[Federal Register Volume 63, Number 187 (Monday, September 28, 1998)]
[Notices]
[Pages 51592-51602]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-25827]
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DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 95-54]
Paul J. Caragine, Jr., Grant of Restricted Registration
On July 10, 1995, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration (DEA), issued an
Order to Show Cause to Paul Caragine, M.D., (Respondent) of Denville,
New Jersey, 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), as being inconsistent with the public interest.
By letter dated September 6, 1995, Respondent, through counsel,
filed a request for a hearing, and following prehearing procedures, a
hearing was held in Newark, New Jersey on June 25, 26 and 27 and
November 19, 20 and 21, 1996, before Administrative Law Judge Mary
Ellen Bittner. At the hearing, both parties called witnesses to testify
and introduced documentary evidence. After the hearing, counsel for
both parties submitted proposed findings of fact, conclusions of law
and argument. On March 31, 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 be denied. On April 17, 1998, Respondent filed exceptions
and objections to Judge Bittner's opinion and on May 4, 1998, the
Government filed its response to Respondent's exceptions. Thereafter,
May 8, 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
ordered based upon findings of fact and conclusions of law as
hereinafter set forth. The Acting Deputy Administrator adopts, the
findings of fact and conclusions of law set forth in the Opinion and
Recommended Ruling, Findings of Fact, Conclusions of Law and Decision
of the Administrative Law Judge, except as specifically noted below,
but does not adopt the Administrative Law Judge's recommended ruling.
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 received his
medical degree in 1971 from what is now the University of Medicine and
Dentistry of New Jersey, and first become licensed to practice medicine
in New Jersey in 1973. He has practiced orthopedic medicine in various
locations throughout the State of New Jersey. According to Respondent
he has treated approximately 15,000 patients over a 20-year period.
In 1988, a New Jersey state agency initiated an investigation of
Respondent based upon information from a pharmacist about prescriptions
Respondent had issued to two individuals. Thereafter, a state
investigator collected and reviewed controlled substance prescriptions
issued by Respondent to 11 patients.
Based upon the investigator's review, the New Jersey Medical Board
(Medical Board) held an informal hearing on November 27, 1991,
regarding Respondent's prescribing practices. Respondent testified at
that hearing that he believed in using pain killing drugs for patients
who needed them to function. However, Respondent also stated that,
``I'm a lot stricter and tougher about this than I was. I mean, as I
look back I realize that I was really too lenient with all these
people. * * * I must appear to be a fool and I'm setting myself up here
by going along with all these people, going along with all these
stories. * * * No more. In the last three years I've had a really
exemplary record. I'm very careful. I'm not so easy to get drugs out of
like I use[d] to be.'' Respondent emphasized that only two of the
patients at issue were still under his care and that he had told them
that he would stop prescribing controlled substances to them on April
1, 1992. Respondent further asserted that ``there are no new people out
there who represent future problems for this board or for me,'' and
that ``I want the board to know that I really made an effort to clean
up my act and not be permissive. My only past sin was being too
gullible and too charitable.'' When asked what had prompted the change,
Respondent stated that, ``It just occurred to me after a period of time
that this couldn't be right.''
During this same time period, a local police department received
information in August 1991 that two individuals were suspected of
distributing narcotics. A subsequent survey of area pharmacies revealed
that Respondent had issued most of the controlled substance
prescriptions for these individuals. A review of the prescriptions
showed, among other things, that one of the individuals obtained 480
dosage units of Vicodin, a Schedule III controlled substance, between
August 22 and September 23, 1992, pursuant to prescriptions and refills
authorized by Respondent. On October 2, 1992, a search warrant was
executed at the individuals' apartment, during which investigators
discovered marijuana, marijuana paraphernalia, 88 prescription vials
(86 of which were empty), a prescription for Percocet written by
Respondent and postdated October 7, 1992, and notes indicating drug
distributions. Approximately 85-90% of the prescription vials indicated
that they were authorized by Respondent.
The individuals were interviewed following their arrest for among
other things, possession of marijuana and drug paraphernalia. One of
the individuals admitted that she had filled
[[Page 51593]]
prescriptions from Respondent at one pharmacy and had then called him,
said that she had lost a prescription, and had him authorize another
prescription by telephone at a different pharmacy. The other individual
admitted that he was addicted to controlled substances and stated that
he sold controlled substances prescribed to him by Respondent.
On October 14, 1992, Respondent was interviewed by state and DEA
investigators. According to the investigators, Respondent told them
that he knew from the beginning of his treatment of the one individual
that the patient was addicted to prescription drugs. At the hearing in
this matter, Respondent disputed that he told this to the
investigators, however Judge Bittner found the investigators to be more
credible than Respondent. Respondent also admitted to the investigators
that he issued the postdated prescription, but that he did so to save
the individual the expense of another office visit and to better
control his intake of controlled substances.
On July 12, 1993, a complaint was filed with the Medical Board
seeking the temporary suspension and permanent revocation of
Respondent's medical license on grounds that he had excessively
prescribed controlled substances, issued prescriptions for controlled
substances before the supply previously dispensed to the patient should
have been exhausted, failed to maintain medical records on patients to
whom he prescribed controlled substances, continued to prescribe
narcotic analgesics to a patient after she was hospitalized for
treatment of an overdose of these medications, and issued postdated
prescriptions. Following a hearing, the Medical Board issued an order
temporarily suspending Respondent's license to practice medicine
effective August 25, 1993, and suspending his authority to handle
controlled substances as of August 11, 1993, on grounds that Respondent
had inappropriately prescribed controlled substances to 14 patients. As
a result of the Medical Board's action, Respondent surrendered his
previous DEA Certificate of Registration on August 16, 1993.
Subsequently, the Medical Board issued a supplemental complaint
alleging that Respondent inappropriately prescribed controlled
substances to two more individuals. Following a hearing, a state
administrative law judge issued an initial decision dated June 29,
1994, finding that the patients at issue had serious problems which may
have resulted in legitimate complaints of pain, but that Respondent
ignored warning signs which should have alerted him to the dangers of
dependency, that Respondent did not control the dispensing of
controlled substances, and that the record supported a conclusion that
each of the patients was drug dependent. The Judge concluded that
Respondent's treatment of these patients constituted gross malpractice,
gross negligence and gross incompetence, professional incompetence, and
professional misconduct, and that revocation of Respondent's medical
license was therefore justified.
On August 11, 1994, the Medical Board issued a Final Order adopting
the administrative law judge's findings of fact (with minor exceptions)
and conclusions of law. However, the Medical Board found that there was
no evidence that Respondent's conduct was ``infected by improper
motive, such as desire for profit, or complete disregard for patient
well-being.'' Accordingly, the Medical Board concluded that instead of
revocation of his medical license, the appropriate sanction was a two
year suspension, retroactive to August 11, 1993, but with the second
year stayed and served as a period of probation. The Medical Board also
prohibited Respondent from prescribing controlled substances until it
approved a plan for his resumption of such prescribing.
On August 11, 1994, Respondent executed the application for
registration with DEA that is the subject of these proceedings. On
October 28, 1994, the Medical Board modified its order, permitting
Respondent to handle controlled substances if and when he gets his DEA
privileges restored provided that for at least one year, he must
maintain a log of his prescribing and dispensing; he may not prescribe
or dispense more than a 14-day supply at one time to a patient; and he
must refer a patient to a pain management specialist for a second
opinion prior to completion of 90 days of prescribing or dispensing to
the patient.
On February 24, 1994, a civil complaint was filed against
Respondent in the United States District Court for the District of New
Jersey alleging violations of 21 U.S.C. 842. On March 11, 1996, the
parties filed a Stipulation for Compromise Settlement, pursuant to
which Respondent agreed to pay $22,500 plus interest. The stipulation
provided, among other things, that Respondent did not admit liability
or fault and that the complaint would be dismissed with prejudice.
