DIs identified themselves, and presented the
Respondent with a DEA Form 82, Notice of Inspection of Controlled
Premises, which the
[[Page 72393]]
Respondent reviewed and signed.\9\ Tr. 438; Gov't Ex. 7. DI Brinks also
requested that the Respondent provide "all DEA Form 222s for the
purchases of Schedule II controlled Substances, his purchase records
for Schedule III-V [controlled substances, and] his dispensing records
for Schedules II-V [controlled substances.]" Tr. 442. DI Brinks also
requested "any DEA form 41s * * * Destruction of Controlled
Substances, and any DEA Form 106, the Theft and Losses of Controlled
Substances, and then [Respondent's biennial] inventory." Tr. 443. DI
Brinks testified that, during their conversations,\10\ he found the
Respondent to be "very nervous and his hands were shaking." \11\ Tr.
442, 624.
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\9\ Inexplicably, despite the details he provided about his
visit to the Respondent's office, when asked about his recollection
of the event, DI Brinks stated that he could "vaguely recall
walking in there * * *." Tr. 590.
\10\ DI Brinks indicated that no recording devices were employed
during the inspection. Tr. 442, 594. The Respondent testified that
he believed that his conversation with Brinks was recorded. Tr. 781-
82.
\11\ On cross-examination DI Brinks conceded that, while other
practitioners have appeared nervous during his investigations, he
had "not seen somebody shake like that in my experience." Tr. 624-
25.
---------------------------------------------------------------------------
The Respondent was able to produce only three controlled substance
order forms (DEA Form 222) that related to a two-year period of
practice, but even that modest number had one that did not contain all
the information required. Tr. 444, 446-48, 639-40. When he realized he
was unable to supply more than three Form 222s, the Respondent
contacted his controlled substance supplier and had company purchase
records faxed to his office for Brinks to review. Tr. 444, 638. The
Respondent did provide his dispensing logs, Tr. 563, but no controlled
substance destruction forms (DEA Form 41) or controlled substance
theft/loss reports (DEA Form 106).\12\ Tr. 443, 448-49.
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\12\ The Government's theory on noting the absence of theft/loss
forms was rooted in its concept that its audit demonstrated losses
that should have been noted by such documentation. As discussed in
some detail, infra, the quality of the audit results presented by
the Government in these proceedings renders the presence or absence
of theft/loss forms largely irrelevant here.
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After using the forms provided to conduct an audit that Brinks
characterized as "extremely short on * * * midazolam and * * *
fentanyl," the DIs asked the Respondent if he had a way of justifying
the shortages. Tr. 451. The Respondent responded that he had records
and controlled substances at an office in Avon. Tr. 451. After
completing their inspection of the Norwalk Office, the DIs traveled to
the Respondent's (unregistered) office at Avon, where they found
additional files and three-fourths of a bottle of fentanyl.\13\ Tr.
452.
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\13\ Brinks testified that the Avon practice is not a location
that is registered as a COR address that would be subject to an
inspection, and accordingly, the DIs remained in the Respondent's
waiting area, and were presented with the fentanyl and records by
the Respondent after he went into the practice portion of the office
by himself. Tr. 452-53.
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During the inspection of the Respondent's dispensing logs, DI
Brinks "observed * * * that [Respondent] had provided large quantities
of midazolam." Tr. 455.\14\ DI Brinks testified that he became
concerned "as soon as I started seeing 70 and * * * 100 [miligrams
administered]." \15\ Tr. 457. DI Brinks asked Peg Herner, a dental
assistant at Respondent's office, about doses of the medication that
the DI divined were excessive, and was told that "I just write down
what [the Respondent] tells me to write down." Tr. 456. After
consulting with Ms. Herner, DI Brinks asked the Respondent about the
midazolam prescribing, and the Respondent told him that the patients
"build up a tolerance." Tr. 457-58. At some point during this
conversation, DI Brinks questioned the Respondent about whether he was
abusing controlled substances, and the Respondent twice volunteered to
show the DIs his arms. Tr. 460, 621. When the Respondent pulled up the
sleeves of his lab coat, DI Brinks observed three or four small "poke
marks" on the left arm, but no bruising or scarring. Tr. 460-62.
Respondent said that the marks were caused by dental students he
allowed to practice IV techniques in a sedation class he taught at Case
Western Reserve School of Dentistry on Fridays. Tr. 462. The following
day, the DIs went to Case Western Reserve. Tr. 596. During their visit
the DIs encountered the Respondent and, at the request of officials at
the university,\16\ he invoked his right to an attorney. Tr. 596.
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\14\ DI Brinks clarified that "I know from experience * * *
what midazolam should be, what should be given before surgery." Tr.
455.
\15\ In his experience, DI Brinks had never "seen anything
close to 70 milligrams [administered] in one visit in one patient."
Tr. 456-57.
\16\ Tr. 707.
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As a result of his visit to the Respondent's practice, DI Brinks
concluded that Respondent violated the DEA's regulations by failing to
have a registration for his Avon Office. Tr. 640. DI Brinks also
concluded that Respondent had violated DEA regulations by failing to
maintain purchase records, and by failing to maintain accurate
dispensing records. Tr. 639-40. It was Brinks' recollection that he
informed the Respondent of "some of the record keeping issues [and]
the storing controlled substances at an unregistered location." Tr.
597-598. Brinks characterized the Respondent as "cooperative" during
the investigation. Tr. 603, 637.
Brinks also discovered evidence that unused controlled substances
that were left over in hypodermic needles at the conclusion of dental
procedures conducted at the Respondent's practice were being disposed
of by squirting them down the sink. Brinks explained that practitioners
are not routinely provided with written guidance by the local DEA
office on the issue of waste procedures authorized by the
regulations,\17\ and although there are options for compliance
(utilization of DEA-registered reverse distributors, Ohio Pharmacy
Board assistance, and providing medications directly to DEA),\18\ "a
large portion" of the practitioners he has inspected over the course
of his career dispose of residual controlled substance medication from
hypodermic needles by squirting it "either down the sink or the
toilet." Tr. 631.
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\17\ Tr. 630.
\18\ Tr. 630-33.
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During his testimony, DI Brinks attempted to explain the results of
his drug audit. Apart from individual doses of medications reflected in
the medication logs which, based on his experience, he concluded were
high, Brinks' testimony regarding his audit was confusing,
inconsistent, and unreliable. Brinks was unable to explain the data
that he had collected and compiled. Brinks had processed his findings
into a multicolor chart which he designed to compare the Respondent's
levels of midazolam dispensing at his private practices with levels he
dispensed at Case Western University School of Dentistry and the U.S.
Food and Drug Administration (FDA) recommended maximum dosages. Tr.
464-77. When the numbers on his proposed chart could not be reconciled
with the raw data he claimed to have based it on, the witness
acknowledged that he really had no idea what the chart (he created)
signified.\19\ Tr. 475. The data in Brink's audit computation chart
suffered from like blunders and was similarly excluded. Gov't Ex. 8
(ID); Tr. 478-90. An overnight break in the proceedings afforded the DI
the opportunity to make revisions on his initial, ill-fated computation
chart,\20\ but there were issues with the revised version as well.
Gov't Ex. 16; Tr. 583-
[[Page 72394]]
89, 610, 612-17. The DI's initial computation chart was ultimately
received into evidence at the behest of the Respondent. Resp't Ex. M.
Given the confusing nature of the Government's presentation and the
surprise nature of its revised audit results (generated during the
proceedings) the revised document, Gov't Ex. 16, was not considered to
establish its purported results in these proceedings.
---------------------------------------------------------------------------
\19\ Inasmuch as a sufficient foundation for admission could not
be established, the proposed exhibit was excluded from the record
upon a timely, cogent and correct objection. Gov't Ex. 9 (ID).
\20\ Tr. 488-90.
---------------------------------------------------------------------------
DI Brinks presented testimony that was detailed, plausible, and
generally credible. Ironically, the candor with which this witness
addressed some profound preparation errors actually enhanced his
credibility, even to the extent that it compromised his testimony's
effectiveness. The errata that marred the Government's evidence
regarding the audit of the Respondent's practice, although certainly
the product of self-inflicted wounds, did not bear the indicia of any
form of intentional malice toward the Respondent. Interestingly
however, they were clearly also not the result of a rush to justice. DI
Brinks testified that, after completing his investigation sometime in
March 2010, the investigation (and the collected data) lay dormant for
sixteen (16) months until approximately July of 2011, when this matter
was initiated.\21\ Tr. 599. During this time of investigative inaction,
the Respondent applied for, and on September 14, 2010 received, the COR
for his dental office in Milwaukee, Wisconsin. Tr. 601; Gov't Exs. 2,3.
That registration is also the subject of these proceedings. ALJ Ex. 1.
---------------------------------------------------------------------------
\21\ Brinks testified that he was working on another
investigation. Tr. 633-35.
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The Government also presented the testimony of Lili C. Reitz, the
Executive Director of the Ohio State Dental Board, the agency who
referred this matter to DEA. Ms. Reitz holds a law degree from the
Cleveland Marshall College of Law and formerly worked as an Assistant
Attorney General with the Ohio Attorney General's Office.\22\ During
her testimony, Ms. Reitz explained the permitting requirements for
conscious sedation versus general anesthesia for dentists in Ohio, and
testified that a records check she conducted informed that the
Respondent possesses the former permit, but not the latter. Tr. 374-83,
421.
---------------------------------------------------------------------------
\22\ Ms. Reitz's resume was received into evidence. Gov't Ex. 5.
---------------------------------------------------------------------------
Ms. Reitz also provided some background regarding the manner in
which the Ohio Dental Board executes its mandate to investigate
complaints of wrongdoing related to its licensed dentists. Tr. 384-85,
388. Ms. Reitz testified that she supervises a 15-person office that
investigates 500 to 1,000 complaints per year against the state's 7,000
dentists. Id. Furthermore, Reitz discussed her agency's practice of
sharing information with other law enforcement and regulatory
authorities, including DEA. Tr. 390-91.
Regarding the Respondent, Ms. Reitz testified to the results of the
Ohio Dental Board's investigation into Respondent's practice that
commenced upon the receipt of an anonymous complaint alleging that the
Respondent was using controlled substances from his practice at
home.\23\ Tr. 397-399. As a result of the complaint, the Ohio Dental
Board sent two of its investigators to the Respondent's practice to
conduct an infection control evaluation.\24\ Tr. 400. The Respondent
was not at the Norwalk office, so the Board investigators met him at
his Avon location. Tr. 401. The report of the Board's investigators
(which Reitz read from with no apparent knowledge beyond the four
corners of the document) indicated, inter alia, that they found an
unsecured plastic bin in the Respondent's office containing
medications, including fentanyl and Valium. Tr. 401-03. According to
Ms. Reitz, a complaint was subsequently filed by Ms. Crockett that
strongly resembled the anonymous complaint previously received
regarding the Respondent's alleged drug use. Tr. 405-06. Based on the
information they had at the time, the investigators interviewed Ms.
Crockett, and the matter remains under investigation. Tr. 408-12.
---------------------------------------------------------------------------
\23\ There was also testimony that in November of 2008 the Board
and the Respondent entered into a consent agreement related to an
issue that has no logical nexus to any issue germane to these
proceedings. Tr. 391-92, 394-96.
\24\ Reitz testified that an infection control evaluation
examines issues related to sterilization, infection control, and
licensing. Tr. 400.
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Ms. Reitz's testimony was sufficiently detailed, consistent, and
plausible to be afforded credibility,\25\ but the weight of her
testimony regarding the Board's investigation of the Respondent is
diminished by the reality that she was doing no more than relating the
results of a report prepared by her subordinates, and admitted that she
knew nothing more than (and could provide no insight beyond) the words
on the page of her investigators' report. Tr. 401-03. Thus, it would be
unreasonable to afford her testimony in this regard greater weight than
if the report upon which she so heavily depended (and which was her
constant companion on the stand) was admitted and considered without
her appearance.\26\
---------------------------------------------------------------------------
\25\ The Respondent's theory that the Board's investigation was
the result of bad blood that had its genesis in Reitz's disagreement
in the Respondent's support for state legislation regarding the
conduct of Board proceedings and a potential lawsuit was not
sufficiently developed on this record to affect Ms. Reitz
credibility. Tr. 414-17.
\26\ Although the Respondent, through counsel, noticed his
intention to call the Ohio Dental Board's case investigator as a
witness (ALJ Exs. 10, 12), the unrefuted testimony of record
establishes that he refused to tender the required witness fee to
the investigator. Tr. 417-21; 21 U.S.C. 876; Fed. R. Civ. P. 45; 28
CFR 76.25. Thus, the decision by the Respondent's counsel to forego
the opportunity to cross-examine the investigator bears the
hallmarks of a tactical election.
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The Government also presented affidavits and testimony from three
individuals who were employed at the Respondent's dental practice
during the events that form the basis of its current revocation
actions. The first of these former employees was Rebecca Crockett.\27\
Ms. Crockett testified that at the outset of her employment at the
Respondent's practice she was charged with the responsibility of
maintaining drug logs completed on patients during procedures, and with
alerting the Respondent when sedation medication stocks were dwindling
to a level where more needed to be ordered. Tr. 154, 182, 196; see also
Gov't Ex. 12 at 2. Crockett recalled no occasion during her tenure as
the drug-log custodian when controlled substances were missing or
unaccounted for,\28\ but did recall that Rebecca Tetzloff, an employee
who subsequently assumed responsibility for the drug log, approached
her with concerns about missing medication. Id. Crockett testified that
the Respondent maintained two Ohio offices; one at Norwalk and another
at Avon, and that she worked at both locations (which were each open
two days per week) and observed the Respondent transport controlled
substances to and from both practice locations. Tr. 154-58. The
controlled substances (lorazepam, diazepam, and fentanyl) were
transported on a cart that was loaded at the Norwalk office and driven
to the Avon office. Tr. 157, 186-88, 197. According to Crockett,
controlled substances were routinely stored in both the Norwalk and the
Avon offices. Tr. 156-57, 186-88, 197-98. Crockett stated that because
the daily preparations in the Avon office were frequently done in a
hurry, controlled substances were routinely left unsecured on top of a
sterilization room counter. Tr. 158. The sterilization room at the Avon
office although not locked, was located in an inner, treatment area of
the practice, to the rear of front reception desk, and was separated
from the patient waiting room
[[Page 72395]]
by some form of controlled-access door.\29\ Tr. 158-60, 210.
