Case Document 38

Filed 08/05/20 Page 1 of 6

 

 

Presented to the Court by the foreman of the
Grand Jury in Open Conn, in the presence
of the Grand Jury and FILED in the US.
DISTRICT COURT at Seattle, Washington
August 5, 2020

WILLIA . L, Clerk
By Deputy

 

 

UNITED STATES DISTRICT COURT FOR THE
WESTERN DISTRICT OF WASHINGTON
AT TACOMA

UNITED STATES OF AMERICA,
Plaintiff

V.

RICHARD MARSCHALL,
Defendant.

 

 

The Grand Jury charges that:
A. INTRODUCTION

At all times relevant to this Indictment:

N0. Clue-5270 RIB

INDICTMENT

l. The Food, Drug and Cosmetic Act (hereafter provided the

regulatory scheme governing the manufacture and distribution of foods, drugs, medical

devices, biologicals, and cosmetics in the United States. In addition to creating

requirements for these products, the FDCA also prohibited certain acts pertaining to

these products.

2. Under the FDCA, ?interstate commerce? meant commerce between any

State or Territory and any place outside thereof, and commerce within the District of

Columbia or within any other Territory not organized with a legislative body. 21

U.S.C. 321(b).

lndictmenlf Richard Marschall- 1

UNITED STATES ATTORNEY
IZOI PACIFIC AVENUE, SUITE 700
TACOMA. WASHINGTON 93402
{253} 428-3800

 






 

 

Case Document 38 Filed 08/05/20 Page 2 of 6

3. Under the FDCA, ?label? meant a display of written, printed, or graphic
matter upon the immediate container of any article. 21 U.S.C. 321(k). The term
?labeling" was de?ned as all labels and other printed or graphic matter upon any article
or any of its containers or wrappers, or accompanying such article. 21 U.S.C.
321(m). Among other things, internet websites from which an article could be
obtained or which were associated with the manufacturers or distributors of the article
coold be labeling for that article.

4. Under the FDCA, ?drugs? were defined as, among other things, any
articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of
disease in man or other animals, and articles (other than food) intended to affect the
structure or function ofthe body ofman. 21 U.S.C. 321(g)(l)(B) and (C).

5. The ?intended use? of an article meant the objective intent of the persons
legally responsible for its labeling. The intent was determined by such persons?
expressions, or could be shown by the circumstances surrounding the distribution of the
article. It could, for example, be shown by labeling claims, advertising matter, or oral
or written statements by such persons or their representatives; or by the circumstances
in which the article was, with the knowledge of such persons or their representatives,
offered and used for a purpose for which it was neither labeled nor advertised. The
intended uses of an article could change after it was introduced into interstate
commerce by its manufacturer. If, for example, a packer, distributor, or seller intended
an article for different uses than those intended by the person from whom she received
the article, such packer, distributor, or seller was required to supply adequate labeling in
accordance with the new intended uses. 21 C.F.R 201.128.

6. Under the DCA, a ?prescription drug? was, among other things, a drug
which, because of its toxicity and other potential for harmful effects, or the method of
its use, or the collateral measures necessary to its use, was not considered safe for use
except under the supervision of a practitioner licensed by State law to administer such
drugs. 21 U.S.C. 

lndictmentf Richard Marschall- 2 UNITED STATES ATTORNEY
I201 PACIFIF AVENUE. ran

WASHINGTON 93402
{253) 423-3800






 

 

Case Document 38 Filed 08/05/20 Page 3 of 6

7. A prescription drug could only be lawfully dispensed to a patient or
consumer upon the valid prescription of a practitioner licensed by State law to dispense
prescription drugs. The act of dispensing a prescription drug without a valid
prescription was deemed an act which resulted in the drug being misbranded while held
for sale. 21 U.S.C. 353(b)(l).

8. Under the FDCA, every person, upon ?rst engaging in the manufacture,
preparation, propagation, compounding, or processing of drugs in any establishment
they owned or operated was required to immediately register their name, places of
business, and all such establishments. 21 U.S.C. 360(c). The terms ?manufacture,
preparation, propagation, compounding, or processing? included repackaging or
otherwise changing the container, wrapper, or labeling of any drug in ?rrtherance of the
distribution of the drug from the original place of manufacture to the person who made
the ?nal sale to the ultimate consumer or user. 21 U.S.C. 360(a)(l).

9. A drug was misbranded if it was manufactured, prepared, propagated,
compounded, or processed in an establishment not duly registered with FDA, or if it
was not included in a list of drugs manufactured by a facility registered with FDA. 21
U.S.C. 352(0).

10. A drug was misbranded if, among other things, its labeling was false or
misleading in any particular. 21 U.S.C. 352(a).

1 1. A drug was also misbranded if the labeling on the drug did not bear
adequate directions for use. 21 U.S.C. 352(t)(1). ?Adequate directions for use? were
de?ned as directions under which a layperson could use a drug safely for the purposes
for which it was intended without a doctor?s supervision. Directions under which a
layperson could use a drug safely could not be written for a prescription drug because
such drugs could, by de?nition, only be used safely at the direction, and under the
supervision, of a licensed practitioner. Prescription drugs dispensed pursuant to a valid
prescription were exempt from the requirement for adequate directions for use by a
layperson. But prescription drugs dispensed without a valid prescription were

lndictmentf Richard Marschall- 3 UNITED STATES ATTORNEY
120] PACIFIC AVENUE, SUITE 700

TACOMA. WASHINGTON 98402
(253)423-3300






 

 

Case Document 38 Filed 08/05/20 Page 4 of 6

necessarily misbranded for lacking adequate directions for use. 21 U.S.C. 353(b); 21
CPR. 201.5.