Since Respondent's patients that are at issue in this proceeding
were supposedly being treated by Respondent for chronic pain, there was
evidence presented by both the Government and Respondent regarding the
treatment of chronic pain patients. An expert in pain management
testified on behalf of the Government and his report regarding
Respondent's patients was admitted into evidence. Respondent offered
the report and the testimony before the Medial Board of his expert in
pain management. The Government's expert testified that chronic pain is
pain from the same etiology that lasts longer than six months.
Respondent's expert opined that chronic pain patients are the most
difficult patient population to treat, that many of these patients are
angry and depressed, and that psychological complications make managing
them more difficult.
Regarding the treatment of pain, the Government's expert testified
that narcotics do not relive pain, but block the perception of pain in
the brain, while non-steroidal anti-inflammatory drugs (NSAIDs) may
operate on the source of the pain. According to the Government's
expert, narcotic analgesics may be used in conjunction with NSAIDs
where the pain is severe; preferably starting the patient on the
narcotic first, then prescribing NSAIDs, and then gradually taking the
patient off the narcotic and increasing the NSAIDs. Respondent's expert
testified in the Medical Board proceeding that narcotics may be an
appropriate permanent solution to a patient's pain problem but that
``[i]t's certainly not the first one we consider. Usually it's a choice
of last resort, not first.''
Respondent also introduced into evidence at the hearing pages of
the Handbook of Pain Management, G. John DiGregorio, M.D., Ph.D., et
al. (3rd ed. 1991), which recommends initial treatment of chronic
benign pain with NSAIDs. The Handbook further advises that ``[t]he
regular use of opioid analgesics in benign pain syndromes is
controversial,'' and that
[p]hysicians who choose to use these types of opioids should be
aware of the potential escalation by the patient to stronger types
of medication during their treatment program. It is for these
reasons that all efforts should be made not to utilize opioid
treatment in these types of syndromes. the administration of strong
opioids in chronic benign pain syndromes is to be avoided if at all
possible, since the resulting problems of tolerance, physical
dependence, and drug-seeking behavior are usually more life-
disrupting than the pain process itself.
Judge Bittner found that New Jersey law requires that physicians
prescribe controlled substances only for legitimate medical purposes in
the course of professional treatment and that physicians must take
complete histories
[[Page 51594]]
and perform physical examinations of patients. In addition, physicians
in New Jersey are required to maintain a chart on patients for whom
they prescribe controlled substances for pain.
The Government's expert testified that in treating a chronic pain
patient, the physician should include both positive and negative
findings in a patient's chart, including information for each visit as
to whether the pain is better or worse, and whether it is in the same
place. Respondent's expert asserted that pain is highly subjective and
the physician must rely on the patient's description of pain, family
members' reports of it, and how well the patient is able to function.
Because the Government alleged that a number of Respondent's
patients were drug dependent, the Government's expert listed some ``red
flags'' which should alert a physician to possible drug-seeking
behavior. Specifically, the Government's expert testified that drug-
seeking patients may complain of symptoms that would normally lead a
doctor to consider prescribing controlled substances, express symptoms
that are incompatible with the purported injury, try to avoid
diagnostic procedures which may show that their conditions do not
warrant treatment with narcotics, ask for a controlled substance by
name on a first visit, visit physicians some distance from the
patient's residence, have a history of problems but no medical records,
often have multiple accidents, multiple fractures, or complain of
injuring themselves at home or at work, insist on a drug of choice,
lose prescriptions or medication, take more medication than directed,
request more medication before the previously dispensed supply should
have been exhausted, use controlled substances prescribed for others,
use controlled substances in combination or with alcohol, or obtain
controlled substance prescriptions from multiple physicians or have
prescriptions filled at multiple pharmacies. The expert acknowledged
however, that many doctors ignore these ``red flags.''
At the hearing in this matter, there was extensive testimony and
documentary evidence presented regarding Respondent's treatment of 18
patients, including the prescribing of controlled substances. While the
patient charts were not offered into evidence, various witnesses,
including Respondent and the Government's expert, used the charts while
testifying. In addition, Respondent prepared summaries of his patient
records which were admitted into evidence. Further, two affidavits by
Respondent in 1990, Respondent's 1991 testimony in the Medical Board's
Preliminary Evaluation Committee hearing, the state investigator's 1991
report, and the state administrative law judge's opinion were admitted
into evidence without objection. Respondent argues that the Government
expert's reports should not be relied upon because the underlying
patient records were missing. Judge Bittner rejected this argument
noting ``that hearsay is admissible, that [the expert's] reports were
referenced in a Government prehearing statement filed in January 1996,
and that Respondent had had a substantial opportunity to raise any
questions he had about the records on which the report was based.'' The
Acting Deputy Administrator agrees with Judge Bittner and also notes
that the reports were properly admitted into evidence at the hearing
because Respondent's objections to the reports being received into
evidence were not based upon the lace of underlying patient records.
In her Opinion and Recommended Ruling, Findings of Fact,
Conclusions of Law and Decision, Judge Bittner went into great detail
regarding the medical problems and treatment, including the prescribing
of controlled substances, of the patients at issue in these
proceedings. 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 treatment of the
patients at issue.
Respondent treat R.C. over a period of approximately eight years.
Respondent initially saw R.C. for shoulder and elbow pain following a
motorcycle accident. On a number of occasions, Respondent performed
surgery on R.C.'s shoulder and ring finger where he removed a benign
tumor. Throughout the years, R.C. continued to complain of shoulder and
finger pain. At various times, Respondent prescribed R.C. Percocet,
Talwin, Darvon and Tylenol with codeine #3. For example, between
January 2 and January 30, 1985, Respondent prescribed R.C. 335 dosage
units of Talwin, and during February 1986, he prescribed 290 dosage
units.
A note in the patient file dated August 30, 1982, stated, ``give no
more Darvon.'' Another note in R.C.'s patient file dated May 21, 1985,
said, ``This is the very last Rx--make it last. Follow exactly as
written. If he abuses this one--he's finished with us. complaints from
drug store that entire family does narcotic drug [sic].'' However,
Respondent continued to prescribe Talwin to R.C., because according to
Respondent, R.C. re-injured himself. In September 1986, R.C. sought
another prescription from Respondent claiming that his wife washed his
pants with the 60 Talwin in them that had been prescribed the day
before. In a letter to R.C. dated October 9, 1986, Respondent advised
R.C. that ``I am aware of your desire to have more Talwin tablets. It
has been brought to my attention by many people, including my
secretary, pharmacist and the emergency staff at St. Clare's Hospital
that you have grossly abused this drug.'' Respondent further stated
that ``to protect my own medical license and to maintain good relations
with other doctors and nurses, I have to stop giving you this drug and
any other drugs of comparable strength. You certainly have no reason to
need this drug anymore anyway. It would be reasonable for you to take
lesser medications from time to time, such as Darvocet or Tylenol with
codeine: if you wish, I can give you a prescription for those. You will
have to obtain Talwin elsewhere.'' Nonetheless, Respondent continued to
prescribe R.C. Talwin throughout 1987 following continuing complaints
of shoulder pain. In September 1988, Respondent issued R.C. a duplicate
prescription after R.C. claimed that he had lost a prescription.
Before Judge Bittner, Respondent testified that although he did not
recognize at the time that he was issuing prescriptions that R.C. had a
drug problem, he would recognize it now. Respondent further testified
that he believed R.C.'s pain warranted the prescribed medications, but
that ``I shouldn't have done it. I should have been tougher.''
