IN THE UNITED STATES DISTRICT
COURT
FOR THE WESTERN DISTRICT OF TENNESSEE
WESTERN DIVISION
- UNITED STATES OF AMERICA,
- PLAINTIFF,
-
- VS.
-
- GEORGE KINDNESS,
- AND
- AMSCOT MEDICAL LABS, INC.
- (A CORPORATION)
-
- DEFENDANTS.
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- CR. NO 03-20433BV
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- 18 U.S.C., § 2
- 18 U.S.C., § 371
- 21 U.S.C., § 331 (a)
- 21 U.S.C., § 333(a)(2)
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INDICTMENT
THE GRAND JURY CHARGES
COUNT 1:
INTRODUCTION
The Food. Drug. and Cosmetic Act
1. The United States Food and Drug Administration (hereinafter
"FDA") is the federal agency within the United States
Department of Health and Human Services (hereinafter "DHHS")
charged with the responsibility for protecting the health and
safety of the American public by ensuring that drugs are safe
and effective for their intended uses before they may be legally
marketed in interstate commerce. In order to legally market a
drug in interstate commerce, the drug's manufacturer must comply
with all applicable provisions of the Federal Food, Drug, and
Cosmetic Act (hereinafter lithe Act"), 21 U.S.C. §
321, et seq., and its implementing regulations.
2. The Act prohibits causing the introduction or delivery
for introduction into interstate commerce of misbranded drugs
and introducing or delivering for introduction into interstate
commerce misbranded drugs. 21 U.S.C. § 331 (a).
3. The Act defines drugs to include articles intended for
use in the cure, mitigation, treatment, or prevention of disease
in man or other animals or intended to affect the structure or
any function of the human body and components of such articles.
21 U.S.C. § 321(g). The term "drug" includes "articles
intended for use as a component" of the drug. 21 U.S.C.
§ 321 (g)(1 )(0). "Components" are further defined
to include "any ingredient intended for use in the manufacture
of a drug product." 21 C.F.R. 9210.3(b)(3).
4. Certain autologous vaccines manufactured by Defendant AMSCOT
MEDICAL LABS, INC., commonly known as Gene Activated Therapy
(GAT) and Theracine, (hereinafter one or more of these substances
are sometimes referred to generically as "Defendant AMSCOT's
autologous vaccines") were intended for use in the cure,
mitigation, treatment, or prevention of disease in man and were
drugs within the meaning of the Act, 21 U.S.C. §§ 321(g)(1)(b);
5. Under the Act, a drug is deemed to be misbranded for anyone
of a number of reasons. Relevant to this indictment, a drug is
misbranded if it fails to bear adequate directions for its use.
21 U.S.C. § 352(f)(1).
6. A drug is "adulterated" if: 1) if it has been
prepared, packed, or held under unsanitary conditions whereby
it may have been contaminated with filth or whereby it may have
been rendered injurious to health; or 2) if the methods used
in, or the facilities or controls used for, its manufacture,
processing, packing, or holding do not conform to or are not
operated or administered in conformity with current good manufacturing
practice to assure that such drug meets the requirements of the
Act as to safety and has the identity and strength, and meets
the quality and purity characteristics. which it purports or
is represented to possess. 21 U.S.C. §§ 351(a)(2)(B)
and (C).
The Defendants
7. Defendant GEORGE KINDNESS, currently a resident of Middletown,
Ohio, was president and part-owner of Defendant AM SCOT MEDICAL
LABS. INC., from January 2,1992, to the date of this indictment.
Defendant GEORGE KINDNESS has also been the lab director of Defendant
AM SCOT from January 2. 1992, to present and active in the day-to-day
operation of the business
8. From on and after January 2, 1992. to the date of this
indictment, Defendant AMSCOT MEDICAL LABS, INC. was an Ohio for-profrt
corporation part-owned and operated by Defendant GEORGE KINDNESS.
with its principal place of business initially in Hamilton, OH
and later in Cincinnati, OH. The Conspiracy Charge
9. From in or about September. 1997, through in or about April
2001 in the Western District of Tennessee, and elsewhere, defendants
did knowingly and intentionally combine, conspire, confederate
and agree together and with diverse other persons both known
and unknown to the Grand Jury to violate laws of the United States,
to wit. introducing and delivering and causing the introduction
and delivery into interstate commerce of misbranded and adulterated
drugs with the intent to defraud or mislead in violation of 21
U.S.C. §§ 331(a) and 333(a}(2).
