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Case: 13-1690 Document: 20 Page: 1 05/13/2013 935359 223

No. 13-1690

IN THE UNITED STATES COURT OF APPEALS

FOR THE SECOND CIRCUIT

ANNIE TUMMINO, et al.,

Plaintiffs-Appellees,





v.














MARGARET HAMBURG, Commissioner of Food and Drugs, et al.,

Defendants-Appellants.

ON APPEAL FROM THE UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF NEW YORK

ADDENDUM TO MOTION FOR STAY PENDING APPEAL


LORETTA E. LYNCH
United States Attorney
F. Franklin Amanant
Assistant United States Attorney
DAVID J. HOROWITZ
Deputy General Counsel
ELIZABETH H. DICKENSEN
Chief Counsel, Food and Drug Division
ANNAMARIE KEMPIC
Deputy Chief Counsel, Food and Drug Division
SCOTT A. KAPLAN
Assistant Chief Counsel, Food and Drug Division
U.S. Department of Health and Human Services

STUART F. DELERY
Acting Assistant Attorney General
BETH S. BRINKMANN
Deputy Assistant Attorney General
MARK B. STERN
ADAM C. JED

(202) 514-8280
Attorneys, Appellate Staff
Civil Division, Room 7240
U.S. Department of Justice
950 Pennsylvania Ave., N.W.
Washington, D.C. 20530





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ADDENDUM TABLE OF CONTENTS



Statutes





















Page

Citizen Petition ............................................................................................................... Add-1

Fifth Amended Complaint ......................................................................................... Add-60

Second Amended Supplemental Complaint .......................................................... Add-104

Memorandum and Order (“Order”) (April 5, 2013) ............................................. Add-125

Judgment (April 10, 2013) ........................................................................................ Add-184

Notice of Appeal (May 1, 2013) .............................................................................. Add-186

Declaration of Janet Woodcock, M.D., and attachments .................................... Add-189

Memorandum and Order (“May Order”) (May 10, 2013) ................................... Add-204



Case: 13-1690 Document: 20 Page: 3 05/13/2013 935359 223

T H E

C E N T E R

F O R

R E P R O D U C T I V E

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L A W A N D
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P O L I C Y

February 14,200 1

Dockets Management Branch
Food and Drug Administration
Department of Health and Human Services
Room lo-61
5630 Fishers Lane
Rockville MD 20857

To Whom it May Concern:

Enclosed for filing, please find the original and three copies of a
Citizen’s Petition filed on behalf of the American Public Health
Association, the American Medical Women’s Association, the
Association of Reproductive Health Professionals, the National Asian
Women’s Health Organizations, the National Black Women’s Health
Project, the National Family Planning and Reproductive Health
Association, the Planned Parenthood Federation of America, the
Reproductive Health Technologies Project and 58 other organizations
listed therein.

NEW YORK IOOOj

US.4

917/637-3600

917/637-3666.fnx

1116 I()TH STREET, NW

WXSHINGTON, DC 20036

CSh

roz/530-2.975

202/j30-2976 fax

Add-1Case: 13-1690 Document: 20 Page: 4 05/13/2013 935359 223

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ORIGINAL

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Dockets Management Branch
Food and Drug Administration
Department of Health and Human Services
Room 10-6 1
5630 Fishers Lane
Rockville MD 20857

CITIZEN’S PETITION

The American Public Health Association, the American Medical Women’s Association,

the Association of Reproductive Health Professionals, the National Asian Women’s Health

Organizations, the National Black Women’s Health Project, the National Family Planning and

Reproductive Health Association, the Planned Parenthood Federation of America, the

Reproductive Health Technologies Project and 58 other organizations listed below, by their

counsel, the Center for Reproductive Law & Policy, submit this petition pursuant to 21 C.F.R. Q

10.30 (1999), to request that the Food and Drug Administration (FDA) switch from prescription

to over-the-counter (OTC) status two FDA-approved emergency contraceptive drugs, PrevenTM

and Plan [email protected], and any new drug eligible for filing an abbreviated new drug application because of
its equivalence to PrevenTM or Plan [email protected] (hereinafter these drugs will be collectively referred to as

EC). Such a switch is authorized under 21 U.S.C. 5 353(b)(3) and 21 C.F.R. 6 310.200(b)

because, as set forth below and in the supporting Declaration of David Grimes, M.D (“Grimes

Dec.“), EC is safe and effective for OTC use. Accordingly, the FDA should grant this Petition

and exempt EC from prescription dispensing limitations.

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ACTION REQUESTED

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Petitioners request that the FDA exempt from prescription-dispensing requirements,

pursuant to 21 U.S.C. 5 353(b)(3) and 21 C.F.R. 5 310.200(b), PrevenTM, Plan [email protected], and any new

drug eligible for filing an abbreviated new drug application because of its equivalence to

Preverz TM or Plan B’.

STATEMENT OF GROUNDS

Under the Food, Drug and Cosmetic Act and FDA regulations, “[alny drug limited to

prescription use . . . shall be exempted from prescription-dispensing requirements when the

Commissioner finds such requirements are not necessary for the protection of the public health

by reason of the drug’s toxicity or other potentiality for harmful effect, or the method of its use,

or the collateral measures necessary to its use, and he finds that the drug is safe and effective for

use in self-medication as directed in proposed labeling.” 21 C.F.R. $3 10.200(b); see also 21

U.S.C. 9 353(b)(3) (“The Secretary may by regulation remove drugs subject to sections 352(d)

and 355 of this title from the requirements of paragraph (1) of this subsection when such

requirements are not necessary for the protection of the public health.“). FDA regulations also

explicitly authorize the use of a citizen’s petition to seek a switch from prescription to OTC

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status: “A proposal to exempt a drug from the prescription-dispensing requirements of section

503(b)(l)(C) of the act may be initiated by . . . any interested person . . . . fil[ing] a petition . . .

pursuant to Part 10 of this chapter. . . .” 21 C.F.R. 6 310.200(b).

