Amicus Curiae Brief — Zubik v. Burwell, 136 S. Ct. 444 (2015) (No. 14-1418)

Nos. 14-1418, 14-1453, 14-1505,

15-35, 15-105, 15-119 & 15-191

gn The

Supreme Court of the Gnited States

¢

MOST REVEREND DAVID A. ZUBIK, et al.,

Petitioners,

Vv.

SYLVIA BURWELL, Secretary of

Health and Human Services, et al.,

Respondents.

°

On Writs of Certiorari To The

United States Courts Of Appeals

For The Third, Fifth, Tenth And

District Of Columbia Circuits

+

AMICUS CURIAE BRIEF OF ASSOCIATION OF

AMERICAN PHYSICIANS & SURGEONS,

AMERICAN ASSOCIATION OF PRO-LIFE

OBSTETRICIANS & GYNECOLOGISTS, CHRISTIAN

MEDICAL ASSOCIATION, CATHOLIC MEDICAL

ASSOCIATION, PHYSICIANS FOR LIFE, NATIONAL

ASSOCIATION OF PRO LIFE NURSES, NATIONAL

ASSOCIATION OF CATHOLIC NURSES-U.S.A., AND

THE NATIONAL CATHOLIC BIOETHICS CENTER

IN SUPPORT OF PETITIONERS

*

DENISE M. BURKE

MAILEE R. SMITH

Counsel of Record

ANNA R. PAPROCKI

Mary E. HARNED

AMERICANS UNITED FOR LIFE

655 15th St. NW, Suite 410

Washington, D.C. 20005

Telephone: 202-289-1478

Facsimile: 202-289-1473

Email: Mailee.Smith@AUL.org

COCKLE LEGAL BRIEFS (800) 225-6964

WWW COCKLELEGALBRIEFS.COM

i

TABLE OF CONTENTS

Page

, § fs Fs, : _, , nen Se ner EE iii

STATEMENT OF INTEREST OF AMICI CU-

SI icitisliininsshdasintsadhiateebbittaddeiabanbiinntadiaisegicaniinnibanindebdes 1

SUMMARY OF ARGUMENT ....................cceeeceee 5

EET a een ee cee NEAT 7

I. It is Undisputed that a New Human

Organism is Created at Fertilization........ 7

II. Drugs and Devices Defined by the FDA as

“Emergency Contraception” Have Post-

Fertilization Mechanisms of Action ........... 10

A. Plan B can prevent implantation........ 12

B. Ulipristal Acetate (ella) can prevent

implantation or kill an implanted

Tila icnsndinasindenecenpiebenitncnnanpnaniateiadnianien 13

C. Intrauterine Devices can also prevent

I llntihs 18

Ill. The Mandate Violates Sincerely Held

Religious Beliefs and Freedom of Con-

ERC wee ae ae ee a 19

A. HHS’ alleged “accommodation” for re-

ligious non-profits requires. their

compliance with the Mandate............. 19

B. Freedom of Conscience is a funda-

mental right affirmed by our Found-

il

TABLE OF CONTENTS -— Continued

Page

C. Freedom of Conscience is a funda-

mental right affirmed by the U.S. Su-

an calinencadanmeialanbantiiied 27

D. Freedom of Conscience is a funda-

mental right affirmed by Congress ..... 31

a iiiciininninnsccincntsncininntaminiinennttatainniiintes 34

ili

TABLE OF AUTHORITIES

Page

CASES

Association of American Physicians & Surgeons

v. Clinton, 997 F.2d 898 (D.C. Cir. 1993).................. 2

Association of American Physicians & Surgeons

v. Mathews, 423 U.S. 975 (1975) .........cccccccececeeeeeeeees 2

Baird v. State Bar of Ariz., 401 U.S. 1 (1971) ........... 28

Burwell v. Hobby Lobby, 134 S. Ct. 2751

ESE CERES oer sade SO er mn 11, 22, 23

Cantwell v. Conn., 310 U.S. 296 (1940) ..................00. 28

Cheney v. United States Dist. Court, 542 U.S.

al 2

District of Columbia v. Heller, 554 U.S. 570

heather 3

Planned Parenthood v. Casey, 505 U.S. 833

ETE EER eeenn oer enn eee anne RNS 29

Roe v. Wade, 410 U.S. 113 (1973) ................cccccccseeeeees 32

Stenberg v. Carhart, 530 U.S. 914 (2000).................... 3

Tinker v. Des Moines Indep. Cmty. Sch. Dist.,

I lel 28

United States v. Seeger, 380 U.S. 163 (1965)............. 30

Welsh v. United States, 398 U.S. 333 (1970)........ 30, 31

West Virginia State Board of Education uv.

Barnette, 319 U.S. 624 (1943)... cceeeeeeee 28, 29

iv

TABLE OF AUTHORITIES — Continued

Page

CONSTITUTIONAL PROVISION

ee Ce, MIL Or . .cmsnpeomeninsnunene 7, 24, 28, 29

FEDERAL LAW AND REGULATIONS

eR 32

aceasta 32

I irinsiccetiensnsiensinnninepinenimniniiicatapianntt 33

I cicrcinciccintenpetniiimmmmaninieniantinua” 33

Io scsiremieniitenionnaemeinmneil 33

Ti crscnintsicdniitininioniinnibinminieaieaseiitil 33

RE anna ET 33

es SII Scrtrtntvniccenpesuvescenniuniesl 5, 13, 16, 31

42 U.S.C. $1396 w-22jNSNMB).........cccccscsssccrcccccsesseeees 33

ER eR D 31

ee EET Picrsesccccsoncsncsessccstnsreessencneesel 33

CTT a tri iraeeiecciaeeanionnaenieiiieiminamnill 20

aetna cneratnanaininnnaminientdl 21

Pub. L. No. 108-7, 117 Stat. 11, 126-27 (2000)........... 33

Pub. L. No. 108-7, 117 Stat. 11, 472 (1999)............... 33

Pub. L. No. 108-25, 117 Stat. 711, 733 (2003) ........... 33

Pub. L. No. 110-161, §508(d), 121 Stat. 1844,

IE cicctcrscciinininensicninimnaniennsinnseniniscapunsnenseed 33

v

TABLE OF AUTHORITIES — Continued

OTHER SOURCES

Adams, A Declaration of the Rights of the

Inhabitants of the Commonwealth of Massa-

chusetts, in REPORT FROM COMMITTEE BEFORE

THE CONVENTION OF DELEGATES (1779) ..............

Berg, Free Exercise of Religion, in THE HERIT-

AGE GUIDE TO THE CONSTITUTION (2005).............

Condic, When Does Human Life Begin? A

Scientific Perspective (The Westchester Insti-

tute for Ethics & The Human Person Oct.

2008), http://odfund.org/wordpress/wp-content/

uploads/2012/06/wi_whitepaper_life_print.pdf..

Cong. Rec. S12274 (daily ed. Dec. 3, 2009)

(colloquy between Sen. Mikulski and Sen.

Casey), http://Congress. gov ...............ccsceeseeeeeeees

Coy et al., Roles of the oviduct in mammalian

fertilization, REPRODUCTION 144(6):649 (Oct.

