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

Filing 39

MEMORANDUM OF LAW in Support re: 38 MOTION for Leave to File Supplemental Complaint.. 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
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Plaintiffs,
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v.
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UNITED STATES FOOD AND DRUG
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ADMINISTRATION; MARGARET
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HAMBURG, in her official capacity as
Commissioner, United States Food and Drug )
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Administration; CENTER FOR
VETERINARY MEDICINE; BERNADETTE )
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DUNHAM, in her official capacity as
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Director, Center for Veterinary Medicine;
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UNITED STATES DEPARTMENT OF
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HEALTH AND HUMAN SERVICES; and
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KATHLEEN SEBELIUS, in her official
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capacity as Secretary, United States
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Department of Health and Human Services,
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Defendants.
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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.,

11 CIV 3562 (THK)
ECF Case

MEMORANDUM OF LAW IN SUPPORT OF PLAINTIFFS’
MOTION FOR LEAVE TO FILE A SUPPLEMENTAL COMPLAINT
Plaintiffs Natural Resources Defense Council (NRDC), Center for Science in the Public
Interest (CSPI), Food Animal Concerns Trust (FACT), Public Citizen, and Union of Concerned
Scientists (UCS) seek leave to file a Supplemental Complaint to challenge the U.S. Food and
Drug Administration’s (FDA’s) denial of two citizen petitions. Granting Plaintiffs’ motion will
promote an efficient resolution of the entire controversy between the parties and will not
prejudice the Defendants (collectively, FDA).

STATEMENT OF FACTS
Plaintiffs filed this action on May 25, 2011, and filed an amended complaint on July 7,
2011. Plaintiffs claimed that (1) FDA had violated the Administrative Procedure Act, 5 U.S.C.
§ 706(1), and the Federal Food, Drug, and Cosmetic Act (Food and Drug Act), 21 U.S.C.
§ 360b(e)(1), by failing to withdraw approvals for subtherapeutic uses of penicillin and
tetracyclines in animal feed, after finding in 1977 that these drug uses were not shown to be safe
for human health; and (2) FDA had delayed unreasonably in ruling on citizen petitions filed in
1999 and 2005 (the Petitions). The Petitions, filed by CSPI, FACT, Public Citizen, and UCS,
requested that FDA withdraw approvals for nontherapeutic uses of antibiotics in livestock if
those antibiotics are also important to human medicine. The Petitions cited numerous studies and
reports by public health organizations worldwide, all concluding that using medically important
antibiotics in livestock—particularly for nontherapeutic purposes such as increasing the rate of
weight gain—presents serious risks to human health. Such drug use promotes the development of
antibiotic-resistant bacteria that can be, and have been, transferred from animals to people.
FDA sought a sixty-day extension to respond to Plaintiffs’ complaint. Plaintiffs
consented, on the condition that FDA agree to an expeditious schedule for briefing the merits,
given the long history of agency inaction and the urgency of the public health concerns. Plaintiffs
filed a motion for summary judgment on October 6, 2011, in accordance with the Court-ordered
briefing schedule. On November 7, 2011, the day before FDA’s response to Plaintiffs’ motion
for summary judgment was due, FDA denied both Petitions, mooting the unreasonable delay
claim. FDA then requested, and eventually received, an additional extension of time to file its
response and cross-motion for summary judgment on Plaintiffs’ remaining claim, which are now
due on January 9, 2012.

