[Federal Register Volume 62, Number 77 (Tuesday, April 22, 1997)]
[Notices]
[Pages 19603-19607]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10371]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 96-21]
Ellis Turk, M.D.; Denial of Application
On February 12, 1996, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Ellis Turk, M.D., (Respondent) of Baltimore,
Maryland, notifying him of an opportunity to show cause as to why DEA
should not deny his application for registration as a practitioner
under 21 U.S.C. 823(f), for reason that such registration would be
inconsistent with the public interest.
By letter received by DEA on March 12, 1996, Respondent, through
counsel, timely filed a request for a hearing, and following prehearing
procedures, a hearing was held in Arlington, Virginia on September 4,
1996, before Administrative Law Judge Paul A. Tenney. At the hearing
both parties called witnesses to testify and introduced documentary
evidence. After the hearing, both sides submitted proposed findings of
fact, conclusions of law and argument. On November 22, 1996, Judge
Tenney issued his Opinion and Recommended Ruling, Findings of Fact,
Conclusions of Law and Decision, recommending that Respondent's
application for a DEA Certificate of Registration should be granted
subject to various temporary limitations. On December 11, 1996,
Government counsel filed exceptions to the Recommended Ruling of the
Administrative Law Judge, and subsequently, Respondent's counsel filed
a response to the Government's exceptions. Thereafter, on January 14,
1997, Judge Tenney transmitted the record of these proceedings to the
Acting Deputy Administrator.
The Acting Deputy Administrator has considered the record in its
entirety, and pursuant to 21 CFR 1316.67, hereby issued his final order
based upon findings of fact and conclusions of law as hereinafter set
forth.
The Acting Deputy Administrator finds that Respondent previously
possessed DEA Certificate of Registration, AT2444711. On April 15,
1993, and Order to Show Cause was issued proposing to revoke that
Certificate of Registration, alleging that Respondent's continued
registration would be inconsistent with the public interest. Following
a hearing before Administrative Law Judge Mary Ellen Bittner, the then-
Deputy Administrator adopted the Opinion and Recommended Decision of
Judge Bittner and revoked Respondent's DEA registration in a final
order dated March 30, 1995, and effective May 8, 1995. See Ellis Turk,
M.D., 60 FR 17,577 (April 6, 1995).
In the prior proceeding, the then-deputy Administrator found that
in 1987, DEA had received reports from drug distributors that
Respondent had purchased excessive quantities of phentermine and
phendimetrazine, both controlled substances. Consequently, on two
occasions in December 1988, DEA, pursuant to administrative inspection
warrants, conducted an accountability audit of controlled substances at
Respondent's office covering the period December 29, 1987, through
December 12, 1988. This audit revealed shortages of phentermine and
phendimetrazine. These shortages were confirmed by a second audit
conducted by a different DEA investigator using different records than
those used for the previous audit. As a result of the audits, on
November 22, 1989, a civil complaint was filed in the United States
District Court for the District of Maryland. Following a bench trial,
the court found that Respondent failed to comply with the recordkeeping
requirements of the Controlled Substances Act (CSA) and assessed a
civil penalty of $24,000.00. The decision of the District Court was
upheld by the United States Court of Appeals for the Fourth Circuit.
Respondent brought a civil action
[[Page 19604]]
against the United States Government alleging abuse of process,
malicious abuse of process, constitutional violations, interference
with the physician-patient relationship, harassment, intentional
infliction of emotional distress, and invasion of privacy. Respondent's
complaint was dismissed for lack of federal subject matter jurisdiction
and lack of process.
In his final order, the then-Deputy Administrator noted that Judge
Bittner had found that ``the evidence provided by the Government
clearly established the shortages in Respondent's accountability of
controlled substances, and that although Respondent offered various
documents into evidence, none of them offered any plausible or coherent
explanation for the discrepancies found in the investigation.'' In
addition, Judge Bittner found ``that the Respondent, throughout the
course of his previous litigation, as well as the instant case,
continuously had been defensive, hostile, and uncooperative and had
insisted on clouding the issues with tangential arguments and
rhetorical allegations of political wrongdoing.'' The then-Deputy
Administrator adopted Judge Bittner's opinion and recommended decision
in its entirety.