Ty SEED cvcscsevssenscenessennenneninvenineniinnnuiteniiinminngniiontia

Cushing, THE WRITINGS OF SAMUEL ADAMS (vol.

Tilp SEED verevesnanessvninsesenesvissseenenemteninnenbennenmannnntin

Department of Health and Human Services,

Birth Control Methods (updated Nov. 21, 2011),

http://www.womenshealth.gov/publications/

our-publications/fact-sheet/birth-control-methods.

Duramed Pharmaceuticals, How Plan B One-

Step Works (2015), http://www.planbonestep.

CUE PO IIIES, cccnceseccceenssesteevinienesiamnanes

Page

vi

TABLE OF AUTHORITIES — Continued

Page

ella Labeling Information, http://www.access

data.fda.gov/drugsatfda_docs/label/2010/0224

Ee 14

European Medicines Agency, Evaluation of

Medicines for Human Use: CHMP Assessment

Report for Ellaone (2009), http://www.ema.

europa.eu/docs/en_GB/document_library/EPAR_-

_Public_assessment_report/human/001027/

ESE eee ceee ae Le 14

Food and Drug Administration, Birth Control:

Medicines To Help You (updated Dec. 2,

2015), http://www.fda.gov/ForConsumers/By

Audience/ForWomen/FreePublications/ucm

ERY RE EA 6

Food and Drug Administration, FDA’s Decision

Regarding Plan B: Questions and Answers

(updated Dec. 7, 2015), http://www.fda.gov/

cder/drug/infopage/planB/planBQandA. ht» ......... 13

Gacek, Conceiving Pregnancy: U.S. Medical

Dictionaries and Their Definitions of Concep-

tion and Pregnancy, 9 NAT'L CATHOLIC Bio-

ETHICS QUARTERLY 542 (2009) .................ccccceeee 10, 14

George & Tollefsen, EMBRYO (2008) ..................00000000+ 7

Glasier et al., Ulipristal acetate versus

levongestrel for emergency contraception: A

randomized non-inferiority trial and meta-

analysis, 375 THE LANCET 555 (Jan. 2010)............. 14

Vii

TABLE OF AUTHORITIES — Continued

Harrison & Mitroka, Defining Reality: The

Potential Role of Pharmacists in Assessing

the Impact of Progesterone Receptor Modula-

tors and Misoprostol in Reproductive Health,

45 ANNALS PHARMACOTHERAPY 115 (Jan. 2011)....... 14

Health Resources and Services Administration,

Women’s Preventive Services Guidelines (Aug.

1, 2011), http:/www.hrsa.gov/womensguidelines/.

Jefferson, Letter to Edward Dowse, Esq. (Apr.

Ba Bee ccnstenccnninnssnnsiescteneiuiahinnniinnineumentaniedienmanceses 27

Jefferson, Letter to New London Methodists

Jefferson, Notes on Virginia (1785).....................-

Madison, Memorial and Remonstrance Against

Religious Assessments ¥ 15 (1785) ...................

Madison, Speech Delivered in Congress (Dec.

ily. IIT ccecesccccccsnsseccesssuenccenesnvetennnnesesapseorsseenenss

Marcello et al., Fertilization, ADv. Exp. BIOL.

PES GD ceocccsnccccsservenscecenssnnssnnssensecensneennesee

Marsden et al., Model systems for membrane

fusion, CHEM. Soc. Rev. 40(3):1572 (Mar.

McConnell, The Origins and Historical Under-

standing of Free Exercise of Religion, 103

HARV. L. REV. 1409 (1990)...............cccccccccccccceees

Milton, THE QUOTABLE FOUNDING FATHERS: A

TREASURY OF 2,500 WISE AND WITTY QUOTA-

ee iicercnintnctiicsiiataiasocciienesitinsinmeesiiainiiaininal

Vili

TABLE OF AUTHORITIES — Continued

Moore & Persaud, THE DEVELOPING HUMAN (7th

National Institutes of Health, Medline Plus

Merriam-Webster Medical Dictionary (2015),

http://www.merriam-webster.com/medlineplus/

SEES EEE eon e ence Renn

Novak & Novak, WASHINGTON’s Gop (2006).........

Okada et al., A role for the elongator complex in

zygotic paternal genome demethylation, NaA-

TURE 463:554 (Jan. 28, 2010).................00scee0000

Plan B Approved Labeling, http://www.access

data.fda.gov/drugsatfda_docs/nda/2006/021045

s011_Plan_B_PRNTLBL.pdf .............................

Raymond et al., Embracing post-fertilisation

methods of family planning: A call to action,

J. FAM. PLAN. REPROD. HEALTH CARE (2013)......

Rights of Conscience Overview, in DEFENDING

LIFE 2013: DECONSTRUCTING ROE: ABORTION’S

NEGATIVE IMPACT ON WOMEN (2013), http://

www.aul.org/wp-content/uploads/2013/04/06-

Freedom-of-Conscience.pdf...................0ccceeeeeee0

Signorelli et al., Kinases, phosphatases and

proteases during sperm capacitation, CELL

TISSUE REs. 349(3):765 (Mar. 20, 2012).............

—_— 34

ix

TABLE OF AUTHORITIES — Continued

Transcript, Food and Drug Administration

Center for Drug Evaluation and Research

(CDER), Advisory Committee for Reproductive

Health Drugs (June 17, 2010), http://

www.fda.gov/downloads/AdvisoryCommittees/

CommitteesMeetingMaterials/Drugs/Reprod-

uctiveHealthDrugsAdvisoryCommittee/UCM

Trussell et al., Emergency Contraception: A last

chance to prevent unintended pregnancy (Of-

fice of Population Research at Princeton

I inn etinrrerennninpmneegtats

Trussell et al., Emergency Contraception: A last

chance to prevent unintended pregnancy (Of-

fice of Population Research at Princeton

III, TI ssniitaineneemonsenetontnientnaivenen

Trussell et al., Emergency Contraception: A last

chance to prevent unintended pregnancy (Of-

fice of Population Research at Princeton

I Tc ccrrrrestinimnsitiepanmuensiensions

Washington, Letter to the Religious Society

Called Quakers (1789) ................ccccsssccessssssereese

1

STATEMENT OF INTEREST

OF AMICI CURIAE'

It is undisputed as a matter of science that a

new, distinct human organism comes into existence

during the process of fertilization — at the moment of

sperm-egg fusion — and before implantation of the

already-developing embryo into the uterine wall.

Many drugs and devices labeled by the U.S. Food and

Drug Administration as “emergency contraception,”

however, have post-fertilization (i.e., life-ending)

mechanisms of action which destroy the life of a

human organism. In other words, these drugs and

devices can work after a new human organism is

created (at fertilization). Such “contraceptive” meth-

ods may prevent implantation and therefore “preg-

nancy,” as defined by Respondents and their amici,

but by preventing implantation these drugs and

devices end the life of a unique human being.

Amici curiae are eight national organizations

whose members include physicians, bioethicists, and

other healthcare professionals who have a profound

interest in protecting all stages of human life. As

experts in the medical field, Amici file this brief to

provide documented scientific analysis that a new

' The parties have granted blanket consent to the filing of

amicus briefs in these consolidated cases. Pursuant to this

Court’s Rule 37, Amici state that no counsel for any party

authored this brief in whole or in part, and no such counsel or

party made a monetary contribution intended to fund the

preparation or submission of the brief.

