Federal
Register Notices > Registrant
Actions - 2005 > Felix
K. Prakasam, M.D. Revocation of Registration
FR Doc 05-11248 [Federal Register: June 7, 2005 (Volume 70, Number 108)]
[Notices] [Page 33203-33206] From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jn05-87]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 02-28]
Felix K. Prakasam, M.D. Revocation of Registration
On February 6, 2002, the Deputy Assistant Administrator, Office of Diversion
Control, Drug Enforcement Administration (DEA), issued an Order to Show Cause to
Felix K. Prakasam, M.D. (Respondent) notifying Respondent of an opportunity to
show cause as to why DEA should not revoke his DEA Certificates of Registration
BP3420344 and BP44160029, pursuant to 21
U.S.C. 824(a)(1) and (a)(4) on the grounds he had materially falsified four
DEA renewal applications and that his continued registration would be
inconsistent with the public interest, as that term is used in 21 U.S.C. 823(f)
and 824(a)(4). The Order to Show Cause also proposed that any pending
applications for renewal should be denied under 21
U.S.C. 823(f).
The Order to Show Cause alleged, in sum, that during 1995-1996, Respondent
failed to maintain complete and accurate records of controlled substances
dispensed at this medical offices located in Redlands and Salinas, California,
and accountability audits during this period revealed overages and shortages of
controlled substances at both registered locations. As a result, on March 10,
1997, after an informal administrative hearing at the DEA San Francisco office,
Respondent entered into a Memorandum of Understanding with DEA in which he
agreed to address the record-keeping violations and provide effective controls
against theft and diversion of controlled substances.
The Order to Show Cause further alleged that on April 30, 1997, the
California Medical Board (California Board) brought on Accusation against
Respondent's California medical license. As a result, on February 11, 1998, the
California Board revoked Respondent's medical license, effective March 13, 1998.
However, the Board stayed the revocation, placing Respondent's license on
probation for three years, with conditions. On March 20, 2001, as a result of
the California action, Respondent entered into a Consent Order with the
Louisiana State Board of Medical Examiners (Louisiana Board) in which he agreed
to an indefinite suspension of his Louisiana medical license.
Finally, it was alleged that in February 1998 and February 2001, Respondent
materially falsified a total of four applications for renewal of his DEA
registrations by failing to disclose the California Board's action placing his
medical license in a probationary status.
Respondent requested a hearing on the issues raised by the Order to Show
Cause and following pre-hearing procedures, a hearing was held in San Francisco,
California, on March 12 and 13, 2003. At the hearing, both parties called
witnesses to testify and introduced documentary evidence. After the hearing,
both parties submitted proposed findings of fact, conclusions of law, and
argument.
On January 30, 2004, Presiding Administrative Law Judge Mary Ellen Bittner
(Judge Bittner/ALJ) issued her Opinion and Recommended Ruling, Findings of Fact,
Conclusions of Law and Decision of the Administrative Law Judge (Opinion and
Recommended Ruling) in which she recommended that Respondent's two DEA
registrations be revoked and any pending applications for renewal denied. No
exceptions were submitted by the parties, and on March 2, 2004, Judge Bittner
transmitted the record of these proceedings to the then-Acting Deputy
Administrator of DEA. The Deputy Administrator has considered the record in its
entirety and pursuant to 21
CFR 1316.67, hereby issues her final order based upon finding of fact and
conclusions of law as hereinafter set forth. The Deputy Administrator adopts the
findings of fact and recommendation of the Administrative Law Judge that
Respondent's DEA Certificates of Registration be revoked.\1\
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\1\ In an evidentiary/discovery ruling which did not impact relevant
findings of fact or her recommendation for revocation, the ALJ concluded the
Government should have provided Respondent copies of several DEA-6 Reports of
Investigation which had been prepared by a DEA Diversion Investigator while
investigating the allegations, several years before the hearing. Before
testifying for the Government, the Diversion Investigator had used the reports
to refresh his memory and Respondent's request for the documents was made
after the Diversion Investigator completed testifying on direct examination.
Notwithstanding the ALJ's ruling, the Government declined to provide
Respondent the reports, contending they were not releasable under the rules
and statutes governing DEA administrative hearings. Transcript, pages 168-169;
Opinion and Recommended Ruling, page 5, fn. 1.
The reports appear to be Jencks Act material (18 U.S.C.
