[Federal Register Volume 83, Number 155 (Friday, August 10, 2018)]
[Notices]
[Pages 39784-39787]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-17141]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
Bharanidharan Padmanabhan, M.D., Ph.D.; Decision and Order
On October 20, 2017, the Acting Assistant Administrator, Diversion
Control Division, Drug Enforcement Administration (hereinafter, DEA or
Government), issued an Order to Show Cause to Bharanidharan
Padmanabhan, M.D., Ph.D. (hereinafter, Respondent), of Brookline,
Massachusetts. Order to Show Cause (hereinafter, OSC), at 1. The Show
Cause Order proposes the revocation of Respondent's Certificate of
Registration on the ground that he does ``not have authority to handle
controlled substances in the Commonwealth of Massachusetts, the state
in which . . . [he is] registered with the DEA.'' Id. at 1 (citing 21
U.S.C. 823(f) and 824(a)(3)).
Regarding jurisdiction, the Show Cause Order alleges that
Respondent holds DEA Certificate of Registration No. BP7993290 at the
registered address of 30 Gardner Road #6A, Brookline, Massachusetts
02445. OSC, at 1. This registration authorizes Respondent to dispense
controlled substances in schedules II through V as a practitioner. The
Show Cause Order alleges that this registration expires on March 31,
2020. Id.
The substantive ground for the proceeding, as alleged in the Show
Cause Order, is that Respondent is ``without authority to handle
controlled substances in the Commonwealth of Massachusetts, the state
in which . . . [he is] registered . . . with the DEA.'' Id. at 1.
Specifically, the Show Cause Order alleges that the Massachusetts
``Board of Registration in Medicine Indefinitely Suspended . . .
[Respondent's] medical license'' on May 11, 2017, and that this
indefinite suspension ``became effective on July 11, 2017 and remains
in effect.'' Id.
The Show Cause Order notifies Respondent of his right to request a
hearing on the allegations or to submit a written statement while
waiving his right to a hearing, the procedures for electing each
option, and the consequences for failing to elect either option. Id. at
2 (citing 21 CFR 1301.43). The Show Cause Order also notifies
Respondent of the opportunity to submit a corrective action plan. OSC,
at 2-3 (citing 21 U.S.C. 824(c)(2)(C)).
By letter dated November 13, 2017, Respondent requested a hearing.
Hearing Request, at 1. According to the Hearing Request, Respondent
``wish[es] to show why . . . [he] should retain'' Certificate of
Registration No. BP7993290. Id. Respondent's Hearing Request refers to
the ``alleged'' action of the Massachusetts Board of Registration in
Medicine (hereinafter, Massachusetts Board) ``indefinitely suspending .
. . [his] license'' as ``corrupt and legally void,'' and states his
``position [to be] that DEA must hold all action in abeyance till the
federal courts have ruled on the unlawfulness of the racketeers' action
in May 2017.'' Id. at 2.\1\
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\1\ There is no corrective action plan, or indication that
Respondent submitted a corrective action plan, in the record before
me.
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The Office of Administrative Law Judges put the matter on the
docket and assigned it to Administrative Law Judge Mark M. Dowd
(hereinafter, ALJ). I adopt the following statement of procedural
history from the ALJ's Order Denying The Respo[n]dent's Request for
Abeyance, Granting the Government's Motion for Summary Disposition, and
Recommended Rulings, Findings of Fact, Conclusions of Law, and Decision
of the Administrative Law Judge dated January 26, 2018 (hereinafter,
R.D.).
On November 20, 2017, this tribunal ordered the Government to
file evidence to support the allegations that the Respondent lacked
state authority to handle controlled substances.
On December 4, 2017, the Government filed a Motion for Summary
Disposition . . . . The Government submitted evidence that the
Commonwealth of Massachusetts Board of Registration in Medicine
indefinitely suspended the Respondent's medical license on May 11,
2017, in the form of the Final Decision and Order from Commonwealth
of Massachusetts Board of Registration . . . . Gov't Mot. at Ex. 2,
a. The Suspension was stayed for sixty days [a period which has
since expired] to allow the
[[Page 39785]]
Respondent to enter into a probation agreement with the Board and to
comply with a series of conditions set out within the Board's Final
Decision and Order of Suspension. Id. The Government also offered
the Declaration of . . . the Lead Diversion Investigator (DI . . .)
in the instant investigation, who swore under oath that the
Respondent's Massachusetts Medical License remained suspended, as of
December 1, 2017. Gov't Mot. at Ex. 2. On the basis of the
Respondent's suspended medical license, the Government argued that
the Respondent no longer meets the definition of ``practi[ti]oner''
under the Controlled Substances Act, 21 U.S.C. 802(21), and under 21
U.S.C. 823(f), which ``sets forth the requirements for obtaining a
registration as a practi[ti]oner.'' Gov't Mot. at 4. As such, the
Government argued that Respondent's . . . [registration] should be
revoked. Id. at 6.
