Registrant Actions - 2011
[Federal Register Volume 76, Number 147 (Monday, August 1, 2011)]
[Notices]
[Pages 45867-45878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19376]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 10-39]
Michael S. Moore, M.D.; Suspension of Registration
On October 4, 2010, Administrative Law Judge John H. Mulrooney, II,
issued the attached recommended decision. Neither party filed
exceptions to the decision.
Having reviewed the record in its entirety, I have decided to adopt
the ALJ's rulings, findings of fact, and conclusions of law except for
his conclusion regarding the applicability of factor five.\1\ See ALJ
Dec. at 21-22.\2\ For the reasons explained below, I adopt in part and
reject in part the ALJ's recommended order that I suspend Respondent's
registration for a period of six months and impose various conditions
on his registration. Instead, I conclude that Respondent's registration
should be suspended for a period of one year and impose two of the four
conditions recommended by the ALJ.
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\1\ In light of the conduct proved on the record, a finding
under factor five is not necessary to conclude that Respondent has
committed acts which render his registration inconsistent with the
public interest. See Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005)
(The Agency is "not required to make findings as to all of the
factors[.]").
\2\ All citations to the ALJ's Recommended Decision are to the
slip opinion as issued on October 4, 2010.
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The record in this case establishes that Respondent was convicted
of a felony offense under Wisconsin law "relating to any substance
defined in [the Controlled Substances Act] as a controlled substance."
\3\ 21 U.S.C. 824(a)(2). More specifically, Respondent has been
convicted of the felony offense of unlawful manufacture, distribution
or delivery of "[t]wo hundred grams or less, or 4 or fewer plants
containing tetrahydrocannabinols," in violation of Wis. Stat. Sec.
961.41(1)(h)(1). ALJ Dec. at 4. Moreover, while Respondent was allowed
to plead no contest to this charge, the evidence showed that Respondent
had in his possession at least 1725 grams of marijuana, plus marijuana
seeds, four marijuana plants, and the equipment needed to grow
[[Page 45868]]
marijuana hydroponically. Id. at 8-9. The evidence also showed that
Respondent had in his possession multiple marijuana pipes and pipe
cleaners.\4\ GX 7, at 30.
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\3\ On July 14, 2011, Respondent's counsel notified this Office
that he had completed his probation and that his conviction has been
reduced to a misdemeanor. Be that as it may, under the public
interest inquiry, DEA is also required to consider Respondent's
compliance with applicable Federal and State laws related to
controlled substances. See 21 U.S.C. 823(f)(4). As explained above,
notwithstanding Respondent's completion of his probation and the
reduction of his conviction to a misdemeanor, his conduct still
constitutes a felony offense under Federal law. See 21 U.S.C. 841(a)
& (b)(1)(D).
\4\ Respondent was also convicted of possession of drug
paraphernalia, a misdemeanor offense under Wisconsin law. ALJ Dec.
at 4 (citing Wis. Stat. Sec. 961.573(1)).
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The evidence further showed that on numerous occasions,
Respondent's niece (who was the legal ward of his wife) smoked
marijuana with two boyfriends at Respondent's house and that on some
occasions she provided the marijuana. GX 7, at 1, 7-8. Moreover, one of
the boyfriends reported to the police that on two occasions, he
observed marijuana leafs drying in the bedroom closet of Respondent's
niece. Id. at 7.
As the ALJ recognized, the Government established a prima facie
case for revocation on two separate grounds: (1) his felony conviction
for manufacturing marijuana, and (2) his having committed acts which
render his registration inconsistent with the public interest. ALJ at
22 (citing 21 U.S.C. 824(a)(2) & (4)). The ALJ correctly recognized
that the burden then shifted to Respondent to demonstrate why
revocation of his registration would be inappropriate and that he was
"required not only to accept responsibility for [his] misconduct, but
also to demonstrate what corrective measures [he has] undertaken to
prevent the reoccurrence of similar acts." Id. (quoting Jeri Hassman,
M.D., 75 FR 8194, 8236 (2010)).
DEA has also repeatedly held that a registrant's candor during both
an investigation and the hearing itself is an important factor to be
considered in determining both whether he has accepted responsibility
as well as the appropriate sanction. Robert F. Hunt, D.O., 75 FR 49995,
50004 (2010); see also Hassman, 75 FR at 8236 (quoting Hoxie v. DEA,
419 F.3d 477, 483 (6th Cir. 2005) ("Candor during DEA investigations,
regardless of the severity of the violations alleged, is considered by
the DEA to be an important factor when assessing whether a physician's
registration is consistent with the public interest[.]") Moreover, in
assessing an appropriate sanction, DEA also properly considers the need
to deter others from engaging in similar acts and the egregiousness of
the misconduct. See Joseph Gaudio, 74 FR 10083, 10094 (2009); Southwood
Pharmaceuticals, Inc., 72 FR 36487, 36504 (2007) (citing Butz v. Glover
Livestock Commission Co., Inc., 411 U.S. 182, 187-88 (1973)).
Here, the ALJ found that Respondent credibly testified that he was
in compliance with the terms of his probation, as well as the terms of
the Order of the Wisconsin Medical Board, which include that he undergo
treatment and be subject to random drug testing. ALJ at 22. While the
ALJ found that Respondent "demonstrate[d] an acknowledgement that his
actions were illegal," he further observed that "Respondent's
testimony at the hearing did not reflect a high level of contrition,"
and that "true remorse, to the extent Respondent may possess it, was
not patently evident from his presentation at the hearing." Id. at 23.
As the ALJ further explained, "[d]uring his testimony, the Respondent
gave the distinct impression that he was not so much sorry about his
transgression as he was sorry that he got caught and was laboring under
the criminal and administrative consequences of that reality." Id.
In addition, I note that in his testimony, Respondent maintained
that he "never" provided marijuana to his niece, that she had
obtained it behind his back, and that he had no knowledge that she was
using marijuana and doing so with others prior to when the police
searched his house. Tr. 47-48. However, the ALJ found this testimony
"implausibl[e]," ALJ at 11, as do I.\5\ Based on the ALJ's finding, I
further find that Respondent's testimony was not entirely candid. Thus,
even giving weight to the ALJ's findings regarding Respondent's
rehabilitation and his acceptance of responsibility, Respondent's lack
of candor supports a substantial period of suspension.
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\5\ Having observed Respondent testify, the ALJs
finding is entitled to substantial deference. Beyond this, the
finding is consistent with other evidence of record including the
statement of one of the informants that whenever the subject of the
marijuana plants would come up, Respondent's niece "would say that
she couldn't talk about it"; that on at least two occasions, he
observed marijuana leaves drying in her closet; and that on another
occasion, when he and the niece needed marijuana, she left the
bedroom and returned with a large bud which "was packed down
dried." GX 7, at 13. Thus, it is clear that his niece had ready
access to Respondent's marijuana; moreover, Respondent offered no
explanation as to why he allowed his niece to have access to it. In
any event, Respondent's testimony that he was unaware that she was
using marijuana begs credulity.
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In seeking the revocation of Respondent's registration, the
Government cited three cases, each of which the ALJ distinguished on
the grounds that the various practitioners had engaged in far more
egregious misconduct either because they also "had significant * * *
prescribing anomalies," or because they were found to have grown far
larger amounts of marijuana than Respondent. ALJ at 23-24. However,
possession of a four pound stash of a schedule I controlled substance
is nothing to sneeze at, and indeed, under Federal law, it is a felony
offense punishable by up to five years imprisonment and a $250,000
fine. See 21 U.S.C. 841(a) & (b)(1)(D). Moreover, as explained above,
this is not simply a case of self-abuse. Rather, the evidence is clear
that Respondent distributed the marijuana to his wife,\6\ and whether
he actually physically delivered the drug to his niece, it is clear
that she had ready access to it and also distributed it to at least one
of her boyfriends.
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\6\ Respondent likewise maintained that his wife used marijuana
because she thought it eased a medical condition, but then
acknowledged that "[s]he would have smoked it anyway." Tr. 61.
Moreover, Wisconsin does not permit the so-called "medical" use of
marijuana.