Limiting EC to prescription use is not necessary for the protection of public health. As

set forth in greater detail in the accompanying Declaration of Dr. Crimes, EC meets all the

criteria for OTC availability. In general, an approved drug is suitable for OTC use when: (1) the

drug is safe for self-medication, 21 C.F.R. 0 310.2OO(b)(1999); 21 C.F.R. 6 330.10(a)(4)(i)

(1999); Tamar Nordenberg, Now Available Without a Prescription, FDA Consumer 7,9 (Nov. 6,

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Case: 13-1690 Document: 20 Page: 6 05/13/2013 935359 223

1996); Marian Segal, RX to OX: The Switch is On, www.fda.gov,bbs/topics/consumer/

CNOOO12c.html (March 1991); R. William Soller, “OTCness”, 32 Drug Information Journal 555,

556-58 (1998); Debra L. Bowen, Making the Switch to OTC, III Cosmetics & Toiletries 102

(May 1996); Nancy L. But, The Switch from Prescription to Over the Counter, in The Pill: From

Prescription to Over the Counter 237,238-39 (eds. Samuels & Smith 1994); (2) the drug is

effective when self-administered, 21 C.F.R. 0 3 10.2OO(b)(1999); 21 C.F.R.

5 330.1 O(a)(4)@){ 1999); Soller, supra at 556,558-59; Bowen, supra; But, supra; Nordenberg,

supra at 7; (3) the condition to be treated is self-diagnosable, Segal, supra; Bowen, supra, But,

supra; and (4) the drug’s labeling is tailored to self-administration, 21 C.F.R.

6 3 10.200(b)( 1999); 2 1 C.F.R. 6 330.1 O(a)(4)(v)( 1999); Soller, supra, at 559-60; Segal, supra;

Bowen., supra; But, supra; Nordenberg, supra at 7-8,9, 11.

First, EC is safe for self-medication because it is not toxic to the woman (or to the

embryo or fetus if a pregnancy had been previously established in the woman); it has a low risk

of abuse or overdose; overdose is unlikely to lead to serious consequences; and its side effects

are well known and minor. Crimes Dec. 77 8A, B, C, F. Second, EC is effective when self-

administered. Its administration is simple and relies only on assessments as to time elapsed since

sexual intercourse that can be independently made by the woman, and any interaction between

EC and other drugs would be nonfatal and unlikely to seriously affect EC’s efficacy. Crimes

Dec. 7 81. Third, the condition EC treats - contraceptive failure or failure to use contraception

during intercourse - is one that is readily diagnosable by a woman, and EC has no

contraindications that would pose a danger to the patient. Crimes Dec. 18D. Fourth, the

existing patient labeling for Preven T”and Plan [email protected] is tailored to self-administration in that it is

simple, clear, comprehensive and easy to follow. Grimes Dec. fi 8H. Finally, switching EC to

3

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OTC status will promote public health because EC is only effective for a short time after

unprotected sex, and it works most effectively ‘if used within twenty-four hours of unprotected

sex. Because contacting a physician and obtaining and filling a prescription hinder women from

obtaining EC in a timely fashion, making EC available OTC will allow more women to use the

treatment, and enable more women to prevent unwanted pregnancies, to the benefit of public

health. Grimes Dec. 715, 6, 7. Accordingly, both the American Medical Association and the

American College ofObstetricians and Gynecologists have publicly supported efforts to move

EC to OTC status. See Dec. 5, 2000 Statement of American Medical Association,

http:/www.ama-assn.org/ama/pub/article/16 17-3547.html (copy attached hereto); February 14,

2001 Statement of the American College of Obstetricians & Gynecologists Supporting the

Availability of Over-the-Counter Contraception (filed herewith).

Because limiting EC to prescription dispensing is not necessary for the protection of

public health, the FDA should exempt it from that limitation. 2 1 C.F.R. 0 3 10.200(b) (a drug

“shall be exempted from prescription-dispensing requirements when the Commissioner finds

such requirements are not necessary for the protection of the public health”).

ENVIRONMENTAL IMPACT

The proposed action is exempt from the requirement of an environmental impact

statement under 21 C.F.R. $0 25.24(a)(8) and (c)(6).

ECONOMIC IMPACT

No information is required at this time.

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CERTlFICATION

The Center for Reproductive Law & Policy, counsel for petitioners certifies that, to the

best of its knowledge and belief, this petition includes all information and views on which the

itioners know of no data unfavorable to the petition.

Law 4% Policy
Attorneys for Petitioners
120 Wall Street, 14th floor
New York NY 10005
(917) 637-3600

Counsel for Petitioners

Helene T. Krasno ff
Planned Parenthood Federation of America
1780 Massachusetts Avenue, NW
Washington, DC 20036
(202) 973-4890

Of-Counsel for Petitioner Planned Parenthood Federation of America

Add-6Case: 13-1690 Document: 20 Page: 9 05/13/2013 935359 223

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PETITIONERS

Advocates for Youth
The Alaska Emergency Contraceptive Project
American Association of University Women
American Academy of Pediatrics
American College of Nurse-Midwives
Americans for Democratic Action
American Medical Women’s Association
The American Nurses Association
American Public Health Association
American Society for Emergency Contraception
American Society for Reproductive Medicine
Arizona Family Planning Council
Association of Reproductive Health Professionals
Beaverhead Family Planning Clinic
Center for Entrepreneurship in International Health and Development, School of Public Health,