10. On or about April 12 -13,1999, FDA conducted an inspection
of Defendant AMSCOT, located at 11365 Williamson Road., Cincinnati,
Ohio, pursuant to its regulatory authority, 21 U.S.C. 374. The
FDA discovered that Defendant AMSCOT had been and was currently
manufacturing autologous vaccines from cancer patients' own tumor
tissue and blood samples. The vaccines were intended as a treatment
for cancer. The patients were administered these vaccines. The
vaccine was being administered to patients as part of a study
known as the Gene Activated Therapy (GAT) study.
11. Unnamed co-conspirator 1 was the clinical investigator
for the GAT study and had an office located in Memphis, Tennessee.
12. The FDA inspection revealed that unnamed co-conspirator
1 would prescribe the vaccine for the cancer patients. Unnamed
co-conspirator 1 would extract or cause to be extracted a blood
and/or tumor tissue sample from the patients and subsequently
ship the samples in interstate commerce to Defendant AMSCOT.
Defendant AMSCOT, under the direction of Defendant GEORGE KINDNESS,
would process the blood and tumor samples into a finished vaccine.
The vaccine was then shipped in interstate commerce from Defendant
AMSCOT in Cincinnati to either unnamed co-conspirator 1 in Memphis
or directly to patients and/or others in states other than Tennessee.
Defendant AMSCOT and Defendant GEORGE KINDNESS were informed
by FDA investigators during the inspection that the GAT study
required an Investigational New Drug Application (IND) to be
in effect. Defendant GEORGE KINDNESS was informed by FDA investigators
that conducting the GAT study without an IND in effect was a
violation of the Food, Drug. and Cosmetic Act.
13. On or about April 15, 1999. Defendant AMSCOT submitted
an IND application for the GAT study to the FDA. Defendant AMSCOT
was listed as the study sponsor and vaccine production site in
the IND application. The IND for the GAT study was never approved
by FDA.
14. On or about May 14. 1999, FDA placed the IND for the
GAT study on clinical hold. A clinical hold requires that all
clinical work requested under an IND is either delayed or suspended
until the IND is approved. (See 21 CFR 312.42(a».
15. On or about December 7 - 9, 1999, the FDA inspected unnamed
co- conspirator 1's office in Memphis. The FDA learned that after
the IND for the GAT study was placed on hold, unnamed co-conspirator
1 continued to treat patients taking part in the GAT study with
the same autologous tumor vaccine manufactured by Defendant AMSCOT.
The FDA also learned that unnamed co-conspirator 1 had treated
patients with an almost identical vaccine called Theracine. Like
the GAT study vaccine, the Theracine was also manufactured by
Defendant AMSCOT. The FDA had neither received I evaluated nor
approved an INO application for the study of the Theracine vaccine.
16. On or about May 2 - 10, 2000, the FDA inspected Defendant
AMSCOT and found evidence that since June 1999 Defendant AMSCOT
had been manufacturing Theracine. Defendant GEORGE KINDNESS acknowledged
in a sworn statement to FDA investigators on May 10, 2000, that
an IND for Theracine had not been submitted to the FDA. The inspection
also revealed that 63 Theracine vaccines had been processed since
November 14, 1999, all of which were shipped to unnamed co-conspirator
1 and others prior to performing sterility, endotoxin and mycoplasma
testing.