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In short, while many cases brought under sections 303 and 304 of
the Controlled Substances Act,\7\ involve registrants who have engaged
in substantial unlawful distributions to others, Respondent's felonious
conduct is nonetheless sufficiently egregious to warrant the revocation
of his registration.\8\ See 21 U.S.C. 824(a)(2) (authorizing Agency to
suspend or revoke a registration based on conviction for felony related
to controlled substance). Moreover, even though Respondent now appears
to acknowledge most of his illegal behavior and has been in compliance
with the State Board's Order, I agree with the ALJ that the Agency's
interest in deterring similar misconduct on the part of others warrants
a substantial period of outright suspension. However, because I
disagree with the ALJ's recommendation that a six-month suspension
sufficiently protects the Agency's interest in deterring misconduct on
the part of others and also note Respondent's less than candid
testimony regarding his niece's access and use of marijuana, I will
order that Respondent's registration be suspended for a period of one
year.\9\ Further, while Respondent's renewal application will be
granted (subject to the suspension of
[[Page 45869]]
his registration as set forth above), I further adopt the following
conditions as recommended by the ALJ:
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\7\ 21 U.S.A. 823 and 824.
\8\ Indeed, in Alan H. Olefsky, 57 FR 928 (1992), DEA revoked a
practitioner's registration based on his have in presented (in a
single act) two fraudulent prescriptions to a pharmacist for
filling. Respondent's conduct is at least as egregious as, if not
considerably more so than, the conduct which warranted revocation in
Olefsky.
\9\ In determining the appropriate sanction, I have also
considered the June 14, 2011 letter written by the Langlade County
District Attorney on Respondent's behalf which was submitted to this
Office on July 14, 2011. However, other than the information that
Respondent has completed his probation and the terms of his
sentence, the remainder of the letter does not constitute newly
discovered evidence and I give it no weight.
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(1) The Respondent will comply with the terms and conditions of his
criminal sentence and the Order of the Wisconsin Medical Board that are
currently in effect, as well as any conditions which may be imposed in
the future by either the state court or the Wisconsin Medical Board;
Respondent shall provide a copy of all reports which he is required to
submit to the Wisconsin Medical Board or the Department Monitor to the
local DEA office within five business days of the submission.
(2) Respondent shall agree and ensure that copies of all drug
screening test results are submitted to the local DEA office, whether
those tests are ordered by the state court, the Wisconsin Medical
Board, or the approved drug and alcohol monitoring program in which he
has enrolled pursuant to the Final Order of the Wisconsin Board.\10\
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\10\ Because the Wisconsin Board imposed extensive drug testing
on Respondent in its final order, and Respondent has passed each of
these tests, I conclude that it is unnecessary to subject Respondent
to additional drug testing. For this reason, as well as that there
is no evidence that Respondent has diverted controlled substances in
his professional capacity, I conclude that is unnecessary to require
as a condition of his registration, that he agree to warrantless
searches of his residence and principal place of business.
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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) and 0.104, I hereby order that the
application of Michael S. Moore, M.D., to renew his DEA Certificate of
Registration be, and it hereby is, granted subject to the conditions
set forth above. I further order that the registration of Michael S.
Moore, M.D., be, and it hereby is, suspended for a period of one year.
This Order is effective August 31, 2011.
Dated: July 21, 2011.
Michele M. Leonhart,
Administrator.
James Hambuechen, Esq., for the Government;
David Madison, Esq., for the Respondent.
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge
John J. Mulrooney, II, Administrative Law Judge. On February 26,
2010, the Drug Enforcement Administration (DEA) Deputy Assistant
Administrator issued an Order to Show Cause (OSC) seeking revocation of
the Respondent's Certificate of Registration (COR), Number BM6464147,
as a practitioner, pursuant to 21 U.S.C. 824(a)(2) and (a)(4), and
denial of any pending applications for renewal or modification of such
registration, pursuant to 21 U.S.C. 823(f), alleging that the
Respondent has been convicted of a felony and misdemeanor involving
controlled substances, and that his continued registration is otherwise
inconsistent with the public interest, as that term is used in 21
U.S.C. Sec. 823(f). On March 23, 2010, the Respondent timely requested
a hearing, which was conducted in Arlington, Virginia, on August 31,
2010.\11\
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\11\ Following the unexpected and unfortunate passing of the
Gene Linehan, Esq., who had represented the Respondent at and prior
to the hearing in this matter, representation was undertaken by
current counsel, David Madison, Esq., an attorney who was associated
with Mr. Linehan's law firm.
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The issue ultimately to be adjudicated by the Deputy Administrator,
with the assistance of this recommended decision, is whether the record
as a whole establishes by substantial evidence that Respondent's
registration with the DEA should be revoked as inconsistent with the
public interest as that term is used in 21 U.S.C. 823(f) and 824(a)(4).
The Respondent's DEA COR is set to expire by its terms on January 31,
2011.
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
below.
The Evidence
The OSC issued by the Government alleges that revocation of the
Respondent's COR is appropriate because of the Respondent's April 9,
2009 no contest plea to a felony charge of manufacturing and delivering
tetrahydrocannabinols (THC),\12\ and a misdemeanor charge of possession
of drug paraphernalia, both of which, according to the Government's
allegations, constitute criminal convictions that "arose from [the
Respondent] growing large amounts of marijuana at [Respondent's] home,
which was discovered upon the execution of a search warrant on August
3, 2007." \13\
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\12\ A Schedule I controlled substance. 21 U.S.C. 812; 21 CFR
1308.11.
\13\ Initially, the OSC also alleged that a positive urinalysis
result rendered the Respondent in violation of the terms of an
October 17, 2007 Final Decision and Order of the State of Wisconsin
Medical Examining Board (Wisconsin Medical Board), requiring him to
abstain from the personal use of controlled substances without a
legitimate prescription. At the outset of the hearing, however, the
Government withdrew that allegation. ALJ Ex. 11; Tr. at 12-14, 82.
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At the hearing, the Government presented the testimony of DEA
Diversion Investigator (DI) Thomas B. Hill, in support of its case for
revocation. Through DI Hill's testimony, the Government introduced the
Final Decision and Order relative to the Respondent which was issued by
the Wisconsin Medical Examining Board (Wisconsin Medical Board) on
October 17, 2007. Gov't Ex. 3; Resp't Ex. 7; Tr. at 20. That document
contains the Respondent's stipulation to the Wisconsin Medical Board's
factual finding that, on August 3, 2007, he "possess[ed]
tetrahydrocannabinol, a Schedule I controlled substance, not in the
course of professional practice, and without any other authorization to
do so," and that said conduct "violated Wis. Stat. Sec. 961.41(3g)
[possession of controlled substance], Wis. Adm. Code Sec. Med
10.02(2)(p) [obtaining controlled substance outside legitimate
practice], and (z) [violation of related law or rule]," and that
"[s]uch conduct constitutes unprofessional conduct within the meaning
of the Code and statutes." Gov't Ex. 3 at 1-2; Resp't Ex. 7 at 1-2. As
a result of these factual findings and conclusions of law, the
Respondent's state medical license was indefinitely suspended for a
period of at least five years, subject to a stay of that suspension,
which was conditioned upon the Respondent remaining in compliance with
certain conditions and limitations contained in the Order. The
conditions of the stay include rehabilitation, drug monitoring, and
treatment regimens, all of which are directed to be conducted at his
expense. The regimens set forth in the Wisconsin Medical Board's Order
require the Respondent to, inter alia, attend individual and/or group
therapy sessions, attend weekly Narcotics and/or Alcoholic Anonymous
meetings, abstain from all personal use of alcohol, abstain from
controlled substances "except when prescribed, dispensed or
administered by a practitioner for a legitimate medical condition,"
notify his designated treating physician and the Department Monitor
within twenty-four hours of ingestion or administration of any and all
medications and drugs, provide those officials with any associated
prescription, and submit to drug and alcohol urinalysis screens at a
frequency of not less than ninety-six times per year for the first year
of the program. Gov't Ex. 3 at 3-4; Resp't Ex. 7 at 3-4. With respect
to practice limitations, the Wisconsin Medical Board's Order limits the
Respondent's practice of medicine to serving as an emergency physician
in a Board-approved setting, and prohibits him from prescribing or
ordering
[[Page 45870]]
controlled substances outside of that setting. Furthermore, the Order
forbids the Respondent from the administering or dispensing of all
controlled substances, and provides that all controlled substance
orders issued by Respondent through his practice as an emergency
physician "shall be reviewed by another physician within twenty-four
hours of issuance, in a manner which documents the review." Gov't Ex.
3 at 4; Resp't Ex. 7 at 4.
Through the testimony of DI Hill, the Government also introduced
various documents obtained from the Wisconsin Court system relative to
the Respondent's state criminal case, which arose out of the same
conduct at issue in the state medical board proceedings. Gov't Ex. 6.