2

human organism undisputedly begins at fertilization,

and that “emergency contraception” has _post-

fertilization mechanisms of action which can destroy

the life of a human organism.

Amici are sensitive to healthcare disparities and

support a variety of public and private efforts that

address healthcare affordability and accessibility.

Amici oppose, however, Respondents’ requirement

that private insurance plans cover drugs and devices

with post-fertilization (i.e., life-ending) mechanisms of

action. Cooperating with Respondents to arrange for

and facilitate such coverage violates the sincere

religious beliefs and freedom of conscience held by

Petitioners and, therefore, to the extent that the

government coerces their compliance and cooperation,

that coercion is unlawful under the Religious Free-

dom Restoration Act (RFRA) and is unconstitutional.

Amici include the following medical and ethics

associations:

Association of American Physicians & Sur-

geons (AAPS) is a national association of physicians.

Founded in 1943, AAPS has been dedicated to the

highest ethical standards of the Oath of Hippocrates

and to preserving the sanctity of the patient-

physician relationship. AAPS has been a litigant

before this Court and in other appellate courts. See,

e.g., Cheney v. United States Dist. Court, 542 U.S. 367,

374 (2004) (citing Association of American Physicians

& Surgeons v. Clinton, 997 F.2d 898 (D.C. Cir. 1993));

Association of American Physicians & Surgeons v.

3

Mathews, 423 U.S. 975 (1975). In addition, this Court

has specifically cited amicus briefs submitted by

AAPS in high-profile cases. See, e.g., Stenberg uv.

Carhart, 530 U.S. 914, 933 ‘2000); id. at 959, 963

(Kennedy, J., dissenting); District of Columbia v.

Heller, 554 U.S. 570, 704 (2008) (Breyer, J., dissent-

ing).

American Association of Pro-Life Obstetri-

cians & Gynecologists (AAPLOG) is a non-profit

professional medical organization consisting of ap-

proximately 2,500 obstetrician-gynecologist members

and associates. AAPLOG held the title of “special

interest group” within the American College of Obste-

tricians & Gynecologists (ACOG) for 40 years, from

1973 until 2013, when ACOG discontinued the desig-

nation of “special interest group.” AAPLOG is con-

cerned about the potential long-term adverse

consequences of abortion on a woman’s future health

and continues to explore data from around the world

regarding abortion-associated complications in order

to provide a realistic appreciation of abortion-related

health risks.

Christian Medical Association, founded in

1931, is a non-profit national organization of Chris-

tian physicians and allied healthcare professionals

with almost 14,000 members. It also has associate

members from a number of allied health professions,

including nurses and physician assistants. Christian

Medical Association provides up-to-date information

on the legislative, ethical, and medical aspects of

abortion and its impact on maternal health.

4

Catholic Medical Association is a non-profit

national organization comprised of over 2,000 mem-

bers representing over 75 medical specialties. Catho-

lic Medical Association helps to educate the medical

profession and society at large about issues in medi-

cal ethics, including abortion and maternal health,

through its annual conferences and quarterly bioeth-

ics journal, The Linacre Quarterly.

Physicians for Life (PFL) is a non-profit

medical organization that exists to draw attention to

the issues of abortion and contraception. PFL encour-

ages physicians to educate their patients regarding

the innate value of human life at all stages of devel-

opment, as well as the risks inherent in abortion.

National Association of Pro Life Nurses

(NAPN) is a national non-profit nurses’ organization

with members in every state. NAPN unites nurses

who seek excellence in nursing for all, including

mothers and the unborn. NAPN seeks to establish

and protect the ethical values of the nursing profes-

sion.

National Association of Catholic Nurses-

U.S.A. is a national non-profit organization that gives

nurses of different backgrounds the opportunity to

promote Catholic moral principles in nursing and to

stimulate desire for professional development. The

organization focuses on educational programs, spir-

itual nourishment, patient advocacy, and integration

of faith and health.

5

The National Catholic Bioethics Center,

established in 1972, conducts research, consultation,

publishing, and education to promote human dignity

in health care and the life sciences, and derives its

message directly from the teachings of the Catholic

Church.

Based on the destructive, post-fertilization effect

of “emergency contraception” and the coercive, uncon-

stitutional actions of Respondents requiring Petitioners

to violate their religious beliefs and consciences,

Amici urge this Court to grant relief to the Petitioners.

¢

SUMMARY OF ARGUMENT

The Affordable Care Act (ACA) requires that non-

grandfathered private health insurance plans “pro-

vide coverage for and shall not impose any cost

sharing requirements for preventive care and

screenings [for women].” Respondents’ regulatory

mandate implementing this provision (the “Man-

date”) requires these plans to fully cover, without co-

pay, all drugs and devices labeled by the Food and

Drug Administration (FDA) as “contraception.” It is

scientifically undisputed that the life of a new human

* 42 U.S.C. §300gg-13.

* See Health Resources and Services Administration,

Women’s Preventive Services Guidelines (Aug. 1, 2011), http://

www.hrsa.gov/womensguidelines/. All internet sites visited

December 14, 2015.

6

organism begins at fertilization. See Part I, infra.

However, the FDA's definition of “contraception”

includes drugs and devices with known post-

fertilization (i.e., life-ending) mechanisms of action.‘

See Part II, infra. Forcing employers to cooperate

with Respondents in providing coverage of life-ending

drugs and devices violates the conscientious beliefs of

Petitioners and Americans across the nation.

In addition to the plans and policies that are

exempted from the Mandate because of their “grand-

fathered” status, Respondents exercised their discre-

tion to create exemptions for churches and their

integrated auxiliaries and conventions/associations.

However, Respondents demand that certain religious

non-profit employers, including Petitioners, which

share the same religious objections as those churches

that were granted exemptions, comply with the

Mandate through a so-called “accommodation.” See

Part III.A., infra.

When the life-ending mechanisms of action of

“emergency contraception” are understood, it is clear

that, under this alleged “accommodation,” Respon-

dents effectively force Petitioners’ cooperation in facili-

tating coverage for these drugs and devices in

violation of fundamental rights guaranteed under the

Religious Freedom Restoration Act (RFRA) and the

* See FDA, Birth Control: Medicines To Help You (updated

Dec. 2, 2015), http://www.fda.gov/ForConsumers/ByAudience/For

Women/FreePublications/ucm313215.htm.

7

First Amendment. Importantly, this action is in direct

conflict with this nation’s long-standing commitment

to the freedom of conscience. See Part III.B., C., and

D., infra.

.

ARGUMENT

I. It is Undisputed that a New Human Or-

ganism is Created at Fertilization.

It is undisputed as a matter of science that a

new, distinct human organism comes into existence

during the process of fertilization, which begins at the

time of sperm-egg fusion and before implantation.’

Scientific literature is replete with statements re-

garding the beginning of human life:

¢ “The fusion of sperm and egg mem-

branes initiates the life of a sexually

reproducing organism.”

¢ “The life cycle of mammals begins

when a sperm enters an egg.”

