66138 Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices 

1While I also immediately suspended 

Respondent’s registration based on my conclusion 

that his continued registration during the pendency 

of the proceeding ‘‘would constitute an immediate 

danger to public health and safety,’’ Show Cause 

Order at 7, on October 14, 2005, I subsequently 

stayed the suspension after Respondent maintained 

that he was the victim of identity theft. ALJ Ex. 4. 

Overview of This Information 

Collection 

(1) Type of Information Collection: 

Extension of a currently approved 

collection. 

(2) Title of the Form/Collection: 

Identification of Explosive Materials. 

(3) Agency form number, if any, and 

the applicable component of the 

Department of Justice sponsoring the 

collection: Form Number: None. Bureau 

of Alcohol, Tobacco, Firearms and 

Explosives. 

(4) Affected public who will be asked 

or required to respond, as well as a brief 

abstract: Primary: Business or other forprofit. Other: None. The regulations of 

27 CFR 55.109 require that 

manufacturers of explosive materials 

place marks of identification on the 

materials manufactured. Marking of 

explosives enables law enforcement 

entities to more effectively trace 

explosives from the manufacturer 

through the distribution chain to the 

end purchaser. This process is used as 

a tool in criminal enforcement activities. 

(5) An estimate of the total number of 

respondents and the amount of time 

estimated for an average respondent to 

respond: It is estimated that 1,563 

respondents will respond to this 

information collection. Estimated time 

for a respondent to respond is none. 

Because the manufacturers are required 

to place markings on explosives, the 

burden hours are considered usual and 

customary. 5 CFR 1320.3(b)(2) states, 

there is no burden when the collection 

of information is usual and customary. 

(6) An estimate of the total public 

burden (in hours) associated with the 

collection: The estimated annual total 

burden hours associated with this 

collection is 1 hour. 

If additional information is required 

contact: Lynn Murray, Department 

Clearance Officer, Policy and Planning 

Staff, Justice Management Division, 

United States Department of Justice, 

Two Constitution Square, Room 2E–502, 

145 N Street NE., Washington, DC 

20530. 

Dated: October 21, 2010. 

Lynn Murray, 

Department Clearance Officer, PRA, U.S. 

Department of Justice. 

[FR Doc. 2010–27115 Filed 10–26–10; 8:45 am] 

BILLING CODE 4410–FY–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 06–8] 

George Mathew, M.D.; Denial of 

Application 

On September 19, 2005, I, the Deputy 

Administrator of the Drug Enforcement 

Administration, issued an Order to 

Show Cause and Immediate Suspension 

of Registration to George Mathew, M.D. 

(Respondent), of Seattle, Washington. 

The Order proposed the revocation of 

Respondent’s DEA Certificate of 

Registration, BM5009065, which 

authorized him to dispense controlled 

substances in schedules II through V as 

a practitioner, and the denial of any 

pending applications to renew or 

modify his registration on the ground 

that 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).’’ Show Cause Order at 1. 

The Show Cause Order alleged that 

Respondent had participated in a 

criminal scheme run by Johar Saran, the 

owner of Carrington Healthcare 

Systems/Infiniti Services Group (CHS/ 

ISG) of Arlington, Texas, which used 

numerous pharmacies owned by ‘‘sham 

corporations’’ to obtain the DEA 

registrations necessary to ‘‘purchase and 

dispense large quantities of controlled 

substances via the Internet.’’ Id. at 5. As 

for Respondent’s involvement, the 

Order alleged that between May 1, 2005 

and June 17, 2005, Respondent, who 

was licensed in the State of Washington, 

had authorized 136 prescriptions for 

residents of ‘‘at least 27 different states’’ 

and that ‘‘[n]inety-three percent of the 

[prescriptions] were for hydrocodone,’’ a 

schedule III controlled substance. Id. at 

6. The Order further alleged that 

Respondent ‘‘did not see [the] 

customers, had no prior doctor-patient 

relationships with the Internet 

customers, did not conduct physical 

exams, * * * did [not] create or 

maintain patient records,’’ and that 

‘‘[t]he only information usually 

reviewed prior to issuing [the] drug 

orders was the customer’s online 

questionnaire.’’ Id. The Order thus 

alleged that Respondent ‘‘participated’’ 

in a scheme to ‘‘facilitate [the] 

circumvention of legitimate medical 

practice’’ by ‘‘prescribing controlled 

substances to Internet customers despite 

never establishing a genuine doctorpatient relationship with the Internet 

customer.’’ Id. at 5. 

Next, the Show Cause Order alleged 

that a DEA Diversion Investigator (DI) 

had accessed a Web site, http:// 

www.heynowmeds.com, and, after 

providing his name, address, phone 

number, date of birth, gender, and 

filling out a brief medical questionnaire, 

purchased hydrocodone. Id. at 6. The 

Order further alleged that the DI 

received the drug three days later, that 

he had not been contacted by any one 

affiliated with the Web site, and that the 

bottle’s label listed Respondent as the 

prescriber and Southwest Fusion, an 

entity in Fort Worth, Texas, as the 

dispensing pharmacy. Id. 

The Show Cause Order thus alleged 

that Respondent ‘‘did not establish 

legitimate physician-patient 

relationships with the Internet 

customers to whom [he] prescribed 

controlled substances’’ and that ‘‘such 

prescriptions [were] not [issued] for a 

legitimate medical purpose in the usual 

course of professional practice.’’ Id. at 7. 

The Order thus alleged that the 

prescriptions violated 21 CFR 

1306.04(a).1

On September 22, 2005, Respondent 

requested a hearing on the allegations, 

which he denied, maintaining that he 

had been the victim of identity theft, 

ALJ Ex. 2; the matter was then placed 

on the docket of the Agency’s 

Administrative Law Judges (ALJ). 

Moreover, on October 7, 2005, 

Respondent requested a stay of the 

immediate suspension based on his 

contention of identity theft. See ALJ Ex. 

4. On October 14, 2005, I stayed the 

suspension pending resolution of his 

claim. Id. 

Thereafter, on October 19, 2005, the 

parties filed a Joint Motion to Stay the 

Proceedings, ALJ Ex. 3, and on October 

26, 2005, the ALJ granted a stay. ALJ Ex. 

5. On December 4, 2006, the parties 

filed a joint status report. ALJ Ex. 6. 

Therein, the parties notified the ALJ of 

their inability to reach a resolution of 

the matter and requested that the stay of 

the proceedings be lifted and that the 

hearing be held as soon as possible. Id. 

In its prehearing statement of January 

5, 2007, the Government notified 

Respondent that it also intended to 

present evidence regarding statements 

he made during an interview with DEA 

Investigators on September 22, 2005. 

Gov. Prehearing Statement at 7. More 

specifically, the Government alleged 

that Respondent had contracted with 

EDrugs, an entity which operated a Web 

site (http://www.eDrugstore.com), and 

that ‘‘on a daily basis’’ ‘‘for about 6 


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2With respect to factor one (the recommendation 

of the State board), the ALJ noted that the State 

Board ‘‘has not made a direct recommendation 

concerning [his] DEA registration.’’ ALJ at 25. The 

ALJ further found, however, that the State ‘‘Board 

has engaged in considerable oversight of the 

Respondent’s medical practice’’ which included 

summarily suspending his license after finding that 

his ‘‘continued practice of medicine constitute an 

immediate danger to the public health and safety’’ 

and that he had committed unprofessional conduct 

on two occasions (2007 and March 2009). Id. at 25– 

26. The ALJ did not, however, state whether this 

factor supported a finding that his continued 

registration is inconsistent with the public interest. 

With respect to factor three (Respondent’s 

conviction record of offenses related to controlled 

substances), the ALJ found that there was ‘‘no 

evidence of [his] having a conviction record.’’ Id. at 

30. 

months between July 2003 and February 

2004,’’ he would go to the ‘‘company 

webpage and review a list’’ which 

‘‘contain[ed] patient names and 

suggested prescription drugs.’’ Id. at 7– 

8. The Government also alleged that 

Respondent ‘‘stated that he approved 

prescriptions for non-controlled 

substances and diet medications,’’ that 

‘‘[h]e was paid $3.00 for each noncontrolled prescription and $10.00 for 

each diet prescription,’’ and that he 

‘‘received approximately $30,000 from 

EDrugs for his services.’’ Id. at 8. 

After delays authorized by the ALJ, a 

hearing was held in Seattle, Washington 

on July 24–26, 2007. At the hearing, 

both parties called witnesses to testify 

and introduced documentary evidence. 

After the hearing, both parties submitted 

Proposed Findings of Fact, Conclusions 

of Law and Arguments. 

On September 22, 2008, the parties 

filed a Joint Motion to Stay the 

Administrative Proceedings until March 

31, 2009. ALJ Ex. 12. The basis of the 

motion was that on July 8, 2008, the 

Washington Medical Quality Assurance 

Commission (MQAC) had summarily 

suspended Respondent’s State medical 

license and that his hearing on that 

matter was not scheduled until March 6, 

2009. ALJ Ex. 12. On September 26, 

2008, the ALJ granted the motion and 

directed the parties to file a joint status 

report by March 31, 2009. ALJ Ex. 13. 

On March 30, 2009, the parties filed 

a Joint Status Report, Motion to Lift Stay 

of Proceedings and Motion to Reopen 

the Record. ALJ Ex. 15. Therein, the 

parties noted that the MQAC had 

entered an Agreed Order which allowed 

Respondent to resume practicing 

medicine provided he satisfied various 

terms and conditions set forth therein; 

the parties also sought to supplement 

the record with various documents 

related to the MQAC proceeding and to 

file supplemental briefs. Id. On April 1, 

2009, the ALJ lifted the stay, reopened 

the record to admit the MQAC 

documents, granted the parties 

additional time to file supplemental 

post-hearing briefs, and then closed the 

record. ALJ Ex. 16. On July 22, 2009, the 

ALJ also reopened the record on 

Respondent’s motion to admit an 

exhibit and then closed the record 

again. ALJ Ex. 18. Finally, on July 29, 

2009, the ALJ reopened the record sua 

sponte to admit various documents 

related to the matter’s procedural 

history and then finally closed the 

record. ALJ Ex. 17. 

On October 2, 2009, the ALJ issued 

her recommended decision (ALJ). 

Therein, the ALJ concluded that the 

Government had made a prima facie 

showing that Respondent had 

committed acts which render his 

registration inconsistent with the public 

interest, finding that the evidence under 

factors two (Respondent’s experience in 

dispensing controlled substances) and 

four (Respondent’s compliance with 

State and Federal laws related to 

controlled substances) supported the 

revocation of Respondent’s registration. 

ALJ at 29 & 31. 

The ALJ found that Respondent had 

contracted with eDrugstore, an internet 

pharmacy, and that from July 2003 

through early 2004, Respondent had 

issued over 300 controlled substance 

prescriptions. Id. at 26. The ALJ also 

found that Respondent had issued 

prescriptions after reviewing online 

questionnaires and that he did not keep 

any medical records for the individuals 

to whom he prescribed the controlled 

substances. Id. 

With respect to these prescriptions, 

she further found that Respondent, who 

is only licensed to practice medicine in 

Washington, ‘‘prescribed controlled 

substances to individuals in other states, 

to include California, Indiana, 

Massachusetts, Texas, and Virginia,’’ 

which require a physician to be licensed 

by them prior to issuing prescriptions to 

a State resident, and that this conduct 

violated the Controlled Substances Act 

(CSA) because he engaged in the 

unauthorized practice of medicine and 

thus acted outside of the usual course of 

professional practice. Id. at 27, 28 

(collecting cases). She also concluded 

that Respondent violated the CSA in 

issuing these prescriptions because he 

did not have ‘‘a face-to-face meeting’’ 

with the patient and ‘‘violate[d] the 

standard of care * * * for prescribing 

controlled substances’’ and thus did not 

establish ‘‘a valid doctor-patient 

relationship.’’ Id. at 29. 

