[Federal Register Volume 69, Number 48 (Thursday, March 11, 2004)]
[Notices]
[Pages 11658-11661]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-5484]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration


Marvin L. Gibbs, Jr., M.D.; Revocation of Registration

    On July 28, 2003, the Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration (DEA), issued an 
Order to Show Cause to Marvin L. Gibbs, Jr., M.D. (Dr. Gibbs) of Tempe, 
Arizona, notifying him of an opportunity to show cause as to why DEA 
should not revoke his Certificate of Registration No. AG7790644 under 
21 U.S.C. 824(a)(4) and deny any pending applications for renewal or 
modification of his practitioner registration. As a basis for 
revocation, the Order to Show Cause alleged Dr. Gibbs' continued 
registration was inconsistent with the public interest. The Order 
alleged that from October 2000 through December 2001, Dr. Gibbs was 
affiliated with companies selling controlled substances and other drugs 
over the internet. During that period he issued thousands of controlled 
substance prescriptions, including refills, which were not issued in 
the normal course of professional practice, in violation of 21 CFR 
1306.04 and 21 U.S.C. 841(a).
    The Order alleged that without conducting physical examinations, 
Dr. Gibbs issued prescriptions to individuals requesting controlled 
substance prescriptions over internet web sites with which he had no 
prior doctor-patient relationship. Dr. Gibbs would review 
questionnaires completed on-line by the customer and then have a brief, 
pre-scheduled telephone conversation with the requestor. He did not 
consult with the customer's primary physician and failed to maintain 
any patient records of his own. The bulk of the controlled substance 
prescriptions issued by Dr. Gibbs in this manner were alleged to have 
been for hydrocodone 7.5 mg., a Schedule III controlled substance. It 
was further alleged Dr. Gibbs filed a prescription for Vicodin in the 
above manner which was requested by a DEA investigator using a 
fictitious name and medical complaint.
    The order notified Dr. Gibbs that (1) he could file a written 
request for a hearing, (2) file a written waiver of hearing, together 
with a statement regarding his position on the matters of fact and law 
involved, or (3) if he failed to file a request for a hearing within 30 
days, that his hearing right would be deemed waived.
    The Order to Show Cause was sent by certified mail to Dr. Gibbs' 
registered location at 2078 E. Southern Avenue, Suite D101, Tempe, 
Arizona 85282-7521. According to the return receipt, the Order to Show 
Cause was accepted on Dr. Gibbs' behalf on or around August 8, 2003. On 
September 4, 2003, Dr. Gibbs filed a response with Administrative Law 
Judge Gail A. Randall which was ambiguous as to which option he was 
electing. After Judge Randall afforded him an opportunity to file a 
clear election, by his letter dated October 9, 2003, Dr. Gibbs selected 
option two, waiving his right to a hearing and asking that his October 
1, 2003, written submission be considered.
    On October 30, 2003, consistent with that election, Judge Randall 
terminated the case and returned the file to the Government's counsel 
for further administrative processing. On November 26, 2003, the Chief 
Counsel forwarded the file to the Acting Deputy Administrator for final 
agency action in accordance with 21 CFR 1301.43(e) and 1301.46.
    Other than as set forth above, DEA has not received a request for a 
hearing from Dr. Gibbs or anyone representing him in this matter. 
Therefore, the Acting Deputy Administrator, finding that Dr. Gibbs has 
waived his hearing right and requested that the agency make its 
decision based on the investigative file and his written submission, 
now enters her final order without a hearing pursuant to 21 CFR 
1301.43(c) and (e) and 1301.46.
    The Acting Deputy Administrator finds that Dr. Gibbs is registered 
with DEA as a practitioner under Certificate AG7790644 for Schedule II 
through V controlled substances, with a registered location of Alliance 
Healthcare Services, 2078 E. Southern Avenue, Tempe, Arizona. He was 
previously registered with DEA under Certificate BG729030, which was 
retired on September 30, 1991. He is currently licensed with the 
Arizona Medical Board of Medical Examiners (Board) under License Number 
13736, which was issued on November 26, 1982, and expires on December 
21, 2004. He is currently engaged in a solo medical practice and his 
only specialty is obstetrics and gynecology.
    In February 2001, Dr. Gibbs was identified as an integral 
participant in Myprivatedoc, an Internet business which had contracted 
with him to prescribe narcotics and other controlled substances to 
requesters after reviewing on-line questionnaires filled out by the 
customers and a brief telephone call. The prescriptions were then 
filled by Genrich Pharmacy of Phoenix, Arizona and sent to the 
customer's address by mail or delivery service.
    A joint investigation conducted by DEA and the Board showed that in 
May or June 2000, Dr. Gibbs had been approached by two men about 
prescribing medicine over the Internet. They were owners of an auto 
parts business in Mesa, Arizona. At the time, Dr. Gibbs had recently 
lost his privileges at Mesa Lutheran Hospital, the facility where 
ninety percent of his patient volume was generated. Another physician, 
who recommended that Dr. Gibbs become involved in the Internet 
prescribing business, knew he needed help in generating income at the 
time.
    Dr. Gibbs agreed to participate in Myprivatedoc's scheme and would 
be paid $20 for each consultation. Visitors to the Web site would 
initially fill out a questionnaire regarding their medical history and 
complaint. Dr. Gibbs then reviewed the forms over the Internet and 
received a schedule of when customers would be calling him for a 
consultation. Initially he evaluated 10 to 15 individuals per day, 
spending approximately five to ten minutes with each customer. By 
December 2000, his consultations had increased to approximately 30 per 
day.
    Dr. Gibbs made no effort to validate information provided to him 
via the Internet and while Myprivatedoc requested that customers verify 
their identities with picture identifications, Dr. Gibbs made no 
independent verification of the caller's identity. Dr. Gibbs, who had 
not taken any courses or continuing medical education in chronic pain 
management or identification of drug seeking behavior, did not perform 
physical examinations on customers, request or obtain medical records 
from their treating physicians or maintain any medical records on the 
individuals he prescribed to over the Internet. The majority of 
prescriptions prescribed were for thirty day supplies of controlled 
substance medications, with a maximum of two refills. Dr. Gibbs stated 
he did not believe he was establishing a doctor-patient relationship 
with the individuals requesting prescriptions.
    Around February 2001, after receiving approximately $52,000 in 
consultation fees, Dr. Gibbs terminated his relationship with 
Myprivatedoc. In April 2001, he associated with Medsworldwide, another 
internet

