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

Filing 46

MEMORANDUM OF LAW in Opposition re: 36 FIRST MOTION for Leave to File Supplemental Complaint., 38 MOTION for Leave to File Supplemental Complaint.. 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 OF LAW IN OPPOSITION TO PLAINTIFFS’
MOTION FOR LEAVE TO FILE A SUPPLEMENTAL COMPLAINT
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 above-captioned defendants (hereafter, the ―Government‖), by their attorney, Preet
Bharara, United States Attorney for the Southern District of New York, respectfully submit this
memorandum of law in opposition to Plaintiffs‘ motion for leave to file a supplemental
complaint dated January 6, 2012 (―Plfs‘ Br.‖).
PRELIMINARY STATEMENT
This case, involving two narrow claims, is nearly over. Plaintiffs‘ first claim, that the
Government unreasonably delayed in responding to two Citizen Petitions (the ―Citizen Petitions
Claim‖), has been resolved and dismissed as moot. Briefing on the second claim, which pertains
to the legal significance of two 34-year-old ―notices of opportunity for hearing‖ (the ―1977
NOOHs‖) for the possible withdrawal of approvals for the ―subtherapeutic‖ uses of penicillins
and tetracyclines in animal feed (the ―NOOH Claim‖), is nearly complete. Within just a few
short weeks, this case will be ready for final judgment.
Now, with the end of the case in sight, Plaintiffs are attempting to bootstrap on an
entirely new claim, this one based on different facts and law. Plaintiffs‘ proposed new claim (the
―Third Claim‖) alleges that the responses to the two Citizen Petitions issued by the Food and
Drug Administration (―FDA‖ or ―Agency‖) on November 7, 2011 (the ―Petition Responses‖),
should be remanded to the Agency on the ground that they are ―arbitrary and capricious‖ under
section 706(a)(2) of the Administrative Procedure Act (―APA‖), 5 U.S.C. § 501 et seq. As
discussed further below, the proposed Third Claim is very different from the NOOH Claim, and
it should be resolved by way of a new complaint.
Plaintiffs‘ motion should also be denied because the expedited approach that they
advance to resolve the Third Claim would prejudice the Government by not providing it with
sufficient time to adequately preparing for and defend against the proposed Third Claim. The

schedule that Plaintiffs propose provides little time for defense counsel to, among other things,
compile an administrative record in support of the Petition Responses, if one is ultimately
required. Just as troubling is Plaintiffs‘ proposal that the proposed Third Claim be resolved
almost instantly through a ―supplemental‖ motion to be filed on February 13, 2012, to which the
Government would have only 13 calendar days to respond.
In the alternative, if this Court grants Plaintiffs‘ motion, it should allow the Government
60 days to respond to the Third Claim. That amount of time matches the period provided to the
United States and its agencies to respond to new complaints. See Fed. R. Civ. P. 12(a)(2). No
less time should be allowed here given that the Third Claim would substantially broaden the
scope of this litigation.
BACKGROUND
Plaintiffs filed their complaint on May 25, 2011, which they amended on July 7, 2011.
See Dkt. Nos. 1 &11. The amended complaint contains two claims pursuant to APA section
706(1), both seeking to ―compel agency action unlawfully withheld or unreasonably delayed.‖
First, the NOOH Claim alleges that the Government has unlawfully failed to withdraw approval
for ―subtherapeutic‖ uses of penicillin and tetracycline antibiotics based on the 1977 NOOHs.
Am. Compl. ¶ 98 (Dkt. No. 11). The parties are almost finished briefing the NOOH Claim,
which is scheduled to be completed on February 10, 2012.
Second, the Citizen Petitions Claim alleges that the Government has ―delayed
unreasonably‖ in issuing a final response to Citizen Petitions submitted by certain Plaintiffs in
1999 and 2005, which requested that the Agency withdraw approval of subtherapeutic uses of
five classes of antibiotics in livestock. Am. Compl. ¶ 101. The Government issued tentative
responses to these Citizen Petitions on February 28, 2001 and October 4, 2005, respectively,