University of California, Berkeley

Center for Women’s Policy Studies
Choice USA
The Compton Foundation
The Consortium for Emergency Contraception
Family Health Care, Inc.
Family Health International
Family Planning Association of Northern Ohio, Inc.
Family Planning Council
Family Planning Councils of America
Family Planning Council of Iowa
Family Planning Association of Maine
Family Tree Clinic
Fargo Cass Public Health

6

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Health Care of Southeast Massachusetts
Health Quarters
TPS
Lake County Family Planning
Medical and Health Research Association of New York ,City, Inc
National Abortion Federation
National Abortion and Reproductive Rights Action League

California Abortion and Reproductive Rights Action League
Massachusetts Abortion and Reproductive Rights Action League
Minnesota Abortion and Reproductive Rights Action League
New York Abortion and Reproductive Rights Action League

National Asian Women’s Health Organization
National Association of Nurse Practitioners in Women’s Health
National Black Women’s Health Project
National Coalition Against Domestic Violence
National Consumers League
National Family Planning and Reproductive Health Association
The National Organization for Women Legal Defense and Education Fund
The National Organization on Adolescent Pregnancy, Parenting & Prevention
National Partnership for Women and Families
Okanogan Family Planning
Oops- Emergency Contraception Hotline
Pacific Institute for Women’s Health
Pathfinder International
Physicians for Reproductive Choice and Health
Planned Parenthood Federation of America and all Planned Parenthood Affiliates Nationwide

Planned Parenthood of Central Washington
Planned Parenthood Chicago Area
Planned Parenthood of Connecticut
Planned Parenthood Heart of Illinois
Planned Parenthood of Houston and Southeast Texas, Inc

7

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Planned Parenthood Association of Lubbock
Planned Parenthood of Nassau County
Planned Parenthood of the Saint Louis Region
Planned Parenthood of Southern Arizona
Planned Parenthood of Stark County
Planned Parenthood of the Texas Capital Region
Planned Parenthood of Western Washington

The Population Council
Population Services International, U.S. Programs
Pro Choice Resource Center
Program for Appropriate Technology in Health
The Reproductive Health Technologies Project
The Sexuality Information and Education Council of the United States
Texas Family Planning Association
Tri City Health Center
Voters for Choice
Women’s Health Center of West Virginia

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AMA (Comm) AMA on acceqfl to emergency contraception

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Page 1 of 1

print story ( bc&merk.page

For immediate release
December 5,200O

Statement attributable to:
Ed-wacd..J,e.Hi!. 1M D_.
AMA trustee

“The AMA today approved recommendations regarding greater access to
emergency contraception pills (ECPs). Two brand names for emergency
contraceptive pills are Preven and Plan B.

“in addition to reaffirming current AMA policy that holds that no physician or
other professional personnel should be required to perform an act that violates
personally held moral principles, the AMA passed new policies to encourage
physicians to play a more active role in providing education about access to
ECPs. The new policies also direct the AMA to intensify efforts to improve
awareness and understanding about the drugs and to enhance efforts to expand
access to them, including making them more available through hospitals,
clinics, emergency rooms, acute care centers, and physicians’ offices.

“In order to expand access to ECPs, the AMA also decided to support and
monitor the application process of manufacturers filing for over-the-counter
approval of emergency contraception pills with the Food and Drug
Administration (FDA). If the FDA determines that ECPs are safe for over-the-
counter use, the AMA would support that increased access.”

.mor.e articlesc (B

Last updated: Dee 05,200O

Content Provided By: AMA Media Relations

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0 Copyright 1995-2001 American Medical Association. All rights reserved.

http://www.ama-assn.org/amdpub/article/1617-3547.html

l/17/01

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T,:i; A M E R I C A N COLLEGI: OF O~S’I’E~‘I~I.J~ANS ARKI CYtiECOLOCISTS

T: 202.484.332J f: zoxq7g.6826 email: [email protected],

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The American College Of Obstetricians and cGynecologi ;&

Statement of

Supporting the Availability of

Over-the-Counter Emergency Contraceptioti

February 14,200l

The American College of Obstetricians and Gynecologi$s (ACO( ;) supports
emergency oral contraception available to women over the count{ r in a

making
designated product.

The time has come for women to have access to a product that the 4 need. Almost’

half of the 6.3 million annual pregnancies in the US are unintended. Eme gency
contraception holds the potential to cut this figure in half. This in turn co 11d substantially
reduce the US abortion rate of about 1 in every 4 pregnancies.

The US Food and Drug Administration has declared emergency cc:ntraceptive
pills to be safe and effective in preventing pregnancy. Yet substantial bar iers exist to
women obtaining this fallback contraceptive method that must be used wi :hin 72 hours
after unprotected intercourse. We believe that emergency oral contracept: on can meet the
FDA criteria for over-the-counter availability. Then, at last, women would have access to
an important method of preventing pregnancy.

###

The American Coliege of Obstetricians and Gynecologists is the national medical
organization representing over 40,OOOphysicians who provide health car1 !.fix- women.

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’ 11.

Trussell J, Ellertson C, Stewart F, Koenig J, Raymond EG. Emergency contraception: a
cost effective approach to preventing unintended pregnancy. Woman Health Primary Care
1998;1:52-69.

i

12.

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

Ellertson C, Koenig 9, Trussell J, Bull J. How many U.S. women need emergency
contraception? Contemp Ob Gyn 1997;42: 102-28.

Trussell J, Stewart F, Guest F, Hatcher RA. Emergency contraceptive pills: a simple
proposal to reduce unintended pregnancies. Fam Plann Perspect 1992;24:269-73.

Ellertson C, Trussell J, Stewart FH, Winikoff B. Should emergency contraceptive pills be
available without prescription? J Am Med Womens Assoc 1998;53:226-9,232.