The Respondent . . . timely filed his Opposition to the
Government's Submission of Evidence and Request for Summary
Disposition on December 15, 2017. In his reply, the Respondent avers
three claims. First, ``Respondent does indeed possess a
Massachusetts medical license.'' \3\ [Resp't Reply at 1.] [n.3: The
Respondent argues that Merriam-Webster's definition of the term
``possess'' is controlling and that the Government ``consciously
mischaracterize[ed] the Respondent's Request for a Hearing,'' as the
Respondent's medical license[ ] is ``still in his possession . . . .
It still exists. It is owned.'' Resp't Reply at 1.] Second, that he
has not lost state authority to handle controlled substances because
his Massachusetts Controlled Substance Registration Certificate
(Massachusetts CSR) issued by the Massachusetts Department of Health
is still in effect, thus, he argues, there are factual and legal
issues in dispute. Resp't Reply at 3-5. Third, this tribunal should
not rely on [the] DI . . . affidavit as it ``aims to conceal facts
and falsely present the party line'' and [the] DI . . . has
``intentionally, deliberately, consciously [. . .] and in bad faith
[. . .] made a concerted effort to mislead the ALJ in order to
assist the market actors [to] exclude a competitor from the medical
marketplace.'' Id. at 9-10. Thus, the Respondent argued that
``[g]ranting the Government's request for a summary taking,
euphemistically called here a `disposition,' would be inequitable,
contrary to law and would reward renting of state powers.'' Id. at
10. As such, the Respondent requested this tribunal deny the
Government's request for summary disposition and dismiss the instant
case. Id. at 11.
On December 19, 2017, this tribunal ordered the Government to
respond to the Respondent's reply opposing the Government's
submission of evidence and summary disposition request. The Order
directed the Government to file a copy of the Respondent's
Massachusetts CSR Certificate and evidence of its present status, as
well as any evidence of official state action that may have been
taken regarding the Registration in 2017. Moreover, the Government
was ordered to brief relevant Massachusetts case law, statutory law,
and regulations, as well as relevant federal case law, statutory law
and regulations.
The Government filed its response in further support of its
request for summary disposition on January 5, 2018. The Government
argued that ``the formal status of Respondent's Massachusetts CSR
Certificate is irrelevant to these proceedings, as any Massachusetts
CSR Certificate which Respondent possessed became void as a matter
of law the moment that Respondent's medical license was suspended''
pursuant to 105 Code of Massachusetts Regulations Sec. 700.120 and
Massachusetts General Laws Ch. 94C Sec. Sec. 7(f), 9(a). Gov't
Resp. Mot. at 4. On January 26, 2018, the Government filed a copy of
Respondent's Massachusetts CSR Certificate. Gov't Mot for Leave, at
. . . [5]. The Government does not ``dispute Respondent's assertion
that he is in [physical] possession of a Massachusetts CSR
Certificate and that the Massachusetts Department of Public Health
has not yet taken action to revoke his certificate.'' . . . [Gov't
Resp. Mot. at 5.] Rather, the Government argues that ``it is
irrelevant whether formal action has been taken to revoke
Respondent's Massachusetts CSR Certificate as it is already void . .
. [for] the pendency of Respondent's [medical license] suspension.''
Id. at 6. Thus, while the Respondent does ``possess a Massachusetts
CSR Certificate, [ ] he does not possess authority to handle
controlled substances.'' Id.
The Respondent replied to the Government's Response further
supporting summary disposition on January 24, 2018. The Respondent
argues that the Government falsely defamed him as a liar, the
Government deliberately flouted a clear order from this tribunal,
the Respondent's medical license suspension is void ab initio,\4\
and the controlling legal authority is the Massachusetts statute
(Massachusetts General Laws Ch. 94C[)], not the regulation cited by
the Government (105 Code of Massachusetts Regulations Sec.
