IN THE UNITED STATES DISTRICT COURT
FOR THE EASTERN DISTRICT OF NEW YORK
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ANNIE TUMMINO, et al.,
Plaintiffs,
No. 12-CV-0763 (ERK/VVP)
v.
MARGARET HAMBURG, et al.,
Defendants.
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PLAINTIFFS’ MEMORANDUM IN SUPPORT OF MOTION FOR
ATTORNEYS’ FEES AND COSTS
INTRODUCTION
Plaintiffs seek an award of attorneys’ fees and costs for work performed in this highly
complex and exceptional challenge under the Administrative Procedures Act (APA) which was
necessitated by and ultimately remedied Defendants’ corruption of the administrative process for
over a decade concerning the over-the-counter status of emergency contraception. Plaintiffs
fought over a 12-year period to remedy the unlawful government interference and undue delays
in the administrative process amounting to an “administrative agency filibuster,” involving eight
years of cumulative litigation in two District Court cases and an appeal to the Second Circuit.
Plaintiffs successfully obtained injunctive relief under the APA requiring the Food and Drug
Administration (FDA) and Health and Human Services to grant a Citizen Petition for
unrestricted over-the-counter access to emergency contraception. Defendants had improperly
denied the Citizen Petition twice, and it was Plaintiffs’ efforts that resulted in the removal of all
scientifically unsupported, arbitrary, capricious and unlawfully politically motivated age and
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point-of-sale restrictions enacted by the government to obstruct over-the-counter access to
emergency contraception. Tummino v. Hamburg (hereinafter “Tummino II”), No. 12-CV-763
(ERK)(VVP), 2013 U.S. Dist. Lexis 49666, *87, 101-02, 105-06 (E.D.N.Y. April 5, 2013).
Plaintiffs’ tenacious and skilled litigation of this case resulted in success which has removed
unlawful political interference from the science-based federal drug approval process and
positively impacted the reproductive health and lives of millions of women and girls around the
United States who now have timely access to emergency contraception to avoid the risk of
unintended and unwanted pregnancy.
As established below, Plaintiffs satisfy all statutory requirements for an award of fees and
costs under the Equal Access to Justice Act (EAJA), 28 U.S.C. § 2412. Plaintiffs indisputably are
prevailing parties, and neither the government’s pre-litigation conduct, nor its litigation position,
were substantially justified. Moreover, the government’s claims in this litigation were without
any legal or factual basis and were made for improper purposes, including delay and political
interference with the drug approval process. Therefore, having achieved excellent success in this
action, Plaintiffs are entitled to their reasonable attorneys’ fees and costs expended in this case
pursuant to the EAJA, 28 U.S.C. § 2412.
1
PROCEDURAL AND FACTUAL BACKGROUND
This Court is familiar with the underlying facts of this case which are set forth in detail in
the Court’s opinions in Tummino v. Torti (hereinafter “Tummino I”), 603 F. Supp. 2d 519, 540
1
Plaintiffs’ Motion for Attorneys’ Fees and Costs, and for Enlargement of Time to File Petition or,
Alternatively, to Stay This Motion Until Resolution of all Post-Judgment Requests for Relief was filed on May 9,
2013. (ECF No. 97.) Plaintiffs hereby incorporate that motion by reference with appropriate amendments to the
estimates of the reasonable number of hours and costs as was noted in the motion. Plaintiffs have also,
contemporaneously with this memorandum, filed a Notice of Motion nunc pro tunc.
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(E.D.N.Y. 2009),
2
Tummino II, at *4-18, and Tummino v. Hamburg (hereinafter “Tummino III”),
No. 12-CV-763 (ERK)(VVP), 2013 U.S. Dist. Lexis 67019, *3-9 (E.D.N.Y. May 10, 2013).
Accordingly, Plaintiffs provide an abbreviated set of facts and proceedings here for purposes of
this motion. The facts and proceedings in Tummino I are reviewed here for context, but
Plaintiffs are only seeking compensation here for work completed after Tummino I, post-remand
to present.
Over the last 12 years, Defendants engaged in a pattern of arbitrary and capricious
conduct ultimately culminating in the improper denial of the Citizen Petition seeking unrestricted
over-the-counter status for Plan B – the original two-pill emergency contraceptive product – and
all drugs that are equivalent to Plan B. Tummino III, at *5. For over a decade, the FDA failed to
properly consider scientific evidence that supported unrestricted over-the-counter approval of
levonorgestrel-based emergency contraception for all ages and without any point-of-sale
requirements. See Tummino II, at *12 (the FDA’s Center for Drug Evaluation and Research has
concluded that “Plan B One-Step should be approved for nonprescription use for all females of
child-bearing potential”) (internal quotation marks omitted); Tummino I, at 528-34 (citing FDA
2003 advisory committee vote 23-4 to recommend “Plan B for over-the-counter status without
age or point-of-sale restrictions,” unanimous vote that “Plan B is safe for use in a non-
prescription setting,” and history of FDA review staff scientific findings to approve over-the-
counter access without restriction).
The effort to bring these products over-the-counter began in 2001, when Plaintiff
Association of Reproductive Health Professionals and others filed a Citizen Petition asking the
2 By Order dated March 6, 2013, ECF No. 78, the Court amended its opinion of March 23, 2009. Unless
otherwise specified, citations to Tummino I refer to sections of the opinion that were not altered by the Court’s
March 6, 2013, Order and to the published version of the opinion in the Federal Supplement.
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FDA to switch Plan B “and any new drug eligible for filing an abbreviated new drug application
because of its equivalence to . . . Plan B” from prescription only to over-the-counter status.
Citizen Petition (Feb. 14, 2001), ECF No. 95 at 8; Tummino I, at 526. For most of the time that
the Citizen Petition was pending, the FDA considered various requests from the manufacturer of
Plan B and subsequently, Plan B One-Step, known as supplemental new drug applications
(SNDAs), to put their products over-the-counter. Throughout these proceedings, Defendants
“inextricably tied” the consideration of the Citizen Petition with the SNDAs. See Tummino I, at
523, 543; see also Tummino II, at *73-74, 86-87.
In 2005, after four years of inaction, Plaintiffs brought this litigation to compel the FDA
to make a decision whether to grant or deny the Citizen Petition. In June of 2006, the FDA
denied the Citizen Petition. Tummino I, at 536. Even though the FDA had effectively made a
decision on the Citizen’s Petition at the time it denied the Plan B sponsor’s first SNDA, it waited
almost three years (and only after this lawsuit was filed) to communicate that decision to
Plaintiffs. Id., at 536-37. The record is clear that from early on the process was tainted by
improper political interference which “significantly affect[ed]” FDA’s decision-making on the
over-the-counter switch, including “pressure coming from the White House.” Id., at 529.
The lawsuit uncovered numerous examples of significant departures from FDA policies
and procedures as to both the Citizen Petition and the SNDAs. For example, despite the fact that
the FDA had helped craft the actual use
3
study performed by the Plan B sponsor in connection
with its first SNDA, the FDA subsequently denied that application largely on the grounds that
3
An actual use study simulates over-the-counter use of a product to predict if a drug will be used correctly
by the target population. Tummino II, at *43-44, citing Decl. of Cynthia C. Harper, Ph.D. in Support of Pls.’ Mot.
for Prelim. Inj. and Summ. J. (Feb. 16, 2012) ¶ 5, ECF No. 3 at 2-3. The FDA typically does not require subjects of
any particular age to be included in actual use studies, Tummino II, *41-42 (citations omitted), rather, “the Agency
has a long history of extrapolating findings from clinical trials in older patients to adolescents.” Tummino I, at 527
(internal quotation marks omitted).
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the study was inadequate. Tummino I, at 526, 532. The evidence also showed that the decision to
deny the Plan B SNDA was made by the Commissioner “before FDA staff had completed their
scientific reviews of the data.” Id., at 530.
In August 2006, the FDA approved a SNDA to make Plan B available over-the-counter
for consumers 18 and older, creating an unprecedented dual-tier marketing regime under which
women needed either government-issued photo-identification or a prescription to access the
product. Id., at 536. “At the FDA’s insistence, the sponsor agreed to . . .distribute the product
only to licensed pharmacists, and to direct pharmacies to keep Plan B behind-the-counter.” Id.
This decision was one among many “suspect” moves. Id., at 523, 546 (“[T]he evidence strongly
suggests that even the decision to permit the OTC [over-the-counter] sale of Plan B to women
over the age of 18 was made solely to facilitate the confirmation of Dr. von Eschenbach as
Commissioner of the FDA.”).
Based on this record, in 2009, the District Court concluded that the FDA’s denial of the
Citizen Petition was “arbitrary and capricious” and “not the result of reasoned and good faith
agency decision-making.” Id., at 523. The Court remanded to the agency to reconsider the
Citizen Petition, but directed the FDA “to make Plan B available to 17 year olds without a
prescription,” finding that “[a] remand would serve no purpose” because the exclusion of 17 year
olds “runs counter to the evidence and is so implausible that it could not be ascribed to a
difference in view or the product of agency expertise.” Id., at 549-50 (internal quotation marks
omitted).
On remand, prior to the filing of Tummino II, Defendants engaged in the same bad faith
that had preceded the District Court’s 2009 decision. Tummino II, at *10-13. Causing further
undue delay of almost three years, the FDA refused to take any steps to reconsider the Citizen
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Petition. Id. Instead, the agency informed Plaintiffs that it believed that “the best way” to comply
with the order was “to review a supplemental new drug application expected to be submitted by
the sponsor of [Plan B One-Step]” for over-the-counter access for all ages. See Letter from
Frank Amanat to Suzanne Novak (Aug. 13, 2010), Case No. 05-CV-366 (ERK/VVP), ECF No.
307-3.
In November 2010, Plaintiffs filed a motion to hold Defendants in contempt based on the
FDA’s failure to make any meaningful efforts to comply with the Court’s Order directing it to
reconsider its denial of the Citizen Petition. (ECF No. 307.)
Less than one day before Plaintiffs’ Motion for Contempt was scheduled to be heard by
the Court, the FDA denied the Citizen Petition. (ECF No. 2 at 25.) Just prior to the hearing, the
FDA had recommended approval of the Plan B One-Step SNDA because “science-based
evidence” established that the drug is “safe and effective and should be approved for
nonprescription use for all females of child-bearing potential.” Tummino II, at *12 (quoting
Statement from FDA Commissioner Margaret Hamburg, M.D., on Plan B One-Step (Dec. 7,
2011), Pl. Add. 36). However, in a wholly unprecedented move, Health and Human Services
Secretary Kathleen Sebelius overruled this decision on December 7, 2011, for reasons that the
Court determined in Tummino II were “obviously political.” Tummino II, at *20-23. Although
the FDA had previously indicated to the Court that it would indefinitely defer reconsider ruling
on the Citizen Petition because it believed a decision on the Plan B One-Step SNDA would
satisfy the Court’s Order, (ECF No. 315, Defs’ Mem. of Law in Opp. to Pls.’ Mot. for Civil
Contempt, at 20-24), the government scurried at the eleventh hour to re-rule on the Citizen
Petition before having to appear in Court on Plaintiffs’ Motion for Contempt. (ECF No. 2 at 25.)
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Based on this turn of events, at the motion hearing for contempt, Plaintiffs asked to add
Secretary Sebelius as a Defendant and amend their allegations to include the actions taken
concerning the Citizen Petition and the SNDA. The Court directed that the case should be re-
opened – Tummino II was filed.
Plaintiffs filed a Supplemental Complaint, and Motions for Preliminary Injunction and
Summary Judgment, seeking an order directing Defendants to permit the drug sponsors of
levonorgestrel-based emergency contraceptives, and any drug eligible for filing an abbreviated
new drug application because of its equivalence to Plan B or Plan B One-Step, to make these
products available over-the-counter without age or point-of-sale restrictions. (ECF Nos. 2, 14.) In
essence, Plaintiffs argued that the denial of the Citizen Petition was based on significant
departures from agency policy and procedure, implausible justifications, and improper political
interference that the Court had previously found to be arbitrary, capricious and made in bad faith
in Tummino I. Id.