* See, e.g., Condic, When Does Human Life Begin? A Scien-

tific Perspective (The Westchester Institute for Ethics & The

Human Person Oct. 2008), http://bdfund.org/wordpress/wp-

content/uploads/2012/06/wi_whitepaper_life_print.pdf; George &

Tollefsen, EMBRYO 39 (2008).

* Marsden et al., Model systems for membrane fusion, CHEM.

Soc. Rev. 40(3):1572 (Mar. 2011) (emphasis added).

” Okada et al., A role for the elongator complex in zygotic

paternal genome demethylation, NATURE 463:554 (Jan. 28, 2010)

(emphasis added).

8

¢ “Fertilization is the process by which

male and female haploid gametes (sperm

and egg) unite to produce a genetically

distinct individual.”

¢ “The oviduct or Fallopian tube is the an-

atomical region where every new life

begins in mammalian species. After a

long journey, the spermatozoa meet the

oocyte in the specific site of the oviduct

named ampulla, and fertilization takes

place.”

¢ “Fertilization — the fusion of gametes

to produce a new organism -— is the

culmination of a multitude of intricately

regulated cellular processes.”””

Respondents’ own definition attests to the fact

that human life begins at fertilization. According to

the National Institutes of Health (NIH), “fertilization”

is the “process of union of two gametes whereby the

somatic chromosome number is restored and the

development of a new individual is initiated.”" In

" Signorelli et al., Kinases, phosphatases and proteases

during sperm capacitation, CELL TISSUE RES. 349(3):765 (Mar.

20, 2012) (emphasis added).

* Coy et al., Roles of the oviduct in mammalian fertilization,

REPRODUCTION 144(6):649 (Oct. 1, 2012) (emphasis added).

Marcello et al., Fertilization, Apv. Exp. BioL. 757:321

(2013) (emphasis added).

"NIH, Medline Plus Merriam-Webster Medical Dictionary

(2015), http://www.merriam-webster.com/medlineplus/fertilization

(emphasis added).

9

the context of human life, a new individual human

organism is initiated at the union of ovum and sperm.

Further, one scientific textbook similarly explains

the following:

Human development begins at fertilization

when a male gamete or sperm (spermatozo-

on) unites with a female gamete or oocyte

(ovum) to produce a single cell — a zygote.

This highly specialized, totipotent cell

marked the beginning of each of us as a

unique individual.”

Thus, a new human organism is created before

the developing embryo implants in the uterus — i.e.,

before that time at which some people consider a

woman “pregnant.”

Respondents and their amici have at times tried

to distract from Petitioners’ objections to the Mandate

by arguing over terminology concerning when “preg-

nancy” begins rather than when life begins (at fertili-

zation). Relying on a definition of pregnancy that

begins at “implantation,” they have claimed that

“emergency contraceptives” are not “abortifacients.”

This semantic gamesmanship fails to respond to the

concern that the objected-to drugs and devices can

destroy human life after fertilization by blocking the

implantation of an already-developing human em-

bryo. Petitioners — and Amici — conscientiously oppose

" Moore & Persaud, THE DEVELOPING HuMAN 16 (7th ed.

2003) (emphasis added).

10

the voluntary ending of human life at any time fol-

lowing fertilization when such a termination is not

necessary to save the life of the mother.

Ii. Drugs and Devices Defined by the FDA as

“Emergency Contraception” Have Post-

Fertilization Mechanisms of Action.

Drugs and devices with post-fertilization mecha-

nisms of action are included in the FDA definitions of

“contraception” and “emergency contraception” even

though these drugs and devices may end a developing

and distinct human being’s life by preventing implan-

tation. Referring to such drugs and devices as “con-

traception” is deceiving in that the term implies to

the public only the prevention of conception (fertiliza-

tion). However, for the FDA, the endpoint which

defines a drug as a “contraceptive” is the ability to

prevent a “pregnancy” — which, in operational terms,

means preventing a positive pregnancy test ten days

to two weeks after possible embryo formation. Thus,

drugs and devices that interfere with implantation,

which occurs days after fertilization and the creation

of a new human organism, are categorized as “contra-

ception.””

" For an overview of how the definition of “pregnancy” has

changed, see Gacek, Conceiving Pregnancy: U.S. Medical

Dictionaries and Their Definitions of Conception and Pregnancy,

9 Nat’L CATHOLIC BIOETHICS QUARTERLY 542 (2009).

11

There is no dispute among the parties that at

least some forms of “contraception” have post-

fertilization mechanisms of action and can prevent

implantation of an already-developing human em-

bryo. For example, in Burwell v. Hobby Lobby, this

Court noted:

[T]he [plaintiffs] have a sincere religious be-

lief that life begins at conception. They

therefore object on religious grounds to

providing health insurance that covers

methods of birth control that, as HHS

acknowledges, may result in the destruction

of an embryo.

134 S. Ct. 2751, 2775 (2014) (citation omitted).

This post-fertilization effect is further supported

by Dr. James Trussell, who has appeared as an ami-

cus supporting Respondents in a number of cases

challenging the Mandate.” In a study on “emergency

contraception,” he states: “To make an informed choice,

women must know that [emergency contraception

‘ For example, an amicus brief of Physicians for Reproduc-

tive Health, the American College of Obstetricians & Gynecol-

ogists, Dr. James Trussell, and other medical organizations and

individuals has been filed in numerous cases. The brief contains

semantic arguments, such as when “pregnancy” begins and

whether a drug can be considered an “abortifacient.” However,

the relevant scientific benchmark is when the life of a human

organism begins, which undisputedly occurs at fertilization.

12

pills} § may at times inhibit implantation. ””° He

has also stated that these post-fertilization effects

“should certainly be [acknowledged and] celebrated,

because without them the [contraceptive] method

would not provide as much benefit as they do.”” In

other words, if fertilization has occurred, the method

provides “benefit” by preventing implantation.

Moreover, a drug classified by the FDA as “emer-

gency contraception” — Ulipristal Acetate (ella) — can

kill a human embryo after implantation. These post-

fertilization mechanisms of action demonstrate that

“emergency contraception” can end the life of an

already-developing human organism.

A. Plan B can prevent implantation.

The FDA-approved labeling acknowledges that

the “emergency contraception” drug known as Plan B

can prevent implantation of an already-developing

human embryo.” The FDA states on its website, “ilf

fertilization does occur, Plan B may prevent a fertilized

* Trussell et al., Emergency Contraception: A last chance to

prevent unintended pregnancy (Office of Population Research at

Princeton University June 2010).

* Raymond et al., Embracing post-fertilisation methods of

family planning: A call to action, J. FAM. PLAN. REPROD. HEALTH

Care (2013).

" Plan B Approved Labeling, http://www.accessdata.fda.gov/

drugsatfda_docs/nda/2006/021045s011_Plan_B_PRNTLBL.pdf.

13

egg from attaching to the womb (implantation).”" The

same explanation is provided by Duramed Pharma-

ceuticals, the manufacturer of Plan B One-Step.”

Under Respondents’ Mandate, Petitioners are

forced to arrange for coverage of Plan B, despite its

life-ending effect on already-formed, unique human

organisms, in violation of Petitioners’ sincerely held

religious beliefs.