On July 10, 1995, Respondent submitted an application for a new DEA
registration. That application is the subject of these proceedings. The
Acting Deputy Administrator concludes that the then-Deputy
Administrator's March 30, 1995 decision regarding Respondent is res
judicata for purposes of this proceeding. See, Stanley Alan Azen, M.D.,
61 FR 57,893 (1996) (where the findings in a previous revocation
proceeding were held to be res judicata in a subsequent administrative
proceeding.) The then-Deputy Administrator's determination of the facts
relating to the previous revocation of the Respondent's DEA
registration is conclusive. Accordingly, the Acting Deputy
Administrator adopts the March 30, 1995 final order in its entirety.
The Acting Deputy Administrator concludes that the critical
consideration in this proceeding is whether the circumstances, which
existed at the time of the prior proceeding, have changed sufficiently
to support a conclusion that Respondent's registration would be in the
public interest.
The Acting Deputy Administrator finds that on April 13, 1995, after
receiving notice of the revocation of his previous DEA registration,
Respondent telephoned the DEA Baltimore office and complained about
both the District Court Judge in the civil action and Judge Bittner.
Respondent asserted that there was a conspiracy against him and that if
the drug distributors had not reported him, none of this would have
happened. He further asserted that his records have always been good.
On May 5, 1995, when Respondent met with representatives of DEA to
surrender his DEA Certificate of Registration and his controlled
substances prior to the effective date of the revocation, it was
discovered that Respondent had in his possession outdated drugs that he
had failed to include in his inventory of controlled substances.
Respondent testified at the hearing in this matter that he came into
possession of these outdated drugs when he purchased the medical
practice of another doctor in 1980. Respondent stated that he advised
state agents about the drugs at the time he took over the medical
practice, but did not feel comfortable disposing of the drugs in the
manner suggested by the state agents, and instead kept them locked up
until turning them over to DEA in May 1995.
On February 22, 1996, DEA received a letter from Respondent to the
Administrator of DEA complaining about the DEA Baltimore office ``and
others'' and requesting that his DEA registration be returned to him.
Respondent asserted that, ``[i]n December of 1988, DEA officials from
the Baltimore office along with a State of Maryland drug official,
entered my office three times unannounced and without a proper warrant.
They illegally seized my records and harassed me, my staff, and
numerous patients.'' Regarding the civil case, Respondent argued that
``I proved that my inventory of these two medications was properly
reconciled in writing and the issue should never have gone to trial!
However, [the District Court Judge] would not or could not believe the
pleading I entered in the case! He is very ill with Parkinson's disease
and probably suffers from dementia.'' Respondent then stated that ``my
DEA license was taken from me fraudulently on May 8, 1995.'' He stated
that Judge Bittner had the same pleading that the District Court Judge
had ``showing proper reconciliation of my inventory.'' Respondent
claimed that ``[his] case went from Judge Bittner to Mr. Steve Green,
your deputy, who rubber-stamped Judge Bittner * * *.'' He then alleged
that several doctors who had treated him in the past made ``the false
complaint [that initiated this matter] since they have the motive and
strong government connections.'' Respondent went on to state, ``I can
understand a false complaint, but why would DEA (of Baltimore) etc.
take it to such extremes (seven years now!)--was somebody paid off?''
At the hearing in this matter, Respondent testified that he had
adopted the inventory techniques used by the prior physician who owned
the practice which consisted of a ledger book with reconciliation every
six months. Respondent unequivocally stated at the hearing that his
records were correct and that the audits conducted by DEA were wrong.
Specifically, Respondent stated that ``I think there was an incorrect
count, whether on purpose or unintentionally by the DEA. They were in
error * * * I will continue to state that.'' Later, Respondent
testified, ``There were no errors on my part * * *. The mistakes were
made by the DEA * * *. They made up 11\1/2\ bottles missing.'' In
response to a question as to how he would keep records differently now,
Respondent stated, ``I have simplified it a little bit * * *. It isn't
much different * * *.'' He then described an eight column accounting
form that can be reconciled on a daily basis.