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\27\ Ms. Crockett's affidavit was received into evidence. Gov't
Ex. 12.
\28\ Gov't Ex. 12 at 2.
\29\ Notwithstanding some initial confusion on this issue, Tr.
160, 199, the witness ultimately and credibly testified that the
patients waiting to be seen were maintained on the other side of a
door that led to the waiting room. Tr. 200-01, 208-09.
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Crockett testified that she and other employees noticed marks on
the Respondent's upper extremities that they feared may have indicated
IV drug use on his part, and observed behavior on the part of the
Respondent that they communally deemed to be overly erratic, moody, and
emotional. Tr, 164-67. After discussing these observations amongst
themselves, they met with him as a group (in what some of their number
termed an "intervention") and received his assurance that he was
"getting help" for what ailed him. Tr. 164-67, 181, 202-03; Gov't Ex.
12 at 2-3. The Respondent did not share with the group what help he was
getting or what it was for. Id. Crockett related a 2009 incident where
she believed that the Respondent appeared to be intoxicated and/or
disoriented at the outset of a procedure \30\ and raised the issue with
the office manager, Christina Painley. Tr. 172-73, 202.
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\30\ Of particular concern to Crockett during this episode was
the Respondent's action in removing a hypodermic needle cap with his
mouth. Tr. 173, 201-02.
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Ms. Crockett testified that she voluntarily elected not to return
to her position at the Respondent's practice at the conclusion of a
period of maternity leave,\31\ due to her concerns regarding her safety
brought about by the Respondent's animated, angry outbursts, as well as
concerns she had for the Respondent's patients, based on her suspicion
that the Respondent was abusing sedation controlled substances
maintained in the office. Gov't Ex. 12 at 3; Tr. 167-69, 174, 190.
Crockett related that subsequent to her departure from the Respondent's
employment she filed for unemployment benefits and sent a letter to the
Ohio Dental Board outlining her suspicions regarding the Respondent's
drug abuse. Tr. 177, 206-07. Ms. Crockett testified that her letter to
the Dental Board was motivated by her concern for the safety of both
the Respondent and his patients. Tr. 177-79.
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\31\ Although the witness's affidavit fixes her resignation in
June 2009, Gov't Ex. 12 at 3, Crockett credibly testified that her
decision in this regard was made in September 2009, while still out
on maternity leave following the birth of her son. Tr. 191, 194-95.
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Ms. Crockett's testimony was sufficiently detailed, internally
consistent, and plausible to be relied upon as credible in this
recommended decision. No persuasive reason for her to fabricate
evidence against the Respondent has been offered into, or is supported
by, the current record.
The Government also presented the testimony and affidavit \32\ of
former employee Rebecca Tetzloff, who worked on the Respondent's staff
from March 2008 through October 2009. Gov't Ex. 10 at 1. Like Ms.
Crockett, Ms. Tetzloff testified that she worked at both the Norwalk
and Avon offices of the Respondent's practice, transported controlled
substances to the Avon office, and that the Respondent routinely
administered and stored controlled substances at the Avon office. Tr.
221, 223-27; Gov't Ex. 10 at 2. In fact, Ms. Tetzloff testified that
she actually maintained a log recording controlled substances stored at
Avon. Tr. 225-26. According to Tetzloff, before the Ohio Dental Board
insisted on the installation of a safe, controlled substances were
routinely kept at Avon in an intermittently-locked filing cabinet in an
arrangement that frequently yielded ready access to the keys that could
lock (or unlock) it. Tr. 227-32.
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\32\ Gov't Ex. 10.
---------------------------------------------------------------------------
Consistent with Crockett's testimony, Tetzloff recollected that
when controlled substances were unpacked at the Avon office, they were
left unsecured in the "rush, rush, rush" of setting up equipment at
the outset of the day. Tr. 233. According to Tetzloff, the controlled
substances (midazolam, diazepam, and fentanyl) would be transported to
Avon in a bin on a cart and left on a counter in the sterilization
room. Tr. 233-36.
At some point during her employment at the Respondent's practice,
Tetzloff was charged with the responsibility of accounting for the
controlled substances used and on-hand in the practice. Gov't Ex. 10 at
2. In the discharge of these duties, Ms. Tetzloff became concerned
about an apparent spike in the level at which office supplies were
requiring replacement, and began having trouble reconciling the
quantities of medications on hand. Tr. 237; Gov't Ex. 10 at 2. Ms.
Tetzloff tacitly acknowledged that this was a rather unscientific
process where, by the mere act of counting vials of medication, she
would somehow divine whether too many vials had been used based on her
expectation of how many vials should have been present, with no
appreciable expertise to appraise how many vials were used on the
procedures performed. Tr. 282-84, 291, 295, 307, 314-15. Tetzloff
recalled that on one occasion when she called the Respondent while he
was at his teaching position at Case Western Reserve University and
asked him about a particular controlled substance deficit, he informed
her that he had taken the medication with him. Tr. 237-38; Gov't Ex. 10
at 2-3. On another occasion, upon her arrival at the Norwalk office one
morning, Tetzloff discovered a vial of diazepam sitting unsecured on
top of the office safe. Tr. 241. When queried on the issue of why a
controlled substance was left out in the open in that fashion, the
Respondent's answer was merely to acknowledge what Tetzloff perceived
with her own eyes, without any attempt at explanation. Tr. 241-42. When
Tetzloff's suspicions grew, and she became increasingly concerned that
medications were not being effectively locked up in the Norwalk office,
she sought the advice of an attorney, who assisted her in drafting a
letter raising her concerns to the Respondent and seeking discharge
from her duties related to the accounting of office controlled
subsances. Tr. 238, 243-47, 296-97. Tetzloff credibly testified that
she presented the letter \33\ to the Respondent and a member of his
staff. Tr. 247-48; Gov't Ex. 10 at 3-4.
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\33\ Gov't Ex. 11.
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Tetzloff also related her recollection of marks on the Respondent's
upper extremities which she felt were suspiciously reminiscent of track
marks,\34\ as well as bouts of animated anger bursts, "irritability,"
\35\ and essentially eratic behavior \36\ during the work day on the
Respondent's part,\37\ all of which culminated in a staff meeting on a
Friday when no patient appointments were scheduled ("the
intervention"), wherein the Respondent
[[Page 72396]]
assured all present that he was seeking (unspecified) help that was
related, Tetzloff thought, to a depression condition. Tr. 223, 249-32,
255-60, 263, 285, 298; Gov't Ex. 10 at 4. According to Tetzloff, the
Respondent took a week-long vacation immediately after the meeting. Tr.
252.
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\34\ Ms. Tetzloff did not deem the Respondent's explanation that
his large dogs caused the marks by scratching his arms to be
particularly credible. Tr. 253-55.
\35\ Tr. 276-77.
\36\ Tetzloff also related an incident wherein, on some date
that she was unable to recall, she observed an uncapped hypodermic
needle on the floor of the van used by the Respondent and other
employees to transport medications and supplies between the Norwalk
and Avon offices. Tr. 268-272, 308-10. The evidence of record
indicates that the van routinely carried practice supplies,
including hypodermic needles, and also supports the proposition that
there were routinely multiple operators of the van. Tr. 269, 795-99.
Accordingly, the evidence does not impact upon any issue that must
be decided in these proceedings and was not considered in this
recommended decision. The same can be said of an alleged episode of
what Tetzloff perceived as erratic driving on the Respondent's part.
Tr. 272-74, 625-26, 799-801. These incidents, at least to the extent
they have been developed in the current record, simply have no
bearing on any issues properly before this tribunal.
\37\ Ms. Tetzloff acknowledged that although the Respondent was
"a demanding employer," that he is not the only dentist she knows
of who possesses that trait. Tr. 288.
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On the issue of disposal, Tetzloff recalled routinely squirting
controlled substances remaining in hypodermic needles at the conclusion
of procedures into the sink. Tr. 305.
Ms. Tetzloff, like Ms. Crockett, testified that she cared about the
Respondent, describing him as "a good surgeon" and "a very good
boss." Tr. 278. Ms. Tetzloff's testimony was sufficiently detailed,
internally consistent, and plausible to be relied upon as credible in
this recommended decision. No persuasive reason for her to fabricate
evidence against the Respondent has been offered into, or is supported
by, the current record.
The final former employee presented by the Government in its case-
in-chief was Dr. Brian Toth, D.D.S.\38\ Like the Respondent, Dr Toth,
is a DEA registrant and a licensed Ohio dentist in good standing. Gov't
Exs. 4, 13; Tr. 320-21, 337, 344. Although Dr. Toth's affidavit states
that he "worked at [Respondent's] Norwalk and Avon dental offices from
January 2009 through January 2010," Gov't Ex. 13, at ] 2, during his
testimony he agreed that the period of his employment could have been
from April 2009 through February 2010. Tr. 336.
---------------------------------------------------------------------------
\38\ An affidavit executed by Dr. Toth was received into
evidence. Gov't Ex. 13.
---------------------------------------------------------------------------
Also in his affidavit, Dr. Toth asserts that, "[f]rom my
observations, I believe that [Respondent] has injected himself with
fentanyl and Versed (midazolam). I base my belief on my training as
well as my observations of [Respondent's] erratic and aggressive
behavior, red eyes, mood swings, anger, frustration, and lack of care
while treating patients." Gov't Ex. 13, at ] 2. The affidavit also
identifies the following as alleged indices of drug abuse: (1)
Respondent's physical assault of Christina Painley; (2) track marks on
Respondent's arms; \39\ (3) "meth bugs," described as "scratching,
and sores about the wrists, arms, and head;" \40\ (4) an incident on a
undated Friday \41\ morning where Dr. Toth observed Respondent enter
the Norwalk dental office, appearing "[d]isheveled, out of sorts,
[and] wobbly," \42\ in "pajamas and flip flops," and walk in the
general direction of the office drug safe stating that he needed
antibiotics for a cold.\43\ Gov't Ex. 13, at ]] 3-4; Tr. 327-28. Toth,
like other witnesses, testified that the Respondent was prone to
"drastic mood swings" and "erratic behavior." Tr. 332.
---------------------------------------------------------------------------
\39\ In his testimony, Dr. Toth opined that the marks on the
Respondent's arm bore the appearance of IV drug abuse, not the marks
of a teacher allowing students to practice IV insertion techniques.
Tr. 326. In view of the absence of any foundation for Dr. Toth's
expertise in this area, this testimony has been afforded no weight
in this recommended decision.
\40\ Dr. Toth testified that he has never tried methamphetamine.
Tr. 347-48. In view of the absence of any foundation for Dr. Toth's
expertise in this area beyond spending time at a rehabilitation
clinic related to other substances, Tr. 326-27, this testimony has
been afforded no weight in this recommended decision.
\41\ Though Dr. Toth's identified the incident as occurring on a
Saturday morning, during the administrative hearing he clarified
that the incident occurred on a Friday. Tr. 327, 361-62.
\42\ Tr. 330.
\43\ Dr. Toth found this explanation implausible because
"antibiotics are not used to treat colds," and because "the
Norwalk office did not store antibiotics in the drug safe." Gov't
Ex. 13, at ] 4.
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Toth's affidavit also described a post-DEA inspection restaurant
interaction wherein the Respondent purportedly confessed to Toth that
he was taking Valium \44\ as a sleep aid, and subsequently told him
that adjustments were being made to office controlled substance records
to shield the losses from DEA scrutiny. Gov't Ex. 13 at 3. When pressed
on the issue, however, Dr. Toth was not at all clear on whether the
incident happened before or after DEA's involvement in the case. Tr.
353-56.
---------------------------------------------------------------------------
\44\ Valium is a brand of diazepam tablets. See 6-V Attorneys'
Dictionary of Medicine V-121686.
---------------------------------------------------------------------------
Dr. Toth testified that he is a recovering alcoholic and cocaine
addict, and that he has been "clean and sober" since 2006. Tr. 322-
23. Notwithstanding the witness's unambiguous assurance of his
uninterrupted recovery and sobriety, when confronted with documentation
concerning his April 2011 convictions for disorderly conduct/
intoxication and marijuana possession,\45\ Dr. Toth conceded that he
had been arrested and pled guilty to those offenses. Tr. 337-44, 346.
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\45\ Resp't Exs. K, L.
---------------------------------------------------------------------------
The issue of Dr. Toth's success at his substance abuse recovery
efforts (at least on the present record) is, without question, a
collateral issue. However, when Dr. Toth volunteered, under oath, that
he had been clean and sober since 2006, and then grudgingly
acknowledged marijuana and alcohol-related convictions seven months
prior to the commencement of the hearing, he deprived his own testimony
of any measure of credibility in these proceedings.\46\ Simply stated,
Dr. Toth is not a person who is willing to provide candid and truthful
testimony under oath, and in those instances where his account
conflicts with other credible evidence of record it cannot be believed.
