[Federal Register Volume 63, Number 223 (Thursday, November 19, 1998)]
[Notices]
[Pages 64280-64284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-30884]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 96-4]
Cuong Trong Tran, M.D.; Denial of Application
On October 13, 1995, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Cuong Trong Tran, M.D. (Respondent), of
Alexandria, Virginia, 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 dated November 13, 1995, Respondent filed a request for a
hearing, and following prehearing procedures, a hearing was held in
Arlington, Virginia on June 3, 4 and 17, 1996, before Administrative
Law Judge Mary Ellen Bittner. At the hearing both parties called
witnesses to testify and introduced documentary evidence. After the
hearing, the Government submitted proposed findings of fact,
conclusions of law and argument, and Respondent filed a letter in reply
to the Government's submission. On January 13, 1998, Judge Bittner
issued her 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 denied. On
April 24, 1998, Respondent filed exceptions to Judge Bittner's Opinion
and Recommended Ruling, and subsequently, Government counsel filed a
response to Respondent's exceptions. Thereafter, on May 14 and 21,
1998, Judge Bittner 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 issues his final order
based upon findings of fact and conclusions of law as hereinafter set
forth. The Acting Deputy Administrator adopts, in full, the Opinion and
Recommended Ruling of the Administrative Law Judge. His adoption is in
no manner diminished by any recitation of facts, issues and conclusions
herein, or of any failure to mention a matter of fact or law.
The Acting Deputy Administrator finds that Respondent graduated
from medical school in 1965. He has been practicing as a general
practitioner in Alexandria, Virginia since 1974. In 1979, a state
inspector advised Respondent that a number of his patients were known
drug abusers; that it appeared that the patients were seeing Respondent
only to obtain drugs; and that Respondent should be more careful in
prescribing to his patients. According to the inspector, Respondent
indicated that he would be more careful.
Sometime prior to December 1990, DEA and a local police department
received reports from local pharmacies and from the Virginia Board of
Medicine that Respondent was excessively prescribing controlled
substances over extended periods of time. As a result of
[[Page 64281]]
this information, investigators conducted a survey of 35 area
pharmacies and determined that approximately 30 individuals were
receiving a large number of controlled substance prescriptions from
Respondent.
Between December 19, 1990 and February 21, 1991, two undercover
officers and a cooperating individual went to Respondent's office in an
attempt to obtain controlled substance prescriptions for no legitimate
medical purpose. The cooperating individual went to Respondent's office
on December 19, 1990 and January 10 and 16, 1991, wearing a concealed
body wire which was monitored. During these visits, the cooperating
individual had visible needle marks on his hands and arms from
intravenous heroin use. At the first visit, the cooperating individual
told Respondent that he had knee surgery in the past and that he had
been taking pain killers for a long time. He indicated to Respondent
that he needed to see him once a month, and asked for a specific
controlled substance. After further conversation, Respondent asked
``Where is the pain now?'' and the cooperating individual reminded
Respondent that it was an old knee injury and it was better. However,
Respondent later asked whether the cooperating individual had knee pain
and the individual answered, ``Yes.'' Respondent issued the cooperating
individual a prescription for Vicodin following a very cursory
examination.
During the second visit, the individual indicated that he had run
out of his medicine and referred to ``that old knee injury from '85.''
Respondent told the cooperating individual that Vicodin ``is
addicting,'' to which the individual responded, ``I know it's
addicting, I've been taking it for five years and it's hard to get
through without it, you know.'' Respondent nonetheless issued the
individual a prescription for Vicodin. During the final visit,
Respondent warned the individual of the addictive properties of Vicodin
and advised him to take as little of the drug as possible and only when
needed. Respondent did not examine the individual's knee.
An undercover police officer went to Respondent's office on eight
occasions between December 19, 1990 and February 21, 1991. At first,
the undercover officer indicated that he liked to feel a ``little
mellowed out.'' Respondent asked if the officer was nervous, to which
he replied, ``okay.'' The officer received a prescription for Valium.
While Respondent's patient chart for the officer indicates that a
physical examination was performed, the officer testified that there
was no examination. During the second visit on December 27, 1990,
Respondent asked if the undercover officer was nervous. The officer
said, ``Yeah * * * that Valium just didn't make me feel any better. * *
*'' Respondent refused the undercover officer's request for Percodan,
but gave him a prescription for Xanax instead. According to the
officer, Respondent listened to his breathing, but did not perform any
other physical examination. At the next visit, the undercover officer
indicated that he was not nervous, but that he wanted something
stronger than Xanax. Respondent issued him a prescription for Ativan.