Based on an undercover purchase, the 

ALJ found that ‘‘Respondent’s name and 

DEA number were used to authorize 

prescriptions through the Heynowmeds 

website.’’ Id. While the ALJ 

acknowledged Respondent’s contention 

that he did not issue prescriptions for 

this Web site, she concluded that 

because Respondent had ‘‘allow[ed] 

such a website to gain access and to use 

his DEA registration number,’’ he 

‘‘remains responsible for the outcome of 

that use.’’ Id. She further reasoned that 

Respondent’s failure to safeguard his 

registration from unauthorized use 

‘‘create[d] a risk of diversion’’ and ‘‘a risk 

to the public health and safety’’ because 

it allowed persons ‘‘without a legitimate 

need for * * * controlled substances’’ to 

obtain them and thus was relevant 

conduct under factor five (such other 

conduct which may threaten public 

health and safety).2 Id. at 30. 

The ALJ then turned to other facts 

which she deemed relevant in the 

public interest determination. The ALJ 

found that ‘‘Respondent was cooperative 

and truthful’’ in his interview with DEA. 

Id. She also found significant the 

MQAC’s 2007 finding ‘‘that there was no 

evidence that the Respondent 

mishandled controlled substances 

during the Board’s’’ 2005 investigation. 

Id. at 30–31. She further found it 

‘‘significant’’ that, under the most recent 

MQAC order, Respondent is being 

supervised by a mentoring physician 

who is required to report to the Board. 

Id. 

While the ALJ concluded that the 

Government had made out its prima 

facie case, and that Respondent had 

violated both the CSA and State laws ‘‘in 

prescribing controlled substances over 

the Internet’’ and by his failure to 

safeguard his registration, she also noted 

that since the initiation of the 

proceedings, ‘‘Respondent has had 

approximately four years to handle 

controlled substances without any 

adverse action being taken or evidence 

being seized by the DEA’’ and that the 

‘‘Medical Board is very diligent in 

monitoring [his] medical practice and 

will continue to do so in the future.’’ Id. 

at 31–32. Believing that ‘‘this proceeding 

has instilled in * * * Respondent a 

grave respect for the authority and 

responsibilities which attach to his DEA 

registration,’’ the ALJ apparently 

recommended that I grant Respondent a 

new registration subject to the condition 

that he file his mentor’s reports with 

this Agency and that he take the 

additional medical education courses 

order by the MQAC. Id. at 32. 

Neither party filed exceptions to the 

ALJ’s decision. Thereafter, on November 

3, 2009, the ALJ forwarded the record to 

me for final agency action. 

Having considered the record as a 

whole, I adopt the ALJ’s findings of fact 


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66140 Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices 

and legal conclusions except as noted 

herein. However, I further find that 

Respondent prescribed controlled 

substances for Heynowmeds.com. While 

I also agree with the ALJ that the 

Government made out a prima facie 

case for revocation, I reject the ALJ’s 

conclusion that the other facts and 

circumstances support granting him a 

new registration. As explained below, 

the ALJ ignored the extensive Agency 

precedent which holds that an applicant 

is not entitled to be registered unless he 

accepts responsibility for his 

misconduct. Because Respondent did 

not testify in this proceeding and 

continues to maintain that ‘‘he ha[s] 

done nothing wrong,’’ Tr. 645, he has 

not satisfied the Agency’s rule for 

regaining his registration and his 

application must be denied. I make the 

following findings. 

Findings of Fact 

Respondent’s Registration and License 

Status 

Respondent is a physician who 

previously held DEA Certificate of 

Registration, BM5009065, which 

authorized him to dispense controlled 

substances in schedules II through V as 

a practitioner; his registered location 

was in Seattle, Washington, and his 

registration expired on January 31, 2008. 

GX 1, at 1–2. Respondent did not, 

however, file a renewal application 

until January 24, 2008. ALJ Ex. 12, 

Appendix I, at 1 (Joint Stipulation). The 

parties also agree that Respondent’s 

registration ‘‘did not continue in effect 

after January 31, 2008.’’ Id. While 

Respondent no longer holds a 

registration, he does have an application 

for a new registration currently pending. 

Respondent is board-certified in 

internal medicine and holds a medical 

license issued by the State of 

Washington. RX 4, at 1. While 

Respondent has a current license, he has 

been the subject of two recent 

disciplinary proceedings before the 

Washington Medical Quality Assurance 

Commission (MQAC). 

On June 24, 2005, the MQAC filed a 

statement of charges which alleged that 

in July 2003, Respondent contracted 

with eDrugstore.md ‘‘to prescribe legend 

drugs to patients that were referred to 

him though the website,’’ and was paid 

by the Web site and ‘‘not the patients.’’ 

GX 27, at 1–2. The MQAC alleged that 

its ‘‘investigation included a portion of 

[his] prescriptions,’’ and that ‘‘[f]rom 

August 2003, through approximately 

February 2004, Respondent authorized 

approximately 2,700 prescriptions in 

the sample obtained in the 

investigation.’’ Id. at 2. The MQAC 

further alleged that: 

Respondent did not conduct a history and 

physical on any of these patients. He did not 

have face-to-face contact with any patient to 

evaluate them. Respondent did not have the 

patient’s medical records available for 

review, and he did not have any way to 

verify any of the information provided to him 

via the online consultation form, nor did he 

attempt to do so. Respondent did not have a 

pre-existing physician-patient relationship 

with any of these patients. Respondent did 

not attempt to verify any pre-existing or 

underlying conditions, contraindications, or 

other medications that the patient was taking, 

other than via the online consultation form, 

filled out by the patient or through email. 

Nonetheless, Respondent undertook to 

provide diagnosis and treatment of every one 

of these patients. 

Id. at 2. 

In addition, the MQAC alleged that 

Respondent had prescribed controlled 

substances to three State residents and 

that he had no medical records for these 

persons. Id. at 3–4. More specifically, 

the MQAC alleged that ‘‘Respondent 

provided prescriptions for Percocet, 

Hydrocodone, and Amphetamine’’ to 

Patient 1, that he ‘‘prescribed 

Oxycodone and Alprazolam for Patient 

2,’’ and that he ‘‘prescribed 

Hydrocodone and Cyclobenzaprine for 

Patient 3.’’ Id. at 3. With respect to each 

of these three patients, the MQAC also 

alleged that Respondent ‘‘has no record 

of a history and physical for this patient, 

and no information to explain this 

patient’s diagnosis and treatment. There 

are no medical records, no test results, 

or documentation of any kind to support 

this patient’s diagnosis and treatment.’’ 

Id. at 3–4. 

The MQAC thus alleged that 

Respondent’s conduct with respect to 

both his prescribing over the Internet 

and his prescribing to the three patients 

constituted unprofessional conduct in 

violation of State law. Id. at 4. More 

specifically, the MQAC alleged that 

Respondent’s prescribing violated 

Washington law prohibiting: (1) 

‘‘[i]ncompetence, negligence, or 

malpractice which results in injury to a 

patient or which creates an 

unreasonable risk that a patient may be 

harmed,’’ id. (quoting Wash. Rev. Code 

§ 18.130.180(4)), and (2) ‘‘[t]he 

possession, use, prescription for use, or 

distribution of controlled substances or 

legend drugs in any way other than for 

legitimate or therapeutic purposes, 

diversion of controlled substances or 

legend drugs, the violation of any drug 

law, or prescribing controlled 

substances for oneself.’’ Id. (quoting 

Wash. Rev. Code § 18.130.180(6)). 

On January 18, 2007, following a 

hearing, the MQAC issued a Final Order 

on the allegations. GX 28. Therein, the 

MQAC found proved the allegations that 

Respondent had contracted with 

eDrugstore.md ‘‘to prescribe legend 

drugs to patients that were referred to 

him through the web site’’ and that he 

‘‘was compensated by eDrugstore.md 

[and] not by the patients.’’ Id. at 5. The 

MQAC further found that Respondent 

used his DEA registration to prescribe 

medications and that ‘‘[f]rom August 

2003 through March 2004, [he] 

authorized approximately 2,700 

prescriptions.’’ Id. at 6. The Board 

further found that: 

The Respondent did not conduct a history 

and physical on any of these patients. He did 

not have a face-to-fac[e] contact with any 

patient to evaluate them. The Respondent did 

not have the patient’s medical records 

available for review, and he did not have any 

way to verify any of the information provided 

to him via the online consultation form, nor 

did he attempt to do so. The Respondent did 

not have pre-existing or underlying 

conditions, contraindications, or other 

medications that the patient was taking, other 

than via the online consultation form filled 

out by the patient or through email. 

Nonetheless, Respondent undertook to 

provide diagnosis and treatment of every one 

of these patients. 

Id. 

The MQAC further found that, 

because ‘‘Respondent did not physically 

see, interview, or examine the patients 

he treated through eDrugstore.md, [he] 

could not verify their identity and could 

not establish a diagnosis through the use 

of accepted medical practices to justify 

prescribing medications’’ and that 

‘‘[t]hrough eDrugstore.md, [he] 

prescribed [p]hentermine, a diet 

medication to treat obesity.’’ Id. at 7. 

Continuing, the MQAC found that ‘‘[b]y 

prescribing’’ phentermine ‘‘over the 

Internet without proper counseling, 

follow up, and treatment plan, the 

Respondent failed to comply with 

standards of care from the perspective of 

managing obesity.’’ Id. The MQAC also 

found that his prescribing of 

phentermine ‘‘over the Internet was 

negligent and such conduct created [an] 

unreasonable risk that the patients may 

be harmed.’’ Id. 

The MQAC further found that 

Respondent’s internet prescribing ‘‘was 

contrary to [its] Guidelines for the 

Appropriate Use of the Internet in 

Medical Practice,’’ which it had issued 

on October 11, 2002. Id. at 6. See also 

GX 24. The MQAC noted that the 

Guidelines: 

Provide that treatment that is based solely 

on online questionnaires or online 

consultations do[es] not constitute an 

acceptable standard of care. Specifically, 

patient evaluation must be obtained prior to 


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3On April 27, 2001, DEA published a guidance 

document, Dispensing and Purchasing Controlled 

Substances over the Internet, 66 FR 21181. Therein, 

the Agency explained that ‘‘Federal law requires 

that ‘[a] prescription for a controlled substance to 

be effective must be issued for a legitimate medical 

purpose by an individual practitioner acting in the 

usual course of his professional practice’ ’’ and that 

‘‘[u]nder Federal and state law, for a doctor to be 

acting in the usual course of professional practice, 

there must be a bona fide doctor/patient 

relationship.’’ Id. at 21182. The Agency further 

noted that ‘‘many state authorities’’ look to ‘‘four 

elements as an indication that a legitimate doctor/ 

patient relationship has been established.’’ Id. These 

are: (1) ‘‘[a] patient has a medical complaint’’; (2) 

‘‘[a] medical history has been taken’’; (3) ‘‘[a] 

physical examination has been performed’’; and (4) 

‘‘[s]ome logical connection exists between the 

medical complaint, the medical history, the 

physical examination, and the drug prescribed.’’ Id. 

at 21182–83. The Document then noted that 

‘‘[c]ompleting a questionnaire that is then reviewed 

by a doctor hired by the Internet pharmacy could 

not be considered the basis for a doctor/patient 

relationship. * * * It is illegal to receive a 

prescription for a controlled substance without the 

establishment of a legitimate doctor/patient 

relationship, and it is unlikely for such a 

relationship to be formed through Internet 

correspondence alone.’’ Id. at 21183. 

4Based on its findings that Respondent had 

committed unprofessional conduct, the MQAC 

imposed various sanctions on Respondent 

including a suspension (which was stayed), a 

restriction that he could only practice as an 

emergency medicine physician, and a fine of $2500. 

Id. at 10–119. The MQAC also ordered him to 

complete an approved education and assessment 

course and six hours of continuing medical 

education in ethics and professionalism, to file a 

declaration each quarter stating that he was in 

compliance with the Order, and to appear before 

the Commission for compliance hearings. Id. at 11– 

12. 