OBJECTS OF THE CONSPIRACY
17. It was the object of the conspiracy: (A) to produce and
distribute in interstate commerce to health care professionals
and consumers misbranded drugs, Le. one or more autologous vaccines,
with the intent to deceive or defraud, and (2) to produce and
distribute in interstate commerce to health care professionals
and consumers adulterated drugs, i.e. one or more of autologous
vaccines, with the intent to deceive or defraud, in violation
of 21 U.S.C., Section 331(a) and 333(a}(2).
OVERT ACTS
18. In furtherance of the conspiracy and to effect the objects
thereof, defendants and others known and unknown to the Grand
Jury committed and caused to be committed the following overt
acts, among others, in the Western Distrtct of Tennessee, and
elsewhere:
A. On or about April 12, 1999 and during the course of FDA's
inspection at Defendant AMSCOT, Defendant GEORGE KINDNESS falsely
represented to FDA investigators that he had an M.D. in general
medicine.
B. On or about January 5. 2000, unnamed co-conspirator 1 of
Memphis, Tennessee, sent a blood sample and tumor biopsy drawn
from patient GN to . Defendant AMSCOT for the purpose of manufacturing
an injectable biologic to be administered to patient GN for the
treatment of cancer.
C. On or about January 12, 2000, certain employees at Defendant
AMSCOT at the direction of Defendant AMSCOT owner Defendant GEORGE
KINDNESS, processed the blood and tumor of patient GN into an
injectable biologic called Theracine.
D. On or about January 12, 2000, Defendant GEORGE KINDNESS
caused to be transported via United Parcel Service ("UPS")
the Theracine biologic manufactured from the blood and tumor
of patient GN to unnamed co-conspirator 1 in Memphis for the
purpose of administering it to patient GN for the treatment of
cancer.
E. On or about January 6,2000, unnamed co-conspirator 1 of
Memphis, Tennessee, sent a blood sample and tumor biopsy drawn
from patient KS to Defendant AMSCOT for the purpose of manufacturing
Theracine to be administered to patient KS for the treatment
of cancer.
F. On or about January 13. 2000, certain employees at Defendant
. AMSCOT at the direction of Defendant GEORGE KINDNESS, processed
the blood and tumor of patient KS into the injectable biologic
Theracine.
G. On or about January 17, 2000. Defendant GEORGE KINDNESS
caused to be transported via UPS the Theracine manufactured from
the blood and tumor of patient KS to unnamed co-conspirator 1
in Memphis for the purpose of administering it to patient KS
for the treatment of cancer.
H. On or about February 4,2000. unnamed co-conspirator 1
of Memphis, Tennessee. sent a blood sample and tumor biopsy from
patient KN to Defendant AMSCOT for the purpose of manufacturing
Theracine to be administered to patient KN for the treatment
of cancer.
I. On or about February 11, 2000, certain employees at Defendant
AMSCOT at the direction of Defendant GEORGE KINDNESS, processed
the blood and tumor of patient KN into the injectable biologic
Theracine.
J. On or about February 14. 2000, Defendant GEORGE KINDNESS
caused to be transported via UPS the Theracine processed from
the blood and tumor samples of patient KN to unnamed co-conspirator
1 in Memphis for the purpose of treating patient KN for cancer.
K. On or about February 8.2000, unnamed co-conspirator 1 in
Memphis, Tennessee, caused to be transported to Defendant AMSCOT
a blood sample and tumor biopsy from patient SW for the purpose
of manufacturing Theracine to be administered to patient SW for
the treatment of cancer.
L. On or about February 16, 2000, certain employees at Defendant
AMSCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient SW into the injectable
biologic Theracine.
M. On or about February 16. 2000. Defendant GEORGE KINDNESS
caused to be transported via UPS the Theracine processed from
the blood and tumor samples of patient SW to unnamed co-conspirator
1 in Memphis. Tennessee, for the purpose of administering the
Theracine to patient SW for the treatment of cancer.
N. On or about February 21,2000, unnamed co-conspirator 1
in Memphis caused a blood sample and tumor biopsy from patient
Y J to be transported to Defendant AMSCOT for the purpose of
manufacturing Theracine to be administered to patient Y J for
the treatment of cancer.