Respondent was asked whether he was willing to cooperate with DEA
and to discuss his inventorying techniques. He responded, ``Well, I
hope if they want to come and review my inventory, I certainly will
allow them. I hope it's not like the last time.'' Respondent's counsel
asked, ``You would just hope that that wouldn't occur during office
hours; am I hearing you correctly?'' Respondent answered, ``That's what
I thought when it said reasonable time and place. I didn't think it
meant in the middle of office hours.'' Later Respondent stated, ``And I
would hate to have the same thing happen that happened in 1988 when
they came in three times improperly.'' Specifically in response to
questions about his future cooperation with DEA, Respondent testified,
``I have eight years of harassment and false charges that make me very
wary of the DEA.'' Respondent further testified, ``I've always
cooperated with the authorities.'' However, Respondent acknowledged
that the only time that DEA has ever inspected his recordkeeping was in
December 1988.
One of Respondent's patients testified that she has known
Respondent for 16 years and finds him to be an honest and good doctor,
who not only dispenses medication, but talks to his patients. She has
never known him to dispense medication so as to increase her dosage.
Respondent introduced evidence at the hearing that indicates that
he is in good standing with the Maryland Board
[[Page 19605]]
of Physician Quality Assurance and the Maryland Division of Drug
Control.
The Government contends that Respondent's application for
registration should be denied based upon the shortages of phentermine
and phedimetrazine that were established at the prior proceeding, as
well as Respondent's continued refusal to accept responsibility for the
shortages and to recognize DEA's statutory authority to conduct
inspections. The Government further contends that Respondent's
testimony indicates that he is unwilling to cooperate with DEA in the
future. Finally, the Government argues that Respondent failed to
maintain an inventory of outdated drugs as required by the regulations.
Respondent contends that he should be granted a DEA registration.
Although he believes that DEA erred, he is willing to work with DEA
regarding his controlled substance handling practices. He is in good
standing with the state licensing boards and has never been convicted
of a controlled substance offense. Respondent further contends that the
outdated drugs were abandoned by his predecessor and that he kept them
securely locked rather than disposing of them in an environmentally
unsound manner. Respondent argues that the Government is estopped from
raising the issue of the outdated drugs because the DEA was aware of
these drugs from its 1988 inspection, yet did not raise the issue
during the previous revocation proceeding.
Respondent suggests that should he not be issued an unrestricted
DEA Certificate of Registration, he should be issued a registration
subject to the following limitations:
A. Dr. Turk will provisionally resume use of a Certificate of
Registration to prescribe Schedule II controlled substances and to
dispense Schedule III, IV and V controlled substances.
B. Dr. Turk will provide carbon (carbonless) copies of his
prescriptions for Schedule II controlled substances to authorized DEA
personnel upon request, with patient names redacted.
C. The Certificate is provided upon the condition that Dr. Turk
waives any requirement(s) for an administrative warrant for ``spot''
inventories to be conducted by authorized DEA personnel. Said waiver
shall continue for a least two years from the date of this
recommendation.
D. The Certificate is provided upon the condition that Dr. Turk
maintain a readily retrievable inventory ledger in addition to his
``med sheets,'' and will provide the same to DEA personnel upon
request, with patient names redacted. Dr. Turk must agree that he will
fully comply with all applicable sections and sub-sections of 21 CFR
1301-1304 (6/1/96 and subsequent editions).
E. The Certificate is provided on the condition that Dr. Turk agree
to meet with appropriate DEA personnel on a scheduled basis (mutual
convenience) once every six months (for at least a two year-period) and
to review records and conduct discussions deigned to maximize
cooperation between the parties.
