IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF IOWA
CENTRAL DIVISION
UNITED STATES OF AMERICA, ) No.
)
Plaintiff, ) INDICTMENT
)
v. ) 18 U.S.C. § 371
) 21 U.S.C. § 331(c)
) 21 U.S.C. § 333(b)
XXXX X. XXXXXXXX, ) [since July 22, 1988,
) has been recodified as
Defendant. ) 21 U.S.C. 333(a)(2)]
__________________________________)
THE GRAND JURY CHARGES:
COUNT 1 (Conspiracy)
Introductory Allegations
1. At all times relevant to this Indictment, the United
States Food
and Drug Administration (hereafter referred to as "FDA") was the
agency
of the United States charged with the responsibility of protecting
the
health and safety of the American public by ensuring, among other
things, that drug products which were offered for use in animals
(hereafter referred to as "animal drugs" or "animal drug products")
were
safe and effective for their intended uses and did not leave
harmful
residues in the meat, milk, or eggs of the animals treated with
those
drugs.
2. Animal drug products which do not possess the proper
strength,
quality, purity, or other essential characteristics may not be safe
and
effective in one or more of the following ways:
(1) the drug product may not effectively treat the disease
condition for
which it is used and thus harm the animal;
(2) the drug product may leave harmful residues in an animal's
meat,
milk, or eggs that are ultimately consumed by humans; and
(3) the drug product may be harmful to the treated animal or to
humans
who come in contact with the drug while it is being administered.
3. As used in this Indictment, "animal drugs" and "animal drug
products" are drugs within the meaning of Title 21, United States
Code,
Section 321(g)(1).
4. At all times relevant to this Indictment, the Federal Food,
Drug, and Cosmetic Act required that, prior to marketing, the
sponsor of
a new animal drug product establish that the drug product was safe
and
effective under specified conditions of production, formulation,
labeling, and use. This was accomplished through the submission to
FDA
of comprehensive and well-controlled studies in support of a new
animal
application ("NADA"), which application then had to be approved by
FDA
before the new animal drug could be legally sold.
5. Defendant XXXX X. XXXXXXXX was, at all times relevant to
this
Indictment, a principal in the Everfriendly Veterinary Clinic
located at
222 E. 33rd Street, Lincoln, Iowa. [NOTE: names and places changed
from
original.]
The Conspiracy
8. From in or about December 1987 until in or about September
1988,
the exact dates being unknown to the Grand Jury, within the
Northern
District of Iowa and elsewhere, defendant XXXX X. XXXXXXXX did
unlawfully, knowingly and willfully combine, conspire, confederate,
and
agree with persons known and unknown to the Grand Jury, to commit
offenses against the United States; that is, to violate the Federal
Food, Drug, and Cosmetic Act, Title 21, United States Code,
Sections 331
and 333.
9. It was a part of the purpose and object of this conspiracy
that
the defendant and his coconspirators, with the intent to defraud
and
mislead, agreed to and did -- contrary to Title 21, United States
Code,
Section 331(a), (c) & (k) -- receive, manufacture, package, hold
for
sale, distribute, and introduce and cause to be introduced into
interstate commerce animal drug products that were adulterated
within
the meaning of Title 21, United States Code, Section 351(a)(2)(B)
and
(a)(5) in that they were new animal drugs which were unsafe within
the
meaning of Title 21, United States Code, Section 360b, because they
lacked approval from FDA.
10. It was a further part of the purpose and object of the
conspiracy that the defendant and his coconspirators, with the
intent to
defraud and mislead, agreed to and did -- contrary to Title 21,
United
States Code, Section 331(a), (c) & (k) -- receive, manufacture,
package,
hold for sale, distribute, and introduce and cause to be introduced
into
interstate commerce animal drug products that were misbranded
within the
meaning of Title 21, United States Code, Section 352(a), (b)(1),
and
(f)(1), in that their labeling:
(a) was false and misleading;
(b) lacked the name and place of business of the
manufacturer,
packer or distributor; and,
(c) lacked adequate directions for use.