5By letter of June 15, 2009, Dr. David Lush 

indicated that he was Respondent’s mentor 

physician for purposes of the Agreed Order. RX 37, 

at 1. Dr. Lush further indicated that Respondent had 

commenced to work under his supervision at his 

community clinic in Raymond, Washington. Id. at 

1, 2. Dr. Lush requested that ‘‘the DEA permit 

[Respondent] to hold a registration number so that 

he will be able to make the most constructive 

possible contribution to the operations of [the] 

clinic.’’ Id. at 2. He averred that, given the 

Commission’s restrictions on Respondent’s license, 

‘‘there would be no danger to the public as a result 

of permitting [Respondent] to continue to hold a 

DEA registration number.’’ Id. 

providing treatment, including issuing 

prescriptions, electronically or otherwise. A 

patient evaluation includes a history and 

physical examination adequate to establish a 

diagnosis and to identify underlying 

conditions and/or contraindications to the 

treatment being recommended or provided. 

GX 28, at 6; see also GX 24, at § 5.3

With respect to the three patients who 

were State residents, the MQAC found 

that Respondent had prescribed 

controlled substances to them and had 

‘‘failed to keep any medical records for 

these patients.’’ GX 28, at 7. The MQAC 

also found that Respondent ha[d] no 

record of a history and physical exam 

for these patients and no information to 

explain the patients’ diagnosis and 

treatment. There are no medical records, 

no test results, or documentation of any 

kind to support the patient’s diagnosis 

and treatment.’’ Id. The MQAC further 

found that Respondent’s treatment of 

these patients ‘‘was below the standard 

of care for a physician in the state of 

Washington, and [that] his conduct 

created an unreasonable risk of harm.’’ 

Id. at 8. 

The MQAC ultimately concluded that 

the State had ‘‘proved by clear and 

convincing evidence that * * * 

Respondent’s conduct constituted 

unprofessional conduct in violation of’’ 

Wash. Rev. Code § 18.130.180(4). Id. at 

9. However, apparently because the 

State produced no evidence showing 

that Respondent prescribed controlled 

substances ‘‘for use other than for 

therapeutic purposes,’’ id. at 8, the 

MQAC concluded that the State had 

‘‘failed to prove by clear and convincing 

evidence that * * * Respondent’s 

conduct constituted unprofessional 

conduct in violation of’’ Wash. Rev. 

Code § 18.130180(6).4 Id. at 9. 

On July 3, 2008, the MQAC filed 

another Statement of Charges against 

Respondent, alleging that he had 

committed unprofessional conduct in 

providing treatment (or lack thereof) of 

four emergency room patients. ALJ Ex. 

15, at 2; Jt. Ex. 1, at 1, 4. However, none 

of the allegations involved the 

prescribing of controlled substances. 

Five days later, on July 8, 2008, the 

Commission entered an Ex Parte Order 

of Summary Suspension. ALJ Ex. 15, at 

2; Jt. Ex. 2, at 1, 3. 

On March 5, 2009, Respondent 

entered into a Stipulated Findings of 

Fact, Conclusions of Law and Agreed 

Order with the Commission in which 

Respondent agreed that he had 

committed unprofessional conduct in 

his treatment of the patients in question 

in violation of Wash. Rev. Code 

§ 18.130.180(4). The Commission 

permitted Respondent to return to the 

practice of medicine pursuant to terms 

and conditions of the Agreed Order. ALJ 

Ex. 15, at 2; Jt. Ex. 3, at 1, 3. On the same 

date, finding that the Agreed Order 

superseded and appropriately 

incorporated all the outstanding terms 

and conditions of the January 2007 

Final Order, the Commission released 

Respondent from that Order. ALJ Ex. 15, 

at 2; Jt. Ex. 4, at 2. 

Under the Agreed Order, which is to 

remain in effect for at least three years, 

Respondent is limited to ‘‘office-based 

family and internal medicine group 

practice.’’ Jt. Ex. 3, at 4. In addition to 

some continuing education and medical 

proficiency requirements, Respondent 

must ‘‘arrange for another physician to 

serve as a mentor at all times prior to 

termination of these practice 

conditions.’’ Id. at 5. Among other 

matters, under the Agreed Order, the 

mentor must make periodic reports to 

the Commission, exercise oversight of 

the office-based practice, and review all 

of Respondent’s charts and entries ‘‘until 

otherwise directed by the 

Commission.’’ 5 Id. at 5–6. 

The DEA Investigation of Respondent 

In June 2004, DEA began investigating 

a criminal conspiracy run by Mr. Johar 

Saran and various associates, which 

among other crimes, unlawfully 

distributed controlled substances in 

violation of 21 U.S.C. 841(a)(1)(a) & 

(b)(1)(D), 846. See generally GX 23. 

More specifically, the Saran conspiracy 

controlled more than twenty corporate 

entities (including Carrington Health 

Services (CHS) and Infiniti Services 

Group (ISG)) which were used to 

fraudulently obtain the DEA pharmacy 

registrations that are legally necessary to 

purchase controlled substances from 

registered manufacturers and 

distributors. GX 24, Factual Resume at 

5–6; Tr. 24–25. Saran and his coconspirators purchased the controlled 

substances and then distributed them to 

customers who sought them through 

over 100 Web sites. GX 24, Factual 

Resume at 8. As Johar Saran admitted in 

his plea agreement, he and his coconspirators ‘‘agreed to distribute and 

possess with the intent to distribute, 

controlled substances to Internet drug 

seeking customers without legitimate 

prescriptions. [He] knew that controlled 

substances would be distributed to 

Internet customers without the 

existence of a doctor patient 

relationship [and that] the Internet 

controlled substance distributions were 

outside the scope of professional 

practice and not for a legitimate medical 

purpose.’’ Id. 

As part of the investigation, on 

December 9, 2004, DEA investigators 

conducted a ‘‘trash run’’ at CHS/ISG. Tr. 

24. Among the evidence recovered were 

a dozen prescription labels for 

controlled substances (including 

phentermine, hydrocodone/apap, and 

alprazolam), which ‘‘appear[ed] to be the 

portion of a multi-part printout that 

should have been filed by the pharmacy 

as a record of the transaction or the 

prescription being filed.’’ Id. at 33–34; 

GX 37. The labels indicated that ‘‘George 

Mathew, M.D.’’ was the prescribing 

physician, gave his registered address in 

Seattle, Washington (albeit without the 

suite number and having a one-digit 

mistake in the zip code), and listed his 

DEA registration number. GXs 1 & 37. 

According to a DI, the pharmacy listed 


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6The ALJ observed that the record contained no 

evidence that the medications reflected in the 

documents seized during the trash runs were 

actually sent to the individuals whose names 

appear on the seized documents. See also ALJ at 6. 

Ordinarily, a pharmacy would not go to the trouble 

of creating these documents unless it was 

dispensing a drug. 

7The testimony established that the ‘‘lead’’ was an 

employee of Saran who managed various 

companies’ accounts. 

8The document does not, however, list a 

physician for heynowmeds.com. See GX 33, at 4. 

9A July 6, 2005, ‘‘Affidavit for Arrest’’ for Abel 

Rodriguez identified Michael Schwerdt as Abel 

Rodriguez’s son-in-law. RX 22, at 28. It also 

indicated that documents printed from Florida 

Corporations Online and seized at the time of a 

search warrant for certain business properties listed 

Abel Rodriguez as the registered agent for La 

Familia Pharmacy III, Inc. Id. at 32. 

10The instructions sent to the DI about payment 

for the shipment indicated that he should make his 

money order payable to Adserv, but the DI made 

the money order payable to SouthWest Infusion in 

order to track the payment back to the ‘‘fill’’ 

pharmacy. Tr. 86–87. Adserv employed Craig 

Schwerdt, the brother of Michael Schwerdt; the 

latter sent the former to Saran’s headquarters ‘‘to 

make sure that [Heynowmed’s] orders were going 

out in a timely fashion.’’ Id. at 104; see also id. at 

137; RX 24, at 47. 

11The DI testified that ‘‘at one point’’ Johar Saran 

had ‘‘23 pharmacies’’ but that the number ‘‘dwindled 

down to 19 by the end.’’ Tr. at 61. 

12The ALJ noted that Government did not 

produce any testimony or statements from 

individuals associated with Saran including Johar 

Saran (and Heather Elliot) implicating Respondent. 

See ALJ at 5. However, this is hardly dispositive 

given that the Government did not allege that 

Respondent worked directly for a Saran-owned Web 

site. Moreover, given that this was a blatantly 

criminal scheme, it is not clear why Ms. Elliot 

would have needed to speak with Respondent 

rather than the Web site owners. 

on the labels (Anchor Services, Inc. of 

Fort Worth, Texas) was a Saranaffiliated pharmacy; however, drug 

orders were not filled there but rather at 

the CHS location.6 Tr. 36; see GX 22, at 

3–4. 

DEA Investigators also obtained a 

court order authorizing them to 

intercept electronic communications 

(including e-mail and downloads) to 

and from CHS/ISG from April 17, 2005 

through the ensuing 90 days. Tr. 50–51; 

GX 36, at 2. The intercept yielded 136 

prescriptions for controlled substances 

which were filled between May and 

June 17, 2005 by Southwest Infusion, 

one of Saran’s sham pharmacies, and 

which bore Respondent’s name as the 

prescribing doctor, his DEA number, 

and his signature. See generally GX 4. 

The prescriptions listed the same street 

address, suite number and city as 

Respondent’s registered location but 

indicated the State as Massachusetts, 

rather than Washington, and a zip code 

of 98104, rather than 98121. See GXs 1 

& 4. 

The vast majority of the prescriptions 

were for schedule III controlled 

substances containing hydrocodone 

(typically containing 10 mg. of this 

controlled substance); other 

prescriptions were for the schedule IV 

controlled substances alprazolam and 

diazepam. See generally GX 4. The 

prescriptions were sent to patients 

throughout the United States (and 

outside of Washington State) and 

included the UPS shipping labels. Id. 

DEA also executed search warrants for 

Saran’s business and the residence of 

Ted Solomon, one of Saran’s coconspirators, who ran several of his own 

Web sites. Among the items seized at 

both CHS/ISG and at Solomon’s home 

was a spreadsheet which listed persons 

who were identified as the ‘‘lead[s],’’ 7

the names of various companies and 

their Web sites, a contact for the 

companies, and various physician 

names. GX 33, at 3–4. Under the lead of 

‘‘Heather,’’ the spreadsheet listed several 

companies and their Web sites 

including Pacific Blue Rx 

(PacifcBlueRx.com) and FMS 

(rxmetro.com); the spreadsheet also 

listed Heynowmeds.com.8 Tr. 98–100; 

GX 33, at 3–4. The spreadsheet listed 

Respondent as the Dr. for both 

PacificBlueRx and FMS. GX 33, at 3. 

According to a DI, these three Web 

sites (as well as FMS) were owned by 

Michael Schwerdt, whose father-in-law 

was Abel Rodriguez.9 Tr. 100 & 111. 

Heather Elliot managed their accounts 

for Saran. Id. at 102. According to the 

DI, Elliot would access the Internet and 

download approximately 50 

prescriptions and print out their labels, 

which she then gave to people in the 

pharmacy who filled the vials and 

readied the drugs for shipping. Id. at 

103. Elliot was eventually indicted and 

pled guilty to several Federal felony 

offenses. RX 27. 

On May 23, 2005, a DI went to 

Heynowmeds.com, which he selected 

because it was one of the busier Web 

sites, to purchase hydrocodone. Tr. 67; 

GX 3, at 1. The Web site listed various 

types of medicine available, and the DI 

clicked on ‘‘pain relief.’’ Id. at 73. The 

DI then ordered 90 tablets of 

hydrocodone/acetaminophen 10/325. 