Grimes DA. Emergency contraceptives over the counter. Allowing easy access is important
[published erratum appears in West J Med 2000 May; 172(5):340]. West J Med
2000; 172: 148-9.

Jacobs LR. Prescription to over-the-counter drug reclassification. Am Fam Physician
1998;57:2209-14.

Grimes DA. The safety of oral contraceptives: epidemiologic insights from the first 30
years. Am J Obstet Gynecol 1992; 166: 1950-4.

Lake SR, Vernon SA. Emergency contraception and retinal vein thrombosis. Br J
Ophthalmol 1999$3:630-l.

U. S. Department of Health and Human Services. Vital statistics of the United States 1992,
Volume II Mortality Part A. Hyattsville, Maryland: National Center for Health Statistics,
1996.

Efficacy and side effects of immediate postcoital levonorgestrel used repeatedly for
contraception. United Nations Development Programme/ United Nations Population
Fund/World Health Organization/World Bank Special Programme of Research,
Development and Research Training in Human Reproduction, Task Force on Post-
Ovulatory Methods of Fertility Regulation. Contraception 2000;61:303-8.

Raman-Wilms L, Tseng AL, Wighardt S, Einarson TR, Koren G. Fetal genital effects of
first-trimester sex hormone exposure: a meta- analysis. Obstet Gynecol 1995;85: 141-9.

ACOG practice patterns. Emergency oral contraception. Number 3, December 1996.
American College of Obstetricians and Gynecologists. Int J Gynaecol Obstet 1997;56:290-
7.

Consortium for emergency contraception. Expanding global access to emergency
contraception. Seattle, WA: Program for Appropriate Technology in Health, 2000.

Goldzieher JW. Pharmacokinetics and metabolism of ethynyl estrogens. In: Goldzieher JW,
Fotherby K, eds. Pharmacology of the Contraceptive Steroids. New York: Raven Press,
1994.

Affidavit of DA Grimes and EG Raymond

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Add-12Case: 13-1690 Document: 20 Page: 15 05/13/2013 935359 223

25. Obach RS. Inhibition of human cytochrome P450 enzymes by constituents of St. John’s
Wort, an herbal preparation used in the treatment of depression. J Pharmacol Exp Ther
2000;294:88-95.

26. Guerts TBP, Goorissen EM, Sitsen JMA. Summary of drug interactions with oral

contraceptives. Camforth, England: Parthenon Publishing Group, Ltd., 1993.

27. Webb A. Deregulating emergency contraception. The alternative may be unwanted

pregnancies. BMJ 1994;308:135.

--

Affidavit of DA Grimes and EG Raymond

9

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Table 1. Side effects associated with two ECP regimens

% with symptom (95% CL)

Nausea
Vomiting
Dizziness
Fatigue
Headache
Breast tenderness
Low abdominal pain
All other adverse effects*
*Mostly diarrhea and some irregular bleeding or spotting.

Yuzpe (n=979)
50.5 (47.3 - 53.6)
18.8 (16.4-21.4)
16.7 (14.4 - 19.1)
28.5 (25.7 - 31.4)
20.2 (17.8 - 22.9)
12.1 (10.1 - 14.3)
20.9 (18.4 - 23.6)
16.7 (14.4 - 19.1)

Levonorgestrel (n=977)

23.1 (20.5 - 25.9)

5.6 (4.3 - 7.3)
11.2 (9.3 - 13.3)
16.9 (14.6 - 19.4)
16.8 (14.5 - 19.3)
10.8 (8.9 - 12.9)
17.6 (15.3 - 20.1)
13.5 (11.4 - 15.8)

From: Task Force on Postovulatory Methods of Fertility Regulation. Randomised controlled trial
of levonorgestrel versus the Yuzpe regimen of combined oral contraceptives for emergency
contraception. Lancet 1998;352:428-33.

Affidavit of DA Grimes and EG Raymond

10

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Table 2. Contraindications listed on FDA approved labeling of two approved ECP products

PtWt?nN

Plan [email protected]

Plan [email protected] should not be used by women
who have:

l pregnancy
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unexplained vaginal bleeding
allergy to any ingredient in the
product

Combination oral contraceptive pills [including
PrevenTM] should not be used by women who have:

pregnancy
history of blood clots in deep veins of legs
history of heart attack
history of stroke
valvular heart disease with complications
severe high blood pressure
diabetes with blood vessel involvement
severe headaches
liver tumors
active liver disease
heavy smoking and older than 35 years
allergy to any components of the product

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“May not be advisable to use ECPs” if you have had:

heart attack or stroke
blood clots in legs, lungs, or eyes
breast, endometrial, cervical, or vaginal cancer
unexplained vaginal bleeding
jaundice during pregnancy or OCP use

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Affidavit of DA Grimes and EG Raymond

11

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IN?RODUCTION

This book is to help teach you how to use the PREVENTM Emergency Contraceptive Kit correctly. When
used according to the directions, only 2 out of 100 women might become pregnant after a single act
of intercourse.
If no method of contraception is used, about 8 out of 100 might become pregnant.
Like all oral contraceptives, emergency contraceptive pills do not protect against infection with HIV (the
virus that causes AIDS) and other sexually transmitted diseases.
For more detailed information, please
refer to the Detailed Patient Labeling included in this kit.
If you still have questions or do not fully
understand how to use the kit after reading this book, you should talk to your healthcare professional.

1

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Your healthcare professional has prescribed the PREVEN TM Emergency Contraceptive Kit for you in
the event you may be at risk for an unintended pregnancy after unprotected sex. Unprotected sex
is when you know or suspect that your birth control failed (for instance, a condom broke during
sex) or you may have had sex without using birth control.

The pills in the PREVEN TM Emergency Contraceptive Kit will reduce the risk of unintended preg-
nancy if you start taking them as soon as possible but within 72 hours of having unprotected sex. They
will not work if you are already pregnant.