Defendants filed a Motion to Dismiss the Fifth Amended and First Amended
Supplemental Complaint in which they raised identical arguments – previously rejected by this
Court in Tummino I, at 539-42 – that Plaintiffs lacked standing to challenge the FDA’s denial of
the Citizen Petition and that the Court lacked jurisdiction to review the FDA or the Secretary’s
decision making process concerning the Plan B One-Step SNDA. (ECF No. 42.) Once again,
these arguments were rejected by the Court. Tummino II, at *10, n.3. Subsequently, Plaintiffs
filed a Second Amended Supplemental Complaint, adding adolescents under the age of 17. (ECF
No. 56-2.) Defendants filed yet another Motion to Dismiss (ECF No. 62.), that was also denied.
(ECF No. 62.) Despite the fact that Defendants had argued to this Court that a Plaintiff would
need to be under seventeen to have standing (Tr. of April 27, 2012, 140:1-11), Defendants
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persisted in rehashing old arguments including, for example, that 14-year old Anaya Kelly did
not have standing. (ECF No. 62.)
4
Plaintiffs also had to expend resources to respond to a Motion to Intervene by the drug
manufacturer of Plan B One-Step, Teva Women’s Health, Inc. (Teva). This required addressing
the issues created by Teva’s role in the over-the-counter approval process, including its ongoing
discussions with Defendant FDA concerning its SNDA for Plan B One-Step and various
concessions made with Defendants in age and point-of-sale restrictions by the manufacturer
which were inconsistent with Plaintiffs’ position. Plaintiffs were only advised of the decisions
resulting from these discussions concerning Teva’s SNDA when it was convenient for
Defendants. Teva was ultimately denied intervenor status and deemed an amicus curiae by the
Court. (ECF No. 86.)
Plaintiffs were also required to review what the government filed as the administrative
record in this case in July 2012. (ECF Nos. 69, 69-1 to 69-7.)
The Court also issued an Order to Show Cause at oral argument in December 2011 after
noting that to deny emergency contraception access over-the-counter to those consumers about
whom Defendants have not even expressed concerns, and for whom the data, on its face, shows
that the standards for over-the-counter access have been met, “would be the height of
arbitrariness.” (Tr. of Dec. 13, 2011, Hearing, 27:18-28:3, Case No. 05-CV-366 (ERK/VVP).)
The Order to Show Cause (OTSC) focused on the question as to “why the FDA should not be
directed to make Plan B available to those persons whom the studies submitted to the FDA
demonstrate are capable of understanding when the use of Plan B is appropriate and the
4
The government’s argument regarding standing is further evidence of bad faith. It was the government’s
position that one of the Plaintiffs must be under 17, when due to the government’s extraordinary delay Plaintiffs
who were as young as 14 during Tummino I had reached the age of majority when Tummino II commenced. (Tr. of
April 7, 2012, 139:10-142:14.) See Tummino I, Angelica Jaffe Decl. ECF. No. 259 at 5.
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instructions for its use,” see Minute Order, Tummino v. Hamburg, Case No. 05-cv-366 (Feb. 16,
2012). Plaintiffs’ were granted leave to respond to Defendants’ response to the OTSC. (ECF
Nos. 27-30, 36.)
Plaintiffs had to oppose Defendants’ Cross-Motion for Summary Judgment in which
Defendants’ primary and unsuccessful argument was that it is not FDA policy to extrapolate data
from adults to pediatric populations, and decisions about whether extrapolation is appropriate are
a matter of scientific judgment depending on data and circumstances presented in each
application. (ECF No. 71.) Defendants made these arguments concerning extrapolation even
though the Court had addressed this issue in Tummino I and found “evidence of the lack of good
faith is also confirmed by the manner in which the FDA departed from its normal procedures for
evaluating the OTC switch applications when it considered the Plan B applications[,]” including
“the FDA’s refusal to extrapolate actual use study data from the older age group to the 16 and
younger age group. There is evidence in the record that the FDA routinely extrapolated such data
when reviewing the safety and effectiveness of various other contraceptives.” Tummino I, at 526-
27, 528-29, 531-34, 547-48.
Ultimately, the Court granted Plaintiffs’ Motion for Summary Judgment and denied
Defendants’ Cross-Motion for Summary Judgment. (ECF Nos. 85, 87.)
The denial of the Citizen Petition was inevitable after Defendant Sebelius ordered the
FDA to reject the SNDA because the data that the Secretary (unreasonably) found lacking in the
SNDA was also lacking in the Citizen Petition. Tummino II, at *18-19; Tummino III, at *5-6.
The District Court additionally found the FDA’s denial of the Citizen Petition was “unsound”
based on numerous significant departures from agency policies and failures to acknowledge and
consider relevant data within its possession. Tummino II, at *72-87. These facts led the Court
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to conclude, based on an extensive factual record, that Defendants arbitrarily, capriciously and
unreasonably denied the Citizen Petition – for a second time – based on actions and decisions
that were “politically motivated, scientifically unjustified, and contrary to agency precedent.”
Tummino II, at *86.
Accordingly, the Court remanded with directions that Defendants, “grant the Citizen
Petition and make levonorgestrel-based emergency contraceptives available without a
prescription and without point-of-sale or age restrictions within thirty days.” Id., at 181-82.
Just prior to the expiration of the Court’s 30 day deadline and contrary to the Court’s
directive, the FDA announced that it had approved an amended SNDA allowing Plan B One-
Step to be sold on the shelf in retail locations with an on-site pharmacy, without a prescription, to
those 15 and older with proof of age. Tummino III, at *10-12. As a result of this change, Plan B
One-Step would not be available by prescription to anyone. All other levonorgestrel products
remained subject to the restrictions imposed on Plan B – they could only be sold behind-the-
counter at pharmacies, to women 17 and older with government-issued photo identification and
to all others only by prescription. Id., 10-13. The day after the FDA approved Teva’s amended
SNDA, Defendants filed a Notice of Appeal of this Court’s Order. (ECF No. 92.) Defendants
then moved for a stay pending appeal, attempting to rely on its approval of Teva’s amended
SNDA to show that “no plaintiff will be harmed by a stay.” Id. Plaintiffs had to litigate
Defendants’ last minute Motion for a Stay. (ECF Nos. 91-93, 95.) This Court rejected that
argument in its Order denying the Motion for Stay, finding that the approval was “intended to
provide sugarcoating for the FDA’s appeal.” Tummino III, at *11-12.
Plaintiffs then had to oppose Defendants’ appeal of the denial of their Motion for a Stay.
In denying a stay, the U.S. Court of Appeals for the Second Circuit agreed with this Court on
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June 5, 2013 “insofar as the [district court] order mandates immediate over-the-counter access to
the two-pill variants of emergency contraceptives, a stay is denied because the Appellants have
failed to meet the requisite standard. See McCue v. City of N.Y. (In re World Trade Ctr. Disaster
Site Litig.), 503 F.3d 167, 170 (2d Cir. 2007).” Doc. 85, Case No. 13-1690, U.S. Court of
Appeals for the Second Circuit. Following Defendants’ unsuccessful Motion for a Stay in the
Second Circuit, this Court approved Defendant’s plan to comply with the Court’s Order and
recognized it was the Plaintiffs alone who were responsible for the outcome in this case in
making emergency contraception over-the-counter without age or point-of-sale restrictions. (ECF
No. 106 at 6.)
The parties filed a Stipulation with the U.S. Court of Appeals for the Second Circuit
providing that Defendants voluntarily dismissed, with prejudice, the appeal of this Court’s April
5, 2013, Memorandum and Order and Final Judgment and that Plaintiffs would seek fees and
costs, including related to the appeal, from the United States District Court for the Eastern
District of New York to the extent available under the EAJA, 28 U.S.C. § 2412, or under any
other appropriate statute or authority and that Defendants may oppose any such petition. Docs.
95 & 102, Case No. 13-1690, U.S. Court of Appeals for the Second Circuit.
ARGUMENT
I. Plaintiffs Meet EAJA Requirements For a Fee Award
A. Plaintiffs are “Prevailing Parties”
Plaintiffs are entitled to attorneys fees under the EAJA if they are prevailing parties in the
litigation. 28 U.S.C. § 2412(d). Plaintiffs are considered the prevailing party for purposes of
attorneys’ fees if they succeed “on any significant issue in the litigation which achieves some of
the benefit the parties sought in bringing the suit.” Hensley v. Eckerhart, 461 U.S. 424, 433
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(1983). Plaintiffs are, without any question, prevailing parties in this litigation on their APA
claim based on the Court’s April 5, 2013, Memorandum and Order in Tummino II and the
judgment of this Court entered on April 10, 2013. (ECF No. 87.)
This Court granted injunctive and substantive legal relief in two respects on Plaintiffs’
main claim under the APA in this litigation: (1) the Court determined that Plaintiffs had
established their central legal claim, by holding that the government’s actions were arbitrary,
capricious and abuse of discretion, and (2) the Court granted Plaintiffs’ substantive relief on the
merits of their claims, by remanding the case to the FDA with “the instruction to grant the
Citizen Petition and make levonorgestrel-based emergency contraceptives available without a
prescription and without point-of-sale or age restrictions within thirty days.” Tummino II, at *86,
101-02.
B. The Government’s Position in this Case was not Substantially
Justified
Under the EAJA, a prevailing party shall be awarded fees unless the government can
prove that its position was “substantially justified.” 28 U.S.C. § 2412(d)(1)(A). To establish that
its position was substantially justified, the government must prove that both the agency’s
underlying conduct at issue in the litigation and its litigation position were substantially
justified.
5
28 U.S.C. § 2412(d)(2)(D) (“position of the United States” is defined as “ in addition
to the position taken by the United States in the civil action, the action or failure to act by the
agency upon which the civil action is based.”); see Comm’r, INS v. Jean, 496 U.S. 154, 159
(1990); see also Trichilo v. Sec’y of Health and Human Services, 823 F.2d 702, 708 (2d Cir.
5
Once a determination that the government’s position lacks substantial justification has been made, “a fee
award presumptively encompasses all aspects of the civil litigation,” including litigation to recover fees. Comm’r,
INS v. Jean, 496 U.S. 154, 160-61 (1990). Plaintiffs’ entitlement to fees also includes any fees and expenses
reasonably incurred in connection with the vindication of rights related to any appeal. Trichilo v. Secretary of Health
and Human Services, 832 F.2d 743, 745 (2d Cir. 1987), citing Trichilo v. Sec’y of Health and Human Services, 823
F.2d 702, 707-08 (2d Cir. 1987).
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1987). This must be accomplished by a “strong showing.” Environmental Def. Fund v. Watt, 722
F.2d 1081, 1085 (2d Cir. 1983) (citations omitted). To meet this burden, the government must
show that its position had a reasonable basis in both law and fact. Pierce v. Underwood, 487 U.S.
552, 565 (1988). A finding that either the government’s underlying conduct or its litigation
position was not substantially justified is sufficient to support an award under the EAJA.
Environmental Def. Fund, 722 F.2d at 1085-86.
The Court’s well reasoned and detailed opinion in Tummino II establishes how the
government’s pre-litigation and litigation position concerning the denial of the Citizen Petition
on remand lacked substantial justification. Based on a thorough and careful review of the
extensive factual record in this case and the legal arguments raised by Defendants, the Court
found the Defendants’ actions in denying the Citizen Petition were arbitrary, capricious, contrary
to agency precedent, taken for improper political reasons and in bad faith in violation of the
APA.