O. On or about February 26, 2000. certain employees at Defendant
AM SCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient Y J into the injectable
biologic Theracine.
P. On or about February 29,2000, Defendant GEORGE KINDNESS
caused to be transported via UPS the Theracine processed from
the blood and tumor samples of patient Y J to unnamed co-conspirator
1 in Memphis for the purpose of administering the Theracine to
patient Y J for the treatment of cancer.
a. On or about February 21,2000, unnamed co-conspirator 1
in Memphis caused a blood sample and tumor biopsy from patient
RL to be transported to Defendant AM SCOT for the purpose of
manufacturing Theracine to be administered to patient RL for
the treatment of cancer.
R. On or about February 27, 2000, certain employees at Defendant
AMSCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient RL into the injectable
biologic Theracine.
S. On or about February 29,2000, Defendant GEORGE KINDNESS
caused to be transported via UPS the Theracine processed from
the blood and tumor samples of patient RL to unnamed co-conspirator
1 in Memphis for the purpose of administering the Theracine to
patient RL for the treatment of cancer.
T. On or about February 29,2000, unnamed co-conspirator 1
in Memphis caused a blood sample and tumor biopsy from patient
DP to be transported to Defendant AMSCOT for the purpose of manufacturing
Theracine to be administered to patient DP for the treatment
of cancer.
U. On or about March 8, 2000, certain employees at Defendant
AM SCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient DP into the injectable
biologic Theracine.
V. On or about March 8,2000, Defendant GEORGE KINDNESS caused
to be transported via UPS the Theracine processed from the blood
and tumor samples of patient DP to unnamed co-conspirator 1 in
Memphis for the purpose of administering the Theracine to patient
DP for the treatment of cancer.
W. On or about March 23, 2000, unnamed co-conspirator 1 in
Memphis caused to be transported to Defendant AMSCOT a blood
sample and tumor biopsy from patient SO for the purpose of manufacturing
Theracine to be administered to patient SD for the treatment
of cancer.
X. On or about March 31,2000, certain employees at Defendant
AMSCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient SD into the injectable
biologic Theracine.
Y. On or about April 3, 2000, Defendant GEORGE KINDNESS caused
to be transported via UPS the Theracine processed from the blood
and tumor samples of patient SO to unnamed co-conspirator 1 in
Memphis for the purpose of administering the Theracine to patient
SO for the treatment of cancer. .
Z. On or about March 28, 2000, unnamed co-conspirator 1 in
Memphis caused to be transported to Defendant AMSCOT a blood
sample and tumor biopsy from patient VM for the purpose of manufacturing
Theracine to be administered to patient VM for the treatment
of cancer.
AA. On or about April 5. 2000, certain employees at Defendant
AMSCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient VM into the injectable
biologic Theracine. BB. On or about April 5, 2000, Defendant
GEORGE KINDNESS caused to be transported via UPS the Theracine
processed from the blood and tumor samples of patient VM to unnamed
co-conspirator 1 in Memphis for the purpose of administering
the Theracine to patient VM for the treatment of cancer.
CC. On or about March 29. 2000, unnamed co~conspirator 1 in
Memphis sent a blood sample and tumor biopsy from patient EP
to Defendant AMSCOT for the purpose of manufacturing Theracine
to be administered to patient EP for the treatment of cancer.
DD. On or about April 6, 2000, certain employees at Defendant
AMSCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient EP into the injectable
biologic Theracine.
EE. On or about April 6, 2000, Defendant GEORGE KINDNESS caused
to be transported via UPS the Theracine processed from the blood
and tumor samples of patient EP to unnamed co-conspirator 1 in
Memphis for the purpose of administering the Theracine to patient
EP for the treatment of cancer.
FF. On or about June 7, 2000~ unnamed co-conspirator 1 in
Memphis caused to be transported a blood sample and tumor biopsy
from patient GN to Defendant AMSCOT for the purpose of manufacturing
Theracine to be administered to patient GN for the treatment
of cancer.
