Case 1:06-cr-00337-CC-JFK Document 172 Filed 05/04/2007 Page 1 of 8

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF GEORGIA
ATLANTA DIVISION

UNITED STATES OF AMERICA : CRIMINAL INDICTMENT

:
V. : NO. 1:06-CR-337
:
CHRISTOPHER STOUFFLET :
TROY SOBERT :
VLADIMIR ANDRIES, M.D. :
THU ANH HOANG, M.D. :
STEVEN DANIEL HOLLIS, M.D. :
AHSAN U. RASHID, M.D., and :
ANDRE D. SMITH, M.D. :

DEFENDANT STOUFFLET’S OBJECTIONS TO REPORT AND

RECOMMENDATIONS OF THE MAGISTRATE RECOMMENDING DENIAL
OF MR. STOUFFLET’S MOTIONS TO DISMISS INDICTMENT

Comes now the defendant Chris Stoufflet, by and through undersigned counsel,

and pursuant to 28 U.S.C. §636 (b) (1), who hereby objects to the Magistrate’s Report

and Recommendation denying the motions to dismiss the above referenced indictment.

Mr. Stoufflet moved for dismissal on a number of different grounds challenging

the propriety of the indictment in this case. The Magistrate recommended that the motion

to dismiss be denied on all grounds asserted by Mr. Stoufflet. We object to the

Magistrate’s recommendation, and respectfully assert that the Magistrate’s

recommendation is based on a basic misreading of Mr. Stoufflet’s arguments. We state

our reasons for this assertion below.

As stated in the original motion, the gravamen of the indictment is that

defendants, including the five doctors charged, operating an on-line pharmacy, and

dispensing prescriptions based on information in an on-line questionnaire. Crucial to the

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indictment is the allegation that the doctors did not meet with the patient’s face to face

before dispensing the prescriptions.

Contrary to the government’s response, Mr. Stoufflet and his co-defendants argue

that the indictment is based on violations not only of the CSA but just important, on 21

CFR 21 §1306.04, a regulation written by the Attorney General that requires that

“prescriptions be issued for a legitimate purpose by an individual practitioner in the usual

course of his professional practice.”

Additionally, central to Mr. Stoufflet’s argument as to the propriety of the

indictment, is that the government pled Composite Georgia State Board of Medical

Examiners rules governing medicine practiced by electronic means. The reason that the

inclusion of these State regulations of professional conduct in the indictment is of such

significance, is that by their inclusion, the Federal government has taken this matter out

of the context of a simple violation of the Controlled Substances Act, and has stepped

into the arena of enforcing State regulations.1 The government alleged in its response to

Mr. Stoufflet’s motions that these regulations were included merely as an illustrative tool.

We submit that this is a vain attempt to avoid the legal problems created by including the

Georgia Law in the pleadings. The only reasonable interpretation is that these regulations

will be read to a jury, and will be incorporated as part of the charges in the case. We re-

assert that the indictment is vulnerable because of its inclusion of both the CFR and the

Georgia regulations.

1
In fact, defendant Sorbet moved to strike these state regulations as surplusage. Their removal from the
indictment might have alleviated defendants’ concerns that they were being criminally prosecuted for state
regulations governing professional conduct. However, the Magistrate recommended the denial of this
motion, and the constitutionally troublesome issue of federal enforcement of state professional norms
remains.
Case 1:06-cr-00337-CC-JFK Document 172 Filed 05/04/2007 Page 3 of 8

I. The report and recommendation misinterprets Mr. Stoufflet’s motion to assert that
Gonzalez v. Oregon should over-rule precedent in the area of CSA prosecution of
Doctors.

The main thrust of Mr. Stoufflet’s motions to dismiss is that Gonzalez v. Oregon,

126 S.Ct. 904 (2006). places the authority of the Attorney General to operate in the area

of state regulation of physician’s conduct in a different light than it had been seen before.