Thus, his testimony cannot be afforded weight in supporting a
substantial-evidence finding by this recommended decision and
ultimately, by the Agency. Furthermore, inasmuch as he was unable to
supply virtually any temporal details of the factual events he
described, and his purported observation of a "disheveled" and
"wobbly" Respondent standing in his own office, on some unspecified
date, headed in the general direction in his office where controlled
substances were stored, would (even if deemed credible) shed no light
on anything that must be decided in this case, the absence of his
testimony here will be of no moment.
---------------------------------------------------------------------------
\46\ In like fashion, when cross-examined about (mostly
irrelevant) statements he purportedly placed on a Facebook page, Dr.
Toth initially denied having such a page during the relevant period,
and then conceded that he did. Tr. 347-50. In this manner, Toth once
again managed to morph irrelevant matter (the arguably unsavory
comments he posted on his Facebook page) into a relevant issue (his
disinclination to provide accurate testimony under oath).
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The Government also presented the testimony and written report,\47\
of Daniel Becker, D.D.S. Dr. Becker,\48\ currently serves as an
Associate Director of Education in the General Dental Practice
Department at Miami Valley Hospital, in Dayton, Ohio, is an Associate
Editor of Anesthesia Progress for the American Dental Society of
Anesthesiology, and also serves as an Adjunct Professor of Life and
Health Sciences at Sinclair Community College in Dayton, Ohio. Gov't
Ex. 14. Additionally, Dr. Becker is the Chairman of the Human Patient
Simulation Training Subcommittee at the American Dental Society of
Anesthesiology. Id. Dr. Becker also testified that he teaches
intravenous sedation techniques to dental residents, and is actively
engaged in the practice of IV sedation to patients at numerous dental
practices in Ohio. Tr. 32. Dr. Becker was received without objection as
an expert in the practice of general dentistry in regards to
pharmacology, sedation, and anesthesia. Tr. 29-30.
---------------------------------------------------------------------------
\47\ Gov't Ex. 15.
\48\ This Dr. Becker is not related to the Respondent.
---------------------------------------------------------------------------
In his testimony, Dr. Becker (like Ms. Reitz) explained that in
Ohio there are two varieties of dental sedation that are sanctioned by
state law, with separate practitioner permits specified for each type.
A "conscious sedation permit," is required to sedate a patient to a
depth where the patient is capable of being aroused, that is capable of
responding to verbal commands. Tr. 41, 71. A "deep
[[Page 72397]]
sedation/general anesthesia permit," in contrast, is required to
sedate a patient to unconsciousness. Tr. 42. A conscious sedation
permit may be obtained by a dentist after the completion of a course on
the subject, while a deep sedation/general anesthesia permit requires
the successful completion of a year-long residency. Tr. 41-42, 44-45.
Becker testified that where general anesthesia is utilized,\49\
additional personnel and monitoring equipment normally will be
required. Gov't Ex. 15 at 1; Tr. 62-64, 85-86.
---------------------------------------------------------------------------
\49\ Dr. Becker testified that sedation in excess of conscious
sedation is generally utilized in cases involving special needs,
such as physically or mentally handicapped patients. Tr. 76.
---------------------------------------------------------------------------
At the Government's request, Dr. Becker reviewed forty-three
records of IV sedation \50\ that had been administered by the
Respondent and found all but one of the records were below "the
standard of practice" because they did not reflect current vital signs
or actual time at the time the medications were administered. Gov't Ex.
15 at 1. Dr. Becker's report further identified 17 patient charts which
he found to be "egregious." Id. The report also sets forth Becker's
expert opinion that the doses recorded in the charts he reviewed were
sufficiently high that, at least in his view, monitoring, staff,
equipment, and general anesthesia training beyond what was apparent in
the reviewed documents would have been required. Id. Becker noted that
despite what he characterized as "staggering doses," the records he
evaluated reflected only four occasions where reversal drugs were
administered, and that the records reflected none of the complications
such as hypotension or respiratory arrest that he would have expected
to encounter with doses at those levels. Id. At 2. In Becker's opinion,
"[t]his raises a question as to whether these doses were actually
administered [because] [f]ollowing these dosages, serious complications
would most surely have been encountered." Id.
---------------------------------------------------------------------------
\50\ Dr. Becker testified that it was common practice among
dentists to have these records completed by staff members during
dental procedures. Tr. 146-47. This is consonant with the testimony
of Ms. Crockett that office staff merely acted as a scrivener with
regard the document, entering the numbers dictated by the
Respondent. Tr. 183-85.
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According to Dr. Becker, in most cases where midazolam is used for
conscious sedation, the required level of sedation could be obtained by
10 mgs or less, but that more midazolam might be needed for a longer
appointment.\51\ Tr. 58-60. Dr. Becker further testified that a
patient's resistance to midazolam could alter the amount of drug
necessary to achieve the desired sedation. For example, Dr. Becker
opined that for a "fairly resistant" patient, twenty to thirty
milligrams of midazolam might be necessary for a 3-4 hour procedure,
and that there are some patients who are simply not sedatable with this
medication.\52\ In Becker's opinion, however, those cases that require
the higher doses and demonstrate resistance are rare. Tr. 60-61.
Midazolam, according to Dr. Becker, is administered in one-to-two
milligram increments to achieve the desired level of sedation. Tr. 62.
A five-miligram increment would cause a patient to lose consciousness,
which in turn risks throat obstruction and breathing impairment. Tr.
62. Becker explained that it is for these reasons that procedures where
general anesthesia is employed require additional staffing (of at least
one additional person) during the procedures to monitor the patient
breathing and EKG \53\ via precordial stethoscope or capnography. Gov't
Ex. 15 at 1; Tr. 62-64, 85-86.
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\51\ Dr. Becker's difference of professional opinion with the
Respondent's practice regarding the relative merits of combining
midazolam and diazepam versus increasing the doses of those
respective medications, Tr. 77-78, 731-32, 735; Gov't Ex. 15 at 1,
does not provide any insight on the issue of diversion risk or
whether the Respondent's continued DEA registration is inconsistent
with the public interest, and has played no part in this recommended
decision. See Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
\52\ Dr. Becker testified that the sedation logs reflect
medication given, but ordinarily do not reflect any rationale for
higher-than-normal doses of sedation medication or sufficient data
from which that decision could be extrapolated. Tr. 66-67, 74, 76-
77.
\53\ During his testimony, the Respondent stated that his
patients were routinely monitored by EKG and pulse oximeter. Tr.
736.
---------------------------------------------------------------------------
Dr. Becker identified seventeen records of Respondent's sedation
dispensing that he characterized as egregiously below the expected
standard of care. Gov't Ex. 15 at 1. Among these seventeen records are
instances where: (1) A patient was administered 55 mgs of midazolam and
200 micrograms of Fentanyl over a span of 15 minutes; (2) a patient was
administered 40 mgs of midazolam, 40 mgs of Diazepam and 100 mcgs of
fentanyl over a span of approximately 15 minutes; (3) a patient was
administered 30 mgs of midazolam, 10 mgs of diazepam and 100 mcgs of
fentanyl over a span of approximately a minute; and (3) a patient was
administered 100 mgs of midazolam, 70 mgs of diazepam and 200 mcgs of
fentanyl over a time span of approximately 90 minutes. Id. In his
report and his testimony, Becker affirms that the medications in these
doses would have rendered the patients unconscious. Id. at 1; Tr. 79,
84-85, 87-89. Becker's view is that sedation to unconsciousness was not
an intent supported by the records he reviewed, as evidenced by the
lack of additional professional monitoring staff, and would have
required the deep sedation/general anesthesia permit that the
Respondent does not possess. Tr. 85-86; Gov't Ex. 15 at 1.
Dr. Becker testified that, absent some type of resistance to
midazolam, the doses identified in his expert report would
"predictably" produce unconsciousness." Tr. 84. However, Dr. Becker
noted that such resistance, while possible, is "rare," and that over
thirty years of practice he had not seen as many resistant patients as
Respondent's patient records appeared to contain during a relatively
brief period. Gov't Ex. 15 at Tr. 84-85. Assuming that not all the
patients in the charts analyzed were resistant, Dr. Becker testified
that the sedation records reflected a treatment regime below the
standard of care for moderate sedation. Becker opined that there were
simply too many patients receiving deep-sedation levels of medication
during the time he analyzed Respondent's records to attribute that
number to medication resistance. Tr. 84-85. Although Becker identified
four occasions where medication reversal drugs were administered by the
Respondent, the records shed no light on whether that was done pursuant
to persistent somnolence or some other complication. Tr. 112-13.
Finally, Dr. Becker provided his conclusion that based on the
likelihood of widespread unconsciousness among the patients, the
Respondent's lack of training and certification in general anesthesia,
the lack of complications documented in the record regarding breathing
obstruction, he entertains serious questions as to whether the amounts
of controlled substances documented in the sedation reports were
actually administered to the enumerated patients. Tr. 90-92. In
Becker's view, since these high levels of medications were unlikely to
have been administered to this number of patients without evidence of
adverse effect, either the sedation records he reviewed were simply
erroneous, or the medications listed in those records were not
administered as documented and something else became of them. Tr. 93.
Dr. Becker testified that the "staggering" doses of controlled
substances reflected as administered in the sedation records he
reviewed support his conclusion that the Respondent's handling of
controlled substances was "below the standard of practice." Tr. 94-
95.
[[Page 72398]]
At one point during his testimony, Dr. Becker conceded that on one
occasion medication was drawn for a patient \54\ who did not appear for
treatment, and the medication was disposed of. Tr. 115-17. In an
unfortunate choice of words employed during his re-evaluation of
whether the record relating to the drawn and discarded medication was
comparable to the other records he characterized as "egregious," Dr.
Becker stated that although he still found the practice of drawing
sedation medication prior to patient arrival "strange," "odd," and
"funny," he believed that he "should be punished" for his initial
characterization. Tr. 117-23. Nonetheless, Dr. Becker stated that the
practice of drawing medication prior to the arrival of a patient did
not impact on documentation obligations, and did not fall below an
acceptable level of practice. Tr. 145, 123.
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\54\ The Respondent testified that this patient did not appear
for her appointment. Tr. 784-85.
---------------------------------------------------------------------------
On the issue of the "track marks" that were purportedly seen on
the Respondent's arms by his staff, Dr. Becker acknowledged that, as
part of his teaching responsibilities, he instructs students on
establishing IV access. Tr. 33. Consistent with the position taken by
the Respondent, Dr. Becker testified that he does allow patients to
practice IV insertion on himself, including on the backs of his hands.
Tr. 33-34, 135. Becker conceded that some days the practice attempts by
his students have him resembling a "pin cushion," \55\ but he
described the needle punctures routinely made on arms by the relatively
small needles handled by students in his class, which in his view,
"generally [does not] leave much of a mark." Tr. 34. Dr. Becker also
explained that a "difficult attempt" by a less skilled individual can
result in a hematoma, or bruise. Tr. 34-35. Dr. Becker testified that
the scars generally referred to as "track marks" are the product of
repeated attempts into the same veins by habitual drug abusers. Tr. 37-
38. According to Dr. Becker, those experienced teachers who allow their
students to practice venipuncture on them in class minimize the risk of
scarring by requiring their students to avoid repeated attempts at the
same location. Tr. 37-38. It is Dr. Becker's opinion that poorly-done
clinical attempts at IV insertions by students are more likely than
drug use to produce bruising. Tr. 39. A bruise left by an improper IV
insertion could last for "several" days. Tr. 40.
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\55\ Tr. 135.
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Notwithstanding the Government's posture that the Respondent has
violated the regulations by squirting controlled substances remaining
in the hypodermic needles after procedures into the sink, Becker (the
Government's own expert) testified that this is his practice as well.
Tr. 55-58, 100-01. Furthermore, Dr. Becker expressed agreement with the
Respondent's expert that the DEA regulations on disposal are unclear.
Tr. 105.
On the issue of whether the observations of the Respondent's
moodiness, grouchiness, and erratic behavior support the concerns of
his former employees that he was abusing the controlled substances
acquired for procedures in his practice, Dr. Becker testified that an
individual under the influence of midazolam would likely exhibit
symptoms of lethargy or calming. Tr. 69, 71. Thus, none of the
characteristics highlighted by the Respondent's former employees in
their testimony or during the "intervention" conducted in his office
support an inference that the Respondent was abusing the controlled-
substance medications he employed to sedate his patients.
Dr. Becker was by no means an ideal expert witness. He was vague
about the method that his "most egregious" list of cases were
selected, and retreated from his designation of one case as egregious
by the flip remark that he "should be punished" \56\ for his initial
opinion in this regard. Still, his testimony was sufficiently
authoritative, consistent, and reasonable that it will be credited and
afforded significant weight in this recommended decision.
---------------------------------------------------------------------------
\56\ Tr. 117-23.
---------------------------------------------------------------------------
The Respondent's case-in-chief consisted of his own testimony and
an affidavit from Dr. Joel Weaver, D.D.S., Ph.D., an individual he
previously noticed as an expert witness. The affidavit executed by Dr.
Weaver was admitted on motion and without Government objection during
the hearing. Resp't Ex. J.
According to his curriculum vitae, Dr. Weaver served from 1981-
2006, as a professor in the Department of Anesthesiology at the Ohio
State University. Resp't Ex. G, at 1. He holds a Bachelors of Science
from Ohio Northern University and a D.D.S., from the Ohio State
University College of Dentistry. Resp't Ex. G, at 1. Additionally, Dr.
Weaver has completed residencies at the Ohio State University in both
Anesthesiology and in Ambulatory General Anesthesia and Sedation. Id.