B. Ulipristal Acetate (ella) can prevent

implantation or kill an implanted em-

bryo.

The FDA approved the drug Ulipristal Acetate

(ella) as another “emergency contraceptive” in 2010,

after the enactment of the ACA. Importantly, ella is

not an “improved” version of the Plan B drug. The

chemical make-up of ella, unlike Plan B, is similar to

the abortion drug RU-486 (brand name Mifeprex).

Like RU-486, ella is a selective progesterone

receptor modulator (SPRM), and “(t]he mechanism of

action of ulipristal (ella) in human ovarian and en-

dometrial tissue is identical to that of its parent

* FDA, FDA's Decision Regarding Plan B: Questions and

Answers (updated Dec. 7, 2015), http://www.fda.gov/cder/drug/

infopage/planB/planBQandA htm.

* Duramed Pharmaceuticals, How Plan B One-Step Works

(2015), http://www.planbonestep.com/HowltWorks.aspx (explain-

ing that Plan B can work by “[p]reventing attachment (implan-

tation) to the uterus (womb)”).

14

compound mifepristone.” This means that, though

labeled as “contraception,” ella works the same way

as RU-486. By blocking the progesterone — necessary

to build and maintain the uterine wall during preg-

nancy — ella can either prevent a developing human

embryo from implanting in the uterus, or it can kill

an implanted embryo by essentially starving the

embryo to death. Thus, regardless of whether “preg-

nancy” is defined as beginning at fertilization or at

implantation, ella can abort a pregnancy.”

Studies confirm that ella can harm an embryo.”

The FDA-approved labeling notes that ella may

“affect implantation” and contraindicates use of ella

if pregnancy is known or suspected. A study funded

by ella’s manufacturer explains that SPRMs, “including

ulipristal acetate,” can “impair implantation.”“ While

the study’s researchers theorize that the dosage used

* Harrison & Mitroka, Defining Reality: The Potential Role

of Pharmacists in Assessing the Impact of Progesterone Receptor

Modulators and Misoprostol in Reproductive Health, 45 ANNALS

PHARMACOTHERAPY 115 (Jan. 2011).

" See Gacek, Conceiving Pregnancy, supra.

™ See, eg., European Medicines Agency, Evaluation of

Medicines for Human Use: CHMP Assessment Report for Ellaone

16 (2009), http/www.ema.europa.eu/docs/en_GB/document_library/

EPAR_-_Public_assessment_report/human/001027/WC500023673.

pdf.

* ella Labeling Information, http://www.accessdata.fda.gov/

drugsatfda_docs/label/2010/022474s000Ibl.pdf.

“ Glasier et al., Ulipristal acetate versus levongestrel for

emergency contraception: A randomized non-inferiority trial and

meta-analysis, 375 THE LANCET 555 (Jan. 2010).

15

in its trial “might be too low to inhibit implanta-

tion,” they state affirmatively that “an additional

postovulatory mechanism of action” (e.g., impairing

implantation) “cannot be excluded.”

Dr. Trussell’s “emergency contraceptives” study

further demonstrates ella’s potential to destroy a

human embryo. An emergency contraceptive “could

not be effective on average when started after 96

hours (four days) without a post-fertilization effect;

the reason is that with increasing delay, a greater

proportion of women would be too near to ovulation.””

Significantly, Dr. Trussell’s study notes that trials of

ella showed no statistically significant reduced effec-

tiveness for up to 120 hours or five days (the time

frame studied).” Simply, to be so “effective” four and

* In the Glasier study, “follow-up was done 5-7 days after

expected menses. If menses had occurred and a pregnancy test

was negative, participation [in the study] ended. If menses had

not occurred, participants returned a week later.” Considering

that implantation must occur before menses, the study could not,

and did not attempt to, measure an impact on an embryo prior

to implantation or even shortly after implantation. Upon

enrollment, participants were given a pregnancy test and

pregnant women were excluded from the study. The only

criterion for ella “working” was that a woman was not pregnant

in the end. Whether that was achieved through blocking implan-

tation or killing the embryo after implantation was not determi-

nable.

* Trussell et al., Emergency Contraception: A last chance to

prevent unintended pregnancy (Office of Population Research at

Princeton University Dec. 2013).

* Id.

16

five days after intercourse, ella would need to have a

post-fertilization (i.e. , life-ending) effect.

At the FDA advisory panel meeting for ella, Dr.

Scott Emerson, a professor of Biostatistics at the

University of Washington and a panelist, raised the

point that the low pregnancy rate for women who

take ella four or five days after intercourse suggests

that the drug must have an “abortifacient” quality.”

In short, ella goes beyond any other “contracep-

tive” that was approved by the FDA at the time of the

ACA’s enactment. By approving ella as “contracep-

tion,” the FDA removed, not simply blurred, the line

between “contraception” and “abortion” drugs because

ella can work by terminating an established “preg-

nancy.

Further, though “indicated” for contraceptive use,

mandated coverage for ella opens the door to the

funding (through health insurance) of purposeful, off-

label abortion usage of the drug. Already, ella is

available for sale online, where a purchaser need only

fill out a questionnaire to obtain the drug, with no

* See Transcript, Food and Drug Administration Center for

Drug Evaluation and Research (CDER), Advisory Committee for

Reproductive Health Drugs (June 17, 2010), http://www.fda.

gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/

Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM2 18560.

pdf.

17

physician or pharmacist to examine the patient,

explain the risks in person, or verify the identity and

intentions of the purchaser.

By mandating coverage for life-ending drugs and

devices, including the abortion-inducing drug ella,

HHS exceeded its discretion. The statutory language

of Section 2713(aX(4) of the ACA, which requires

private insurance plans to cover certain preventive

services, does not require the inclusion of any “con-

traception” as a covered service. Further, during a

debate over the amendment on the Senate Floor on

December 3, 2009, Senator Mikulski clarified that

abortion was not intended to be covered “in any way”

and, in fact, her amendment was “strictly concerned

with ensuring that women get the kind of preventive

screenings and treatments they need to prevent

diseases particular to women. ”™

* Cong. Rec. S12274 (daily ed. Dec. 3, 2009) (colloquy

between Sen. Mikulski and Sen. Casey) (emphasis added), http://

Congress.gov. Senator Mikulski’s full quote is as follows:

This amendment does not cover abortion. Abortion

has never been defined as a preventive service. This

amendment is strictly concerned with ensuring that

women get the kind of preventive screenings and

treatments they need to prevent diseases particular to

women such as breast cancer and cervical cancer.

There is neither legislative intent nor legislative lan-

guage that would cover abortion under this amend-

ment, nor would abortion coverage be mandated in

any way by the Secretary of Health and Human Ser-

vices.

Id.

18

Contrary to Senator Mikulski’s assurance and

their religious and conscientious beliefs, Petitioners

are required to arrange for coverage of ella — an

abortion-inducing drug — under Respondents’ Man-

date, even under the alleged “accommodation.”

C. Intrauterine Devices can also prevent

implantation.

Copper Intrauterine Devices (IUDs) are heavily

promoted as another form of “emergency contracep-

tion” and can block the implantation of a human

embryo after fertilization.” Dr. Trussell’s study on

“emergency contraceptives” concludes that “li]ts very

high effectiveness implies that emergency insertion of

a copper IUD must be able to prevent pregnancy after

fertilization.” Put another way, IUDs are so effective

because they do not just prevent conception — they

can kill an already-developing human embryo.