As the court noted, because the SNDA and Citizen Petition “were clearly linked together”
by the Defendants, once the Secretary unlawfully directed the FDA to deny the Plan B One-Step
SNDA, the FDA had no possible basis on which to approve the Citizen Petition. Tummino II, at
*63-64. Under these circumstances, it was not possible to exercise meaningful judicial review
over the denial of the Citizen Petition without considering the propriety of the Secretary’s actions
regarding the SNDA because the FDA’s own justification for its denial of the Citizen Petition
indicated a substantial reliance on the SNDA process. Id. The government’s denial of the SNDA
and the Citizen Petition, lacking a reasonable basis in fact or law, was accomplished by
significant unexplained departures from a number of established policies and practices followed
by the FDA. Furthermore, the Secretary’s unprecedented “directive to the FDA to reject the Plan
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B One-Step SNDA forced the agency to ride roughshod over the policies and practices that it has
consistently applied in considering applications for switches in drug status to over-the-counter
availability.” Tummino II, at *18-87.
The Court was clear as to the ways the government’s actions concerning the SNDA were
significant departures from agency policy, lacked any reasonable basis in fact based on the
record and violated the APA. Tummino II, at *18-36, 51-52. The most significant departure was
the unprecedented intervention of the HHS Secretary, Defendant Sebelius, in overruling the FDA
in an area which Congress has entrusted primarily to the FDA and which fell within the scope of
the authority that the Secretary expressly delegated to the Commissioner. Tummino II, at *21,
(citations omitted). Similar to the government’s actions in Tummino I where the political
interference in decision making by the FDA was improperly influenced by the Bush White
House, in taking this action, “[t]he motivation for the Secretary’s action was obviously political.”
Tummino II, at *21-22. “[T]he secretary’s decision to retain behind-the-counter status for Plan B
One-Step was based on politics rather than science. It cannot be based on issues of safety, since a
12 year-old can purchase a lethal dose of acetaminophen in any pharmacy for about $11, no
questions asked. [] Any objective review makes it clear that Plan B is more dangerous to
politicians than to adolescent girls.” Tummino II, at *23.
The Secretary’s observations about supposed “cognitive and behavioral differences”
between “older adolescent girls and the youngest girls of reproductive age” were also determined
by the Court to lack reasonable factual basis and violate the APA. Tummino II, at *25-29. In the
FDA’s scientific staff review of the first SNDA for Plan B, these observations were refuted as
beyond the scope of the FDA’s review and were “more applicable to the ability of adolescents to
make reasoned decisions about engaging in sexual intercourse, not their ability to understand
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how to use Plan B safely and effectively as an emergency contraceptive[.]” Tummino II, at *26
(emphasis added). The Secretary’s observations also had no factual basis in statistics showing
that 12% of the total U.S. population over age 16 are deemed “below basic” document literacy
(for prescription labels), yet the Secretary has never required data to conclusively establish that
100% of potential users of a drug can understand the label or precluded over-the-counter sale of
drugs for that reason. Tummino II, at *29. The Court also noted the Secretary’s failure to
articulate or define any harm that would result from over-the-counter use of levonorgestrel-based
contraceptives by this population. Unlike other over-the-counter drugs which can be readily
purchased by teens and have very dangerous or even life threatening effects or known abuses
such as acetaminophen or dextromethorphan, levonorgestrel-based contraceptives would be
among the safest drugs approved for over-the-counter sale for the pediatric population. Tummino
II, at *30-33. Finally, in highlighting the arbitrariness of the Secretary’s action, the Court also
noted that the Secretary never questioned the adequacy of the evidence regarding the ability of
older adolescents between the ages of 13 and 16 to understand Plan B One-Step’s label and use it
correctly, nor did the government ever explain its position why Plan B One-Step should not be
made available to them. Tummino II, at *34-37.
In perhaps the “most significant unexplained deviation from FDA practice ordered by the
Secretary” which lacked a reasonable factual or legal basis, the FDA failed to extrapolate studies
and data concerning emergency contraception from one age group to support approval in another
age group contrary to agency policy, practice and the APA. Tummino II, at *37-48. Defendants’
motion for summary judgment did “not provide any evidence to contradict a record which shows
that the FDA has engaged in extrapolation at the very least from older to older adolescents with
respect to the issues of actual use and label comprehension.” Tummino II, at *47-48.
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The Court’s opinion was very specific and detailed in reviewing the unreasonableness of
the government’s pre-litigation and litigation positions in this area in which they claimed that
extrapolation was not the policy of the agency. (ECF No. 71.) The Court’s findings included,
for example: (1) the government’s failure to extrapolate the data available through studies on
emergency contraception consistent with FDA policy after telling the Plan B sponsor that the
results from trial in the adult population could be extrapolated to the postmenarcheal population;
(2) the FDA’s own advisory committee of outside experts voted overwhelmingly 23-4 in favor of
over-the-counter status in 2003 and 27-1 that the actual use study data by the Plan B sponsor
could be generalized to the overall population of potential non-prescription users of Plan B (i.e.,
data from older groups could be extrapolated to younger ones); (3) in reviewing the actual use
data presented by the Plan B sponsor concerning adolescents enrolled in an actual use study,
FDA scientific staff confirmed “the Agency has a long history of extrapolating findings from
clinical trial in older patients to adolescents in both prescription and nonprescription approvals,”
a practice incorporated into the Pediatric Research and Equity Act; (4) minutes from an internal
FDA meeting in May 2004 commenting that the FDA’s failure “to extrapolate adolescent safety
and effectiveness data for under 14 year old females is not consistent with how [the Center for
Drug Evaluation and Research] handles approval and distribution of prescription oral
contraceptives”; and (5) that the FDA did engage in extrapolation in considering the Plan B One-
Step SNDA.
6
Id., at *37-48.
6
In addition, the Court found that Defendants’ own summary judgment motion identified a significant
related departure from agency practice in this area: when the FDA has declined to extrapolate because of safety
concerns, it used labeling to indicate that the drug was not to be made available to children. Tummino II, at *48-51.
The government cited examples where FDA allowed drugs to be sold over-the-counter that it did not consider safe
for use in the pediatric population. Id. (emphasis in original). “FDA’s willingness to rely on labeling to make these
drugs available for sale over-the-counter without any age or point-of-sale restrictions, even though they are unsafe
for unsupervised use by young adolescents, stands in stark contrast to its refusal to make equally available
concededly safe and time-sensitive levonorgestrel-based emergency contraceptives.” Id., at *51.
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The point-of-sale restriction on over-the-counter sale of levonorgestrel-based emergency
contraception was also determined by the Court to have no reasonable factual or legal basis. Id.,
at *51-63. The FDA “did not have the authority to mandate point-of-sale restrictions on drugs
approved for nonprescription sale that it found to be safe and effective for all women of
childbearing age[,]” and “even if it had such authority, it clearly deviated from the policy here.”
Id., at *62. Defendants’ arguments were rejected as unreasonable because they were
contradicted by the factual record and lacked any legal basis. See id., at *54-56 (noting record
evidence showing that point-of-sale restrictions not adopted voluntarily by Plan B sponsor).
The Court found that the FDA’s decision denying the Citizen Petition was
“compelled” and “inevitable” based on the reasoning and order by the Secretary to reject
the Plan B One-Step. Id., at *64-87. For example, “[t]he FDA spent a considerable
portion of the Citizen Petition Denial Letter discussing the Plan B One-Step SNDA and
the various studies submitted in its support. More significantly, the very reason the FDA
claimed it denied the Citizen Petition was the lack of age-specific data, as compared to
that submitted with the Plan B One-Step SNDA.” Id., at *64. However, even if Plaintiffs
had been able to provide such data, the FDA still would have been forced to deny their
petition on the grounds articulated by the Secretary. Id., at *75. Therefore, the Court
found that “the suggestion that the plaintiffs need to provide ‘additional data’ comparable
to that in the Plan B One-Step application ‘to support a switch of Plan B for women
young than 17 years of age’ is simply a complete pretext – another example of the bad
faith that has permeated the FDA’s consideration of the Citizen Petition from beginning
to end.” Id.
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18
The Court also noted the unsound factual reasoning of the Citizen Petition denial
letter, including the lack of any affidavit or other support on Defendants’ motion for
summary judgment to explain its flawed reasoning. Id., at *76. The FDA failed to offer
any explanation, much less factual or legal support, as to why Plan B should be treated
differently from other drugs so as to require numerous deviations from agency policies
and practices, including failing to acknowledge or explain the FDA’s own policy and
precedent of approving drugs for over-the-counter sale even where there is a real concern
about their safety. Id., at *76-77. The FDA also failed to justify the creation and
maintenance of a new and unprecedented behind-the-counter point-of-sale marketing
program to pharmacies and health clinics (for a drug where safety and efficacy is
unquestioned and poses a lesser risk to health than many other over-the-counter drugs).
Id.
While “these unexplained departures from precedent alone render the denial
arbitrary, capricious and unreasonable, they are not the only reasons” on which the Court
reversed the denial of the Citizen Petition. Id., at *77. The record showed that FDA’s
claim that no new data had been submitted by Plaintiffs or any other sources to meet the
requirements for the FDA to remove the prescription requirements for Plan B for women
under age 17 since the 2009 remand was untrue. Id., at *77. The FDA had data from at
least two sources: (1) the actual use and label comprehension studies submitted by the
Plan B sponsor in support of its SNDA; and (2) the FDA conceded that in its independent
literature review, it considered the label comprehension study conducted by Dr. Miriam
Cremer which indicated that adolescents understood the concepts necessary for safe and
effective use of emergency contraception as well as adults do. Id., at *77-82.
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19
Defendants’ position, during and prior to the litigation, that the Plan B One-Step
actual use study (or any data or studies for Plan B One-Step) could not be used to support
over-the-counter access to Plan because Plan B involves two pills taken 12 hours apart
instead of one pill was determined to be unreasonable based on the agency’s own
approval of Plan B One-Step which demonstrated the agency’s “recognition that there
would be no adverse consequences or decrease in effectiveness if the two pills were taken
at the same time or less than 12 hours apart.” Id., at *82-84. As the Court found, the
regime the Defendants had in place affected the “most significant factor in terms of
effectiveness of the product because it increases the delay between sexual intercourse and
the first dose (the only dose in the case of Plan B One-Step)” which “scientific evidence
in the record establishes” as “[t]he most important factor concerning timing of dosing and
effectiveness” and that “[i]t is [] unlikely that the effectiveness of Plan B will be reduced
if the second tablet is taken 6 to 18 hours, instead of exactly 12 hours, after the first
dose.” Id., at *84 (quoting Medical Officer’s Safety Rev. of SNDA at T-30799 (March
25, 2004), Case No. 05-cv-366, ECF No. 235-3; Raymond Decl. ¶ 36).
Moreover, the two-pill actual use study submitted with the original Plan B SNDA
demonstrated that there was “excellent compliance” with the label dosing regimen among
subjects under 18 years of age. Id., at *85. These results were confirmed by an FDA
scientific staff review. Id., at *85-86. The actual use study also did not support
Defendants’ position that the intervention by a health care provider (such as pharmacist
or doctor) impacts the timing of the second dose. Tummino II, at *86, n.11 (citing
Deputy Div. Dir. Summ. Rev. at T-30840-41, Case No. 05-cv-366, ECF No. 235-4).
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20
The Court’s ruling on the government’s action on the denial of the Citizen Petition made
clear that “despite the FDA’s fanciful effort to make it appear that it undertook an independent
review of the Citizen Petition[,]” the denial letter, “which came five days after the denial of the
Plan B One-Step SNDA, was clearly prompted by the Secretary’s action[.]” Id., at *86.
Because the Secretary’s action was politically motivated, scientifically
unjustified, and contrary to agency precedent, it cannot provide a basis to sustain
the denial of the Citizen Petition. [E]ven considering the Citizen Petition Denial
Letter in isolation, the agency’s decision cannot withstand any degree of scrutiny,
not only because of its unexplained failure to follow the FDA policies [] but also
because of its disregard for the scientific evidence that the FDA had before it.