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which informed the petitioners that the relief requested could not be granted at that time. See
Exhibits J & L to the Declaration of Jennifer A. Sorenson dated October 5, 2011 (Dkt. No. 33).
The Government issued final response to the two Citizen Petitions on November 7, 2011. See
Exhibits I & J to the Declaration of Amy A. Barcelo dated January 9, 2012 (Dkt. No. 44).
Accordingly, the parties stipulated to the dismissal of the Citizen Petitions Claim as moot, and
the Court ―so-ordered‖ that dismissal on January 6, 2012. See Dkt. No. 37.
On January 6, 2012—two months after the Government issued the Petition Responses—
Plaintiffs filed the instant motion for leave to file a supplemental complaint bringing the Third
Claim. Unlike the Citizen Petitions Claim, which challenged the Agency‘s delay in responding
to the Citizen Petitions under section 706(1) of the APA, the Third Claim alleges that the Citizen
Petition Responses themselves were ―arbitrary and capricious‖ under section 706(2)(A) of the
APA. In their motion, Plaintiffs also ask the Court to order an expedited briefing schedule to
resolve their Third Claim. See Plfs‘ Br. at 5-6.
ARGUMENT
I. PLAINTIFF’S MOTION FOR LEAVE TO FILE A SUPPLEMENTAL COMPLAINT
SHOULD BE DENIED
A. The Court has Discretion to Deny Leave to File a Supplemental Complaint
Pursuant to Rule 15 of the Federal Rules of Civil Procedure (the ―Federal Rules‖), a court
―may, on just terms, permit a party to serve a supplemental pleading setting out any transaction,
occurrence, or event that happened after the date of the pleading to be supplemented,‖ and ―may
order that the opposing party plead to the supplemental pleading within a specified time.‖ Fed.
R. Civ. P. 15(d). The ―decision whether to grant leave to amend or supplement a pleading is
within the sound discretion of the Court.‖ Ruotolo v. City of New York, No. 03 Civ. 5045 (SHS)
(DF), 2005 WL 1253936, *5 (S.D.N.Y. May 25, 2005) (citing Quarantino v. Tiffany & Co., 71
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F.3d 58, 66 (2d Cir. 1995)). A court may properly exercise its discretion by denying leave to
supplement where, as here, the claim asserted in the original complaint is now moot and
plaintiffs would have the opportunity to ―reassert the matters set out in the purported
supplemental complaint in an appropriate proceeding.‖ See, e.g., Cherry v. Morgan, 267 F.2d
305 (5th Cir. 1959) (affirming district court‘s denial of motion for leave to file supplemental
complaint). A motion to supplement under Rule 15(d) should also be denied where the
supplementation is ―proposed in bad faith, or would be unduly prejudicial or futile.‖ Ruotolo,
2005 WL 1253936, at *5 (S.D.N.Y. May 25, 2005) (citing Quarantino, 71 F.3d at 66).
B. The Court Should Deny Plaintiffs’ Motion for Leave to File a Supplemental
Complaint
Because Plaintiffs‘ Third Claim is entirely distinct from both the Citizen Petitions Claim
(which has been dismissed as moot) and the NOOH Claim, this Court would be acting well
within its discretion to deny Plaintiffs‘ request. See Cherry, 267 F.2d 305.
Plaintiffs are wrong to argue that the Third Claim is ―strikingly similar‖ to their NOOH
Claim (Plfs‘ Br. at 4), merely because both claims relate to the Government‘s regulation of
antibiotics in animal feed. Indeed, both the factual and legal bases for the two claims are very
different. The NOOH Claim was brought pursuant to APA section 706(1), ―can proceed only
where a plaintiff asserts that an agency failed to take a discrete agency action that it is required
to take.‖ Norton v. Southern Utah Wilderness Alliance, 542 U.S. 55, 64 (2004) (emphasis in
original). As the Government argued in its summary judgment brief, the NOOH Claim raises
narrow legal issues that are now positioned for prompt resolution. See Dkt. No. 41 at 11-19.
Simply put, FDA made no ―findings‖ decades ago that could compel a withdrawal of any drug
approvals now. Id.