700.120). Resp't Sur-Reply at 1-6. [n.4: The Respondent cites
multiple cases in support of his conclusion that ``the May 2017
action by criminal racketeers within the state medical board in
violation of the Sherman Act was extra-jurisdictional and legally
void, it naturally follows that any action by other actors, state or
federal, who claim authority based on a previous action that is void
ab . . . [initio], is equally void.'' Resp't Sur-Rely at 5-6. These
cases are inapt and irrelevant to Respondent's argument, and relate
to matters way beyond the narrow focus of this inquiry.] \2\
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\2\ The record contains illegible material submitted by
Respondent. Chambers staff was contacted to ascertain whether
legible versions of Respondent's submissions are available. The
versions that Chambers staff provided are not more legible than the
original versions that the ALJ certified and transmitted. I
reviewed, analyzed, and considered the legible material in the
record. As I am not able to read illegible material, my Decision and
Order are based only on the legible material in the record.
R.D., at 2-4.\3\
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\3\ I agree with the ALJ's conclusions about the Respondent's
following allegations and arguments. First, regarding Respondent's
allegations that Government personnel engaged in wrongdoing, I agree
with the ALJ that, ``There is no evidence before me suggesting [that
the] DI . . . or any other Government personnel . . . engaged in any
false assertions or misrepresentations to this tribunal.'' R.D., at
5. I also agree with the ALJ that, ``[T]here is no evidence in the
record before me that the Government falsely defamed the Respondent
as a liar, or even suggested that service at a later date than that
of the tribunal was done for unfair advantage.'' Id. Second,
concerning Respondent's claim that the Government deliberately
violated an ALJ Order, I agree with the ALJ that ``the Government
has fully complied with this tribunal's order.'' Id. Third, as to
Respondent's position that these proceedings should be dismissed or
held in abeyance pending the outcome of his federal court
litigation, the ALJ's Order Directing the Filing of Government
Evidence of Lack of State Authority Allegation and Briefing Schedule
states that, ``A review of the docket sheets in the pending law
suits cited by the Respondent fail[s] to disclose any order by the
District Court to hold the instant proceeding in abeyance.'' Order
Directing the Filing of Government Evidence dated November 20, 2017,
at 1 n.2. Against the backdrop of the ALJ's review, I agree with him
that Respondent's requests are inconsistent with Agency precedent.
As the ALJ notes, `` `[i]t is not DEA's policy to stay
[administrative] proceedings . . . while registrants litigate in
other forums.' '' R.D., at 6, citing Newcare Home Health Servs., 72
FR 42,126, 42,127 n.2 (2007). I agree with the ALJ that ``the
Respondent's request for an abeyance--in essence to stay these
proceedings--until the federal courts have ruled on his cases and
his request to dismiss the proceedings'' should be denied. R.D., at
7. As the Agency has pointed out, ``Respondent can always apply for
a new registration if [he] prevails'' regarding the indefinite
suspension of his medical license. Newcare Home Health Servs., 72 FR
at 42,127 n.2.
I further note that the ALJ specifically granted Respondent
``leave to file notice and proof regarding (but limited to) any
restoration of his state medical license prior to the transmission
of the matter to the Administrator.'' R.D., at 7. According to the
ALJ's certification and transmittal of the record dated February 21,
2018, the Respondent had not filed notice and proof regarding any
restoration of his State medical license by that time. The record,
therefore, contains no evidence that Respondent is currently
authorized to practice medicine in Massachusetts.
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The ALJ granted the Government's Motion for Summary Disposition and
recommended that Respondent's registration be revoked.
At this juncture, no dispute exists over the fact that the
Respondent currently lacks state authority to handle controlled
substances in the Commonwealth of Massachusetts because the Medical
Board suspended his medical license, thus voiding his Massachusetts
CSR Certificate. Because the Respondent lacks state authority at the
present time, Agency precedent dictates that he is not entitled to
maintain his DEA registration. Simply put, there is no contested
factual matter that could be introduced at a hearing that would, in
the Agency's view, provide authority to allow the Respondent to
continue to hold his DEA . . . [registration].
Id. at 10. By letter dated February 21, 2018, the ALJ certified and
transmitted the record to me for final Agency action. In that letter,
the ALJ advised that neither party filed exceptions and that the time
period to do so had expired.