Id., at *86-87.
Finding that Defendants’ positions – prior to and during the litigation – were
unreasonable as a matter of fact and law, the Court reversed the FDA’s decision denying the
Citizen Petition and remanded the case to the FDA with the instruction to “grant the Citizen
Petition and make levonorgestrel-based emergency contraceptives available without a
prescription and without point-of sale or age restrictions within thirty days.” Id., at *102.
The Court noted that “if the FDA actually believes there is any difference between the
one- and two-pill products, it may limit its over-the-counter approval to the one-pill product. Id.
The government ultimately agreed to remove all age restrictions on Plan B One-Step, following
with the Court’s Order, but only after engendering additional litigation by filing an appeal of the
Court’s decision in Tummino II and further restricting access to emergency contraception to only
allowing access to the most expensive product, Plan B One-Step, to those 15 and older who
could show government issued ID at stores with on-site pharmacies and ending prescription
access for anyone younger, and keeping all other products behind-the-counter subject to the
same restrictions at issue in the litigation. Tummino III, at *11-12, 19.
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21
In response to their announcement of intent to dismiss their appeal and “comply” with the
Court’s Order by making Plan B One-Step available over-the-counter without age or point-of-
sale restriction (only after unsuccessful requests for stays of this Court’s Order before this Court
and the U.S. Court of Appeals for the Second Circuit), Plaintiffs’ filed objections to Defendants’
continued refusal to approve all levonorgestrel-based emergency contraceptives over-the-counter
based on this Court’s decision in Tummino II, including two-pill products. (ECF Nos. 103, 105.)
In reviewing Defendants’ plan to comply with the Court’s Order, the Court re-iterated that
Defendants were ordered “to make levonorgestrel-based emergency contraceptives available
without a prescription and without point-of-sale restrictions” within thirty days. (ECF No. 106 at
3.) Granting an SNDA for Plan B One-Step “will have the effect of making it available without
a prescription or point-of-sale or age restrictions,” since “Plan B One-Step is one such
emergency contraceptive,” but the Court had not “order[ed] the defendants to make the brand-
name Plan B One-Step available over-the-counter without age or point-of-sale restrictions” as a
matter of jurisdiction. Id. The Court acknowledged concerns expressed by Plaintiffs that a grant
of marketing exclusivity to Teva was not warranted and would “only burden poor women.” Id. at
6. The Court also noted that [i]t is because of the extraordinary efforts by the plaintiffs in
pursuing their Citizen Petition that Teva is able to seek approval of an SNDA” and “such
approval, if given, will be nothing more than a reward to Teva for playing along with the
defendants’ efforts to maintain their legally and scientifically unjustified restrictions on the
marketing of levonorgestrel-based emergency contraceptives.” Id.
II. The Amount of Fees Sought is Reasonable
As discussed below in Section II.B., certain members of Plaintiffs’ legal team are entitled
to enhanced hourly rates above the EAJA statutory rate based on the application of a “special
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22
factor.” Accordingly, the lodestar calculations herein reflect these calculations. See 28 U.S.C. §
2412(d)(2)(a)(ii). Plaintiffs have not sought an across the board enhancement for all counsel, but
have carefully applied the applicable factors to seek enhancement where warranted as discussed
in Section II.B.1.a.b., infra.
Following the determination of an entitlement to EAJA fees, the court determines what
fee is reasonable by a calculation known as the lodestar: the number of hours reasonably
expended on the litigation multiplied by a reasonable hourly rate. Hensley, 461 U.S. at 433.
Plaintiffs’ lodestar calculations are included below and supported by the declarations and
accompanying exhibits for each attorney and paralegal listed below filed contemporaneously
herewith.
7
Plaintiffs seek fees totaling $743,862.75 for work before the District and Appellate
Courts as discussed below. The chart below provides the lodestar calculations for the counsel
seeking an enhanced hourly rate based on application of a special factor and for other counsel
based on an EAJA statutory rate applying a cost of living increase as explained in Section
II.B.1.c., infra. (The calculation for all counsel using the “bad “faith” application of market rates
in the EAJA, 28 U.S.C. § 2412(b), is in Section II.B.2, infra.)
Attorney Law School
Graduation
Requested
Rate
Hours Total
Janet Crepps
1983 $650 117.1 $76,115
Suzanne Novak
1997 $560 449.3 $251,608
Andrea
Costello
1998 $560 305.2 (PCJF)
51.3 (FILS)
$170,912 (PCJF)
$28,728 (FILS)
Kirsten Clanton
2005 $450 131.4 $59,130
7
The application of the “special factor” above the EAJA hourly rate for counsel is explained in Section
II.B., infra.
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23
Natalie
Maxwell
2005 $450 26.6 $11,970
Mara
Verheyden -
Hilliard
EAJA with cost
of living
43.2 $8,638.75
Carl Messineo EAJA with cost
of living
17.8 $3,560.00
Fried Frank
Attorneys and
Paralegal
EAJA with cost
of living
747.1 $131,698.00
8
Candice Kalis Paralegal and
2012 Law
School
Graduate
(PCJF)
$90 16.7 $1,503.00
LODESTAR
TOTAL:
$743,862.75
A. The Number of Hours Claimed is Reasonable
“Where a plaintiff has obtained excellent results, his attorney should recover a fully
compensatory fee. Normally this will encompass all hours reasonably expended in this
litigation…” Hensley, 461 U.S. at 435. Plaintiffs’ counsel achieved excellent results – the Court
found that Defendants had violated the APA and had arbitrarily, capriciously and unreasonably
denied the Citizen Petition based on actions and decisions that were “politically motivated,
scientifically unjustified, and contrary to agency precedent.” Tummino II, at *86. Accordingly,
the Court remanded with directions that Defendants, “grant the Citizen Petition and make
levonorgestrel-based emergency contraceptives available without a prescription and without
point-of-sale or age restrictions within thirty days.” Id., at *102. Plaintiffs were awarded the
injunctive relief which they sought and should be compensated for all of the hours claimed.
8
See Declaration of Janice Mac Avoy, ¶ 8 for explanation of calculations of EAJA rates for all Fried
Frank counsel and paralegals. As explained therein, Fried Frank has applied a 10% reduction in the number of hours
for which they are seeking compensation to account for any additional potential inefficiencies that may have not
been accounted for in Ms. Mac Avoy’s prior adjustments of the time entries. Id., ¶ 7.
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24
As explained in the declarations of Plaintiffs’ counsel, the number of hours for which
compensation is sought is reasonable. Declaration of Andrea Costello (Costello Decl.), Ex. A, B,
¶¶ 11, 15; Declaration of Janet Crepps (Crepps Decl.), Ex. A, ¶¶ 2-3; Declaration of Suzanne
Novak (Novak Decl.), Ex. A, ¶ 8; Declaration of Kirsten Clanton (Clanton Decl.), Ex. B, ¶¶ 16;
Declaration of Natalie Maxwell (Maxwell Decl.), Ex. B, ¶ 11, 17; Declaration of Mara
Verheyden-Hilliard (Verheyden-Hilliard Decl.), Ex. A, ¶¶ 12-14; Declaration of Carl Messineo
(Messineo Decl.), Ex. A, ¶¶ 12-13; Declaration of Janice Mac Avoy (Mac Avoy Decl.), Ex. A,
¶¶ 3-4, 6-7; Declaration of Candice Kalis (Kalis Decl.), Ex. A. The attorneys and other staff
carefully documented the work they performed by maintaining contemporaneous time records
and detailed the time spent broken down by date and activity. Id. Plaintiffs’ counsel also
exercised substantial billing discretion in the submission of hours and costs, including the
exclusion of de minimis phone calls, meetings, consultations and emails, as well as not billing for
travel costs for out of state counsel and other no billed costs.
Throughout this litigation, counsel divided responsibilities for work in the case to avoid
duplication of effort and have also exercised billing judgment to eliminate unnecessary or
duplicative hours. Id. Plaintiffs are also not seeking compensation for approximately 200 hours
spent by several legal fellow attorneys, law students, or legal assistants employed by the Center
for Reproductive Rights who, over the course of the litigation, provided hours of assistance with
tasks which were necessary for this litigation. Crepps Decl., ¶ 13. The relevant time period for
all of Plaintiffs’ counsels’ billing records commence after this Court’s decision in Tummino I.
B. The Hourly Rate Claimed is Reasonable
1. Compensation is Warranted Above the EAJA Statutory Hourly Rate
for Attorneys Whose Special Expertise and Experience was Needed in
the Litigation
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25
The EAJA generally authorizes fees at $125 per hour adjusted for inflation, however, a
court may award fees at a higher rate where “a special factor, such as the limited availability of
qualified attorneys for the proceedings involved, justifies a higher fee.” 28 U.S.C. §
2412(d)(2)(a)(ii). “[L]imited availability of qualified attorneys for the proceedings involved”
refers to “attorneys having some distinctive knowledge or specialized skill needful for the
litigation in question – as opposed to an extraordinary level of general lawyerly knowledge and
ability useful in all litigation.” Pierce, 487 U.S. at 572. Examples would be an “identifiable
practice specialty such as patent law, or knowledge of foreign law or language.” Id. Thus,
enhanced hourly rates based on this “special factor” may be awarded where the attorney has a
distinctive knowledge or specialized skill, such knowledge and skills were necessary for the
litigation and can only be obtained at rates in excess of the statutory cap. Id.; David v. Sullivan,
777 F. Supp. 212, 220-21 (E.D.N.Y. 1991).
a. Plaintiffs’ Counsel Have Distinctive Knowledge or Skill Which
Was Required for This Litigation
Awards under the EAJA are awarded as matter of practice from courts applying this
special factor.
9
Moreover, an award based on the special factor of the limited availability of
qualified attorneys with knowledge or specialized skill is appropriate when the attorneys have
extensive and unique knowledge of the procedural history and legal issues in a matter, where for
example, they have previously litigated a virtually identical case. See, e.g., David, 777 F. Supp.
at 221; see also Declaration of Carol A. Sobel (Sobel Decl.), ¶11. These attorneys have direct
expertise with the complex statutory scheme at issue, knowledge of the agency involved, and an
9
See, e.g., Martin v. Secretary of the Army, 463 F. Supp. 2d, 287, 293 (collecting cases where District
Courts have applied fee enhancement in cases for lawyers with specialized expertise), citing Raines v. Shalala, 44
F.3d 1355, 1361 (7th Cir. 1995); Pirus v. Bowen, 869 F.2d 536 (9th Cir. 1989); Nadarajah v. Holder, 569 F.3d 906
(9th Cir. 2009); Jean v. Nelson, 863 F.2d 759 (11th Cir. 1988); Nat’l Labor Relations Bd. v. Pueblo of San Juan,
305 F. Supp. 2d 1229 (D.N.M. 2003); Conn. State Dep’t of Soc. Servs. v. Thompson, 289 F. Supp. 2d 198 (D. Conn.
2003).
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understanding of the needs of the population involved. In fact, such attorneys may be the “only
[counsel that]… showed the interest and capacity necessary to investigate and obtain relief,” and
were “uniquely suited to handle the post-judgment proceedings in this action efficiently in light
of the highly specialized legal and factual knowledge necessary to undertake them.” See, e.g.,
David, 777 F. Supp. at 220-21; see also Pirus v. Bowen, 869 F.2d 536 (9th Cir. 1989) (fees in
excess of EAJA cap awarded to attorneys who had represented plaintiff class in class action and
had previously taken similar class action to Supreme Court). These factors are present here.
Through their experience litigating the unprecedented complex legal and factual issues in
Tummino I, Plaintiffs’ counsel
10
has distinctive knowledge or specialized skill needed for this
litigation which afforded them a unique familiarity and expertise that no other attorneys in the
country possessed concerning the FDA’s administrative process related to the over-the-counter
status of emergency contraception. See Declaration of Jennifer Dalven in Support of Plaintiffs’
Motion for Attorneys’ Fees, ¶¶ 5-11; Sobel Decl., ¶¶ 11-14; Declaration of Peter P. Sleasman
(Sleasman Decl.), ¶¶ 3-8. This knowledge and specialized skill was critical to Plaintiffs’ success
here.