2

What are Emergency Contraceptive Pills (ECPs)?
The PREVENTM Emergency Contraceptive Kit pills contain hormones similar to those found in daily,
combination birth control pills (COCs): an estrogen (ethinyl estradiol) and a progestin (levonorges-
trel). The difference is that daily combination birth control pills are taken one pill each day for
21 per cycle to prevent pregnancy, whereas emergency contraceptive pills are taken as two pills in
two doses to prevent pregnancy. The first dose of two pills is taken as soon as possible but within :
72 hauls after unprotected sex, and the second dose of two pills is taken 12 hours later. The pills
in the PREVENT” Emergency Contraceptive Kit are meant for emergency use only and should not be used
as your regular method of birth control.

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What does the kit contain?
The PREVENTM Emergency Contraceptive Kit contains:
0
l a pregnancy test;

this Patient Information Book and Detailed Patient Information;

l

four light blue emergency contraceptive pills.

3

4

How do the pills in the PREVEN” Emergency Contraceptive Kit prevent pregnancy?
The horriiones contained in the emergency contraceptive pills prevent pregnancy in the same way
that daily birth control pills do.

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they delay or prevent ovulation (the process of maturation and the release of an egg from the ovary);
they may make it difficult for sperm to fertilize an egg if one has been released from the ovary;
they may produce changes in the lining of ‘the womb (uterus).

5

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Diagram of the Female Reproductive System

fallopian
tubes

fallopia
tubes

ovary

If you are already pregnant, emergency contraceptive pills cannot end the pregnancy.
Instead, the pills prevent a pregnancy from beginning.

6

Who should not use PREVEN” Emergency Contraceptive Kit pills?
Do not use the pills in the PREVENTM Emergency Contraceptive Kit if you are already pregnant as
a result of a previous intercourse (not the intercourse within the last 72 hours).
Emergency contraceptive pills may not be right for all women.
if you have had:

It may not be advisable to use ECPs

a heart attack, or a stroke;
blood clots in your legs, lungs, or eyes;
breast cancer or cancer of the lining Of the Uterus, cervix, or vagina;

7

unexplained vaginal bleeding;
jaundice (Yellowing of the whites of the eyes or skin) during a prior pregnancy or during previous
daily use of the combination birth control pill;
a liver tumor.

.
Be sure to tell your healthcare professional if you have ever had any of these conditions.

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How to use the PREVEN” Emergency Contraceptive Kit

Step 1. Please finish reading this patient book in full before using the Kit.
Step 2. Use the pregnancy test.
The pregnancy test is provided to help you dete,rmine if you are already pregnant from sex earlier
in the month or in previous months.
It will not tell you if you are pregnant from sex which took
place within the preyious 72 hours. The test detects pregnancy by showing if a hormone called
human chorionic gonadotropin or (hCG) (made by cells which are a part of the pregnancy) is pre-
sent in your urine.

9

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How to use the pregnancy test:

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Perform the test while sitting on the toilet.
Remove the test from the foil wrapper by tearing at the notches on the package. Throw away
the freshness packet (drying agent) inside the wrapper.
Take off the protective cap covering the absorbent tip. m
Hold the test stick with the absorbent tip pointing downward and place the tip into your urine
stream for at least five seconds. The entire tip should get wet. Do not urinate on the windows of
the test stick.
Remove the test stick from the urine stream. It is not necessary to replace the cap over the tip.

10

Lay the test stick on a flat surface with the windows facing up. As the test begins to work, you
will notice a pink/purple color moving across the windows. Don’t be alarmed-this is the nor-
mal ‘development’ process.

How to read the pregnancy test:

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You should wait at least three minutes after exposure to your urine for the results, but not longer
than 20 minutes. You can tell the test is ready to be read when you see a pink/purple line in ttie
SQUARE control window. All tests which have been performed correctly will show a pink/purple
line in the SQUARE control window. You must see a line in this SQUARE control window in order

for the test to be valid. Contact your healthcarenprofessional if you do
not see the pink/purple line in the SQUARE control window.
If a pink/purple line appears in the ROUND result window,
you are pregnant.

2 iines-
Pregnant

*

IMPORTANT: If you get a positive pregnancy result, do not take any
of the pills in the PREVEN TM Emergency Contraceptive Kit.
Contact your healthcare professional.

11

1 line-

Not pregnant

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The lines can be any shade of pink, as long a%you can see two clear and distinct lines as shown.
The test may show you are pregnant when you are not if you have had a miscarriage or have given birth
within the past 8 weeks. You should ask your healthcare professional for help in interpreting the result
of your pregnancy test if you have recently been pregnant.

NOTE: It doesn’t matter which line is darker. As long as there is a line in the SQUARE control window to indi-
cate the test is meaningful, the presence of a line in the ROUND result window indicates you are pregnant.

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If the test is negative-meaning no pink/purple line appears in the ROUND result window-continue on
to step 3.

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IMPORTANT:
Emergency Contraceptive Kit. The pills will not work.

If the pregnancy test shows that ypu are already pregnant, do not take the pills in the PREVENTM

13

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Case: 13-1690 Document: 20 Page: 22 05/13/2013 935359 223

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Step 3. Take the PREVENTM Emergency Contraceptive Kit Pills.
Each kit contains four light blue pills, which are taken in two doses of two pills per dose.
l

Take the first dose of two pills as soon as possible but within 72 hours of having unprotected sex.
Take the second dose of two pills 12 hours after the first dose. For example, if you take the first two
pills at 8 a.m., you m.ust take the second dose of two pills at 8 p.m.

