Natural Resources Defense Council, Inc. et al v. United States Food and Drug Administration et al

Filing 83

MEMORANDUM OF LAW in Opposition to Motion to Strike Non-Record Material. Document filed by Center for Veterinary Medicine, Bernadette Dunham, Margaret Hamburg, Kathleen Sebelius, United States Department of Health and Human Services, United States Food and Drug Administration. (Barcelo, Amy)

UNITED STATES DISTRICT COURT
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,

11 Civ. 3562 (THK)
ECF Case

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.

MEMORANDUM IN OPPOSITION TO PLAINTIFFS’
MOTION TO STRIKE NON-RECORD MATERIAL

PREET BHARARA
United States Attorney for the
Southern District of New York
Attorney for Defendant
86 Chambers Street, 5th Floor
New York, New York 10007
Tel.: [phone]
AMY A. BARCELO
Assistant United States Attorney
– Of Counsel

The Government opposes Plaintiffs’ Motion to Strike Non-Record Material, dated April
18, 2012 (“Motion” or “Mot.”). Because all of the materials that are the subject of Plaintiffs’
Motion are properly before this Court, the Court should deny that Motion, which requests that
this Court: (1) “strike” from the record in this case a public statement from the Animal Health
Institute (the “2012 AHI Statement”), and (2) “disregard” three documents FDA published on
April 11, 2012 (the “April 11 Documents”).
I.

This Court Should Deny Plaintiffs’ Motion to Strike the 2012 AHI Statement
As a preliminary matter, Plaintiffs do not cite any authority in support of the premise of

their motion—that a court may strike from the record an exhibit to a declaration submitted in
support of a motion for summary judgment. While Rule 12(f) of the Federal Rules of Civil
Procedure provides a basis for courts to strike material from a “pleading,” a declaration
submitted in support of a motion for summary judgment does not constitute such a “pleading.”
See, e.g., Rochester-Genesee Reg. Trans. Auth. v. Hynes-Cherin, 531 F. Supp. 2d 494, 519 n.17
(W.D.N.Y. 2008) (citing cases); National Union Fire Ins. Co. of Pittsburg, PA v. Hicks, Muse,
Tate & Furst, Inc., 02 Civ. 1334 (SAS), 2002 WL 1482625, * 6 (S.D.N.Y. Jul. 10, 2002)
(“Declarations and affidavits are not pleadings.”). In any event, even if Plaintiffs’ Motion were
properly brought pursuant to Rule 12(f) (it is not), such motions to strike are “disfavored and will
be denied unless the allegations have ‘no possible relation or logical connection to the subject
matter of the controversy and may cause some form of significant prejudice to one or more of the
parties to the action.’” Id. at 518 (quoting Bank of Beaver City v. Branham, No. 3:03-CV-575,
2006 WL 1469300, at *4 (E.D. Tenn. May 24, 2006) (quoting 5C Charles A Wright & Arthur R.
Miller, Federal Practice & Procedure § 1382 (3d ed. 2004)). Plaintiffs’ Motion has not met that
standard.

In any event, the 2012 AHI Statement is properly before this Court regardless of whether
it is part of the administrative record underlying the Petition Responses. 1 This Court may
properly consider background information about the animal drug industry’s current stance
towards FDA’s plans to regulate the use of antibiotics in food producing animals where that
evidence is not part of the formal administrative record. See Rochester-Genesee, 531 F. Supp.
2d at 518 (the “district court may go outside the administrative record for the purposes of
background information”) (collecting cases; internal quotation omitted); Sadler v. Mineta, No.
3:05-CV-1189, 2006 WL 2772699, at * 2 n.3 (D. Conn. Sept. 26, 2006) (holding that courts may
look to evidence outside the administrative record “as general background information that
clarifies the administrative record in assessing Plaintiffs’ claim,” and noting that “no party has
contested” the information contained in the evidence). Even if this Court were to conclude that
the AHI’s August 2010 comments (more than a year before FDA issued the Petition Responses)
reflected some concern with FDA’s proposed approach at that time, the Court may properly
consider that industry appears now to support FDA’s approach and that the status quo may have
changed.
More fundamental than the significance or admissibility of the AHI statements, however,
is the incorrect premise upon which Plaintiffs’ Motion is based—i.e., that this court’s
determination regarding whether to disturb the Petition Responses depends on the strength of
FDA’s “asserted . . . faith” or “professed confidence” in the voluntary compliance program, Mot.
at 2. This flawed reasoning only underscores why FDA’s decision not to initiate drug
withdrawal proceedings (for now) is committed to its unreviewable discretion. In deciding
1

Abbreviations in this brief are the same as in the Government’s Opening Brief dated March 21,
2012, in support of its cross-motion for summary judgment on the claims contained in Plaintiffs’
First Supplemental Complaint (Dkt. No. 64), and Reply Brief in support of that motion (Dkt. No.
77).