The nuanced understanding of the FDA’s long and complicated over-the-counter
administrative process concerning emergency contraception possessed by Plaintiffs’ counsel in
this litigation is knowledge or skill that cannot be obtained by a competent practicing attorney
through routine research or legal experience and is a “distinctive or specialized skill needful for
the litigation in question – as opposed to an extraordinary level of the general lawyerly
knowledge and ability useful in all litigation.” Pierce, 487 U.S. at 572; see also Pirus, 869 F.2d
at 536. This experience and skill could only be obtained by litigating the factual and legal
10
As noted previously, only certain of Plaintiffs’ counsel are seeking an enhanced rate under the special
factors, and thus, are generally referred to here.
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27
complexities which were based on the government’s 12 year abuse of the administrative process
through arbitrary and capricious decision-making concerning emergency contraception for
improper political purpose. Counsels’ experience in litigating the highly unusual – and perhaps
unprecedented – legal challenge under the APA in Tummino I was “an experience which
afforded them the unique familiarity with its procedural history and the knowledge of legal
issues which was essential to the post-judgment proceedings.” David, 777 F.Supp. at 221. This
specialized knowledge and experience made Plaintiffs’ counsel the only advocates uniquely
suited to handle the post-judgment proceedings in the action efficiently in light of the highly-
specialized legal and factual knowledge necessary to undertake it. Id. The Court acknowledged
the specialized experience and knowledge possessed by Plaintiffs’ counsel in litigating Tummino
II when it noted that it was “only because of the extraordinary efforts by the plaintiffs in
pursuing their Citizen Petition that Teva is able to seek approval of an SNDA that will permit it
to market its product with no point-of-sale or age restrictions” and that “plaintiffs… are
responsible for the outcome of this case.” (ECF No. 106 at 6.)
As the Court noted at the hearing on Defendants’ motion for a stay of the April 5, 2013,
Order, this case was a highly unusual and unique legal challenge under the APA. (Tr. of May 7,
2013, Hearing, 75:23-25)(“[] I'm going to write an opinion in this case. I'm not deciding this
today. The irony of this all is that I would be allowing what the FDA wanted to do and an
exercise of its best scientific and expertise, to be done. I mean this is got to be one of the most
unusual administrative law cases I've ever seen[.]”) This case is precisely the type of non-routine
complex litigation which is litigated by attorneys with specialized knowledge and experience that
is entitled to an increased fee award under EAJA. See, e.g., Lagana v. Sec. of Health and Human
Services, 1992 U.S. Dist. Lexis 10424, *9 (E.D.N.Y. July 13, 1992); see also Dalven Decl. ¶ 8.
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In addition to the specialized skills and knowledge explained above, as summarized
below and explained more fully in supporting Declarations, Plaintiffs’ counsel possess
distinctive knowledge and expertise in complex civil rights litigation, advocacy for women’s
reproductive healthcare, an understanding of healthcare needs of the population whose rights
were at stake in this case and a long and close relationship with the population and client base
represented in this case. See Crepps Decl., ¶¶ 4-7; Costello Decl., ¶¶ 4-6, 14, 16-20; Novak
Decl., ¶¶ 1, 4-6, 8; Clanton Decl. ¶¶ 6-13, 17-27; Maxwell Decl., ¶¶ 5-6, 18-24; see also Sobel
Decl., ¶¶ 6-11; Dalven Decl., ¶ 6. This level of expertise was needed in this litigation and is not
available at the EAJA statutory rate, as explained in the supporting Declarations. Id.
Janet Crepps, lead counsel for CRR, is one of the most experienced reproductive rights
litigators in the country. Crepps Decl., ¶ 7. Since 1993, she has worked continuously at CRR
(formerly the Center for Reproductive Law & Policy), beginning as a staff attorney dedicated to
state legislative analysis and advocacy, including extensive work on insurance coverage for
contraceptives. Id. ¶ 5. In 1995, Ms. Crepps began working on the Center’s litigation. Id. In
1998, she was the Acting Director of the Center’s Washington, D.C. office, responsible for
developing the Center’s positions on federal legislation and for lobbying on Capitol Hill. Id.
From 1998 until now, Ms. Crepps’s work has focused primarily on the Center’s litigation. Id.
During that time, she has worked on complex reproductive rights cases at all levels of the state
and federal court systems. Id., ¶¶ 5-6. Ms. Crepps brings specialized experience and knowledge
to this litigation having litigated cases involving the impact of abortion restrictions on low-
income and rural women, and challenges to parental notification and consent requirements for
young women seeking abortion. Id., ¶ 6. Through this work, Ms. Crepps brought specialized
knowledge of how restrictions on access to reproductive health care affect vulnerable
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29
populations, such as those women most affected by the restrictions on access to emergency
contraception. In addition, Ms. Crepps endeavors to keep up with the social science literature
related to access to reproductive health care, and had reviewed many of the studies on emergency
contraception prior to her direct involvement in the litigation. Ms. Crepps is a recognized legal
expert in the field of reproductive rights and frequently presents at conferences, including
meetings of the National Abortion Federation, the Abortion Care Network, and the American
Public Health Association. Id., ¶ 7. Ms. Crepps first entered an appearance in the original
litigation challenging the Defendants’ refusal to grant the Citizen Petition on April 7, 2008. Id.,
¶ 9. Having been employed at CRR at the time of the filing of the emergency petition, she was
familiar with the issues. Even prior to entering her appearance, she followed the case closely,
reading the pleadings and regularly consulting with CRR attorneys on strategy and other issues.
Id. Her extensive knowledge of the case assisted her in effectively litigating the issues when she
became actively involved. Beginning in 2010, Ms. Crepps worked closely with Suzanne Novak
and reviewed virtually all significant pleadings from the development of the motion for contempt
through the summary judgment filings related to the supplemental complaint. Id. Beginning in
October 2012, when Ms. Novak left CRR, Ms. Crepps became lead counsel on this case. Id. In
that capacity, Ms. Crepps drafted pleadings, participated in and approved of all strategic
decisions in this case, participated in telephonic conferences with co-counsel, worked closely
with experts, reviewed and approved of all submissions to the Court, managed the work of CRR
staff, and took the lead at oral argument on the government’s motion to stay the district court’s
April 5, 2013, judgment pending appeal. Id.
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30
Suzanne Novak, former lead counsel for CRR,
11
has extensive experience litigating
reproductive rights and complex constitutional cases in both state and federal courts. Novak
Decl., ¶ 6. She graduated cum laude with a J.D. from the New York University School of Law in
1997. Id., ¶ 4. After clerking for the Honorable Stephen M McNamee in the federal district
court in Arizona, Ms. Novak spent two years at CRR as a Blackmun Fellow before working as
an associate at Arnold & Porter LLP. Id., ¶ 5. She returned to CRR as a staff attorney and then
went on to serve as the Deputy Director of the Democracy Program at the Brennan Center. Id.
In September 2007, Ms. Novak left the Brennan Center and came back to CRR as a consulting
attorney. Id. From August 2008 until October 2012, Ms. Novak was a Senior Staff Attorney in
CRR’s U.S. Legal Program and litigated numerous complex reproductive rights cases in the
federal and state courts. Id. Among the cases that Ms. Novak has litigated are Planned
Parenthood v. State, a challenge to an Alaska law requiring minors to obtain parental consent
prior to abortion. Id., ¶ 6. Through this case and others, Ms. Novak gained specialized
knowledge about access to reproductive health care for minors. As lead counsel in a challenge to
restrictions on medication abortion in North Dakota, Ms. Novak built a record documenting the
impact of restrictions on women in a rural state with limited reproductive health care services.
Ms. Novak was lead counsel on this case from the time the Court entered summary judgment in
favor of Plaintiffs’ in March 2009 until her departure from the Center in October 2012. Id., ¶ 8.
During that time, she did much of the thinking regarding strategy for the case, consulted with co-
counsel, and took primary responsibility for implementing decisions. Id. She was responsible
for all written documents, many of which she drafted, and participated in several court
11
Ms. Novak served as lead counsel for the Center for Reproductive Rights in this case until October 30,
2012, when she was no longer employed at CRR. See ECF No. 76.
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31
appearances. Id. Ms. Novak was also the main point person for contact with outside consultants,
declarants/experts witnesses, and opposing counsel. Id..
Andrea Costello, lead counsel for the National Women’s Liberation (NWL) individual
Plaintiffs and Anaya Kelly, has extensive experience as a national civil rights litigator for the
past 15 years serving as lead counsel or co-counsel in cases brought in federal District and
Appellate Courts, in New York, Florida and the District of Columbia. See Costello Decl., ¶¶ 4-8;
see also Sobel Decl., ¶¶13-14. Ms. Costello graduated from the City University School of Law in
Queens College in 1998. Id., ¶ 3. Ms. Costello brings specialized experience and knowledge to
this litigation having served as lead counsel for the NWL Plaintiffs
12
since Tummino I was
originally filed in 2005 and is the only attorney who has been involved, and remained involved,
in this matter since its inception. Id., ¶ 13. As a result, she has extensive knowledge of the factual
record and legal issues in this case, the procedural history in Tummino I and the FDA’s
consideration of emergency contraception from prescription only to an over-the-counter drug –
all of which played an important role in Plaintiffs’ successful efforts in Tummino II. Id., ¶¶ 13-
14, 16, 19. She has served as lead counsel in complex civil rights class actions against
government agencies in Florida, New York and federally, including, for example, class actions
and systemic impact litigation against the New York City Police Department to challenge its
unconstitutional stop-and-frisk practices, Florida Agency for Health Care Administration,
Florida Department of Health and Florida Department of Juvenile Justice related to the failure to
provide health care to persons through state or federal health programs or in state custody. Id.,
¶¶ 4-6. She has also engaged in policy work in the State of Florida to secure access to needed
healthcare services for low-income persons with disabilities and seniors. Id., ¶¶ 4-5. As part of
12
Formerly known as the Morning-After Pill Conspiracy. See First Amended Supplemental Complaint
(ECF No. 14 at ¶¶ 7-8.)
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her litigation and policy work concerning access to healthcare for persons with disabilities and
youth in, or at risk for the criminal justice system in Florida, she was recognized as an expert in
the state and consulted regularly with attorneys, advocates and the media on these issues based
on her experience and specialized knowledge. Id., ¶ 8. She has lectured to legal organizations,
public interest organizations, law schools and the public concerning civil rights issues and
reproductive rights. Id., ¶ 9.
Ms. Costello has a unique and long-standing relationship with the NWL Plaintiffs and has
provided legal representation and assistance to NWL, and its members, including as part of their
activities to advocate for unrestricted over-the-counter access to emergency contraception
concerning over-the-counter access on emergency contraception which relate to this litigation.
Id., ¶¶ 13-14, 17-19. Ms. Costello also provided legal representation to minors in the State of
Florida who were seeking a judicial waiver of Florida’s law requiring parental notification to
obtain an abortion and trained and provided consultation to other attorneys to conduct these
hearings. Id., ¶¶ 4, 6.j.. She brought the specialized knowledge and understanding gained from
working with adolescents on issues of access to reproductive health to her work in this litigation.
In addition to her legal experience, she has been a committed advocate for access to women’s
reproductive healthcare for 20 years through work in women’s rights advocacy organizations, as
a member and leader in progressive legal organizations, and as a reproductive health educator
prior to her legal career and applied this knowledge in this litigation. Id. ¶ 20.