Respondent treated M.C. from September 1986 to June 1989.
Initially, Respondent treated M.C. for back pain and headache resulting
from a myelogram. Throughout the years, Respondent treated M.C.
following several falls and car accidents for pain down her leg,
cervical radiculopathy, and back and shoulder pain. He regularly
prescribed M.C. Demerol for pain, Halcion for sleep, and Restoril as a
muscle relaxer and for pain. According to Respondent, only Demerol
helped M.C.'s pain. Respondent also gave M.C. anti-inflammatories, had
her undergo physical therapy and traction, and recommended exercise to
strengthen her muscles. Notes in M.C.'s patient file indicated that
M.C. sometimes telephoned Respondent requesting prescriptions for pain
medication and that pharmacies had called Respondent advising that M.C.
was not following the directions on prescriptions and she was
attempting to obtain refills of the prescriptions early.
[[Page 51595]]
At the hearing before Judge Bittner, Respondent indicated that his
prescribing to M.C. helped her, but it also subjected her to possible
danger.
Respondent treated patient S.D. from March 28, 1985 through June
30, 1988. Initially, Respondent treated S.D. for chronic low back pain
from an old surgery and he and his partner aspirated the site. In 1985,
S.D. fractured her ankle and she had surgery to remove scar tissue.
S.D. was hospitalized in 1986 for low back pain and in November 1986,
she had surgery to remove bone chips. Between July 11, 1985 and June 6,
1988, Respondent prescribed S.D. 240 Demerol, 430 Percodan, 50 Seconal,
475 Percocet, 1,387 Tylenol No. 4, 177 Nembutal, and 260 Tylenol No. 3.
Respondent indicated that S.D. had a threshold for pain and that only
the drugs prescribed ever helped her. A note in S.D.'s patient file
dated August 27, 1987, indicated that S.D. was hospitalized for a drug
overdose and that a pharmacy reported that it would no longer serve
S.D. since she had seen every doctor in the area in an effort to obtain
drugs. Four days after this note was written, Respondent issued S.D. a
prescription for Tylenol No. 4
The Government's expert testified that he considered Respondent's
prescribing to S.D. ``egregious'' and that it ``jeopardized certainly
the welfare and the health and the safety, and even the life of this
patient.'' The expert further testified that ``this is not gullibility,
this is total irresponsibility in the prescribing of controlled
dangerous substances.'' Respondent stated that he ``tried to act in as
responsible a way as possible,'' that in the last months he saw her,
S.D. asked for less medication, and that he had given her ``a hard
time'' with respect to Demerol. Respondent further testified that he
was concerned about S.D.'s use of controlled substances because the
first time he met her she told him that she needed more medication than
most people to achieve the same effect, but that he thought she was
being honest. Respondent testified that this incident ``goes to show
how oblivious I was to red flags in front of me.''
According to T.K., he was Respondent's patient from 1979 until
January 1993. Respondent diagnosed T.K. in 1981 with a complicated form
of Osgood-Schlatter's disease which causes inflammation and pain. In
addition, T.K. had knee operations in 1983 and 1985, and was treated by
Respondent at various times for tennis elbow, gout and tendonitis in
the left forearm. Respondent regularly prescribed T.K. both Tylenol
with codeine and Doriden without always noting it in the patient chart,
and sometimes without seeing the patient. The Government's expert
testified that there is no medical justification for prescribing
Tylenol with codeine and glutethimide (the generic name for Doriden) in
combination. The combination of these drugs is commonly abused because
it creates a heroin-like effect. In fact, in 1984, the Medical Board
sent a newsletter to all physicians which indicated that barring
unusual circumstances there was no legitimate medical indication for
prescribing a combination of glutethimide and codeine. Respondent
testified that he did not recall receiving this newsletter. After the
1991 hearing before the Preliminary Evaluation Committee of the Medical
Board, Respondent continued to prescribe both of these drugs to T.K.
T.K. told the state investigator that ``I never felt that the doctor
acted in anything but good faith.''
The Government's expert stated that Respondent issued T.K. new
prescriptions for Tylenol with codeine before the supply dispensed
pursuant to previous prescriptions should have been exhausted. The
expert opined that Respondent's prescribing of controlled substances to
T.K. was not for a legitimate medical purpose because the prescribed
medications were not compatible with the diagnosis of what was wrong
with the patient.
Respondent testified that he prescribed Doriden to T.K. because he
had a chronic sleep disorder, and that other physicians had prescribed
T.K. the drug. He further stated that he never told T.K. to take the
Tylenol No. 3 and Doriden together.
G.K. first saw Respondent's partner in January 1990 suffering from
back spasms and was prescribed Dilaudid. Respondent than began treating
him approximately one year later for chronic back pain. Respondent
regularly prescribed G.K. Dilaudid, often issuing a new prescription
before the previous one should have run out, and often not noting the
prescription in the patient chart. On one occasion, Respondent issued
G.K. a new prescription after G.K. represented that he had lost a
prescription. The pharmacy reviews revealed that Respondent postdated
Dilaudid prescriptions for G.K. on several occasions. There were notes
in the file stating that Respondent would not issue any more Dilaudid
prescriptions to G.K., yet Respondent continued to do so.
The Government's expert concluded that Respondent prescribed one of
the most potent narcotics to G.K. notwithstanding G.K.'s obvious drug-
seeking behavior. Respondent testified that G.K. needed Dilaudid for
pain and especially to sleep, or else he could not go to work. He
further testified that G.K. would improve for a period of time but then
would have setbacks. In retrospect, Respondent through that he was
lenient with G.K. and that G.K. was a drug-seeking patient.
D.K. initially saw Respondent in August 1982, for injuries that he
had sustained in a car accident that had occurred several months
earlier. D.K. was a patient of Respondent's for over ten years. He was
treated for injuries sustained in five car accidents and other types of
accidents. During the course of his treatment, D.K. had two low back
surgeries and ultimately used a cane to walk because his knees
frequently buckled. According to Respondent, D.K. was the sole support
for his three children, so he needed pain medication to be able to keep
working. After anti-inflammatory medications did not work, Respondent
prescribed D.K. Percodan. Throughout D.K.'s treatment, Respondent
regularly prescribed, Tylenol No. 3, Vicodin and/or Percodan for pain,
and sometimes prescribed Restoril for sleep and Valium for muscle
spasms.
On several occasions, Respondent's records indicated that he
intended to either diminish or cease prescribing Vicodin and Percodan
to D.K. In a November 1990 affidavit, Respondent stated that ``each
time [D.K.] was just about ready to get off habit-forming medicine,
that another accident would occur.'' Respondent further stated that he
wanted D.K. to go to another physician who might be better at getting
him off of all medicine, but that ``I have no evidence of [D.K.] ever
abusing medications that I gave him; it was my belief they were so that
he could go to work.'' However, Respondent nonetheless continued to
prescribe controlled substances after this affidavit.
The Government's expert testified that prescribing two narcotics
simultaneously should be intermittent, and not done on a regular basis
like Respondent did. The expert further testified that it was his
opinion that there was no valid medical purpose for Respondent's
prescribing to D.K. in the types and quantities of controlled
substances that he did. He emphasized that a physician loses control
when he prescribes a large quantity of controlled substances with
refills.
Respondent testified that it never occurred to him that D.K.'s
accidents may have been related to his use of controlled substances.
Respondent further testified that D.K. was one of the
[[Page 51596]]
patients he felt he had not handled properly and that he should have
been more reluctant to prescribe controlled substances to him.
Respondent began treating D.K.M. following a car accident in 1982.