Those documents reflect that on April 9, 2009, the Respondent entered a
no contest plea \14\ to Wisc. Stat. Sec. 961.41(1)(h)(1),
Manufacturing or Delivering \15\ less than or equal to 200 grams of THC
(a felony), and Wisc. Stat. Sec. 961.573(1), Possession of Drug
Paraphernalia (a misdemeanor), and, pursuant to that plea, was found
guilty of both charges. Id. The documents reflect that the Respondent
was sentenced to probation (sentence withheld two years), conditioned
upon serving thirty days at Langlade County Jail with work-release
privileges, 160 hours of community service, a monetary fine, a six
month suspension of his driver's license, and several other terms. Id.
at 3-4.
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\14\ A plea of no contest or nolo contendere that results in a
judgment of conviction constitutes a conviction for purposes of the
Controlled Substances Act (CSA). Pearce v. DEA, 867 F.2d 253, 255
(6th Cir. 1988); Noell v. Bensinger, 586 F.2d 554, 556-57 (5th Cir.
1978); Sokoloff v. Saxbe, 501 F.2d 571, 575 (2d Cir. 1974).
\15\ A Plea Questionnaire/Waiver of Rights form subsequently
entered into the record through Respondent's testimony reflects that
the Respondent only pleaded guilty to the manufacturing of THC,
rather than the statutory elements relating to delivery/
distribution. Resp't Ex. 3 at 3; see also Tr. at 21-22, 67-70.
Accordingly, the disposition of this charge is referenced
hereinafter as a felony conviction for controlled substance
manufacturing.
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The transcript of the state court guilty plea was offered by the
Respondent and received into evidence.\16\ Tr. at 67; Resp't Ex. 1.
Although at his sentencing hearing, the Respondent provided an unsworn
statement assuring the criminal trial judge that he "never sold
[marijuana and] never shared it," \17\ the record contains the
following comments from the trial judge on the subject:
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\16\ The Respondent initially marked individual pages of the
state court sentencing transcript as separate proposed exhibits, but
the entire transcript was relatively brief and was received into
evidence as a single exhibit.
\17\ Resp't Ex. 1 at 23.
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I don't totally accept that [the Respondent] was growing simply
for his own use. I think it was for probably, in all likelihood, him
and his guests of like mind, his wife, but I do agree I am looking
at this, and I see to a large extent these are plants, seeds, stems.
Looks to me that there's probably some processed here. Looks to be
down to the buds that are in the plastic bags, and probably more than you would normally find.
Resp't Ex. 1 at 26.
The criminal sentencing transcript also reflects an acknowledgement
by the trial court that, under Wisconsin law, the Respondent, upon
successful completion of his probation, may apply to have the felony
conviction reduced to a misdemeanor. Resp't Ex. 1 at 3. Although there
is no indication in the record that such an application has been
granted, is pending, or has even been submitted to competent state
officials for action,\18\ it is worthy of note that Agency precedent
has long held that even a subsequent dismissal would not undermine the
validity of a criminal conviction for purposes of the CSA. Edson W.
Redard, M.D., 65 FR 30616, 30618 (2000); Stanley Alan Azen, M.D., 61 FR
57893, 57895 (1996). Thus, following his plea to felony manufacturing
of tetrahydrocannabinol (THC), Respondent remains a convicted felon,
"convicted of a felony under [the law of Wisconsin] relating to * * *
a controlled substance. * * *" \19\
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\18\ Tr. at 90.
\19\ 21 U.S.C. 824(a)(2).
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The Government, through the testimony of DI Hill, also introduced a
packet containing information related to the state criminal case that
culminated in the convictions that form the basis of the Wisconsin
Board Order. Gov't Ex. 7. Specifically, the Government provided the
search and arrests warrants associated with the August 3, 2007 arrest
that resulted in the Respondent's conviction of felony manufacturing of
THC and misdemeanor possession of drug paraphernalia, as well as the
associated affidavits prepared by the executing state law enforcement
officers.\20\ Gov't Ex. 7 at 1-5. The Government also supplied numerous
investigation reports, inventories and allied documents prepared by
members of two local county law enforcement entities, and sworn, hand-
written statements from current and former boyfriends of the
Respondent's niece. Id. at 6-31, 42-46. Also included in the packet
were numerous documents that the Government alleged were seized at the
Respondent's residence in connection with the search warrant execution,
and which, according to the Government, demonstrated the Respondent's
participation in a significant marijuana growing operation. Id. at 32-
41.
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\20\ The Government did not produce live testimony from any of
the state law enforcement officers.
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It is well-settled that hearsay may be correctly considered at an
administrative hearing and may even support a finding of substantial
evidence. Richardson v. Perales, 402 U.S. 389, 402 (1971) (signed
reports prepared by licensed physicians correctly admitted at Social
Security disability hearing); Keller v. Sullivan, 928 F.2d 227, 230
(7th Cir. 1991) (insurance company investigative reports correctly
admitted in Social Security disability hearing where sufficient indicia
of reliability established); Calhoun v. Bailar, 626 F.2d 145, 149 (9th
Cir. 1980) (hearsay affidavits correctly admitted where indicia of
reliability established). However, there are limits that circumscribe
the admission and utility of hearsay evidence before an administrative
tribunal. The touchstone is that before it may be used to support of
finding of substantial evidence, the offered hearsay evidence must have
sufficient reliability and credibility. Divining the correct use of
hearsay evidence requires a balancing of four factors: (1) Whether the
out-of-court declarant was not biased and had no interest in the
outcome of the case; (2) whether the opposing party could have obtained
the information contained in the hearsay before the hearing and could
have subpoenaed the declarant; (3) whether the information was
inconsistent on its face; and (4) whether the information has been
recognized by the courts as inherently reliable. J.A.M. Builders v.
Herman, 233 F.3d 1350, 1354 (11th Cir. 2000).
Government Exhibit 7 divides analytically into five general
categories of evidence: (1) A signed search and arrest warrant with its
underlying supporting affidavit (executed by a local law enforcement
officer) and some blank affiliated paperwork; \21\ (2) two sworn
statements apparently procured by local law enforcement personnel,
signed by two individuals whom claim, respectively, to be the current
and former boyfriend of the Respondent's niece (the boyfriends); \22\
(3) unsigned typewritten police reports prepared by named local law
enforcement personnel with apparent personal knowledge of the events
contained therein, along with an apparently affiliated narcotics field
[[Page 45871]]
test report \23\ and documents that appear to reflect an inventory of
items seized from the Respondent's residence on the night the search
warrant was executed; \24\ (4) documents purportedly seized from the
Respondent's residence; \25\ and (5) unsigned, handwritten notes that
may have been prepared by law enforcement personnel on the scene of the
search warrant executed at the Respondent's home.\26\
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\21\ Gov't Ex. 7 at 1-5.
\22\ Id. at 13-14.
\23\ Although at least part of the Respondent's objection to the
field test portion of the exhibit was founded in counsel's assertion
that the type of field test employed was not adequately identified,
Tr. at 30, the police paperwork indicates that a Nark II test 05 was
utilized. Gov't Ex. 7 at 15.
\24\ Id. at 6-12, 15-31.
\25\ Id. at 32-41.
\26\ Id. at 44-46.
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Regarding the fifth category (handwritten police notes), the
documents are intermittently legible, insufficiently explained by any
witness with personal knowledge, were excluded from consideration at
the hearing,\27\ and will play no role in the disposition of this case.
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\27\ Tr. at 38-39.
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The documents offered by the Government in the fourth category
(seized from the Respondent's residence) were authenticated by the
Respondent, himself, who testified that he prepared the handwritten
notes in the packet related to preparing for and monitoring the
progress of his marijuana grow. Tr. at 50. Some of the seized notes
related to information the Respondent accumulated to help him select
the most effective lighting to maximize his marijuana yield. Id. at 49-
50; Gov't Ex. 7 at 32. There are other notes that the Respondent
indicated were taken from a book he read regarding marijuana grow
methods,\28\ and still more notes reflected his careful monitoring of
the growth progress of his marijuana plants. Tr. at 49-51; Gov't Ex. 7
at 35-36. The Respondent identified a portion of the documents as an
Internet recipe for preparing "hash," an enterprise that he
apparently attempted in vain. Tr. at 52; Gov't Ex. 7 at 37-41. The
Respondent's marijuana research notes and materials were sufficiently
authenticated and relevant to merit admission and consideration in
these proceedings and clearly demonstrate a high level of planning in
his efforts to circumvent the CSA.