Plaintiffs’ counsel, Kirsten Clanton and Natalie Maxwell served as co-counsel for the
NWL Plaintiffs (Ms. Clanton also represented Anaya Kelly) and specialize in complex civil
rights litigation. Ms. Maxwell graduated from American University, Washington College of
Law in 2005. Ms. Clanton graduated from University of Florida, also in 2005. They each have a
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33
level of skill and knowledge that was required in this litigation and is not available at the EAJA
statutory rate, as explained in the supporting declarations. See Clanton Decl.; Maxwell Decl.;
and Sleasman Decl..
Ms. Maxwell was involved in Tummino I, experience that was necessary to her
representation of the Plaintiffs after remand and during contempt proceedings.
13
Maxwell Decl.
¶ 13. Ms. Maxwell is a recognized leader in public interest law. She has planned and trained at
statewide trainings for legal services lawyers on litigation. Maxwell Decl. ¶ 7, Ex. A. She has
presented on issues regarding reproductive rights of minors. Id. She served as a Committee
Member of the National Housing Law Project’s, HUD Housing Programs: Tenant Rights’
Manual, the most comprehensive resource available on this topic. Id. She edited and revised
sections on tenant participation, and has also presented on First Amendment rights of public
housing tenants. Id.
Ms. Clanton substituted for Ms. Maxwell on Plaintiffs’ team after Ms. Maxwell’s
departure from Southern Legal Counsel (SLC). Clanton Decl., ¶ 19. Although Ms. Clanton was
not attorney of record until March 2012, she had knowledge of the facts and legal issues
involved with Tummino I when she began working at SLC in 2007 because SLC attorneys meet
regularly to discuss cases and Ms. Clanton also kept apprised of the case by reading court filings
to be able to provide opinions about case strategy and other legal issues at the attorney meetings.
Clanton Decl., ¶¶ 19-20, 25.
Ms. Clanton’s skill and experience in complex constitutional litigation, particularly in
cases involving intersections of statutory, administrative and constitutional law, was important to
this litigation. Id., ¶¶ 5-26, 24, 26. Ms. Clanton is a recognized leader in public interest law.
13
Ms. Maxwell served as co-counsel for the NWL Plaintiffs in this case until she left employment at
Southern Legal Counsel. See Maxwell Decl.
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34
She was the Chair of the Public Interest Law Section of The Florida Bar from 2011-2012. Id., ¶
9. She is invited to speak regularly at conferences on civil rights, particularly constitutional
issues, and was invited by the Sargent Shriver National Center on Poverty Law to be a trainer for
their Affirmative Litigation Training, a nationally recognized training on federal court litigation.
Id., ¶¶ 10-11. She also was invited to be a reviewer for the Center’s 2014 update of their
Federal Practice Manual for Legal Aid Attorneys, a popular resource that covers all stages of
federal litigation. Id., ¶ 12.
Ms. Clanton and Ms. Maxwell have provided legal representation to minors in the state of
Florida who seek a judicial waiver of Florida’s law requiring parental notification of termination
of pregnancy. Clanton Decl., ¶ 6; Maxwell Decl., ¶¶ 5-6. This representation has involved
litigation over the constitutional right to privacy of minors in these proceedings. Id. Ms.
Clanton and Ms. Maxwell have provided technical assistance and training to other lawyers in
these cases, and also have received regular referrals from the courts and clinics around North
Florida to provide advice and legal counseling to minors regarding their reproductive rights. Id.
b. Attorneys with Counsels’ Knowledge and Skill are not
Available at the Statutory EAJA Rates
Where an attorney is entitled to a special factor increase of the statutory fee rate under
EAJA, the court awards a reasonable fee based on that attorney’s prevailing market rate. See,
e.g., David, 777 F. Supp. at 220-21; SEC v. Wilson,
14
2009 U.S. Dist. LEXIS 66245, at *31-35;
Martin, 463 F. Supp. 2d at 293. Plaintiffs are seeking reimbursement for time expended at the
hourly rates of $650 for Janet Crepps, $560 for Suzanne Novak, $560 for Andrea Costello, $450
for Kirsten Clanton and $450 for Natalie Maxwell. (All other counsel are seeking reimbursement
14
In SEC v. Wilson, 2009 U.S. Dist. LEXIS 66245, at * 34 (D. Conn. July 31, 2009), similar to here, no
special factor was sought for a private firm which also provided services for the prevailing party. The court used the
cost of living adjustment for the EAJA statutory rate in calculating the fees for which plaintiff was entitled for the
services of the firm.
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35
at the EAJA hourly rate adjusted for inflation, or, in the alternative, fees at the prevailing market
rate based on the “bad faith” exception. See Section II.B.2., infra.) As explained below, these
rates are reasonable for the Eastern District of New York.
The process of determining the appropriate hourly rate requires weighing a number of
factors. The Supreme Court has declared that the reasonable hourly rate to be applied in
awarding fees under statutory fee provisions is the “prevailing market rate,” that is, the rate that
lawyers of similar skill, reputation and experience would charge in the legal market of that
geographic area. Blum v. Stenson, 465 U.S. 886, 895-96, n.11 (1984). A court must initially
determine what lawyers of comparable skill and experience handling other complex litigation
charge their private clients, as “the rates charged in private representations may afford relevant
comparisons.” Id. at 895, n.11.
Other factors considered by the court in addition to the prevailing market rates, include:
(1) the time and labor required; (2) the novelty and difficulty of the questions; (3) the skill
required to perform the legal service properly; (4) the preclusion of employment by the attorney
due to acceptance of the case; (5) the attorney’s customary hourly rate; (6) whether the fee is
fixed or contingent; (7) the time limitations imposed by the client or the circumstances; (8) the
amount involved in the case and the results obtained; (9) the experience, reputation, and ability
of the attorneys; (10) the “undesirability” of the case; (11) the nature and length of the
professional relationship with the client; and (12) awards in similar cases. See U.S. and Vulcan
Society v. City of New York (“Vulcan Society”), 2013 U.S. Dist. Lexis 125461, *25-28 (E.D.N.Y.
Aug. 30, 2013), citing Johnson v. Georgia Highway Exp., Inc., 488 F.2d 714, 717-19 (5th Cir.
1974) (awarding higher than average rates for EDNY where Johnson factors indicate case is
“exceptional” requiring extraordinary effort and skill, long-running litigation which involved
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36
numerous complex issues and required work by many attorneys, attorneys had exceptional
qualifications, obtained significant equitable relief and plaintiffs faced some “unique and
significant obstacles”).
For Plaintiffs’ counsel with the specialized knowledge needed in this litigation which is
not available at the EAJA statutory rate, as explained above, Plaintiffs have used the market rate
data based on billing rates utilized by attorneys in the Eastern District of New York with
comparable experience, skill, knowledge and qualifications based on precedent from this
jurisdiction and the Valeo Attorney Hourly Rates Database. See E.D.N.Y. attorney fee award
case citations, infra; see also Declaration of Chuck Chandler of Valeo Partners LLC (Chandler
Decl.), Ex. A (for attorney graduating in 1983 establishing mean rate of $932 and median rate of
$950; for attorney graduating in 1997 establishing mean rate of $810 and median rate of $835);
for attorney graduating in 1998 establishing mean rate of $862 and median rate of $867; for
attorneys graduating in 2005 establishing mean rate of $666 and median rate of $700); Mac
Avoy Decl., ¶¶ 9-13. Plaintiffs have set counsels’ market rates at or below the actual market
rates for attorneys with comparable experience. Id. They also establish that the rates Plaintiffs
counsel are seeking are at or below the prevailing market rates at which attorney with such
specialized expertise are available. See Mac Avoy Decl., ¶¶ 9-13; Chandler Decl., Ex. A.
Precedent in the Eastern District establishes the reasonableness of the rates sought by
Plaintiffs. Further, “when reviewing caselaw that comments on prevailing market rates, a court
must take into account the rapidity with which such rates can rise. Thus, a case decided even as
recently as [three years prior] could be out of date as far as the rates are concerned.” See Tokyo
Electron Arizona, Inc. v. Discreet Indus. Corp., 215 F.R.D. 60, 63 (E.D.N.Y. 2003) (awarding
rates in 2003 of $400 per hour for partners in case brought in Suffolk County); see also, U.S. v.
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37
$61,900, 856 F. Supp. 2d 484, 494 (E.D.N.Y. 2012) (awarding $600/hour for partner, $400 for
associate and $150 for paralegal noting that certain “cases, in which Brooklyn lawyers generally
specialize, are high-volume practices that bear little semblance to” the case at bar, which was
“based on non-repetitive fact patterns and diverse and complex fields of law.”); Rodriguez v.
Pressler, LLP, 2009 U.S. Dist. Lexis 20655 (E.D.N.Y. March 16, 2009) (awarding $450/hour in
2009 to partner with 17 years of experience and $300 to staff attorney with four years experience
in FDCPA case).
When complex litigation is brought in the commercial field, hourly rates of more than
$600 are awarded. See In re Visa Check/Mastermoney Antitrust Litigation, 2009 U.S. Dist. Lexis
100873 (E.D.N.Y. Oct. 15, 2009) (adopting special master’s recommendation that lead counsel
be awarded requested rates of $250 to $625, issuer’s counsel be awarded between $198 and
$792, underwriter’s counsel be awarded between $220 and $945 and paralegal be awarded $110
to $170). This was three years ago. Since the hourly rates in complex civil rights cases are
intended to follow awards in other complex litigation, those decisions should be a model for this
case as well.
Paralegal fees are not subject to the EAJA cap and so may be recovered at prevailing
market rates. See 28 U.S.C. § 2412(d)(2)(A)(ii) (“attorney fees shall not be awarded in excess of
$125 per hour”) (emphasis added); see also Richlin Sec. Serv. Co. v. Chertoff, 553 U.S. 571, 590
(2009) (“a prevailing party that satisfies EAJA’s other requirements may recover its paralegal
fees from the Government at prevailing market rates”). The rates sought by Plaintiffs for
paralegal work in this case are reasonable. U.S. v. $61,900, 856 F. Supp. 2d at 494 (2012 award
of $150 for paralegal); Kiely v. Astrue, 2012 U.S. Dist. LEXIS 135784 at *5 (D. Conn. Apr. 2,
2012) (court awarded rate of $100 for paralegal work in EAJA case).
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The attorneys involved in this case are at the highest level of their profession and are well
deserving of the requested rates. Complete biographies are provided for each attorney in each
individual’s Declaration. Abbreviated versions of the attorneys’ experience are also included (for
those seeking reasonable market rates based on the specialized knowledge needed in this
litigation which is not available at the EAJA statutory rate). See Section II.B.1.a., supra.
The Johnson factors indicate that this is an exceptional case meriting the prevailing
market rates of Plaintiffs’ counsel. Id. This case was a unique challenge involving complex
legal and factual issues and required intensive efforts by the counsel involved who were highly
skilled civil rights and reproductive rights litigators highly respected by their peers. Defendants
fought any relief in this case every step of the way, including by attempting to preempt a
decision by this Court on Plaintiffs’ Motion for Contempt, by repeating factual and legal
arguments previously rejected by this Court and refusing to comply with this Court’s Order by
further restricting access to emergency contraception and then filing an appeal which was
ultimately voluntarily dismissed.
The case required extensive time and labor. See Novak Decl., Ex. A; Crepps Decl., Ex.
A; Costello Decl., Exs. A, B; Clanton Decl., B; Maxwell Decl., Ex. B; and Dalven Decl., ¶ 8.