3500) and the Deputy Administrator has previously ruled that "pursuant to
applicable law and regulations governing DEA administrative hearings, neither
the principles of the Jencks decision nor the Jencks Act are applicable to
these proceedings.'' See e.g., Branex Inc., 69 FR 8,682, 8,685 (2004)
(Emphasis added) [Confirming predecessor Deputy Administrator's interlocutory
decision that the Government is not required to supply a respondent at an
administrative hearing, statements made and adopted by Government witnesses
during their direct testimony.]
Applying the principles of Branex and its predecessors,
which addressed evidentiary/discovery standards applicable to DEA
administrative hearing and detailed the Government's limited obligations to
provide discovery before and during the course of hearings under the
Administrative Procedures Act (5 U.S.C. 556(d)) and DEA regulations (21 CFR
1316.54-1316.59), the Deputy Administrator concludes the Government correctly
declined to provide Respondent the reports in question here. See e.g.,
Nicholas A. Sychak, d.b.a. Medicap Pharmacy, 65 FR 75,959, 75,960-75,961
(2000) [No requirement for Government to disclose potentially exculpatory
information to respondents in DEA administrative hearings]; Rosalind A.
Cropper, M.D., 66 FR 41,040, 41,041 (2001) ["the Federal Rules of Evidence do
not apply directly to these proceedings''].
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The record before the Deputy Administrator shows Respondent received his
medical degree in 1971 from Christian Medical College in Vellore, India. He
interned and completed a residency in Maryland and in 1981 was licensed to
practice in California. He also practiced medicine in Louisiana from an
undetermined date until 1992, when he moved to California and opened a practice
in Redlands. He eventually began working in the Salinas office of Rinaldo Fong,
M.D. and took over that practice when Dr. Fong was deported. Respondent has held
DEA Certificate of Registration BP3420344 for the Redlands location since
November 18, 1992, and DEA resignation BP4416029 for the Salinas office since
May 8, 1995. While Respondent is Board eligible in anesthesiology, his specialty
at all relevant times has been bariatric medicine i.e., weight control.
In July 1996, after reports were received of Respondent's possible purchase
of excessive quantities of controlled substances, DEA Diversion Investigators,
accompanied by an investigator from the California Board, conducted an
inspection and accountability audit at Respondent's Salinas office. The
inspection revealed Respondent had not complied with multiple regulatory
requirements, including failures: (1) Maintain an inventory of controlled
substances as of a specific date and as of the opening or closing of business;
(2) maintain
[[Page 33204]]
addresses of patients to whom Respondent directly dispensed controlled
substances or the initials or name of the dispenser; (3) adequately document a
return of controlled substances to a supplier; (4) document a transfer of
controlled substances between his Redlands and Salinas offices; and (5) retain a
purchase invoice.
An accountability audit performed in conjunction with the investigation in
July 1996 indicated substantial overages of phentermine 30 mg. and 15 mg. and a
substantial shortage of phentermine 37.5. However, Judge Bittner concluded the
overages were most likely attributable to the use of a zero opening inventory
and did not necessarily indicate diversion.
With regard to the shortage, there was a conflict in the evidence as to
whether investigators had inventoried some 48,000 dosage units of phentermine
37.5 mg. which, if counted, would have resulted in an overage of that drug. A
second inventory was performed at the Salinas Office on October 29 and 30, 1996,
showing a substantial overage of phentermine 37.5 mg. and no significant
shortages. Given the numbers, Judge Bittner concluded the second audit's overage
indicated the 48,000 units of phentermine 37.5 mg. had actually been on hand in
July, but not counted in the first audit.
The Deputy Administrator agrees with Judge Bittner that the record is
inadequate to determine whether or not the July 1996 inventory was accurate.
Therefore, it cannot be established whether or not Respondent was responsible
for the shortage indicated by the first audit. On February 6, 1997, a Notice of
Hearing was issued by DEA informing Respondent an informal hearing would be held
in San Francisco on March 10, 1997. The notice alleged the record keeping and
regulatory violations from the 1996 DEA investigations. Respondent appeared,
represented by counsel, and testified regarding the reasons for the regulatory
violations, but disputed the accuracy of the inventories.