Dr. Weaver also holds a Ph.D. in pharmacology from the Ohio State
University, and has been previously certified as a pharmacist in
Ohio.\57\ Resp't Ex. G.
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\57\ Although initially noticed as an expert witness by the
Respondent, Dr. Weaver was never called as a witness at the hearing.
the Respondent's counsel, citing a logistical issue, represented
that Dr. Weaver was unavailable, and that this information only
became available to counsel on the eve of the commencement of the
hearing. Tr. 9. Accepting counsel's representation of late notice of
Dr. Weaver's availability, it is not insignificant that no
continuance request or other accommodation (such as video
teleconferencing) was requested by the Respondent to facilitate the
witness's testimony. A perhaps unintended consequence of what may
well have been a tactical decision on the part of the Respondent and
his counsel, is that Dr. Weaver was never offered or accepted as an
expert in anything during the proceedings. Confounding the issue
further, the Government's expert, Dr. Becker, conceded that Dr.
Weaver is "well more experienced" than he is in terms of both
training and experience. Tr. 106. DEA's regulations comport with the
generally reasonable notion that information received through
affidavit must be weighted consistent with the opposing party's lack
of cross examination ability. 21 CFR 1316.58 ("Affidavits admitted
into evidence shall be considered in light of the lack of
opportunity for cross-examination in determining the weight to be
attached to the statements made therein.") Accordingly, as the
record now stands, the Government's expert testified that Dr. Weaver
is a superior expert, but no one has offered him to the tribunal as
such, and the Government, by surprise at the outset of the hearing,
has not been afforded any manner of cross-examination. Still, the
Government consented to the admission of Dr. Weaver's affidavit, and
did not make any attempts to compel his appearance by process.
---------------------------------------------------------------------------
In his affidavit, Dr. Weaver described what he characterized as a
"concern * * * as to the proper procedure to dispose of injectable
drugs remaining when perhaps 5 [milliliters' (ML)] is drawn into a
syringe but only 4 ML is actually injected into the patient's
[intravenous (IV)]." Resp't Ex. J at ] 2. Although Dr. Weaver's report
did not address a practitioner's obligation to comply with regulatory
requirements under 21 CFR 1307.21,\58\ after providing some anecdotal
evidence relative to logistical concerns attendant upon disposal
issues, his affidavit set forth his view that:
[t]he standard practice among dentists in Ohio * * * is for the
dentist to log the dose of the drug taken from his inventory, record
the dose given to the patient in the patient sedation/anesthesia
record and record any "wasted" doses in either the drug log, the
patient's anesthesia record or both as soon as the case is
concluded. The "wasted" drug is typically squirted into the sink
(no longer politically correct because of community water trace
contamination), into the trash or sharps container, or into the soil
of potted plants as a source of nitrogen-containing
---------------------------------------------------------------------------
\58\ The obligation to interpret the law and regulations falls
squarely within the purview of this tribunal initially, and then
secondarily with the Agency. Dr. Weaver's purported legal analysis
of the regulations and DEA's interpretation of the applicable
requirements has been accepted into evidence without objection as
part of the affidavit he prepared, but cannot control the legal
analysis employed by this recommended decision.
---------------------------------------------------------------------------
[[Page 72399]]
fertilizer. Some practitioners have a witness initial the record of
"wasted drug."
Resp't Ex. J, at ] 5.
Dr. Weaver also provided his opinion regarding what he
characterized as "mobile sedation and anesthesia practitioners."
Resp't Ex. J, at ] 9. In essence, the practice of mobile sedation and
anesthesia is where a practitioner has "one permanent office address
where they do business and that is where they are registered for their
DEA license. They order, receive, and securely store controlled
substances at that single address and maintain all drugs logs and
patient records at that one office location." Resp't Ex. J, at ] 10.
The practitioner will then administer the drugs at various dental and
medical offices where anesthesia or sedation might be required. Id. In
any year, a mobile anesthesiologist "may service more than 50-100
offices." Id. In light of the foregoing, Dr. Weaver opines that "[i]t
would be impractical if not impossible for the anesthesiologist or
other healthcare worker to have a separate DEA license for every
location they service so long as the drugs and records are not stored
at those multiple locations but rather at their single office
location." Id., at ] 11. Inasmuch as the Government has not alleged
that the Respondent was required to obtain a COR to take controlled
substances to varying locations and return and store them as required,
Dr. Weaver's endorsement of such a procedure adds nothing here. The
Respondent is alleged to have administered and stored controlled
substances at an unregistered permanent private practice, a scenario
which Dr. Weaver, even if assumed competent to express a view on a this
issue of law, did not address.
While Dr. Weaver's qualifications are doubtless impressive, even
setting aside the absence of any foundational predicate for the
presentation of expert opinion, his affidavit provides no expert
opinion that sheds light on any issue that must be decided by this
recommended decision. However, his observation that his experience that
Ohio practitioners routinely dispose of small amounts of residual
controlled substance by squirting into drains all over the state is
consistent with the testimony provided by the Government's expert, its
investigator, and its lay witnesses, and will be credited in these
proceedings. Weaver's opinion concerning the wisdom or logistical
practicalities of the relevant DEA regulations regarding the authorized
manner of controlled substance disposal have been afforded no weight
whatsoever.
The Respondent testified on his own behalf at the hearing.
According to the Respondent, he holds a Bachelor of Arts from the
University of Toledo and a D.D.S. from the Ohio State University.\59\
The Respondent also holds a certificate in periodontics from the Case
Western Reserve University School of Dentistry, a certificate in Zygoma
Implant placement from the Northwestern School of Dentistry and a IV
certification from the University of Southern California School of
Dentistry, and from 1996 through the present he has maintained a
private practice in Norwalk and Avon, Ohio.\60\ Id. Respondent
testified that he limits his dental practice to the field of
periodontics, "which involves bone grafting, dental implants [and] gum
and bone surgery." Tr. 656. The Respondent testified that because many
of his patients "are very apprehensive in regards to that type of
procedure," IV sedation is a "critical component" of his practice.
TR. 660.
---------------------------------------------------------------------------
\59\ The Respondent's CV was received into evidence. Resp't Ex.
E.
\60\ The Respondent testified that he also owns a dental clinic
at his registered location in Milwaukee, but does not practice IV
sedation at that location. Tr. 661-64; see also Gov't Ex. 2.
---------------------------------------------------------------------------
The Respondent testified that his practice is "all referral-
based," and he receives referrals of patients who require treatment
"that's a little bit more advanced" and who sometimes present "very
difficult cases." Tr. 657-58. When asked to explain what he meant by
"very difficult cases" and "more advanced" treatment, the
Respondent clarified that he was referring to the fact that there was a
limited number of periodontics specialists in the geographic area of
his practice, and these were patients who required treatment in that
specialty. Tr. 658. The Respondent stated that there was also a limited
number of dentists in his geographic area who practiced conscious-
sedation dentistry. Tr. 659. Thus, from the Respondent's testimony it
is clear that it was not that periodontists were referring difficult
patients to him who were difficult to anesthetize, but that dentists
were referring patients his way who simply needed periodontic treatment
or desired conscious sedation within the Respondent's geographic area.
Tr. 749. Thus, the Respondent's assertion that higher doses are
required because he is a specialist is a non sequitur.
The Respondent subsequently diminished his credibility even further
on the issue of patient resistance. When asked about Dr. Becker's
assertion that the sedation logs from the Respondent's practice that he
examined had more allegedly sedation-resistant patients than he had
encountered in his thirty years of practice, the Respondent stated that
Becker's opinion was borne of the fact he is a "general dentist," and
not a specialist, such as the Respondent. Tr. 748-49. The problem here
is that Dr. Becker (whom the Respondent acknowledges knowing on a
professional basis even before the proceedings began),\61\ testified
that his entire practice is focused on the administration of conscious
sedation to patients for other practitioners. Tr. 23. Again, the
Respondent seeks to confuse the difference between the specialization
required to perform periodontic dental work with some special expertise
in hard-to-sedate patients.\62\
---------------------------------------------------------------------------
\61\ Tr. 747-48.
\62\ Even temporarily suspending for a moment the undisputed
reality that the Government's expert practices exclusively in the
area of conscious sedation for dentists and sees all manner of
patients, had the Respondent taken the view that the seemingly high
doses were attributable to nothing more than a simple difference of
opinion between professionals his position would have been likely
more effective, and certainly less revealing on the issue of
credibility than the analytical red herring of widespread
resistance.
---------------------------------------------------------------------------
When queried on the issue of whether his doses were high compared
to other practitioners, the Respondent acknowledged that his former
instructor, and the author of the textbook he uses in connection with
his teaching responsibilities, suggests that the range of acceptable
midazolam doses of 2.5 to 7.5 milligrams. Tr. 732-33. The Respondent
even acknowledged that one patient received 70 milligrams of the
medication during a procedure, an amount that the even the Respondent
characterized as "a large amount." Tr. 743, 745. Another 100
milligram dosage was also acknowledged as "high" by the Respondent.
Tr. 754. The Respondent also agreed with the Government's expert that
his sedation records reflected "a high proportion of [sedation-]
resistant patients." Tr. 734. The explanation that the Respondent
volunteered for this phenomenon served him worse than if he had
remained silent on the point. The Respondent stated:
Like I had stated earlier, I am a specialist, all right. I get
cases sent to me that a lot of other people cannot handle, and so
that is not unusual. I've got a lot of medically compromised
patients that do come in the door for services, because other
general practitioners are not comfortable handling those patients.
Tr. 734 (emphasis supplied). While it is unquestionably true (as
acknowledged elsewhere in this recommended decision) that decisions
regarding
[[Page 72400]]
medical care which are unrelated to the issue of diversion are beyond
the jurisdiction of DEA,\63\ the Respondent attempted to explain the
high (by his own admission) doses he administered by positing that as
he had explained earlier, because he was a specialist he utilized
higher levels of medication on his patients, which tended present more
difficult cases. Id. Even a cursory review of what he had "stated
earlier" in his testimony reveals that he gets periodontic referrals
because there are not many periodontists near him, not that he gets
unsedatable patients who must routinely be sedated with copious amounts
of controlled substances. Tr. 749. His testimony in this regard was
misleading. The Respondent was attempting to blur the line of his
specialization in periodontics and conscious sedation with a
hypothetical expert practitioner who is routinely sought by others in
his field to consciously sedate patients who had been previously found
difficult to sedate. This attempt to muddle the record did not enhance
his credibility and has drawn attention to an issue that might
otherwise have lived in benign, analytical obscurity.
---------------------------------------------------------------------------
\63\ See Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
---------------------------------------------------------------------------
The Respondent, the holder of an Ohio-issued conscious sedation
permit, testified that he monitors his IV sedation patients "under an
EKG strip, as well as a pulse oximeter," and he unambiguously stated
that among the sedation records reviewed by the Government's expert,
Dr. Becker, all patients remained conscious during the sedation
employed in the procedures. Tr. 736-37. In fact, the Respondent
followed up this response with an unsolicited, detailed explanation of
the reasons he is confident that all patients were conscious. Tr. 737-
38. The Respondent declared that "if you were to ask my staff, they'll
tell you nobody has ever been out of consciousness in my office." Tr.
755. When pressed on the issue of the level of medication of one
patient in particular, the Respondent replied:
This patient, I can't tell you if this person was on a Fentanyl
patch, which might require more medications. I can't tell you if
this patient has had multiple IVs at other locations. Multiple
occasions of having drugs such as benzodiazepines in your body, you
develop a cellular adaption, all right. What happens is your
metabolism becomes a tolerance to that, and so what happens, it
takes more of the drug to get the same type of effect that you did
maybe from the first time that you ever used that drug. So I have--
based on not having the medical history from the patient's chart
here, I can't answer anything else other than that. This patient is
not dead.
Tr. 742. One problematic aspect of the Respondent's explanation is that
as the custodian of his own patient charts, contrary to his testimony,
he is the one person who actually could have authoritatively and
conclusively divined all these factors about these patients, but chose
not to do so. Tr. 746, 749-51, 807. Another possible explanation
offered by the Respondent is that some of his patients were well-to-do,
elective surgery veterans who may have had sedation for other elective
surgeries in the past. Tr. 750-51. Yet another possible explanation
offered by the Respondent is that some of his patients may have had
histories of drug abuse that they were reluctant to share.\64\ Tr. 758.
The Respondent's election to spin all manner of hypothetical
contingency to provide potential explanations for the dosing levels is
a tacit acknowledgement that his dosing levels were so high that they
actually did require additional explanation; a proposition that he
eventually conceded. Tr. 750. The point is hammered home by the
Respondent's terse conclusory assurance that the patient did not expire
as a result of his sedation procedures. Id. If, as it seems from the
Respondent's lengthy diatribe on the subject, the only possible
explanation in the high dosage levels lies in extraordinary
contingencies, it would seem reasonable that these contingencies would
be at his disposal to produce. Another problematic issue is that the
sedation logs associated with these high-dose patients note no current
medications in the block designated for that purpose. Tr. 742, 747,
758. This is another example of the Respondent's answer raising the
relative importance of an inquiry that easily could have remained in
the shadows.
---------------------------------------------------------------------------
\64\ In response to a series of leading questions posed by his
counsel, the Respondent also suggested that obesity, age, and past
surgical history could also be contributing factors to the high
dosage levels that the Respondent was routinely using on his
patients. Tr. 805-06. The Respondent also mentioned diabetes and
smoking. Tr. 806. Informative as this list may have been, the record
contains no evidence that so much as a single patient described in
the sedation logs was impacted by any of these factors.
