Registrant Actions - 2012
[Federal Register Volume 77, Number 238 (Tuesday, December 11, 2012)]
[Notices]
[Pages 73678-73682]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29816]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Robert M. Brodkin, D.P.M.; Decision and Order
On June 6, 2011, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to Robert Brodkin, D.P.M. (hereinafter, Respondent), of
Lubbock, Texas. The Show Cause Order proposed the denial of
Respondent's application for a DEA Certificate of Registration as a
practitioner because his "registration would be inconsistent with the
public interest." GX 10, at 1 (citing 21 U.S.C. 823(f)).\1\
---------------------------------------------------------------------------
\1\ The Show Cause Order also alleged that Respondent lacks
"authority to handle controlled substances in the State of
Arizona." GX 10, at 1. This fact is not in dispute, as in his
hearing request, Respondent admitted that he "do[es] not have a
license to handle controlled substances in the state of Arizona [and
has] never made any claim to the contrary." GX 11, at 1. However,
it is not apparent why the allegation is material as Respondent's
practice is based in Texas, where he does hold both a medical
license and a state controlled substance registration and the Show
Cause Order does not allege that he committed any misconduct in
Arizona, or in any State outside of Texas. Id.; see also GX 25. Nor
does the Government offer any explanation as to why Respondent's
lack of an Arizona license is a basis for the denial of his
application.
---------------------------------------------------------------------------
[[Page 73679]]
The Show Cause Order alleged that "[b]etween April 7, 2007, and
February 19, 2008, [Respondent] ordered nearly 5,000 dosage units of
controlled substances * * * and diverted those controlled substances
for personal use." Id. The Show Cause Order further alleged that
Respondent provided "false information" to distributor Henry Schein,
Inc., when questioned about his usage of the controlled substances. Id.
Next, the Show Cause Order alleged that, on November 20, 2008,
Respondent "entered into a Memorandum of Understanding with the [Texas
State Board of Podiatric Medical Examiners]" after the State Board
issued a "complaint, indicating that [Respondent] had exceeded [his]
podiatric practice limitations." Id. at 2. The Show Cause Order also
alleged that Respondent's previous DEA registration was surrendered
"for cause, on April 16, 2008, as a result of allegations that
[Respondent was] using [his] registration for ordering and self-
administering controlled substances." Id. at 1.
The Show Cause Order notified Respondent of his right to request a
hearing on the allegations or to file a written statement in lieu of a
hearing, the procedures for electing either option, and the
consequences of failing to do either. Id. at 2. On June 13, 2011, the
Order was served on Respondent by certified mail. Id. at 3.
On June 14, 2011, Respondent submitted a timely hearing request,
see GX 11, and the matter was placed on the docket of the Office of
Administrative Law Judges. On June 27, 2011, the assigned
Administrative Law Judge ("ALJ") issued an Order for Prehearing
Statements. See GX 12. The Government submitted its Prehearing
Statement on July 18, 2011, see GX 13, and Respondent submitted his
reply on July 28, 2011. See GX 14. The ALJ initially scheduled a
prehearing conference for August 2, 2011; upon Respondent's unopposed
request for a continuance, the conference was rescheduled until
September 7, 2011. See GX 15.
On September 8, 2011, the ALJ issued a Prehearing Ruling, setting a
hearing date of December 13-14, 2011. See GX 16. On November 4, 2011,
Respondent requested a continuance of the hearing, citing the competing
demands of an "extensive [Medicare] audit procedure." GX 17. The
Government opposed this request. GX 19. Before ruling on the
continuance, the ALJ sought to "conduct a conference call with both
parties." GX 20, at 1. In her November 21, 2011 Order Regarding
Respondent's Request for a Continuance, the ALJ noted that previous
attempts to "contact Respondent to set up a conference call" had been
"unsuccessful," and she ordered Respondent to submit a "listing [of]
the dates and times of his availability" by November 28, 2011. Id. at
1-2.