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\28\ Gov't Ex. 7 at 33-34.
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Regarding the other documents in Government Exhibit 7, the first
three J.A.M. Builders factors militate in favor of admission. There is
no indication of bias on the part of the local law enforcement officers
who swore out the warrant affidavits, prepared the investigative
reports, and took the sworn statements from the two boyfriends.
Likewise, no bias is readily apparent regarding the statements from the
boyfriends.\29\ The Respondent clearly had the opportunity to subpoena
\30\ any of the authors of any of the documents but elected (presumably
for tactical reasons) not to do so. The documents are internally
consistent and essentially consistent with one another.
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\29\ To the extent that bias borne of jealousy or unrequited
affection may have existed, it was not developed, elicited, or
argued by any party to this litigation. To assign bias on the
current record would be to engage in unwarranted and unfair
speculation.
\30\ In fact, the Prehearing Ruling, which was issued after
service of the Government's Prehearing statement outlining its
evidence, set a date by which subpoena requests were due. ALJ Ex. 7
at 4. No subpoena requests from the Respondent were filed.
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Consideration of the fourth factor, that is, whether the
information has been recognized by the courts as inherently reliable,
is something of a mixed bag regarding Government Exhibit 7. In this
administrative setting, the inventory log is reliable to the same
extent generally accorded to records prepared in the regular course of
business,\31\ and courts routinely rely on sworn affidavits to support
searches, seizures, and other intrusions,\32\ but there is no
precedential basis to accord any special weight to police reports. In
Richardson,\33\ the Supreme Court squarely based its holding on the
narrow fact that the party opposing admission never used the available
procedural devices to seek the personal appearances of the declarants,
but the Richardson court took pains to point out that the case dealt
with the admission of medical reports, each of which was "prepared by
a practicing physician who had examined [the opponent of admission and
where each of whom had] set[] forth his medical findings in his area of
competence. * * *" 402 U.S. 389, 402 (1971). As the post-Richardson
cases have evolved, the emphasis has increasingly focused on whether
the opponent could have subpoenaed the declarant but declined to do so,
and whether the hearsay is reliable and trustworthy. In U.S. Pipe &
Foundry Co. v. Webb, 595 F.2d 264, 270 (5th Cir. 1979), the court re-
emphasized that medical reports are inherently reliable and
trustworthy. In Klinestiver v. DEA, 606 F.2d 1128, 1130 (D.C. Cir.
1979), the court held that hearsay at a DEA administrative hearing may
constitute substantial evidence where the opponent of the evidence
could have subpoenaed the declarant but declined to do so, and that the
controlling guidance regarding admission is found in the DEA
regulations. The current DEA regulations provide for the admission of
evidence that is "competent, relevant, material, and not unduly
repetitious." 21 CFR 1316.59(a).
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\31\ This heightened level of reliability is based on the
likelihood that inventory logs reflecting seized property have been
accurately kept, given that such logs are judicially-mandated
pursuant to Fed. R. Crim. P. 41(f)(1)(b) (or, as is relevant to this
case, the equivalent Wisconsin state criminal procedural rule, i.e.
Wisc. Stat. Sec. 968.17) and routinely relied on for a property
itemization and accounting purpose by the courts, law enforcement,
and the person whose property was seized.
\32\ See Fed. R. Crim. P. 41(d).
\33\ 402 U.S. 389 (1971).
---------------------------------------------------------------------------
Balancing the J.A.M. Builders factors, the sworn statements, police
reports, and allied paperwork (excluding the withdrawn, illegible
handwritten notes) were admitted and considered, albeit with the
heightened scrutiny correctly attached to evidence that has not been
exposed to the rigors of cross-examination. Cf. 21 CFR 1301.43(c) (DEA
regulations provide for the consideration of waiver-related statements
to be "considered in light of the lack of opportunity for cross-
examination in determining the weight to be attached to matters of fact
asserted therein."). Government Exhibit 7, as admitted, establishes
that the search warrant and ultimate arrest was the result of an
investigation initiated based on information gleaned from a former
boyfriend of the Respondent's niece. The niece was living in the
Respondent's home and apparently smoking and sharing marijuana with
guests, including (by their own accounts and at different times) the
two boyfriends. When officers executed the state-authorized \34\ search
warrant, they uncovered a hidden, locked room with elaborate equipment
utilized for the growing of marijuana, as well as multiple bags and
other containers that held marijuana plant parts and seeds. According
to the paperwork, 4.76 pounds \35\ of marijuana were identified,
tested,\36\ and seized from the Respondent's residence. Gov't Ex. 7 at
17-18. Additionally, the executing officers seized some paperwork they
believed to be related to the growing of marijuana, and through a
previous, separate authorization, learned that the Respondent's power
bill, at least in the opinion of the state investigators, was
[[Page 45872]]
unusually large.\37\ Id. at 1. The officers observed and seized what
they characterized as "four large stalks [of marijuana] in the
hydroponic growing stages." \38\ Id. at 9.
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\34\ The search warrant was authorized by a Langlade County
Court Commissioner. Gov't Ex. 7 at 2-3.
\35\ DI Hill testified that 1,725 grams were seized, Tr. at 16,
which would be a little less than four pounds.
\36\ Gov't Ex. 7 at 15.
\37\ Presumably this information was included on the affidavit
in support of the search warrant under the theory that it was
consistent with the power required to run electrical equipment
associated with a marijuana grow operation.
\38\ Although the police paperwork indicates that both still and
video photographs of the hidden room, marijuana, and paraphernalia
were generated at the scene contemporaneous with the search warrant
execution, the Government, inexplicably, did not offer any of this
evidence at the hearing. During his testimony, DI Hill initially
testified that three (3) marijuana plants were seized from the
Respondent's residence. Tr. at 39-40. This is curious in light of
the fact that he readily maintained that all his knowledge about the
case was obtained through the paperwork he provided, Id. at 19, 41,
and the paperwork indicates that four (4) plants were seized. Gov't
Ex. 7 at 9. In his testimony, the Respondent confirmed that four (4)
plants were seized. Tr. at 46.
---------------------------------------------------------------------------
Inasmuch as DI Hill gleaned all the information he had about the
case from documents that he obtained from local law enforcement
officers and a court database check, the factual aspects of the case
depend less on the credibility of his testimony than the truth of the
facts established by the Government's exhibits introduced through
Hill's testimonial foundations. Furthermore, even considering that the
acknowledgement of virtually all the factual matters asserted in the
paperwork by the Respondent in his testimony further diminishes the
significance of Hill's testimony, it is worth noting that DI Hill
provided testimony that was sufficiently detailed, plausible, and
internally consistent to be deemed credible.
The Respondent testified at the hearing.\39\ By his own account,
the Respondent, who lives with his wife, two small children,\40\ and
his niece, has quite a history with marijuana. He recalled smoking
marijuana most days he attended college, most non-working days after
college, and several times a week through his medical residency
program. Tr. at 44-45. After presumably purchasing marijuana on a
regular basis for most of his adult life, the Respondent testified that
he began growing his own marijuana during the 2004-2005 time frame. Id.
at 46. At the time his house was searched, his current marijuana crop
(grow) had four (4) plants, the yield of which, at least according to
his testimony, was reserved for use by himself and his wife. Id. at 47.
The Respondent acknowledged that he and his wife share their family
home with their two children, ages nine and eleven, as well as a niece,
and that his in-laws were the only people outside his home who knew
about his foray into the world of marijuana production. Id. at 47.
While the Respondent did not dispute the accounts in the police
paperwork that ascribe significant marijuana consumption to his niece,
he testified that this information came as a surprise to him. Id. at
47-48.
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\39\ Although the Respondent noticed himself as a witness, he
testified as a witness called by the Government.
\40\ Tr. at 56.
---------------------------------------------------------------------------
Regarding his conviction, the Respondent freely acknowledged all
the attendant facts raised in the court records and the police
paperwork, as well as the illegality of his conduct and the propriety
of the conviction. Id. at 55, 77, 79. The Respondent represented that
he intended to avoid violating controlled substance laws in the future.
Id. at 76. In response to questioning by the Government, the Respondent
agreed that marijuana is an illegal substance and concurred that his
conviction was not unfair. Id. at 55. When asked why he elected to grow
marijuana (after an adult lifetime of presumably acquiring the
substance by other means), the Respondent related that he lived in a
small community and would likely be easily identified as a physician
during any exploit to purchase marijuana from those "on the street"
in his local area willing to sell it.\41\ Id. at 78.