---------------------------------------------------------------------------
The Respondent's account of DI Brinks' May 2009 visit to his
Norwalk office was generally consistent with Brinks' version. Tr. 671-
79. It was the Respondent's recollection that when Brinks suggested his
own drug use as a source for shortages,\65\ he not only offered his arm
for inspection, but also offered to submit to a urinalysis.\66\ Tr.
676-79. Consistent with Brinks' testimony, the Respondent recalled
volunteering during the visit that he also was operating a practice in
the Avon, Ohio \67\ where controlled substances were stored and
dispensed. Tr. 677-78.
---------------------------------------------------------------------------
\65\ The Respondent also recalled that DI Brinks similarly
accused his office manager of abusing controlled substances that
were not accounted for in the paperwork presented. Tr. 679-80.
\66\ The Respondent testified that he has been randomly drug
tested about once a year by Fisher Titus Hospital without positive
results. Tr. 709, 730, 761-62.
\67\ The Respondent testified that separate controlled substance
sedation logs were maintained at the Avon office. Tr. 694.
---------------------------------------------------------------------------
The Respondent provided additional insights into potential
distractors that existed at the time of the DEA inspection, such as his
heavy patient traffic on the day of the visit and his high level of
other professional commitments during that period in his career. Tr.
664-67, 676. Of even greater import, was the Respondent's account of
his treatment for a mental health issue during this time. The
Respondent initially sought treatment from his physician, progressed
through a therapist, and ultimately sought the aid of a psychiatrist.
Tr. 686-88, 726-28. The Respondent recounted various medications
prescribed to address his mental health symptoms, and how, in March-
April 2009, one attempted course of prescribed Lamictal landed him in
the Cleveland Clinic to address a medication-caused decompensation. Tr.
686-89. This setback resulted in the Respondent taking a week off from
work. Tr. 689-90. The Respondent also discussed the frustrations
associated with the trials of psychiatric medication and side-effects
that included concentration diminishment and mood lability. Tr. 689-92.
The Respondent recalled the Friday morning meeting that his staff has
euphemistically dubbed an "intervention." Tr. 786. According to the
Respondent, the term "intervention" was not utilized, suspicions of
drug abuse on his part were never discussed, and the meeting was a
vehicle to notify that staff that he would be out of the office for a
week, a necessity precipitated by his adverse reaction to Lamictal. Tr.
786-87. The Respondent described how his professional commitments
caused stress that, at least in his view, contributed to his mental
health difficulties, and that some of this was ameliorated when he
retreated from his teaching responsibilities at Case Western in 2010.
Tr. 690-91.
The Respondent commendably took the evidence of what his former
staff members considered erratic behavior head on, and acknowledged
that he is "a
[[Page 72401]]
very hard person to work for," and that he has thrown surgical
instruments in the past, and has yelled at more than one employee
during his career as a dentist. Tr. 790-92. On the subject of his late
morning arrival and puncture wounds on the tops of his hands on a day
where he was not teaching at Case Western, the Respondent offered no
explanation, other than his assertion that he is "a picker," who
picks at the skin on his head, and that he has a playful, large
Newfoundland dog. Tr. 792-94.
Regarding the allegations that controlled substances were
periodically unsecured at the Avon office, the Respondent testified
that it was the practice of his office to transport controlled
substances to the Avon Office in a bin about the size of a shoe box.
Tr. 768-69. The bin was taken into the sterilization room of the Avon
Office by a cart, and staff members were "supposed to put [the
controlled substances] on [the Respondent's] desk [where] they get
locked." Tr. 768-69. Despite this policy, the Respondent did not
dispute that controlled substances were left on the counter, or that
they may have been left on the counter when the Ohio Dental Board
investigators conducted their inspection. Tr. 770, 772-74. However, the
Respondent claimed that "at some point [the drugs] would have gotten
to my office." Tr. 770.
Although the Respondent acknowledged that he teaches his students
to simultaneously record amounts of controlled substances utilized
during conscious sedation procedures on the form designed for that
purpose, his own practice was to write the administered doses on a
paper towel and transfer those numbers to the sedation logs later. Tr.
680-84. Curiously, the Respondent's testimony diverged from that of his
testifying staff members to the extent that they were unambiguous and
unanimous in their assertion that when completing sedation logs they
acted as scriveners, merely recording the amounts of medication that
the Respondent called out.\68\ The Respondent, for his part, claims
that the staff members independently divined the medication amounts by
their own examination of the syringes while the procedures were in
progress and entered those values onto the sedation logs without his
input. Tr. 695-97, 743. But in earlier testimony, when describing his
paper-towel procedure, he employed the word "we" when describing the
manner in which the amounts were recorded. Tr. 680-84. If a staff
member were the sole individual charged with monitoring and entering
the amounts, it is unlikely that the Respondent would use the word
"we." Based on the Respondent's testimony that it was his practice to
maintain a contemporaneous record of administered medication on a paper
towel that was then routinely discarded, and the absence of any
conceivable motivation on the part of the staff members to fabricate
such a seemingly innocuous detail (at least to them) of standard
operating procedure, coupled with what appeared to be genuine confusion
(not defensiveness) in their demeanor when asked about the subject, the
Respondent's account of this process is less credible than the account
of his former employees. The Government's expert, Dr. Becker, testified
that in an office setting, auxiliaries of the practitioner routinely
make these entries in the sedation logs, but he did not indicate
whether it was based exclusively on the word of the practitioner or on
their own personal observations. Tr. 146-47. The credible evidence
supports the testimony supplied by Crockett and Tetzloff that they were
tasked with recording the amounts of medication dictated by the
Respondent.
---------------------------------------------------------------------------
\68\ In addition to the testimony of Tetzloff and Crockett, this
version of events is consistent with the account provided by another
employee, Peg Herner, in her conversation with DI Brinks. Tr. 456.
---------------------------------------------------------------------------
The sedation logs that were noticed and initially provided by the
Respondent was another aspect of this case that did not reflect well on
his credibility. The Respondent testified that separate logs were
generated and maintained at Norwalk and Avon,\69\ but a consolidated
version was provided to the tribunal. Resp't Ex. A (ID). Whether the
Respondent's account of who completed the sedation logs or the account
provided by his former employees is credited, no one who testified at
the hearing suggested that multiple pages of entries were
simultaneously prepared or maintained, yet the version of the logs
initially provided by the Respondent was so replete with duplication
that a modified version with the duplications culled out was prepared
by his counsel after the commencement of the hearing. Resp't Ex. A-1;
Tr. 703-05, 713-14. Additionally, although the sedation log pages
contained an internal capacity to designate them as belonging to
Norwalk, Avon, or another office, the pages provided did not designate
any location. Resp't Ex. A-1; Tr. 756-57. The Respondent testified that
as a result of Brinks' visit, he took the sedation logs and the
medication from Avon to Norwalk, but when pressed on why there were so
many duplicates among the sedation log pages, the Respondent stated
that his office staff (specifically, "the front desk people") \70\
prepared the logs and that he "rel[ied] on other people to help [him]
me try to keep track of this." Tr. 697-700. Since DEA already knew the
Respondent kept two sets of logs, consolidating them into one,
disorganized version would accomplish no reasonable purpose.
Puzzlingly, the Respondent's counsel then attempted to shift
responsibility for the duplicates to staff at his law office. Tr. 701.
It would simply make no sense that the clerical staff at counsel's
office would spontaneously supplement the sedation logs provided by
their client with multiple copies of randomly selected pages. Likewise,
the fact that the version brought to the hearing had entries that were
not initially presented to DI Brinks, and those additions are not
readily apparent from the documents,\71\ also casts doubt on their
reliability. Paradoxically, the Respondent's version of who bears the
responsibility of a plethora of duplicate records is the more plausible
account, although it reflects poorly on his credibility, his
recordkeeping, or both. In an acknowledgement of this reality, the
Respondent ultimately conceded that the responsibility of the
preparation of the logs as they were provided "falls to [him]." Tr.
703.
---------------------------------------------------------------------------
\69\ Tr. 694.
\70\ Tr. 703.
\71\ Tr. 591-92.
---------------------------------------------------------------------------
During his testimony, when the Respondent was asked to provide an
account of what is required of a registrant "[b]ased on what you've
learned" from DI Brinks' testimony, he replied as follows:
I understand what [Brinks is] saying that every syringe I've got
left over, I guess I've got to package it up and send it to either
the Pharmacy Board or have the Pharmacy Board come or send it to
[Brinks'] office in Cleveland, as I understand it now."
Tr. 709. Thus, by the Respondent's account, he has first learned of his
disposal obligations as a registrant as he sat at his own revocation
hearing and guesses that he is required to send it to an appropriate
place for disposal. See also, Tr. 776. Remarkably, although served in
August 2010 with an OSC which alleges, inter alia, that he has been
improperly disposing of controlled substance without notifying DEA, the
Respondent testified that his practice has not altered the manner in
which it has been disposing of residual controlled substances (to wit,
by squirting it down the drain without DEA approval), and did so as
recently as the
[[Page 72402]]
week before the hearing. Tr. 762-64, 777-78. More remarkable still, is
the Respondent's testimony that, although he has stopped storing
controlled substances at Avon, he continues to administer controlled
substances there, despite the fact that it has never been a registered
COR location. Tr. 764-66. When asked why he has persisted in this
conduct, notwithstanding the current charges, the Respondent explained
that he finds proper disposal "to be very laborious." Tr. 775-76.
Respondent also testified that every dentist he knows disposes of
substances in a similar way and that, therefore he "didn't know if
that [regulation] really pertained to me." Tr. 780-81.
The issue of the Respondent's credibility was a mixed bag. As
discussed at length, supra, the Respondent's answers were
intermittently inconsistent, implausible, and periodically lacking in
detail. There were some issues, such as his background, education, and
mental health issues, where his testimony had sufficient indicia of
reliability to be credited, and there were other matters, several of
which were in conflict with other evidence, where his version of events
must be found to be less than completely credible.
Additional facts required for a resolution of the issues in this
matter are set forth below.
The Analysis
Pursuant to 21 U.S.C. 824(a)(4) (2006), the Administrator \72\ is
permitted to revoke a COR if persuaded that the registrant "has
committed such acts as would render * * * registration under section
823 * * * inconsistent with the public interest * * *." The following
factors have been provided by Congress in determining "the public
interest":
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The [registrant's] experience in dispensing, or conducting
research with respect to 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) (2006 & Supp. III 2010).
---------------------------------------------------------------------------
\72\ This authority has been delegated pursuant to 28 CFR
0.100(b) and 0.104 (2010).
---------------------------------------------------------------------------
"[T]hese factors are considered in the disjunctive." Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003). Any one or a combination of
factors may be relied upon, and when exercising authority as an
impartial adjudicator, the Administrator may properly give each factor
whatever weight she deems appropriate in determining whether a
registration should be rejected. Morall v. DEA, 412 F.3d 165, 173-74
(D.C. Cir. 2005); JLB, Inc., d/b/a Boyd Drugs, 53 FR 43945, 43947
(1988); David E. Trawick, D.D.S., 53 FR 5326, 5327 (1988); see also
Joy's Ideas, 70 FR 33195, 33197 (2005); David H. Gillis, M.D., 58 FR
37507, 37508 (1993); Henry J. Schwarz, Jr., M.D., 54 FR 16422, 16424
(1989). Moreover, the Administrator is "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, 412 F.3d at 173-74. The Administrator is
not required to discuss consideration of each factor in equal detail,
or even every factor in any given level of detail. Trawick v. DEA, 861
F.2d 72, 76 (4th Cir. 1988) (the Administrator's obligation to explain
the decision rationale may be satisfied even if only minimal
consideration is given to the relevant factors and remand is required
only when it is unclear whether the relevant factors were considered at
all). The balancing of the public interest factors "is not a contest
in which score is kept; the Agency is not required to mechanically
count up the factors and determine how many favor the Government and
how many favor the registrant. Rather, it is an inquiry which focuses
on protecting the public interest * * *." Jayam Krishna-Iyer, M.D., 74
FR 459, 462 (2009).
In an action to revoke a registrant's COR, the DEA has the burden
of proving that the requirements for revocation are satisfied. 21 CFR
1301.44(e) (2011). The Government may sustain its burden by showing
that the Respondent has committed acts inconsistent with the public
interest.\73\ Jeri Hassman, M.D., 75 FR 8194, 8235-36 (2010). Once DEA
has made its prima facie case for revocation of the registrant's COR,
the burden of production then shifts to the Respondent to present
sufficient mitigating evidence to assure the Administrator that he or
she can be entrusted with the responsibility commensurate with such a
registration and that revocation is not appropriate. Steven M.
Abbadessa, D.O., 74 FR 10077, 10078, 10081 (2009); Medicine Shoppe-
Jonesborough, 73 FR 364, 387 (2008); Samuel S. Jackson, D.D.S., 72 FR
23848, 23853 (2007); Morall, 412 F.3d at 174; Humphreys v. DEA, 96 F.3d
658, 661 (3d Cir. 1996); Shatz v. U.S. Dept. of Justice, 873 F.2d 1089,
1091 (8th Cir. 1989); Thomas E. Johnston, 45 FR 72311, 72312 (1980).
Further, "to rebut the Government's prima facie case, [the Respondent]
is required not only to accept responsibility for [the established]
misconduct, but also to demonstrate what corrective measures [have
been] undertaken to prevent the reoccurrence of similar acts." Jeri
Hassman, M.D., 75 FR at 8236. Normal hardships to the practitioner and
even to the surrounding community that are attendant upon the lack of
registration are not relevant considerations. Linda Sue Cheek, M.D., 76
FR 66972, 66973 (2011); Abbadessa, 74 FR at 10078; see also Gregory D.