Indeed, Defendants’ failure to remedy the bad faith that permeated consideration of Plan B
during Tummino I is the reason Plaintiffs had the difficult task of expending 12 years of litigation
efforts to achieve the excellent results here. Not only did counsel have a longstanding
relationship with Plaintiffs, the course of this litigation demonstrated that only Plaintiffs had the
political will and fortitude to take on the FDA, the Secretary, and two Presidential
Administrations in their fight to make emergency contraception available to all women of child-
bearing age without age or point-of-sale restrictions. The conduct of Teva in this case
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39
demonstrated that the integrity of the drug approval process as it relates to emergency
contraception could not be left in the hands of pharmaceutical companies and their lawyers. The
“undesireability” of jeopardizing other business interests and the drug manufacturers’
willingness to acquiesce to unjustified and burdensome age and point-of-sale restrictions in
exchange for economic gain is the reason Plaintiffs’ extensive efforts were required. See
Tummino II, *55-56; Tummino III, ECF No. 98 at 5-10; Tr. of April 27, 2012, 8:16-9:14; see also
Dalven Decl., ¶ 5.
As this Court stated in its Order approving Defendants’ plan to comply with the April 5
Order:
It is only because of the extraordinary efforts by the plaintiffs in pursuing their
Citizen Petition that Teva is able to seek approval of an SNDA that will permit it
to market its product with no point-of-sale or age restriction. Such approval, if
given, will be nothing more than a reward to Teva for playing along with the
defendants’ efforts to maintain their legally and scientifically unjustified
restrictions on the marketing of levonorgestrel-based emergency contraceptives.
It is the plaintiffs, rather than Teva, who are responsible for the outcome of this
case, and it is they, and the women who benefitted from their efforts who deserve
to be rewarded.
(ECF No. 106 at 6.)
c. The EAJA Statutory Rate Should be Adjusted for Inflation for
Those Counsel Not Seeking at or Below the Prevailing Market
Rate
The EAJA establishes a presumptive maximum fee rate of $125 per hour, but permits the
court to apply an increase in the cost of living. See 28 U.S.C. § 2412(d)(2)(A)(ii). The statutory
fee rate – which was set at $125 per hour in March 1996, has not kept pace with inflation.
Accordingly, courts, including the Second Circuit and the Eastern District of New York, have
routinely applied a cost of living adjustment for inflation when awarding EAJA fees. Harris v.
Sullivan, 968 F.2d 263, 265 (2d Cir. 1992) (establishing that the cost of living increase under the
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EAJA is properly measured by the Consumer Price Index – Urban (CPI-U), prepared on a
monthly basis by the Bureau of Labor Statistics, U.S. Department of Labor). The court must
apply a different cost of living adjustment for each year in which hours were billed, rather than a
single adjustment to the total hours.
For Plaintiffs’ counsel Mara Verheyden-Hilliard, Carl Messineo, and Fried Frank
Counsel for whom compensation is sought, the Court should award fees for all work expended at
the EAJA statutory hourly rate adjusted for inflation for fees sought in 2012 and 2013. (These
amounts are included in the chart above for Plaintiffs’ Total Fees, but included here for the
Court’s reference.) To calculate the cost of living increase for EAJA fees, the hourly rate should
be increased by the corresponding Consumer Price Index for each year in which the legal work
was performed. See, e.g., Kerin v. United States Postal Service, 218 F.3d 185, 193 (2d Cir.
2000).
15
These calculations result in the rates set out as follows:
Attorney 2012 Rate Hours Total
Mara Verheyden-
Hilliard
$197.50 0.5 $98.75
Fried Frank Attorneys
and Paralegal
708.6 $138,631.16
16
2012 TOTAL: $138,729.91
Attorney 2013 Rate Hours Total
Mara Veryheyden- $200 42.7 $8,540.00
15
The procedure is for each year in which work was performed, the rate should be determined by dividing
that year’s CPI-U for the Northeast Region by the CPI-U for March 1996 (the date of the amendments to EAJA that
set the $125 per hour statutory rate) and the resulting ratio should be multiplied by $125. The CPI-U for August
2013 – the most recent month available – is 249.85, while the CPI-U for March 1996 was 155.7. See
ftp://ftp.bls.gov/pub/special.requests.cpi/cpiai.txt. Thus, 249.85/155.7 = 1.6 which is multiplied by $125 per hour,
resulting in an inflation-adjusted rate of $200 per hour for 2013. For 2012, the calculation is: 246.46/155.7 = 1.58
which is multiplied by $125 per hour, resulting in an inflation-adjusted rate of $197.50 per hour.
16
See n. 8, supra. Fried Frank has applied a 10% discount for the 2012-2013 EAJA fees total for its counsel
and paralegals that performed work in this litigation. This discount is reflected in the lodestar total, but this chart
reflects calculations for actual hours billed.
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Hilliard
Carl Messineo $200 17.8 $3,560.00
Fried Frank Attorneys
and Paralegal
38.5 $7,700.00
2013 TOTAL: $19,800.00
TOTAL FEES FOR ATTORNEYS WITH COST
OF LIVING ADJUSTMENT
$158,529.91
2. Compensation is Warranted Above the EAJA Statutory Hourly Rate
Based Upon the Application of “Bad Faith” Market Rates in the
EAJA
As an independent and alternative basis, Plaintiffs are entitled to market rates based on
the “bad faith” market rates in the EAJA.
17
This provision stands completely apart from those
under which the government may be held liable for fees at certain statutory rates unless its
position in litigation is substantially justified. See Wells v. Bowen, 855 F.2d 37, 46 (2d Cir.
1988). 28 U.S.C. Section 2412(b) provides:
Unless expressly prohibited by statute, a court may award reasonable fees and
expenses of attorneys . . . to the prevailing party in any civil action brought by or
against the United States or any agency or any official of the United States acting
in his or her official capacity in any court having jurisdiction of such action. The
United States shall be liable for such fees and expenses to the same extent that
any other party would be liable under the common law or under the terms of any
statute which specifically provides for such an award.
An award of attorneys’ fees under this exception applies when the losing party’s claims
were meritless and made for reasons of harassment or delay or for other improper purposes. Id. at
46 (citations omitted); see, e.g., Kerin, 218 F.3d at 190; Brown v. Sullivan, 724 F. Supp. 76
(W.D.N.Y. 1989) (defendant found to have acted in bad faith because, inter alia, disregarded the
17
Under the special factor test, supra, market rates should be awarded to certain identified counsel. Under
the bad faith basis, market rates should be awarded to all counsel as explained herein.
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Circuit’s controlling law and its conduct in litigating the matter was for reasons of delay).
District courts may also consider pre-litigation conduct in making a determination that there was
bad faith sufficient to justify a fee award. See Kerin, 218 F.3d at 195-96.
The actions of the government in this case are the epitome of bad faith meriting an
appropriate fee award. Tummino II, at *75 (“bad faith…has permeated the FDA’s consideration
of the Citizen Petition from beginning to end”); see also id. at *100 (“strong showing of bad
faith” justified consideration of materials outside of administrative record.) The entire litigation
was necessary and prolonged because of the government’s improper conduct; therefore,
Plaintiffs are entitled to the full amount of their attorneys’ fees as this is the amount necessary to
counter the government’s bad faith. See Kerin, 218 F.3d at 192-93. Therefore, Plaintiffs are
entitled to attorneys’ fees at prevailing market rates for all legal services provided in this matter.
Id. at 193.
a. The Government’s Actions Were Meritless
The government’s actions are meritless when lacking any legal or factual basis. Kerin,
218 F.3d at 190. For many of the same reasons the government’s conduct was substantially
unjustified as lacking any reasonable basis in fact or law, see Section I.B., supra, the
government’s egregious conduct was also meritless for purposes of an award of fees pursuant to
the bad faith exception. The government’s conduct in this case – both which necessitated the
litigation, as well as its conduct throughout the litigation – was based on improper political
decision making completely at odds with the proper function of a major government agency
designated to protect the health of the American public. The Administration made political
decisions interfering with the health and safety of American women and girls and used U.S.
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taxpayer funds to pursue and defend these acts that were the essence of bad faith. Two federal
agencies defied their regulatory and procedural obligations, acting in abrogation of their duties.
In 2009, the District Court concluded that the FDA’s denial of the Citizen Petition was
“arbitrary and capricious” and “not the result of reasoned and good faith agency decision-
making.” Tummino I, at 523. The Court remanded to the agency to reconsider the Citizen
Petition, but directed the FDA “to make Plan B available to 17 year olds without a prescription,”
finding that “[a] remand would serve no purpose” because the exclusion of 17 year olds “runs
counter to the evidence and is so implausible that it could not be ascribed to a difference in view
or the product of agency expertise.” Id., at 549-50 (internal quotation marks omitted).
On remand, Defendants’ conduct was plagued by bad faith and undue delay. Defendants
relied on arguments and certain evidence in support of their claims in this case which were
previously addressed and rejected by this Court in Tummino I related to the Plaintiffs’ standing
and the FDA’s failure to extrapolate. Tummino II, at *8, n.3, 37-48. These arguments were found
to be just as lacking here as they were in Tummino I. Id. Plaintiffs were forced to expend time
and resources to address the government’s bad faith obstruction and litigation tactics. The
Court’s orders in Tummino II and Tummino III detail the complete lack of factual or legal basis
for the government’s position in this litigation. The Court was put in the extraordinary position
of being asked by the FDA, the very agency whose authority was usurped unlawfully by the
Secretary, to approve of this scientifically unjustified and politically motivated departure from
laws and regulations governing the drug approval process. Tummino II, at *10-13. The
government’s “flagrant misconduct” is the reason the Court declined to remand the Citizen
Petition because the government could not provide “any assurance that the result [on remand]
would be any different.” (ECF No. 98 at 16.)
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The government’s conduct was found to be scientifically unjustified and contrary to
agency precedent, demonstrating the complete lack of any factual or legal support for
Defendants’ position in this case. Tummino II, at*18-63, 73-87. Even though this case “involves
the interpretation of a general statutory and regulatory scheme relating to the approval of drugs
for over-the-counter sale[,]” the standards for which are the same for aspirin as for
contraceptives, id., at *17, the government’s denial of the SNDA and Citizen Petition “was
accomplished by unexplained departures from a number of established policies and practices
followed by the FDA.” Id., at *20.
The Court found that “the most significant departure from agency practice was the
intervention of the Secretary of Health and Human Services.” Id., at *21. The reasons she gave
for this intervention were “so unpersuasive as to call into question her good faith.” Id., at *23.
The Court found that her decision was not entitled to the deference due to the FDA “as a result of
its specialized expertise and judgment” because she has no specialized technical expertise and
that the Secretary was either “unaware” of the FDA’s drug approval procedures or “she
consciously ignored them.” Id., at *66-67. The Secretary’s failure to acknowledge, much less
explain, these deviations in policy made it clear that it was not the type of decision deserving of
deference because it was not made by the Commissioner, whom Congress entrusted the
responsibility to make the necessary scientific judgment. Id., at *70-72 (“Indeed it is hardly
clear that the Secretary had the power to issue the order, and if she did have that authority, her
decision was arbitrary, capricious, and unreasonable.”) Defendants’ complete failure to provide
a good faith rationale for its deviations in policy further evidences its bad faith conduct. The
Secretary’s positions, in particular, were undefended and Defendants’ positions, in general, were
indefensible.
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In reviewing the government’s denial of the Citizen Petition, the Court also found other
evidence of the government’s meritless claims. The government was deceptive about the
scientific evidence it had before it. Id., at *77-87. This provided a separate basis for denial of
the Citizen Petition based on the government’s “disregard for the scientific evidence that the
FDA had before it.” See also Tummino III, at *5 (“The Citizen Petition Denial Letter…was
clearly prompted by the Secretary’s action despite the FDA’s fanciful effort to make it appear
that it undertook an independent review of the Citizen Petition.”) The Defendants’ deceptions in
the course of the litigation are further evidence of its bad faith conduct. The government’s
conduct following the Tummino II decision was just as meritless as its position throughout the
litigation. First, “in something of an alternate reality” the government sought a stay of an order
that restored the FDA’s scientific integrity “to pursue an appeal that would vindicate the
Secretary’s disregard of the very principle they advocate.” Id., at *9. Furthermore, after this
Court held that “the FDA did not have the authority to mandate point-of-sale restrictions on
drugs approved for nonprescription sales that it found to be safe and effective for all women of
childbearing age,” the FDA persisted in this policy. In its attempt to sugar coat its appeal, it
approved Teva’s amended SNDA which would have resulted in “a convoluted triple-tiered
marketing scheme that will only increase the confusion that already prevents women from
obtaining timely access to emergency contraceptives.” Id., at 23.