Pursuant to 21 U.S.C. Sec. 823(f), the Deputy Administrator may
deny an application for a DEA Certificate of Registration if he
determines that such registration would be inconsistent with the public
interest, In determining the public interest, the following factors are
considered:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting
research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety. These factors are to be considered in the disjunctive; the
Deputy Administrative may rely on any one or a combination of factors
and may give each factor the weight he deems appropriate in determining
whether a registration should be revoked or an application for
registration be denied. See Henry J. Schwarz, Jr., M.D., Docket No. 88-
42, 54 FR 16,422 (1989).
The Administrative Law Judge found that all five factors are
relevant in this proceeding. Regarding factor one, Judge Tenney found,
and the Acting Deputy Administrator concurs, that there is no evidence
of any adverse action against Respondent by the state licensing
authorities. It is controverted that Respondent's medical license and
license to handle controlled substances in the State of Maryland are in
good standing.
As to factor two, the Administrative Law Judge found that ``[t]here
is no adverse evidence concerning Respondent's dispensing experience.''
As of the date of the hearing, he had been practicing medicine for 27
years, and had been conducting a diet practice since 1980. Judge Tenney
noted that a patient of Respondent testified that Respondent had never
dispensed her medication so as to increase her dosage. In its
exceptions to Judge Tenney's Opinion and Recommended Ruling, the
Government argues that Judge Tenney improperly allowed the testimony of
this patient, since she had not been disclosed as a potential witness
to the Government until the day of the hearing. In its response to the
Government's exceptions, Respondent contends that rebuttal witnesses
need not be disclosed in advance of a hearing, and the Administrative
Law Judge was careful to limit the patient's testimony. The Acting
Deputy Administrator finds that DEA's regulations do not address
rebuttal testimony, nevertheless as a general proposition, rebuttal
witnesses need not be disclosed in advance of a hearing. The Acting
Deputy Administrator therefore rejects the Government's exception and
concurs with Judge Tenney's finding that there is no adverse evidence
concerning Respondent's dispensing experience.
Concerning factor three, the Acting Deputy Administrator concurs
with Judge Tenney's finding that Respondent has not been convicted of
any Federal or State laws relating to the manufacture, distribution or
dispensing of controlled substances.
Regarding Respondent's compliance with controlled substance laws
under factor four, the Administrative Law Judge found that the United
States District Court for the District of Maryland found Respondent
liable for failing to comply with the recordkeeping requirements of the
CSA and his previous registration was revoked based upon the shortages
discovered as a result of the accountability audits. However, Judge
Tenney noted that Respondent has now agreed to change his inventory
practices to have a readily retrievable inventory.
The Acting Deputy Administrator finds that the shortages revealed
by the accountability audits demonstrate Respondent's failure to
maintain complete and accurate records of controlled substances as
required by 21 U.S.C. 827 and 21 CFR 1304.21. Respondent's
noncompliance with these provisions has previously been found by a
United States District Court Judge, the United States Court of Appeals
for the Fourth Circuit, Judge Bittner and the then-Deputy Administrator
in the previous revocation proceeding. Despite these findings,
Respondent continues to deny that there was anything wrong with this
recordkeeping, instead blaming DEA and alleging that DEA made up the
shortages. Respondent has not presented any credible evidence in any of
these proceedings to explain the discrepancies in his recordkeeping.
[[Page 19606]]
The Acting Deputy Administrator is not convinced that Respondent's
asserted changes to his recordkeeping practices will result in improved
compliance with the laws relating to controlled substances. First,
Respondent emphatically denies that there was anything wrong with his
previous recordkeeping practices. Respondent's failure to accept
responsibility for his misconduct does not augur well for his future
compliance. Also, in describing the proposed changes in his
recordkeeping, Respondent testified ``I have simplified it a little bit
* * * It isn't much different * * *.''