For the next two visits, the undercover officer did not discuss any
health problems whatsoever with Respondent and just asked for a
prescription. Respondent warned the officer of the addictive nature of
the prescribed drugs, but nonetheless issued prescriptions for Ativan.
On the sixth visit, Respondent asked the officer if he felt ``like
[you're] a little nervous and everything,'' to which the officer
responded, ``yeah.'' Respondent gave the officer a prescription for
Ativan. Finally, on the last two visits, the undercover officer
indicated that he was feeling good. On one occasion, Respondent stated
that the officer had come back too soon for another prescription.
Respondent issued the officer Ativan prescriptions on both occasions.
A second undercover officer went to Respondent's office on four
occasions between January 23 and February 21, 1991. During the first
visit, the officer repeatedly asked for a prescription for Percodan. He
offered to pay Respondent $100.00 instead of the $35.00 office visit
charge. The officer told Respondent that he had obtained Percodan from
another physician who told him that he had to have severe pain, but
``between you and me I really don't have severe pain. * * *'' He also
told Respondent that he had sold Percodan in the past. Respondent asked
the undercover officer if he had back pain, and the officer replied,
``I guess if I have to, I'll have back pain.'' After further
conversation, Respondent said ``if you have pain come in here. I don't
want to see you if you don't have pain.'' Respondent gave the officer a
prescription for 30 Vicodin, telling him to take it only for pain. At
the second visit, the undercover officer asked for Percocet and
repeatedly said that he was not in any pain. Respondent issued the
officer a prescription for 30 Vicodin, but told him not to take it if
he was not in pain. During the next visit, the undercover officer
indicated that he had run out of medicine. Respondent stated that the
officer was back too soon for another prescription and should only take
the drugs if he was in pain. The officer than stated, ``So, if I don't
have any pain, I don't get any, right?'' The officer then stated that
he had pain and asked Respondent to check his back. Respondent gave the
officer a prescription for 20 Vicodin. On Respondent's final visit,
Respondent again stated that the officer had returned too soon and
repeatedly told the officer that he should only take the pills when he
had pain and that they were addictive. The undercover officer said
that, ``if I have to come back, I'll make sure I have pain.''
Respondent issued the officer a prescription for 20 Vicodin.
After the pharmacy surveys and the undercover visits, search
warrants were executed at Respondent's office in October 1991 and April
1992, during which various patient records were seized. Subsequently, a
number of Respondent's patients were interviewed.
In her Opinion and Recommendation Ruling, Findings of Fact,
Conclusions of Law and Decision, Judge Bittner went into great detail
regarding the prescriptions discovered during the pharmacy surveys, the
information contained in the patient charts, what was learned during
the patient interviews and the testimony of some of these individuals
in subsequent criminal trials. Since the Acting Deputy Administrator is
adopting Judge Bittner's findings of fact in their entirety, there is
no need for him to reiterate them. However, the Acting Deputy
Administrator makes the following general findings regarding
Respondent's prescribing to the individuals at issue.
In general, the individuals complained of headaches, backaches,
pain in various other parts of the body, nervousness and anxiety. They
usually saw Respondent two to five times a month for several years. At
virtually every visit, they were prescribed controlled substances with
little or no other treatment. Respondent performed little or no
physical examinations and there were very few, if any, referrals to
specialists. There was no apparent attempt by Respondent to determine
the cause of the alleged problems. A number of the individuals were
admitted drug abusers and exhibited some of the classic signs of drug
abuse. Most of the individuals were required by Respondent to sign
documents which essentially stated that they had been advised of the
habit forming nature of the prescribed controlled substances; that they
have tried other medications in the past, but the prescribed
[[Page 64282]]
controlled substances are the only medications that help; and that they
assume all responsibility for the misuse of the medication prescribed
by Respondent. Respondent told some of the individuals to avoid taking
the prescriptions to certain pharmacies, particularly ones with
computers; to take the prescriptions to various pharmacies; or to take
the prescriptions to Maryland or Washington, D.C. to be filled.
One patient indicated that Respondent had a reputation in the
community as a physician from whom it was easy to obtain drugs. A
pharmacist called Respondent and told him that Respondent was issuing
controlled substance prescriptions to an individual who was also
getting such prescriptions from other physicians. Respondent told the
pharmacist to go ahead and fill the presented prescription. Respondent
refused to issue an individual another controlled substance
prescription, indicating that some of his other patients had gotten him
in trouble with DEA, and he stopped prescribing to another individual,
telling her that he was having some troubles.