Clearly, under Respondents’ Mandate, Petitioners

are required to arrange for coverage of devices that

can kill human embryos, contrary to their religious

and conscientious beliefs.

* See Department of Health and Human Services, Birth

Control Methods (updated Nov. 21, 2011), http//www.womens

health.gov/publications/our-publications/fact-sheet/birth-control-

methods.pdf (“If fertilization does occur, the TUD keeps the

fertilized egg from implanting in the lining of the uterus.”).

" See Trussell et al., Emergency Contraception (2010), supra

(emphasis added).

19

III. The Mandate Violates Sincerely Held

Religious Beliefs and Freedom of Con-

science.

There can be no genuine dispute that the Man-

date includes drugs and devices with life-ending

mechanisms of action. Petitioners have made clear

their religious objections to paying or arranging for

life-ending drugs and devices, but are threatened

with onerous fines if they follow their religious and

conscientious beliefs. The Mandate’s coercive dichot-

omy — break the law or betray your religious beliefs —

violates the U.S. Constitution’s guarantee of freedom

of conscience.

Freedom of conscience is a fundamental right

that has been respected and protected since the

founding of our Nation. The paramount importance of

this historic right has been affirmed by the U.S.

Supreme Court and by Congress. History, tradition,

and jurisprudence affirm that a person cannot be

forced to commit an act that is against his or her

moral, religious, or conscientious beliefs — including

payment for such an act — and this history, tradition,

and jurisprudence unequivocally support the Peti-

tioners.

A. HHS’ alleged “accommodation” for re-

ligious non-profits requires their com-

pliance with the Mandate.

HHS’ own explanation of how the alleged “ac-

commodation” works contradicts its claim that the

20

“accommodated” religious groups “would not contract,

arrange, pay, or refer for [the coverage that violates

their religious beliefs].” 78 Fed. Reg. 39870, 39878

(2013). The July 2013 final rule clarifies that plan

participants and beneficiaries on an accommodated

plan do not have “two separate health insurance

policies.” Jd. at 39876. Rather, the insurance issuer

(the insurance company for the religious organiza-

tion) will make what HHS calls “separate payments”

for the objectionable coverage. Id. at 39874.

These payments are directly linked to the insur-

ance plan from which they are supposedly separate.

There are no opt-in or opt-out provisions. Payments

are automatically made for the “accommodated”

plan’s participants and beneficiaries and start and

end with a person’s enrollment in the “accommodat-

ed” plan. HHS acknowledges that “issuers typically

do not receive enrollee information prior to enroll-

ment.” Jd. at 39881. The relationship between the

issuer making the “separate payments” and the plan

enrollees is completely dependent on and related to

the supposedly “accommodated” organization’s plan.

The July 2013 final rule explained that these

payments can be envisioned as “cost neutral” for the

insurance issuer “because they would be insuring the

same set of individuals under both the group health

insurance policies and [the separate payments].” Jd.

at 39877. Even accepting HHS’ assumption that

providing coverage of contraceptives (use of which is

already ubiquitous) without co-pays would result in

fewer pregnancies and at least equally lower costs on

21

the “accommodated” group health plan,” the math

only works if these contraceptive payments are

considered in conjunction with the supposedly sepa-

rate health plan provided by the religious employer.

Under the interim final rule issued in August

2014, the so-called “accommodation” operates exactly

the same way as the July 2013 final rule. HHS ex-

plains the change as simply “provid[ing] an alterna-

tive process” for “notice of __ religious objections.” 79

Fed. Reg. 51092. That “alternative process” requires

handing over the name and contact information “for

any of the plan’s third party administrators and

health insurance issuers.” Jd. at 51098. HHS explains

that it will use that information to force the religious

employer’s health insurance issuer to include the

objected-to items and services. Id. The coercive im-

pact on the plan paid and arranged for by the reli-

gious employer remains the same and renders the

religious employer complicit with arranging coverage

for life-ending drugs and devices.

“ Dr. Trussell, who has appeared as an amicus supporting

Respondents in numerous related cases, readily acknowledges

that “no published study has yet demonstrated that increasing

access to [emergency contraception] reduces pregnancy or

abortion rates in a population. ” His study on “emergency

contraceptives” concludes that “it is unlikely that expanding

access will have a major impact on reducing the rate of unin-

tended pregnancy. ~” Trussell et al., Emergency Contraception:

A last chance to prevent unintended pregnancy (Office of Popula-

tion Research at Princeton University Sept. 2015).

22

The alleged “accommodation” effectively requires

a religious non-profit’s cooperation in the arranging

and facilitating coverage for the drugs and devices to

which it objects. Thus, it substantially burdens

religious beliefs in a manner similar to that of the

plaintiffs in Burwell v. Hobby Lobby. Importantly,

this Court held that “(bly requiring [plaintiffs] and

their companies to arrange for such coverage, the

HHS mandate demands that they engage in conduct

that seriously violates their religious beliefs.” Hobby

Lobby, 134 S. Ct. at 2775. Likewise, if a non-profit

religious employer does not “yield to this demand, the

negative economic consequences will be severe.” Id.

Notably, HHS has expressly exempted churches

and their auxiliaries that have objections similar to

those of Petitioners from compliance with the Man-

date. Concurring in Hobby Lobby, Justice Kennedy

noted that RFRA “is inconsistent with the insistence

of an agency such as HHS on distinguishing between

different religious believers — burdening one while

accommodating the other — when it may treat them

both equally by offering both of them the same ac-

commodation.” Jd. at 2786 (Kennedy, J., concurring).

HHS continues to unlawfully distinguish between

religious believers; instead of treating individuals or

entities with the same religious objection equally and

offering them the exemption, HHS burdens some

through what it inaccurately calls an “accommoda-

tion.”

Ultimately, it is for Petitioners to determine

whether what HHS has styled as an “accommodation”

23

burdens their religious beliefs. This Court squarely

addressed this point in Hobby Lobby, holding that

Petitioners “sincerely believe that providing the

insurance coverage demanded by the HHS regula-

tions lies on the forbidden side of the line, and it is

not for us to say that their religious beliefs are mis-

taken or insubstantial.” Jd. at 2779. Here, as in

Hobby Lobby, it is not for Respondents or the courts

to determine what “lies on the forbidden side of the

line” for Petitioners’ religious beliefs regarding com-

plicity with life-ending drugs and devices.”

* Further, as in Burwell v. Hobby Lobby, the ramifications

of condoning Respondents’ Mandate extend beyond the forced

cooperation in arranging or facilitating coverage for life-ending

drugs misleadingly labeled as “contraception.” This Court

recognized in Hobby Lobby that “[uJnder HHS’s view, RFRA

would permit the Government to require all employers to

provide coverage for any medical procedure allowed by law in

the jurisdiction in question — for instance, third-trimester

abortions or assisted suicide.” 134 S. Ct. at 2775, 2783. Likewise,

under the theory proposed by Respondents in the present case,

the Government could require those with sincere religious

objections to cooperate in arranging or facilitating coverage for

third-trimester abortions or assisted suicide. Through a forced-

participation scheme that it terms an “accommodation,” HHS

could, as this Court warned in Hobby Lobby, “effectively ex-

clude” pro-life Americans “from full participation in the economic

life of the Nation.” Jd. As this Court held in Hobby Lobby, “RFRA

was enacted to prevent such an outcome.” Jd.