When Respondent failed to comply with the ALJ's order, the
Government moved to terminate the proceeding. See GX 21. Thereupon, on
November 29, 2011, the ALJ issued a second Order affording Respondent
another opportunity to contact the Court. See GX 22. Therein, the ALJ
"warn[ed] Respondent that if he fail[ed] to contact the Court by
December 5, 2011, he [would] be deemed to have waived his right to a
hearing and [the ALJ] [would] grant the Government's Motion to
terminate these proceedings." Id. at 2.
Once again, Respondent failed to comply with the ALJ's order.
Accordingly, on December 6, 2011, the ALJ, having found that
"Respondent [had] constructively waived his right to a hearing under
21 CFR 1301.43(c)," granted the Government's Motion to Terminate the
proceeding. GX 23, at 2.
Under Agency precedent, the failure to comply with an ALJ's orders
may constitute a waiver of a hearing request and cause for termination
of the proceeding. See Kamir Garces-Mejias, 72 FR 54931, 54932 (2007);
Andrew Desonia, 72 FR 54293, 54294 (2007); Brenton D. Glisson, 72 FR
54296 (2007); Alan R. Schankman, 63 FR 45260 (1998); see also Fitzhugh
v. DEA, 813 F.2d 1248 (DC Cir. 1987) (upholding revocation order
entered after a respondent failed to appear for his hearing). Here,
Respondent violated two of the ALJ's orders. Moreover, the ALJ's
repeated attempts to contact Respondent proved unsuccessful.
I therefore adopt the ALJ's finding that Respondent has waived his
right to a hearing and her order terminating the hearing. I further
issue this Decision and Order based on relevant evidence contained in
the record submitted by the Government.\2\
---------------------------------------------------------------------------
\2\ On August 3, 2012, the Government forwarded the
investigative record to this office with its request for Final
Agency Action.
---------------------------------------------------------------------------
Having reviewed the record, I further hold that Respondent has
committed acts which render his registration "inconsistent with the
public interest." 21 U.S.C. 823(f). I make the following factual
findings.
Findings
Respondent is a Doctor of Podiatric Medicine, whose medical
practice is limited to podiatry. GX 1, at 3 and GX 2, at 1-4. Under
Texas state regulations, Respondent is authorized to "treat any
disease, disorder, physical injury, deformity, or ailment of the human
foot." Tex. Occ. Code Sec. 202.001(4).
On September 29, 2008, Respondent submitted an application for a
DEA Certificate of Registration as a practitioner, seeking authority to
dispense controlled substances in Schedules II though V. GX 1, at 3. As
the application form states, in order to be eligible for a DEA
registration, an applicant "MUST be currently authorized to prescribe
* * * controlled substances * * * under the laws of the state or
jurisdiction in which [he or she is] operating or propose[s] to
operate." Id. at 4 (Section 4 of the application). See also 21 U.S.C.
823(f). Respondent listed a Texas address but noted that his Texas
controlled substance licensure was "pending." Id. However, on
December 2, 2009, Respondent obtained a state controlled substance
registration from the Texas Department of Public Safety. GX 25.
In addition to demonstrating that he possesses state authority to
dispense controlled substances, an applicant must answer several other
liability questions which seek information regarding any prior
administrative or criminal proceedings. GX 1, at 4 (Section 5 of the
application). When asked if he had "ever surrendered (for cause) or
had a federal professional license or controlled substance registration
revoked, suspended, denied, restricted, or placed on probation,"
Respondent circled "No" and handwrote in the margin, "invol.
surrender under duress but not 'for cause.'" Id. at 4 (Section 5,
Question 2). In response to the application's question regarding
disciplinary action taken at the state level, Respondent again circled
"No" and handwrote in the margin, "non-judicial; non-due process."
Id. at 4 (Section 5, Question 3). Finally, in the explanatory section
below the liability questions, Respondent wrote: "There have not ever
been any incidents." Id. at 4 (Section 5).
However, Respondent has been the subject of both federal and state
disciplinary action. Respondent previously held DEA Certificate of
Registration AB1847043, see GX 24, which he surrendered for cause on
April 16, 2008. GX 7. On the "Voluntary
[[Page 73680]]
Surrender" form, Respondent signed his name under language indicating
that he "freely execute[d] this document" in light of his "alleged
failure to comply with the Federal requirements pertaining to
controlled substances, and as an indication of my good faith in
desiring to remedy any incorrect or unlawful practices." Id.