He diagnosed her as having a cervical sprain with radiculopathy and
prescribed Talwin and exercises. When the Talwin did not appear to be
working, Respondent prescribed D.K.M. Percodan. Over the next ten
years, D.K.M. was involved in approximately five more car accidents
with some requiring emergency room treatment. She was assaulted by
patients during her work as a nurse and by her spouse on several
occasions. In addition, she was injured lifting a heavy patient at
work, her knees buckled several times causing her to fall, and she
broke her ankle following a fall off a truck and later sprained the
same ankle. During his treatment of D.K.M., Respondent regularly
prescribed large quantities of various controlled substances. For
example, between May 4, 1987 and January 20, 1988, Respondent
prescribed D.K.M. 415 Percodan, 780 Tylenol No. 3 and 760 Vicodin. In
April 1992, Respondent stated that his goal was to get D.K.M. off all
medication by July 1992, yet he subsequently issued her a prescription
for 100 hydrocodone with APAP with five refills.
Respondent testified that it did not occur to him that D.K.M.'s
accidents may have been related to her abuse of controlled substances,
but that in retrospect, her multiple injuries were ``red flags.'' The
Government's expert testified that none of D.K.M.'s accidents justified
prescribing her the quantity of controlled substances that Respondent
did and that people who are abusing medication frequently develop falls
and injuries in an attempt to obtain more drugs. In addition, D.K.M.
allegedly lost prescriptions, which according to the expert is further
evidence of drug-seeking behavior. The expert opined that Respondent
did not prescribe for D.K.M. for a legitimate medical purpose.
Respondent began testing S.K. in April 1990. S.K. had significant
motor weakness of both legs as a result of brain surgery, had severe
scoliosis for which she had had a spinal fusion, and needed crutches in
order to walk. She first saw Respondent complaining of neck pains and
headaches. Respondent diagnosed S.K. as suffering from a cervical
sprain. S.K. saw Respondent periodically until February 1993, suffering
from continuing pain in the back, hip and groin, headaches and muscle
spasms. Respondent prescribe S.K. various controlled substances and
anti-inflammatories, and referred her for physical therapy. On two
occasions, Respondent prescribed S.K. 100 Vicodin with 5 refills.
Respondent testified that he prescribed S.K. such large quantities of
Vicodin because he did not expect her condition to change quickly, that
orthopedic conditions generally change slowly, and that pharmacists
frequently encouraged him to prescribe in quantities of 100 because it
is less expensive.
Between June 5, 1989 and May 21, 1990, Respondent issued N.R. 29
prescriptions (6 original prescriptions plus refills) for a total of
1,690 Tylenol No. 3. N.R. was K.D.M's elderly mother and she suffered
from advanced arthritis of multiple joints. N.R. was never officially a
patient of Respondent's and he did not maintain a patient record for
her. Respondent stated that he prescribed for N.R. as a favor and did
not charge her. However, Respondent informed D.K.M. that if N.R. wanted
prescriptions or treatment in the future she would ``have to become an
official patient and be worked up thoroughly with x-rays and other
tests, become `favors' cannot go on forever.'' The Government's expert
testified that patent records are not only legally required but are
necessary to establish a doctor-patient relationship, to determine the
patient's progress or lack thereof, to determine how the patient will
respond to treatment, and to protect the physician. It was the
Government expert's opinion that the prescriptions issued to N.R. were
not for a legitimate medical purpose.
Respondent issued prescriptions to A.R. and C.R., the couple whose
house was searched and were later arrested that was discussed above.
Respondent did not offer any explanation for the controlled substance
prescriptions issued to A.R. Regarding C.R., Respondent first treated
him in June 1991 for lumbosacral sprain with radiculopathy stemming
from various accidents in 1990 and 1991. Initially, Respondent ordered
an MRI, and prescribed 60 Percocet, 100 Xanax with 5 refills, and 60
Valium with 5 refills. In addition, C.R., dislocated his shoulder three
times and fell causing more pain. During his treatment of C.R.,
Respondent prescribed large quantities of Percocet, Xanax and Valium,
and prescribed Dalaudid for a period of time. For example, over a 117-
day period in 1991. Respondent prescribed C.R. 950 Valium or about 8.1
pills per day. Between February 28 and March 25, 1992, Respondent
prescribed C.R. 310 Percocet or about 11.5 pills per day. Respondent
almost always issued new prescriptions before the supply from the
previous prescription should have run out. On one occasion, Respondent
issued C.R. a new prescription after C.R. indicated that he had spilled
water on his Percocet causing the pills to dissolve. In addition,
Respondent often postdated prescriptions for C.R.
Notes in the patient file dated July 15, 1991, indicated that a
pharmacist had called because C.R. was taking more Percocet that
directed; that Respondent's partner refused to give C.R. more
medication; and that the patient had two herniated discs, a dislocated
shoulder and a bad knee and was in great pain and wanted Percocet
before his next scheduled visit. Respondent testified that he ended his
doctor-patient relationship with C.R. after the local police told him
that they suspected that C.R. was a drug dealer and that he cooperated
in the investigation. Respondent also testified that the local
prosecutor wrote to him thanking him for his help in the investigation
of A.R. and C.R.
The Government's expert stated that in his opinion to a reasonable
degree of medical certainty, C.R. was addicted to drugs, that
Respondent maintained C.R. on controlled substances knowing that he was
addicted to them, and that Respondent unlawfully attempted to detoxify
a narcotic addict with narcotic medications by telling C.R. to cut down
gradually on his use of these medications. The expert further stated
that in his opinion, Respondent grossly deviated from the standard of
care and the normal doctor-patient relationship by his prescribing to
C.R. Respondent testified that he was ``lenient'' with C.R. and that
C.R. was ``almost a waking red flag.''
Respondent also treated C.R.'s brother, J.R. for a little over two
years beginning in March 1991. J.R. was a garbage man with chronic
lumbosacral sprain and a fracture in the lower back that could by
itself require surgery and that resulted in other low back ailments to
take longer to heal. During the course of his treatment, J.R. also
suffered a number of accidents at work which further injured his back.
J.R. needed to work to support his family. Respondent regularly
prescribed J.R. Percocet and at various times also prescribed him
Valium, Xanax and Darvocet. Respondent also referred J.R. for physical
therapy. At one point, J.R. was seen by Respondent's partner who also
prescribed J.R. Percocet.
At some point during his treatment, J.R. told Respondent that he
was a former addict, but felt that he needed the medication for his
pain and not because he was addicted. The Government's expert stated
that an x-ray report in J.R.'s file did not indicate any
[[Page 51597]]
condition that would cause sufficient pain to warrant treatment with
Schedule II narcotics in the quantities and over the period of time
that Respondent prescribed them.
A review of the prescriptions issued by Respondent to J.R. also
revealed a number of postdated prescriptions. Respondent testified that
he postdated prescriptions for this patient when his office would be
closed on the day the prescription would normally be issued, and that
he understood at the time he issued these prescriptions that a
pharmacist would not dispense them until the date written on them.
The Government's expert stated that in his opinion, J.R. was
addicted to drugs and that Respondent prescribed these drugs to him
even though he knows or should have known that J.R. had no medical need
for them. The expert further stated that Respondent did not take
adequate histories or perform adequate physical examinations of this
patient, that Respondent prescribed controlled substances to J.R.
without seeing him, that the patient showed obvious drug-seeking
behavior and that Respondent knowingly perpetuated J.R.'s addiction.
Respondent testified that he did not think that he was lenient with
J.R. and did not think that J.R. was a drug-seeking patient.