[[Page 11659]]

company located in Tampa, Florida. Using essentially the same 
evaluation process as with Myprivatedoc, Dr. Gibbs prescribed 
controlled substances to customers requesting them over Medsworldwide's 
web site. He was now paid $70.00 per consult and received approximately 
$36,000 before his relationship with that company was severed.
    In August 2001, Dr. Gibbs started his own web site titled 
Expressmedcare.com. He associated with a Florida pharmacy which issued 
medications prescribed by Dr. Gibbs and began charging $100.00 to 
$125.00 per consult. Up until December 21, 2001, when DEA confiscated 
his computers and Dr. Gibbs stopped internet prescribing, he had 
consulted with approximately 900 customers through Expressmedcare's web 
site. As with Myprivatedoc and Medsworldwide, Dr. Gibbs prescribed 
controlled substances to Expressmedcare requestors after reviewing 
their questionnaires and a brief telephone conversation, but without 
physical examinations or entries in medical records.
    Genrich Pharmacy records showed that from October 25, 2000, to 
August 28, 2001, Dr. Gibbs prescribed 8,040 controlled substance 
prescriptions, including refills, to approximately 2620 internet 
clients. This amounted to approximately 639,430 dosage units of 
controlled substances, including 560,650 dosage units of hydrocodone, 
55,250 dosage units of benzodiazepines, 6,960 dosage units of 
controlled substances with the ingredient codeine and 16,570 dosage 
units of various other controlled substances. Additionally, Dr. Gibbs 
prescribed 56,460 dosage units of carisoprodol (Soma), which is not a 
controlled substance, but is frequently abused together with 
hydrocodone products.
    In July 2001, a DEA investigator entered a fictitious name on the 
Medsworldwide web site seeking Vicodin ES, count 60, after purportedly 
suffering a back injury from an automobile accident. He was directed to 
phone Dr. Gibbs at a specific time on July 31, 2001. After minimal 
questioning as to when the accident occurred, if the caller was on any 
medications and what medication he wanted, Dr. Gibbs prescribed 60 
Vicodin tablets with two refills. He did not question the agent about 
allergic reactions, his overall physical condition or any prior 
surgeries.
    On September 15, 2001, at approximately 8 p.m., the 30 year-old son 
of the Aikin County, South Carolina, coroner was killed in a single car 
accident when he ran off the road and suffered fatal head injuries. He 
had talked to his mother about an hour before the accident, when he 
told her he was on his way home. The coroner's preliminary 
investigation indicated the victim most likely fell asleep or became 
unconscious at the wheel after taking alprazolam (Xanax), which was 
obtained through an Internet pharmacy. A prescription bottle for Xanax, 
issued by Genrich Pharmacy in Phoenix, Arizona, was found in the 
victim's car and documents reflected he received the medication through 
a prescription authorized by Dr. Gibbs.
    On October 2, 2001, the Aikin County Coroner's Office contacted Dr. 
Gibbs by phone in his Arizona office. He advised investigators that the 
victim was not a patient of his because he was an OB/GYN physician. DEA 
investigators reviewing Dr. Gibbs' Physician Profile from Genrich 
Pharmacy then found he had prescribed the victim 1 mg aplrazolam 
(Xanax), 30 count, on March 3, 2001. Two 30 count refills were 
authorized by Dr. Gibbs and filled by Genrich Pharmacy on April 19, 
2001 and June 5, 2001. Based on the circumstances of the accident and 
Dr. Gibbs having prescribing Xanax, the Coroner's Office believed it 
was very likely Dr. Gibbs contributed to the accident and the victim's 
subsequent death.