11. In furtherance of the conspiracy and to effect the objects
and
purposes thereof, the defendant and his coconspirators committed
the
following overt acts, among others, within the Northern District of
Iowa, and elsewhere:
(1) On or about December 31, 1987, defendant XXXX
X. XXXXXXXX
issued
a check to XYZ Veterinary Clinic of Algona, Iowa,
as payment for
animal
drugs.
(2)On or about June 21, 1988, defendant XXXX X.
XXXXXXXX caused
a
package containing animal drugs to be shipped to
Everfriendly
Veterinary
Clinic.
(3) On or about July 5, 1988, defendant XXXX X.
XXXXXXXX caused
a
package containing animal drugs to be shipped to
Everfriendly
Veterinary
Clinic.
(4) On or about August 12, 1988, defendant XXXX X.
XXXXXXXX
prepared
a billing statement reflecting that he had treated
a client's
animals
with "Spec" when in fact he had used the drug
chloramphenicol
to treat
those animals.
All in violation of Title 18, United States Code, Section 371.
COUNT 2 (Misbranded Drug)
1. Paragraphs 1 through 5 of Count 1 are hereby realleged and
incorporated by reference as if set forth in full herein.
2. On or about December 7, 1987, within the Northern District
of Iowa
and elsewhere, defendant XXXX X. XXXXXXXX did, with the intent to
defraud and mislead, receive in interstate commerce and proffer the
delivery for pay of a quantity of the animal drug chloramphenicol
which
drug was misbranded, within the meaning of Title 21, United States
Code,
Section 352(a) and (f)(l), in that the labeling was false and
misleading
because, among other reasons, it did not indicate that the drug was
chloramphenicol, and in that the labeling did not bear adequate
directions for use because, among other reasons, it failed to state
that
chloramphenicol should not be administered to food-producing
animals.
All in violation of Title 21, United States Code, Sections
331(c) and
333(b).
COUNT 3 (Misbranded Drug)
1. Paragraphs 1 through 5 of Count 1 are hereby realleged and
incorporated by reference as if set forth in full herein.
2. On or about June 21, 1988, within the Northern District of
Iowa and
elsewhere, defendant XXXX X. XXXXXXXX did, with the intent to
defraud
and mislead, receive in interstate commerce and proffer the
delivery for
pay of a quantity of the animal drug chloramphenicol which drug was
misbranded, within the meaning of Title 21, United States Code,
Section
352(a) and (f)(l), in that the labeling was false and misleading
because, among other reasons, it did not indicate that the drug was
chloramphenicol, and in that the labeling did not bear adequate
directions for use because, among other reasons, it failed to state
that
chloramphenicol should not be administered to food-producing
animals.
All in violation of Title 21, United States Code, Sections
331(c) and
333(b).
COUNT 4 (Misbranded Drug)
1. Paragraphs 1 through 5 of Count 1 are hereby realleged and
incorporated by reference as if set forth in full herein.
2. On or about August 12, 1988, within the Northern District of
Iowa and
elsewhere, defendant XXXX X. XXXXXXXX did, with the intent to
defraud
and mislead, receive in interstate commerce and proffer the
delivery for
pay of a quantity of the animal drug chloramphenicol which drug was
misbranded, within the meaning of Title 21, United States Code,
Section
352(a) and (f)(l), in that the labeling was false and misleading
because, among other reasons, it did not indicate that the drug was
chloramphenicol, and in that the labeling did not bear adequate
directions for use because, among other reasons, it failed to state
that
chloramphenicol should not be administered to food-producing
animals.
All in violation of Title 21, United States Code, Sections
331(c) and
333(a)(2).
A TRUE BILL
Foreperson
CHARLES W. LARSON
United States Attorney
HENRY I. LaHAIE
Attorney
United States Department of Justice
[cited in USAM 4-8.255]
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