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TIP: Try to take the first dose at a time that will make it convenient to take the second
hours later. However, remember that the first dose must be taken as soon as possible
72 hours after unprotected sex.
l Do not take any extra pills unless recommended by your

healthcare professional.

dose 12
but within

14

Emergency Contraceptive Kit will experience

Side Effects
Some women who use the pills in the PREVEN TM
side effects.
The most common side effect is nausea (being sick to your stomach). It is usually mild, and goes
away within a few hours, but may last one to two days. Taking the pills with food may reduce thf!
chance of nausea.
Some women who take the pills in the PREVENTM Emergency Contraceptive Kit may also vomit. If
vomiting occurs within an hour after you take either dose of emergency contraceptive pills, call your
healthcare professional to discuss whether to repeat the dose or to take antinausea medication.
15

Your next menstrual period may arrive a few days earlier or later than you expect. Menstrual blood
flow may also be heavier or lighter than usual.
If bleeding lasts longer than your period normally
does, or if your period doesn’t arrive within 21 days of taking emergency contraceptive pills, con-
tact your healthcare professional.

WARNING SIGNALS

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If you experience any of the following ill effects during or shortly after taking emergency contracep-
tive pills, contact your healthcare professional ifnmediately:

16

chest pain, coughing up of blood, or sudden shortness of breath;

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sudden severe headache, dizziness, weakness, numbness, or faintness;
sudden difficulty seeing or speaking;
severe pain or tenderness in the stomach area;
jaundice (yellowing of the skin or eyeballs).

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COMMONLY ASKED QUESTIONS AND ANSWERS
How do I know if the PREVENw Emergency Contraceptive Kit pills-have worked?
Within 21 days, you should get your menstrual period.

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If you don’t, see your healthcare professional.

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After using PREVEN” Emergency Contraceptive Kit pills, when can I have sex again?
You can have sex again right away, but you should use a regular form of birth control to protect yourself
from pregnancy. You may want to contact your healthcare professional to discuss your contraception.

18

Will PREVEN” Emergency Contraceptive Kit pills taken now prevent me from
pregnancy if I have sex without birth control in the future?
No, they will not. ECPs will also not protect you from sexually transmitted diseases.

How often can I use PREVEN” Emergency Contraceptive Kit pills?
,
ECPs are meant for one-time emergency protection. ECPs are not as effective as some forms of
regular birth control. If you have unprotected sex more than once per menstrual cycle and have
already taken the emergency contraceptive pilts for that cycle, you are advised to consult with your
healthcare professional.

19

Can I still use PREVEN” Emergency Contraceptive Kit pills if my healthcare
professional has told me that I should not take combination oral contraceptives?
You and your healthcare professional should discuss the risks and benefits of the PREVENfM
Emergency Contraceptive Kit pills and agree on the best course of action for you.

2 0

What happens if i don’? perform the pregnancy test correctly, and it says I’m not
pregnant when I really am? Will taking the PREVEN” Emergency Contraceptive
Kit pills harm my baby?
The pills in the PREVENTM Emergency Contraceptive Kit contain the same or similar hormones
as found in combination oral contraceptive pills. Scientific studies do not suggest that use of com-
bination oral contraceptives is associated with an increased risk of harm to the fetus, when taken
inadvertently during early pregnancy.

,

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Will taking PREVEN’” Emergency Contraceptive Kit pills cause changes in my
menstrual cycle?
You may find that your next menstrual period comes a few days earlier or late; than expected. Your
menstrual blood flow may also be heavier or lighter than us&.
If menstrual bleeding lasts longer
than your normal period or if your period does not arrive within 21
days of taking the emergency con-
traceptive pills, contact your healthcare professional.

22

FOR MORE

INFORMATION

If you have additional questions about the use of the PREVENTM Emergency Contraceptive Kit, please
consult the package insert. Information is also available at our website at www.PREVEN.com and our
toll free line l-888-PREVEN2.

Gyn&ics Inc.
P.O. Box-8509,
Somerville, NJ 08876

Issued: October, 1998
Print Code: 0891-098
PREVENTM Emergency Contraceptive Kit is made in the USA
Printed in USA
0 1998 Gynktics Inc.

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INTRODUCTlON
Any woman who considers using Plan 8” should
understand the benefits and risks. The following
information should help your understanding, but it
is not meant to replace a discussion between you and
your health care provider.

.

WHAT IS PLAN B?
plan 8 is intended to prevent pregnancy after unprotected
sex (if a contraceptive fails or if no contraception was used).
]t COfl&/fl5 [email protected],Qnc:g&m!, .+Li.-h ic 1 r~.~+L-+*” L-“-
..i*-2, *.e N d,a1b”‘.lL .l”,l,,Gne
(progesttn) commonly used in birth control pills. Plan 8
is for emergency use, and should not be used in place
of regular contraception since it is not as effective as
regular contraceptives.

zj Take the second tablet 12 hours after

you take the first tablet.

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eC.dSa,J.,

HOW EFFECTIVE IS PLAN S?
Plan ff reduces the risk of pregnancy following a single act of
unprotected sex from about 8% down to 1%. This represents
an 89% reduction in risk of pregnancy for this single act of
unprotected sex.

Plan 8 is more effective the sooner treatment is started
following unprotected sex.

WHO SHOULD NOT TAKE PLAN E?
;‘ii’*n 8 ;ho&j hot be t&o itvou are aiwxiv nr.-mm~ nr ii
you have an allergy to any ingredient in Plan B. Do not use
Plan B if you have unexplained vaginal bleeding,

._

-

WHAT IF I AM ALREAQY PREGNANlAND TAKE PLAN B?
Plan 8 is not appropriate if you are already pregnant; it will nor
work. iiowever, ifyou take Pian B and are already pregnant, it
is unlikely that this would affect the pregnancy. Several studies
involving the long-term use. of progestin hormone-containing
contraceptives have not shown any effects on the fetus.