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Plaintiffs‘ proposed Third Claim, on the other hand, is brought pursuant to APA section
706(2)(A), and challenges FDA‘s November 7, 2011 Petition Responses as ―arbitrary and
capricious.‖ See Plaintiff‘s proposed First Supplemental Complaint for Declaratory and
Injunctive Relief (the ―Supp. Comp.‖) ¶ 38 (Dkt. No. 38). The law to be applied to an APA
section 706(2)(A) claim is different from the law applicable to the NOOH Claim. Under section
706(2)(A), agency actions are to be upheld so long as they are ―rational, based on consideration
of the relevant factors and within the scope of the authority delegated to the agency by the
statute.‖ Motor Vehicle Mfrs. Ass’n of the United States, Inc. v. State Farm Mut. Auto Ins. Co.,
463 U.S. 29, 42 (1983). The substantive merits review of final agency action under section
706(2) bears little relation to the determination of whether the agency has a duty to act under a
section 706(1) analysis.
The factual bases for the proposed Third Claim also have little to do with FDA‘s
proposed administrative proceedings in 1977, which form the basis for Plaintiffs‘ NOOH Claim.
The proposed Third Claim pertains solely to the bases for FDA‘s denial of the Citizen Petitions
two months ago in November 2011. See Supp. Compl. ¶¶ 3, 20. Whether these denials were
arbitrary and capricious would depend on an analysis of FDA‘s justification for its recent action,
not the proposed bases for issuing the 1977 NOOHs 34 years ago. Indeed, FDA has recently
made clear that it considers the 1977 NOOHs to be largely outdated, and that its current actions
with regard to the issue of antimicrobial resistance are guided by the scientific knowledge and
scientific policy considerations as they exist today. See Memorandum of Law in Support of the
Government‘s Motion for Summary Judgment and in Opposition to Plaintiffs‘ Motion for
Summary Judgment at 10-11 (Dkt. No. 41) (discussing the reasons behind the FDA‘s recent
withdrawals of the 1977 NOOHs).

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The Third Claim is also much broader than the NOOH Claim, which provides another
sound reason why it can properly be brought only through a freestanding complaint.
Specifically, penicillin and tetracycline classes of animal drug products are the only drugs classes
at issue in the NOOH Claim (see, e.g., Am. Compl. ¶ 96), and FDA believes that this Court‘s
disposition of that claim could implicate more than 73 approved penicillin and tetracycline
animal drug products. The Third Claim, however, pertains not only to penicillins and
tetracyclines, but also to antimicrobials in the aminoglycoside, streptogramin, macrolide,
lincomycin, and sulfonamide classes (see Supp. Compl. ¶ 14), which FDA estimates could
implicate more than 107 approved animal drug products in addition to those products at issue in
the 1977 NOOHs.1 While it is too early to know what effect the broader scope of the Third
Claim would have on the conduct of this litigation, it is plain that a substantial expansion of this
case now would not aid in the efficient disposition of the claims that are almost fully briefed and
ready for final judgment.
Plaintiffs‘ attempt to expedite review of this new claim with a substantially expanded
factual scope would prejudice the Government because it would not provide the Government
with an adequate opportunity to prepare by assessing and integrating new legal and factual
claims. Plaintiffs‘ argument that the Government will not suffer prejudice because no ―trial‖
date has been set for Plaintiffs‘ NOOH Claims (Plfs‘ Br. at 5), is inapposite because there is no
―trial‖ in APA cases. In an action under the APA, no trial is necessary because ―when a party
seeks review of agency action under the APA, the district judge sits as an appellate tribunal [and]