    A review of seized computer files indicated that Dr. Gibbs also 
prescribed controlled substances to four health care professionals who 
were also obtaining controlled substances from other physicians 
associated with different internet websites.
    Updated pharmacy records, including those obtained from United 
Prescription Services in Tampa, Florida, indicated that from October 
2000 until December 2001, Dr. Gibbs was responsible for issuing a total 
estimated 14,500 controlled substance prescriptions and approximately 
1200 carisoprodol prescriptions, including refills, over the internet. 
He prescribed in excess of 1,018,000 dosage units of controlled 
substances and 90,000 dosage units of carisoprodol during that period. 
It is estimated that over a fourteen month period Dr. Gibbs received in 
excess of $180,000 for prescribing controlled substances through the 
Myprivatedoc, Medsworldwide and Expressmedcare websites.
    Based on the DEA and Arizona Medical Board's investigation, the 
Board initiated case No. MD-01-0861 against Dr. Gibbs. On May 14, 2003, 
after a formal interview with Dr. Gibbs in which he was represented by 
counsel, the Board issued its Findings of Fact, Conclusions of Law and 
Order. The Board found the standard of care for the management of 
prescribing medications requires there be a doctor-patient 
relationship, established on a face-to-face basis, before prescribing 
and that Dr. Gibb's conduct was unreasonable, given that standard of 
care. The Board found Dr. Gibbs' conduct posed the potential harm of 
patients becoming addicted to the medications and harm to the community 
through the diversion of those medications.
    The Board concluded Dr. Gibbs' actions constituted unprofessional 
conduct as defined in A.R.S. Sec.  32-1401 by failing or refusing to 
maintain adequate records on a patient, engaging in conduct or practice 
that is or might be harmful or dangerous to the health of the patient 
or the public and by prescribing prescription medication without a 
physical examination to persons whom he did not have a previously 
established a doctor-patient relationship.
    The Board issued Dr. Gibbs a Decree of Censure, ordered him to pay 
a civil penalty of $10,000 within one year and placed him on ten years 
probation, which included the following provisions: He was to prescribe 
Schedule II and III controlled substances only for individuals who were 
established patients of his obstetrics and gynecology practice; attend 
CME classes; pay for costs associated with monitoring his probation; 
and submit quarterly declarations under penalty of perjury that he has 
complied with all conditions of probation.
    In his written submission to the Order to Show Cause, Dr. Gibbs 
does not contest the allegations in the Order to Show Cause and 
concedes having prescribed controlled substances over the internet 
without taking patient's histories, conducting physical examinations or 
documenting information in medical records.
    In defense, Dr. Gibbs notes he has been in practice for 23 years 
and never inappropriately prescribed controlled substances in his 
obstetrics and gynecology practice. He states he was unaware of any 
prohibitions against internet prescribing and became involved with ``2 
local businessmen'' after they were referred to him by an 
anesthesiologist who Dr. Gibbs had known for 21 years. He states the 
``2 businessman [SIC] told me they had retained legal counsel, and not 
knowing there were statutes governing the practice of medicine I did 
not do my own inquiries.'' Based on reading a text titled ``Practical 
Management of Pain,'' Dr. Gibbs states he took a ``naive approach'' to 
internet consulting and