Id. at 74. The DI selected this drug based 

on its popularity with drug abusers, 

which the DI explained was because 

‘‘you can get the strongest strength of 

hydrocodone and the smallest strength 

of additives, like acetaminophen.’’ Id. 

While the Web site prompted the DI 

to provide some medical information, it 

did so only after asking for his contact 

and payment information. Id. at 77–78. 

The Web site also asked for contact 

information for his physician; the DI 

entered the name and cell phone of a 

DEA Special Agent. Id. at 79–80. The DI 

paid $265.84 for the drugs using a 

money order.10 GX 3, at 2 & 5. 

Two days later, on May 25, the DI 

received the hydrocodone that he had 

ordered. Id. at 82. The label indicated 

that the filling pharmacy was 

SouthWest Infusion, one of Saran’s 

pharmacies; 11 the prescriber was listed 

as ‘‘George Mathew, M.D.’’ Id. at 61; GX 

3, at 3. 

The DI testified that Respondent was 

‘‘the contracting physician’’ for 

Heynowmeds, PacificBlueRx, and Rx 

Metro, Tr. 100, in that he was ‘‘the 

physician that [wa]s approving the drug 

orders and [was]s being compensated by 

these websites for doing so.’’ Id. at 102– 

03. The DI also testified that while he 

had ‘‘no knowledge’’ as to whether 

Respondent had personally approved 

his order for hydrocodone, id. at 110, 

Respondent had ‘‘entered into a contract 

with Abel Rodriguez’’ and made both his 

DEA registration and his State license 

available to Rodriguez. Id. at 111. 

The DI then admitted that he had not 

found any contract between Respondent 

and the three Web sites. Id. at 114. 

Moreover, the DI further testified that 

during the Title III search, the 

Investigators found no evidence of 

personal contact between Respondent 

and the Saran pharmacies. Id. at 62–63. 

The DI explained, however, that ‘‘when 

a physician enters into a contract with 

a Web site owner, the Web site owner 

arranges for the fill pharmacy’’ and there 

is ‘‘no reason for the physician to 

contact that fill pharmacy unless he’s 

* * * following up on any questions or 

concerns that there might be about the 

drugs.’’ Id. at 63. The DI further testified 

that because Respondent’s case was an 

‘‘administrative’’ matter, the 

Investigators ‘‘did not follow the money 

trail’’ with respect to him. Id. Moreover, 

the Investigators did not have evidence 

of e-mails which Respondent may have 

sent to the three Web sites and which 

the Web sites may have sent to 

him.12 Id. at 158 & 164. 

On September 20, 2005, a Grand Jury 

indicted Johar Saran, 18 of his coconspirators, and Saran’s corporations 

for multiple felony offenses under 

Federal law. GX 22; Tr. 26. Thereafter, 

on September 22, 2005, DEA 

Investigators from the Seattle Division 

Office served the Order to Show Cause 

and Immediate Suspension on 

Respondent. Tr. 147, 149, 595, 597–98. 

Later that day, the DIs met with 

Respondent and his attorney at the 

latter’s office. Id. at 598. According to 

one of the DIs, during the interview 

Respondent told the DIs that 

‘‘everything’’ in the Show Cause Order 


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13To demonstrate, even if half of the 2,700 

prescriptions (1,350) were for controlled 

substances, he would have earned less than $18,000 

based on the amounts he received for the controlled 

($10) and non-controlled ($3) prescriptions. Given 

the number of prescriptions, the only way that 

Respondent would have earned $30,000 was if 

nearly all the prescriptions were for controlled 

substances. 

14Respondent denied having provided Rodriguez 

with his DEA number. Id. at 628. 

15Earlier, the affidavit noted that during a search, 

officers had found in a personnel file of one of Abel 

Rodriguez’s associates ‘‘[a]n entry labeled ‘George 

Matthew, 121 Vine St, Seattle WA, 98122,’’ which 

also included his DEA number). RX 22, at 38. In 

parentheses, the affidavit stated that Respondent 

‘‘has previously been identified as a doctor writing 

prescriptions for the internet pharmacy operation.’’ 

Id. 

16Even were I to hold Respondent’s polygraph 

evidence admissible, I would give it no weight as 

each of the questions was compounded. More 

specifically, the examiner asked Respondent if he 

had: (1) ‘‘ever done business with Johar Saran, CHS/ 

HIS [sic], or http://www.heynowmeds.com,’’ (2) 

‘‘ever personally prescribed controlled substances 

for customers of Johar Saran, CHS/HIS [sic], or 

http://www.heynowmeds.com, and (3) ‘‘ever 

received any payment and/or money from Johar 

Saran, CHS/ISH [sic] or http:// 

www.heynowmeds.com.’’ Tr. 506–07. 

Continued 

was ‘‘false.’’ Id. at 599. Respondent 

admitted, however, that ‘‘he had at one 

time * * * authorized some 

prescriptions on the Internet,’’ which 

was between ‘‘July 2003 and early 2004,’’ 

when he had a ‘‘contract with a 

company called eDrugs or eDrugstore.’’ 

Id. at 599, 600. 

Respondent told Investigators that he 

approved drug orders for eDrugstore by 

reviewing an online questionnaire and a 

drug recommendation; if he agreed with 

the recommendation, he would 

authorize the drug order. Id. at 609. He 

further stated that the prescriptions he 

authorized were for ‘‘mainly noncontrolled substances’’ and that, while 

he had authorized some prescriptions 

for ‘‘diet medications,’’ he ‘‘had not 

authorized any narcotic controlled 

substances.’’ Id. at 599. Respondent 

further maintained ‘‘that the quantity of 

the controlled substance prescriptions 

versus the non-controlled substance 

prescriptions was very small.’’ Id. at 606. 

Respondent did not have medical 

records pertinent to his prescribing for 

eDrugstore. Id. at 606–07. 

Respondent told the DIs that he had 

been paid $30,000 by eDrugstore during 

the six- month period he prescribed for 

it. Id. at 599–600, 605–06. He also stated 

that he was paid $3 for non-controlled 

substances and $10 for the diet drugs, 

which he admitted were controlled 

substances. Id. at 606. While 

Respondent further told the DIs that he 

would provide them with bank records 

regarding the payments he received 

from eDrugstore, he never did. Id. at 

606–07. 

However, his contention that he wrote 

only a ‘‘very small’’ number of 

controlled substance prescriptions 

cannot be reconciled with the MQAC’s 

finding that Respondent authorized 

2,700 prescriptions for eDrugstore, the 

total amount of the compensation 

($30,000) he admitted to having 

received from eDrugstore, and the 

respective amounts eDrugstore paid him 

for the controlled ($10) and noncontrolled prescriptions ($3). Indeed, 

this evidence suggests that the great 

majority of the prescriptions he wrote 

for eDrugstore were for controlled 

substances.13

With respect to the allegations of the 

Show Cause Order, Respondent stated 

that while he was prescribing for 

eDrugstore, he received a telephone call 

from Abel Rodriguez, who ‘‘had 

obtained his name from a faxed 

prescription that he had received from 

eDrugstore.’’ Id. at 602. Respondent told 

the DIs that eDrugstore used Rodriguez’s 

pharmacy, La Familia Pharmacy, to fill 

some of its prescriptions, and that that 

was how Rodriguez received the 

prescription (which contained his DEA 

registration number).14 Id. at 624, 629. 

Rodriguez solicited Respondent to write 

prescriptions for his Web site; 

Respondent told the DIs that Rodriguez 

offered to pay him $30 to $35 for each 

controlled substance prescription. Id. at 

611. After the phone call, Respondent 

went to Florida to visit Rodriguez and 

his pharmacy because he did not know 

Rodriguez, and Rodriguez came to 

Seattle. Id. at 612. 

During the interview, Respondent 

maintained that he had written only 

about 100 prescriptions for noncontrolled substances for Rodriguez’s 

Web site. Id. at 614. He also denied 

having written any controlled substance 

prescriptions for him. Id. He denied 

receiving any money from Johar Saran. 

Id. at 601. He also denied knowing any 

of the individuals or entities listed in 

the Order to Show Cause and ‘‘said that 

someone else had provided [his] DEA 

number to them because he had not 

provided anything to any of these 

people’’ because he did not ‘‘know any 

of these people.’’ Id. at 604. 

The Supervisory DI present at 

Respondent’s interview testified that 

Respondent was cooperative, supportive 

of the DEA, and that ‘‘[h]e appeared 

truthful.’’ Id. at 604, 628. In a report 

submitted to the DEA Fort Worth office, 

she described Respondent’s demeanor 

during the interview as candid and 

cooperative. Id. at 150. 

In support of his contention that 

Rodriguez had used his registration 

number without his permission, 

Respondent offered into evidence an 

affidavit prepared by Special Agents of 

the Florida Department of Law 

Enforcement in support of an 

application for a warrant to arrest 

Rodriguez. RX 22, at 12 et seq. 

According to Respondent, the affidavit 

stated that ‘‘Rodriguez had forged the 

name of a physician, Miguel Mora, by 

‘rubber-stamping’ Dr. Mora’s name to 

prescriptions filled by the La Familia 

group, even though he was not actually 

involved in prescribing the 

medications.’’ Resp. Br. at 17 (quoting 

RX 22, at 49). However, the affidavit 

does not identify Respondent as a 

physician whose name and registration 

were used to prescribe controlled 

substances without his 

authorization.15 See generally RX 22. 

Respondent did not testify in this 

proceeding. Instead, to bolster the 

credibility of his statement to the 

investigators that he did not authorize 

controlled prescriptions pursuant to his 

arrangement with Abel Rodriguez, he 

offered evidence that, in May 2007, he 

took and passed a polygraph 

examination which was arranged by his 

attorney. Tr. 505–07; RXs 6 & 33. The 

ALJ admitted this evidence over the 

objection of the Government. Tr. 641. 

In United States v. Scheffer, 523 U.S. 

303 (1998), the Supreme Court upheld 

a rule of evidence, which renders 

polygraph evidence inadmissible in a 

criminal proceeding, against a 

constitutional challenge. Fundamental 

to the Court’s holding was its 

conclusion that polygraph evidence is 

not reliable. As the Court explained, 

‘‘there is simply no consensus that 

polygraph evidence is reliable,’’ and 

‘‘[t]o this day, the scientific community 

remains extremely polarized about the 

reliability of polygraph techniques.’’ 

Scheffer, 523 U.S. at 309 (citations 

omitted). 

Under the Administrative Procedure 

Act (APA), the Agency’s order must be 

‘‘supported by and in accordance with 

the reliable, probative, and substantial 

evidence.’’ 5 U.S.C. 556(d) (emphasis 

added). Respondent has made no 

showing that the scientific community 

and the courts consider this evidence 

any more reliable today than they did 

when Scheffer was decided. While 

Respondent argues that several Agencies 

(including this one) use polygraphs for 

a variety of administrative and 

investigatory purposes, the Scheffer 

Court rejected the same argument, 

noting, most significantly, that these 

uses ‘‘do not establish the reliability of 

polygraphs as trial evidence.’’ 523 U.S. 

at 312 n.8.16 Accordingly, I conclude 


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After the hearing, the Government submitted an 

affidavit by a DEA Supervisory Special Agent (SSA) 

who was also the Polygraph Staff Coordinator. GX 

38. The SSA reviewed the testimony of 

Respondent’s polygraph examiner as well as 

Respondent’s Exhibits 33 (pre-polygraph interview 

notes), 34 (Polygraph examination agreement), and 

35 (Backster Zone Comparison Test Variations). Id. 

at 2. The SSA concluded that all three target 

questions in the polygraph exam were 

compounded, which ‘‘could substantially diminish 

the accuracy of’’ the exam results, as the questions 

could have been truthfully answered either yes or 

no. Id. (emphasis in original). To avoid this result, 

the questions should have been asked individually 

as to Johar Saran, CHS/ISG, and http:// 

www.heynowmeds.com. Id. The SSA further stated 

that the Respondent’s exam would be deemed an 

‘‘Administrative Opinion,’’ because the results were 

not based upon the physiological responses to 

applied stimuli. Id. at 3. 