OVERDOSAGE: Taking too much Plan 6 may cause
nausea or vomiting. You should contact your health
care provider if you take too much Plan 8.

OTHER INFORMATION: Plan B has been prescribed
specifically for you; do not give it to others.

Mfg. by Cede-m Richter, Ltd.. Budapest, Hungary
Distributed by women’s Capitol Corporatim
5400 Carillon Point
Klrkland WA. g&o33
Phone: I-fioa-~0.1171
Fax: 1307-407+’

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January, 200 1

CURRICULUM VITAE

DAVID A. GRIMES, M.D.

B0RN:Februar-y 18,1947

Waterbury, Connecticut

PERSONAL:

EDUCATION:

Wife: Katherine
Children (name and birth year): Robin, (1970) and Heather (1973)

19651969
1969-1973

1973-1975
1977-1979

Harvard University, 1969, B.A. cum laude
University of North Carolina
School of Medicine, 1973, M.D.
Resident, Obstetrics and Gynecology,
N.C. Memorial Hospital, Chapel Hill

MILITARY SERVICE:
19751977
1979-1980
1981-1986
U.S. Public Health Service
Centers for Disease Control

Surgeon (04)
Surgeon (04)
Senior Surgeon (05)

HONORS:

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Harvard National Scholar 1965
Morehead Scholar 1965
Morehead Fellow in Medicine 1969
Isaac Hall Manning Award 197 1
Whitehead Society First Award, Student Research Day, 1971 and 1973
North Carolina Obstetrical and Gynecological Society
Student Aptitude Award, 1972
Alpha Omega Alpha 1972
William deB. MacNider Award 1973
Alumni Loyalty Merit Award 1973
Lange Book Award 1973
Second Prize Paper: Presented at the District IV Meeting, American College of
Obstetricians and Gynecologists, Junior Fellow Research Awards, 1976
Prize Paper: Presented at the District IV Meeting, American College of Obstetricians
and Gynecologists, Junior Fellow Research Awards, 1980
Honorary Member of the Graduating Class, Emory University School of Medicine, 198 1
Commendation Medal, U.S. Public Health Service, 1982

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1992

Professionals,

Presented at the Eighth Annual Meeting, National

Ortho Prize Paper: Presented at the 21st Annual Scientific Meeting of the Association of
Planned Parenthood Professionals, 1983
DSA Medical Services Prize Paper:
Abortion Federation, 1984
Christopher Tietze Humanitarian Award, National Abortion Federation, 1987
Kaiser Permanente Award for Excellence in Teaching in the Clinical Sciences, USC
School of Medicine, 1989
Lester T. Hibbard Teaching Award, Department of Obstetrics and Gynecology, USC
School of Medicine, 1989
Carl Schultz Award, Population and Family Planning Section, American Public Health
Association 1990
Max Bulian Memorial Lecturer, Beth Israel Hospital, Boston, 199 1
Fundamental Right of Reproductive Freedom Award, American Civil Liberties Union of
Southern California, 1992
Bitterman Distinguished Lecturer, Beth Israel Medical Center, New York,
Eliot L. Silbar Memorial Lecturer, Northwestern University School of
Medicine, 1992
Outstanding Academic Faculty, Department of Obstetrics, Gynecology and Reproductive
Sciences, UCSF, 1993
Paul C. Weinberg Memorial Lecturer, American Society for Psychosomatic Obstetrics
and Gynecology, 1994
ACOG Issue of the Year Award, 1994
Distinction in Teaching Award, Academic Senate, University of California,
San Francisco, 1994
Alan Guttmacher Lectureship, Association of Reproductive Health
1994
Frank R. Lock Lecturer, Bowman Gray School of Medicine, 1994
Clinical Faculty Teaching Award, University of California, San Francisco, 1995
Visiting Professor, Alpha Omega Alpha, UCSF, 1995
Outstanding Lecture Award, 1995-96, UCSF Class of 1999
C. Houston Alexander Lecturer, St. Joseph Hospital, Denver, 1996
Rumbolz Visiting Professor, University of Nebraska Medical Center, 1996
Rubovits Memorial Lecturer, University of Illinois at Chicago, 1996
John Figgis Jewett Lecturer, Massachusetts Medical Society, 1996
Edith Potter Memorial Lecturer, American College of Obstetricians and Gynecologists,
1996
Alvin F. Goldfarb, M.D. Lecturer, North American Society for Pediatrics
and Adolescent Gynecology, 1996
Catherine L. Dobson Visiting Professor, University of Chicago, 1997 and 1999
Rudolph Holmes Memorial Lecturer, Chicago Gynecological Society, 1997
Clinical Faculty Teaching Award, University of California, San Francisco, 1997
Distinguished Service Award, American College of Obstetricians and Gynecologists,
1997
Presidential Speaker, North Carolina Obstetrical and Gynecological Society, 1997
Gallagher Lecturer, Society for Adolescent Medicine, 1997
Duncan Reid Lecturer, Harvard Medical School, 1997
Julian Wells Memorial Lecturer, Baylor University Medical Center, 1997
Atlee Memorial Lecturer, Dalhousie University School of Medicine,

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Halifax, Nova Scotia, 1997
Frank Kaltreider Memorial Lecturer, Johns Hopkins University School of Medicine, 1997
Keynote Speaker, Kenya Obstetrical and Gynaecological Society, 1999
Frederick Zuspan Scholar and Allan Barnes Memorial Lecturer, Ohio State University
College of Medicine, 1999
R. T. Weaver Lecturer, McMaster University School of Medicine, 1999
Outstanding Scientific Achievement Award, The National Family Planning and
Reproductive Health Association, Inc., 2000
Distinguished Technical Communication, Society for Technical Communication, NY
Metro Chapter, 1999-2000
Bradford W. Kincheloe Lecturer, University of Tennessee, Memphis, 2000
Honorable Mention, Special Service Award, National Association for Women’s Health,
2000

