Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al
Filing
56
MOTION for Summary Judgment on Plaintiffs Third Claim for Relief. Document filed by Center For Science In The Public Interest, Food Animal Concerns Trust, Natural Resources Defense Council, Inc., Public Citizen, Inc., Union Of Concerned Scientists, Inc..(Bernard, Mitchell)
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF NEW YORK
NATURAL RESOURCES DEFENSE
COUNCIL, INC.; CENTER FOR SCIENCE
IN THE PUBLIC INTEREST; FOOD
ANIMAL CONCERNS TRUST; PUBLIC
CITIZEN, INC.; and UNION OF
CONCERNED SCIENTISTS, INC.,
)
)
)
)
)
)
)
Plaintiffs,
)
)
v.
)
)
UNITED STATES FOOD AND DRUG
)
ADMINISTRATION; MARGARET
)
HAMBURG, in her official capacity as
)
Commissioner, United States Food and Drug )
Administration; CENTER FOR
)
VETERINARY MEDICINE; BERNADETTE )
)
DUNHAM, in her official capacity as
)
Director, Center for Veterinary Medicine;
)
UNITED STATES DEPARTMENT OF
)
HEALTH AND HUMAN SERVICES; and
)
KATHLEEN SEBELIUS, in her official
)
capacity as Secretary, United States
)
Department of Health and Human Services,
)
)
Defendants.
)
11 CIV 3562 (THK)
ECF Case
PLAINTIFFS’ NOTICE OF MOTION FOR SUMMARY JUDGMENT
ON THEIR THIRD CLAIM FOR RELIEF
Pursuant to Rule 56 of the Federal Rules of Civil Procedure, plaintiffs Natural Resources
Defense Council, Center for Science in the Public Interest, Food Animal Concerns Trust, Public
Citizen, and Union of Concerned Scientists hereby move for summary judgment on their Third
Claim for Relief, on the basis that there is no genuine issue of material fact, and plaintiffs are
entitled to judgment as a matter of law. Defendants’ denials of plaintiffs’ citizen petitions are
contrary to the Federal Food, Drug, and Cosmetic Act (Food and Drug Act), 21 U.S.C.
§ 360b(e)(1), and lack a reasoned basis, in violation of the Administrative Procedure Act (APA),
5 U.S.C. § 706(2). The denials must be set aside as “arbitrary, capricious, . . . or otherwise not in
accordance with law.” Id. § 706(2)(A).
The citizen petitions, submitted by plaintiffs in 1999 and 2005, requested that the U.S.
Food and Drug Administration (FDA) withdraw approvals for nontherapeutic uses of medically
important antibiotics in livestock, on the ground that these drug uses present human health risks.
FDA denied the petitions in November 2011. Refusing to engage with the scientific evidence on
which the petitioners relied, the agency denied the petitions in favor of an unenforceable plea for
industry cooperation. FDA’s approach finds no basis in the Food and Drug Act and is thus “not
in accordance with law” within the meaning of the APA. Id. Moreover, FDA failed to articulate a
rational connection between its own conclusion that the challenged drug uses jeopardize human
health and its decision not to take binding action. Nor has the agency presented a shred of
evidence that its alternative, extrastatutory method will work. The lack of such evidence deprives
FDA’s action of a reasoned basis, in further violation of the APA. For these reasons, plaintiffs
seek an order vacating the denials and remanding the matter to FDA with instructions to address
the petitions promptly on their merits.
In support of this motion, plaintiffs submit the accompanying (1) memorandum of law in
support of plaintiffs’ motion for summary judgment on their Third Claim for Relief; (2)
statement of material facts as to which there is no genuine dispute; and (3) declaration of
Mitchell S. Bernard and accompanying exhibits.
//
//
//
2
Dated: February 21, 2012
Respectfully submitted,
s/ Mitchell S. Bernard
Mitchell S. Bernard (MB 5823)
Natural Resources Defense Council, Inc.
40 West 20th Street
New York, New York 10011
(212) 727-2700
(212) 727-1773 (fax)
mbernard@nrdc.org
Avinash Kar, admitted pro hac vice
Jennifer A. Sorenson, admitted pro hac vice
Natural Resources Defense Council, Inc.
111 Sutter Street, 20th Floor
San Francisco, California 94104
(415) 875-6100
(415) 875-6161 (fax)
akar@nrdc.org; jsorenson@nrdc.org
Counsel for Plaintiffs
Of Counsel for Plaintiff Center for Science
in the Public Interest:
Stephen Gardner (SG 3964)
Center for Science in the Public Interest
5646 Milton Street, Suite 211
Dallas, Texas 75206
(214) 827-2774
(214) 827-2787 (fax)
sgardner@cspinet.org
3
Disclaimer: Justia Dockets & Filings provides public litigation records from the federal appellate and district courts. These filings and docket sheets should not be considered findings of fact or liability, nor do they necessarily reflect the view of Justia.
Why Is My Information Online?