A pharmacist sent letters to Respondent regarding two patients
asking Respondent for a diagnosis for the prescriptions issued since
they were receiving a large number of prescriptions from Respondent. An
insurance company wrote to Respondent regarding one of his patients
seeking a diagnosis in light of an overabundance of prescriptions.
There is no indication that Respondent replied to any of these letters.
One patient told Respondent that he had abused drugs in the past.
Respondent routinely issued him controlled substance prescriptions for
an alleged back problem. At some point, Respondent indicated that he
could no longer issue the individual prescriptions for his back problem
and the individual would have to have some other problem. The
individual said that a tooth was bothering him when in fact he did not
have a toothache. Respondent issued the individual controlled substance
prescriptions regularly for five months for his alleged toothache.
Thereafter, the patient chart indicates that Respondent prescribed the
individual controlled substances supposedly for knee pain following
surgery even though the individual was being treated by an orthopedist
and he did not have any pain after the first week following surgery.
Experts for both the Government and Respondent reviewed
Respondent's controlled substance prescribing. The Government experts
essentially concluded that there was no legitimate medical purpose for
Respondent's continued prescribing of controlled substances to the
individuals at issue, or at the very least it was not good medicine.
One expert found Respondent's prescribing to be clear abuse, gross
misuse of addicting substances, inappropriate and indiscriminate. The
other expert stated that with no tests to determine the cause, ``the
continued use of narcotics for headaches is reprehensible.'' He further
testified that,
I am not saying he is a bad doctor. I'm simply saying that he
was duped many times over, and I think that's the reprehensible
problem. He needed to think more clearly about why he was giving
narcotics. There was one person here who had 500 prescriptions for a
narcotic. I mean, * * * that's just never going to happen in real
life with primary care physicians. It's just not going to happen.
And yet it happened in his case, and it happened many times over * *
*.
This expert also testified that when treating individuals with severe
prolonged pain, he generally maintains them on narcotics for no more
than one to two weeks and invariably refers them to a specialist if the
narcotics are not successful. This expert further testified that while
it is appropriate to warn patients of the addictive potential of
controlled substances, he had never seen in his 35 years of practice a
consent for, or a waiver for narcotics like the one that was used by
Respondent.
Respondent's experts essentially felt that Respondent's prescribing
was appropriate. However, neither of Respondent's experts were family
practitioners. One of the experts felt that Respondent's patients
described the normal signs of people suffering from migraine headaches
and that prescribing of controlled substances is common for an acute
migraine. But according to the expert, long-term use of controlled
substances causes addiction which results in a vicious cycle because
abrupt cessation of the medication will cause the patient to develop a
headache. The expert testified that in such a situation, the patient
needs to be hospitalized to manage the withdrawal from the controlled
substances. Respondent's other expert indicated that if a patient with
chronic pain made four or five visits to him and the pain was only
alleviated by a narcotic, he would refer the patient to a specialist.
In 1992, Respondent was indicted in the United States District
Court for the Eastern District of Virginia on 136 counts of prescribing
controlled substances outside the usual curse of medical practice and
for other than legitimate medical purposes in violation of 21 U.S.C.
841(a)(1). Following a jury trial, Respondent was found guilty of 127
counts of unlawful distribution of controlled substances.
As a result of his conviction, on April 26, 1993, the Virginia
Board of Medicine (Medical Board) revoked Respondent's license to
practice medicine in Virginia. Thereafter, DEA revoked Respondent's
previous DEA Certificate of Registration by order published on July 12,
1993. See 58 Fed Reg. 37,506 (1993).
On February 28, 1994, the United States Court of Appeals for the
Fourth Circuit reversed Respondent's conviction on 80 counts based upon
insufficient evidence to convict, and reversed and remanded for a new
trial the convictions on 47 counts because reputation evidence and a
medical expert's hearsay opinion were improperly admitted into
evidence. Subsequently Respondent was charged in a superseding
indictment with 45 counts of unlawful distribution of controlled
substances in violation of 21 U.S.C. 841(a)(1). Respondent was tried on
these counts in July 1994 and was acquitted on all charges. Following
his acquittal, the Medical Board issued an order on August 15, 1994,
vacating its earlier revocation of Respondent's medical license.