On May 8, 1997, Respondent executed a Memorandum of Understanding with DEA's
San Francisco Field Division. In that Memorandum Respondent agreed to: (1)
Comply with the provisions of the Controlled Substances Act and its implementing
regulations at each of his registered locations; (2) take an inventory of
controlled substances upon receiving a new DEA registration; (3) maintain
dispensing logs that met regulatory requirements; (4) keep complete and accurate
records; (5) keep required receiving records; (6) follow drug destruction
procedures established by the DEA San Francisco office; and (7) provide
effective controls against theft and diversion of controlled substances.
The California Board conducted additional investigations of Respondent and on
April 30, 1997, issued an Accusation against Respondent alleging multiple
violations, including the matters from the 1996 DEA inquiries. On February 11,
1998, the California Board issued a Decision, effective March 13, 1998, adopting
a Stipulated Settlement and Decision (Stipulation) that Respondent and his
then-attorney executed on January 5, 1998. In the Stipulation, Respondent waived
various rights but did not admit engaging in any of the alleged misconduct.
The Stipulation revoked Respondent's medical license and license to supervise
physician assistants, but stayed the revocations and placed his licenses on
probation for three years. Among its provisions, the Stipulation required
Respondent to take continuing medical education courses and courses in
prescribing practices and ethics, to maintain records of all controlled
substances he prescribed, dispensed or administered, to make these records
available for inspection, to take and pass an oral clinical examination, to have
a third party present while examining or treating female patients and to comply
with a probation surveillance program.
The Stipulation provided that upon successful completion of probation,
Respondent's California licenses would be reinstated. That, in fact, occurred
and on May 11, 2001, Respondent was notified he had successfully completed
probation. He has since been licensed to practice medicine in California without
restriction. The evidence introduced at the DEA hearing indicates that since the
1996 DEA inquiry, he has complied with controlled substance record keeping
requirements.
Respondent was also licensed to practice medicine in Louisiana for a period
of time prior to 1998, when his license expired. Under Louisiana law, he was
entitled to renew the license for a period of four years from its expiration. On
Februry 2, 2001, Respondent entered into a Consent Order with the Louisiana
Board, in which the Board indefinitely suspended Respondent's entitlement to
reinstatement of his Louisiana medical license. It further imposed, as a
condition of eventual reinstatement, that Respondent successfully complete all
probationary conditions levied by the California Board and obtain an
unrestricted license to practice medicine in California. Respondent was also
required to notify and appear before the Louisiana Board, prior to seeking
renewal or reinstatement of his Louisiana license and he would accept any terms
or conditions the Louisiana Board might impose as a condition of reinstatement.
Respondent testified at the DEA hearing that when he signed the Memorandum of
Understanding with DEA in May 1997, he understood "that the matter would be laid
to rest at that moment, and never again brought up; but it was not done so.'' He
also testified he agreed to settle the California Board proceedings because he
paid "thousands of dollars'' in attorney fees and had no money left. However, he
regretted that decision because he considered the allegations to be false. With
regard to the Louisiana Consent Order, Respondent testified he signed it because
he "had not desire to go back to Louisiana.''
On February 25 and 28, 1998, Respondent executed renewal applications for the
DEA registrations at his Redlands and Salinas locations. On both applications,
Respondent checked "No'' in response to the question, "Has the applicant even
been convicted of a crime in connection with controlled substances under State
or Federal law or ever surrendered or had a Federal controlled substance
registration revoked, suspended, restricted, or denied or ever had a State
professional license or controlled substance registration revoked, suspended,
denied, restricted, or placed on probation or is any such action pending against
the applicant?'' (Emphasis added). An applicant who responds affirmatively to
this question is required to explain his answer on the back of the application.
Respondent left this space blank on both applications.
On February 27 and 28, 2001, Respondent again executed renewal applications
for his Salinas and Redlands offices. These applications included the so-called "liability
questions'' pertaining to individual applicants. Question 3(d) asked, "Has the
applicant ever had a state professional license or controlled substance
registration revoked, suspended, denied, restricted, or placed on probation?''
(Emphasis added). Respondent answered this question in the negative on both
applications and left the space for explanations of affirmative answers blank.
In June 2001, a Diversion Investigator from DEA's Riverside office looking
into Respondent's February 2001 renewal applications, contacted the California
Board and learned that Respondent's medical license for that state had been
[[Page 33205]]
placed on probation. In October 2001, the investigator wrote a report
concluding Respondent had not truthfully answered the liability questions and
recommend initiation of the instant Show Cause proceedings.