17Respondent also called an expert witness in 

information technology, who attempted to trace the 

source and destination Internet Protocol addresses 

identified in the intercepted prescriptions to show 

that Respondent did not have a connection with, or 

own, the addresses. Tr. 397–405. The witness, 

however, acknowledged that his ‘‘research was 

inconclusive.’’ Id. at 405; see also id. at 413. He 

further acknowledged that he was not asked to 

research whether Respondent had accessed the IP 

addresses and that his research did not establish 

that Respondent had not accessed them. Id. at 422. 

that the evidence should not have been 

admitted and I decline to rely on it.17

The Government also called Dr. 

George Van Komen, who was qualified 

as an expert witness in the prescribing 

of controlled substances including 

prescribing over the Internet. Tr. 284. 

Dr. Van Komen holds board certification 

in internal medicine, is a fellow of the 

American College of Physicians, and is 

an assistant professor of clinical 

medicine at the University of Utah 

School of Medicine, where he teaches a 

course in medical ethics and 

professionalism. GX 10, at 1; Tr. 261–63. 

Previously, Dr. Van Komen was a 

member and chairman of the Utah 

Physicians Licensing Board as well as a 

member of the Board of Directors and 

President of the Federation of State 

Medical Boards (FSMB); currently, he is 

the chairman of the Utah Medical 

Association’s Committee for Controlled 

Substances. GX 10, at 2–3. Dr. Van 

Komen was also a member of the 

committee which drafted the FSMB’s 

Model Guidelines for the Appropriate 

Use of the Internet in Medical Practice 

(2002). Tr. 290; see also GX 18. 

Dr. Van Komen testified that there is 

‘‘a well defined standard of care’’ for 

prescribing controlled substances and 

establishing a legitimate doctor patient 

relationship. Tr. 295. He further noted 

that the standards for Internet 

prescribing adopted by the MQAC (GX 

24), closely follow the FSMB’s 

guidelines and ‘‘outline for physicians 

in very clear language what’s 

appropriate and what’s not appropriate.’’ 

Tr. 297. Dr. Van Komen then testified 

that the standard of care for prescribing 

a controlled substance requires that a 

doctor-patient relationship be 

established. Id. at 304–05. More 

specifically, Dr. Van Komen testified 

that this begins with the patient 

presenting with an ailment or medical 

problem and that the physician must 

then: (1) Meet the patient face-to-face to 

take a history and perform a physical 

examination; (2) order appropriate tests 

to confirm or eliminate a potential 

diagnosis; (3) make a diagnosis; (4) 

discuss the diagnosis and treatment 

options with the patient; and (5) discuss 

the risks and benefits of specific 

treatment choices. Id. at 304–06. The 

standard of care for prescribing a 

controlled substance also requires that 

the physician maintain patient files 

documenting ‘‘what has occurred in the 

doctor/patient relationship’’ and 

following up with the patient to make 

sure that the treatment is having the 

intended effect and not causing side 

effects. Id. at 307–08, 344. 

Dr. Van Komen subsequently 

explained that reviewing an online 

questionnaire or engaging in a telephone 

consultation does not provide ‘‘the same 

information’’ regarding a patient’s 

potential drug dependency as does ‘‘a 

face-to-face meeting.’’ Tr. 334–35. 

Moreover, after writing a prescription, a 

doctor can reassess the patient when he 

comes back to the office. Id. at 334. 

Based on his review of the MQAC’s 

2005 Statement of Charges (GX 27) and 

its 2007 Final Order (GX 28), Dr. Van 

Komen opined that Respondent 

‘‘prescribe[d] outside the standard of 

care usually accepted or as is accepted 

by the medical community.’’ Tr. 328. He 

also opined that the DVD which showed 

how the DI obtained hydrocodone 

through the Heynowmeds Web site, as 

well as the prescriptions that were listed 

on the spreadsheet of intercepted data, 

supported his conclusion. Id. at 329–30. 

The Government then asked Dr. Van 

Komen whether he had an opinion as to 

whether Respondent’s prescriptions 

were issued for ‘‘a legitimate medical 

purpose.’’ Id. at 330. Dr. Van Komen 

explained that there was no ‘‘way of 

knowing if any of the prescriptions are 

for a legitimate medical purpose 

because there’s no contemporaneous 

medical records on any of the patients.’’ 

Id. Continuing, Dr. Van Komen 

explained that the failure to maintain 

medical records is ‘‘a huge breach of the 

responsibility of a physician when he’s 

prescribing any medication * * * 

especially with controlled drugs.’’ Id. 

As for the MQAC’s finding that 

Respondent had violated State law in 

prescribing phentermine, Dr. Van 

Komen testified that this drug is a 

schedule IV controlled substance which 

‘‘can be abused and that the physician 

needs to [engage in] very close 

monitoring of patients,’’ and that ‘‘it 

makes no sense at all to prescribe 

phentermine without a doctor/patient 

relationship.’’ Id. at 331. He further 

testified that phentermine is a 

stimulant, and that ‘‘[o]f all of the drugs 

that we prescribe, stimulants are by far 

the most addictive.’’ Id. at 343. 

With respect to hydrocodone, Dr. Van 

Komen testified that a physician has to 

have ‘‘a real interaction’’ with ‘‘the 

patient before’’ deciding to ‘‘use opioid 

medication in the treatment of [the 

patient’s] pain’’ and that once the 

physician prescribes the drug, he has to 

‘‘have the patient come back’’ to ‘‘make 

sure that [the patient is] using the 

medication appropriately.’’ Id. at 337. 

Dr. Van Komen also explained that 

hydrocodone is ‘‘very abused’’ and is 

‘‘one of the leading cause[s] of drug 

overdose deaths in the United States.’’ 

Id. at 338. 

On cross-examination, Dr. Van Komen 

further explained that even if he did not 

consider the evidence that the 

Government obtained in the Saran 

investigation, his ‘‘opinion’’ regarding 

the medical propriety of Respondent’s 

prescribing ‘‘would be the same as the 

[MQAC] found.’’ Id. at 360. Continuing, 

Dr. Van Komen opined that Respondent 

‘‘abuse[d] his authority as a physician by 

prescribing on the Internet without 

bonafide doctor/patient relationships.’’ 

Id. at 360–61. He further noted that 

Respondent ‘‘did allow his DEA number 

and his medical license to remain with 

the Internet company’’ and ‘‘[h]e did 

very little after his initial stopping of 

prescribing in 2004 to try and get back 

the information from the Internet 

company.’’ Id. at 361. 

Discussion 

Pursuant to Section 303(f) of the 

Controlled Substances Act (CSA), ‘‘[t]he 

Attorney General may deny an 

application for [a practitioner’s] 

registration if he determines that the 

issuance of such registration would be 

inconsistent with the public interest.’’ 

Id. § 823(f). With respect to a 

practitioner, the Act requires the 

consideration of the following factors in 

making the public interest 

determination: 

(1) The recommendation of the 

appropriate State licensing board or 

professional disciplinary authority. 

(2) The applicant’s experience in 

dispensing * * * controlled substances. 

(3) The applicant’s conviction record 

under Federal or State laws relating to 

the manufacture, distribution, or 

dispensing of controlled substances. 


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18For reasons explained in my discussion of the 

sanction, I conclude that the conditions imposed by 

the MQAC do not adequately protect the public 

interest. 

19On October 15, 2008, the President signed into 

law the Ryan Haight Online Pharmacy Consumer 

Continued 

(4) Compliance with applicable State, 

Federal, or local laws relating to 

controlled substances. 

(5) Such other conduct which may 

threaten the public health and safety. 

Id. § 823(f). 

‘‘These factors are considered in the 

disjunctive.’’ Robert A. Leslie, M.D., 68 

FR 15227, 15230 (2003). I may rely on 

any one or a combination of factors, and 

may give each factor the weight I deem 

appropriate in determining whether to 

deny an application or revoke an 

existing registration. Id. Moreover, I am 

‘‘not required to make findings as to all 

of the factors.’’ Hoxie v. DEA, 419 F.3d 

477, 482 (6th Cir. 2005); see also Morall 

v. DEA, 412 F.3d 165, 173–74 (DC Cir. 

2005). 

With respect to a practitioner’s 

registration, the Government bears the 

burden of proving (by a preponderance 

of the evidence) that granting the 

application would be inconsistent with 

the public interest. 21 CFR 1301.44(d). 

However, where the Government 

satisfies its prima facie burden, as for 

example, by showing that an applicant, 

who was previously registered, 

committed acts which are inconsistent 

with the public interest, the burden then 

shifts to the applicant to demonstrate 

why he can be entrusted with a 

registration. 

In this matter, I agree with the ALJ 

that the Government has satisfied its 

prima facie burden by showing that 

Respondent committed acts which 

render his registration inconsistent with 

the public interest. See ALJ at 31 (‘‘The 

Government clearly met its burden of 

proving that justification exists for 

revoking the Respondent’s DEA 

registration.’’). However, I reject the 

ALJ’s implicit conclusion that 

Respondent has rebutted the 

Government’s prima facie case and her 

recommendation that Respondent ‘‘be 

given an opportunity to demonstrate,’’ 

while he is being mentored, ‘‘his 

continuing ability and willingness to 

comply with the statutory and 

regulatory provisions that adhere to a 

DEA registration.’’ Id. at 32. 

As explained below, the ALJ 

disregarded the extensive body of 

Agency precedent holding that an 

applicant must acknowledge his prior 

misconduct and accept responsibility 

for it. See, e.g., Medicine ShoppeJonesborough, 73 FR 364, 387 (2008) 

(collecting cases). Respondent did not 

testify in this proceeding and continues 

to assert that he has ‘‘done nothing 

wrong.’’ Tr. 645 (closing argument); see 

also Resp. Br. at 46. Accordingly, 

Respondent has not shown that he is 

entitled to a new registration. 

Factor One—The Recommendation of 

the State Licensing Board 

Respondent has twice been subjected 

to disciplinary proceedings brought by 

the MQAC. The latter MQAC case, 

which included a summary suspension 

for his failure to properly treat 

emergency room patients, did not 

involve his prescribing of controlled 

substances. 

However, the first case was based on 

his internet prescribing of phentermine 

to patients he never physically 

examined, as well as his prescribings of 

controlled substances to three other 

patients on whom he did not maintain 

medical records. Based on this conduct, 

the MQAC found Respondent guilty of 

unprofessional conduct and imposed a 

suspension, which it stayed, as well as 

restrictions on his practice. 

Notably, in this matter, the MQAC has 

not made a recommendation that he 

retain his DEA registration. Respondent 

nonetheless argues that its decision 

reflects its conclusion that permitting 

him to continue to practice ‘‘would not 

create a danger to public health and 

safety.’’ Resp. Br. at 29. In his closing 

argument, Respondent further 

maintained that this Agency is required 

to defer to the MQAC’s decision 

allowing him to continue to practice 

under conditions. Tr. 655. 

While the MQAC’s reinstatement of 

his medical license (following the 

second proceeding) now makes him 

eligible to hold a DEA registration, see 

21 U.S.C. 823(f), this Agency has 

repeatedly held that possessing a valid 

State license is not dispositive of the 

public interest inquiry. See Patrick W. 

Stodola, 74 FR 20727, 20730 n.16 

(2009); Robert A. Leslie, 68 FR at 15230. 

DEA has long held that ‘‘the Controlled 

Substances Act requires that the 

Administrator * * * make an 

independent determination as to 

whether the granting of controlled 

substances privileges would be in the 

public interest.’’ Mortimer Levin, 57 FR 

8680, 8681 (1992).18 Accordingly, I am 

not required to defer to the MQAC’s 

decision to allow Respondent to 

practice medicine, and I conclude that 

this factor is not dispositive either for, 

or against, granting Respondent’s 

application. 

