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Case: 13-1690 Document: 49 Page: 1 05/15/2013 938864 261

UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT

CIVIL APPEAL PRE-ARGUMENT STATEMENT (FORM C)

1. SEE NOTICE ON REVERSE. 2. PLEASE TYPE OR PRINT. 3. STAPLE ALL ADDITIONAL PAGES

Case Caption:

District Court or Agency:

Judge:

Date the Order or Judgment Appealed
from was Entered on the Docket:

District Court Docket No.:

Date the Notice of Appeal was Filed:

Is this a Cross Appeal?

9 Yes 9 No

Attorney(s) for
Appellant(s):

Counsel’s Name: Address: Telephone No.: Fax No.: E-mail:




Counsel’s Name: Address: Telephone No.: Fax No.: E-mail:

9 Plaintiff

9 Defendant

Attorney(s) for
Appellee(s):

9 Plaintiff

9 Defendant

Has Transcript
Been Prepared?

Approx. Number of
Transcript
Pages:

Number of
Exhibits
Appended to
Transcript:

Has this matter been before this Circuit previously? 9 Yes 9 No

If Yes, provide the following:

Case Name:

2d Cir. Docket No.: Reporter Citation: (i.e., F.3d or Fed. App.)

ADDENDUM “A”: COUNSEL MUST ATTACH TO THIS FORM: (1) A BRIEF, BUT NOT PERFUNCTORY, DESCRIPTION OF THE
NATURE OF THE ACTION; (2) THE RESULT BELOW; (3) A COPY OF THE NOTICE OF APPEAL AND A CURRENT COPY OF
THE LOWER COURT DOCKET SHEET; AND (4) A COPY OF ALL RELEVANT OPINIONS/ORDERS FORMING THE BASIS FOR

THIS APPEAL, INCLUDING TRANSCRIPTS OF ORDERS ISSUED FROM THE BENCH OR IN CHAMBERS.

ADDENDUM “B”: COUNSEL MUST ATTACH TO THIS FORM A LIST OF THE ISSUES PROPOSED TO BE RAISED ON APPEAL,

AS WELL AS THE APPLICABLE APPELLATE STANDARD OF REVIEW FOR EACH PROPOSED ISSUE.

PART A: JURISDICTION

1. Federal Jurisdiction

2. Appellate Jurisdiction

9 U.S. a party 9 Diversity

9 Federal question 9 Other (specify):
(U.S. not a party)

9 Final Decision 9 Order Certified by District Judge (i.e.,
Fed. R. Civ. P. 54(b))
9 Interlocutory Decision
Appealable As of Right 9 Other (specify):

IMPORTANT. COMPLETE AND SIGN REVERSE SIDE OF THIS FORM.

Case: 13-1690 Document: 49 Page: 2 05/15/2013 938864 261

PART B: DISTRICT COURT DISPOSITION (Check as many as apply)

1. Stage of Proceedings



9 Pre-trial
9 During trial
9 After trial

2. Type of Judgment/Order Appealed

3. Relief

9 Default judgment 9 Dismissal/other jurisdiction
9 Dismissal/FRCP 12(b)(1) 9 Dismissal/merit
lack of subj. matter juris. 9 Judgment / Decision of the Court
9 Dismissal/FRCP 12(b)(6) 9 Summary judgment
failure to state a claim 9 Declaratory judgment
9 Dismissal/28 U.S.C. § 1915(e)(2) 9 Jury verdict
frivolous complaint 9 Judgment NOV
9 Dismissal/28 U.S.C. § 1915(e)(2) 9 Directed verdict
other dismissal 9 Other (specify):

9 Damages: 9 Injunctions:

Sought: $ 9 Preliminary
Granted: $ 9 Permanent
Denied: $ 9 Denied


PART C: NATURE OF SUIT (Check as many as apply)

1. Federal Statutes

2. Torts

3. Contracts

4. Prisoner Petitions

9 Antitrust 9 Communications 9 Freedom of Information Act
9 Bankruptcy 9 Consumer Protection 9 Immigration
9 Banks/Banking 9 Copyright 9 Patent 9 Labor
9 Civil Rights 9 Trademark 9 OSHA
9 Commerce, 9 Election 9 Securities
9 Energy 9 Soc. Security 9 Tax
9 Commodities 9 Environmental
9 Other (specify):

9 Admiralty/
Maritime
9 Assault /
Defamation
9 FELA
9 Products Liability
9 Other (Specify):

5. Other

9 Forfeiture/Penalty
9 Real Property
9 Treaty (specify):
9 Other (specify):

6. General
9 Arbitration
9 Attorney Disqualification
9 Class Action
9 Counsel Fees
9 Shareholder Derivative
9 Transfer

9 Civil Rights
Habeas Corpus
9 Mandamus
9 Parole
9 Vacate Sentence
9 Other

9 Admiralty/
Maritime
9 Arbitration
9 Commercial
9 Employment
9 Insurance
9 Negotiable
Instruments
9 Other Specify

7. Will appeal raise constitutional issue(s)?
9 Yes 9 No

Will appeal raise a matter of first
impression?

9 Yes 9 No

1. Is any matter relative to this appeal still pending below? 9 Yes, specify: 9 No

2. To your knowledge, is there any case presently pending or about to be brought before this Court or another court or administrative agency
which:
(A) Arises from substantially the same case or controversy as this appeal? 9 Yes 9 No

(B) Involves an issue that is substantially similar or related to an issue in this appeal? 9 Yes 9 No

If yes, state whether 9 “A,” or 9 “B,” or 9 both are applicable, and provide in the spaces below the following information on the other action(s):

Case Name:

Name of Appellant:

Docket No.

Citation:

Court or Agency:

Date:

Signature of Counsel of Record:

NOTICE TO COUNSEL

Once you have filed your Notice of Appeal with the District Court or the Tax Court, you have only 14 days in which to complete the following
important steps:

1. Complete this Civil Appeal Pre-Argument Statement (Form C); serve it upon all parties, and file it with the Clerk of the Second Circuit in
accordance with LR 25.1.
2. File the Court of Appeals Transcript Information/Civil Appeal Form (Form D) with the Clerk of the Second Circuit in accordance with LR 25.1.
3. Pay the$455 docketing fee to the United States District Court or the $450 docketing fee to the United States Tax Court unless you are authorized to
prosecute the appeal without payment.

PLEASE NOTE: IF YOU DO NOT COMPLY WITH THESE REQUIREMENTS WITHIN 14 DAYS, YOUR APPEAL WILL BE
DISMISSED. SEE LOCAL RULE 12.1.