---------------------------------------------------------------------------
\41\ During his criminal sentencing hearing, the Respondent's
counsel argued that he chose to grow marijuana to help his wife with
a digestive disorder and as a way to withhold support from Mexican
drug cartels. Resp't Ex. 1 at 19. The Respondent's response at his
DEA administrative hearing appears to be a more candid and plausible
handling of the issue.
---------------------------------------------------------------------------
The Respondent credibly testified that he has complied with the
conditions fixed by the Wisconsin Medical Board during the first three
years of the five-year duration of its Order. Id. at 58-59. In
particular, the Respondent testified that he has complied with the
Order's mandate of random urinalysis, including one directive to
provide a random sample which serendipitously arose while he was
traveling to the hearing of this case. Id. at 59.
The Respondent also elaborated on the community service that he
provided at the direction of the Wisconsin Medical Board. Although he
performed work at a hospice as directed by the criminal court, the
Respondent also indicated that he continues to contribute his time to
the nun-operated hospice, even after the community service time in his
sentence has been completed. Id. at 64-65. The Respondent also
testified that he had performed volunteer work at the hospice before
his conviction. Id.
The Respondent characterized his community as "sparsely
populated," discussed his perception that physician recruitment was
problematic in the area, and indicated that he would be unable to
provide his emergency room services if rendered unauthorized to handle
controlled substances. Id. at 65-66.
While the Respondent implausibly testified that the marijuana he
produced was only consumed by himself and his wife, and that he was
surprised to learn that his niece (who was also the legal ward of his
wife) was also smoking his pot by herself and with company, the bulk of
his other testimony, though admittedly self-serving, was sufficiently
plausible, detailed, and internally consistent to be deemed generally
credible for purposes of this recommended decision.
The Respondent offered letters of support from various medical
practitioners in his community. Resp't Exs. 8-11. A carefully-worded
letter authored by Noel N. Deep, M.D., F.A.C.P., the Chief of Staff at
the Langlade Hospital, relates that the Respondent has "scored high on
patient satisfaction surveys, that his "professionalism and clinical
skills" have won praise from members of the hospital staff, that he
has volunteered to serve in numerous capacities in the hospital, and
that Dr. Deep has "never been aware of any adverse clinical outcomes
or patient care concerns" related to the Respondent's work. Resp't Ex.
8. The principal thrust of Dr. Deep's letter is to essentially
highlight the potential impact that would be felt by Langlade Hospital
and the rural community surrounding it should one of its four emergency
room physicians be deprived access to controlled substance handling
authority by DEA. Id. In particular, the letter indicates that an
adverse DEA decision in this regard "would burden the other three
physicians who currently share the Emergency Room call rotation with
[the Respondent]." Id.
Another Langlade Hospital administrator, David Schneider, the
executive director, also provided a letter of support. Resp't Ex. 10.
Like the wording in Dr. Deep's letter, this hospital official
references the Respondent's patient satisfaction survey scores, and
indicates that there have been "[n]o clinical adverse issues"
associated with the Respondent's practice at the hospital, which (like
the survey results) Mr. Schneider characterizes as "at the upper end
of quality scales." Id. Mr. Schneider, like Dr. Deep, spends a
significant portion of his letter seeking leniency for the Respondent,
based upon community
[[Page 45873]]
impact, stating that "Langlade Hospital serves a medically underserved
area [where] it has been and is increasingly difficult to obtain and
maintain skilled practitioners in full-time [emergency room] service."
Id.
A third letter admitted into evidence is co-signed by the three
emergency medicine physicians who, according to the Respondent,\42\ are
his partners at Northwoods Emergency Physicians, LLP (the Northwoods
Group), a medical entity that provides emergency room physicians to
Langlade Hospital. Resp't Ex. 9; Tr. at 63. The letter from the
Respondent's associates details the conditions fixed by the Wisconsin
Medical Board in its Order, and (somewhat self-servingly) concludes
that "[t]hese are adequate measures to assure patient safety." Resp't
Ex. 9. Like the other letters, there is a reference to the doctors'
perception that the area surrounding Langlade Hospital is
"underserved" and currently benefits by the Respondent's presence
there, and presumably also his access to controlled substances.
---------------------------------------------------------------------------
\42\ Tr. at 73.
---------------------------------------------------------------------------
The Respondent also provided a letter from Sister Dolores
Demulling, R.N., M.S., the Administrator at the LeRoyer Hospice
affiliated with the hospital where the Respondent serves in the
emergency room. Resp. Ex. 11. Sr. Demulling confirmed the Respondent's
representations that he has volunteered his time doing hospice work and
provides her estimation that the Respondent's "medical care in the
emergency room has always been very satisfactory." Id.
In evaluating the weight to be attached to the representations in
the letters provided by the Respondent's hospital administrators and
peers, it can hardly escape notice that, in addition to the fact that
the authors were not subjected to the rigors of cross examination, each
source has a significant influencing consideration that bears caution.
The emergency room doctors are the Respondent's partners. As partner-
members to a group which is contracted to cover Langlade Hospital, it
is not improbable that the doctors would likely be understandably
reluctant to question the abilities of one of their own. Criticism of a
member's ability to safely continue to serve the hospital would
perforce call into question the Northwoods Group's ability to continue
to staff the emergency room. Similarly, the hospital administrators who
have elected to allow the Northwoods Group to continue to utilize the
Respondent's services for patient care would be virtually unable to
provide an unflattering assessment of any concerns they possess without
exposing the institution to significant potential past and future tort
and/or regulatory liability. However, even bearing these concerns in
mind, the letters can, should, and will nevertheless provide evidence
that other medical professionals and administrators feel sufficiently
confident in the Respondent and his level of professional commitment
that they believe his continued authorization to handle controlled
substances will not pose an unacceptable risk to the patients served by
Langlade Hospital.
Other evidence required for a disposition of this issue is set
forth in the analysis portion of this decision.
The Analysis
The Deputy Administrator \43\ may revoke a registrant's DEA
Certification upon a finding that the registrant has been convicted of
a felony relating to a CSA-designated controlled substance. 21 U.S.C.
Sec. 824(a)(2). As discussed supra, a conviction resulting from a nolo
contendere, or "no contest" plea, is a conviction providing a
sufficient basis for the revocation of a DEA COR under section
824(a)(2). Pearce v. DEA, 867 F.2d 253, 255 (6th Cir. 1988); Noell v.
Bensinger, 586 F.2d 554, 556-57 (5th Cir. 1978); Sokoloff v. Saxbe, 501
F.2d 571, 574-75 (2d Cir. 1974); Edson W. Redard, M.D., 65 FR 30616,
30618 (2000). Furthermore, inasmuch as the Agency has consistently held
that a deferred adjudication of guilt following a guilty plea, even
where the proceedings are later dismissed, still constitutes a
conviction within the statutory meaning of the CSA,\44\ the potential
for some future reduction of the Respondent's conviction before the
Wisconsin state courts bears little on any issue relevant to a
disposition of this administrative case. Hence, inasmuch as the
uncontroverted evidence of record conclusively establishes that the
Respondent has been convicted of a state felony relating to controlled
substances, to wit, the manufacture of a Schedule I controlled
substance (marijuana), the Government has established a basis under
which the revocation relief it seeks may be evaluated to determine
whether it constitutes a provident exercise of discretion. Pearce, 867
F.2d at 256.
---------------------------------------------------------------------------
\43\ This authority has been delegated pursuant to 28 CFR
0.100(b) and 0.104.
\44\ Vincent J. Scolaro, D.O., 67 FR 42060, 42065 (2002) (citing
Yu-To Hsu, M.D., 62 FR 12840 (1997)); Redard, 65 FR at 30618;
Stanley Alan Azen, M.D., 61 FR 57893, 57895 (1996). Agency precedent
has previously validated the position that to hold otherwise would
mean "the conviction could only be considered between its date and
the date of subsequent dismissal * * * [which would be] inconsistent
with holdings in other show cause cases that the passage of time
since misconduct affects only the weight to be given the evidence."