Factors Two and Four—Respondent’s 

Experience in Dispensing Controlled 

Substances and His Record of 

Compliance With Laws Related to 

Controlled Substances 

Under a longstanding DEA regulation, 

a prescription for a controlled substance 

is not ‘‘effective’’ unless it is ‘‘issued for 

a legitimate medical purpose by an 

individual practitioner acting in the 

usual course of his professional 

practice.’’ 21 CFR 1306.04(a). This 

regulation further provides that ‘‘an 

order purporting to be a prescription 

issued not in the usual course of 

professional treatment * * * is not a 

prescription within the meaning and 

intent of [21 U.S.C. 829] and * * * the 

person issuing it, shall be subject to the 

penalties provided for violations of the 

provisions of law related to controlled 

substances.’’ Id. See also 21 U.S.C. 

802(10) (defining the term ‘‘dispense’’ as 

meaning ‘‘to deliver a controlled 

substance to an ultimate user by, or 

pursuant to the lawful order of, a 

practitioner, including the prescribing 

and administering of a controlled 

substance’’) (emphasis added). 

As the Supreme Court recently 

explained, ‘‘the prescription 

requirement * * * ensures patients use 

controlled substances under the 

supervision of a doctor so as to prevent 

addiction and recreational abuse. As a 

corollary, [it] also bars doctors from 

peddling to patients who crave the 

drugs for those prohibited uses.’’ 

Gonzales v. Oregon, 546 U.S. 243, 274 

(2006) (citing United States v. Moore, 

423 U.S. 122, 135, 143 (1975)). 

Under the CSA, it is fundamental that 

a practitioner must establish and 

maintain a bonafide doctor-patient 

relationship in order to act ‘‘in the usual 

course of * * * professional practice’’ 

and to issue a prescription for a 

‘‘legitimate medical purpose.’’ Laurence 

T. McKinney, 73 FR 43260, 43265 n.22 

(2008); see also Moore, 423 U.S. at 142– 

43 (noting that evidence established that 

physician ‘‘exceeded the bounds of 

‘professional practice,’ ’’ when ‘‘he gave 

inadequate physical examinations or 

none at all,’’ ‘‘ignored the results of the 

tests he did make,’’ and ‘‘took no 

precautions against * * * misuse and 

diversion’’). At the time of the events at 

issue here, the CSA generally looked to 

State law to determine whether a doctor 

and patient had established a bonafide 

doctor-patient relationship. See Kamir 

Garces-Mejias, 72 FR 54931, 54935 

(2007); United Prescription Services, 

Inc., 72 FR 50397, 50407 (2007).19


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Protection Act of 2008, Public Law 110–425, 122 

Stat. 4820 (2008). Section 2 of the Act prohibits the 

dispensing of a prescription controlled substance 

‘‘by means of the Internet without a valid 

prescription,’’ and defines, in relevant part, the 

‘‘[t]he term ‘valid prescription’ [to] mean[] a 

prescription that is issued for a legitimate medical 

purpose in the usual course of professional practice 

by * * * a practitioner who has conducted at least 

1 in-person medical evaluation of the patient.’’ 122 

Stat. 4820 (codified at 21 U.S.C. 829(e)(1) & (2)). 

Section 2 further defines ‘‘[t]he term ‘in-person 

medical evaluation’ [to] mean[] a medical 

evaluation that is conducted with the patient in the 

physical presence of the practitioner, without 

regard to whether portions of the evaluation are 

conducted by other health professionals.’’ Id. 

(codified at 21 U.S.C. 829(e)(2)(B)). These 

provisions do not, however, apply to Respondent’s 

conduct. 

20At the hearing, Respondent contended that the 

Government violated his right to Due Process by 

introducing the evidence regarding the MQAC’s 

2005 statement of charges and its 2007 order 

because the Government did not make any 

allegations in the Show Cause Order regarding the 

first MQAC proceeding. Tr. 322. Respondent did 

not dispute, however, that the documents were 

noticed in the Government’s pre-hearing statement 

and that they were timely exchanged. Id. at 324– 

25. The ALJ properly overruled Respondent’s 

objection in holding that the Government had 

complied with due process. 

One of the fundamental tenets of Due Process is 

that the Agency must provide a respondent with 

notice of those acts which the Agency intends to 

rely on in seeking the revocation of its registration 

so as to provide a full and fair opportunity to 

challenge the factual and legal basis for the 

Agency’s action. See NLRB v. I.W.G., Inc., 144 F.3d 

685, 688–89 (10th Cir. 1998); Pergament United 

Sales, Inc., v. NLRB, 920 F.2d 130, 134 (2d Cir. 

1990). See also 5 U.S.C. 554(b) (‘‘Persons entitled to 

notice of an agency hearing shall be timely 

informed of * * * the matters of fact and law 

asserted.’’). 

However, ‘‘ ‘[p]leadings in administrative 

proceedings are not judged by the standards applied 

to an indictment at common law.’ ’’ Citizens State 

Bank of Marshfield v. FDIC, 751 F.2d 209, 213 (8th 

Cir. 1984) (quoting Aloha Airlines v. Civil 

Aeronautics Bd., 598 F.2d 250, 262 (DC Cir. 1979)). 

See also Boston Carrier, Inc. v. ICC, 746 F.2d 1555, 

1560 (DC Cir. 1984) (quoted in Edmund Chein, 72 

FR 6580, 6592 n.21 (2007) (‘‘an agency is not 

required ‘to give every [Respondent] a complete bill 

of particulars as to every allegation that [he] will 

confront’ ’’). Thus, the failure of the Government to 

disclose an allegation in the Order to Show Cause 

is not dispositive, and an issue can be litigated if 

the Government otherwise timely notifies a 

respondent of its intent to litigate the issue. 

The Agency has thus recognized that ‘‘the 

parameters of the hearing are determined by the 

prehearing statements.’’ Darrell Risner, D.M.D., 61 

FR 728, 730 (1996). Accordingly, in Risner, the 

Agency held that where the Government has failed 

to disclose ‘‘in its prehearing statements or indicate 

at any time prior to the hearing’’ that an issue will 

be litigated, the issue cannot be the basis for a 

sanction. 61 FR at 730. See also Nicholas A. 

Sychak, d/b/a Medicap Pharmacy, 65 FR 75959, 

75961 (2000) (noting that the function of prehearing statements is to provide Due Process 

through ‘‘adequate * * * disclosure of the issues 

and evidence to be submitted in * * * 

proceedings’’); cf. John Stafford Noell, 59 FR 47359, 

47361 (1994) (holding that notice was adequate 

where allegations were not included in Order to 

Show Cause but ‘‘were set forth in the Government’s 

Prehearing Statement’’). 

21The MQAC also found that Respondent had 

prescribed controlled substances to three State 

residents and yet had ‘‘failed to keep any medical 

records for these patients’’ and thus lacked 

documentation of having taken the patient’s history, 

physical exam, and had no ‘‘documentation of any 

kind to support the patient’s diagnosis and 

treatment.’’ GX 28, at 7. Here again, the MQAC 

found that Respondent had committed 

unprofessional conduct and violated the standard of 

care applicable under Washington law. Id. 

However, the MQAC found that the State had failed 

to prove that Respondent lacked a therapeutic 

purpose in issuing these prescriptions. 

While the ALJ’s opinion erroneously suggests that 

the CSA requires that a physician maintain patient 

records, see ALJ at 26–27, the CSA requires only 

that a doctor maintain records showing the 

disposition of controlled substances which are 

dispensed and administered (but not prescribed) as 

a regular part of his professional practice. See 21 

CFR 1304.04(d). However, a practitioner’s failure to 

maintain records required under State law which 

relate to the prescribing of controlled substances is 

properly considered by the Agency under factors 

two, four, and five of the public interest standard. 

It is undisputed that Respondent 

prescribed for the eDrugstore Web site 

and issued numerous prescriptions for 

phentermine, a schedule IV controlled 

substance, to persons located 

throughout the United States. As the 

MQAC found, Respondent did not take 

a medical history on any of these 

persons and did not perform physical 

examinations of them. As the MQAC 

further found, he did not obtain each 

person’s medical records and did not 

attempt to verify (and had no way to 

verify) the information which these 

persons provided. Yet as the MQAC 

found, he diagnosed each person and 

prescribed to them. As the MQAC 

found, and as Dr. Van Komen testified, 

Respondent failed to comply with the 

standard of care for prescribing 

phentermine.20

It is acknowledged that the MQAC 

found that there was no evidence that 

Respondent ‘‘diverted controlled 

substances * * * for illegitimate 

purpose in violation of any drug law.’’ 

GX 28, at 8. However, the MQAC did 

not explain what legal standard it 

applied in making this finding. While 

the State of Washington can, of course, 

apply any standard it chooses in 

defining diversion for purposes of State 

law, the State has no authority to 

definitively interpret the CSA and 

determine what constitutes diversion 

under Federal law. 

Several Federal courts of appeals have 

held that conduct similar to what the 

MQAC found Respondent to have 

engaged in by prescribing phentermine 

over the Internet violates the 

prescription requirement of Federal law 

and constitutes an unlawful distribution 

under 21 U.S.C. 841(a). See United 

States v. Nelson, 383 F.3d 1227, 1231– 

32 (10th Cir. 2004) (upholding 

physician’s conviction for conspiracy to 

distribute prescription controlled 

substances ‘‘outside the usual course of 

professional practice’’ through internet 

scheme when physician approved 

‘‘prescription drug requests * * * 

without ever examining his purported 

patient’’); see also United States v. 

Smith, 573 F.3d 639, 657–58 (8th Cir. 

2009) (upholding conviction of operator 

of internet drug distribution scheme for 

violations of 21 U.S.C. 841(a)(1) where 

‘‘ ‘[t]here was never an established 

doctor/patient relationship. There was 

never a face-to-face examination. There 

was never a history. There was no 

physical examination.’ ’’ (citation 

omitted)); United States v. Fuchs, 467 

F.3d 889 (5th Cir. 2006) (rejecting 

pharmacist’s challenge to convictions 

for dispensing controlled substance ‘‘not 

in the usual course of professional 

practice in violation of 21 U.S.C. 

841(a);’’ scheme involved customers 

going to pharmacist’s Web site, 

completing an online profile and 

requesting medication, which was then 

forwarded to physician who ‘‘reviewed 

the patient’s profile and approved and 

signed the prescription without 

communicating with the patient either 

face to face or over the telephone’’). 

As these decisions make plain, a 

physician acts outside of the usual 

course of professional practice and lacks 

a legitimate medical purpose when he 

issues a controlled substance 

prescription to a person with whom he 

has not established a legitimate doctorpatient relationship. As the MQAC’s 

finding makes clear—and as Dr. Van 

Komen’s testimony corroborates—by 

failing to take a medical history, review 

medical records and perform physical 

examinations, Respondent did not 

establish a legitimate doctor-patient 

relationship with any of the persons he 

prescribed phentermine to through 

eDrugstore. Tr. 330 & 360–61. 

Respondent’s conduct was not simply 

‘‘malpractice, or even intentional 

malpractice.’’ United States v. Feingold, 

454 F.3d 1001, 1010 (9th Cir. 2006). 

Rather, he ‘‘wantonly ignored the basic 

protocols of the medical profession’’ and 

‘‘his actions completely betrayed any 

semblance of legitimate medical 

treatment.’’ Id. Accordingly, I hold that 

Respondent, in issuing phentermine 

prescriptions for eDrugstore, acted 

outside of the usual course of 

professional practice and lacked a 

legitimate medical purpose and 

therefore violated Federal law. 21 U.S.C. 

841(a)(1); 21 CFR 1306.04(a). And to 

make clear for purposes of Federal law, 

where, as here, a physician violates the 

CSA’s prescription requirement, the 

drug is deemed diverted.21

I further find that the Government has 

proved by a preponderance of the 


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22The act of writing a prescription, by itself, 

constitutes the delivery of a controlled substance 

under Federal law even if the prescription is never 

dispensed by a pharmacy. 