Gonzalez v. Oregon also alters the interpretation of 21 CFR § 1306.04, and future

prosecutions employing that regulation are now suspect.

However Mr. Stoufflet never asserts that physicians cannot be prosecuted under

the CSA, after Gonzalez v. Oregon, nor does he assert that Gonzalez v. Oregon over-rules

all precedent in the area. To the contrary, United States v. Moore, 423 U.S. 122 (1975),

the seminal Supreme Court decision in the area of CSA prosecutions of doctors is cited

with approval in Gonzalez v. Oregon to illustrate the point that it is an uncontroversial

application of the CSA to prosecute a doctor that acted at a “pusher’ of methadone, and

admitted that he did not observe generally accepted medical practices.id.126. Mr.

Stoufflet also cites Moore as an example where application of 21 CFR 3106.04 is not

vague. (Stoufflet brief p.19). Thus the Magistrate interprets that Mr. Stoufflet is asking

for more relief than he in fact is requesting. Mr. Stoufflet’s argument does not rise or fall

on the myriad precedent cited by the government and the Magistrate.

II. The Magistrate erred in finding that Mr. Stoufflet’s motions were motions for

summary judgment.

Mr. Stoufflet’s motions rest on the four corners of the indictment and the

infirmities contained therein. Mr. Stoufflet is not asking for a pre-trial ruling on whether
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the facts of the case are sufficient.2 Mr. Stoufflet’s principal claim is that the recent

Supreme Court decision of Gonzalez v. Oregon calls into question the indictment as it

stands, because of its pronouncements on 21 CFR §1306.04 and the Attorney General’s

authority to act in the area of the state province of medical practice.

III. The Magistrate erred in its interpretation of Gonzalez v. Oregon and its

application to the instant indictment.

After citing to a number of CSA prosecutions of doctors, pharmacists and non-

registrants3, the Magistrate turns to its interpretation of Gonzalez v. Oregon, terming it

“inapposite to this case”. While the facts in Gonzalez v. Oregon are not “on point”, the

decision stands for three propositions that put the instant indictment in jeopardy.

1. 21 CFR §1306.04 is ambiguous. Its use of the term ‘legitimate medical

purpose is a generality, susceptible to more precise definition and open to

varying constructions, and thus ambiguous in the relevant sense. Id at 915.

2. 21 CFR §1306 gives little or no instruction on who decides whether a

particular activity is in “the course of professional practice, or done for a

legitimate medical purpose. Id.

3. The Attorney General has no authority to define medical standards for care or

treatment of patients. These decisions are strictly in the State arena.

2
Part of the confusion is that Mr. Stoufflet entered into the record the findings of FDA Agent Paul
Southern to make his void for vagueness as applied clam. These facts can be ignored, and we submit that
the indictment is void for vagueness as applied to the facts alleged in the indictment.
3
Decisions that all but 2 pre-date Gonzalez v. Oregon. Both of these decisions are district Court decisions
that have no binding authority on this Court. See United States v. Prejean, 429 F. Supp. 2d 782
(E.D.La.2006); United States v. Edwin, 2006 WL 763653 (N.D.Ill.)(Edwin implies that Gonzalez might
have struck down the “legitimate medical purpose” element of regulation 21 CFR §1306.04. Id.
Case 1:06-cr-00337-CC-JFK Document 172 Filed 05/04/2007 Page 5 of 8

Gonzalez v. Oregon must be reckoned with whenever the government chooses to

prosecute under 21 CFR §3106.04. We argue here and did previously, as have some of

our co-defendants, that 21 CFR §1306.04 is simply too ambiguous to give a doctor

guidance on the activity charged here. Second, the attempt of the government to define

proper medical practice in the context of the conduct alleged here is beyond the scope of

their legislative mandate. And last, reliance on state regulations quoted in the indictment

is an improper action on the part of the government to enter into the State arena of

defining proper medical practice.

IV. The Magistrate erred in recommending that the motion for void for vagueness as

applied to the facts of this case be denied.