24

B. Freedom of Conscience is a fundamen-

tal right affirmed by our Founders.

The First Amendment guarantees that Congress

shall make no law prohibiting the free exercise of

religion. U.S. CONST. amend. I. The very root of that

promise is the guarantee that the government cannot

force a person to commit an act in violation of his or

her religion.”

The signers to the religion provisions of the First

Amendment were united in a desire to protect the

“liberty of conscience.”” Having recently shed blood to

throw off a government which dictated and controlled

their faith and religious practices, guaranteeing

freedom of conscience was of utmost importance.

Thomas Jefferson was clear that freedom of

conscience is not to be subordinate to the government:

{Ojur rulers can have authority over such

natural rights only as we have submitted to

them. The rights of conscience we never

“* See generally McConnell, The Origins and Historical

Understanding of Free Exercise of Religion, 103 Harv. L. Rev.

1409 (1990).

* The Founders often used the terms “conscience” and

“religion” synonymously. Berg, Free Exercise of Religion, in THE

HERITAGE GUIDE TO THE CONSTITUTION 310 (2005). Thus, adoption

of the “religion” clauses does not mean that the Founders were

ignoring freedom of conscience. The two were inextricably

intertwined.

25

submitted, we could not submit. We are an-

swerable for them to our God.”

Jefferson also stated that no provision in the Consti-

tution “ought to be dearer to man than that which

protects the rights of conscience against the enter-

prises of civil authority.”

Likewise, James Madison, considered the Father

of the Bill of Rights, was deeply concerned that the

freedom of conscience be protected. Madison stated:

The Religion then of every man must be left

to the conviction and conscience of every

man; and it is the right of every man to exer-

cise it as these may dictate. This right is in

its nature an unalienable right.”

Madison described the conscience as “the most sacred

of all property.”” Madison also amended the Virginia

Declaration of Rights to state that all men are enti-

tled to full and free exercise of religion, “according to

the dictates of conscience.”

Madison understood that if man cannot be loyal

to his conscience, then a government cannot expect

him to be loyal to less compelling obligations, statutes,

* Jefferson, Notes on Virginia (1785).

” Jefferson, Letter to New London Methodists (1809).

“ Madison, Memorial and Remonstrance Against Religious

Assessments ¥ 15 (1785) (emphasis added).

* Milton, THE QUOTABLE FOUNDING FATHERS: A TREASURY OF

2,500 WISE AND WITTY QUOTATIONS 36-37 (2005).

26

judicial orders, or professional duties. If the govern-

ment demands that he betray his conscience, the

government has eliminated the only moral basis for

obeying any law. Madison considered it “the particu-

lar glory of this country, to have secured the rights of

conscience which in other nations are least under-

stood or most strangely violated.”

George Washington maintained that “the estab-

lishment of Civil and Religious Liberty was the

Motive that induced me to the field of battle.” Wash-

ington advised that the law should always extensive-

ly accommodate conscience:

The conscientious scruples of all men should

be treated with great delicacy and tender-

ness: and it is my wish and desire, that the

laws may always be extensively accommo-

dated to them, as a due regard for the protec-

tion and essential interests of the nation may

justify and permit.“

John Adams stated that “no subject shall be hurt,

molested, or restrained, in his person, liberty, or

estate, for worshipping God in the manner most

“ Madison, Speech Delivered in Congress (Dec. 22, 1790).

“ Novak & Novak, WasHINGTON’s Gop 111 (2006); Milton,

supra.

“ Washington, Letter to the Religious Society Called

Quakers (1789).

27

agreeable to the dictates of his own conscience.”

Patriot leader Samuel Adams wrote that the liberty of

conscience is an original right.“

Forcing Petitioners to arrange for and facilitate

coverage for life-ending drugs and devices to which

they are conscientiously opposed eviscerates one of

the very purposes for which this Nation was formed.

As Thomas Jefferson charged us:

[Wle are bound, you, I, every one, to make

common cause, even with error itself, to

maintain the common right of freedom of

conscience. We ought with one heart and one

hand hew down the daring and dangerous ef-

forts of those who would seduce the public

opinion to substitute itself into tyranny

over religious faith. “

C. Freedom of Conscience is a fundamen-

tal right affirmed by the U.S. Supreme

Court.

This Court has consistently ruled in favor of

protecting the freedom of conscience. “Freedom of

“ Adams, A Declaration of the Rights of the Inhabitants of

the Commonwealth of Massachusetts, in REPORT FROM COMMIT-

TEE BEFORE THE CONVENTION OF DELEGATES (1779).

“ Cushing, THE Writincs oF SAMUEL ApamMs 350-59 (vol. II,

1906).

“ Jefferson, Letter to Edward Dowse, Esq. (Apr. 19, 1803)

(emphasis added).

28

conscience” is referenced explicitly throughout Su-

preme Court jurisprudence. See, e.g., Baird v. State

Bar of Ariz., 401 U.S. 1, 6 (1971) (“This conjunction of

liberties is not peculiar to religious activity and

institutions alone. The First Amendment gives free-

dom of mind the same security as freedom of con-

science.”); Tinker v. Des Moines Indep. Cmty. Sch.

Dist., 393 U.S. 503, 506 n.2 (1969) (referencing “con-

stitutionally protected freedom of conscience”).

This Court has stated that “/f/reedom of con-

science cannot be restricted by law.” Cantwell v.

Conn., 310 U.S. 296, 303 (1940) (emphasis added).

While the “freedom to believe” is absolute, the “free-

dom to act” is not; however, “in every case,” regula-

tions on the freedom to act cannot “unduly infringe

the protected freedom.” Jd. at 303-04.

In the 1940s, the Court considered regulations

requiring public school students to recite the pledge

to the American flag, ultimately vindicating the

students’ freedom of conscience. In West Virginia

State Board of Education v. Barnette, the Court

stated:

If there is any fixed star in our constitutional

constellation, it is that no official, high or

petty, can prescribe what shall be orthodox in

politics, nationalism, religion, or other mat-

ters of opinion or force citizens to confess by

word or act their faith therein. [L]ocal

authorities [may not] transcend [] constitu-

tional limitations on their power and in-

vade[] the sphere of intellect and spirit

29

which it is the purpose of the First Amend-

ment to our Constitution to reserve from all

official control.

Barnette, 319 U.S. 624, 642 (1943) (emphasis in

original). The Court also stated, “[F]reedom to differ

is not limited to things that do not matter much.

The test of its substance is the right to differ as to

things that touch the heart of the existing order.” Jd.

Based upon these principles, the Court ruled it un-

constitutional to force public school children to per-

form an act that was against their religious beliefs.

Barnette has been affirmed on numerous occa-

sions, including in Planned Parenthood v. Casey, 505

U.S. 833 (1992), where the Court stated:

It is conventional constitutional doctrine that

where reasonable people disagree the gov-

ernment can adopt one position or the other.