In addressing the outdated drugs that were in Respondent's
possession, the Administrative Law Judge found that ``Respondent failed
either to dispose of or to maintain an inventory of outdated drugs in
his possession and his estopped argument is not developed.'' However,
Judge Tenney noted that Respondent's failure to dispose of or inventory
the expired drugs is not likely to recur since he has only changed his
practice once and that was sixteen years ago. The Acting Deputy
Administrator agrees with Judge Tenney. Respondent violated 21 CFR
1304.13 by failing to include the outdated drugs in his inventory of
controlled substances. However, given the circumstances regarding
Respondent's possession of these drugs, it is unlikely that this
violation will be repeated.
As to factor five, Judge Tenney found that ``Respondent has had a
diet practice since 1980. The accountability audits revealed shortages.
However, there is no evidence that Respondent diverted any controlled
substances. At most, Respondent had faulty inventory practices.''
The Government disagreed, in its exceptions to Judge Tenney's
Opinion and Recommended Ruling, with Judge Tenney's characterization
under factor five that the shortages of controlled substances merely
reflected faulty inventory practices. The Government contends that
``[s]ince Respondent has never demonstrated that the audits were
incorrect, the more plausible explanation is that the controlled
substances were somehow diverted into illicit uses.'' Furthermore, the
Government argues that since the findings of the previous revocation
proceeding are res judicata, it would be inconsistent to find that the
shortages warranted revocation in the prior proceeding, but not in the
present case. The Government noted that the significant question in
this proceeding is whether there has been a significant change in
circumstances from the prior proceeding. The Government argues that the
Administrative Law Judge failed to make any findings ``pertaining to
Respondent's continued denial of the audit shortages and Respondent's
continued hostility towards regulation by DEA.'' The Government
asserted in its exceptions that ``[i]t would be hard to imagine a case
where a DEA applicant has exhibited less of a change in attitude than
Respondent has between the revocation proceeding and the present
hearing.''
In his response to the Government's exceptions, Respondent argues
that the Government is collaterally estopped from arguing that
Respondent unlawfully diverted controlled substances. Respondent
further argues that ``the Government provides no factual basis,
whatsoever, for its assertion that the more plausible explanation [for
the shortages] is that the controlled substances in question were
somehow diverted into illicit use.'' Respondent also takes issue with
the Government's exception that the Administrative Law Judge did not
consider Respondent's continued denials of the audit shortages and his
alleged hostility toward DEA. Respondent argues that ``[n]owhere is
hostility addressed in the record by Government counsel'' and the
Government is bound by the record.
As to the Government's assertions regarding Respondent's diversion
of controlled substances, the Acting Deputy Administrator finds that no
evidence was presented at the prior proceeding that the shortages
revealed by the audits were a result of illicit diversion. Therefore,
the Acting Deputy Administrator agrees with Respondent that the
Government is colleratelly estopped from raising that argument in this
proceeding. However, the Acting Deputy Administrator understands the
Government's concern regarding Judge Tenney's statement about the
shortages that, ``[a]t most, Respondent had faulty inventory
practices.'' The Acting Deputy Administrator concludes that while
diversion was not proven in the prior proceeding, at the very least,
the audit results revealed faulty recordkeeping. This is extremely
significant, because without proper recordkeeping, it is difficult to
detect whether or not diversion is occurring.
The Acting Deputy Administrator agrees with the Government's
assertion that the Adminitrative Law Judge did not make findings
regarding Respondent's continued denial of the audit shortages and his
continued hostility towards regulation by DEA. Respondent contends that
the Government cannot now raise this issue because ``[n]owhere is
hostility addressed in the record by Government counsel'' and the
Government is bound by the record. As noted above, the critical
consideration in this proceeding is whether the circumstances, which
existed at the time of the prior proceeding, have changed sufficiently
to support a conclusion that Respondent's registration would be in the
public interest. While the Administartive Law Judge found that
Respondent has vowed to change his inventory practices, Judge Tenney
did not address whether other circumstances that were found to exist in
the prior proceeding have changed. In the final order revoking
Respondent's previous registration, the then-Deputy Administrator
adopted Judge Bittner's finding that ``Respondent, throughout the
course of his previous litigation, as well as the instant case,
continously had been defensive, hostile, and uncooperative and had
insisted on clouding the issues with tangential arguments and
rhetorical allegations of political wrongdoing.''