B.S. was a nurse who first was Respondent's partner in August 1986
after being injured at work. She became Respondent's patient in January
1987 and was hospitalized that month. Over the next six and half years
B.S. underwent surgery several times. In October 1992, an MRI revealed
a large lesion destroying bone in her back which was probably caused by
a bone infection. She subsequently underwent a nine hour surgery. In
addition, she was involved in a car accident, fell down some stairs and
had a severe asthma attack, all of which exacerbated her neck and back
pain.
Respondent prescribed B.S. various controlled substances over the
years. On six occasions between January 7 and August 4, 1991,
Respondent issued B.S. prescriptions for both Percocet and Demerol for
a total of 260 Demerol and 390 Percocet. Following her last surgery,
Respondent prescribed B.S. Dilaudid for approximately three and a half
months. Over the years, Respondent referred B.S. to a spine specialist,
a neurosurgeon, a neurologist and an infectious disease specialist.
Respondent's records revealed that Respondent reissued
prescriptions for Percocet to B.S. after her house was burglarized two
times, the locker room at her work was robbed, her motel room was
robbed while she was on vacation, she spilled some Percocet at a ball
game, and her daughter threw some of the drugs away.
The Government's expert opined that three and a half months is a
long time for any patient to be routinely taking Dilaudid. The expert
reported that Respondent issued prescriptions for Dilaudid to B.S.
before her previous supply should have been exhausted, that Percocet
and Dilaudid are not normally prescribed in combination, and that they
both attach to the same receptor sites in the brain. He concluded that
Respondent's prescribing to B.S. was irresponsible and a ``gross
deviation from the standard of care in the practice of medicine in New
Jersey, or in the United States.'' Respondent testified that he knew
B.S. before he began treating her and that he thought she had personal
integrity and would not be likely to divert controlled substances.
Respondent began treating C.T. Sr. in 1978 for a knee injury.
Respondent treated C.T. Sr. until 1990 for various problems including
chronic should pain, cervical and lumbosacral sprain suffered as a
result of a car accident, impingement in the shoulder, and pain
following surgery on his shoulder and arthroscopic surgery on his knee.
C.T. Sr. had a number of work-related accidents and injuries and was
hit by a car. During his treatment of C.T. Sr., Respondent prescribed
him various controlled substances for pain. Between 1984 and 1990,
Respondent issued C.T. Sr. 208 Percocet prescriptions, even issuing two
on the same day, one for 21 dosage units and the other for 20.
Respondent admitted that after a while, he became suspicious of C.T.
Sr.
Respondent often issued C.T. Sr. controlled substance prescriptions
before the supply from the previous prescription should have run out.
Respondent admitted to this, but testified that he did so because
patients' conditions change daily and the directions on the
prescription represent the physician's ``best guess and estimate'' as
to how often the patient should take the medication.
Respondent began treating C.T. Sr's wife, D.T. in 1979 for pulled
muscles and tendonitis of the knee and possible phlebitis. At one
point, she was hospitalized and a neurologist diagnosed her as
suffering from neuromuscular derangement syndrome. At a later point,
D.T. had surgery for scar tissue and thereafter, surgery for a ganglion
cyst and inflamed tendons of the left wrist. Over the years, Respondent
prescribed large amounts of Percocet to D.T. On one occasion, C.T. Sr.
called Respondent and told him that D.T. was suffering from severe back
and knee pain, and Respondent issued her a Percocet prescription.
Respondent testified that now he would recognize this as ``a rather
blatant attempt to try and get some Percodan out of me.''
Respondent issued D.T. prescriptions for Percocet before the supply
from the previous prescription should have been exhausted, and would
often issue new prescriptions after D.T. represented that she had lost
a prescription. While Respondent believed that D.T. clearly had
problems with her arm, he ultimately told her to go elsewhere because
he was not able to cure her wrist and would not give her any more
medication.
According to the Government's expert, Respondent's prescribing to
D.T. was not for a legitimate medical purpose. The expert stated that
``[i]t is incomprehensible to think that this physician was not aware
of the substance abuse by these patients.'' He further testified that,
``If you don't see a patient and you get asked to fill prescriptions
for a patient you haven't seen, and the wife is getting the same
medicine and she's fabricating and exaggerating symptoms as he is,
that's pretty obvious. I mean, that's not something that you would call
gullibility.''
Respondent also issued Percocet prescriptions to C.T. Sr.'s son,
C.T. Jr., who was 12 years old when Respondent first began treating
him. According to Respondent C.T. Jr. had had major injuries to his
right hand five years before, and Respondent issued him prescriptions
for flare-ups of severe pain. Respondent did not have any patient
record for C.T. Jr., and Respondent indicated that C.T. Jr. was not
really a patient of his, but that he issued him the prescriptions as an
act of charity because the family could not afford to send C.T. Jr. to
see his family physician. Respondent admitted that between July 6, 1985
and February 3, 1990, he issued C.T. Jr. 11 prescriptions for a total
of 370 dosage units of Percocet. Respondent testified that although
C.T. Jr. was an adolescent, he was physically large so there was no
physiological difference between him and an adult with respect to
prescribing pain medication.
Respondent stated that in retrospect, many of C.T. Jr.'s complaints
were fabricated in order to please his parents who were addicted to
Percocet. In one month Respondent prescribed to the father, mother and
son a total of 369 dosage units of Percocet.
Respondent first saw E.T. in 1981 when she was hospitalized with
diabetes-associated problems. He did not see her again until 1985 when
her
[[Page 51598]]
family physician referred her to Respondent because she was suffering
from intractable diabetic neuropathy and she was taking large
quantities of Percodan. Respondent continued to prescribe Percodan to
E.T., authorizing 227 dosage units during a five week period in 1985.
Ultimately, Respondent referred E.T. back to her family physician
stating in a letter that, ``Since I have an [enormous] number of
Percodan patient[s] myself, I request that you take this patient
back.''
A notation in E.T.'s patient file dated January 22, 1986, indicated
that this was the last prescription and the patient was so advised.
However Respondent issued her several more prescriptions for Percodan.
On one occasion, E.T's husband called and indicated that his wife was
in a lot of pain and requested that Respondent issue her a prescription
for 25 Percocet to hold her until her next appointment.
The Government's expert testified that E.T. and her husband were
exhibiting drug seeking behavior, and that even if E.T. had painful
diabetic neuropathy, she could have been treated with non-habit forming
medications. The expert did not believe that there was a legitimate
medical purpose for the drugs Respondent prescribed for E.T. because
Respondent was treating this patient for a condition out of his area of
expertise and he was ``simply prescribing controlled drugs for another
doctor's patient.''
Respondent began treating E.T.'s husband, J.T. in 1980 for multiple
injuries sustained in a car accident in 1977 and for which J.T. had
undergone three surgeries. When Respondent first saw J.T. he had an
unhealed and draining fracture of his left leg and it was crooked so
that he had been unable to walk for three and a half years. Respondent
performed several operations on J.T.'s leg and prescribed J.T. mainly
Percodan. As an example, Respondent prescribed J.T. 735 dosage units of
Percodan between April 1 and August 26, 1982.
Subsequently, J.T. fell, rupturing his Achilles tendon, and later
sprained his left ankle and had surgery in New York. By 1986, J.T.'s
left leg was worse and it was ultimately amputated in 1987 in New York.
The doctors in New York prescribed J.T. MS Contin, so Respondent began
prescribing him the drug. Thereafter, Respondent performed a procedure
on J.T.'s leg since the wound was still draining. In addition, J.T.
experienced severe phantom limb pain. Respondent continued to prescribe
J.T. large quantities of MS Contin, even after J.T. appeared to be
improving. Respondent referred J.T. to a detoxification center, but
J.T. would not go for fear of losing his job. At some point later, J.T.
was in a car accident where he injured both knees, his ribs, neck and
lower back. Respondent referred J.T. to a neurosurgeon.