Respondent testified at the DEA hearing that when he executed the two
February 1998 applications, no discipline had yet taken effect against either
his California or Louisiana medical licenses. When asked his understanding of
the relevant question, Respondent replied he thought the question applied only
to a separate state license to handle controlled substances, such as he had in
Louisiana, and that no action had been taken against that license. He further
testified he would have expected someone from DEA to contact him if there was a
problem with the 1998 applications and that did not occur.
On cross-examination, Respondent acknowledged that as of January 5, 1998, he
was aware he was entering into an agreement with the California Board which
would result in his California medical license being placed on probation and
that the questions on his February 1998 applications referred to pending
disciplinary actions, in addition to discipline already imposed. Nonetheless,
when asked, "isn't it true that, on February 25, 1998, you were aware that the
California Medical Board was going to place [you] on probation?''--Respondent
answered, "Yes, but that's not how I read that.'' Asked further what he thought
the correct answer to the application's question was, Respondent replied, "My
opinion would be the correct answer is no.''
Similarly, when asked whether the February 2, 2001, Consent Order with the
Louisiana Board resulted in a suspension or probation of his Louisiana medical
license, Respondent replied the Consent Order was based on the California
settlement and he had agreed not to practice in Louisiana and not renewed his
license in that state.
With respect to the two 2001 DEA applications, Respondent testified his
answers to question 3(d) were correct because the probationary period for his
California medical license had run by that time and he thought the question
referred to his controlled substance license, rather than his medical license.
The Controlled Substances Act specifies in 21
U.S.C. 824(a)(1) that the Deputy Administrator may revoke a DEA Certificate
of Registration if she finds the registrant has materially falsified any
application for DEA registration. The Act also provides in section 824(a)(4)
that the Deputy Administrator may revoke a registration if she determines the
registrant has committed acts that would render his continued registration
inconsistent with the public interest, as that term is determined under 21
U.S.C. 823(f). That section requires the following factors be considered 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 or safety.
These factors are to be considered in the disjunctive; the Deputy
Administrator may rely on any one or a combination of factors and may give each
factor the weight she deems appropriate in determining whether a registration
should be revoced or an application for registration denied. See Henry J.
Schwartz, Jr., M.D., 54 FR 16,422 (1989).
With regard to the public interest factors, the Deputy Administrator finds,
in agreement with Judge Bittner as to factor one, that Respondent has regained
his unrestricted license to practice medicine in California and this weighs in
favor of continued registration. However, inasmuch as State license is a
necessary but not sufficient condition for DEA registration, this factor is not
determinative. See Edson W. Redard, M.D., 65 FR 30,616, 30,619 (2000); James C.
LaJevic, D.M.D., 64 FR 55,962, 55,964 (1999).
As to factor two, Respondent's experience in handling controlled substances,
Judge Bittner concluded that the recordkeeping deficiencies disclosed in the
1996 investigation indicated that continued registration would not be in the
public interest. However, with regard to the 1996 audits, Judge Bittner
concluded the evidence introduced at the DEA hearing was insufficient to show
Respondent responsible for any shortages of controlled substances and thus
weighed in favor of continued registration. The Deputy Administrator agrees with
these conclusions.
As to factor three, there is no evidence Respondent has ever been convicted
of a crime relating to controlled substances.
As to factor four, his compliance with applicable laws relating to controlled
substances, Respondent's falsification of the renewal applications and the
regulatory violations discussed above, establish he has not complied with the
laws relating to controlled substances. The Deputy Administrator agrees with
Judge Bittner that this factor weighs against continued registration.
As to factor five, other conduct that may threaten the public health and
safety, Judge Bittner noted that, although Respondent committed various
regulatory violations prior to 1996, his subsequent recordkeeping apparently
complied with DEA regulations. She therefore found this factor weighs in favor
of continued registration. The Deputy Administrator agrees.
In sum, Judge Bittner concluded Respondent corrected the recordkeeping
deficiencies uncovered in 1996 and under the circumstances, the audit results
did not warrant a finding that Respondent mishandled controlled substances
during the period July 1995 to October 1996. She concluded that the factors
considered pursuant to 21
U.S.C. 832(f), other than those relating to falsification of applications,
did not establish that Respondent's continued registration was inconsistent with
the public interest under 21
U.S.C. 824(a)(4). The Deputy Administrator agrees revocation is unwarranted
under that section.
