[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

[[Page 39787]]

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]
 BILLING CODE 4410-09-P