Shortly after Respondent surrendered his DEA registration, state
authorities initiated a disciplinary investigation against Respondent.
On April 27, 2008, the Texas State Board of Podiatric Medical Examiners
issued him a "Notice of Complaint Allegation." GX 2, at 7. Citing
Respondent's written communications to the State Board and his letters
to drug distributor Henry Schein, Inc., the Complaint alleged that
Respondent had "acknowledged self-treatment of diseases, disorders,
physical injuries, deformities, or ailments of conditions beyond the
foot/ankle limits of [his] Podiatry license." Id. at 15. The Complaint
further contended that Respondent's "justifications for purchasing
drugs/controlled substances [from] Henry Schein, Inc., were misleading,
deceptive, and fraudulent given [Respondent's] own admissions [and]
made under false pretenses." Id.
The federal and state disciplinary investigations stemmed from
Respondent's alleged practice of self-prescribing medication outside
the scope of his podiatry practice. Between April 2007 and February
2008, Respondent obtained controlled substances from Henry Schein,
Inc., and Moore Medical LLC. GX 6. These controlled substances included
225 ampules of Demerol 50 mg/ml (meperidine, a schedule II narcotic);
1200 tablets of diazepam (a schedule IV benzodiazepine); 1500 tablets
of hydrocodone/acetaminophen 10/500 mg and 1700 tablets of hydrocodone/
acetaminophen 10/325 mg (both schedule III narcotics); 100 vials of
midazolam 1 gm (a schedule IV benzodiazepine); 200 tablets of
propoxyphene (a schedule IV narcotic); and four bottles of testosterone
cypionate 10 ml/bottle (a schedule III anabolic steroid). Id.
On May 7, 2007, Respondent sent a letter to Henry Schein, Inc.,
responding to the company's questioning of his controlled substance
orders. GX 3. In the letter, Respondent claimed that he did "12 to 15
surgical cases per week," including "major-type foot surgeries,"
necessitating that he have a steady supply of pain control medications:
In general, in my clinic I do three major-type foot surgeries
per week, usually one each on Monday, Wednesday and Friday. On some
weeks we will add one or two additional case[s] on either Tuesday or
Thursday. So, the baseline total of cases comes out to 12 to 15
surgical cases per week.
Id. at 1-2. Respondent then explained how he was administering drugs
such as Demerol, Valium, and midazolam to his surgical patients, as
well as dispensing additional drugs including hydrocodone tablets to
the purported patients for post-operative pain control. Id. at 2-3.
Following the letter, Schein continued to distribute controlled
substances to Respondent. GX 6, at 1-2.
However, in an April 4, 2008 letter to the Executive Director/
Investigator of the Texas State Board of Podiatric Medical Examiners,
Respondent wrote that he had "voluntarily quit doing foot surgery in
June of 2002" due to his severe back pain. GX 8, at 1. Respondent
further admitted that he "voluntarily quit seeing patients directly as
of June, 2003" and that his practice "consisted of my supervising
highly trained podiatry assistants in providing mycotic nail care for
elderly patients." Id.
Respondent's letter to the State Board's Investigator was thus
fundamentally inconsistent with his earlier statements to Schein that
he was "do[ing] three major-type foot surgeries per week," plus
additional cases for a total of "12 to 15 surgical cases per week."
GX 3, at 1. Moreover, in his letter to the Board, Respondent intimated
that he had been using the controlled substances he ordered from Henry
Schein and Moore Medical to treat his own back pain.\3\ For example,
Respondent explained that he had stopped seeing patients due to a
"hellish pain" in his lower back. GX 8, at 1. Respondent then offered
a description of his use of controlled substances:
I was able to quit taking Lortab pills, a Class III substance
for pain control in January, 2008 for the simple reason that I no
longer needed them. The last time I ordered any [C]lass II products
was also in January, 2008; I simply did not need this powerful a
substance to control what had been nearly unendurable pain. I still
had a generalized achiness about my entire back[,] and I am now
using a low dose Class IV product.