23 In his brief, Respondent argues that the 

Government has not met its evidentiary burden 

because it did not present additional evidence 

establishing his involvement with Heynowmeds 

such as ‘‘proof of payments’’ to him from 

Heynowmeds or ‘‘testimony from an undercover 

officer or from bona fide drug-seeking customers 

about direct contacts with’’ him. Resp. Br. at 34–36. 

Respondent’s position would have some merit if he 

had presented substantial, reliable and probative 

evidence that he was not involved with 

Heynowmeds. He did not. 

I further note that while Respondent promised to 

turn over his bank records, he never did. 

24See also Hageseth v. Superior Court, 59 Cal. 

Rptr. 3d 385 (Ct. App. 2007) (upholding 

prosecution of out-of-State and unlicensed 

physician who prescribed drug to State resident 

over the Internet for the unauthorized practice of 

medicine); United Prescription Services, 72 FR at 

50401 n.10 (discussing actions brought by Medical 

Continued 

evidence that Respondent also wrote the 

prescriptions which were identified as 

having been ordered through the 

Heynowmeds Web site and which were 

filled by the Saran pharmacies. See GXs 

2–5. Relatedly, I reject Respondent’s 

affirmative defense that his name, 

signature and DEA registration number 

were ‘‘stole[n] and misused’’ by Abel 

Rodriguez. 

As found above, Respondent’s name, 

registration number, and signature were 

found on more than 130 controlled 

substance prescriptions which were 

intercepted by the Government in its 

investigation of the Saran conspiracy; 22

these prescriptions were clearly 

distributed as evidenced by the attached 

shipping labels. GX 3. The presence of 

Respondent’s name, registration 

number, and signature on these 

prescriptions creates a rebuttable 

presumption that he authorized them. 

Moreover, during the execution of 

search warrants at both CHS/ISG and 

the home of one of Saran’s coconspirators, Investigators seized a 

document which listed Respondent as 

the prescribing physician for several 

Web sites whose prescriptions were 

filled at Saran’s pharmacies. Finally, in 

an interview with investigators, 

Respondent admitted that he had 

travelled from Washington State to 

Florida to meet Abel Rodriguez and that 

he had written prescriptions for 

Rodriguez (although he denied writing 

controlled substance prescriptions for 

his Web site). 

Respondent did not testify in this 

proceeding. Instead, to support his 

defense, he put forward: (1) The results 

of a polygraph examination; (2) an 

affidavit submitted by Florida law 

enforcement officers in support of an 

arrest warrant for Abel Rodriguez, 

which stated that another physician’s 

signature was used by an associate of 

Rodriguez to authorize prescriptions 

even though the physician was not 

involved in prescribing the drugs; and 

(3) the testimony of a DI who served the 

Show Cause Order and interviewed him 

later the same day during which he 

denied having written prescriptions for 

Heynowmeds. 

Respondent’s evidence is not 

sufficient to rebut the presumption that 

he wrote the prescriptions. With respect 

to the polygraph evidence, even putting 

aside the criticism of the Government’s 

expert regarding the manner in which 

the test was administered, there is no 

consensus among the scientific 

community and the courts that 

polygraph evidence is reliable. See 

United States v. Scheffer, 523 U.S. at 

309. As explained above, this evidence 

does not meet the standard of reliability 

imposed by the APA. 

As for the affidavit’s statement (which 

was based on the statement of one of 

Rodriguez’s associates) that another 

physician’s signature was used without 

his authority, all this establishes is that 

that physician’s signature was misused. 

It does not prove that Respondent’s 

registration was misused in writing the 

prescriptions. 

Finally, Respondent relies on his 

statement to the DIs in which he denied 

that he wrote the controlled substance 

prescriptions identified in the Order to 

Show Cause. Respondent also points to 

the testimony of the DI that she found 

him to be credible. 

However, Respondent’s interview was 

not sworn. Moreover, the DI who did 

the interview was based in Seattle, had 

no previous role in the Saran 

investigation which was run by the Fort 

Worth, Texas office, and thus was not 

familiar with what the investigation had 

uncovered. Accordingly, the DI did not 

have the underlying knowledge of the 

facts of the investigation necessary to 

probe Respondent’s story and to 

evaluate his credibility. 

Beyond this, there is no reason to give 

dispositive weight to this statement 

when Respondent could have testified 

(and subjected himself to crossexamination) at his hearing but chose 

not to. It is well established that the 

Agency can draw an adverse inference 

from a respondent’s failure ‘‘to testify in 

response to probative evidence offered 

against’’ him. See Baxter v. Palmigiano, 

425 U.S. 308, 316 (1976); see also 

United States v. Solano-Godines, 120 

F.3d 957, 962 (9th Cir. 1997) (‘‘In civil 

proceedings * * * the Fifth 

Amendment does not forbid fact finders 

from drawing adverse inferences against 

a party who refuses to testify.’’). It is 

appropriate to draw an adverse 

inference here, where the Government 

produced evidence showing that his 

name, registration number and signature 

were used to authorize controlled 

substance prescriptions and Respondent 

failed to testify.23

I thus find that Respondent 

authorized the intercepted 

prescriptions. And for the same reasons 

that I found that the phentermine 

prescriptions violated Federal law (i.e., 

he did not establish a legitimate doctor/ 

patient relationship with those he 

prescribed for), I conclude that these 

prescriptions were also issued outside 

of the usual course of professional 

practice and lacked a legitimate medical 

purpose and thus violated Federal law. 

See 21 U.S.C. 841(a)(1); 21 CFR 

1306.04(a). 

The prescriptions violated Federal 

law for a further reason. As the Supreme 

Court explained shortly after the CSA’s 

enactment, ‘‘[i]n the case of a 

physician[,] [the Act] contemplates that 

he is authorized by the State to practice 

medicine and to dispense drugs in 

connection with his professional 

practice.’’ United States v. Moore, 423 

U.S. at 140–41. See also 21 U.S.C. 

802(21) (defining ‘‘[t]he term 

‘practitioner’ [to] mean[] a physician 

* * * or other person licensed, 

registered, or otherwise permitted, by 

the United States or the jurisdiction in 

which he practices * * * to dispense 

* * * a controlled substance in the 

course of professional practice.’’). 

Accordingly, DEA has held that ‘‘[a] 

physician who engages in the 

unauthorized practice of medicine 

under state law is not a ‘practitioner 

acting in the usual course of * * * 

professional practice,’ ’’ and that ‘‘[a] 

controlled-substance prescription issued 

by a physician who lacks the license 

necessary to practice medicine within a 

State is therefore unlawful under the 

CSA.’’ United Prescription Services, Inc., 

72 FR at 50407 (quoting 21 CFR 

1306.04(a)). Likewise, the MQAC’s 2002 

Guidelines clearly stated that 

‘‘[p]hysicians who treat or prescribe 

through Internet Web sites are 

practicing medicine and must possess 

appropriate licensure in all jurisdictions 

where patients reside.’’ GX 24, at 6. 

Because Respondent was licensed only 

in Washington State, the prescriptions 

identified in Government Exhibits 2–5 

were unlawful under both Federal law 

and the laws of numerous States for this 

reason as well. See, e.g., Ala. Code § 34– 

24–502 (2005); id. § 34–24–51; Cal. Bus. 

& Prof. Code § 2052 (2005) 24; N.C. Gen. 


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Board of California against out-of State physicians 

for prescribing to State residents). 

25None of the other circumstances identified by 

the ALJ is sufficient to overcome Respondent’s 

failure to acknowledge his misconduct, and only 

one of them—his being monitored by a mentor— 

would tend to establish that he can be entrusted 

with a new registration. 

If Respondent had accepted responsibility, the 

MQAC’s limitation of his practice to an office-based 

setting, which is supervised by another physician 

who must report to the MQAC, would be entitled 

to some weight. However, the gravamen of this case 

involved Respondent’s misconduct in prescribing 

over the Internet and not his prescribing in a 

clinical setting. Thus, it is not clear that 

Respondent’s mentor has either the authority or the 

capability to properly monitor him to ensure that 

he does not engage in internet prescribing. 

Respondent has therefore also failed to carry his 

burden with respect to showing that he can be 

entrusted with a new registration. 

As for the ALJ’s finding that he was ‘‘cooperative,’’ 

this ignores that during his interview with the DIs 

he agreed to provide them with his bank records but 

never did. While the ALJ also noted that 

Respondent was ‘‘truthful,’’ this finding was based 

Stat. § 90–18; Tenn. Code Ann. § 63–6– 

201; Tenn. Comp. R. & Regs. 0880–2.16; 

Tex. Occ. Code Ann. §§ 151.056 & 

155.001. 

As the forgoing demonstrates, 

Respondent issued numerous controlled 

substance prescriptions in violation of 

both Federal and State laws. He also 

lacked the records required under 

Washington law to justify his 

prescribing of controlled substances. 

Accordingly, I conclude that the 

evidence presented by the Government 

on factors two and four satisfies its 

prima facie burden of showing that 

granting Respondent’s application 

‘‘would be inconsistent with the public 

interest.’’ 21 U.S.C. 823(f). 

Sanction 

Under Agency precedent, where, as 

here, ‘‘the Government has proved that 

a registrant has committed acts 

inconsistent with the public interest, a 

registrant must ‘ ‘‘present[] sufficient 

mitigating evidence to assure the 

Administrator that [he] can be entrusted 

with the responsibility carried by such 

a registration.’’ ’ ’’ Medicine ShoppeJonesborough, 73 FR 364, 387 (2008) 

(quoting Samuel S. Jackson, 72 FR 

23848, 23853 (2007) (quoting Leo R. 

Miller, 53 FR 21931, 21932 (1988))). 

‘‘Moreover, because ‘past performance is 

the best predictor of future 

performance,’ ALRA Labs, Inc. v. DEA, 

54 F.3d 450, 452 (7th Cir.1995), [DEA] 

has repeatedly held that where a 

registrant has committed acts 

inconsistent with the public interest, the 

registrant must accept responsibility for 

[his] actions and demonstrate that [he] 

will not engage in future misconduct.’’ 

Medicine Shoppe, 73 FR at 387; see also 

Jackson, 72 FR at 23853; John H. 

Kennedy, 71 FR 35705, 35709 (2006); 

Cuong Tron Tran, 63 FR 64280, 62483 

(1998); Prince George Daniels, 60 FR 

62884, 62887 (1995). See also Hoxie v. 

DEA, 419 F.3d at 483 (‘‘admitting fault’’ 

is ‘‘properly consider[ed]’’ by DEA to be 

an ‘‘important factor[]’’ in the public 

interest determination). 

The ALJ did not acknowledge any of 

these cases in her recommended 

decision. See ALJ at 30–32. Instead, she 

noted that it was ‘‘appropriate to 

consider all of the facts and 

circumstances’’ which, in her view, 

include that he ‘‘was cooperative and 

truthful when working with DEA 

personnel,’’ the Medical Board’s 2007 

finding that ‘‘there was no evidence that 

[he] mishandled controlled substances 

during the MQAC’s’’ June’s 2005 

investigation, and ‘‘most significant[ly],’’ 

that under the MQAC’s 2009 Order, 

Respondent is now being supervised by 

another physician. Id. Apparently, the 

ALJ also deemed it significant that since 

the institution of the proceeding, the 

Agency had not found any evidence of 

Respondent’s mishandling of controlled 

substances. Id. at 31–32. Expressing her 

belief that ‘‘this proceeding has instilled 

in the Respondent a grave respect for 

the authority and responsibilities which 

attach to his DEA registration,’’ the ALJ 

recommended that Respondent ‘‘be 

given an opportunity to demonstrate, 

during his mentorship, his continuing 

ability and willingness to comply with 

the statutory and regulatory provisions 

that adhere to a * * * registration.’’ Id. 

at 32. 

The ALJ’s reasoning is unpersuasive. 