Edson W. Redard, M.D., 65 FR 30616, 30618 (2000) (citing Mark
Binette, M.D., 64 FR 42977, 42980 (1999)); Thomas H. McCarthy, D.O.,
54 FR 20938 (1989), aff'd No. 89-3496 (6th Cir. Apr. 5, 1990).
---------------------------------------------------------------------------
In addition to the controlled-substance-related felony conviction
basis that the Government established in support of the revocation it
seeks, under 21 U.S.C. 824(a)(4), the Deputy Administrator may also
revoke a registrant's DEA COR if persuaded that the registrant "has
committed such acts that 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 applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State
laws relating to the manufacture, distribution, or dispensing of
controlled substances.
(4) Compliance with applicable State, Federal or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
21 U.S.C. 823(f).
"[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 Deputy Administrator may properly give each
factor whatever weight she deems appropriate in determining whether an
application for a registration should be denied. Id.; David H. Gillis,
M.D., 58 FR 37507, 37508 (1993); see also Joy's Ideas, 70 FR 33195,
33197 (2005); Henry J. Schwarz, Jr., M.D., 54 FR 16422 (1989).
Moreover, the Deputy 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 v. DEA, 412 F.3d 165, 173-74 (D.C. Cir.
2005). The Deputy 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) (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
[[Page 45874]]
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 DEA Certificate of
Registration, the DEA has the burden of proving that the requirements
for revocation are satisfied. 21 CFR 1301.44(e). Once DEA has made its
prima facie case for revocation of the registrant's DEA COR, the burden
of production then shifts to the Respondent to show that, given the
totality of the facts and circumstances in the record, revoking the
registrant's registration would not be appropriate. 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, 72311 (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 8194,
8236 (2010).
Where the Government has sustained its burden and established that
a registrant has committed acts inconsistent with the public interest,
that registrant must present sufficient mitigating evidence to assure
the Deputy Administrator that he or she can be entrusted with the
responsibility commensurate with such a registration. Steven M.
Abbadessa, D.O., 74 FR 10077 (2009); Medicine Shoppe-Jonesborough, 73
FR 364, 387 (2008); Samuel S. Jackson, D.D.S., 72 FR 23848, 23853
(2007). Normal hardships to the practitioner, and even the surrounding
community, that are attendant upon the lack of registration are not a
relevant consideration. Abbadessa, 74 FR at 10078; see also Gregory D.
Owens, D.D.S., 74 FR 36751, 36757 (2009).
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; 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.
While the burden of proof at this administrative hearing is a
preponderance-of-the-evidence standard, see Steadman v. SEC, 450 U.S.
91, 100-01 (1981), the Deputy Administrator's factual findings will be
sustained on review to the extent they are supported by "substantial
evidence." Hoxie, 419 F.3d at 481. While "the possibility of drawing
two inconsistent conclusions from the evidence" does not limit the
Deputy 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 Village Pharm. 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
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., Inc., 411 U.S. 182, 188
(1973)), cert. denied, ---- U.S. ----, 129 S. Ct. 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 Deputy
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 Deputy Administrator and do not limit
the exercise of that discretion. 5 U.S.C. Sec. 557(b); River Forest
Pharm., Inc. v. DEA, 501 F.2d 1202, 1206 (7th Cir. 1974); Attorney
General's Manual on the Administrative Procedure Act 8 (1947).
Factor 1: The Recommendation of the Appropriate State Licensing Board
or Professional Disciplinary Authority
The present record reflects that the Wisconsin Medical Board, by
issuing a suspension that was stayed with conditions, implicitly
determined that with the imposition of a number of arguably arduous
monitoring and supervision conditions the Respondent could continue to
practice medicine and handle controlled substances. Gov't Ex. 3; Resp't
Ex. 7.
Action taken by a state medical board is an important, though not
dispositive, factor in determining whether the continuation of a DEA
COR is consistent with the public interest. Patrick W. Stodola, M.D.,
74 FR 20727, 20730 (2009); Jayam Krishna-Iyer, 74 FR at 461. The
considerations employed by, and the public responsibilities of, a state
medical board in determining whether a practitioner may continue to
practice within its borders are not coextensive with those attendant
upon the determination that must be made by the DEA relative to
continuing a registrant's authority to handle controlled substances. 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 and not
state officials. Stodola, 74 FR at 20375. On the issue of revocation,
consideration of this first factor presents something of a mixed bag.
By its own terms, the Order suspends the Respondent's medical license
indefinitely, but stays that action, contingent on the satisfaction of
numerous conditions. Gov't Ex. 3 at 3; Resp't Ex. 7 at 2. In exercising
its public safety responsibilities and medical oversight authority
relative to the Respondent, the Order of the Wisconsin Medical Board
reflected the judgment of that body that the Respondent's
transgressions, while sufficiently grave to warrant a complete
preclusion of all medical privileges, were not of a nature
[[Page 45875]]
that precluded the safe treatment of patients and handling of
controlled substances, so long as significant monitoring and oversight
were mandated. This factor weighs in favor of a significant sanction,
but also lends some possible support to the consideration of a less
stringent alternative to the complete COR revocation sought by the
Government.
Factor 3: The Applicant's Conviction Record Under Federal or State Laws
Relating to the Manufacture, Distribution, or Dispensing of Controlled
Substances
The record reflects the Respondent was convicted of felony
manufacture of marijuana, as referenced under the 21 U.S.C. 824(a)(2)
analysis. Consistent with his plea, the Respondent was also convicted
of a state misdemeanor offense related to the possession of drug
paraphernalia.
By its own terms, as expressed in the record of conviction, the
Respondent's marijuana manufacture felony conviction is clearly related
to the manufacture of controlled substances. That the Respondent was
convicted of illegally manufacturing a Schedule I controlled substance
in a clandestine partition within the bedroom closet of his residence
while he was operating under a DEA COR is, without a doubt, logically
repugnant to the notion that he should ever again be entrusted with the
responsibilities of a DEA registrant, and therefore militates strongly
in favor of the revocation sought by the Government.
As clear as the pendulum under Factor 3 swings regarding the
Respondent's manufacturing conviction, the picture is somewhat murkier
regarding his misdemeanor conviction for drug paraphernalia. While the
paraphernalia conviction undoubtedly relates to controlled substances,
Agency precedent is less clear on whether such a conviction relates to
the manufacture, distribution, or dispensing of controlled substances
under the third public interest factor. For example, with respect to
convictions involving possession of actual narcotics, in Stanley Alan
Azen, M.D., 61 FR 57893, 57895 (1996), aff'd, Azen v. DEA, 76 F.3d 384
(9th Cir. 1996), a state felony conviction for possession of cocaine
was held to be relevant to Factor 3. Likewise, in Jeffrey Martin Ford,
D.D.S., 68 FR 10750, 10753 (2003), a cocaine possession felony
conviction was held to implicate this factor. On the contrary, in
Super-Rite Drugs, 56 FR 46014 (1991), the Agency determined that a
cocaine possession conviction did not implicate Factor 3 based on the
reasoning that "[a]lthough [the respondent] entered a guilty plea to a
drug-related felony, his actions did not relate to the manufacture,
distribution, or dispensing of controlled substances." Id. (emphasis
supplied). Ironically, although Super-Rite Drugs is the more dated
precedent, it is the most persuasive and should be followed. The
analysis in Azen centered on the subsequent state court reversal of the
conviction, and in Ford, the decision actually omitted the phrase
"relating to the manufacture, distribution, or dispensing" when
addressing the issue. A contrary interpretation would eviscerate the
difference between public interest Factors 3 and 5 and ignore the
specific language inserted by Congress. Guidance can be found in the
accepted maxims of statutory interpretation that "a statute of
specific intention takes precedence over one of general intention,"
United States v. Dozier, 555 F.3d 1136, 1140 n.7 (10th Cir. 2009)
(citing NISH v. Rumsfeld, 348 F.3d 1263, 1272 (10th Cir. 2003)), that
"words should ordinarily be given their ordinary meaning," Moskal v.
United States, 498 U.S. 103, 108 (1990), and that "where language is
clear and unambiguous, it must be followed, except in the most
extraordinary situation where the language leads to an absurd result
contrary to clear legislative intent." United States v. Plots, 347
F.3d 873, 876 (10th Cir. 2003) (citing United States. v. Tagore, 158
F.3d 1124, 1128 (10th Cir. 1998)); see Griffin v. Oceanic Contractors,
458 U.S. 564, 572 (1982); Comm'r v. Brown, 380 U.S. 563, 571 (1965).
The ordinary meaning of the clear, unambiguous, specifically limiting
words "relating to the manufacture, distribution, or dispensing of
controlled substances" set forth in 21 U.S.C. 823(f) compels the
result that a conviction that is related to illegal drugs generally,
but not to manufacturing, distributing, or dispensing specifically, is
not relevant to public interest Factor 3.