---------------------------------------------------------------------------
\3\ Respondent later confirmed these allegations in his Request
for Hearing and Pre-Hearing Statement. See GX 11, at 3; GX 14, at 3.
---------------------------------------------------------------------------
Id. at 2.
On April 16, 2008, Respondent voluntarily surrendered his DEA
registration. GX 7. Two days later, Respondent wrote a letter to a DEA
Diversion Investigator, in which he denied being "a drug addict" or
"hav[ing] any addiction issues." GX 5, at 1. Respondent also
explained that "any pain medications [he] previously utilized were
indeed used under medical supervision, in an entirely proper and
correct fashion to control what would otherwise be severe pain of the
most intense nature." Id. at 2. Moreover, in his Request for Hearing,
Respondent replied to the allegations of the Show Cause Order,
asserting that:
[t]he fact is that the State Board did use the terminology
'cease and desist' but only in regard to my having been practicing
general medicine, i.e., self-treating my severe, life-threating back
pain prior to the sixth and last definitive back surgery having been
performed on October 2nd, 2007. That is to say, my State Board
recognized that my self-prescription of pain medication was in fact,
medical practice * * * ."
GX 11, at 3 (emphasis in original).\4\
---------------------------------------------------------------------------
\4\ In his Pre-Hearing Statement, Respondent likewise wrote:
During the period starting approximately in 2004, I developed an
extremely severe level of low back pain. I consulted with numerous
specialist physicians * * * in unsuccessful attempts to determine
the precise cause of the pain. Many of the consulted doctors,
looking strictly at MRI scans which were presumably done on inferior
quality MR scanning devices, claimed that no pathology existed. Why
would any doctor prescribe pain medications for a condition that
they incorrectly believed did not actually exist? As the condition
continued to worsen, I utilized pain medication, in a regimen of
medical treatment supervised by myself, in order to alleviate at
least a small portion of the pain present.
GX 14, at 3.
---------------------------------------------------------------------------
On November 20, 2008, Respondent entered into a Memorandum of
Understanding with the Texas State Board. See GX 2. Respondent signed
the Memorandum in lieu of disciplinary action, acknowledging that
"[p]odiatrists can write prescriptions to treat any disease, disorder,
physical injury deformity or ailment of the human foot, but only for a
valid medical purpose supported by proper medical record documentation
and limited to the Foot/Ankle scope of practice." GX 2, at 3 (emphasis
added).
Discussion
Under the Controlled Substances Act, the "Attorney General may
deny an application for [] registration * * * if the Attorney General
determines that the issuance of such registration * * * would be
inconsistent with the public interest." 21 U.S.C. 823(f). In making
the public interest determination," Congress directed that the
following factors be considered:
(1) The recommendation of the appropriate State licensing board
or professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State
laws relating to the
[[Page 73681]]
manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id.
The public interest factors are considered in the disjunctive.
Robert A. Leslie, 68 FR 15227, 15230 (2003). I may rely on any one or a
combination of factors and may give each factor the weight I deem
appropriate in determining whether to deny an application for a
registration. Id. Moreover, I am "not required to make findings as to
all of the factors." Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir. 2005);
see also MacKay v. DEA, 664 F.3d 808, 816 (10th Cir. 2011); Morall v.
DEA, 412 F.3d 165, 173-74 (D.C. Cir. 2005).
The Government has "the burden of proving that the requirements
for [] registration * * * are not satisfied." 21 CFR 1301.44(d). As no
DEA regulation provides that the consequence of waiving a hearing is a
default, the Government must therefore support its proposed action with
substantial evidence.
Having considered all of the factors, I conclude that the
Government's evidence pertinent to Factors Two (Respondent's experience
in dispensing controlled substances) and Four (Respondent's compliance
with applicable laws related to controlled substances), establishes
that Respondent has committed acts which render his registration
"inconsistent with the public interest." 21 U.S.C. 823(f).\5\ Because
there is no evidence that Respondent acknowledges his misconduct, I
conclude that his application should be denied.