Notes in J.T.'s patient file indicated that a neurologist
recommended that J.T. be detoxified from MS Contin and a pharmacist had
reported that J.T. was using Valium twice as fast as he should.
Respondent nonetheless continued to prescribe J.T. MS Contin, Restoril,
Percocet and Valium.
The Government's expert noted that J.T. called Respondent's office
to obtain prescriptions, sometimes stating that he had lost a
prescription or requesting postdated prescriptions. The expert state
that ``[t]hese tactics are such an obvious attempt of getting and using
more pills than prescribed and it clearly points to the situation where
the patient now is in control of the doctor rather than vice versa. * *
* I do not believe, in this day and age, that any physician would be
that blindfolded to the obvious drugs-seeking behavior.'' The expert
noted that J.T. displayed the classic signs of a drug abuser, and
concluded that Respondent's prescribing of the types and quantities of
controlled substances to J.T. was not for a legitimate medical purpose.
Respondent's expert did not testify in the proceedings before Judge
Bittner, but his testimony before the Medical Board was admitted into
evidence. The expert emphasized that there has ``never been promulgated
clear-cut standards of care in the management of patients with chronic
pain who require long-term narcotic medication,'' and that there is no
law or regulation specifying how much narcotic medication a chronic
pain patient may be prescribed. The expert testified that he was
impressed by the ``medical and surgical complexity,'' of the patients
at issue in that proceeding and that he concluded that Respondent's
prescribing ``mostly does not deviate from the accepted [medical]
standards,'' noting that Respondent documented reasons for his
prescriptions, he followed the patients carefully over a long period of
time and knew the cases well, there was no information of progressive
deterioration related to the prescriptions during the time of the
prescriptions, and that in all but a few cases, Respondent kept
``fairly decent records.'' The expert testified that the only patient
for whom Respondent's prescribing deviated from standard medical care
was T.K.
Although not required by the Medical Board, following the
suspension of his medical license, Respondent underwent rehabilitative
training in late 1993 or 1994 with a physician who is part of the
Academy of Medicine of New Jersey, the educational arm of the New
Jersey Medical Society. This physician is board certified in
psychiatry, psychotherapy, and preventive medicine, and certified in
addiction medicine.
The training consisted of six or seven two-hour sessions over a
four to six month period during which Respondent and the physician
engaged in role playing exercises designed to help with the handling of
drug seeking patients. They also reviewed the potency of medications,
pain management techniques, how to obtain assistance in dealing with
problem patients, and how to recognize ``red flags'' to warn of drug
seeking patients. Respondent was given homework assignments and also
read material outside of his sessions with the physician. Respondent
passed an examination given at the conclusion of the training.
Respondent testified that the course made him better able to handle
controlled substances and to handle drug-seeking patients. He further
testified that as a result of the course. ``I came to believe that I
was an easy mark for patients. I was too believing in everything they
said. I didn't try hard enough to decrease potentially habit-forming
drugs in a number of cases. * * * Although, at the time I felt I was
doing the right thing.''
In retrospect and after his training, Respondent felt that in three
or four cases, ``I over-prescribed, with good intentions, but I didn't
act prudently in retrospect.'' He testified that he had become more
suspicious than he used to be and that he believed that it is not
necessarily incorrect to use controlled substances to treat chronic
pain but that physicians have more alternatives to controlled
substances in treating these patients now.
At the hearing, Respondent acknowledged that he sometimes
prescribed additional controlled substances to patients before their
previous supply should have been exhausted, but testified that if a
patient used up a supply of medication before it should have been
exhausted if the directions for use were followed, then he would
conclude that the patient had more pain than he thought. Respondent
also testified that prescribing two narcotics simultaneously is
justified when a physician thinks that the patient can be managed on
the weaker drug but prescribes some of the stronger one in case the
weaker one does not work. Prescribing the drugs at the same time saves
the patient another trip to the physician's office if the weaker
[[Page 51599]]
medication does not provide relief. Respondent further testified that
the issue of prescribing more than one controlled substance at a time
``comes down to do you trust your patient. And I trusted my patient * *
* I was too gullible in certain situations.''
In this proceeding, Respondent was asked about his 1991 testimony
before the Preliminary Evaluation Committee that, ``I'm a lot stricter
and tougher about this than I was. I mean, as I look back I realize
that I was really too lenient with all these people.'' Respondent
testified at the hearing before Judge Bittner that he ``was more aware
of red flags,'' that ``it was an evolving process,'' and that ``I am
more aware today than I was last year.''
Respondent offered into evidence affidavits from colleagues who
stated that Respondent's medical treatment of his patients was
professional, that he has demonstrated concern and compassion for his
patients, that he is highly regarded, that he conducts himself in the
best interests of his patients, and one stated that he had never
observed Respondent engaging in any unethical conduct. An affidavit
from a patient indicated that Respondent was dedicated to treating and
improving her condition.
In addition, Respondent offered into evidence the testimony of a
colleague at the 1993 Medical Board hearing. The colleague testified
that Respondent had an excellent reputation within the orthopedic and
general medical communities and that Respondent's standard of care was
above reproach. The colleague testified that in his opinion, Respondent
``has exercised appropriate care and concern and appropriate management
of [the patients at issue] prior to prescribing any given medication.''
He further stated that there could be reasonable differences of opinion
among orthopedists as to the type and amount of medication to prescribe
to a given patient. The colleague did testify however that he would not
prescribe more than a four-week supply of Schedule II or III medication
at one time and that he would ``definitely'' not prescribe narcotics
for a patient without maintaining a patient record.
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 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 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 FR 16, 422 (1989).
As to factor one, it is undisputed that Respondent's New Jersey
medical license has been in effect since August 1994, and in October
1994, the Medical Board permitted Respondent to resume prescribing
controlled substances, if and when he is issued a DEA registration,
subject to various restrictions for at least one year. The restrictions
imposed by the Medical Board include that Respondent must maintain a
log of his prescribing and dispensing; he may not prescribe or dispense
more than a 14-day supply at one time to a patient; and he must refer a
patient to a pain management specialist for a second opinion prior to
completion of 90 days of prescribing or dispensing to the patient.
Respondent argues that DEA is bound by the Medical Board's
findings. The Acting Deputy Administrator rejects this argument since
the recommendation of the state licensing authority is only one of the
factors to be considered in determining whether Respondent's
registration would be in the public interest. Like Judge Bittner
states, ``[i]nasmuch as state authority to handle controlled substances
is a necessary but not sufficient condition for DEA registration * * *
this factor is not dispositive.'' However, the Acting Deputy
Administrator does find it significant that after reviewing
Respondent's treatment of the patients at issue, the Medical Board
reinstated Respondent's license to practice medicine and his ability to
handle controlled substances, albeit with restrictions.
Regarding Respondent's experience in dispensing controlled
substances, the Government does not dispute that during Respondent's 20
years in practice he has seen over 15,000 patients. At issue in this
proceeding is Respondent's controlled substance prescribing to 18
patients.
Judge Bittner concluded that Respondent issued controlled substance
prescriptions to two individuals for no legitimate medical purpose. She
found that Respondent did not offer any explanation for the fact that
between August 22 and September 23, 1992, he prescribed 480 Vicodin to
A.R. Judge Bittner stated that ``[w]hen a physician prescribes such an
unusually large quantity of a controlled substance, it is reasonable to
require him to show that the prescribing was for a legitimate medical
purpose.'' Since Respondent did not provide any justification for these
prescriptions, Judge Bittner inferred that they were not issued for a
legitimate medical purpose. The Acting Deputy Administrator disagrees
with Judge Bittner's conclusion. The burden of proof in these
proceedings is on the Government, and the mere fact that Respondent
prescribed A.R. a large quantity of a controlled substance in and of
itself does not warrant the conclusion that there was no legitimate
medical purpose for the drugs.