Tummino v. Hamburg, No. 13-1690

ADDENDUM A

Dated: May 15, 2013







Case: 13-1690 Document: 49 Page: 3 05/15/2013 938864 261

UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT

CIVIL APPEAL PRE-ARGUMENT STATEMENT (FORM C)

(1)

A BRIEF, BUT NOT PERFUNCTORY, DESCRIPTION OF THE NATURE OF
THE ACTION:


This action was brought pursuant to the Administrative Procedure Act (APA), 5 U.S.C.
§ 701 et seq., to challenge the U.S. Food and Drug and Administration’s (FDA) denial of a
citizen petition filed in 2001 pursuant to 21 C.F.R. § 10.30. The citizen petition asked FDA
to allow Plan B, a levonorgestrel-based emergency contraceptive drug product, and its
generic equivalents, to be sold without a prescription to consumers of all ages. FDA denied
the citizen petition in December 2011, after a 2009 decision in a previous case (No. 05-CV-
366) in which the district court had remanded the petition to FDA for reconsideration of its
2006 denial. Plaintiffs are 18 individuals and two organizations that generally seek
expanded availability of emergency contraceptive drugs. Defendants are the Commissioner
of Food and Drugs and the Secretary of Health and Human Services. In February 2012,
plaintiffs filed this suit (and reopened No. 05-CV-366) to seek judicial review of FDA’s
denial of the citizen petition; for relief, they sought an injunction compelling FDA to grant
the citizen petition and to allow all levonorgestrel-based emergency contraceptive drug
products, including products not covered by the citizen petition, to be sold without a
prescription and without age or point-of-sale restrictions. In defense, the government
argued, inter alia, that plaintiffs lacked standing to challenge FDA’s actions, that the court
lacked jurisdiction to grant the relief plaintiffs sought, that the agency’s actions were
neither arbitrary nor capricious, and that the court should defer to the agency’s discretion.

(2)

Simultaneous with their motion to reopen No. 05-CV-366 and their initial filing in No. 12-
CV-763, plaintiffs moved for preliminary and permanent injunction and for summary
judgment. Defendants thereafter moved to dismiss the first amended supplemental
complaint (and the fifth amended complaint in No. 05-CV-366) for lack of subject matter
jurisdiction. The district court denied the motion on the record at a hearing on April 27,
2012, as well as in minute orders dated April 26 and May 1, 2012. Plaintiffs subsequently
filed a second amended supplemental complaint, which the government again moved to
dismiss for lack of subject matter jurisdiction. The district court summarily denied that

THE RESULT BELOW

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motion by minute order dated July 2, 2012. The government then cross-moved for
summary judgment. In a decision entered on April 5, 2013, the district court granted the
plaintiffs’ motion for summary judgment and for permanent injunction and denied the
government’s cross-motion. See Tummino v. Hamburg, ___ F. Supp. 2d ___, 2013 WL
1348656 (E.D.N.Y. Apr. 5, 2013). As set forth in the opinion in pertinent part, “the decision
of the FDA denying the Citizen Petition is reversed, and the case is remanded 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 *31. Judgment to that effect was entered on April 10, 2013.
The government moved for stay pending appeal, which the district court denied in a
decision entered on May 10, 2013. See Tummino v. Hamburg, ___ F. Supp. 2d ___, 2013WL
1921414 (E.D.N.Y. May 10, 2013).

(3) A COPY OF THE NOTICE OF APPEAL AND A CURRENT COPY OF THE

LOWER COURT DOCKET SHEET


Both documents follow.


(4)

A COPY OF ALL RELEVANT OPINIONS/ORDERS FORMING THE BASIS
FOR THIS APPEAL, INCLUDING TRANSCRIPTS OF ORDERS ISSUED FROM
THE BENCH OR IN CHAMBERS


Attached are:
The April 5, 2013, Memorandum and Order granting summary judgment to plaintiffs,
denying summary judgment to the government, and granting a mandatory
permanent injunction

The April 10, 2013, Clerk’s Judgment
The May 10, 2013, Memorandum and Order denying the government’s motion for stay

pending appeal

Transcript of hearing of April 27, 2012, in which the district court denied from the bench

the government’s motion to dismiss for lack of jurisdiction

Minute orders of April 26, May 1, and July 2, 2012




Case: 13-1690 Document: 49 Page: 5 05/15/2013 938864 261

UNITED STATES COURT OF APPEALS FOR THE SECOND CIRCUIT

CIVIL APPEAL PRE-ARGUMENT STATEMENT (FORM C)

Tummino v. Hamburg, No. 13-1690







ADDENDUM B

Dated: May 15, 2013

LIST OF ISSUES PROPOSED TO BE RAISED ON APPEAL

WITH APPLICABLE APPELLATE STANDARD OF REVIEW FOR EACH ISSUE

As of this date, the government proposes to raise the following two issues on appeal:

Whether the district court exceeded its jurisdiction under the Federal Food, Drug,
1.
and Cosmetics Act (FDCA), 21 U.S.C. § 301 et seq., when it exercised judicial review over
FDA’s failure to approve a supplemental new drug application for Plan B One-Step (a
drug that was not the subject of the citizen petition), and when it ordered FDA to make
that drug and its generic equivalents available without a prescription and without age or
point-of-sale restrictions. Appellate standard of review is de novo, as this is an issue of law.

2.
Whether the district court exceeded its authority in issuing a mandatory injunction
ordering FDA to make levonorgestrel-based emergency contraceptive drugs available
without a prescription to women of all ages, which under the FDCA and FDA regulations
can only be accomplished through the promulgation of a regulation. Appellate standard of
review is de novo, as this is an issue of law.

Case 1:12-cv-00763-ERK-VVP Document 90 Filed 05/01/13 Page 1 of 3 PageID #: 2195

Case: 13-1690 Document: 49 Page: 6 05/15/2013 938864 261













UNITED STATES DISTRICT COURT
EASTERN DISTRICT OF NEW YORK



Annie TUMMINO, et al.,


v.

Dr. Margaret HAMBURG, Commissioner of
Food and Drugs, et al.,





Defendants.


Plaintiffs,



















)
)
)
) No. 12-CV-763 (ERK/VVP)
)
)
)
)
)
)

)

(Korman, J.)
(Pohorelsky, M.J.)





NOTICE OF APPEAL




PLEASE TAKE NOTICE that defendants Dr. Margaret Hamburg, Commissioner of Food

and Drugs, and the Honorable Kathleen Sebelius, Secretary of Health and Human Services,

hereby appeal to the United States Court of Appeals for the Second Circuit from the judgment of

this Court entered on April 10, 2013 (ECF No. 87), and this Court’s Memorandum and Order of

April 5, 2013 (ECF No. 85).