Owens, D.D.S., 74 FR 36751, 36757 (2009).
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\73\ The Agency's conclusion that past performance is the best
predictor of future performance has been sustained on review in the
courts, Alra Labs. v. DEA, 54 F.3d 450, 452 (7th Cir. 1995), as has
the Agency's consistent policy of strongly weighing whether a
registrant who has committed acts inconsistent with the public
interest has accepted responsibility and demonstrated that he or she
will not engage in future misconduct. Hoxie, 419 F.3d at 483; Ronald
Lynch, M.D., 75 FR 78745, 78749 (2010) (Respondent's attempts to
minimize misconduct held to undermine acceptance of responsibility);
George Mathew, M.D., 75 FR 66138, 66140, 66145, 66148 (2010); East
Main Street Pharmacy, 75 FR 66149, 66165 (2010); George C. Aycock,
M.D., 74 FR 17529, 17543 (2009); Abbadessa, 74 FR at 10078; Krishna-
Iyer, 74 FR at 463; Medicine Shoppe, 73 FR at 387.
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While the burden of proof at this administrative hearing level is a
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S.
91, 100-01 (1981), the Administrator's factual findings will be
sustained on review to the extent they are supported by "substantial
evidence." Hoxie, 419 F.3d at 481. And while "the possibility of
drawing two inconsistent conclusions from the evidence" does not limit
the Administrator's ability to find facts on either side of the
contested issues in the case. Shatz, 873 F.2d at 1092; Trawick, 861
F.2d at 77, all "important aspect[s] of the problem," such as a
Respondent's defense or explanation that runs counter to the
Government's evidence, must be considered. Wedgewood Vill. Pharmacy v.
DEA, 509 F.3d 541, 549 (D.C. Cir. 2007); Humphreys, 96 F.3d at 663. The
ultimate disposition of the case must be in accordance with the weight
of the evidence, not simply supported by enough evidence to justify, if
the trial were to a jury, a refusal to direct a verdict when the
conclusion sought to be drawn from it is one of fact for the jury.
Steadman, 450 U.S. at 99 (internal quotation marks omitted).
Regarding the exercise of discretionary authority, the courts have
recognized that gross deviations from past agency precedent must be
adequately supported, Morall, 412 F.3d at 183, but mere unevenness in
[[Page 72403]]
application does not, standing alone, render a particular discretionary
action unwarranted. Chein v. DEA, 533 F.3d 828, 835 (D.C. Cir. 2008)
(citing Butz v. Glover Livestock Comm. Co., 411 U.S. 182, 188 (1973)),
cert. denied, ---- U.S. ----, 129 S. Ct. 1033, 1033 (2009). It is well-
settled that since the Administrative Law Judge has had the opportunity
to observe the demeanor and conduct of hearing witnesses, the factual
findings set forth in this recommended decision are entitled to
significant deference, Universal Camera Corp. v. NLRB, 340 U.S. 474,
496 (1951), and that this recommended decision constitutes an important
part of the record that must be considered in the Administrator's
decision, Morall, 412 F.3d at 179. However, any recommendations set
forth herein regarding the exercise of discretion are by no means
binding on the Administrator and do not limit the exercise of that
discretion. 5 U.S.C. 557(b) (2006); River Forest Pharmacy, Inc. v. DEA,
501 F.2d 1202, 1206 (7th Cir. 1974); Attorney General's Manual on the
Administrative Procedure Act 8 (1947).
Factors 1 and 3: The Recommendation of the Appropriate State Licensing
Board or Professional Disciplinary Authority; and Any Conviction Record
Under Federal or State Laws Relating to the Manufacture, Distribution,
or Dispensing of Controlled Substances
In this case, it is undisputed that the Respondent holds a valid
and current state license to practice medicine in Ohio. Although the
Government introduced evidence that the Ohio Dental Board has
previously placed the Respondent's state medical privileges on a period
of suspension that was completed without complication, the matter was
unrelated to the Respondent's obligations as a DEA registrant and not
relevant here. Tr. 391-92, 394-96; see Judulang v. Holder, 132 S.Ct.
476, 556 U.S. ---- (2011) (invalidating Board of Immigration Appeals
decision making practice where the "rule [was] unmoored from the
purposes and concerns of the immigration laws."). Although Ms. Reitz,
from the Ohio Dental Board, testified that there is an ongoing Board
investigation into matters in common with these proceedings,\74\ the
record contains no evidence of a recommendation regarding the
Respondent's medical privileges related to these issues by any
cognizant state licensing board or professional disciplinary authority.
The fact that an investigation by state authorities is pending is
neither supportive of revocation nor antithetical to it. That a state
has not acted against a registrant's medical license is not dispositive
in this administrative determination as to whether continuation of a
registration is consistent with the public interest. Patrick W.
Stodola, M.D., 74 FR 20727, 20730 (2009); Jayam Krishna-Iyer, 74 FR at
461. It is well-established Agency precedent that a "state license is
a necessary, but not a sufficient condition for registration." Leslie,
68 FR at 15230; John H. Kennedy, M.D., 71 FR 35705, 35708 (2006). Even
the reinstatement of a state medical license does not affect the DEA's
independent responsibility to determine whether a registration is in
the public interest. Mortimer B. Levin, D.O., 55 FR 9209, 8210 (1990).
The ultimate responsibility to determine whether a registration is
consistent with the public interest has been delegated exclusively to
the DEA, not to entities within state government. Edmund Chein, M.D.,
72 FR 6580, 6590 (2007), aff'd, Chein v. DEA, 533 F.3d 828 (D.C. Cir.
2008), cert. denied, ---- U.S. ----, 129 S. Ct. 1033 (2009). Congress
vested authority to enforce the CSA in the Attorney General, not state
officials. Stodola, 74 FR at 20375. While Respondent contends that the
lack of board action weighs against revocation, Resp't Brief at 15,
Agency precedent establishes that, where the record contains no
evidence of a recommendation by a state licensing board, such absence
does not weigh for or against a determination as to whether
continuation of the Respondent's DEA certification is consistent with
the public interest. See Ronie Dreszer, M.D., 76 FR 19434, 19444 (2011)
("[T]he fact that the record contains no evidence of a recommendation
by a state licensing board does not weigh for or against a
determination as to whether continuation of the Respondent's DEA
certification is consistent with the public interest."). Accordingly,
Factor One does not weigh for or against revocation in this matter. Id.
---------------------------------------------------------------------------
\74\ Tr. 392-409, 412, 422-23.
---------------------------------------------------------------------------
Regarding the third factor (convictions relating to the
manufacture, distribution, or dispensing of controlled substances), the
record in this case does not contain evidence that the Respondent has
been convicted of a crime related to the manufacture, distribution, or
dispensing of controlled substances. DEA administrative proceedings are
non-punitive and "a remedial measure, based upon the public interest
and the necessity to protect the public from those individuals who have
misused controlled substances or their DEA COR, and who have not
presented sufficient mitigating evidence to assure the [Administrator]
that they can be trusted with the responsibility carried by such a
registration." Jackson, 72 FR at 23853; Leo R. Miller, M.D., 53 FR
21931, 21932 (1988). Where evidence in a particular case reflects that
the Respondent has acquired convictions relating to the manufacture,
distribution, or dispensing of controlled substances, those convictions
must be carefully examined and weighed in the adjudication of whether
the issuance of a registration is in the public interest. 21 U.S.C.
823(f).
Although the standard of proof in a criminal case is more stringent
than the standard required at an administrative proceeding, and the
elements of both federal and state crimes relating to controlled
substances are not always co-extensive with conduct that is relevant to
a determination of whether registration is within the public interest,
evidence that a registrant has been convicted of crimes related to
controlled substances is a factor to be evaluated in reaching a
determination as to whether he or she should be entrusted with a DEA
certificate. While Respondent contends that the lack of convictions
should weigh in his favor, Resp't Posth'g Brf. at 19, the probative
value of an absence of any evidence of criminal prosecution, even if
conceded as relevant arguendo, is perforce diminished by the myriad of
considerations that are factored into a decision to initiate, pursue,
and dispose of criminal proceedings by Federal, State, and local
prosecution authorities. See Robert L. Dougherty, M.D., 76 FR 16823,
16833 n.13 (2011); Dewey C. Mackay, M.D., 75 FR 49956, 49973 (2010)
("[W]hile a history of criminal convictions for offenses involving the
distribution or dispensing of controlled substances is a highly
relevant consideration, there are any number of reasons why a
registrant may not have been convicted of such an offense, and thus,
the absence of such a conviction is of considerably less consequence in
the public interest inquiry.") (citing Jayam Krishna-Iyer, M.D., 74 FR
459, 461 (2009); Edmund Chein, M.D., 72 FR 6580, 6593 n.22 (2007),
aff'd, Chein v. DEA, 533 F.3d 828 (D.C. Cir. 2008), cert. denied, ----
U.S. ----, 129 S. Ct. 1033 (2009)); Ladapo O. Shyngle, M.D., 74 FR
6056, 6057 n.2 (2009).
Accordingly, consideration of the evidence of record under the
first and third factors neither supports the Government's argument for
revocation nor militates against it.
[[Page 72404]]
Factors 2 and 4: Experience in Dispensing Controlled Substances and
Compliance With Applicable State, Federal, or Local Laws Relating to
Controlled Substances
In this case, the gravamen of the Government's case relates to the
allegations that the Respondent: (1) Failed to comply with the CSA's
registration requirements; (2) failed to adhere to the CSA's
recordkeeping and security requirements and was unable to account for
both shortages and overages of controlled substances; and (3) dispensed
controlled substances to himself for illegitimate purposes.\75\
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\75\ The present record is bereft of competent evidence to
support this third factual allegation. The Respondent's erratic
behavior was well-documented in the record, as were the IV marks on
his hands and arms. The Respondent's explanation that the suspect
marks were the product of some sort of hands-on IV experience by
chronically untalented student dentists was more than just somewhat
undermined by the blood and marks on the backs of his hands that
were observed by his staff on a morning where he was inexplicably
late for patients, and not teaching at Case Western Reserve. That
the IV marks were the product of his large Newfoundland was about as
unpersuasive as his "I'm a picker" theory. The evidence of record
(enhanced by the Respondent's testimony) doubtless creates a
suspicion that there was something more afoot than his offered
explanations, but the Agency precedent on the subject has been
commendably clear that "under the substantial evidence test, the
evidence must 'do more than create a suspicion of the existence of
the fact to be established.' " Alvin Darby, M.D., 75 FR 26993,
26999, n.31 (2010) (citing NLRB v. Columbian Enameling & Stamping
Co., 306 U.S. 292, 300 (1939).
---------------------------------------------------------------------------
Regarding Factor 2, in requiring an examination of a registrant's
experience in dispensing controlled substances, Congress manifested an
acknowledgement that the qualitative manner and the quantitative volume
in which a registrant has engaged in the dispensing of controlled
substances, and how long he or she has been in the business of doing
so, are significant factors to be evaluated in reaching a determination
as to whether he or she should be entrusted with a DEA COR. In some
cases, viewing a registrant's actions against a backdrop of how he has
performed activity within the scope of the certificate can provide a
contextual lens to assist in a fair adjudication of whether continued
registration is in the public interest.
Evidence that a practitioner may have conducted a significant level
of sustained activity within the scope of the registration for a
sustained period can be a relevant and correct consideration, which may
be accorded due weight. The registrant's knowledge and experience
regarding the rules and regulations applicable to practitioners also
may be considered. See Volusia Wholesale, 69 FR69409, 69410 (2004)
(List I case).\76\ However, the Agency has taken the reasonable
position that this factor can be outweighed by acts held to be
inconsistent with the public interest. Jayam Krishna-Iyer, 74 FR at
463; see also Jeri Hassman, M.D., 75 FR 8194, 8235 (2010)
(acknowledging Agency precedential rejection of the concept that
conduct which is inconsistent with the public interest is rendered less
so by comparing it with a respondent's legitimate activities which
occurred in substantially higher numbers); Paul J. Cargine, Jr., 63 FR
51592, 51560 (1998) ("[E]ven though the patients at issue are only a
small portion of Respondent's patient population, his prescribing of
controlled substances to these individuals raises serious concerns
regarding [his] ability to responsibly handle controlled substances in
the future.").
---------------------------------------------------------------------------
\76\ In Cynthia M. Cadet, M.D., 76 FR 19450, 19450 n.1 (2011),
the Agency declined to adopt the List I experience analysis for
practitioners charged with intentional diversion. Thus far, Agency
precedent has left open the door to this form of evidence where
intentional diversion has not been established. Compare 21 U.S.C.
823(h) (List I section mandating consideration of "any past
experience of the applicant in the manufacture and distribution of
chemicals,") (emphasis added) with 21 U.S.C. 823(f) (practitioner
section mandating consideration of "[t]he applicant's experience in
dispensing, or conducting research with respect to controlled
substances.); see U.S. v. Tinklenberg, 131 S.Ct. 2007, 2019-20
(2011) ("Identical words used in different parts of a statute are
presumed to have the same meaning absent indication to the
contrary.").
---------------------------------------------------------------------------
Experience which occurred prior or subsequent to proven allegations
of malfeasance may be relevant. Evidence that precedes proven
misconduct may add support to the contention that, even acknowledging
the gravity of a registrant's transgressions, they are sufficiently
isolated and/or attenuated that adverse action against his registration
is not compelled by public interest concerns. Likewise, evidence
presented by the Government that the proven allegations are congruous
with a consistent past pattern of poor behavior can enhance the
Government's case.