Judge Bittner also found that there was no legitimate medical
purpose for the Tylenol with codeine and gluethimide prescriptions
Respondent issued to T.K. for approximately nine years. The Acting
Deputy Administrator agrees with Judge Bittner's conclusion. In 1984,
all New Jersey physicians were warned by a newsletter that ``[b]arring
unusual circumstances, there would be no legitimate medical indication
for the prescribing of the combination of Glutethimide and Codeine.''
In addition, the Government's expert noted in his report that ``there
is no medical rationale for the use of this combination.''
Regarding Respondent's prescribing to the other patients at issue,
Judge Bittner found numerous examples of questionable conduct.
Respondent prescribed various patients other combinations of controlled
substances either simultaneously or within a short period of time. He
issued prescriptions to individuals before the quantity obtained
pursuant to previous prescriptions should have been exhausted.
Respondent postdated prescriptions, and issued prescriptions despite
expressions of concern by physicians, pharmacists or others about the
quantity of medication the patients were obtaining. Respondent
continued to prescribe controlled substances to patients even after he
had indicated that he would stop issuing them
[[Page 51600]]
prescriptions. He ignored signs that patients were abusing the
controlled substances prescribed or were at serious risk of doing so.
For example, he continued prescribing to one individual even after
learning that the individual had been altering earlier prescriptions.
He also ignored the possibility that the multiple accidents and
injuries reported by the patients could be drug-seeking behavior.
Judge Bittner also found that ``Respondent failed to appropriately
document his treatment and prescribing to a number of patients.''
Significantly, Respondent did not maintain any patient file whatsoever
on two of the patients.
Judge Bittner further found that ``Respondent's treatment of
various patients also shows a regrettable lack of responsibility * *
*.'' As examples, she notes that Respondent prescribed large quantities
of certain drugs despite recommendations in the Physician's Desk
Reference that they were not to be used for more than a few days; he
continued to prescribe controlled substances to an individual after she
overdosed; and he prescribed narcotics to an individual after learning
that the individual had unsuccessfully attempted detoxification and was
severely depressed.
The Acting Deputy Administrator agrees that Respondent's
prescribing to these patients appears to be highly questionable.
However, the Acting Deputy Administrator is uncomfortable saying that
Respondent's prescribing of large quantities of controlled substances
or issuing new prescriptions before the previous supply should have
been exhausted or prescribing combinations of controlled substances was
improper given that these patients apparently had medical problems that
caused chronic pain and warranted treatment.
But, Respondent himself admits that he was too lenient regarding
the treatment of some of the patients. In addition, the Medical Board,
through its adoption of the state administrative law judge's findings,
found serious problems with Respondent's prescribing of controlled
substances. As the administrative law judge noted, ``* * * the patients
in question had, to varying degrees, serious problems which no doubt
may have resulted in legitimate pain complaints. The question, however,
is one of degree. Respondent ignored obvious dangers of dependency, as
evidenced in many instances by what were referred to by petitioner's
witnesses as clear ``red flags'' which should have made him suspect. In
addition, it is apparent * * * that [R]espondent did not have control
of the dispensing of [controlled substances], but prescribed largely in
response to communications and complaints from the patients in
question, who frequently requested specific medications and dosages of
medications, as well as specific dates for prescriptions.'' Further,
the Medical Board noted in its 1994 order, ``while we do not condone
the manner in which Dr. Caragine prescribed controlled dangerous
substances to the patients who were the subject of this action, we do
note that the vast majority of those patients were individuals with
significant medical problems or illnesses requiring pain management.''
The Acting Deputy Administrator also notes that the Government's
expert, in his 1993 report, stated that
At one point a doctor may be naive or even gullible but when
patients continuously call the office for refills, lose their
prescriptions, receive pharmacist's reports about refilling
prescriptions frequently and knowledge of an individual's addiction
by virtue of the fact that the doctor decided to wean them from the
medication followed by continuous prescriptions, even after overdose
situations, with more [controlled substances], can no longer be
brushed aside as gullibility.
Therefore, the Acting Deputy Administrator concludes that even
though the patients at issue are only a small portion of Respondent's
patient population, his prescribing of controlled substances to these
individuals raises serious concerns regarding ability to responsibly
handle controlled substances in the future.
As to factor three, there is no evidence that Respondent has ever
been convicted of charges under state or Federal laws relating to the
manufacture, distribution or dispensing of controlled substances.
Regarding factor four, pursuant to 21 CFR 1306.04, prescriptions
for controlled substances may be issued only ``for a legitimate medical
purpose by an individual practitioner acting in the usual course of his
professional practice.'' As discussed above, the Acting Deputy
Administrator finds that the prescriptions to T.K. for Tylenol with
codeine and glutethimide were not issued for a legitimate medical
purpose. Additionally, New Jersey law requires that physicians maintain
patient charts for individuals that are prescribed controlled
substances. It is undisputed that Respondent failed to maintain such
charts for N.R. and C.T. Jr. Also, it is undisputed that Respondent
postdated controlled substances prescriptions for various patients in
violation of 21 CFR 1306.05, which requires that``[a]ll prescriptions
for controlled substances shall be dated as of, and signed on, the day
when issued. * * *''
The Government alleged that Respondent detoxified patients without
being registered to do so. However, the Acting Deputy Administrator
agrees with Judge Bittner that the record does not support a finding
that Respondent violated DEA regulations by conducting detoxification
treatment without being registered to do so.
As to factor five, Judge Bittner found ``Respondent's current
assertions that he will be more responsible in the future are entitled
to little weight.'' She noted that Respondent continued his
questionable prescribing even after being interviewed in 1990 by a
state investigator and after telling the Medical Board's Preliminary
Evaluation Committee in 1991 that ``I'm very careful. I'm not so easy
to get drugs out of like I use[d] to be,'' and that ``I want the board
to know that I really made an effort to clean up my act and not be
permissive.'' The Acting Deputy Administrator disagrees with Judge
Bittner. In 1994, on his own initiative, Respondent underwent training
to better equip himself to handle drug-seeking patients and to more
responsibly handle controlled substances. Additionally at the hearing
in this matter, when asked about his assurances at the 1991 hearing,
Respondent testified that ``I'm a lot stricter and tougher about this
than I was. I mean, as I look back I realize that I was really too
lenient with all these people.'' He further testified that he ``was
more aware of red flags,'' that ``it was an evolving process,'' and
that ``I am more aware today than I was last year.''
Judge Bittner concluded that even though ``the patients at issue
here are a small fraction of the total number he treated over a twenty-
year period[,] * * * that most of these patients suffered chronic pain
and that it was difficult to find appropriate treatment for many of
them'' Respondent's prescribing ``is most charitably described as
irresponsible.'' She further concluded that ``[n]otwithstanding
Respondent's testimony that he will be more responsible in the future
and that he is rehabilitated by his training * * *, it is clear that
Respondent does not yet acknowledge his misprescribing.'' Therefore,
Judge Bittner found ``that a preponderance of the credible evidence in
this record establishes that Respondent's registration would not be in
the public interest'' and she recommended that his application be
denied.
Respondent filed exceptions to Judge Bittner's Opinion and
Recommended Ruling, and the Government filed a
[[Page 51601]]
response to Respondent's exceptions. The Deputy Administrator has
carefully considered both of these filings in rendering his decision in
this matter. First, several of Respondent's exceptions have already
been addressed in this final order such as his argument that the
Medical Board's ruling is binding on DEA, that the Government did not
provide the records relied upon by its expert in rendering his opinion,
and that Judge Bittner improperly found that Respondent prescribed
controlled substances to A.R. for no legitimate medical purpose.