I issue this Decision and Order based on the entire, legible record
before me.
[[Page 39786]]
21 CFR 1301.43(e). I make the following findings of fact.
Findings of Fact
Respondent's DEA Registration
Respondent is the holder of DEA Certificate of Registration No.
BP7993290, pursuant to which he is authorized to dispense controlled
substances in schedules II through V as a practitioner, at the
registered address of 30 Gardner Road #6A, Brookline, Massachusetts
02445. Government's Submission of Evidence and Request for Summary
Disposition dated December 4, 2017 (hereinafter, Government Motion),
Exh. 01 (Facsimile of Registration No. BP7993290). Respondent's
registration expires on March 31, 2020. Id.
The Status of Respondent's State License
By Final Decision and Order dated May 11, 2017, the Massachusetts
Board indefinitely suspended Respondent's medical license number
209168. According to the Final Decision and Order, ``the record
demonstrates that the Respondent has rendered substandard care to two
patients, maintained substandard medical records for seven patients,
and dispensed controlled substances after his Massachusetts Controlled
Substances Registration . . . expired.'' Government Motion, Exh. 02,
Attachment A, at 1 [footnotes omitted]. The Massachusetts Board's Final
Decision and Order afforded Respondent the opportunity to stay the
indefinite suspension by entering into a Board-approved Probation
Agreement and complying with its terms. Id. at 5-6. There is no
evidence in the record that Respondent availed himself of this
opportunity. Instead, the DI's Declaration states that Respondent's
medical license remained ``suspended'' as of December 1, 2017.
Government Motion, Exh. 02, at 2. Further, according to the online
records of the Commonwealth of Massachusetts, of which I take official
notice, I find that Respondent is still not authorized to practice
medicine in Massachusetts, initially due to the suspension and, as of
May 5, 2018, due to the expiration of license number 209168.\4\
Commonwealth of Massachusetts Board of Registration in Medicine
Physician Profiles website, http://profiles.ehs.state.ma.us/Profiles/Pages/FindAPhysician.aspx (last visited July 30, 2018).
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\4\ Under the Administrative Procedure Act, an agency ``may take
official notice of facts at any stage in a proceeding--even in the
final decision.'' United States Department of Justice, Attorney
General's Manual on the Administrative Procedure Act 80 (1947) (Wm.
W. Gaunt & Sons, Inc., Reprint 1979). Pursuant to 5 U.S.C. 556(e),
``[w]hen an agency decision rests on official notice of a material
fact not appearing in the evidence in the record, a party is
entitled, on timely request, to an opportunity to show the
contrary.'' Accordingly, Respondent may dispute my finding by filing
a properly supported motion for reconsideration within 20 calendar
days of the date of this Order. Any such motion shall be filed with
the Office of the Administrator and a copy shall be served on the
Government. In the event Respondent files a motion, the Government
shall have 20 calendar days to file a response.
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Further, according to Massachusetts' online records, of which I
also take official notice, Respondent is not listed among those
authorized to handle controlled substances in Massachusetts.\5\
Massachusetts Controlled Substances Registration Verification website,
https://www.mass.gov/service-details/registration-verification-mcsr
(last visited July 30, 2018). Massachusetts' online records show no
active Massachusetts Controlled Substance Registration issued to
Respondent. Id.
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\5\ See footnote 4. If Respondent disputes this finding, he may
do so according to the terms stated in footnote 4.
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Accordingly, I find that Respondent currently is without authority
to engage in the practice of medicine or to handle controlled
substances in the Commonwealth of Massachusetts, the State in which he
is registered.
Discussion
Pursuant to 21 U.S.C. 824(a)(3), the Attorney General is authorized
to suspend or revoke a registration issued under section 823 of the
Controlled Substances Act (hereinafter, CSA), ``upon a finding that the
registrant . . . has had his State license or registration suspended .
. . [or] revoked . . . by competent State authority and is no longer
authorized by State law to engage in the . . . dispensing of controlled
substances.'' With respect to a practitioner, the DEA has also long
held that the possession of authority to dispense controlled substances
under the laws of the State in which a practitioner engages in
professional practice is a fundamental condition for obtaining and
maintaining a practitioner's registration. See, e.g., James L. Hooper,
M.D., 76 FR 71,371 (2011), pet. for rev. denied, 481 Fed. Appx. 826
(4th Cir. 2012); Frederick Marsh Blanton, M.D., 43 FR 27,616, 27,617
(1978).