That theorem, however, assumes a state of af-

fairs in which the choice does not intrude up-

on a protected liberty. Thus, while some

people might disagree about whether or not

the flag should be saluted, or disagree about

the proposition that it may not be defiled, we

have ruled that a State may not compel or en-

force one view or the other.

Id. at 851 (citing Barnette, 319 U.S. 624) (other

citations omitted) (emphasis added).

Similar to the principle established by the Court

in the context of an obligatory flag salute and pledge,

forcing the Petitioners to choose between adhering to

30

its religious, moral, or conscientious convictions and

complying with the Mandate is an unconstitutional

exercise of state power.

The Court has also protected men who were

conscientiously opposed to war. In United States v.

Seeger and Welsh v. United States, the Court extend-

ed draft exemptions” to “all those whose consciences,

spurred by deeply held moral, ethical, or religious

beliefs, would give them no rest or peace if they

allowed themselves to become part of an instrument

of war.” Welsh, 398 U.S. 333, 344 (1970) (affirming

Seeger, 380 U.S. 163 (1965)).

Welsh acknowledged that §6(j) protected persons

with “intensely personal” convictions — even when

other persons found those convictions “incomprehen-

sible” or “incorrect.” Welsh, 398 U.S. at 339. Seeger

and Welsh “held deep conscientious scruples against

taking part in wars where people were killed. Both

strongly believed that killing in war was wrong,

unethical, and immoral, and their consciences forbade

them to take part in such an evil practice.” Jd. at 337.

Important here is Welsh’s statement:

“ Section 6(j) of the Universal Military Training and

Service Act exempted men from the draft who were conscien-

tiously opposed to military service because of “religious training

and belief.” Early colonial charters and state constitutions

similarly spoke of freedom of conscience as a right, and during

the Revolutionary War, many states granted exemptions from

conscription to Quakers, Mennonites, and others with religious

beliefs against war.

31

I believe that human life is valuable in and

of itself; in its living; therefore I will not in-

jure or kill another human being. I can-

not, therefore conscientiously comply with

the Government’s insistence that I assume

duties which I feel are immoral and totally

repugnant.

Id. at 343.

These holdings demonstrate a strong, ongoing

commitment by this Court to protect freedom of

conscience. Like Welsh, Petitioners believe that

human life is valuable — at all stages and in all situa-

tions. Being forced to arrange for drugs and devices

that terminate a human life is just as objectionable as

being forced to participate in the termination of

human life in war.

D. Freedom of Conscience is a fundamen-

tal right affirmed by Congress.

The ACA expressly states that “[nJothing in this

Act shall be construed to have any effect on Federal

laws regarding — (i) conscience protection. ™

However, the implementation of Respondents’ Man-

date violates the principles of long-standing federal

laws that provide broad conscience protections.

Specifically, Congress has repeatedly passed measures

expressing Americans’ commitment to protecting the

freedom of conscience.

” 42 U.S.C. §18023.

32

For example, in 1973, Congress passed the first

of the Church Amendments following this Court’s

decision in Roe v. Wade, 410 U.S. 113 (1973). The

original and subsequent Church Amendments protect

healthcare providers from discrimination by recipi-

ents of HHS funds on the basis of their objection,

because of religious belief or moral conviction, to

performing or participating in not only abortion but

any lawful health service or research activity.

In 1996, the Coats Amendment, Section 245 of

the Public Health Service Act, was enacted to prohibit

the federal government and state or local govern-

ments that receive federal financial assistance from

discriminating against individual and institutional

healthcare providers, including participants in medi-

cal training programs, who refused to, among other

things, receive abortion training, require or provide

such training, perform abortions, or provide referrals

or make arrangements for such training or abor-

tions.” The measure was prompted by a 1995 pro-

posal from the Accreditation Council for Graduate

Medical Education to mandate abortion training in

all obstetrics and gynecology residency programs.

Congress has also acted to provide specific con-

science protections with regard to the provision of

contraceptives. In 1999, Congress prohibited health

plans participating in the federal employees’ benefits

* 42 U.S.C. §300-7.

* 42 U.S.C. §238n.

33

program from discriminating against individuals who

refuse to prescribe contraceptives.” Similarly, in

2000, Congress passed a law requiring the District of

Columbia to include a conscience clause protecting

religious beliefs and moral convictions in any contra-

ceptive mandate.”

The Hyde-Weldon Amendment, first enacted in

2005, provides that no federal, state, or local govern-

ment agency or program that receives funds under

the Labor, Health and Human Services (LHHS)

appropriations bill may discriminate against a health-

care provider because the provider refuses to provide,

pay for, provide coverage of, or refer for abortion.”

The Amendment is subject to annual renewal and has

survived multiple challenges.”

These laws highlight the commitment of the

American people to protect individuals and employers

from mandates or other requirements forcing them to

violate their consciences and/or religious and moral

® See Pub. L. No. 108-7, 117 Stat. 11, 472 (1999).

*' See Pub. L. No. 108-7, 117 Stat. 11, 126-27 (2000).

“ Pub. L. No. 110-161, §508(d), 121 Stat. 1844, 2209 (2007).

“ Many similar conscience provisions related to federal

funding have been passed over the last 45 years. See, e.g., 42

U.S.C. §1395w-22(jX3XB) (1997); 42 U.S.C. §300a-7(e) (1979); 42

U.S.C. §300a-7(cX2), (d) (1974); 42 U.S.C. §300a-7(b), (cX1)

(1973); 48 C.F_R. §1609.7001(c\7) (1998); Pub. L. No. 108-25, 117

Stat. 711, 733 (2003).

34

beliefs. Respondents’ Mandate ignores the long-

standing national commitment to protect the freedom

of conscience.™

Sf

CONCLUSION

It is undisputed as a matter of science that a new

human organism is created at fertilization. Being

forced to arrange and facilitate coverage for drugs

and devices that can end a human life after fertiliza-

tion amounts to forced participation in the act of

ending that life. Petitioners have genuine conscien-

tious or religious objections to arranging for and

facilitating insurance coverage for such life-ending

drugs and devices. Respondents’ Mandate and its

purported accommodation which requires Petitioners

to cooperate in the provision of such drugs and devic-

es comprise a coercive policy which contradicts the

“ Respondents’ actions also contravene the laws and clear

intent of the vast majority of states. See Rights of Conscience

Overview, in DEFENDING LIFE 2013: DECONSTRUCTING ROE:

ABORTION’S NEGATIVE IMPACT ON WOMEN (2013), http//www.aul.

org/wp-content/uploads/2013/04/06-Freedom-of-Conscience. pdf.

35

history, tradition, and jurisprudence of this Nation,

violates Petitioners’ freedom of conscience, and is,

therefore, unconstitutional.

This Court should grant relief to the Petitioners.

Respectfully submitted,

DENISE M. BURKE

MAILEE R. SMITH

Counsel of Record

ANNA R. PAPROCKI

Mary E. HARNED

AMERICANS UNITED FOR LIFE

655 15th St. NW, Suite 410

Washington, D.C. 20005

Telephone: 202-289-1478

Facsimile: 202-289-1473

Email: Mailee.Smith@AUL.org