Respectfully submitted,







LORETTA E. LYNCH

STUART F. DELERY
Acting Assistant Attorney General United States Attorney

Civil Division



IAN HEATH GERSHENGORN

Deputy Assistant Attorney General

Eastern District of New York
271 Cadman Plaza East
Brooklyn, NY 11201-1820












SHEILA LIEBER
Deputy Director,
Federal Programs Branch


ERIC B. BECKENHAUER
Trial Attorney,

Federal Programs Branch












By: /s/ {FILED ELECTRONICALLY}






F. FRANKLIN AMANAT (FA6117)
Assistant United States Attorney
Eastern District of New York
(718) 254-6024
[email protected]





Dated: May 1, 2013























United States Department of Justice, Civil Division
20 Massachusetts Avenue, N.W.
Washington, DC 20530
(202) 514-3338

Case 1:12-cv-00763-ERK-VVP Document 90 Filed 05/01/13 Page 2 of 3 PageID #: 2196

Case: 13-1690 Document: 49 Page: 7 05/15/2013 938864 261

Of Counsel:













DAVID J. HOROWITZ, Deputy General Counsel
ELIZABETH H. DICKINSON, Chief Counsel, Food and Drug Division
ANNAMARIE KEMPIC, Deputy Chief Counsel, Litigation, Food and Drug Division
SCOTT A. KAPLAN, Assistant Chief Counsel, Food and Drug Division





United States Department of Health and Human Services
Office of the General Counsel
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002



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U.S. District Court

Eastern District of New York (Brooklyn)

CIVIL DOCKET FOR CASE #: 1:12−cv−00763−ERK−VVP

APPEAL

Tummino et al v. Hamburg et al
Assigned to: Judge Edward R. Korman
Referred to: Magistrate Judge Viktor V. Pohorelsky
Cause: 28:1331 Fed. Question

Date Filed: 02/16/2012
Date Terminated: 04/10/2013
Jury Demand: None
Nature of Suit: 890 Other Statutory
Actions
Jurisdiction: Federal Question

Plaintiff
Annie Tummino
in her individual capacity, as Vice−Chair
of the Women's Liberation Birth Control
Project as Coordinator of the
Morning−After Pill Conspiracy, and on
behalf of women who need Emergency
Contraception

represented by Andrea H Costello

Partnership for Civil Justice Fund
617 Florida Avenue, NW
Washington, DC 20001
202−232−1180
Fax: 202−747−7747
Email: [email protected]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Janet Crepps
Center for Reproductive Rights
120 Wall Street
14th Floor
New York, NY 10005
917−637−3674
Fax: 917−637−3666
Email: [email protected]
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
Center for Reproductive Rights
120 Wall Street
14th Floor
New York, NY 10005
917−637−3615
Fax: 917−637−3666
Email: [email protected]
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Kirsten Clanton
Southern Legal Counsel, Inc.
1229 NW 12th Avenue
Gainsville, FL 32601
352−271−8890
Fax: 352−271−8347
Email: [email protected]
PRO HAC VICE
ATTORNEY TO BE NOTICED

Plaintiff
Erin T. Mahoney
in her individual capacity, as Chair of the
Women's Liberation Birth Control Project
as Coordinator of the Morning−After Pill
Conspiracy, and on behalf of women who

represented by Andrea H Costello

(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

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Case: 13-1690 Document: 49 Page: 9 05/15/2013 938864 261

need Emergency Contraception

Plaintiff
Carol Giardina
in her individual capacity, as Coordinator
of the Women's Liberation Birth Control
Project as Coordinator of the
Morning−After Pill Conspiracy, and on
behalf of women who need Emergency
Contraception

Plaintiff
Kelly Mangan
in her individual capacity, as President of
the University of Florida Campus
Chapter of the National Organization for
Women, as Coordinator of the
Morning−After Pill Conspiracy, and on
behalf of women who need

Janet Crepps
(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Kirsten Clanton
(See above for address)
PRO HAC VICE
ATTORNEY TO BE NOTICED

represented by Andrea H Costello

(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Janet Crepps
(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Kirsten Clanton
(See above for address)
PRO HAC VICE
ATTORNEY TO BE NOTICED

represented by Andrea H Costello

(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Janet Crepps
(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Kirsten Clanton
(See above for address)
PRO HAC VICE
ATTORNEY TO BE NOTICED

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Plaintiff
Stephanie Seguin
in her individual capacity, as Chair of the
Florida National Organization for
Women Young Feminist Task Force, as
Coordinator of the Morning−After Pill
Conspiracy, and on behalf of women who
need Emergency Contraception

Plaintiff
Lori Tinney
in her individual capacity, as President of
the Gainesville Chapter of the National
Organization for Women, as Coordinator
of the Morning−After Pill Conspiracy,
and on behalf of women who need
Emergency Contraception

Plaintiff
Jennifer Brown
in her individual capacity, as Coordinator
of the Morning−After Pill Conspiracy,
and on behalf of women who need
Emergency Contraception

represented by Andrea H Costello

(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Janet Crepps
(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Kirsten Clanton
(See above for address)
PRO HAC VICE
ATTORNEY TO BE NOTICED

represented by Andrea H Costello

(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Janet Crepps
(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Kirsten Clanton
(See above for address)
PRO HAC VICE
ATTORNEY TO BE NOTICED

represented by Andrea H Costello

(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Janet Crepps
(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

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Plaintiff
Candace Churchill
in her individual capacity, as Coordinator
of the Morning−After Pill Conspiracy,
and on behalf of women who need
Emergency Contraception

Plaintiff
Francie Hunt
in her individual capacity, as Coordinator
of the Morning−After Pill Conspiracy,
and on behalf of women who need
Emergency Contraception

Plaintiff
Association of Reproductive Health
Professionals
on its own behalf and on behalf of its
members and women who need
Emergency Contraception

Kirsten Clanton
(See above for address)
PRO HAC VICE
ATTORNEY TO BE NOTICED

represented by Andrea H Costello

(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Janet Crepps
(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Kirsten Clanton
(See above for address)
PRO HAC VICE
ATTORNEY TO BE NOTICED

represented by Andrea H Costello

(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Janet Crepps
(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Kirsten Clanton
(See above for address)
PRO HAC VICE
ATTORNEY TO BE NOTICED

represented by Janet Crepps

(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY

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ATTORNEY TO BE NOTICED

Andrea H Costello
(See above for address)
ATTORNEY TO BE NOTICED

Plaintiff
National Latina Institute for
Reproductive Health
on its own behalf and on behalf of women
who need Emergency Contraception

represented by Janet Crepps

(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Andrea H Costello
(See above for address)
ATTORNEY TO BE NOTICED

represented by Janet Crepps

(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Andrea H Costello
(See above for address)
ATTORNEY TO BE NOTICED

represented by Janet Crepps

(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Andrea H Costello
(See above for address)
ATTORNEY TO BE NOTICED

represented by Janet Crepps

(See above for address)
LEAD ATTORNEY
PRO HAC VICE

Plaintiff
Robert Jaffe

Plaintiff
Aurora DeMarco

Plaintiff
Angelica Jaffe

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Plaintiff
Catherine Lederer−Plaskett