1

These totals include the number of approved applications held by companies for the
relevant antimicrobial drugs (including generic versions), for use in animal feed, either alone or
in combination with other approved drugs. These totals do not include approvals the use of the
relevant antimicrobial drug in water, inclusion of which would likely increase the totals by
several dozen.
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the ‗entire case‘ on review is a question of law.‖ American Bioscience, Inc. v. Thompson, 269
F.3d 1077 (D.C. Cir. 2001); see also Florida Power & Light Co. v. Lorian, 470 U.S. 729, 744
(―The factfinding capacity of the district court is thus unnecessary to judicial review of agency
decisionmaking‖).
The Government would likewise suffer substantial prejudice if the Court were to endorse
the briefing schedule that Plaintiffs proposed unilaterally. See Plfs‘ Br. at 5-6. The proposed
schedule would give the Government less time to respond to Plaintiffs‘ summary judgment
motion than this Court‘s Local Civil Rules and the Federal Rules provide.2 Indeed, Plaintiffs do
not provide any reason why such a rushed resolution of this new claim is necessary or warranted,
particularly in light of the two-month period that Plaintiffs waited after the Government issued
the Petition Responses before they filed the instant motion to supplement.
Plaintiffs‘ proposed briefing schedule is also objectionable because it presumes that the
Third Claim must be immediately resolved through cross-motions for summary judgment.
However, nothing in Rule 15(d) precludes the Government from filing a motion to dismiss
Plaintiffs‘ Third Claim on any of the grounds enumerated in Rule 12(b). Nor does Plaintiffs‘

2

Assuming that Plaintiffs would electronically serve the Government with copies of their
motion papers, as they have done with the motions they have filed in this action to date, if
Plaintiffs were to file their proposed motion on February 13, 2012 as they propose, the rules
would provide for Government‘s opposition to be due on March 1, 2012, not February 27, 2012.
See Local Civil Rule 6.1(b) (providing 14 days to oppose a motion filed pursuant to Fed. R. Civ.
P. 56, and referring to Fed. R. Civ. P. 6 for purposes of ―computing period of days‖); Fed. R.
Civ. P. 6(d) (adding ―3 days‖ to the period of a time granted to a party to take action ―within a
specified time‖ where service is made electronically).
Indeed, the original briefing schedule that the parties‘ negotiated to address the Citizen
Petitions Claim and the NOOH Claim granted the Government more than a month to oppose
Plaintiffs‘ motion for summary judgment and cross-move for summary judgment. See Dkt. No.
18 (the Court‘s endorsement of the parties‘ original briefing schedule for the Citizen Petitions
Claim and the NOOH Claim).
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proposed schedule provide time for the Government to file an answer to Plaintiffs‘ new claims or
compile the administrative record that may be necessary to resolve this action.3
C. In the Alternative, the Government Should be Allowed 60 Days to Respond to the
Supplemental Complaint
If the Court were to grant Plaintiffs‘ request for leave to file the supplemental complaint,
Rule 15(d) requires that any such grant be on ―just terms.‖ See Fed. R. Civ. P. 15(d). Here, the
Government should at least be granted 60 days to respond to the supplemental complaint, which
is the time that the Government would have to respond to a new complaint under Federal Rule
12(a)(2). This time would allow the Government to better evaluation Plaintiffs‘ challenges and
determine whether it will be necessary to compile and file an administrative record. If the Court
allows Plaintiffs to file the supplemental complaint and grants the Government 60 days to
respond to the supplemental complaint, and if the Government answers the supplemental
complaint rather than file a motion pursuant to Rule 12, the Government proposes that the parties
then attempt to reach agreement on a briefing schedule that accommodates the needs of all
parties.

In an action brought pursuant to the APA, the court‘s review of a challenged agency
action is generally limited to the administrative record that formed the basis for the agency‘s
decision. See, e.g., IMS, P.C. v. Alvarz, 129 F.3d 618, 623 (D.C. Cir. 1997) (―It is a widely
accepted principle of administrative law that the courts base their review of an agency‘s actions
on the materials that were before the agency at the time its decision was made.‖); see also James
Madison Ltd. v. Ludwig, 82 F.3d 1085, 1095 (D.C. Cir. 1996) (same).
3

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CONCLUSION
For the foregoing reasons, the Court should deny Plaintiffs‘ motion for to leave to file a
supplemental complaint. If the Court does allow Plaintiffs to file the supplemental complaint,
the Court should order the Government to respond to the supplemental complaint within 60 days.
Dated: New York, New York
January 20, 2012
Respectfully submitted,
PREET BHARARA
United States Attorney
Southern District of New York

/s/ Amy A. Barcelo
By: AMY A. BARCELO
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
Acting Chief Counsel, Food and Drug
Division

ERIC M. BLUMBERG
Deputy Chief Counsel, Litigation

THOMAS J. COSGROVE
Associate Chief Counsel

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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