Judge Sullivan's April 6, 2005 Ruling on John Doe et al vs. Donald Rumsfeld
et al.
April, 07 2005
Background
ORDER
On October 27, 2004, this Court issued an order
permanently
enjoining the military's anthrax vaccine program. Specifically,
the Court held, "Unless and until FDA classifies AVA as a safe
and
effective drug for its intended use, an injunction shall
remain in effect
prohibiting defendants' use of AVA on the basis
that the vaccine is either a
drug unapproved for its intended use
or an investigational new drug within
the meaning of 10 U.S.C. ?
1107. Accordingly, the involuntary anthrax
vaccine program, as
applied to all persons, is rendered illegal absent
informed
consent or a Presidential waiver."
Defendants have now
filed an Emergency Motion to Modify the
Injunction, seeking clarification
that there exists a third
option - an alternative to informed consent or a
Presidential
waiver - by which defendants can administer AVA to service
members even in the absence of FDA approval of the drug: that is,
pursuant to an Emergency Use Authorization ("EUA") under
the
Project BioShield Act of 2004, 21 U.S.C.A. ? 360bbb-3.
In
enacting the EUA provision, Congress appears to have
authorized the use of
unapproved drugs or the unapproved use of
approved drugs based on a
declaration of emergency by the
Secretary of Health and Human Services,
which in turn is based on
"a determination by the Secretary of Defense that
there is a
military emergency, or a significant potential for a military
emergency, involving a heightened risk to United States military
forces
of attack with a specified biological, chemical,
radiological or nuclear
agent or agents." 21 U.S.C.A. ? 360bbb-
3(b)(1)(B).
Judge Rulings
Without ruling on the lawfulness or merits of any
EUA, upon
consideration of the defendants' motion, the opposition and
replies thereto, the amicus curiae brief, the arguments heard in
open
court on March 21, 2005, and the draft language jointly
submitted by the
parties in this case, it is hereby
ORDERED that the defendants' Motion to
Modify the Injunction
is GRANTED; it is further
ORDERED that the Court's
injunction of October 27, 2004, is
modified by the addition of the following
language: "This
injunction, however, shall not preclude defendants from
administering AVA, on a voluntary basis, pursuant to the terms of
a
lawful emergency use authorization ("EUA") pursuant to section
564 of the
Federal Food, Drug, and Cosmetic Act, without
prejudice to a future
challenge to the validity of any such EUA.
The Court expressly
makes no finding as to the lawfulness of any
specific EUA that has been or
may be approved by the Department
of Health and Human Services."
Signed: Emmet G. Sullivan
United States District Judge
April 6, 2005