The vagueness challenge is related to the Gonzalez v. Oregon challenge. The

Magistrate cited to a number of cases prosecuted where the CSA and 21 CFR §1306.04

withstood vagueness challenges. All of these decisions pre-date the Gonzalez v. Oregon

decision and its pronouncement that 21 CFR §1306.04 is ambiguous as it relates to

medical practice. Vagueness challenges of the type discussed here are in an as applied

context. The conduct in the indictment is prosecuted under a regulation that the Supreme

Court has declared to be ambiguous. One not need to consult a thesaurus to determine

that ambiguous is a synonym for vague. 21 CFR §1306.04 simply provides no concrete

guidance to the doctors or the non-registrants in this case as to whether prescriptions

based on on-line questionnaires is criminal conduct.

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Thus, we respectfully submit that the Magistrate erred in recommending denial of

Mr. Stoufflet’s motion to dismiss the indictment because it is void for vagueness as

applied to the facts of this case.

V. The magistrate erred recommending denial of the remainder of the motions

submitted Mr. Stoufflet.

Three motions submitted by Stoufflet were not specifically addressed by the

Magistrate. We specifically reserve our objections to the Magistrate’s recommendations.

1. The Magistrate did not specifically rule on Mr. Stoufflet’s motion to dismiss because

the CSA was not meant to be used to create federal felonies out of state regulatory

violations.

This motion was impliedly rejected by the magistrate. We re-urge it here because the

government is attempting to create federal felonies from Georgia State regulations, an

action not authorized by congress.

2. The magistrate did not specifically rule on whether Congress intended to impose

criminal sanctions on the basis of standardless Federal Regulations.

The magistrate impliedly recommended that this motion be denied. We preserve our

objection to the Magistrate’s recommendation.

3. The Magistrate erred in denying Mr. Stoufflet’s motion based on the Non delegation

doctrine.

Mr. Stoufflet moved to dismiss the indictment because it is an attempt by the

Attorney General to create substantive drug laws in violation of the Non-delegation

doctrine. Though this was no specifically ruled on by the Magistrate, the thrust of the
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recommendations were to deny this motion as well. We specifically preserve our

objection to this recommendation.

Respectfully submitted,

GARLAND, SAMUEL & LOEB, P.C.

DONALD F. SAMUEL
Ga. State Bar #624475
3151 Maple Drive, NE
Atlanta, Georgia 30305
Phone 404-262-2225
Fax 404-365-5041
dfs@gsllaw.com
Case 1:06-cr-00337-CC-JFK Document 172 Filed 05/04/2007 Page 8 of 8

IN THE UNITED STATES DISTRICT COURT

FOR THE NORTHERN DISTRICT OF GEORGIA
ATLANTA DIVISION

UNITED STATES OF AMERICA : CRIMINAL INDICTMENT

:
V. : NO. 1:06-CR-337
:
CHRISTOPHER STOUFFLET :
TROY SOBERT :
VLADIMIR ANDRIES, M.D. :
THU ANH HOANG, M.D. :
STEVEN DANIEL HOLLIS, M.D. :
AHSAN U. RASHID, M.D., and :
ANDRE D. SMITH, M.D. :

CERTIFICATE OF SERVICE

I hereby certify that I have this date served the within and foregoing

OBJECTIONS TO REPORT AND RECOMMENDATIONS OF THE

MAGISTRATE RECOMMENDING DENIAL OF MR. STOUFFLET’S MOTIONS

TO DISMISS INDICTMENT with the Clerk of Court using the CM/ECF

system which will automatically send email notification of such filing to the

attorneys of record.

This the 4th day of May, 2007.

GARLAND, SAMUEL & LOEB, P.C.

DONALD F. SAMUEL
Ga. State Bar #624475
3151 Maple Drive, NE
Atlanta, Georgia 30305
404-262-2225
dfs@gsllaw.com