The Acting Deputy Administrator concludes that the record in this
proceeding indicates that Respondent's attitude has not changed since
issuance of the earlier final order. First, in April 1995, immediately
after notification of the earlier revocation, Respondent telephoned the
local DEA office complaining about the District Court Judge and Judge
Bittner and alleging that there was a conspiracy against him.
Respondent submitted the application for registration that is the
subject of this proceeding in July 1995. Then in February 1996,
approximately six months before the hearing in this matter, Respondent
sent a letter to the Administrator of DEA alleging that members of the
local DEA office entered his office improperly and illegally seized his
records; that his evidence to explain the audit results was ignored by
the District Court Judge in the civil action, Judge Bittner, and the
then-Deputy Administrator; that his previous DEA registration was
fraudulently taken from him; and that he believed that the
investigation of him was initiated based upon a false complaint made by
doctors who had treated him in the past. All of these allegations were
made despite findings to the contrary by the United States District
Court Judge and the United States Court of Appeals for the Fourth
Circuit in the civil proceeding, and by Judge Bittner and then then-
Deputy Administrator in the prior revocation proceeding. Finally, at
the hearing in this matter, Respondent continued to deny that there was
anything wrong with his recordkeeping and went so far as to claim that
DEA
[[Page 19607]]
made up the shortages; continued to maintain that DEA was in his office
improperly in 1988; and continued to assert that the claims against him
were false and that he was harassed. Also, while Respondent indicated
that he was willing to cooperate with DEA, he also made it clear that
he was wary of DEA based upon the false charges and harassment against
him, and that he believed that inspections should only be conducted
when it is convenient for him and not during normal business hours.
This last assertion is at odds with DEA's inspection authority under 21
U.S.C. 880, which requires that administrative inspection warrants be
served during normal business hours.
Judge Tenney concluded that registration of Respondent would not
inconsistent with the public interest with the imposition of the
limitations suggested by Respondent. Therefore, Judge Tenney
recommended that Respondent be granted a DEA Certificate of
Registration subject to the temporary limitations suggested by
Respondent. The Government filed an exception to this proposed sanction
arguing that Respondent's application should be denied. Alternatively,
the Government argued that if the Administrative Law Judge's
recommendation is adopted by the Acting Deputy Administrator, the names
and addresses of the patients on the records should not be redacted.
The Acting Deputy Administrator notes that 21 C.F.R. 1306.05 and
1304.24 require that prescriptions and records of dispensing contain
the patient's name and address, and that to allow Respondent to redact
that information would in effect subject him to lesser requirements
than other registrants. However, the Acting Deputy Administrator finds
that the Government has met its burden of proof that Respondent's
registration would be inconsistent with the public interest. As the
Government noted in its exceptions, in Shatz v. United States
Department of Justice, 873 F. 2d 1089, 1091 (8th Cir. 1989), the court
held that once the Government had met its burden, the Respondent then
had the burden to rebut the evidence and to prove sufficient
rehabilitation. As discussed above, while Respondent has stated that he
has changed his inventory practices, there is more than sufficient
evidence in the record to indicate that Respondent has not accepted
responsibility for his prior actions as a DEA registrant, has not
significantly changed his inventory practices, and has not exhibited a
willingness for DEA to inspect his records ``at any time'', as
suggested in his response to the Government exceptions. Consequently,
the Acting Deputy Administrator finds that Respondent's registration
with DEA would be inconsistent with the public interest.
Accordingly, the Acting Deputy Administrator of the Drug
Enforcement Administration, pursuant to the authority vested in him by
21 U.S.C. 823 and 28 C.F.R. 0.100(b) and 0.104, hereby orders that the
application for registration, executed by Ellis Turk, M.D., be, and it
hereby is, denied. This order is effective May 22, 1997.
Dated: April 8, 1997.
James S. Milford,
Acting Deputy Administrator.
[FR Doc. 97-10371 Filed 4-21-97; 8:45 am]
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