At the hearing in this matter, Respondent testified that he is ``a
changed man,'' and that he is now aware and more careful about giving
narcotics to patients. However, he did not acknowledge that he had in
any way improperly prescribed controlled substances. Respondent
admitted that he told patients to go to different pharmacies, but said
that he did so to encourage his patients to find the best price for
their prescriptions. He denied that he ever told his patients to avoid
having their prescriptions filled at pharmacies with computers or to
spread their prescriptions among various pharmacies. Respondent further
testified that pain is subjective, that he gives the patient the
benefit of the doubt, and that ``[m]y conscience say I have to trust
people and now, after I go through that, I know you have to be careful
not to trust people so much. * * *''
Respondent also testified that if he is issued a DEA registration,
``I swear that I will not give controlled substances anymore, because
this does not do any good to me.'' He stated that he needs a DEA
registration in order to obtain hospital privileges, to be accepted by
insurance companies as a provider, and to have his prescriptions for
non-
[[Page 64283]]
controlled substances filled at pharmacies.
Pursuant to 21 U.S.C. 823(f), the Deputy Administrator may revoke a
DEA Certificate of Registration and deny any application for such
registration, if he determines that the continued registration would be
inconsistent with the public interest. Section 823(f) requires that the
following factors be considered:
(1) The recommendation of the appropriate state licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing, 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 pubic heath 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 he deems appropriate in determining
whether a registration should be revoked or an application for
registration denied. See Henry J. Schwarz, Jr., M.D., 54 Fed. Reg.
16,422 (1989).
Regarding factor one, it is undisputed that the Medical Board
revoked Respondent's medical license following his conviction, but then
reinstated it after his acquittal on all charges. Therefore, Respondent
currently possesses an unrestricted state license to practice medicine
and handle controlled substances. But, the Acting Deputy Administrator
agrees with Judge Bittner that ``inasmuch as state licensure is a
necessary but not sufficient condition for DEA registration, * * * this
factor is not dispositive.''
As to factors two and four, Respondent's experience in dispensing
controlled substances and his compliance with applicable laws relating
to controlled substances, the Acting Deputy Administrator agrees with
Judge Bittner that ``[t]he record is replete with examples of
Respondent's prescribing of controlled substances in a manner which is
most charitably described as totally irresponsible.'' Pursuant to 21
CFR 1306.04, controlled substances may only be prescribed for
legitimate medical purpose. There are many instances that suggest that
Respondent was indiscriminately prescribing controlled substances.
Respondent prescribed controlled substances to individuals on a regular
basis over an extended period of time based solely on the subjective
complaints of the individuals with little or no effort to determine the
cause of the individual's problems or to refer them to specialists.
Judge Bittner found the Government's expert who testified at the
hearing to be ``a knowledgeable, credible expert who thoroughly
considered the information available to him.'' The expert found that
there was no legitimate medical reason for Respondent's continued
prescribing of controlled substances to almost all of the individuals.
The undercover visits raise serious concerns regarding Respondent's
dispensing of controlled substances. One undercover officer repeatedly
requested Percodan by name, told Respondent that he sold Percodan, and
offered to pay Respondent $100.00 rather than the standard $35.00
office visit charge. In response to Respondent's question about whether
he had any pain, the undercover officer stated that, ``I guess if I
have to, I'll have back pain.'' While Respondent refused to prescribe
the undercover officer Percodan he did issue him prescriptions for
Vicodin. The other undercover officer's patient chart indicates that
Respondent performed a physical examination on the initial visit before
issuing the officer a controlled substance prescription. However, the
officer testified that Respondent did not perform any sort of an
examination. As to the cooperating individual, Respondent issued him
prescriptions for a narcotic even though the individual had visible
needle marks on his hands and arms.
There are other indications in the record that Respondent himself
was not completely comfortable with his prescribing of controlled
substances to the individuals at issue. First, Respondent had his
patients sign documents wherein the patients indicated that they would
``take all the responsibility of the misuse of the medicine prescribed
for my health by Tran-Cuong MD.'' As a DEA registrant, a physician must
ensure that the controlled substances that he/she prescribes are only
used for a legitimate medical purpose. These waivers are an attempt by
Respondent to abrogate this responsibility. Second, according to a
number of the individuals, Respondent told them to take their
prescriptions to various pharmacies, to avoid pharmacies with computers
and to take them to be filled at pharmacies in Maryland and Washington,
D.C. Respondent contends that he never told the individuals to take
their prescriptions to different pharmacies or to avoid pharmacies with
computers, but that he only encouraged the individuals to find the best
price for their medication. Since a number of the individuals related
the same information, the Acting Deputy Administrator does not find
Respondent's explanation credible. Finally, Respondent stopped
prescribing controlled substances to at least two of the individuals
stating that he was having trouble with DEA. This seems to suggest that
Respondent himself doubted the legitimacy of the prescriptions that he
had been issuing to these individuals.