Plaintiff
Jonathan Marks

Plaintiff
Gabrielle Marks

ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Andrea H Costello
(See above for address)
ATTORNEY TO BE NOTICED

represented by Janet Crepps

(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Andrea H Costello
(See above for address)
ATTORNEY TO BE NOTICED

represented by Janet Crepps

(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Andrea H Costello
(See above for address)
ATTORNEY TO BE NOTICED

represented by Janet Crepps

(See above for address)
LEAD ATTORNEY
PRO HAC VICE
ATTORNEY TO BE NOTICED

Suzanne Ilene Novak
(See above for address)
TERMINATED: 10/18/2012
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Andrea H Costello
(See above for address)
ATTORNEY TO BE NOTICED

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Case: 13-1690 Document: 49 Page: 14 05/15/2013 938864 261

V.
Defendant
Margaret Hamburg
in her official capacity as Commissioner
of the Food and Drug Administration

Defendant
Kathleen Sebelius
in her official capacity as Secretary of the
Department of Health and Human
Services

Intervenor
Teva Women's Health, Inc.

represented by Farzin Franklin Amanat

United States Attorneys Office
Eastern District of New York
271 Cadman Plaza East
Brooklyn, NY 11201−1820
(718) 254−6024
Fax: (718)254−6081
Email: [email protected]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Eric B. Beckenhauer
U.S. Department of Justice
Civil Division, Federal Programs Branch
20 Massachusetts Ave Nw
Washington, DC 20001
202−514−3338
Fax: 202−616−8470
Email: [email protected]
ATTORNEY TO BE NOTICED

represented by Eric B. Beckenhauer
(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Farzin Franklin Amanat
(See above for address)
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

represented by Michael Shumsky

Kirkland &Ellis LLP
655 15th Street Nw
Suite 1200
Washington, DC 20005
202−879−5228
Fax: 202−654−9628
Email: [email protected]
LEAD ATTORNEY
ATTORNEY TO BE NOTICED

Steven Menashi
Kirkland &Ellis LLP
601 Lexington Avenue
New York, NY 10022
212−446−4931
Fax: 212−446−6460
Email: [email protected]
PRO HAC VICE
ATTORNEY TO BE NOTICED

Date Filed

02/15/2012

#

Docket Text

ORDER re 1 MOTION *** The motion to Reopen Case and Supplement
Complaint and Join Defendant is treated as a supplemental complaint challenging

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02/15/2012

02/16/2012

02/16/2012

02/16/2012

02/16/2012

02/16/2012

02/16/2012

02/16/2012

the decision of the FDA denying plttfs application to permit the "Over the Counter"
sale of Plan B. The Clerk is directed to open a new docket related to this action and
copy DE#s 345 through this order onto the new docket. The parties are directed to
file all further papers regarding this issue on the new docket number.. Ordered by
Senior Judge Edward R. Korman on 2/15/2012. (Greene, Donna) (Entered:
02/21/2012)

CORRECTED ORDER ** ORDER. The defendants are directed to respond to the
motion for a preliminary injunction and summary judgment within 60 days of the
date of this order. The defendants are directed to show cause within 21* days of the
date of this order 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 instructions for its use.
Ordered by Senior Judge Edward R. Korman on 2/16/2012. (Greene, Donna)
(Entered: 02/21/2012)

1 MOTION to Reopen Case by Association of Reproductive Health Professionals,

Jennifer Brown, Candace Churchill, Aurora DeMarco, Carol Giardina, Francie
Hunt, Angelica Jaffe, Robert Jaffe, Catherine Lederer−Plaskett, Erin T. Mahoney,
Kelly Mangan, Gabrielle Marks, Jonathan Marks, National Latina Institute for
Reproductive Health, Stephanie Seguin, Lori Tinney, Annie Tummino.
(Attachments: # 1 Civil Cover Sheet) (Bowens, Priscilla) (Entered: 02/17/2012)

2 MOTION for Preliminary Injunction and Summary Judgment by Aurora DeMarco,

Carol Giardina, Francie Hunt, Angelica Jaffe, Robert Jaffe, Catherine
Lederer−Plaskett, Erin T. Mahoney, Kelly Mangan, Gabrielle Marks, Jonathan
Marks, National Latina Institute for Reproductive Health, Stephanie Seguin, Lori
Tinney, Annie Tummino. (Greene, Donna) (Entered: 02/21/2012)

3 DECLARATION re 2 MOTION for Preliminary Injunction and Summary

Judgment by Association of Reproductive Health Professionals, Jennifer Brown,
Candace Churchill, Aurora DeMarco, Carol Giardina, Francie Hunt, Angelica
Jaffe, Robert Jaffe, Catherine Lederer−Plaskett, Erin T. Mahoney, Kelly Mangan,
Gabrielle Marks, Jonathan Marks, National Latina Institute for Reproductive
Health, Stephanie Seguin, Lori Tinney, Annie Tummino (Greene, Donna)
(Entered: 02/21/2012)

4 DECLARATION re 2 MOTION for Preliminary Injunction and Summary

Judgment by Association of Reproductive Health Professionals, Jennifer Brown,
Candace Churchill, Aurora DeMarco, Carol Giardina, Francie Hunt, Angelica
Jaffe, Robert Jaffe, Catherine Lederer−Plaskett, Erin T. Mahoney, Kelly Mangan,
Gabrielle Marks, Jonathan Marks, National Latina Institute for Reproductive
Health, Stephanie Seguin, Lori Tinney, Annie Tummino (Greene, Donna)
(Entered: 02/21/2012)

5 DECLARATION re 2 MOTION for Preliminary Injunction and Summary

Judgment by Association of Reproductive Health Professionals, Jennifer Brown,
Candace Churchill, Aurora DeMarco, Carol Giardina, Francie Hunt, Angelica
Jaffe, Robert Jaffe, Catherine Lederer−Plaskett, Erin T. Mahoney, Kelly Mangan,
Gabrielle Marks, Jonathan Marks, National Latina Institute for Reproductive
Health, Stephanie Seguin, Lori Tinney, Annie Tummino (Greene, Donna)
(Entered: 02/21/2012)