GG. On or about June 19,2000, certain employees at Defendant
AMSCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient GN into the injectable
biologic Theracine.
HH. On or about June 27. 2000, Defendant AMSCOT transported
via UPS the Theracine from the blood and tumor samples of patient
GN to unnamed co- conspirator 1 in Memphis to be administered
to patient GN for the treatment of cancer.
II. On or about June 13,2000. unnamed co-conspirator 1 in
Memphis caused a blood sample and tumor biopsy from patient GK
to be transported to Defendant AMSCOT for the purpose of manufacturing
Theracine to be administered to patient GK for the treatment
of cancer.
JJ. On or about June21. 2000, certain employees at Defendant
AMSCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient GK into the injectable
biologic Theracine.
KK. On or about June 28, 2000, Defendant GEORGE KINDNESS shipped
Theracine processed from the blood and tumor samples of patient
GK to unnamed co- conspirator 1 in Memphis for the purpose of
administering it to patient GK for the treatment of cancer.
LL. On or about June 26, 2000, and July 5, 2000, Defendant
GEORGE KINDNESS caused a Defendant AMSCOT employee to ship Theracine
via UPS to unnamed co-conspirator 1 in Memphis.
MM. On or about June 30, 2000, unnamed co-conspirator 1 caused
to be transported a blood sample and tumor biopsy from patient
RB to Defendant AMSCOT for the purpose of manufacturing Theracine
to be administered to patient RB for the treatment of cancer.
NN. On or about July 10. 2000, certain employees at Defendant
AMSCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient RB into the injectable
biologic Theracine.
OO. On or about June 30,2000, unnamed co-conspirator 1 in
Memphis transported a blood sample and tumor biopsy from patient
CH to Defendant AM SCOT for the purpose of manufacturing Theracine
to be administered to patient CH for the treatment of cancer.
PP. On or about July 10, 2000, certain employees at Defendant
AMSCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient CH into the injectable
biologic Theracine.
QQ. On or about July 14,2000, unnamed co-conspirator 1 in
Memphis transported a blood sample and tumor biopsy from patient
JM to Defendant AMSCOT for the purpose of manufacturing Theracine
to be administered to patient JM for the treatment of cancer.
RR. On or about July 25, 2000, certain employees at Defendant
AMSCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient JM into the injectable
biologic Theracine.
SS. On or about July 26, 2000, Defendant GEORGE KINDNESS provided
the Theracine processed from the blood and tumor samples of patient
JM to unnamed co-conspirator 1 in Memphis for the purpose of
having it administered to patient JM for the treatment of cancer.
TT. On or about July 20.2000, unnamed co-conspirator 1 in
Memphis transported a blood sample and tumor biopsy from patient
J5 to Defendant AMSCOT for the purpose of manufacturing Theracine
to be administered to patient JS for the treatment of cancer.
UU. On or about July 31,2000, certain employees at Defendant
AM SCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient JS into the injectable
biologic Theracine.
WW. On or about August 7,2000, Defendant GEORGE KINDNESS caused
to be provided the Theracine processed from the blood and tumor
samples of patient JS to unnamed co-conspirator 1 in Memphis
for the purpose of administering it to patient JS for the treatment
of cancer. WW. On or about August 2.2000. unnamed co-conspirator
1 in Memphis transported a blood sample and tumor biopsy from
patient AF to Defendant AMSCOT for the purpose of manufacturing
Theracine to be administered to patient AF for the treatment
of cancer.
XX. On or about August 11, 2000, certain employees at Defendant
AMSCOT at the direction of Defendant GEORGE KINDNESS processed
the blood and tumor sample of patient AF into the injectable
biologic Theracine.
YY. On or about August 18, 2000, Defendant GEORGE KINDNESS
caused to be provided the Theracine processed from the blood
and tumor samples of patient AF to unnamed co-conspirator 1 in
Memphis for the purpose of administering it to patient JS or
the treatment of cancer
ZZ. On or about August 3, 2000, Defendant GEORGE KINDNESS
caused to be shipped via UPS Theracine processed from the blood
and tumor tissue of patient RL to unnamed co-conspirator 1 in
Memphis for the purpose of administering the Theracine to patient
RL for the treatment of cancer.