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whether, when, and how to enforce the law, agencies are called upon to balance “a number of
factors which are peculiarly within [their] expertise.” Heckler v. Chaney, 470 U.S. 821, 831
(1985).2 Not only are such agency decisions not to enforce “generally unsuitab[le] for judicial
review” in the first instance, id., but it would usually be impossible for a court to reliably discern
an agency’s degree of confidence that its decision was the correct one (assuming the agency
could even discern that for itself).
Alternatively, even if the Petition Responses were evaluated under an arbitrary and
capricious standard, the Petition Responses meet that standard. Govt’s Reply Br. at 11-13. The
least that can be said is that FDA’s choice among competing regulatory strategies qualifies as the
type of judgment that a “court is not to substitute . . . for that of the agency.” S.E.C. v. Citigroup
Global Markets Inc., 673 F.3d 158, 164 (2d Cir. 2012);3 see also Bellevue Hosp. Ctr. v. Leavitt,
443 F.3d 163, 174 (2d Cir. 2006) (a reviewing court has “no license to substitute [its] policy
judgment for that of the agency”); NRDC v. SEC, 606 F.2d 1031, 1055-56 (D.C. Cir. 1979) (“it is
not the judicial province to upset agency structuring of proceedings,” because the agency is more
“cognizant of the many demands on it, its limited resources, and the most effective structuring
and timing of proceedings to resolve these competing demands”). The Petition Responses
articulate the reasons for FDA’s position that its proposed approach is the best one, see Jan.
Barcelo Decl. Exs. I & J, and this Court should not disturb that exercise of judgment.

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Such factors include “whether a violation has occurred, [] whether agency resources are best
spent on this violation or another, whether the agency is likely to succeed if it acts, whether the
particular enforcement action requested best fits the agency’s overall policies, and . . . whether
the agency has enough resources to undertake the action at all.” Id.

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See also Government’s Opening Brief at 24, citing Vermont Yankee Nuclear Power v. NRDC,
435 U.S. 519, 543 (1978), and Mobil Oil Exploration v. United Distrib. Cos., 498 U.S. 211, 230
(1991).
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Ultimately, if this Court were to find FDA’s reasons insufficient or that Petition
Responses cannot be sustained unless FDA more convincingly demonstrates its confidence that
its preferred approach will be successful, the matter is not resolvable on the AHI statements
alone and should be remanded to provide FDA with an opportunity to further explain the bases
for its decision. See Fla. Power & Light Co. v. Lorion, 470 U.S. 729, 744 (1985) (where a court
believes it cannot evaluate the agency’s action on the basis of the record before it, the “proper
course” for the Court, “except in rare circumstances, is to remand to the agency for additional
investigation or explanation”).
II.

The Court Should Not Disregard FDA’s New Guidance Documents
Although Plaintiffs’ Motion does not request any formal procedural relief with respect to

the April 11 Documents, the Court should reject Plaintiffs’ request that the Court “disregard”
those documents. Mot. at 3. The Government properly provided these documents to the Court
to ensure that the Court is aware of the ways in which the regulatory approach that FDA
described in the Petition Responses has crystallized. Third Barcelo Decl. Exs. A, B & C; 77 Fed.
Reg. 22247 (Apr. 13, 2012); 77 Fed. Reg. 22327 (Apr. 13, 2012); 77 Fed. Reg. 22328 (Apr. 13,
2012). These matters are susceptible of judicial notice, see infra, and because Plaintiffs seek to
force FDA to abandon its proposed approach to regulating antibiotics in animals, this Court
should know what FDA’s approach actually is.
Indeed, pursuant to 44 U.S.C. § 1507, “[t]he contents of the Federal Register shall be
judicially noticed.” See also Elsroth v. Johnson & Johnson, 700 F. Supp. 151, 161 (S.D.N.Y.
1988) (permitting judicial notice of preamble to FDA regulation appearing in Federal Register).
The Government has properly cited the April 11 Documents to support its legal argument that its
decision to abstain from withdrawal proceedings (for now) was within FDA’s regulatory

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discretion. Govt’s Reply Br. at 11-13; see Military Toxics Project v. E.P.A. 146 F.3d 948, 954
(D.C. Cir. 1998) (EPA policy document and General Accounting Office reports were “judicially
cognizable apart from the record as authorities marshaled in support of a legal argument.”).
Ultimately, as with the 2012 AHI Statement, supra, were this Court to conclude that it
may only consider the April 11 Documents to the extent that they are reflected in the formal
administrative record, this matter should be remanded back to FDA so that the new information
can be added. See Fla. Power & Light Co., 470 U.S. at 744. But because this Court may
consider these new developments now, such remand is unnecessary.
CONCLUSION
For the foregoing reasons, Plaintiffs’ Motion should be denied.
Dated: New York, New York
May 7, 2012
Respectfully submitted,
PREET BHARARA
United States Attorney
Southern District of New York
/s/ Amy A. Barcelo
By: AMY A. BARCELO
ELLEN M. LONDON
Assistant United States Attorney
86 Chambers Street
New York, New York 10007
Tel.: [phone]
Fax: [phone]
Email: [e-mail]
OF COUNSEL:
DAVID J. HOROWITZ
Deputy General Counsel

ELIZABETH H. DICKINSON
Chief Counsel, Food and Drug
Division

ERIC M. BLUMBERG
Deputy Chief Counsel, Litigation

THOMAS J. COSGROVE
Associate Chief Counsel

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U.S. Department of Health and Human Services
Office of the General Counsel
White Oak 31 Room 4331
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002
(Tel): [phone]

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