IN THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF COLUMBIA
1
UNITED STATES OF AMERICA, ) Civil Action No. 93-0949 (JGP)
)
Plaintiff, 1
1
V. )
)
AMERICAN NATIONAL RED CROSS, )
a corporation, 1
)
Defendant.- )
MEMORANDUM IN SUPPORT OF MOTION FOR ORDER TO SHOW CAUSE
WHY DEFENDANTS SHOULD NOT BE HELD IN CML CONTEMPT OF AND
TO MODIFY THE CONSENT DECREE OF PERMANENT INJUNCTION
I. INTRODUCTION
Despite more than 16 years of sustained attention from the Food and Drug
Administration ("FDA") and the entry by this Court of a Permanent Injunction on May
1993,l the American National Red Cross ("ARC") continues to conduct its blood service
operations in disregard of the Federal Food, Drug, and Cosmetic Act ("FDCA"), the
Health Service Act, and critical current good manufacturing practice ("CGMP") regulations,
which are designed to stem the spread of dangerous infectious disease by ensuring the
purity, and potency of blood products.2 Because FDA has failed, after 16 months of
to reach a settlement with ARC and has exhausted its resources and regulatory tools to
1, In addition to the 1993 Injunction (the "Decree"), FDA's unsuccessful attempts to
into compliance with the law include nearly thirty three thousand hours spent inspecting
facilities, warning correspondence, notices of intent to revoke licenses and license
and a voluntary compliance agreement.
2 A copy of the 1993 Injunction is attached as Exhibit A.
ARC to comply with the law, the United States must once again seek the assistance of this
to protect the public health.3
ARC's National Headquarters' most recent violative conduct includes, but is not
to:
. incorrect labeling and release of blood contaminated with cytomegalovirus
("CMV"), a virus that may cause severe illness, blindness, or death when transfused
SNIPPETS:
WHY DEFENDANTS SHOULD NOT BE HELD IN CML CONTEMPT OF AND TO MODIFY THE CONSENT DECREE OF
Despite more than 16 years of sustained attention from the Food and Drug Administration
, purity, and potency of blood products.2 Because FDA has failed, after 16 months of discussions,
1, In addition to the 1993 Injunction, FDA's unsuccessful attempts to bring ARC into
ARC to comply with the law, the United States must once again seek the assistance of this
blood products and the inability to recall such products;
The continuing failure of ARC National Headquarters to exercise control over its regional
The tines will become payable only if ARC fails to comply with the Order and the laws
Because blood and blood products cannot be sterilized or chemically treated, their safety can
These CGMP requirements were added to the FDCA ) to give FDA the tools to "attack commerce in
CGMP safeguards for blood and blood products include: educating donors about risk factors to
y notifying consignees when potentially infectious units have been released; promptly detecting,
Overlapping breaches and breaches occurring at the end of the manufacturing process are
Accordingly, to ensure continuing compliance, each blood center must rely on its own Quality
The Historv Of ARC's Violative Conduct ARC's Biomedical Headquarters, located in Arlington,
10 Many of the recalls in fiscal year 2000 were not attributable to violations of the law by
Dr. Healy further acknowledged the improper functioning of ARC's computer system and said
ARC is supposed to label blood components as CMV-negative only when: the donor tests negative
ARC violates paragraph III.B.14 by failing to promptly conduct thorough, documented
Each region submits to ARC National Headquarters the names of donors who have confirmed
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