In a similar vein, conduct which occurs after proven allegations
can shed light on whether a registrant has taken steps to reform and/or
conform his or her conduct to appropriate standards. Contrariwise, a
registrant who has persisted in incorrect behavior, or made attempts to
circumvent Agency directives, even after being put on notice, can
diminish the strength of its case. Novelty, Inc., 73 FR 52689, 52703
(2008), aff'd, 571 F.3d 1176 (D.C. Cir. 2009); Southwood Pharm., Inc.,
72 FR 36487, 36503 (2007); John J. Fotinopoulous, 72 FR 24602, 24606
(2007).
In Jayam Krishna-Iyer, 74 FR at 463, DEA acknowledged the reality
that even a significant and sustained history of uneventful practice
under a DEA certificate can be offset by proof that a registrant has
committed acts inconsistent with the public interest. Id. Even,
"evidence that a practitioner has treated thousands of patients does
not negate a prima facie showing that the practitioner has committed
acts inconsistent with the public interest." Id. The Agency, in its
administrative precedent, has further curtailed the scope of Factor 2.
The Agency's current view regarding Factor 2 is that, while evidence of
a registrant's experience handling controlled substances may be
entitled to some weight in assessing whether errant practices have been
reformed, where the evidence of record raises intentional or reckless
actions on the part of the registrant, such evidence is entitled to no
weight where a practitioner fails to acknowledge wrongdoing in the
matters before the Agency. Cynthia M. Cadet, M.D., 76 FR 19450 n.3
(2011); Roni Dreszer, M.D., 76 FR 19434 n.3 (2011); Michael J. Aruta,
M.D., 76 FR 19420 n.3 (2011); Jacobo Dreszer, M.D., 76 FR 19386-87 n.3
(2011). This reasonable approach accepts the unavoidable logic that a
transgression can only be rationally styled as an aberration when it is
acknowledged by the actor as a transgression for which remorse is
demonstrated.
The Respondent argues that his professional experience supports
favorable consideration under Factor 2. Resp't Posth'g Brf. at 16-19.
Indeed, on the present record, it is undisputed that the Respondent has
uneventfully practiced dentistry for over two decades, is a periodontic
specialist, has published numerous scholarly articles in his field, and
was sufficiently accomplished in his profession that he has served as a
professor and clinical director Case Western Reserve School of Dental
Medicine. Resp't Ex. E; Tr. 655-56. While the Respondent's level of
professional achievement is undeniably impressive, he has offered no
affirmative evidence regarding his experience dispensing controlled
substances from peers, co-workers, or even himself. Still, his
professional experience and contributions to his field have been
considered in this recommended decision.
Regarding Factor 4, Sections 822(e) and 1301.12 require that a
registrant maintain "a separate registration * * * at each principal
place of business or professional practice where the
[[Page 72405]]
applicant manufactures, distributes, or dispenses controlled substances
or list I chemicals." This separate registration requirement has been
called "an essential requirement of DEA's diversion control program."
Preventing the Accumulation of Surplus Controlled Substances at Long
Term Care Facilities, 70 FR 25462, 25463 (2005) ("Long Term Care").
In its prehearing statement, the Government alleged that Respondent
"administered controlled substances to patients from his Avon dental
practice," but did not obtain a registration for the Avon location.
Gov't PHS, at 7. Paragraph 5 of the OSC also alleged that Respondent
"distributed controlled substances including fentanyl, diazepam and
midazolam * * * to an unregistered location in violation of 21 CFR
Sec. 1307.11." \77\ OSC, at ] 5.
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\77\ The CSA provides that "[t]he term 'distribute' means to
deliver * * * a controlled substance or a listed chemical." 21
U.S.C. 802(a)(10). The term "deliver," in turn, is defined as
"the actual, constructive, or attempted transfer of a controlled
substance or a listed chemical, whether or not there exists an
agency relationship." 21 U.S.C. 802(a)(8) (emphasis added). No
authority has been cited which would stand for the proposition that
a practitioner "distributes" controlled substances when he moves
controlled substances from one of his offices to another. Rather, it
seems that, under the CSA and its implementing regulations,
controlled substances are distributed between persons, and not
locations. See 21 CFR 1307.11-12 (Regulating distribution of
controlled substances between parties without mention of location).
Accordingly, the Government's charge brought under Sec. 1307.11--
that the Respondent distributed controlled substances improperly--is
without merit.
---------------------------------------------------------------------------
The evidence of record establishes that Respondent maintained two
dental offices: An office in Norwalk, where Respondent maintained his
DEA registration; and an office in Avon, Ohio. Tr. 155-56, 221, 451-53.
It appears that he practiced out of the Avon office once or twice per
week. Tr. 156, 261. It is undisputed that controlled substances were,
for a period of time, stored at Avon Office and that Respondent does
not have a DEA registration for the Avon location. It is also
undisputed that Respondent has regularly administered controlled
substances for sedation at the Avon Office, and that he continues to do
so. Tr. 764, Resp't Ex. M. Thus, it is clear that Respondent has
administered controlled substances at a location that is unregistered,
and has thus violated sections 822(e) and 1301.12.\78\ Furthermore,
insofar as the Respondent continues to administer controlled substances
at the Avon Office, it appears that Respondent remains in flagrant
violation of this regulation.\79\ Even apart from the reality that the
Respondent, as a DEA registrant is responsible for understanding his
obligations under the clear language of the relevant regulations, he
has been given direct notice that his Avon Office location must be
registered, by the initiation of these proceedings and a full,
contested hearing on the matter; yet the Respondent doggedly refuses to
bring himself into compliance. He has not sought to obtain a
registration for the Avon Office and has not stopped administering
controlled substances there as a regular part of his professional
practice. Hence, in the face of his refusal to obey the law,
consideration of this factor, even standing alone, persuasively and
conclusively balances in favor of revocation.
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\78\ Through counsel in his Posthearing Brief, the Respondent
acknowledges that dispensing in Avon without a valid COR was in
violation of the law. Resp't Posth'g Brf. at 17, 20.
\79\ As discussed, supra, through counsel in his Posthearing
Brief, the Respondent acknowledges that dispensing in Avon without a
valid COR was in violation of the law. Resp't Posthearing Brf. at
17, 20. Interestingly though, the Respondent's Posthearing Brief
also contends that "he discontinued storing drugs at his Avon
location in order to be in compliance with the regulations." Resp't
Posthearing Brf. at 3. This position, consistent as it may be with
the posture the Respondent took on this matter during his testimony,
is unsupported in the law. Tr. 765. DEA regulations clearly
establish that all professional practices at which controlled
substances are distributed must have their own DEA registration. 21
CFR 1301.12. A narrow exception to this requirement applies only
insofar as: (1) The practitioner has a valid DEA registration in the
same state as the second location; (2) the practitioner does not
store controlled substances at the second location; and (3) the
practitioner does not administer controlled substances as a regular
part of the professional practice at the second location. 21 CFR
1301.12(b)(3). The Respondent testified that IV sedation is a
"critical component" of his practice, and that he conducted
procedures administering controlled substances up to the week prior
to the hearing. Tr. 660, 764. Under these circumstances (even apart
from the Respondent's through-counsel concession on this issue), the
Respondent is clearly administering controlled substances is a
regular part of his Avon practice, and therefore, must be separately
registered under the regulations.
---------------------------------------------------------------------------
In addition to the registration violations, the Government also
alleges that Respondent failed to secure controlled substances properly
at the Avon Office, in violation of 21 CFR 1301.75(b). ALJ Ex. 1. With
regard to security, 21 CFR 1301.71(a) provides, in relevant part, that
"[a]ll applicants and registrants shall provide effective controls and
procedures to guard against theft and diversion of controlled
substances. In order to determine whether a registrant has provided
effective controls against diversion, the Administrator shall use the
security requirements set forth in Sec. Sec. 1301.72-1301.76 as
standards for the physical security controls and operating procedures
necessary to prevent diversion." While the security provisions of
sections 1301.72 through 1301.76 are used as standards to determine
compliance with section 1301.71(a), the language of each of these
sections is phrased in mandatory terms. See e.g., 21 CFR 1301.75(a)
("Controlled substances listed in Schedule I shall be stored in a
securely, locked, substantially constructed cabinet.") (emphasis
added); 21 CFR 1301.76(a) ("The registrant shall not * * *")
(emphasis added). Thus, while compliance with the security provisions
is a consideration under 21 CFR 1301.71(a), violation of any of the
relevant security requirements in sections 1301.72-76 will be an
independent consideration under Factor Four.
Section 1301.75(b) provides, in relevant part, that "[c]ontrolled
substances listed in Schedules II, III, IV, and V shall be stored in a
securely locked, substantially constructed cabinet. However, pharmacies
and institutional practitioners may disperse such substances throughout
the stock of noncontrolled substances in such a manner as to obstruct
the theft or diversion of the controlled substances." The security
requirements of section 1301.75 are designed "to prevent the unlawful
diversion of * * * drugs." Jerry Neil Rand, M.D., 61 FR 28895, 28897
(1996). Thus, a reasonable reading of the regulations would compel a
registrant entrusted with the care of controlled substances to ensure
that when the controlled substances are left unattended, they must be
placed in a container meeting the requirements of section 1301.75. See
D-Tek Enterprises, 56 FR 28926, 28926 (1991) ("21 CFR 1301.75 requires
that all Schedule I and II controlled substances be kept in a securely
locked, substantially constructed cabinet.") (emphasis added); see
also Merriam-Webster Dictionary (Defining "kept" as "to cause to
remain in a given place, situation or condition.").
Here, the testimony establishes that, on numerous occasions,
supplies of controlled substances were left in gray, shoebox-sized bins
on the counters of the sterilization room in the Avon Office.
Specifically, Ms. Tetzloff and Ms. Crockett testified that they would
leave the gray bins in the open while preparing for patients in the
morning. Tr. 157-58, 233-34. While true that the sterilization room was
not readily accessible to patients standing by in the waiting room, a
counter is not a locked cabinet. The regulations, which specify that
controlled substances be stored in locked containers, are designed to
provide both security and accountability
[[Page 72406]]
in the maintenance of a closed regulatory system for controlled
substances. Jerry Neil Rand, M.D., 61 FR at 28897. Where accountability
is concerned, the system must be as concerned with the accountability
of health professionals with access to office spaces as it is with
potential access by the patients waiting for treatment. It is clear
that the controlled substances were not left in securely locked,
substantially constructed cabinets, as required by the regulations. 21
CFR 1301.75. Accordingly, substantial evidence supports the conclusion
that Respondent violated the security requirement set forth in section
1301.75, and this factor militates in favor of revocation.
To effectuate the dual goals of conquering drug abuse and
controlling both legitimate and illegitimate traffic in controlled
substances, "Congress devised a closed regulatory system making it
unlawful to manufacture, distribute, dispense, or possess any
controlled substance except in a manner authorized by the CSA."
Gonzales v. Raich, 545 U.S. 1, 13 (2005). Consistent with the
maintenance of that closed regulatory system, accurate and reliable
records are an obvious bedrock safeguard that is essential to ensure
the integrity of the closed regulatory system. A truly closed system
requires not only that certain records and inventories be kept by all
those registrants who either generate or take custody of controlled
substances in any phase of the distribution chain until they reach the
ultimate user, but that those documents be subject to periodic
inspection and ready retrieval for that purpose. Registrants, such as
the Respondent, who are authorized to dispense controlled substances
are required to keep such records, and to maintain those records in a
manner that is "readily retrievable," upon demand of those DEA
officials charged with conducting inspections. See 21 CFR 1304.04(g) &
(f)(2) (2011); see 21 CFR 1304.03 (requiring recordkeeping set forth in
Sec. 1304.04 for dispensing physicians). Readily retrievable is
defined in the regulations as "records kept * * * in such a manner
that they can be separated out from all other records in a reasonable
time * * * " 21 CFR 1300.01(b)(38).
The Government alleged that DI Brinks conducted a regulatory
inspection on the Respondent's practice on December 21, 2009 and found
multiple regulatory violations. ALJ Ex. 5 at 6. It need hardly be
restated that the audit computation results as offered by DI Brinks at
the hearing were profoundly problematic to say the least, and cannot be
used to support a finding of substantial evidence of anything. However,
the record does credibly establish that the Respondent, for his part,
produced no purchase records, and was able to furnish Brinks with only
three Form 222s over the course of a two-year period, which, even based
on a cursory examination of the sedation logs,\80\ was a fraction of
what should have been available. Tr. 444, 446-48, 639-40. Of that
paltry number, one was incomplete. Tr. 451. Notwithstanding the
Respondent's regular practice of "wasting" residual medication, he
was unable to produce any Form 41s. Tr. 443, 449-50.
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\80\ As discussed at length, supra, the sedation logs that were
provided to DI Brinks differed with those provided at the hearing.
Those records provided at the hearing were replete with multiple
duplications and transpositions of the quantities counted.
---------------------------------------------------------------------------
In the present record, every health professional who provided
evidence on the topic, including the Respondent, himself, is of the
opinion that the amounts of controlled-substance medication
administered by the Respondent to the patients depicted in the sedation
logs is high. It was the view of the Government's expert, Dr. Becker,
that the amounts administered would have resulted in unconsciousness
and other complications, and that to the extent that the higher amounts
were based on addressing sedation-resistant patients, that this
temporally-limited sample contained more such resistant patients than
he has encountered in a lifetime of practice. Interestingly, in his
testimony, the Respondent did not dispute that the amounts were high,
but offered that he is a specialist who deals in difficult cases, and
that it could have been that the patients (even though there were quite
a few in a small window of time) could have been medication resistant
for reasons that he hypothesized could have been present. The
Respondent's argument that he is a specialist and gets complicated
cases is unpersuasive because his specialty is in periodontics, not
sedation-resistant patients. His argument that these patients could all
have been medication resistant is undermined by any efforts on the
Respondent's part to introduce evidence to establish medication
resistance based on any patient in issue, even though he is in
possession of the patient charts. As discussed, supra, a scholarly
discussion among health professionals as to what choices, levels and
combinations of medication(s) achieve optimum results is a discussion
for a different forum and beyond the proper jurisdiction of DEA and
this forum to evaluate. Gonzales v. Oregon, 546 U.S. 243, 274 (2006).