12. Under the FDCA, the introduction, delivery for introduction, or causing
the introduction or delivery for introduction into interstate commerce of a misbranded
drug was prohibited. 21 U.S.C. 331(a).

B. RICHARD LICENSES AND PRIOR CONVICTIONS

13. Defendant RICHARD MARSCHALL was licensed as a naturopathic
physician by the Washington Department of Health on August 26, I986.

14. On September 26, 201 l, RICHARD MARSCHALL was convicted in the
Western District of Washington of introducing a misbranded drug into interstate
commerce with the intent to defraud and mislead, in violation of 21 U.S.C.
331(a) and 333(a)(2).

15. On November 20, 2013, RICHARD naturopathic
physician?s license was suspended inde?nitely by the State of Washington Department
of Health due, in part, to the above-described felony conviction.

16. On October 20, 2017, RICHARD MARSCHALL was convicted in the
Western District of Washington of introducing a misbranded drug into interstate
commerce after a previous conviction under 21 U.S.C. 331 had become ?nal, in
violation of21 U.S.C. 331(a) and 333(a)(2).

17. On October 9, 2018, RICHARD credential to practice
as a naturOpathic physician in the state of Washington was permanently revoked, with
no right to reapply, by the Washington Secretary of Health, based on a ?nding that he
?cannot be rehabilitated, nor can he regain the ability to practice with reasonable skill
and safety" and ?nding as aggravating factors the ?Gravity of the unprofessional
conduct. . . . Failure to comply with multiple Agreed Orders, and state and federal court
orders. . . . [and the] Number or frequency of the acts of unprofessional conduct.?

18. Both the September 201 and October 2017 convictions of RICHARD
MARSCHALL for his violations of21 U.S.C. 331 and 333 have become final.

Indictment! Richard Marschall- 4 UNITED STATES ATTORNEY
1201 PACIFIC SUITE 700

TACOMA. WASHINGTON 98402
[25314284800






 

 

Case Document 38 Filed 08/05/20 Page 5 of 6

COUNT 1
(Introduction of Misbranded Drugs into Interstate Commerce)
19. Paragraphs 1-18 of this Indictment are incorporated by reference as if set

forth fully herein.

20. On or about March 31, 2020, in Port Angeles, in the Western District of
Washington, and elsewhere, RICHARD MARSCHALL, after a 'conviction of him
under 21 U.S.C. 331 and 333 had become ?nal, introduced, delivered for
introduction into interstate commerce, and caused to be introduced and delivered for
introduction into interstate commerce, from Port Angeles, Washington, to Oakland,
California, via the US Postal Service, drugs, to wit: ?The Dynamic Duo? products
Allimaxig' Pro (Allimed) and Arabinogalactans, which were misbranded in the
following ways:

a) the labeling was false and misleading in some particular, in
violation of 21 U.S.C. 352(a), in that it suggested that RICHARD MARSCHALL was
a naturopathic doctor by listing him as ?Rick Marschall 

b) the drugs were prescription drugs pursuant to 21 U.S.C.
353(b)(1), because the drugs? method of use, and the collateral means necessary for
their use, rendered them not safe for use except under the supervision of a licensed
practitioner, and the drugs were dispensed without a prescription, in violation of 21
U.S.C. 353(b)(l);

c) the labeling failed to bear adequate directions for use as required
by 21 U.S.C. 352(f)(l), because the drugs were prescription drugs pursuant to 21
U.S.C. 353(b)( because the drugs? method of use, and the collateral means
necessary for their use, rendered them not safe for use except under the supervision of a
licensed practitioner; and

d) the drugs were manufactured, prepared, propagated, compounded
and processed in establishments not registered with the Food and Drug Administration,

and the drugs were not included in any list of drugs manufactured, prepared,

lndictmentr? Richard Marschall- 5 UNITED STATES ATTORNEY
PACIFIC Avenue, SUITE 700

TACOMA. WASHINGTON 98402
(253} 428-3300




Mun?1Case Document 38 Filed 08/05/20 Page 6 of 6



BRI T. MORAN


l?si?Unit States Attorney


ANDREW C. FRIEDMAN
Assistant United States Attorney



BRIAN D. WERNER
Assistant United States Attorney

 

 

Indictment! Richard Marschall- 6

propagated, compounded. and processed in a registered establishment, as required by
21 U.S.C 352(0), 360(b), 360(c), and 3600).
All in violation of Title 21, United States Code, Sections 331(a) and 333(a)(2).

A TRUE BILL:

8/5/6930

(Signature of ore-person redacted
Pursuant to the policy ofthe Judicial
Conference ofthe United States)

 

 

FOREPERSON

UNITED STATES ATTORNEY
120] PACIFIC AVENUE, Sums 700
TACOMA. WASHINGTON 98402
(253} 423-3800