6 DECLARATION re 2 MOTION for Preliminary Injunction and Summary

Judgment by Association of Reproductive Health Professionals, Jennifer Brown,
Candace Churchill, Aurora DeMarco, Carol Giardina, Francie Hunt, Angelica
Jaffe, Robert Jaffe, Catherine Lederer−Plaskett, Erin T. Mahoney, Kelly Mangan,
Gabrielle Marks, Jonathan Marks, National Latina Institute for Reproductive
Health, Stephanie Seguin, Lori Tinney, Annie Tummino (Greene, Donna)
(Entered: 02/21/2012)

7 CERTIFICATE OF SERVICE by Association of Reproductive Health

Professionals, Jennifer Brown, Candace Churchill, Aurora DeMarco, Carol
Giardina, Francie Hunt, Angelica Jaffe, Robert Jaffe, Catherine Lederer−Plaskett,
Erin T. Mahoney, Kelly Mangan, Gabrielle Marks, Jonathan Marks, National
Latina Institute for Reproductive Health, Stephanie Seguin, Lori Tinney, Annie
Tummino (Greene, Donna) (Entered: 02/21/2012)

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02/16/2012

02/16/2012

02/16/2012

02/16/2012

02/16/2012

02/24/2012

02/24/2012

02/29/2012

02/29/2012

02/29/2012

02/29/2012

03/01/2012

03/02/2012

8 RULE 56.1 STATEMENT re 2 MOTION for Preliminary Injunction and Summary

Judgment filed by All Plaintiffs. (Greene, Donna) (Entered: 02/21/2012)

9 NOTICE of Appearance by Eric B. Beckenhauer on behalf of Margaret Hamburg

(aty to be noticed) (Greene, Donna) (Entered: 02/21/2012)

ORDER granting Motion to Reopen Case and to add another defendant is granted.
Ordered by Senior Judge Edward R. Korman on 2/15/2012. (Greene, Donna)
(Entered: 02/21/2012)

ORDER. The defendants are directed to respond to the motion for a preliminary
injunction and summary judgment within 60 days of the date of this order. The
defendants are directed to show cause within 15 days of the date of this order 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 instructions for its use. Ordered by Senior
Judge Edward R. Korman on 2/15/2012. (Greene, Donna) (Entered: 02/21/2012)

Minute Entry for proceedings held before Senior Judge Edward R.
Korman:Telephone Conference held on 2/16/2012. **Telephone conference took
place 2/15/12** (Greene, Donna) (Entered: 02/21/2012)

10 Notice of Related Case (Bowens, Priscilla) (Entered: 02/24/2012)

11 NOTICE of Appearance by F. Franklin Amanat on behalf of All Defendants (aty to

be noticed) (Amanat, F.) (Entered: 02/24/2012)

12 MOTION to Amend/Correct/Supplement /Clarification of Order by Association of

Reproductive Health Professionals, Jennifer Brown, Candace Churchill, Aurora
DeMarco, Carol Giardina, Francie Hunt, Angelica Jaffe, Robert Jaffe, Catherine
Lederer−Plaskett, Erin T. Mahoney, Kelly Mangan, Gabrielle Marks, Jonathan
Marks, National Latina Institute for Reproductive Health, Stephanie Seguin, Lori
Tinney, Annie Tummino. (Novak, Suzanne) (Entered: 02/29/2012)

13 AMENDED COMPLAINT Plaintiffs' Fifth Amended Complaint against Margaret

Hamburg, Kathleen Sebelius, filed by National Latina Institute for Reproductive
Health, Jennifer Brown, Gabrielle Marks, Erin T. Mahoney, Annie Tummino,
Jonathan Marks, Aurora DeMarco, Lori Tinney, Carol Giardina, Francie Hunt,
Robert Jaffe, Angelica Jaffe, Catherine Lederer−Plaskett, Candace Churchill, Kelly
Mangan, Association of Reproductive Health Professionals, Stephanie Seguin.
(Novak, Suzanne) (Entered: 02/29/2012)

14 Supplemental COMPLAINT Plaintiffs' First Amended Supplemental Complaint,

filed by National Latina Institute for Reproductive Health, Jennifer Brown,
Gabrielle Marks, Erin T. Mahoney, Annie Tummino, Jonathan Marks, Aurora
DeMarco, Lori Tinney, Carol Giardina, Francie Hunt, Robert Jaffe, Angelica Jaffe,
Catherine Lederer−Plaskett, Candace Churchill, Kelly Mangan, Association of
Reproductive Health Professionals, Stephanie Seguin. (Novak, Suzanne) (Entered:
02/29/2012)

15 AFFIDAVIT/AFFIRMATION re 12 MOTION to Amend/Correct/Supplement
/Clarification of Order, 13 Amended Complaint, 14 Supplemental Complaint,
Certificate of Service by Association of Reproductive Health Professionals,
Jennifer Brown, Candace Churchill, Aurora DeMarco, Carol Giardina, Francie
Hunt, Angelica Jaffe, Robert Jaffe, Catherine Lederer−Plaskett, Erin T. Mahoney,
Kelly Mangan, Gabrielle Marks, Jonathan Marks, National Latina Institute for
Reproductive Health, Stephanie Seguin, Lori Tinney, Annie Tummino (Novak,
Suzanne) (Entered: 02/29/2012)

16 MOTION for Leave to Appear Pro Hac Vice Filing fee $ 25, receipt number

0207−5337633. by Jennifer Brown, Candace Churchill, Carol Giardina, Francie
Hunt, Erin T. Mahoney, Kelly Mangan, Stephanie Seguin, Lori Tinney, Annie
Tummino. (Attachments: # 1 Affidavit of Kirsten Clanton, # 2 Proposed Order
Admission Pro Hac Vice) (Clanton, Kirsten) (Entered: 03/01/2012)

ORDER granting 12 Motion to Amend/Correct/Supplement. I clarify (1) that my
February 15, 2012 orders granted the plaintiffs motion to reopen Tummino v.
Hamburg, No. 1:05−CV−366 and additionally ordered that the supplemental

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complaint accompanying that motion be a supplement to the plaintiffs Fifth
Amended Complaint in that case; and (2) that the operative complaints in this case
are the plaintiffs Fifth Amended Complaint originally filed in Case No.
1:05−CV−366 and the plaintiffs First Amended Supplemental Complaint. Ordered
by Senior Judge Edward R. Korman on 3/2/2012. (Bedoya, Natalie) (Entered:
03/02/2012)