Respondent also argued that Judge Bittner failed to consider
Respondent's innocent unawareness of errors in judgment; the Medical
Board's finding that Respondent had no improper motive in prescribing
for his patients; the lack of evidence that Respondent knowingly and
intentionally prescribed controlled substances to addicted persons or
persons involved in illicit activity; the lack of evidence of any
complaints about Respondent's prescriptive practices to any government
agency by physicians, patients or staff; and the lack of evidence
demonstrating that Respondent sold any drugs or prescriptions to
anyone. The Acting Deputy Administrator concludes it is not necessary
to prove that any of the above circumstances exist before a
registration can be revoked or an application denied. Just because
misconduct is unintentional, innocent or devoid of improper motivation,
does not preclude revocation or denial. Careless or negligent handling
of controlled substances creates the opportunity for diversion and
could justify revocation or denial.
Respondent argued that Judge Bittner failed to give proper weight
to his previous treatment of patients other than those at issue in this
proceeding, to the medical problems of the patients at issue, and to
the fact that he voluntarily underwent training. Like Judge Bittner,
the Acting Deputy Administrator has considered these facts and has
given them the weight he deems appropriate in rendering his decision in
this matter. Respondent further argued that Judge Bittner failed to
even consider that he cooperated with state officials in their
investigation of his patients. The Acting Deputy Administrator has
considered Respondent's cooperation, however he does not deem it
significant in determining whether Respondent can be trusted to
responsibly handle controlled substances.
Respondent also argued that the Government expert did not speak
with or examine the patients at issue, nor did he speak with
Respondent, his partner or office staff before submitting his report.
The Acting Deputy Administrator finds that the expert could render an
opinion without taking the steps outlined above, however in rendering
his decision in this matter, the Acting Deputy Administrator has taken
into consideration what was relied upon by the expert.
Respondent further argues that Judge Bittner failed to find in
Respondent's favor regarding specific points when ``DEA presented no
evidence and the Respondent presented detailed, uncontradicted
evidence.'' The Acting Deputy Administrator is unable to address this
exception since Respondent did not provide any specific examples where
this may have occurred.
Respondent also contends that the Government did not establish that
he knew or should have known that the combination of Tylenol with
codeine and glutethimide is highly abused and that Judge Bittner was in
error in finding that Respondent prescribed these drugs to be taken in
combination. Respondent asserts that he prescribed these drugs
separately and never told the patients to take them in combination. The
Acting Deputy Administrator finds that it is incumbent upon a DEA
registrant to keep abreast of the illicit uses of controlled
substances. Here, as early as 1984, physicians in New Jersey were
notified that barring unusual circumstances, there was no legitimate
medical purpose for these drugs in combination. In addition, the Acting
Deputy Administrator finds that it is of little significance that
Respondent never actually told the patients to take the drugs together.
By prescribing these drugs at the same time, he created the opportunity
for abuse once the patient left his office.
Respondent argues that Judge Bittner failed to consider a New
Jersey regulation that was in place at the time of the prescribing at
issue which addresses the prescribing of narcotic drugs for persons
suffering from intractable pain. This regulation suggested that
narcotics should be used after no other relief or cure can be found,
that practitioners should be alert to new or alternative forms of
treatment that may be less addictive, and that the practitioner should
periodically either cease the medication, taper the dosage or try other
medications in an effort to reduce the propensity for addiction. The
Acting Deputy Administrator finds that Respondent's reliance on this
regulation to justify his prescribing seems to be misplaced since
Respondent did not appear to follow the suggestions set forth.
Finally, Respondent argues that Judge Bittner failed to consider
that the issuance of a registration limited to hospital patients only
would be in the public interest and whether the Medical Board's
restrictions would reduce or eliminate any potentially abusive
prescriptive practices. These exceptions have been considered by the
Acting Deputy Administrator and will be discussed below.
The Acting Deputy Administrator is extremely concerned by
Respondent's prescribing to the 18 patients at issue up until his
medical license was suspended in 1993. While there may have been no
improper motivation, Respondent ignored many ``red flags'' that should
have alerted him to the possible abuse of controlled substances.
But, the Acting Deputy Administrator notes that the patients at
issue make up a very small percentage of Respondent's total patient
population and that these patients had legitimate medical problems that
warranted some form of treatment. In addition, the Acting Deputy
Administrator recognizes that the events at issue occurred a number of
years ago, and while passage of time alone is not dispositive, it is a
consideration in assessing whether Respondent's registration would be
inconsistent with the public interest. See Norman Alpert, M.D., 58 FR
67,420 (1993). The Acting Deputy Administrator notes that following his
state suspension, Respondent on his own initiative, underwent
rehabilitative training to become better educated in controlled
substances and how to deal with drug-seeking patients, and the
restrictions imposed by the Medical Board on Respondent's handling of
controlled substances will limit the chance for improper prescribing.
Therefore, the Acting Deputy Administrator concludes that it is not in
the public interest to deny Respondent's application for resignation.
However, given the Acting Deputy Administrator's concerns about
Respondent's past prescribing to the patients at issue, a restricted
registration is warranted. This will allow Respondent to demonstrate
that he can responsibly handle controlled substances in his medical
practice, yet simultaneously protect the public by providing a
mechanism for rapid detection of any improper activity related to
controlled substances. See Steven M. Gardner, M.D., Docket No. 85-26,
51 FR 12,576 (1986). For at least one year following the issuance of
the DEA Certificate of Registration, Respondent shall be limited to
handling
[[Page 51602]]
controlled substances for hospital in-patients only. This does not
include emergency room handling of controlled substances since some of
the prescriptions for the patients at issue in this proceeding were
issued when they were seen by Respondent in a hospital emergency room.
During that year, Respondent shall take a course in the proper handling
of controlled substances. The Acting Deputy Administrator finds this
necessary since Respondent received the training discussed in this
proceeding approximately four years ago. At the conclusion of one year,
or upon the submission to the Special Agent in Charge of the DEA Newark
Field Division, or his designee, of evidence of completion of the
course, whichever is later, Respondent can then handle controlled
substances outside of the hospital in-patient setting with the
restrictions ordered by the Medical Board. However, since the Medical
Board's restrictions on Respondent's prescribing of controlled
substances are to be in place for at least one year after he received
his DEA registration, they are really of no consequence because
Respondent is limited by DEA to only handling controlled substances for
hospital in-patients. Therefore, for two years after Respondent is
allowed to handle controlled substances outside of the hospital his
registration shall be subject to the following conditions:
(1) Respondent shall maintain a log of his prescribing,
administering and dispensing of controlled substances and shall make
this log available to DEA personnel upon request. At a minimum, the log
shall include the name of the patient, the date the controlled
substance is prescribed, administered or dispensed, and the name,
dosage and quantity of the controlled substance prescribed,
administered or dispensed.
(2) Respondent may not prescribe or dispense more than a 14-day
supply of a controlled substance at one time to a patient.
(3) Respondent must refer a patient to a pain management specialist
for a second opinion prior to completion of 90 days of prescribing or
dispensing to the patient.
According, the Acting Deputy Administrator of the Drug Enforcement
Administration, pursuant to the authority vested in him by 21 U.S.C.
823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that the
application for registration submitted by Paul J. Caragine, Jr., M.D.,
be, and it hereby is granted subject to the above described
restrictions. This order is effective no later than October 28, 1998.
Dated: September 21, 1998.
Donnie R. Marshall,
Acting Deputy Administrator.
[FR Doc. 98-25827 Filed 9-28-98; 8:45 am]
BILLING CODE 4410-09-M