The Acting Deputy Administrator concurs with Judge Bittner's
finding ``that Respondent prescribed controlled substances to numerous
patients, over long periods of time, in contravention of his
responsibility to establish that there was a medical need for these
prescriptions.''
Regarding factor three, while Respondent was initially convicted of
127 counts of unlawful distribution, these charges were ultimately
disposed of by reversal, dismissal or acquittal. Therefore, there is no
evidence that Respondent has been convicted of any charges relating to
controlled substances.
As to factor five, Judge Bittner stated that ``Respondent's
continuing attempts to justify his prescribing practices warrant the
inferences * * * that although Respondent clearly regrets the legal
financial and personal difficulties that arose from his prescribing
practices, he still does not fully acknowledge his wrongdoing.* * *''
Judge Bittner concluded that ``Respondent is unwilling and/or
unable to accept the responsibilities inherent in holding a DEA
registration.'' Therefore, Judge Bittner found that Respondent's
registration would be inconsistent with the public interest and
recommended that his application be denied.
Respondent filed exceptions to Judge Bittner's recommendation
stating that denial is too harsh a penalty since this is his first
offense and he ``was acquitted of criminal charges which were based on
the same factual situation presented here.'' The Acting Deputy
Administrator notes that these proceedings are not punitive in nature,
but instead look to protect the public health and safety. See Richard
J. Lanham, M.D., 57 Fed. Reg. 40,475 (1992); Richard A. Cole, M.D., 57
Fed. Reg. 8677 (1992). In evaluating this case, the Acting Deputy
Administrator finds it noteworthy that Respondent was warned in 1979
that he was being conned by known drug abusers to issue them controlled
substance prescriptions. Respondent
[[Page 64284]]
acknowledged this information, yet failed to exercise proper care in
his future prescribing. In addition, while it is true that Respondent
was acquitted of all criminal charges, a conviction is not a necessary
prerequisite for denial. Careless or negligent handling of controlled
substances creates the opportunity for diversion and could justify
revocation or denial. As Respondent's counsel noted in his closing
argument at Respondent's second criminal trial:
* * * because if Dr. Tran didn't notice what he should have
noticed, that is not a crime. That may be bad doctoring. That may be
carelessness. That may be a reason perhaps why someone shouldn't be
a doctor * * *.''
The Acting Deputy Administrator concludes that Respondent's careless
and indiscriminate prescribing of controlled substances warrant the
denial of his application for registration.
Also in his exceptions, Respondent contends that ``this procedure
has been a learning experience. I now realize the importance of
maintaining detailed medical records on each patient * * * [and] I am a
more enlightened man when it comes to prescribing controlled substances
for a legitimate medical purpose only.'' Respondent says that he will
only prescribe for a legitimate medical purpose and that he is a
``changed man,'' but he does not acknowledge that he prescribed
improperly. Therefore, the Acting Deputy Administrator is not confident
that Respondent recognizes what needs changing in his handling of
controlled substances. There is no evidence in the record how
Respondent has changed or that he has attempted to better educate
himself in the proper handling of controlled substances. As a result,
the Acting Deputy Administrator does not believe that it is in the
public interest for Respondent to be issued a registration at this
time.
Finally, in his exceptions and during the hearing in this matter,
Respondent indicated that if he is issued a DEA registration, he will
refrain from dispensing controlled substances ``because it not only get
me in trouble, it doesn't do anything to me.'' According to Respondent
without a DEA registration he cannot get hospital privileges, he is not
accepted as a provider by insurance companies, pharmacies will not fill
his non-controlled prescriptions, and pharmaceutical representatives
refuse to give him samples of non-controlled substances. While
Respondent's predicament is unfortunate, it does not justify granting
him a DEA registration. Practitioners are issued DEA registrations so
that they can responsibly handle controlled substances, not so that
they can obtain hospital privileges. In light of Respondent's failure
to acknowledge any wrongdoing, the lack of any details as to how he has
changed, and the absence of any recent training in the proper handling
of controlled substances, the Acting Deputy Administrator concludes
that it would be inconsistent with the public interest to grant
Respondent's application for a DEA Certificate of Registration at this
time.
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 CFR 0.100(b) and 0.104, hereby orders that the
application for registration, executed by Cuong Trong Tran, M.D., be,
and it hereby is, denied. This order is effective December 21, 1998.
Dated: November 13, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-30884 Filed 11-18-98; 8:45 am]
BILLING CODE 4410-09-M