BOARD CERTIFICATION:

1981

1986

American Board of Obstetrics and Gynecology

Recertified, 199 1

American Board of Preventive Medicine

FACULTY APPOINTMENTS:

1979-1982

1981-1985

1983-1986

1985-1986

1986-1992

1986-1992

1993-1997

Clinical Assistant Professor,
Department of Gynecology and Obstetrics,
Emory University School of Medicine

Clinical Assistant Professor,
Department of Community Health,
Emory University School of Medicine

Clinical Associate Professor,
Department of Gynecology and Obstetrics,
Emory University School of Medicine

Clinical Associate Professor,
Department of Community Health,
Emory University School of Medicine

Professor, Department of Obstetrics and
Gynecology, University of Southern’ California
School of Medicine

Professor, Department of Preventive Medicine,
University of Southern California
School of Medicine

Professor and Vice Chairman
Department of Obstetrics, Gynecology and
Reproductive Sciences
University of California, San Francisco

. . .
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1993-1997

Professor, Department of Epidemiology and Biostatistics
University of California, San Francisco

1998

2000-

Clinical Professor, Department of Obstetrics and Gynecology
University of North Carolina School of Medicine

Fellow, Cecil G, Sheps Center for Health Services Research
University of North Carolina

GOVERNMENT POSITIONS:

1975-1977

1979-1982

1982-1983

1983-1984

1984-1986

Epidemic Intelligence Service Officer,
Centers for Disease Control

Assistant Chief,
Abortion Surveillance Branch,
Centers for Disease Control

Chief, Abortion Surveillance Branch,
Centers for Disease Control

Medical Epidemiologist,
Pregnancy Epidemiology Branch,
Centers for Disease Control

Clinical Research Investigator,
Division of Sexually Transmitted Diseases,
Centers for Disease Control

HOSPITAL POSITlONS:

1987-1992

1987-1992

1987-1992

1993-1997

1993-1997

Chief, Ambulatory Care Services
Women’s Hospital, Los Angeles

Vice Chairman, Infection Control Committee,
Women’s Hospital, Los Angeles

Chairman, Quality Assurance Committee,
Women’s Hospital, Los Angeles

Chief, Department of Obstetrics, Gynecology and Reproductive Sciences
San Francisco General Hospital

Clinical Service Chiefs Committee
Strategic Planning Committee
Library Committee
Research Committee
Executive Staff Committee
Clinical Provider Group
Emergency Department Advisory Committee

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36. Grimes DA, Huka JF, McCutchen ME: Midti-imester abortion by dilatation and evacuation WI-SW
intraamniotic instillation ofprostaglandin F2a: A randomized clinical trial. Am J Obstet Gynecol
1980; 137:785-790

37. Grimes DA: Routine circumcision reconsidered. Am J Nurs 1980; 80:108-109

3 8. Grimes DA, Cates W Jr: Fatal myocarditis associated with abortion in early pregnancy. South Med J

1980; 73:236-238

39. Grimes DA, Schulz KF, Gates W Jr, Tyler CW Jr: Local versus general anesthesia: Which is safer

for performing suction curettage abortions? Am J Obstet Gynecoll979; 135:1030-1035

40. Grimes DA, Fowler WC Jr: Adenosquamous carcinoma of the cecum arising in endometriosis.

Gynecol Oncol 1980; 9:254-255

41. Grimes DA, Hulka JF: Midtrimester dilatation and evacuation abortion. South Med J 1980; 73:448-

451

42. Grimes DA, Ekbladh LE, McCartney WH: ‘Cortical blindness in preeclampsia. Int J .Gynaecol Obstet

1 9 8 0 ;

17:601-603

43. Grimes DA, Gates W Jr, Selik RM: Abortion facilities and the risk of death. Fam Plann Perspect

1981; 13:30-32

44. Grimes DA, Cates W Jr, Selik RM: Fatal septic abortion in the United States, 1975-1977. Obstet

Gynecol 1981; 57:739-744

45. Grimes DA, Geary FH Jr, Hatcher RA: Rh immunoglobulin utilization after ectopic pregnancy. Am

J Obstet Gynecol 1981; 140:246-249

46. Grimes DA, Gross GK: Pregnancy outcomes in black women aged 35 and older. Obstet Gynecol

1981; 58:614-620

47. Guidotti RJ, Grimes DA, Cates W Jr: Fatal amniotic fluid embolism during legally induced abortion,

United States, 1972-1978. Am J Obstet Gynecol 1981; 141:257-261

48. Gates W Jr, Grimes DA: Deaths from second-trimester abortion by dilatation and evacuation:

Causes, prevention, facilities, Obstet Gynecoll981; 58:401-408

49. Peterson HB, Grimes DA, Gates W Jr, Rubin GL: Comparative risk of death from induced abortion
at < 12 weeks’ gestation performed with local versus general anesthesia. Am J Obstet Gynecol 1981;
141:763-768

50. Atrash HK, Peterson HB, Gates W Jr, Grimes DA: The risk of death from combined abortion-

sterilization procedures: Can hysterotomy or hysterectomy be justified? Am J Obstet Gynecol 1982;
142:269-276

5 1. Grimes DA: Diagnostic dilation and curettage: A reappraisal. Am J Obstet Gynecol. 1982; 142: l-6

52. Grimes DA, Peterson HB: Should dilation and curettage be performed routinely at the time of

laparoscopy? J Reprod Med 1982; 27:213-216

xii

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53. Grimes DA, Peterson HB, Rosenberg MJ, Fishburne JI Jr