The issue here is diversion, and this tribunal (and this Agency) can
have no reasonable view as to whether reasonable minds can, should, or
do differ on the issue of whether the administered doses were out of
line with accepted medical practice. That said, the Government's
expert, Dr. Becker, provided credible, persuasive, and unrefuted
testimony that the amounts of medication employed by the Respondent as
reflected in the sedation logs he supplied would likely have resulted
in unconsciousness. The Respondent's testimony that none of his sedated
patients were ever unconscious is likewise credible. With the poor
state of the Respondent's controlled substance records, it is not
possible to conclusively determine whether the high levels of
controlled substance medications were administered as noted. The
results of the audit conducted by DEA regarding the Respondent's
recordkeeping demonstrated sufficient inattention to maintaining
required documentation that his records were not reliable. The
accountability concerns credibly conveyed by Crockett and Tetzloff in
their testimony were borne of this same unreliability in the state of
the records. Reliable records are a key aspect of maintaining a closed
system, and this aspect of the Respondent's practice impacts negatively
on consideration of Factor 4.
Finally, it is noteworthy that Respondent concedes that he
regularly disposed of controlled substances without notifying the DEA,
in violation of the governing regulations. See 21 CFR 1307.21(a)
(Registrants must notify regional Special Agent in Charge before
disposing of controlled substances). Respondent also testified that,
notwithstanding the DEA administrative proceedings pending against his
COR, he continues to follow this practice, essentially because he feels
that other professionals in his field do it as well.\81\ Tr. 709, 762-
64, 776-78. A defense of "other people are doing it too" is generally
no more persuasive in administrative enforcement proceedings than it is
in the defense of a traffic violation, however, this case contains the
arguably different wrinkle that every witness who presented evidence on
the issue from each party is in agreement that squirting or "wasting"
residual, unused amounts of controlled substances into the drain is
common practice among registrants. Tr. 55-58,
[[Page 72407]]
100-01, 105, 631; Resp't Ex. J. This forum is without jurisdiction (or
inclination) to question the wisdom of the prior-notification
requirements applicable to controlled substance disposal. While the
issue of a common practice which may be knowingly and routinely ignored
by the Agency \82\ may present an interesting legal issue in another
case where an adequate record on the subject has been developed, under
the circumstances presented here, the Respondent's unwillingness to
cease this disposal practice in the face of actual notice by the Agency
militates against entrusting him with a DEA registration under Factor
4.
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\81\ This posture is likewise assumed by the Respondent in his
Posthearing Brief. Resp't Post H'ring Brf. at 10.
\82\ This issue was not sufficiently developed on the present
record to support a finding that DEA has made a determination to
eschew enforcement of this provision. Indeed the charges in the
present OSC counter such a position in the strongest terms possible.
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Accordingly, consideration of Factors 2 and 4 militate in favor of
the revocation of the Respondent's COR.
Factor 5: Such Other Conduct Which May Threaten the Public Health and
Safety
The fifth statutory public interest factor directs consideration of
"[s]uch other conduct which may threaten the public health and
safety." 21 U.S.C. 823(f)(5) (emphasis supplied). Existing Agency
precedent has long held that this factor encompasses "conduct which
creates a probable or possible threat (and not only an actual [threat])
to public health and safety." Dreszer, 76 FR at 19434 n.3; Aruta, 76
FR at 19420 n.3; Boshers, 76 FR 19403 n.4; Dreszer, 76 FR at 19386-87
n.3. Agency precedent has generally embraced the principle that any
conduct that is properly the subject of Factor Five must have a nexus
to controlled substances and the underlying purposes of the CSA.
Terese, Inc., d/b/a/Peach Orchard Drugs, 76 FR 46843, 46848 (2011);
Tony T. Bui, M.D., 75 FR 49979, 49989 (2010) (prescribing practices
related to a non-controlled substance such as human growth hormone may
not provide an independent basis for concluding that a registrant has
engaged in conduct which may threaten public health and safety); but
see Paul Weir Battershell, N.P., 76 FR 44359, 44368 n.27 (2011) (a
registrant's non-compliance with the Food, Drug, and Cosmetic Act may
be considered on the narrow issue of assessing a respondent's future
compliance with the CSA).
Similar "catch all" language is employed by Congress in the CSA
related to the Agency's authorization to regulate controlled substance
manufacturing and List I chemical distribution, but the language is by
no means identical. 21 U.S.C. 823(d)(6), (h)(5). Under the language
utilized by Congress in those provisions, the Agency may consider
"such other factors as are relevant to and consistent with the public
health and safety." Id. (emphasis supplied). In Holloway Distributors,
72 FR 42118, 42126 (2007), the Agency held this catch all language to
be broader than the language directed at practitioners under "other
conduct which may threaten the public health and safety" utilized in
21 U.S.C. 823(f)(5). In Holloway, the Agency stated that regarding the
List I catch all:
[T]he Government is not required to prove that the
[r]espondent's conduct poses a threat to public health and safety to
obtain an adverse finding under factor five. See T. Young, 71 [FR]
at 60572 n.13. Rather, the statutory text directs the consideration
of "such other factors as are relevant to and consistent with the
public health and safety." 21 U.S.C. Sec. 823(h)(5). This standard
thus grants the Attorney General broader discretion than that which
applies in the case of other registrants such as practitioners. See
id. Sec. 823(f)(5) (directing consideration of "[s]uch other
conduct which may threaten the public health and safety").
72 FR at 42126.\83\ Thus, the Agency has recognized that, while the
factor five applicable to List I chemical distributors--21 U.S.C.
823(h)(5)--encompasses all "factors," the factor five applied to
practitioners--21 U.S.C. 823(f)(5)--considers only "conduct."
Furthermore, because section 823(f)(5) only implicates "such other
conduct," it necessarily follows that conduct considered in factors
one through four may not be considered at factor five.
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\83\ In Bui, the Agency clarified that "an adverse finding
under [Factor Five did not require a] showing that the relevant
conduct actually constituted a threat to public safety." 75 FR
49888 n.12.
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As discussed, supra, the Government has alleged and established
that the Respondent disposed of controlled substances without procuring
the prior DEA approval required in the regulations. The manner of
disposal here, to wit, squirting the controlled substances into the
drain, and thus, the sewage and water treatment system is conduct that
could arguably have public safety implications. Because the public
safety aspect of this conduct was not factually developed at the
hearing, it is not necessary to reach this issue, or the issue as to
whether the ultimate destination of the "wasted" controlled
substances constitutes other conduct separate and apart from the act of
disposing without prior DEA authorization. Accordingly, there being no
other conduct alleged (or proven) which may threaten the public health
and safety, Factor Five weighs neither for nor against revocation.
Recommendation
All relevant acts alleged by the Government and established in the
record relate to the Respondent's registered location in Norwalk and
his unregistered office in Avon. Although no misconduct related to the
Respondent's registered location in Milwaukee have been alleged or
proved, these proceedings relate to whether he "has committed such
acts as would render his registration under [21 U.S.C. 823]
inconsistent with the public interest," (a question answered in the
affirmative here) and whether, as a matter of discretion, the
Respondent should continue to be entrusted by the Agency with
responsibilities as a DEA registrant in all locations that are the
subject of the OSC.
As set forth above, Factors 1, 3 and 5 do not weigh for against
revocation. Under Factor Four, substantial evidence supports a finding
that Respondent: (1) maintained an unregistered professional practice,
in violation of 21 U.S.C. 822(e) and 21 CFR 1301.12; (2) failed to
secure controlled substances properly, in violation of 21 CFR
1301.75(b); and (3) failed to dispose of controlled substances
properly, in violation of 21 CFR 1307.21(a). These acts bear some
resemblance to those found in Daniel Koller, D.V.M., 71 FR 66975,
66982-83 (2006).
In Koller, the Agency found that the respondent had: (1) Not stored
controlled substances in a securely locked, substantially constructed
cabinet, in violation of 21 CFR 1301.75(b); (2) failed to maintain
proper DEA Form 222s, in violation of 21 CFR 1304.22(c); (3)
distributed controlled substances to an unregistered practitioner, in
violation of 21 CFR 1307.11(a); and (4) maintained an unregistered
professional practice, in violation of 21 U.S.C. 822(e) and 21 CFR
1301.12(a). 71 FR at 66982-83. The Agency was unimpressed with Koller's
testimony that in his view it was 'an absurdity' to claim that he
violated the law by taking controlled substances [from a registered
location to an unregistered location] because he had a DEA registration
for his San Diego Residence [and] could 'take those drugs anywhere he
wanted.'" Id. at 66982. In denying Respondent's application for
registration, the Agency held that "Respondent's repeated violations
of the CSA provide ample grounds to deny his application. Moreover,
Respondent's attitude leaves [the Agency] with the firm impression
that, if given the
[[Page 72408]]
opportunity, he will violate the Act again." Koller, 71 FR at 66983.
Like the registrant in Koller, the Respondent's repeated and
continuing violations in the face of--and even motivated by--his
disagreement with his obligations as a registrant, undermine the
confidence that can be placed in him to execute his responsibilities in
compliance with the law. See Koller, D.V.M., 71 FR at 66983
("Respondent's repeated violations of the CSA provide ample grounds to
deny his application.").
Following the guidance of Koller, it is clear that the Government
has sustained its burden of showing that Respondent committed acts
inconsistent with the public interest. Accordingly, the burden shifts
to the Respondent to show that he can be entrusted with a DEA
registration. As discussed above, "to rebut the Government's prima
facie case, [the Respondent] is required not only to accept
responsibility for [the established] misconduct, but also to
demonstrate what corrective measures [have been] undertaken to prevent
the reoccurrence of similar acts." Jeri Hassman, M.D., 75 FR at 8236.
The present record does not present transgressions on a level that
could not have been overcome by a credible and persuasive acceptance of
responsibility coupled with a cogent plan for coming into compliance
and avoiding future violations; but inasmuch as neither demonstration
was convincingly offered by the Respondent, under current Agency
precedent, he cannot prevail.
Here, while Respondent has nominally \84\ acknowledged that his
conduct was wrongful, Tr. 763, 765, he has failed to outline any steps
he has taken to prevent the reoccurrence of the infractions. Generally,
actions speak louder than words, and the Respondent's actions speak
volumes about his level of responsibility acceptance. By his own
admission, the Respondent continues to dispose of controlled substances
down his office drains without DEA authorization, and continues to
administer drugs at his unregistered Avon location. Tr. 764. The
Respondent has also failed to outline any steps which he has taken (or
even intends to take) that would tend to prevent controlled substances
from being left unsecured during mornings at the unregistered Avon
Office. Clear on the evidence presented here, is that far from
demonstrating acceptance and contrition, the Respondent has violated
the law, disagrees with the law, and has continued to violate the law
even after the Agency served him with an OSC. Thus, in this case, the
Respondent has failed to sustain his burden of showing that he can be
entrusted with the responsibilities incumbent upon a DEA registrant.
Koller, 71 FR at 66983; Jeri Hassman, M.D., 75 FR at 8236.\85\
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\84\ Though the Respondent acknowledged wrong doing, he also
testified, in essence, that "everybody does it." These
ministrations echo the righteous protests put forth in Koller; and
are no more compelling here. Accordingly, the evidence here, as in
Koller, leaves "the firm impression that, if given the opportunity,
[Respondent] will violate the [CSA] again." Koller, 71 FR at 66983.
\85\ In its Posthearing Brief the Government contends that "the
agency has recently admitted and considered testimony with regard to
community impact [of revocation]." Gov't Posth'g Brf. at 33.
However, the Agency has recently once again re-affirmed its view
that "community impact evidence is not relevant in determining
whether to * * * revoke an existing registration under the various
authorities provided in 21 U.S.C. 824(a)." Cheek, M.D., 76 FR at
66972. Accordingly, community impact has not played a role in this
recommended decision. Id.
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Where, as here, the Government has made out a prima facie case that
the Respondent has committed acts that render registration inconsistent
with the public interest, Agency precedent has firmly placed
acknowledgement of guilt and acceptance of responsibility as conditions
precedent to merit the granting or continuation of status as a
registrant. Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005); Ronald
Lynch, M.D., 75 FR 78745, 78749 (Respondent's attempts to minimize
misconduct held to undermine acceptance of responsibility); George
Mathew, M.D., 75 FR 66138, 66140, 66145, 66148 (2010); George C.
Aycock, M.D., 74 FR 17529, 17543 (2009); Steven M. Abbadessa, D.O., 74
FR 10077, 10078 (2009); Jayam Krishna-Iyer, M.D., 74 FR 459, 463
(2009); Medicine Shoppe-Jonesborough, 73 FR 364, 387 (2008). As
explained above, Respondent has not rebutted the Government's prima
facie case to the extent that he can avoid the sanction of a revocation
of his registrations. Accordingly, the Respondent's Certificate of
Registrations should be revoked, and any pending renewal applications
should be denied.
Dated: December 21, 2011.
John J. Mulrooney II,
Chief Administrative Law Judge.
[FR Doc. 2012-29333 Filed 12-4-12; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an unofficial version. An official version of this publication may be obtained
directly from the Government Printing Office (GPO).
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