This rule derives from the text of two provisions of the CSA.
First, Congress defined the term ``practitioner'' to mean ``a physician
. . . or other person licensed, registered, or otherwise permitted, by
. . . the jurisdiction in which he practices . . . , to distribute,
dispense, . . . [or] administer . . . a controlled substance in the
course of professional practice.'' 21 U.S.C. 802(21). Second, in
setting the requirements for obtaining a practitioner's registration,
Congress directed that ``[t]he Attorney General shall register
practitioners . . . if the applicant is authorized to dispense . . .
controlled substances under the laws of the State in which he
practices.'' 21 U.S.C. 823(f). Because Congress has clearly mandated
that a practitioner possess State authority in order to be deemed a
practitioner under the CSA, the DEA has held repeatedly that revocation
of a practitioner's registration is the appropriate sanction whenever
he is no longer authorized to dispense controlled substances under the
laws of the State in which he practices. See, e.g., Hooper, supra, 76
FR at 71,371-72; Sheran Arden Yeates, M.D., 71 FR 39,130, 39,131
(2006); Dominick A. Ricci, M.D., 58 FR 51,104, 51,105 (1993); Bobby
Watts, M.D., 53 FR 11,919, 11,920 (1988), Blanton, supra, 43 FR at
27,617.
According to the Massachusetts Controlled Substances Act, ``every
person who . . . dispenses . . . any controlled substance within the
commonwealth shall . . . register with the commissioner of public
health, in accordance with his regulations.'' Mass. Gen. Laws ch. 94C,
Sec. 7(a) (Westlaw, current through Chapter 122 of the 2018 2nd Annual
Session). Further, the automatic issuance of a controlled substances
registration to a physician is only required when the physician is
``duly authorized to practice his profession in the commonwealth.''
Mass. Gen. Laws ch. 94C Sec. 7(f) (Westlaw, current through Chapter
122 of the 2018 2nd Annual Session).
Here, the undisputed evidence in the record is that Respondent's
medical license has been suspended. In addition, as already noted,
Respondent's medical license expired a few months ago. According to
Massachusetts law, Respondent is not eligible to be issued a controlled
substances registration if he is not authorized to practice medicine.
Indeed, as noted above, Respondent is not on the list of those
currently authorized to dispense controlled substances. This lack of
authorization is consistent with the regulations that implement the
Massachusetts Controlled Substances Act: ``A registration is void if
the registrant's underlying professional licensure on which the
registration is based is suspended or revoked.'' 105 Mass. Code Regs.
Sec. 700.120 (Westlaw, current
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through Register No. 1369, dated July 13, 2018).\6\
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\6\ Regarding the terms of 105 Mass. Code Regs. Sec. 700.120, I
agree with the ALJ's rejection of Respondent's argument concerning
the relationship between the Massachusetts Controlled Substances Act
and the regulations implementing that law. As the ALJ notes, the
``statute and regulation are not in conflict.'' R.D., at 9. In
addition, the Massachusetts Controlled Substances Act explicitly
authorizes the Public Health Commissioner to ``promulgate rules and
regulations relative to registration and control of the manufacture,
distribution, dispensing and possession of controlled substances
within the commonwealth.'' Mass. Gen. Laws ch. 94C, Sec. 6
(Westlaw, current through Chapter 122 of the 2018 2nd Annual
Session). See Goldberg v. Bd. of Health of Granby, 444 Mass. 627,
633-34 (2005) (``That the Legislature . . . did not anticipate the
exact factual scenario presented here does not make the
administrative regulations and rulings that did anticipate such
situations invalid.'').
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In sum, Respondent currently lacks authority in Massachusetts to
practice medicine and to handle controlled substances. He is not,
therefore, eligible for a DEA registration. As such, I will order that
Respondent's DEA registration be revoked.
Order
Pursuant to 28 CFR 0.100(b) and the authority thus vested in me by
21 U.S.C. 824(a), I order that DEA Certificate of Registration No.
BP7993290 issued to Bharanidharan Padmanabhan, M.D., Ph.D., be, and it
hereby is, revoked. This Order is effective September 10, 2018.
Dated: July 30, 2018.
Uttam Dhillon,
Acting Administrator.
[FR Doc. 2018-17141 Filed 8-9-18; 8:45 am]
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