17 Consent MOTION for Extension of Time to File Response/Reply as to Order,,
requesting, on consent of the plaintiffs, a short extension of time, until Friday,
March 9, 2012, to submit the government's response to the Court's February 16,
2012, Order to Show Cause. Submitted by Margaret Hamburg, Kathleen Sebelius.
(Amanat, F.) (Entered: 03/07/2012)

18 MOTION for Leave to Appear Pro Hac Vice Filing fee $ 25, receipt number

0207−5350410. by Teva Women's Health, Inc.. (Attachments: # 1 Affidavit in
Support of Motion for the Pro Hac Vice admission of Steven Menashi) (Menashi,
Steven) (Entered: 03/07/2012)

ORDER granting 18 Motion for Leave to Appear. Ordered by Senior Judge
Edward R. Korman on 3/8/2012. (Susi, PaulaMarie) (Entered: 03/08/2012)

ORDER granting 16 Motion for Leave to Appear. Ordered by Senior Judge
Edward R. Korman on 3/8/2012. (Susi, PaulaMarie) (Entered: 03/08/2012)

ORDER granting 17 Motion for Extension of Time to File Response/Reply until
Friday, March 9, 2012, to submit the government's response to the Court's February
16 order. Responses due by 3/9/2012. Ordered by Senior Judge Edward R. Korman
on 3/8/2012. (Susi, PaulaMarie) (Entered: 03/08/2012)

19 NOTICE of Appearance by Kirsten Clanton on behalf of Jennifer Brown, Candace

Churchill, Carol Giardina, Francie Hunt, Erin T. Mahoney, Kelly Mangan,
Stephanie Seguin, Lori Tinney, Annie Tummino (notification declined or already
on case) (Clanton, Kirsten) (Entered: 03/08/2012)

20 MOTION for Leave to Appear Pro Hac Vice of Michael D. Shumsky Filing fee $

25, receipt number 0207−5355784. by Teva Women's Health, Inc.. (Attachments: #
1 Affidavit in Support) (Shumsky, Michael) (Entered: 03/09/2012)

21 Corporate Disclosure Statement by Teva Women's Health, Inc. identifying

Corporate Parent Teva Pharmaceutical Industries Ltd. for Teva Women's Health,
Inc.. (Menashi, Steven) (Entered: 03/09/2012)

22 MOTION to Intervene for Limited Purposes in Support of Neither Party by Teva
Women's Health, Inc.. (Attachments: # 1 Memorandum of Points and Authorities
in Support, # 2 Proposed Brief, # 3 Proposed Order) (Menashi, Steven) (Entered:
03/09/2012)

23 RESPONSE TO ORDER TO SHOW CAUSE by Margaret Hamburg, Kathleen

Sebelius (Attachments: # 1 Ex. A, # 2 Ex. B, # 3 Ex. C, # 4 Ex. D, # 5 Ex. E)
(Beckenhauer, Eric) (Entered: 03/09/2012)

ORDER granting 20 Motion for Leave to Appear Pro Hac Vice. Ordered by Senior
Judge Edward R. Korman on 3/12/2012. (Susi, PaulaMarie) (Entered: 03/12/2012)

24 MOTION for Leave to File Response to Defendants' Response to Order to Show

Cause by Association of Reproductive Health Professionals, Jennifer Brown,
Candace Churchill, Aurora DeMarco, Carol Giardina, Francie Hunt, Angelica
Jaffe, Robert Jaffe, Catherine Lederer−Plaskett, Erin T. Mahoney, Kelly Mangan,
Gabrielle Marks, Jonathan Marks, National Latina Institute for Reproductive
Health, Stephanie Seguin, Lori Tinney, Annie Tummino. (Novak, Suzanne)
(Entered: 03/13/2012)

ORDER granting 24 Motion for Leave to File ** The proposed schedule is
adopted. Ordered by Senior Judge Edward R. Korman on 3/16/2012. (Susi,
PaulaMarie) (Entered: 03/16/2012)

NOTICE of Hearing on Court's order of 2/15/2012 and Motion 22 MOTION to
Intervene for Limited Purposes in Support of Neither Party : Motion Hearing set

03/07/2012

03/07/2012

03/08/2012

03/08/2012

03/08/2012

03/08/2012

03/09/2012

03/09/2012

03/09/2012

03/09/2012

03/12/2012

03/13/2012

03/16/2012

03/16/2012

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03/22/2012

03/30/2012

03/30/2012

03/30/2012

03/30/2012

03/30/2012

03/30/2012

03/30/2012

04/02/2012

04/12/2012

for 4/27/2012 02:30 PM in Courtroom 8A South before Senior Judge Edward R.
Korman. Parties to confirm with each other (Susi, PaulaMarie) (Entered:
03/16/2012)

25 RESPONSE in Opposition re 22 MOTION to Intervene for Limited Purposes in

Support of Neither Party filed by Association of Reproductive Health
Professionals, Jennifer Brown, Candace Churchill, Aurora DeMarco, Carol
Giardina, Francie Hunt, Angelica Jaffe, Robert Jaffe, Catherine Lederer−Plaskett,
Erin T. Mahoney, Kelly Mangan, Gabrielle Marks, Jonathan Marks, National
Latina Institute for Reproductive Health, Stephanie Seguin, Lori Tinney, Annie
Tummino. (Attachments: # 1 Exhibit A) (Novak, Suzanne) (Entered: 03/22/2012)

26 NOTICE by Margaret Hamburg, Kathleen Sebelius (Attachments: # 1 Exhibit)

(Beckenhauer, Eric) (Entered: 03/30/2012)

27 DECLARATION of Suzanne Novak by Association of Reproductive Health
Professionals, Jennifer Brown, Candace Churchill, Aurora DeMarco, Carol
Giardina, Francie Hunt, Angelica Jaffe, Robert Jaffe, Catherine Lederer−Plaskett,
Erin T. Mahoney, Kelly Mangan, Gabrielle Marks, Jonathan Marks, National
Latina Institute for Reproductive Health, Stephanie Seguin, Lori Tinney, Annie
Tummino (Attachments: # 1 Appendix One to Novak Declaration) (Novak,
Suzanne) (Entered: 03/30/2012)

28 DECLARATION of Elizabeth G. Raymond, MD, MPH by Association of

Reproductive Health Professionals, Jennifer Brown, Candace Churchill, Aurora
DeMarco, Carol Giardina, Francie Hunt, Angelica Jaffe, Robert Jaffe, Catherine
Lederer−Plaskett, Erin T. Mahoney, Kelly Mangan, Gabrielle Marks, Jonathan
Marks, National Latina Institute for Reproductive Health, Stephanie Seguin, Lori
Tinney, Annie Tummino (Novak, Suzanne) (Entered: 03/30/2012)