[[Page 11660]]

did not consider the possibility of diversion or abuse in treating 
chronic pain patients. He states he believed people suffering chronic 
pain feared losing their jobs if they took time off from work to see 
physicians and that the internet process afforded them an opportunity 
to alleviate their pain and suffering.
    Based on taking a medical ethics course ordered by the Board and a 
Physician Prescribing Course on his own volition, Dr. Gibbs states he 
now knows why it was wrong ``to address these issues over the 
internet.'' He stresses the state board did not revoke his medical 
license after conducting a 2\1/2\ hour interview and having him undergo 
a comprehensive proficiency evaluation in obstetrics and gynecology, 
general medicine, clinical pharmacology and medical ethics.
    After taking a medical ethics course ordered by the Board, Dr. 
Gibbs states he now knows why prescribing over the internet is the 
``wrong way to meet the needs of chronic pain sufferers'' and that 
``Prior to taking the course, I was unaware of scams in which doctors 
in medical clinics and pharmacies (pharmacists) set up elaborate 
schemes to make large profits from selling and reselling the same 
prescription needs.'' Dr. Gibbs also states he did not consider the 
possibility that people would use the internet for the purpose of 
diversion and abuse of these medications and he ``can assure DEA that I 
am acutely aware, and understand why laws exist governing the practice 
of medicine.''
    He also cites the assessment of Dr. Russell McIntyre, Th.D, 
director of a three day Professional Renewal Through Ethics course 
ordered by the Board, in which Dr. McIntyre concludes Dr. Gibbs now has 
unqualified capacity for ``ethical thinking and insight'' ``should be 
thought of as remediated.'' Dr. Gibbs further notes his voluntary 
completion of a three day Physician Prescribing Course at the 
University of California, San Diego School of Medicine in October 2003.
    He finally stresses the Arizona Medical Board's reputation and 
credibility for protecting the public and assessing the worthiness of 
physicians in maintaining their state medical licenses after 
professional misconduct and that he cannot prescribe Schedule II and II 
controlled substances outside his obstetrics and gynecology practice 
under the terms of his ten year probation. Dr. Gibbs states that in his 
speciality, were DEA to revoke his certificate, it would not be 
possible for him to care for either surgical or non-surgical patients 
and that if he were allowed to retain his certificate, he would do 
nothing to jeopardize his medical license or warrant future revocation 
of his certificate.
    The Acting Deputy Administrator may revoke a DEA Certificate of 
Registration and deny any pending applications for such certificate if 
she determines the respondent's registration would be inconsistent with 
the public interest, as determined pursuant to 21 U.S.C. 823(a)(4) and 
823(f). Section 823(f) requires consideration of the following factors:
    (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.
    As a threshold matter, it should be noted that the factors 
specified in section 823(f) are to be considered in the disjunctive: 
The Acting Deputy Administrator may properly rely on any one or a 
combination of the factors, and give each factor the weight she deems 
appropriate, in determining whether a registration should be revoked or 
denied. Henry J. Schwarz, Jr., M.D., 54 FR 16422 (1989)
    With regard to the first public interest factor, the Arizona 
Medical Board has not made a specific recommendation regarding this 
action. It has allowed Dr. Gibbs to retain his medical license and 
prescribe Schedule II and III controlled substances to established 
patients in the regular course of his obstetrics and gynecology 
practice. However, the Board also concluded he engaged in 
unprofessional conduct, issued him a Decree of Censure, ordered him to 
pay a civil penalty of $10,000 and placed him on ten years probation. 
Since state licensure is a necessary but insufficient condition for DEA 
registration, the Acting Deputy Administrator concludes that this 
factor is not determinative. See Barry H. Brooks, M.D., 66 FR 18305, 
18308 (2001); Martha Hernandez, M.D., 62 FR 61145, 61147-48. Further, 
while it is relevant that the state currently allows Dr. Gibbs to 
prescribe Schedule II and III controlled substances to established 
patients, the Acting Deputy Administrator does not find that 
dispositive of whether his continued registration is in the public 
interest. See Roger Pharmacy, 61 FR 65079, 65080 (1996).
    With regard to the second public interest factor, respondent's 
experience in dispensing controlled substances, the Acting Deputy 
Administrator finds Dr. Gibbs is an experienced obstetrician/
gynecologist who has prescribed controlled substances for many years 
and there is no evidence that he violated state or federal regulations 
until October 2000. However, at that time, when financially pressed as 
a result of losing accreditation at the hospital where the bulk of his 
patient volume was being generated, he was quite willing to engage in 
internet prescribing with an organization run by two men who owned a 
local auto parts business. Dr. Gibbs, who had no experience or 
continuing medical education in chronic pain management or 
identification of drug seeking behavior, entered into this activity 
without even minimal research or inquiry into relevant professional 
standards, the state statutes governing unprofessional conduct, or any 
apparent thought to the threats of diversion and harm to individuals 
receiving controlled substance prescriptions under these circumstances.
    Given the numerous red flags the business proposal should have 
generated and the Arizona statute (A.R.S. Sec.  32-1401(26)(e)), which 
includes as ``unprofessional conduct'' the prescribing of medications 
without physical examination to an individual who does not have a 
previously established doctor-patient relationship, it is readily 
apparent that if Dr. Gibbs was, in fact, unaware of the constraints 
against this activity, it was because he simply turned a blind eye to 
the dangers and the standards of the normal course of professional 
practice. In that regard, his lengthy experience as a physician in 
prescribing controlled substances makes his voluntary participation in 
this scheme even more egregious.
    In a little over a year, Dr. Gibbs prescribed over a million dosage 
units of controlled substance medications to thousands of internet 
requestors without a physical examination, adequate medical history, 
sufficient verification of identity or any documentation in patient 
medical records. Considering the foregoing, the Acting Deputy 
Administrator finds that factor two weighs against Dr. Gibbs' continued 
registration.
    With regard to the third public interest factor, Dr. Gibbs has not 
been convicted of any Federal or State laws relating to the 
manufacture, distribution or dispensing of controlled substances, which 
weighs in favor of continued registration.