While it is true that the MQAC found no 

diversion in its 2005 investigation, as 

explained above, under Federal law, 

when prescriptions are issued outside of 

the usual course of professional practice 

and lack a legitimate medical purpose, 

21 CFR 1306.04(a), the drugs are 

deemed to have been diverted. Indeed, 

in other decisions involving 

practitioners who prescribed over the 

Internet, DEA has noted the egregious 

nature of this misconduct and the 

serious threat it poses to public health 

and safety. See William R. Lockridge, 71 

FR 77791, 77800 (2006) (noting that 

internet prescriber ‘‘was a drug dealer’’ 

and that conduct created ‘‘imminent 

danger to public health and safety’’); 

Mario Avello, 70 FR 11695, 11697 

(2005); cf. Southwood Pharmaceuticals, 

Inc., 72 FR 36487, 36504 (2007) 

(discussing increase in the rates of 

prescription drug abuse and the 

Internet’s ‘‘role in facilitating the growth 

of prescription drug abuse’’); see also 

National Center on Addiction and 

Substance Abuse, ‘‘You’ve Got Drugs!’’ 

IV: Prescription Drug Pushers on the 

Internet (2007), at 11 (‘‘[T]he wide 

availability of dangerous and addictive 

drugs on the Internet reveals a wideopen channel of distribution. This easy 

availability has enormous implications 

for public health, particularly the health 

of our children, since research has 

documented the tight connection 

between availability of drugs to young 

people and substance abuse and 

addiction.’’) (GX 32). 

Moreover, as explained above, the 

Federal courts have recognized that 

prescribing controlled substances under 

these circumstances (i.e., without taking 

medical history, physically examining 

the patient, and maintaining patient 

records) constitutes drug dealing. See 

Nelson, 383 F.3d at 1231–32 (‘‘A 

practitioner has unlawfully distributed a 

controlled substance if she prescribes 

the substance either outside the usual 

course of medical practice or without a 

legitimate medical purpose.’’); United 

States v. Quinones, 536 F.Supp.2d 267, 

271 (E.D.N.Y. 2008) (rejecting motion to 

dismiss indictment under 21 U.S.C. 841; 

‘‘[t]hat the moving defendants allegedly 

carried out their activities through the 

Internet is of no consequence. Two 

circuit courts have approved the 

application of the Federal drugs laws to 

the operation of Internet pharmacies.’’) 

(citing Nelson, 383 F.3d 1227, and 

Fuchs, 467 F.3d 889). Contrary to the 

ALJ’s understanding, Respondent’s 

internet prescribing does not involve 

minor regulatory violations, but rather 

egregious acts which go to the core of 

the CSA’s statutory purpose of 

preventing diversion and abuse. 

As noted above, the ALJ did not even 

acknowledge the extensive Agency case 

law which holds that where a registrant 

has committed acts which render his 

registration inconsistent with the public 

interest, he must do two things: (1) 

Accept responsibility for his actions, 

and (2) demonstrate that he will not 

engage in future misconduct. 

Accordingly, the ALJ made no finding 

as to whether Respondent has accepted 

responsibility for his misconduct. 

However, the Agency is the ultimate 

fact finder so I do make a finding. Based 

on Respondent’s failure to testify in this 

proceeding, as well as his maintaining 

that he has done nothing wrong, I find 

that he has not accepted responsibility 

for his misconduct. See, e.g., Hoxie, 419 

F.3d at 483 (‘‘admitting fault’’ is 

‘‘properly considered’’ to be an 

‘‘important factor’’). Given the egregious 

nature of his misconduct, Respondent’s 

failure to acknowledge his wrongdoing 

provides reason alone to hold that he 

has not rebutted the Government’s 

prima facie case.25 Accordingly, 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 207 / Wednesday, October 27, 2010 / Notices 66149 

on an opinion of an Investigator who lacked 

adequate information to properly assess his 

credibility. Moreover, the inconsistency between 

Respondent’s claim that in prescribing for 

eDrugstore he only wrote a ‘‘small minority’’ of 

controlled substance prescriptions and the evidence 

regarding the total number of prescriptions, the 

amounts he was paid for the respective types of 

prescriptions, and his compensation, provides 

further reason to question the ALJ’s conclusion. 

The ALJ also found it significant that the Agency 

had not produced any evidence that Respondent 

mishandled controlled substances since the 

institution of the proceeding. However, because 

Respondent failed to file a timely renewal 

application, thus allowing his registration to expire 

(and also had his State license suspended), he 

lacked authority to handle controlled substances for 

a substantial portion of this period. In addition, the 

weight to be given this circumstance is significantly 

diminished by the fact that he was then in the midst 

of a Show Cause Proceeding. 

Finally, the ALJ did not cite any evidence to 

support her belief that ‘‘this proceeding has instilled 

in the Respondent a grave respect for the authority 

and responsibility which attach to his DEA 

registration.’’ ALJ at 32. Given the egregious 

misconduct proved on this record, rather than take 

a leap of faith, I rely on the Agency’s longstanding 

rule which requires that a registrant acknowledge 

his misconduct and the relevant evidence or, as in 

this case, the lack thereof. 

1Therein, Respondent denied the allegations 

maintaining that ‘‘Mr. Fletcher, based on his 

experience, training, and expertise, reasonably 

believed that all prescriptions filled were for a 

legitimate medical purpose’’ and that he ‘‘frequently 

exercised independent judgment to determine if the 

prescriptions were for legitimate medical purposes, 

and often refused to fill prescriptions written by 

licensed medical doctors, including Dr. Volkman.’’ 

ALJ Ex. 2, at 2. 

Respondent’s application will be 

denied. 

Order 

Pursuant to the authority vested in me 

by 21 U.S.C. 824(a), as well as 28 CFR 

0.100(b) & 0.104, I order that the 

pending application of George Mathew, 

M.D., for a DEA Certificate of 

Registration as a practitioner be, and it 

hereby is, denied. This Order is effective 

November 26, 2010. 

Dated: October 17, 2010. 

Michele M. Leonhart, 

Deputy Administrator. 

[FR Doc. 2010–27094 Filed 10–26–10; 8:45 am] 

BILLING CODE 4410–09–P 

DEPARTMENT OF JUSTICE 

Drug Enforcement Administration 

[Docket No. 09–48] 

East Main Street Pharmacy; Affirmance 

of Suspension Order 

On April 23, 2009, the Deputy 

Assistant Administrator, Office of 

Diversion Control, Drug Enforcement 

Administration, issued an Order to 

Show Cause to East Main Street 

Pharmacy (‘‘Respondent’’), of Columbus, 

Ohio. The Show Cause Order proposed 

the revocation of Respondent’s DEA 

Certificate of Registration, BE5902615, 

as a retail pharmacy, as well as the 

denial of any pending applications to 

renew or modify its registration, ‘‘for 

reason that [Respondent’s] continued 

registration is inconsistent with the 

public interest, as that term is used in 

21 U.S.C. 823(f) and 824(a)(4).’’ ALJ Ex. 

1, at 1. More specifically, the Order 

alleged that Respondent had violated its 

corresponding responsibility under 

Federal regulations to not fill unlawful 

prescriptions. Id. at 2 (citing 21 CFR 

1306.04(a)). 

The Show Cause Order alleged that 

Respondent was owned by Eugene H. 

Fletcher, Respondent’s sole pharmacist, 

and that from ‘‘September 2005 through 

February 2006’’ it ‘‘filled 6,619 

controlled substance prescriptions’’ 

including 4,979 prescriptions issued by 

Dr. Paul Volkman of Portsmouth, Ohio. 

Id. at 1. The Show Cause Order further 

alleged that on February 10, 2006, DEA 

had immediately suspended Volkman’s 

registration and that the Agency 

subsequently found that he had 

‘‘‘repeatedly violated Federal law by 

prescribing controlled substances 

without a legitimate medical purpose 

and outside the course of professional 

practice.’’’ Id. (citing Paul H. Volkman, 

73 FR 30630, 30642 (2008)). The Order 

also alleged that ‘‘Dr. Volkman directed 

his patients to have their prescriptions 

filled at’’ Respondent, who ‘‘filled them 

mostly in exchange for cash,’’ and that 

‘‘[n]inety-eight percent of Dr. Volkman’s 

patients that filled their prescriptions at 

[Respondent] did not reside in the 

Columbus area.’’ Id. Relatedly, the Order 

alleged that some of Volkman’s patients 

travelled from Portsmouth and 

Chillicothe, Ohio to Respondent, a 

distance of 92 and 45 miles, 

respectively; that one of Volkman’s 

patients had travelled from South 

Central Kentucky to Respondent to 

obtain his prescriptions, that many of 

Volkman’s patients were obtaining 

prescriptions from other physicians, and 

that several of these persons died of 

overdoses. Id. at 2. 

The Show Cause Order further alleged 

that Respondent ‘‘filled prescriptions for 

combinations of controlled substances 

and the non-controlled, but highly 

addictive drug carisoprodal [sic] (Soma), 

under circumstances indicating that the 

prescriptions were issued outside the 

usual course of professional practice.’’ 

Id. at 2. More specifically, the Order 

alleged that Respondent filled for 

numerous patients of Volkman, ‘‘large 

quantity prescriptions’’ for a 

benzodiazepine, two narcotic pain 

medications, and Soma, and that 

‘‘[t]hese drug combinations are generally 

known in the medical and pharmacy 

profession as being favored by drugseeking individuals.’’ Id. The Order also 

alleged that Respondent ‘‘filled several 

of the above combination prescriptions 

when the patients should have had two 

to three weeks’ supply of medication 

from a previous prescription’’ and it 

either ‘‘did not recognize, or ignored 

these indicators of drug diversion and 

abuse.’’ Id. 

Finally, the Order alleged that, with 

regard to Dr. Volkman’s prescriptions, 

Mr. Fletcher had told a DEA Investigator 

‘‘that it was ‘not [his] job to question a 

physician.’ ’’ Id. Based on the above, the 

Order alleged that Respondent ‘‘knew, or 

should have known that [the] controlled 

substance prescriptions it filled for 

patients of Dr. Volkman were for no 

legitimate medical purpose.’’ Id. 

By letter of May 20, 2009, counsel for 

Respondent timely requested a hearing.1

ALJ Ex. 2, at 1. The matter was then 

placed on the docket of the Agency’s 

Administrative Law Judges (ALJs), and 

an ALJ proceeded to conduct prehearing procedures. 

On May 26, 2009, the ALJ issued an 

Order for Pre-Hearing Statements. ALJ 

Ex. 14. The ALJ’s order directed the 

parties to prepare a written statement, to 

be filed with the Hearing Clerk and 

served on opposing counsel, disclosing 

the ‘‘names and addresses of all 

witnesses whose testimony is to be 

presented.’’ Id. at 2. The ALJ further 

ordered the parties to provide a: 

[b]rief summary of the testimony of each 

witness, with the Government to indicate 

clearly each and every act, omission or 

occurrence upon which it relies in seeking to 

revoke Respondent’s DEA Certificate of 

Registration, and the Respondent to indicate 

clearly each and every matter as to which it 

intends to introduce evidence in opposition 

thereto. The summaries are to state what the 

testimony will be, rather than merely listing 

the areas to be covered. The parties are 

reminded that testimony not disclosed in the 

prehearing statements or pursuant to 

subsequent filing is likely to be excluded at 

the hearing. 

Id. 

On July 31, 2009, the ALJ conducted 

a pre-hearing conference call with the 

parties and also issued a Prehearing 

Ruling. See ALJ Ex. 3. In her Prehearing 

Ruling, the ALJ ordered that ‘‘[i]f either 

party chooses to amend its witness list, 

it must file a supplement to its 

Prehearing Statement, noting any 

changes. The names of additional 

witnesses must be listed, along with a 

summary of the proposed testimony.’’ 

Id. at 2. The ALJ further ‘‘reminded’’ the 

parties ‘‘that testimony not summarized 

in prehearing statements or 


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