29 DECLARATION of Miriam Cremer, MD, MPH by Association of Reproductive

Health Professionals, Jennifer Brown, Candace Churchill, Aurora DeMarco, Carol
Giardina, Francie Hunt, Angelica Jaffe, Robert Jaffe, Catherine Lederer−Plaskett,
Erin T. Mahoney, Kelly Mangan, Gabrielle Marks, Jonathan Marks, National
Latina Institute for Reproductive Health, Stephanie Seguin, Lori Tinney, Annie
Tummino (Novak, Suzanne) (Entered: 03/30/2012)

30 MEMORANDUM in Opposition to Defendants' Response to Order to Show Cause

filed by All Plaintiffs. (Novak, Suzanne) (Entered: 03/30/2012)

31 DECLARATION re 30 Sealed, Memorandum in Opposition to Defendants'

Response to Order to Show Cause by Association of Reproductive Health
Professionals, Jennifer Brown, Candace Churchill, Aurora DeMarco, Carol
Giardina, Francie Hunt, Angelica Jaffe, Robert Jaffe, Catherine Lederer−Plaskett,
Erin T. Mahoney, Kelly Mangan, Gabrielle Marks, Jonathan Marks, National
Latina Institute for Reproductive Health, Stephanie Seguin, Lori Tinney, Annie
Tummino (Attachments: # 1 Appendix Two to Novak Declaration) (Novak,
Suzanne) (Entered: 03/30/2012)

32 CERTIFICATE OF SERVICE by Association of Reproductive Health

Professionals, Jennifer Brown, Candace Churchill, Aurora DeMarco, Carol
Giardina, Francie Hunt, Angelica Jaffe, Robert Jaffe, Catherine Lederer−Plaskett,
Erin T. Mahoney, Kelly Mangan, Gabrielle Marks, Jonathan Marks, National
Latina Institute for Reproductive Health, Stephanie Seguin, Lori Tinney, Annie
Tummino re 27 Declaration, 30 Sealed, Memorandum in Opposition, 29
Declaration, 31 Sealed, Declaration,,,, 28 Declaration, (Novak, Suzanne) (Entered:
03/30/2012)

33 REPLY in Support re 22 MOTION to Intervene for Limited Purposes in Support of

Neither Party filed by Teva Women's Health, Inc.. (Shumsky, Michael) (Entered:
04/02/2012)

34 Consent MOTION for Extension of Time to File (1) Defendants' Memorandum in

Opposition to 2 Plaintiffs' Post−Remand Motion for Preliminary Injunction and
Summary Judgment, and (2) Defendants' Response (by way of answer or motion) to
14 Plaintiffs' First Amended Supplemental Complaint. With the consent of the
plaintiffs, we respectfully request a one−week extension of time, until Monday,

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04/18/2012

04/18/2012

04/23/2012

04/23/2012

04/23/2012

04/23/2012

04/23/2012

04/23/2012

04/23/2012

04/23/2012

04/23/2012

04/24/2012

April 23, to complete and file our submissions. Plaintiffs have correspondingly
asked that their deadline to file a reply brief in support of their post−remand
motion for preliminary injunction and summary judgment, and a brief in
opposition to any motion we file in response to their pleading, be extended to May
23, 2012. We have no objection to their request and ask the Court, on plaintiffs
behalf, to extend their deadline as so indicated. Filed by Margaret Hamburg,
Kathleen Sebelius. (Amanat, Farzin) (Entered: 04/12/2012)

35 Letter re Plaintiffs' Corrected Response to Defendants' Response to Court Order to
Show Cause by Association of Reproductive Health Professionals, Jennifer Brown,
Candace Churchill, Aurora DeMarco, Carol Giardina, Francie Hunt, Angelica
Jaffe, Robert Jaffe, Catherine Lederer−Plaskett, Erin T. Mahoney, Kelly Mangan,
Gabrielle Marks, Jonathan Marks, National Latina Institute for Reproductive
Health, Stephanie Seguin, Lori Tinney, Annie Tummino (Novak, Suzanne)
(Entered: 04/18/2012)

36 MEMORANDUM in Opposition Corrected Response to Defendants' Response to

Order to Show Cause filed by All Plaintiffs. (Novak, Suzanne) (Entered:
04/18/2012)

37 MEMORANDUM in Opposition re 2 MOTION for Preliminary Injunction and

Summary Judgment filed by All Defendants. (Attachments: # 1 Exhibit Defendants'
Exhibit F, # 2 Exhibit Defendants' Exhibit G, # 3 Exhibit Defendants' Exhibit H, #
4 Exhibit Defendants' Exhibit I, # 5 Exhibit Defendants' Exhibit J) (Amanat,
Farzin) (Entered: 04/23/2012)

38 RESPONSE in Opposition re 2 MOTION for Preliminary Injunction and Summary

Judgment : Defendants' Response to Plaintiffs' Rule 56.1 Statement of Material
Facts, filed by All Defendants. (Amanat, Farzin) (Entered: 04/23/2012)

39 MOTION to Strike 6 Declaration, 4 Declaration, 29 Declaration, 28 Declaration, 5

Declaration, 3 Declaration, by Margaret Hamburg, Kathleen Sebelius. (Amanat,
Farzin) (Entered: 04/23/2012)

40 MEMORANDUM in Support re 39 MOTION to Strike 6 Declaration, 4

Declaration, 29 Declaration, 28 Declaration, 5 Declaration, 3 Declaration, filed by
All Defendants. (Amanat, Farzin) (Entered: 04/23/2012)

41 MOTION to Dismiss for Lack of Jurisdiction by Margaret Hamburg, Kathleen

Sebelius. (Amanat, Farzin) (Entered: 04/23/2012)

42 MEMORANDUM in Support re 41 MOTION to Dismiss for Lack of Jurisdiction

filed by All Defendants. (Amanat, Farzin) (Entered: 04/23/2012)

43 MOTION to Dismiss for Lack of Jurisdiction : CORRECTED NOTICE OF
MOTION −− REPLACES 41 WHICH WAS FILED IN ERROR by Margaret
Hamburg, Kathleen Sebelius. (Amanat, Farzin) (Entered: 04/23/2012)

44 CERTIFICATE OF SERVICE by Margaret Hamburg, Kathleen Sebelius re 37

Memorandum in Opposition, 38 Response in Opposition to Motion (Amanat,
Farzin) (Entered: 04/23/2012)

Motions terminated, docketed incorrectly: 41 MOTION to Dismiss for Lack of
Jurisdiction filed by Margaret Hamburg, Kathleen Sebelius. Document 43 replaces
document 41. (Greene, Donna) (Entered: 04/24/2012)