[[Page 11661]]

    As to the fourth factor, compliance with State and Federal law and 
regulations, Dr. Gibbs violated Arizona law by (1) failing to conduct 
physical examinations before prescribing controlled substances, (2) 
failing to maintain adequate records on these patients and (3) engaging 
in conduct that is or might be harmful or dangerous to the health of 
the patient or the public. See A.R.S. Sec.  32-1401(26)(e), (q) and 
(ss). Dr. Gibbs also violated Federal regulations by prescribing 
controlled substances outside the usual scope of his professional 
practice. See 21 CFR 1306.04(a). Accordingly, the Acting Deputy 
Administrator finds that factor four weighs against continued 
registration.
    With regard to the fifth public interest factor, such other conduct 
which may threaten the public health and safety, the Acting Deputy 
Administrator finds the conduct of Dr. Gibbs discussed under factors 
two and four, is also applicable under factor five. The large amounts 
of controlled substance medications prescribed by Dr. Gibbs to 
individuals without physical examination or adequate consideration of 
the possibilities for diversion, abuse or adverse effects upon the 
recipients, all lead to the inevitable conclusion that his activities 
presented significant risk to public health and safety.
    The Acting Deputy Administrator has considered the matters 
addressed in Dr. Gibbs' written submission but, in determining the 
weight to be attached to the matters of fact asserted therein, has done 
so in light of the absence of cross-examination. See 21 CFR 1301.43(d). 
While his efforts to educate himself regarding ethical and professional 
responsibilities and the dangers of internet prescribing are laudable, 
they are mitigated by the fact they were initiated only after Dr. Gibbs 
became aware of DEA and Board investigations into his conduct and taken 
in anticipation of or pursuant to state disciplinary proceedings.
    The Acting Deputy Administrator is troubled by Dr. Gibbs' apparent 
continuing assertion that his underlying intent in engaging in internet 
prescribing was to care for patients who suffered from chronic pain and 
were unable financially to consult with a physician. This smacks of 
self-serving and rationalization. To the contrary, the record clearly 
infers that his prime motivation, from the beginning to the end, was 
financial gain. At a time when he had just lost accreditation at the 
hospital where ninety percent of his patient volume was being 
generated, he readily agreed to associate with two then-strangers who 
owned an auto parts business. After that relationship terminated, Dr. 
Gibbs affiliated himself with a second Internet Web site company, which 
increased his consultation fee from the $20 he had been receiving from 
Myprivatedoc, to $70 per consult with Medsworldwide. Even this increase 
was not sufficient, as Dr. Gibbs then formed his own Web site where, 
until his computers were seized by DEA, he charged $100 to $125 per 
consult. In sum, given the investigative record, Dr. Gibbs' assertion 
that his underlying motivation was to serve the public good and relieve 
pain and suffering, rings hollow.
    After considering the totality of the investigative record and Dr. 
Gibbs' written submission, the Acting Deputy Administrator concludes 
his continued registration is inconsistent with the public interest, as 
that term is used in 21 U.S.C. 823(f) and 824(a)(4).
    Accordingly, the Acting Deputy Administrator of the Drug 
Enforcement Administration, pursuant to the authority vested in her by 
21 U.S.C. 823 and 824 and 28 CFR 0.100(b) and 0.104, hereby orders that 
DEA Certificate of Registration AG7790644, issued to Marvin L. Gibbs, 
Jr., M.D., be, and it hereby is, revoked. The Acting Deputy 
Administrator further orders that any pending applications for renewal 
of such registration be, and they hereby are, denied. This order is 
effective April 12, 2004.

    Dated: February 20, 2004.
Michele M. Leonhart,
Acting Deputy Administrator.
[FR Doc. 04-5484 Filed 3-10-04; 8:45 am]
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