In evaluating the Respondent's paraphernalia conviction within this
analytical framework, even assuming, arguendo, that a possession of
drug paraphernalia conviction stemming from items used to manufacture a
controlled substance could conceivably fall within a broad reading of
the conduct contemplated under Factor 3, the record in the instant
case, as it stands, does not provide a sufficient basis to make such a
finding. The lack of factual development and associated evidence
presented at the hearing concerning details regarding the specific
items of alleged drug paraphernalia upon which the conviction was
premised (and the purpose for which said items were utilized, i.e. for
personal use, manufacture, distribution, etc.) simply does not provide
a means to determine whether the conviction relates to the manufacture,
distribution, or dispensing of controlled substances as contemplated
under the statutory language employed under Factor 3 and as interpreted
by Agency precedent.
Accordingly, although an analysis of the Respondent's two
convictions present some mixed considerations regarding Factor 3, the
gravity and circumstances of the manufacturing felony conviction so
profoundly tip the scales against the Respondent's continued
registration that consideration of this factor weighs strongly in favor
of revocation.
Factors 2 and 4: The Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable State, Federal or Local Laws
Relating to Controlled Substances
The evidence of record in this case raises issues regarding both
Factor 2 (experience dispensing \45\ controlled substances) and Factor
4 (compliance with federal and state law relating to controlled
substances). Regarding Factor 2, neither party to the litigation
introduced any evidence relevant to the quality of the controlled
substance dispensing that the Respondent has engaged in relative to his
medical practice.\46\ Ordinarily, the qualitative manner and the
quantitative volume in which a registrant has engaged in the dispensing
of controlled substances, and how long he has been in the business of
doing so are factors to be evaluated in reaching a determination as to
whether he should be entrusted with a DEA certificate. 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. However, the Agency has taken
the reasonable position that although evidence that a practitioner may
have conducted a significant level of sustained activity within the
scope of the registration for a sustained period is a relevant and
correct consideration, this factor can be outweighed by acts
[[Page 45876]]
held to be inconsistent with the public interest. Jayam Krishna-Iyer,
74 FR at 463.
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\45\ The statutory definition of the term "dispense" includes
the prescribing and administering of controlled substances. 21
U.S.C. 802(10).
\46\ The record does reflect that the controlled substance
prescription monitoring condition imposed on the Respondent by the
Wisconsin Medical Board has yielded no negative feedback as of April
9, 2010. See Resp't Ex. 9.
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While true that the record is devoid of evidence related to the
Respondent's prescribing practices at work, at home he was producing a
significant amount of marijuana, a Schedule I controlled substance, and
distributing it (at a minimum) to himself and his wife. Tr. at 47;
Resp't Ex. 1 at 26. The record also contains significant evidence that,
even if the Respondent's dubious testimony that he was surprised that
his niece was using marijuana is credited, it is clear that any
safeguards deployed to ensure against that eventuality were sadly
lacking. Virtually the only evidence of any dispensing of controlled
substance on the part of the Respondent is that he dispensed marijuana
to himself and his wife, and in the process lacked the ability and/or
inclination to keep the drug from his niece and her friends. Thus,
consideration of the Respondent's dispensing history, at least as it
relates to his marijuana harvest, militates in favor of revocation.\47\
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\47\ Although the record contains evidence that a .38 caliber
handgun was located near the entrance to the secret room that
contained the Respondent's marijuana grow and associated equipment,
and that marijuana was found in many small paper and plastic bags
and other containers with other bags readily accessible, the
evidence was not developed sufficiently to allow any relevant
inference (such as an escalated likelihood that these types of items
are often linked with distribution activity) from those factors.
Gov't Ex. 7 at 9, 17, 19, 23-31. Accordingly, no such inference can
fairly be drawn on this record.
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Regarding Factor 4, 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). Every DEA registrant serves
as a guardian of the closed regulatory system, with specific
obligations aimed at protecting against improper diversion. It would be
difficult to imagine a more deliberate, flagrant disregard to the
Respondent's obligations as a registrant than his decision to convert a
portion of his residence into a marijuana factory for himself and his
family. While there is no doubt that there was room for some
elaboration of the evidence on the part of the Government, the record
clearly demonstrates that this was not a single marijuana plant growing
in a tiny pot on the Respondent's bedroom window. The Respondent pled
guilty to a felony-level conviction for the manufacture of a Schedule I
controlled substance, which was conducted in a specially-constructed
secret room, with sophisticated equipment, detailed instructions, and
documented monitoring. Gov't Ex. 7. Consideration of the Respondent's
compliance with state and federal laws related to controlled substances
(Factor 4) militates strongly in favor of revocation.
Factor 5: Such Other Conduct Which May Threaten the Public Health and
Safety
Under Factor 5, the Deputy Administrator is authorized to consider
"other conduct which may threaten the public health and safety." 21
U.S.C. 823(f)(5). It is settled Agency precedent that, "offenses or
wrongful acts committed by a registrant outside of his professional
practice, but which relate to controlled substances may constitute
sufficient grounds for the revocation of a registrant's DEA Certificate
of Registration." David E. Trawick, D.D.S., 53 FR 5326 (1988); Jose
Antonio Pla-Cisneros, M.D., 52 FR 42154 (1987); Walker L. Whaley, M.D.,
51 FR 15556 (1986). As discussed above, the Respondent produced a
significant yield of a Schedule I controlled substance and distributed
it to himself and (at least) his wife. While any action that undermines
the closed regulatory system by the intentional and secretive
production of a controlled substance arguably has the potential to
adversely impact public safety in a broad sense, the issue under Factor
5 is not merely whether the public safety was adversely impacted to any
extent, but rather, whether consideration of any threat to public
safety militates in favor of revocation. In other words, consideration
of evidence under Factor 5 is less of a litmus test for conceivable
public impact than it is a question of degree. The credible, unrefuted
evidence of record establishes that the fruits of the Respondent's
marijuana grow were being abused by not only himself and his wife, but
also by his niece and at least two of her suitors. Gov't Ex. 7 at 13-
14. Admittedly, no admissible evidence established the age of the
Respondent's niece,\48\ and no evidence indicated that the Respondent's
minor children were exposed to the illegal fruits of his grow, but it
is beyond dispute that the marijuana he was growing was being regularly
and continuously abused by persons other than the Respondent. The
Respondent grew marijuana plants, abused marijuana himself, and shared
it with his wife and niece. His niece shared it with others. However,
although the public safety was arguably affected, the issue here is not
so narrow. Even acknowledging the reality that any leak in the closed
system of controlled substances cannot occur without some diminishment
of the public safety in general, a consideration of this Factor (public
health and safety threat), under these circumstances, does not support
the revocation sought by the Government.
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\48\ According to the police reports, the Respondent's spouse
indicated that she is the legal guardian of the Respondent's niece.
Gov't Ex. 7 at 20.
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Recommendation
A balancing of the public interest factors militates sufficiently
in favor of revocation to compel the conclusion that the Government has
borne its burden to establish a prima facie case for revocation under
21 U.S.C. 824(a)(4) as well as (a)(2). Inasmuch as the Government has
made out a prima facie case for revocation, to avoid this sanction, the
burden shifts to the Respondent to demonstrate that COR revocation is
inappropriate. 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 (1980). Further, to
meet this burden "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 8194, 8236 (2010).
The Respondent credibly testified that he is complying with the
conditions of his criminal sentence, including the terms of his
probation, and that he is complying with the monitoring terms fixed by
the Order of the Wisconsin Medical Board, including mandated substance
abuse treatment \49\ and a regimen of random drug tests that have thus
far yielded no adverse results. Tr. at 58-59. The Respondent testified
that he accepts the wrongfulness of his conduct and that he has
resolved not to violate drug laws in the future. Id. at 77-79.
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\49\ However, the Respondent introduced no input from anyone
connected with any drug rehabilitation program in which he has
participated.