---------------------------------------------------------------------------
\5\ Factor one does not support a finding either for, or
against, the continuation of Respondent's registration. The Podiatry
Board has not made a recommendation to DEA, and in any event, while
Respondent currently possesses authority under Texas law to dispense
controlled substances, thus satisfying a prerequisite for obtaining
a registration, the Agency has repeatedly held that a practitioner's
possession of state authority is not dispositive of question of
whether his registration would be consistent with the public
interest. See 21 U.S.C. 823(f); see also Patrick W. Stodola, 74 FR
20727, 20730 n.16 (2009) (citing Mortimer B. Levin, 55 FR 8209, 8210
(1990)).
As for factor three, there is no evidence in the record that
Respondent has been convicted of an offense related to the
manufacture, distribution, or dispensing of controlled substances.
See id. Sec. 823(f)(3). However, DEA has long held that this factor
is not dispositive. See, e.g., Edmund Chein, 72 FR 6580, 6593 n.22
(2007).
---------------------------------------------------------------------------
Factors Two and Four--Respondent's Experience in Dispensing Controlled
Substances and Compliance With Applicable Laws Related to Controlled
Substances
The CSA makes it "unlawful for any person knowingly or
intentionally to possess a controlled substance unless such substance
was obtained directly, or pursuant to a valid prescription or order,
from a practitioner, while acting in the course of his professional
practice, or except as otherwise authorized by this subchapter." 21
U.S.C. 844(a). Moreover, it is "unlawful for any person knowingly or
intentionally * * * to acquire or obtain possession of a controlled
substance by misrepresentation, fraud, forgery, deception, or
subterfuge." Id. Sec. 843(c)(3).
Under the CSA, a practitioner is bound by the scope of his
professional practice. As the Supreme Court has explained, "the scheme
of the [CSA], viewed against the background of the legislative history,
reveals an intent to limit a registered physician's dispensing
authority to the course of his 'professional practice." United States
v. Moore, 423 U.S. 122, 140 (1975). (emphasis added). See also 21
U.S.C. 802(21) (Defining "[t]he term 'practitioner' [to] mean[] a
physician * * * licensed, registered, or otherwise permitted, by the *
* * jurisdiction in which he practices * * * to distribute, dispense,
[or] administer * * * a controlled substances in the course of
professional practice."); United States v. Tran Trong Cuong, 18 F.3d
1132, 1137 (4th Cir. 1994) ("[A] licensed physician who prescribes
controlled substances outside the bounds of his professional medical
practice is subject to prosecution."); 21 CFR 1306.04(a) ("A
prescription for a controlled substance * * * must be issued for a
legitimate medical purpose by an individual practitioner acting in the
usual course of his professional practice * * * An order purporting to
be a prescription issued not in the usual course of professional
treatment * * * is not a prescription within the meaning and intent
of" the CSA.).
As found above, Respondent is a podiatrist, and under Texas law,
his practice is limited to "treat[ing] any disease, disorder, physical
injury, deformity, or ailment of the human foot." Tex. Occ. Code Sec.
202.001(4). See also GX 2, at 2 (Memorandum of Understanding between
Respondent and Texas State Board of Podiatric Medical Examiners)
(Respondent "takes notice that the practice of Podiatry in Texas is
limited to treatment of the Foot/Ankle."). Moreover, as the Memorandum
of Understanding makes clear, "Podiatrists can write prescriptions to
treat any disease, disorder, physical injury, deformity or ailment of
the human foot, but only for a valid medical purpose supported by
proper medical record documentation and limited to the Foot/Ankle scope
of practice." Id. at 3.
The record contains substantial evidence that Respondent dispensed
to himself controlled substances and acted outside of the usual course
of his professional practice. In various statements to both state and
agency officials, Respondent provided evidence that he was
administering controlled substances to himself to treat a back injury.