This Court expressed its opinion that the appeal was “frivolous” on the merits, and
ultimately the appeal was voluntarily dismissed by Defendant after the Second Circuit denied the
Stay as to two-pill emergency contraception products. The Defendants’ persistence in pursuing
unsupported and meritless positions that continued to consume litigation and judicial resources is
further evidence of its bad faith conduct.
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b. The Government’s Conduct was Undertaken for the Improper
Purposes of Delay and Political Interference in the FDA’s Drug
Approval Process
The government’s conduct on remand following Tummino I, in the District Court during
contempt proceedings, in Tummino II and then on appeal were permeated by the improper
purposes of delay and political interference in the FDA’s drug approval process. Indeed, these
improper purposes infected the government’s entire decision making process concerning the
over-the-counter switch of emergency contraception, including the reconsideration of the Citizen
Petition.
As this Court acknowledged, the course of this litigation “most of the time” has been due
to the agency’s delay. (Tr. of April 27, 2012, 141:21-23); see also Tummino II, at *58 (referring
to approval process of Plan B’s dual marketing regime as “long and tortured”). Tummino I was
filed to compel the FDA to make a decision on the citizen’s petition. (Id. at 141:23-24.) It was
not until June of 2006 that the FDA finally made a decision by denying the Citizen Petition five
years after it had been filed. Tummino I, at 536. Even though the FDA had effectively made a
decision on the Citizen Petition at the time it denied the Plan B sponsor’s first SNDA, it waited
more than two years (and after a lawsuit was filed) to communicate that decision to Plaintiffs. Id.
at 536-37.
On remand, for almost three years, the FDA refused to take any steps to reconsider the
Citizen Petition. Tummino II, at *10-11. Instead, the agency informed Plaintiffs that it believed
that “the best way” to comply with the order was “to review a supplemental new drug application
expected to be submitted by the sponsor of [Plan B One-Step]” for over-the-counter access for
all ages. See Letter from Frank Amanat to Suzanne Novak (Aug. 13, 2010), Case No. 05-CV-
366 (ERK/VVP), ECF No. 307-3. The denial of the Citizen Petition finally came on the eve of a
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hearing on Plaintiffs’ Motion for Contempt. (ECF No. 2 at 25.); see also Tummino III, at *4
(“The FDA, responding to unjustified political interference, delayed as long as it possibly could
before it took even one incremental step in the process.”)
The government’s “intolerable delays in processing the [Citizen] Petition” were cited by
this Court as justification for declining to remand to the FDA for rulemaking:
[E]ven if the defendants’ arguments would be sufficient to carry the day in the
run-of-the-mill case, the bad faith that has permeated consideration of the Citizen
Petition, not to speak of the Plan B sponsor's applications, should rule out such
relief here. More than twelve years have passed since the Citizen Petition was
filed and eight years since this lawsuit commenced. The FDA has engaged in
intolerable delays in processing the petition. Indeed, it could accurately be
described as an administrative agency filibuster. Moreover, one of the devices the
FDA has employed to stall proceedings was to seek public comment on whether
or not it needed to engage in rulemaking in order to adopt an age-restricted
marketing regime. After eating up eleven months, 47,000 public comments, and
hundreds of thousands, if not millions, of dollars, it decided that it did not need
rulemaking after all. The plaintiffs should not be forced to endure, nor should the
agency’s misconduct be rewarded by, an exercise that permits the FDA to engage
in further delay and obstruction.
Tummino II, at *105-06.
Even after this Court’s Order, the government did not comply and instead filed an appeal
and a motion to stay “as they continue[d] their administrative agency filibuster through the
appeal process.” Tummino III, at *8. The government relied on its approval of an amended
SNDA by Teva to argue that Plaintiffs would not suffer harm because the FDA had lowered the
age to purchase Plan B One-Step over-the-counter from seventeen to fifteen years of age. Id., at
11-12. This application was approved the day before Defendants filed their notice of appeal. Id.,
at 11. The timing of the approval, and the lack of explanation by the FDA as to why it delayed
more than a year in approving this application, led this Court to conclude that it was “intended to
provide a sugarcoating for the FDA’s appeal.” Id., at *11-12; see also id., at 31 (appeal “taken
for the purpose of delay”).
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After the Defendants’ stay was denied by the Second Circuit as to two-pill products, but
granted as to one-pill products, Defendants’ could no longer delay making some form of
emergency contraception available over-the-counter without age or point-of-sale restrictions.
But, instead of making two-pill products available over-the-counter, Defendants notified this
Court that they planned to comply with the ruling by only making Plan B One-Step available
OTC. Defendants, after delaying for twelve long years, were finally thwarted in this improper
purpose.
In addition to the “intolerable delays”, Defendants’ conduct in this action was taken for
improper purpose by allowing, and defending, unprecedented political interference in the drug
approval process. Even though there was political interference throughout the course of the
government’s decision-making process on emergency contraception, see generally Tummino I,
the Secretary’s overruling of the Commissioner’s decision to approve Teva’s SNDA for Plan B
One-Step was a flagrant departure from the drug approval process. Tummino III, at *8.
The unprecedented intervention of the Secretary was “obviously political.” Tummino II,
at *23 (“It was the first time a cabinet member had ever publicly countermanded a determination
by the FDA”) (citations omitted); see also Tr. of April 27, 2012, 18:15-17 (counsel for Teva
referring to the Secretary’s “unprecedented historical involvement” in the decision to deny its
SNDA). It was “an election year decision that many public health experts saw as a politically
motivated effort to avoid riling religious groups and others opposed to making birth control
available to girls.” Tummino II, at *23 (citations omitted).
The government’s improper political purpose was also evident when it fabricated a
“complete pretext” which was yet “another example of the bad faith that has permeated the
FDA’s consideration of the Citizen Petition from beginning to end” by falsely claiming that the
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Plaintiffs had to provide “additional data” comparable to that in the Plan B One-Step application
when any such data was rejected by the government for reasons found to be “politically
motivated, scientifically unjustified, and contrary to agency precedent.” Tummino II, at *86. The
FDA’s Citizen Petition denial letter was “composed mainly of filler that was designed to create
the illusion that it was engaging in some independent exercise of agency discretion.” Tummino
II, at *74.
An article published in the New England Journal of Medicine by three distinguished
scientists opined that “the secretary’s decision to retain behind-the-counter status for Plan B
One-Step was based on politics rather than science. It cannot be based on issues of safety…Any
objective review makes it clear that Plan B is more dangerous to politicians than to adolescent
girls.” Id. The Court’s Order reversing the Secretary’s decision and directing the Defendants to
grant the Citizen Petition was issued because “the Secretary’s action was politically motivated,
scientifically unjustified, and contrary to agency precedent, and because it could not provide a
basis to sustain the denial of the Citizen Petition.” Tummino III, at *6.
In their Motion for Stay, Defendants did not argue they had any possibility of success in
challenging this finding on appeal. See id., at n. 1. Defendants argued that the public interest
would be harmed if a drug were approved by the Court instead of by the FDA. This Court
rejected that argument, finding that since the Commissioner had found the drug was safe and was
prepared to make it available over-the-counter to all ages, “the public can have confidence that
the FDA’s judgment is being vindicated.” Id., at *21. However, if a stay were to be granted, the
Court stated “it will allow the bad-faith, politically motivated decision of Secretary Sebelius,
who lacks any medical or scientific expertise, to prevail—thus justifiably undermining the
public’s confidence in the drug approval process.” Id. Further, this Court took issue with
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Defendant’s claim that the Court exceeded its authority in issuing a directive instead of
remanding to the agency because the Court did not believe the government could be trusted to
make a fair assessment of the scientific evidence based on the Secretary’s interference. Id., at
*29-30 (“On remand, defendants engaged in the same bad faith that resulted in my initial
remand. They delayed the decision for three years, and ultimately, improper political influence
prevented the FDA from granting the petition.”)
In sum, there is overwhelming evidence in the record that the government’s conduct in
this litigation was undertaken for improper purpose. Kerin, 218 F.3d at 191-92. This Court has
already made detailed findings of the government’s “intolerable delays” and flagrant and
unprecedented political interference in the drug approval process. These improper motives,
together with Defendants’ meritless position (discussed supra), demonstrate that a bad faith
award is justified. Id. at 192. At the heart of the government’s bad faith conduct is the fact that
the Defendants disregarded and jeopardized the health and safety of millions of American
women and girls for over a decade and only through Plaintiffs’ efforts was this conduct forced to
cease.
Plaintiffs’ bad faith fees calculations are as follows (including all counsel):
Attorney Law School
Graduation
Requested
Rate
Hours Total
Janet Crepps
1983 $650 117.1 $76,115
Suzanne Novak
1997 $560 449.3 $251,608
Andrea
Costello
1998 $560 305.2 (PCJF)
51.3 (FILS)
$170,912 (PCJF)
$28,728 (FILS)
Kirsten Clanton
2005 $450 131.4 $59,130
Natalie
Maxwell
2005 $450 26.6 $11,970
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51
Mara
Verheyden -
Hilliard
1994 $600 43.2 $25,920.00
Carl Messineo 1994 $600
17.8 $10,680
Fried Frank
Attorneys and
Paralegal
18
747.1 $330,494.40
Candice Kalis Paralegal and
2012 Law
School
Graduate
(PCJF)
$90 16.7 $1,503.00
LODESTAR
TOTAL:
$967,060.40
III. Plaintiffs’ Claimed Costs are Recoverable Under the EAJA
The EAJA allows a prevailing party to recover “fees and other expenses” associated with
litigating its claim. 28 U.S.C. § 2412(d)(2)(A). The Second Circuit has found costs to be
broadly recoverable under the EAJA, including all out-of-pocket costs that are ordinarily billed
to a client, such as photocopying and transcript costs. Aston v. Sec’y of Health and Human
Services, 808 F.2d 9, 12 (2d Cir. 1986).
In this case, Plaintiffs expended $1,081.82 in reimbursable costs before the District Court
and these amounts should be awarded to them as part of the Court’s order. See Costello Decl.,
Ex. A and Crepps Decl., Ex. B.
CONCLUSION
For the foregoing reasons, the Court should order fees and costs in the amount that
Plaintiffs have requested.
18
See n. 8, supra. Fried Frank has applied a 10% discount for the market rate fees total for its counsel and
paralegals that performed work in this litigation. See also Mac Avoy Decl., ¶ 5, for years of graduation for each
Fried Frank counsel.
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Dated: October 11, 2013 Respectfully submitted,
/s/ Andrea Costello
ANDREA COSTELLO*
Partnership for Civil Justice Fund
617 Florida Avenue, NW
Washington, D.C. 20001
(202) 232-1180 (phone)
(202) 747-7747 (fax)
ac@justiceonline.org
Attorneys for Plaintiffs Tummino, Mahoney,
Giardina, Mangan, Seguin, Tinney, Brown
Churchill, Hunt, and Kelly
*Admitted pro hac vice
JANET CREPPS*
Center for Reproductive Rights
120 Wall Street, 14th Floor
New York, NY 10005
(917) 637-3600
JCrepps@reprorights.org
Attorneys for all Plaintiffs
KIRSTEN CLANTON*
Southern Legal Counsel, Inc.
1229 NW 12th Ave.
Gainesville, FL 32601
(352) 271-8890
kirsten.clanton@southernlegal.org
Attorneys for Plaintiffs Tummino, Mahoney,
Giardina, Mangan, Seguin, Tinney, Brown
Churchill, Hunt, and Kelly
*Admitted pro hac vice
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