AAA. On or about November 3, 2000, and during the course of
an FDA inspection of Defendant AMSCOT, Defendant GEORGE KINDNESS
falsely stated to FDA investigators that he had only manufactured
Theracine for previous Theracine patients and that he did not
maintain certain records documenting the manufacture of Theracine
batches after approximately May 10, 2000.
BBB. During the course of the FDA inspection of Defendant
AMSCOT from on or about October 29 to November 3, 2000, Defendant
GEORGE KINDNESS instructed a Defendant AM SCOT employee to conceal
vaccine log pages documenting the manufacture of Theracine from
after May 19, 2000, from the FDA investigators. The vaccine logs
were not inspected by the FDA during the inspection. All in violation
of 18 U.S.C. § 371
COUNTS 2 THROUGH 11
19. The allegations as set forth in paragraphs 1 through 8
and 10 through 16 in Count 1 of this Indictment are incorporated
by reference as if fully rewritten herein.
20. On or about the following dates as set forth for each
count, within the Western District of Tennessee, and elsewhere,
Defendant AMSCOT and Defendant GEORGE KINDNESS, being aided and
abetted by others, known and unknown to the grand jury, did,
with the intent to defraud and mislead, introduce and deliver
for introduction into interstate commerce and cause to be introduced
and delivered for introduction into interstate commerce, a drug
that was misbranded within the meaning of 21 U.S.C. § 352(f)(1),
in that its labeling did not bear adequate directions for use:
Count Number
|
Date of Violation
|
| 2 |
January
12, 2000 |
| 3 |
January
17, 2000 |
| 4 |
February
14, 2000 |
| 5 |
February
16, 2000 |
| 6 |
February
29, 2000 |
| 7 |
March
8, 2000 |
| 8 |
April
3, 2000 |
| 9 |
April
5, 2000 |
| 10 |
April
6, 2000 |
|
11 |
August 3, 2000 |
All in violation of 21 U.S.C. §§ 331(a) and 333(a)(2)
and 18 U.S.C§ 2.
COUNTS 12 THROUGH 21
21. The allegations as set forth above in this Indictment
in paragraphs 1 through 8 and 10 through 16 in Count 1 of this
indictment are incorporated by reference as if fully rewritten
herein.
22. On or about the following dates as set forth for each
count, within the Western District of Tennessee, and elsewhere,
Defendant AMSCOT and Defendant GEORGE KINDNESS, being aided and
abetted, by persons known and unknown to the grand jury, did,
with the intent to defraud and mislead, introduce and. deliver
for introduction into interstate commerce and cause to be introduced
and delivered for introduction into interstate commerce, a drug
that was adulterated within the meaning of 21 U.S.C. § 351
(a)(2)(B), in that the methods used in, and the facilities and
controls used for, its manufacture. processing, packing and holding
did not conform to and were not operated and administered in
conformity with then current good manufacturing practices to
assure that such drug met the requirements of the Act as to safety
and had the identity and strength, and met the quality and purity
characteristics, which it was purported and represented to possess:
Count Number
|
Date of Violation
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| 12 |
January
12, 2000 |
| 13 |
January
17, 2000 |
| 14 |
February
14, 2000 |
| 15 |
February
16, 2000 |
| 16 |
February
29, 2000 |
| 17 |
March
8, 2000 |
| 18 |
April
3, 2000 |
| 19 |
April
5, 2000 |
| 20 |
April
6, 2000 |
|
21 |
August 3, 2000 |
All in violation of 21 U.S.C. §§ 331 (a) and 333(a)(2)
and 18 U.S.C. § 2.
A TRUE BILL:
___________________
Grand Jury Foreperson
Dated: 11-19-03
____________________
Assistant United States Attomey
Westem District of Tennessee
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