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In denying the Petitions, FDA did not dispute the science or analysis underlying them. On
the contrary, the agency acknowledged that “we share your concern about the use of medically
important antimicrobial drugs in food-producing animals for growth promotion and feed
efficiency indications (i.e., production uses).” FDA explained, nonetheless, that “for various
reasons the Agency has decided not to institute formal withdrawal proceedings at this time and
instead” has sought to address the problem by issuing a nonbinding draft guidance document,
which recommends that livestock producers voluntarily refrain from using medically important
antibiotics for production purposes. FDA made no attempt to explain whether or how its
alternative approach comports with its statutory duty to withdraw approvals for animal drugs that
are unsafe or not shown to be safe for the uses for which they were approved. See 21 U.S.C.
§ 360b(e)(1).
Plaintiffs now move for leave to file a Supplemental Complaint to challenge FDA’s
denials of the Petitions. Counsel for FDA has indicated that FDA will oppose this motion.
ARGUMENT
Rule 15(d) of the Federal Rules of Civil Procedure permits a party to move to “serve a
supplemental pleading setting out any transaction, occurrence, or event that happened after the
date of the pleading to be supplemented.” Fed. R. Civ. P. 15(d). Rule 15(d) reflects “a liberal
policy favoring a merit-based resolution of the entire controversy between the parties.”
Witkowich v. Gonzales, 541 F. Supp. 2d 572, 590 (S.D.N.Y. 2008) (internal quotation marks
omitted); accord Wells v. Harris, 185 F.R.D. 128, 133 (D. Conn. 1999) (“The purpose of Rule
15(d) is to promote as complete an adjudication of the dispute between the parties as possible by
allowing the addition of claims which arise after the initial pleadings are filed.” (internal
quotation marks omitted)). Whether to grant a motion under Rule 15(d) is committed to the
sound discretion of the district court. Leave to file a supplemental pleading “should be freely
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permitted when the supplemental facts connect it to the original pleading.” Quaratino v. Tiffany
& Co., 71 F.3d 58, 66 (2d Cir. 1995). “Absent undue delay, bad faith, dilatory tactics, undue
prejudice to the party to be served with the proposed pleading, or futility,” a motion for leave
“should be freely granted.” Id. (citing Foman v. Davis, 371 U.S. 178, 182 (1962)).
Granting Plaintiffs’ motion would “promote the economic and speedy disposition of the
controversy between the parties.” Bornholdt v. Brady, 869 F.2d 57, 68 (2d Cir. 1989). Plaintiffs’
new claim challenging FDA’s denial of the Petitions is closely related to Plaintiffs’ claim that
FDA’s failure to withdraw approval of subtherapeutic uses of penicillin and tetracyclines in
animal feed, in accordance with its 1977 safety findings, is an agency action unlawfully
withheld. See Eison v. Kallstrom, 75 F. Supp. 2d 113, 116 (S.D.N.Y. 1999) (explaining that the
allegations in the supplemental pleading “‘do not need to arise out of the same transaction or
occurrence as the original; they need only bear some relationship to the subject of the original
pleading’” (quoting 3 James Wm. Moore et al., Moore’s Federal Practice, ¶ 15.30, at 15-108 (3d
ed. 1998))). The facts underlying the two claims are strikingly similar: In both cases, FDA has
acknowledged that nontherapeutic uses of antibiotics in livestock present serious risks to human
health, but, for reasons unrelated to—and in contravention of—its statutory obligations under the
Food and Drug Act, FDA has failed or refused to withdraw its prior approval for such drug uses.
Instead, the agency has relied entirely on the willingness of drug sponsors and livestock
producers to take voluntary measures to address the problem. FDA has offered neither a statutory
justification for this decision, nor evidence that a nonbinding approach will have any effect on
industry practices. The drugs implicated by FDA’s 1977 safety findings are among the drugs
covered by the Petitions. Given the substantial factual overlap, granting Plaintiffs’ motion would

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promote judicial economy and a speedy, merits-based resolution of the entire dispute between
the parties.
Plaintiffs’ motion for leave to supplement is made in good faith and without undue delay.
FDA denied the Petitions just two months ago, on November 7, 2011. See Aktiebolag v. Andrx
Pharms., Inc., 695 F. Supp. 2d 21, 30 (S.D.N.Y. 2010) (finding no undue delay where plaintiffs
informed the court of their intention to move to supplement their complaint three months after
the need for supplementation arose).
Finally, there is no undue prejudice to FDA. In evaluating “prejudice,” courts consider
“whether the assertion of the new claim would . . . require the opponent to expend significant
additional resources to conduct discovery and prepare for trial” or “significantly delay the
resolution of the dispute.” Block v. First Blood Assocs., 988 F.2d 344, 350 (2d Cir. 1993)
(considering motion to amend pleading under matching standards of Fed. R. Civ. P. 15(a); see
Quaratino, 71 F.3d at 66). Granting Plaintiffs’ motion at this stage of the litigation will not
require FDA to expend significant additional resources. Plaintiffs’ Supplemental Complaint
raises issues closely related to those presented by their First Amended Complaint, filed on July 7,
2011, and this case is unlikely to involve discovery. See Witkowich, 541 F. Supp. 2d at 591
(finding no undue prejudice where plaintiff would be adding a new claim after defendants had
filed a motion for summary judgment but before a trial date had been set). Nor will granting the
motion significantly delay the resolution of the dispute. Plaintiffs respectfully propose the
following schedule for briefing the merits of the new claim: (1) Plaintiffs would file a
supplemental motion for summary judgment on February 13, 2012; (2) FDA would respond to
Plaintiffs’ motion by February 27, 2012; and (3) Plaintiffs would reply by March 5, 2012. Under

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this schedule, the entire dispute will be fully briefed less than a month after briefing otherwise
would have concluded.
CONCLUSION
For these reasons, Plaintiffs respectfully request that this Court grant them leave to file
the Supplemental Complaint.

Dated: January 6, 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
[phone]
[phone] (fax)
[e-mail]
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
[phone]
[phone] (fax)
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
[phone]
[phone] (fax)

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