45 MOTION to Unseal Document 36 Sealed, Memorandum in Opposition filed by
Jonathan Marks, Catherine Lederer−Plaskett, Angelica Jaffe, Candace Churchill,
Lori Tinney, Kelly Mangan, Gabrielle Marks, Annie Tummino, Erin T. Mahoney,
National Latina Institute for Reproductive Health, Stephanie Seguin, Association
of Reproductive Health Professionals, Aurora DeMarco, Jennifer Brown, Carol
Giardina, Robert Jaffe, Francie Hunt, 35 Sealed, Letter,, filed by Jonathan Marks,
Catherine Lederer−Plaskett, Angelica Jaffe, Candace Churchill, Lori Tinney, Kelly
Mangan, Gabrielle Marks, Annie Tummino, Erin T. Mahoney, National Latina
Institute for Reproductive Health, Stephanie Seguin, Association of Reproductive
Health Professionals, Aurora DeMarco, Jennifer Brown, Carol Giardina, Robert
Jaffe, Francie Hunt, 30 Sealed, Memorandum in Opposition filed by Jonathan
Marks, Catherine Lederer−Plaskett, Angelica Jaffe, Candace Churchill, Lori

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Tinney, Kelly Mangan, Gabrielle Marks, Annie Tummino, Erin T. Mahoney,
National Latina Institute for Reproductive Health, Stephanie Seguin, Association
of Reproductive Health Professionals, Aurora DeMarco, Jennifer Brown, Carol
Giardina, Robert Jaffe, Francie Hunt, 31 Sealed, Declaration,,,, filed by Jonathan
Marks, Catherine Lederer−Plaskett, Angelica Jaffe, Candace Churchill, Lori
Tinney, Kelly Mangan, Gabrielle Marks, Annie Tummino, Erin T. Mahoney,
National Latina Institute for Reproductive Health, Stephanie Seguin, Association
of Reproductive Health Professionals, Aurora DeMarco, Jennifer Brown, Carol
Giardina, Robert Jaffe, Francie Hunt by Association of Reproductive Health
Professionals, Jennifer Brown, Candace Churchill, Aurora DeMarco, Carol
Giardina, Francie Hunt, Angelica Jaffe, Robert Jaffe, Catherine Lederer−Plaskett,
Erin T. Mahoney, Kelly Mangan, Gabrielle Marks, Jonathan Marks, National
Latina Institute for Reproductive Health, Stephanie Seguin, Lori Tinney, Annie
Tummino. (Attachments: # 1 Exhibit A to Plaintiffs' Motion to Unseal Documents
Filed Under Seal) (Novak, Suzanne) (Entered: 04/24/2012)

46 Letter to Judge Korman transmitting courtesy chambers copies of 37 , 38 , 39 , 40 ,
42 , and 43 . Submitted by Margaret Hamburg, Kathleen Sebelius (Amanat, Farzin)
(Entered: 04/24/2012)

47 Letter from Defendants to Judge Korman providing the Court with recent

supplemental authority that bears on 22 the pending motion of Teva Women's
Health, Inc. to intervene in this case and invites the Court to consider whether it is
premature to hear Teva's motion to intervene at this time (it is scheduled for
argument this Friday April 27) and whether the Court and the parties would be
better served by deferring consideration of Teva's motion until after the
government's motion to dismiss has been full briefed, argued, and decided.
Defendants also respectfully invite the Court to determine whether consideration of
the Court's Order to Show Cause of 02/16/12 may also be premature in view of
defendants' motion to dismiss. Submitted by Margaret Hamburg, Kathleen Sebelius
(Attachments: # 1 Judge Garaufis's Decision in NY v. US Army Corps of
Engineers) (Amanat, Farzin) (Entered: 04/25/2012)

49 Minute Entry for proceedings held before Senior Judge Edward R.

Korman:denying 43 Motion to Dismiss for Lack of Jurisdiction; Motion Hearing
held on 4/27/2012 re 22 MOTION to Intervene for Limited Purposes in Support of
Neither Party filed by Teva Women's Health, Inc., Reserved (Court Reporter
Hong/Rocco.) (Greene, Donna) Modified on 4/5/2013 (Rocco, Christine). (Entered:
05/01/2012)

48 Letter to Judge Korman from Michael D. Shumsky in response to the Government's

April 25, 2012 supplemental authority letter by Teva Women's Health, Inc.
(Shumsky, Michael) (Entered: 04/26/2012)

ORDER granting 45 Motion to Unseal Document. The motion is granted and the
documents filed under ECF Nos. 30, 31, 31−1, 35, and 36 are unsealed. Ordered by
Senior Judge Edward R. Korman on 4/26/2012. (Bedoya, Natalie) (Entered:
04/26/2012)

ORDER denying 39 Motion to Strike. The motion to strike the declarations
appended to plaintiffs' motion for preliminary injunction and summary judgment
and to plaintiffs' response to order to show cause is DENIED. I will, during the
course of ruling on the substantive motions, decide whether consideration of these
declarations is appropriate. Ordered by Senior Judge Edward R. Korman on
4/26/2012. (Bedoya, Natalie) (Entered: 04/26/2012)

ORDER. In a letter dated April 25, 2012, the defendants argue that the threshold
jurisdictional issues that they raise in their motion to dismiss implicate this Court's
authority to adjudicate Teva's intervention motion. They also invite this Court to
determine whether consideration of the Order to Show Cause may be premature. I
reject both suggestions. The first suggestion, which relies on Disability Advocates,
Inc. v. New York Coalition for Quality Assisted Living, Inc., 2012 WL 1143588
(2d Cir. Apr. 6, 2012), is without merit for the reasons set out in the letter
submitted by Teva Women's Health, Inc. on April 26, 2012. Moreover, I reject the
second suggestion because I have already decided the issue of standing in my
March 23, 2009 order. Indeed, the defendants' motion to dismiss asks me to

04/24/2012

04/25/2012

04/25/2012

04/26/2012

04/26/2012

04/26/2012

04/26/2012

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reconsider my ruling. See ECF No. 42 at 14. The defendants are free to re−argue
any issue they choose. While I understand their argument with respect to the
teenage plaintiffs who reached the age of 17 while the FDA interminably delayed
consideration of the Citizen's Petition and compliance with my order remanding the
case, I see no reason to delay consideration of the Order to Show Cause and related
issues.. Ordered by Senior Judge Edward R. Korman on 4/26/2012. (Bedoya,
Natalie) (Entered: 04/26/2012)

50 NOTICE of Change of Firm, Address and Email by