While in some of these statements, Respondent merely alluded to back
injuries which caused him to suspend his podiatry practice while
continuing to order pain medications, in several statements Respondent
expressly admitted that he was self-administering controlled
substances. See GX 11, at 3 (Resp. Req. for Hearing; Statement; "my
State Board recognized that my self-prescription of pain medication was
in fact, medical practice"); GX 14, at 3 (Resp. Pre-Hearing Statement;
"During the period starting approximately 2004, I developed an
extremely severe level of low back pain * * * . As the condition
continued to worsen, I utilized pain medication in a regimen of medical
treatment supervised by myself.").
By engaging in the self-administration of controlled substances to
treat his back injury, Respondent exceeded the bounds of his
professional practice as a Podiatrist. Indeed, he acknowledged as much
in the Memorandum of Understanding. GX 2, at 3 & 5. And because he did
not obtain the controlled substances he self-administered "pursuant to
a valid prescription or order, from a practitioner, while acting in the
course of his professional practice," Respondent unlawfully possessed
those controlled substances. 21 U.S.C. 844(a).
The evidence also supports a finding that Respondent obtained
controlled substances from Henry Schein, Inc., by misrepresentation,
fraud, or deception. Id. Sec. 843(a)(3). When questioned by the
company as to his ordering of controlled substances, Respondent
represented that he was performing three major foot surgeries a week,
as well as additional procedures for a total of "12 to 15 surgical
cases per week." Respondent then explained how he was administering
drugs such as Demerol, Valium, and midazolam to his purported surgical
patients, as well as
[[Page 73682]]
dispensing additional drugs including hydrocodone tablets to the
purported patients for post-operative pain control. However, as
Respondent admitted in his letter to the State Board's Executive
Director, because of his back pain, he had "voluntarily quit doing
foot surgery in June of 2002" and had "voluntarily quit seeing
patients directly as of June, 2003." Thus, I conclude that
Respondent's statements to Henry Schein, Inc., were intentional
misrepresentations of the nature of his medical practice which he made
to induce Schein to continue to distribute controlled substances to
him, which it did.
Accordingly, I find that the Government has established that
granting Respondent's application "would be inconsistent with the
public interest." 21 U.S.C. 823(f). I will therefore order that
Respondent's application for a new registration be denied.\6\
---------------------------------------------------------------------------
\6\ While I have reviewed Respondent's Pre-Hearing Statement and
treated it as if it was a statement submitted in lieu of a hearing,
see 21 CFR 1301.43(c), the only mitigating evidence contained
therein is the statement that the State Board's "inquiry was closed
with a 'Memorandum of Understanding' that the practice of podiatric
medicine and surgery in Texas does not include the medical treatment
of back problems. I agreed with this and agreed to abstain from any
further general medical practice of any sort, particularly the
medical treatment of severe back pain." GX 14, at 4. Nothing in
Respondent's statement manifests that he acknowledges the illegality
of his acts of self-dispensing and obtaining controlled substances
by misrepresentation. See, e.g., Jeri Hassman, 75 FR 8194, 8236
(2010) ("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."). See also Ronald Lynch, 75 FR 78745, 78753-54
(2010) (registrant's attempts to minimize misconduct held to
undermine acceptance of responsibility); George Mathew, 75 FR 66138,
66140, 66145, 66148 (2010) (registrant's failure to address
misconduct warranted revocation of his registration); Steven M.
Abbadessa, 74 FR 10077, 10078 (2009) (registrant's acceptance of
responsibility and demonstration of corrective measures supported
granting application); Jayam Krishna-Iyer, 74 FR 459, 463 (2009)
(registrant granted new registration following suspension where she
finally acknowledged her wrongdoing).
---------------------------------------------------------------------------
Order
Pursuant to the authority vested in me by 21 U.S.C. 823(f), as well
as 28 CFR 0.100(b), I order that the application of Robert M. Brodkin,
D.P.M., for a DEA Certificate of Registration as a practitioner, be,
and it hereby is, denied. This Order is effective January 10, 2013.
Dated: December 3, 2012.
Michele M. Leonhart,
Administrator.
[FR Doc. 2012-29816 Filed 12-10-12; 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).
|