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While the Respondent, with the words of acceptance he carefully
employed in his testimony, has satisfied the Agency-created condition
precedent to seek amelioration of the sanction of revocation, his words
of acceptance are at least somewhat fortified by his
[[Page 45877]]
apparent level of uneventful compliance with a significant level of
restrictions and monitoring. Still, his actions regarding his in-home
marijuana factory, at least as they are depicted in the record
evidence, are remarkable in the extent to which they reflect a high
level of planning and deliberation to thwart the CSA. This was not an
accidental occurrence or a brief dalliance, but an elaborate,
secretive, deliberate, liberally-financed plan to undermine the CSA--
the Act that authorizes the COR that was issued to the Respondent as a
registrant. This is the same COR upon which, according to his
testimony, he bases his livelihood as a physician. Tr. at 65. Under the
circumstances presented here, the Agency has an interest in both
assuring that the Respondent can be entrusted with the responsibilities
attendant upon a COR registrant and (notwithstanding the non-punitive
nature of these proceedings) the Agency's legitimate interest in
deterring others from similar acts. Hassman, 75 FR at 10094; Joseph
Gaudio, M.D., 74 FR 10083, 10095 (2009); Southwood Pharms., Inc., 72
F.R at 36504 (citing Butz v. Glover Livestock Commission Co., Inc., 411
U.S. 182, 187-88 (1973)). Therefore, the appropriate sanction must
factor in the Respondent's acknowledgement of wrongdoing and efforts at
demonstrating sufficient contrition and rehabilitation efforts, while
also incorporating the Agency's interests in the integrity of the
closed system and deterrence of like conduct.
The Government, in its Proposed Findings of Fact and Conclusions of
Law (Government Closing Brief), maintains that the nature of the
marijuana activity as well as what it perceives as a lack of remorse,
supports revocation. Gov't Closing. Br. at 4. As discussed, supra, the
Respondent expressed an acknowledgement of wrongdoing at the hearing.
Tr. at 77-79. Thus, the Government's argument in this regard is
essentially that the Respondent has not said sufficiently that he
regrets his actions, i.e., he is not sorry enough. While, admittedly,
the tenor of the Respondent's testimony at the hearing did not reflect
a high level of contrition, he did demonstrate an acknowledgement that
his actions were illegal and that the punishments meted out by the
criminal justice system were not unfair. Similarly, his thus-far
unblemished compliance with conditions imposed by the Wisconsin Medical
Board and the criminal court sentence demonstrates at least some level
of commitment to rehabilitation. Even so, true remorse, to the extent
that Respondent may possess it, was not patently evident from his
presentation at the hearing. During his testimony, the Respondent gave
the distinct impression that he was not so much sorry about his
transgressions as he was sorry that he got caught and was laboring
under the criminal and administrative consequences of that reality.
In support of its argument that Agency precedent calls for
revocation, in its Closing Brief, the Government cites three cases, all
of which are distinguishable from the present case. In Arthur C.
Rosenblatt, M.D., 55 FR 25901 (1990) and Robert G. Crummie, M.D., 55 FR
5303 (1990), the Agency determined that the respondents not only grew
marijuana, but also had significant controlled substance prescribing
anomalies. The revocation issued in Alan L. Ager, D.P.M., 63 FR 54732
(1998) was the result of sustained allegations that the respondent,
less than a year and a half after being convicted of growing 1,719
marijuana plants, was caught (and ultimately convicted) of growing 135
more marijuana plants. Id. Not only was the respondent in Ager a
recidivist who obviously learned nothing from his first conviction, but
he produced marijuana in quantities far in excess of the established
levels in this case.\50\
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\50\ This was also true in regarding the respondent in the
Crummie case, who was caught growing fifty marijuana plants. 55 FR
at 5304.
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The cases cited in the Government's Closing Brief are
distinguishable on other grounds as well, apart from the disparities in
marijuana production scale and illegal prescribing practices. The
respondent in Crummie untruthfully testified that he never used,
possessed, or manufactured marijuana, and he never accepted
responsibility or remorse for his misconduct. 55 FR at 5304. Relatedly,
the respondent in Ager failed to offer an explanation for his
misconduct, to accept responsibility or remorse, or to provide
assurances he would no longer illegally manufacture marijuana in the
future. 63 FR 54733. Unlike the cited cases, the Respondent in the
instant case, despite his lukewarm remorse, explained the reasons for
his illegal misconduct and at least articulated his assurance that he
would never manufacture marijuana again.
The Government also cites in its closing brief Gordon M. Acker,
D.M.D., 52 FR 9962 (1987) for the proposition that DEA possesses the
authority to revoke a registration for a registrant's felony conviction
involving controlled substances, even if the respondent did not use his
registration in the commission of his felonious actions. While the
Government is certainly correct to the extent a felony conviction
related to controlled substances is a factor to be considered in
deciding whether revocation is appropriate, the facts of each matter
are the operative elements which militate in favor of, or against,
revocation. In Acker, the respondent participated during his dental
school years in the largest cocaine organization ever prosecuted in
Philadelphia. Acker, FR at 9963. The organization profited by millions
of dollars per month, and the respondent acted as a redistributor,
carrier, and money launderer for the enterprise. Id. Here, the
Respondent's criminal behavior, while significant, pales in comparison
to that of Acker. There is no evidence that the Respondent ever sold
the marijuana he produced, nor is there evidence that the Respondent
was part of a large scale, interstate criminal operation. Accordingly,
because the facts of Acker and the present case as distinguishable,
Acker does not compel the same result in this case.
That the cases cited by the Government do not compel the revocation
it seeks is not to say that such an outcome would be undeserved or
unauthorized. The evidence in this case supports a finding that the
Government has established that the Respondent has been convicted of a
felony under Wisconsin state law related to a Schedule I controlled
substance and that he has also committed acts that are inconsistent
with the public interest. Although the nature of the Respondent's
controlled substance-related felony conviction and a careful balancing
of the statutory public interest factors support the revocation of the
Respondent's COR, the determination rendered by the Wisconsin State
Medical Board that fastidious monitoring can sufficiently protect its
interests in public safety, coupled with the Respondent's satisfactory
compliance with the restrictions placed on him by the state criminal
courts and the Wisconsin State Medical Board, add sufficient indicia of
reliability to his professed acceptance of responsibility to support
consideration of a sanction less than outright revocation. Accordingly,
although the Government's petition for revocation is not wholly
unreasonable under the circumstances, the legitimate interests of the
Agency can be attained with the imposition of COR restrictions coupled
with a period of suspension for a period no less than six (6) months
from the
[[Page 45878]]
date that the Agency issues a final order in this matter.\51\
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\51\ The Respondent's current COR expires by its own terms on
January 31, 2011. In the event that a timely COR renewal application
is filed pending final Agency action in this matter in accordance
with 21 CFR 1301.36(i) and that application is granted in the final
Agency decision, the period of suspension and restricted conditions
set forth in this recommended decision may and should be applied to
the COR as renewed.
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The Respondent's COR shall be restricted and conditioned in the
following manner:
(1) The Respondent will comply with the terms of his criminal
sentence and the conditions that are currently in effect, or are
subsequently imposed by the criminal sentencing court and/or the
Wisconsin Medical Board,\52\ and render monthly reports demonstrating
such compliance to an official designated by the DEA (designated DEA
official) in a manner and format directed by DEA;
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\52\ Thus, the conditions fixed by the Order of the Wisconsin
Medical Board and the terms of the Respondent's criminal probation
are adopted and incorporated herein as conditions of the restricted
COR.
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(2) The Respondent will provide the DEA designated official with
the results of any and all urinalysis and/or toxicology reports related
to drug screening tests administered during the period of the
suspension and the restricted COR, irrespective of whether such tests
have been or are directed by the criminal sentencing court, the
Wisconsin Medical Board, and/or any other source, including (but not
limited to) tests mandated by liability carriers and/or other
regulatory bodies;
(3) The Respondent, at his own expense, will participate in such
drug screening tests as may be, from time to time, required by the
designated DEA official;
(4) Within a reasonable period, not to exceed thirty (30) days
after the issuance of a final Agency decision in this case, the
Respondent will execute a document consenting to any and all
inspections of the Respondent's home and/or principal place of business
conducted by DEA during the period of suspension; and,
(5) Any other reasonable conditions consistent with this decision
that may be imposed by the Deputy Administrator in the final Agency
decision issued in this case.
Failure to comply with any of the conditions specified above shall
be grounds for the further suspension or revocation of the Respondent's
registration.
Accordingly, the Respondent's Certificate of Registration should be
suspended and restricted as set forth in this recommended decision.
Dated: October 4, 2010
John J. Mulrooney, II
U.S. Administrative Law Judge
[FR Doc. 2011-19376 Filed 7-29-11; 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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