However, as Judge Bittner concluded, the issue of Respondent's falsification
of renewal applications "is another matter.'' DEA has previously held that in
finding there has been a material falsification of an application, it must be
determined the applicant knew or should have known that the response given to
the liability question was false. See Merlin E. Shuck, D.V.M., 69 FR 22,566
(2004); James C. LaJavic, D.M.D., supra, 64 FR 55,962; Martha Hernandez, M.D.,
62 FR 61,145 (1997). In that regard, Judge Bittner found Respondent materially
falsified four applications for renewal of his DEA registrations.
The two 1998 applications did not refer only to licenses to handle controlled
substances, but to "a state professional license or controlled substance
registration,'' and it is clear that applicants were required to report actions
against their medical or other professional licenses, both completed and
then-pending. Further, although the probation of Respondent's California license
did not take effect until March 13, 1998, the disciplinary action was obviously
pending on February 25 and 28, 1998, when Respondent executed his applications.
Also, regarding the two February 2001 applications, at that time Respondent's
California license had been on probation and the fact that the
[[Page 33206]]
probationary period was over did not justify a negative answer to the
question, as it asked whether the applicant "ever'' had discipline take against
a state license. The Deputy Administrator also agrees with Judge Bittner's
conclusions, made after observing Respondent's demeanor, that "Respondent's
explanations for the misstatements and his continued insistence that his answers
were correct are disingenuous at best'' and that he materially falsified the
applications, which establishes grounds for revoking his registrations under 21
U.S.C. 824(a)(1).\2\
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\2\ Respondent signed the Consent Order with the Louisiana Board on
February 2, 2001, however it was not effective until March 20, 2001. Judge
Bittner noted that the 2001 DEA applications, which Respondent signed on
February 27 and 28, 2001, did not specifically ask whether any disciplinary
proceedings were then "pending.'' Accordingly, she concluded that, "at least
arguably, Respondent was not required to disclose the Louisiana action
inasmuch as it was not effective until March 20, 2001.'' While, given the
wording of the application's questions, Respondent's omissions in failing to
report this action may not have amounted to material misrepresentations under
21 USC 824(a)(1), it demonstrates his willingness to draw exceptionally fine
lines in dealing with DEA regulators.
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As Judge Bittner notes in her Opinion and Recommended Ruling, the governing
statute is discretionary. See Mary Thomson, M.D. 65 FR 75,969 (2000). In
exercising discretion in determining the appropriate remedy in any given case,
the Deputy Administrator considers all the facts and circumstances of the case.
See Martha Hernandez, M.D., supra, 62 FR 61,145.
In recommending revocation of Respondent's registrations, Judge Bittner
concluded,
False statements on an application for DEA registration withhold from DEA
information that is germane to the applicant's fitness to hold that
registration. Kuen H. Chen, M.D., 58 FR 65401 (DEA 1993). Further, as discussed
above, Respondent insisted that his answers to the questions on his 1998 and
2001 applications for renewal of his DEA registrations were accurate.
They were not. In addition and also discussed above, Respondent's
explanations of his answers on these applications were at best disingenuous.
Respondent's cavalier attitude toward his responsibility to truthfully answer
questions on the application raises serious concerns about whether he is willing
to accept the other responsibilities inherent in a DEA registration.
The Deputy Administrator has examined the record and finds the facts and
credibility determinations of Judge Bittner to be well supported by the
evidence. While the record does not establish that Respondent's continued
registration would be inconsistent with the public interest, he materially
falsified four applications for renewal of registration, which constitutes an
independent ground for revocation.
The Deputy Administrator shares Judge Bittner's concern regarding
Respondent's on-going refusal or inability to acknowledge a registrant's
responsibility to provide forthright and complete information to DEA, when
required to do so as a matter of law or regulation. This attitude, reflected
most recently in his testimony at the hearing under oath, does not auger well
for his future compliance with the responsibilities of a registrant.
Accordingly, the Deputy Administrator of the Drug Enforcement Administration,
pursuant to the authority vested in her by 21
U.S.C. 823 and 824
and 28 CFR 0.100(b), and 0.104, hereby orders the DEA Certificates of
Registration BP3420344 and BP4416029, issued to Felix K. Prakasam, M.D., be, and
hereby are, revoked. The Deputy Administrator further orders that any pending
applications to renew or modify said registrations be denied. This order is
effective July 7, 2005.
Dated: May 25, 2005.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. 05-11248 Filed 6-6-05; 8:45 am]
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