Emergency Contraceptives or "Abortion-Inducing" Drugs? Empowering Women to Make Informed Decisions

Washington and Lee Law Review Washington and Lee Law Review

Volume 71 Issue 2 Article 23

Spring 3-1-2014

Emergency Contraceptives or "Abortion-Inducing" Drugs? Emergency Contraceptives or "Abortion-Inducing" Drugs?

Empowering Women to Make Informed Decisions Empowering Women to Make Informed Decisions

Ryan M. Hrobak

Washington and Lee University School of Law

Robin Fretwell Wilson

University of Illinois College of Law

Follow this and additional works at: https://scholarlycommons.law.wlu.edu/wlulr

Part of the Constitutional Law Commons, Health Law and Policy Commons, and the Law and Gender

Commons

Recommended Citation Recommended Citation

Ryan M. Hrobak and Robin Fretwell Wilson,

Emergency Contraceptives or "Abortion-Inducing"

Drugs? Empowering Women to Make Informed Decisions

, 71 Wash. & Lee L. Rev. 1385 (2014).

Available at: https://scholarlycommons.law.wlu.edu/wlulr/vol71/iss2/23

This Session 5 is brought to you for free and open access by the Washington and Lee Law Review at Washington

and Lee University School of Law Scholarly Commons. It has been accepted for inclusion in Washington and Lee

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1385

Emergency Contraceptives or

“Abortion-Inducing” Drugs?

Empowering Women to Make

Informed Decisions

Ryan M. Hrobak*

Robin Fretwell Wilson**

Table of Contents

I. Introduction ................................................................... 1386

II. A Resurgent Abortion Debate ....................................... 1391

III. Factual Basis for Religious Concerns............................ 1397

A. Contraceptives or Abortifacients?: Unraveling

Science and Semantics ............................................ 1398

1. How Plan B Works ............................................. 1400

2. How Ella May Work .......................................... 1402

B. The Meaning of Life—Or at Least Pregnancy ........ 1405

IV. Women Care About Mechanisms of Action ................... 1409

V. The Duty of Informed Consent ...................................... 1413

A. Two Approaches to Informed Consent .................... 1415

B. Abortion Cases ......................................................... 1419

C. The Disclosure Owed to Women ............................ 1422

D. Practical Considerations ......................................... 1423

VI. Conclusion ...................................................................... 1427

* A Gentleman and a Scholar, J.D. Candidate 2014, Washington and Lee

University School of Law.

** Roger and Stephany Joslin Professor of Law and Director, Family Law

and Policy Program, University of Illinois College of Law. I want to thank

Jennifer Bard, Sam Calhoun, Rob Gatter, Kent Greenawalt, David Hyman, Tim

Jost, Howard Katz, Fran Miller, and Wendy Parmet for their comments on this

paper.

1386 71 WASH. & LEE L. REV. 1385 (2014)

I. Introduction

The Obama Administration’s (Adminstration) mandate

under the Patient Protection and Affordable Care Act (ACA)

that

nearly all employers cover certain contraceptive drugs and

devices in any employee health plan (the Mandate)

opened a new

front in the American abortion debate. Religious objectors charge

that coverage of six specific “abortion-inducing”

drugs and

1. Patient Protection and Affordable Care Act, Pub. L. No. 111-148, 124

Stat. 119 (2010) (codified as amended at scattered sections of the Internal

Revenue Code and at 42 U.S.C.), amended by Health Care and Education

Reconciliation Act of 2010, Pub. L. No. 111-152, 124 Stat. 1029 through May 1,

2010.

2. The ACA requires coverage “with respect to women, [of] such additional

preventive care and screenings not described in paragraph (1) as provided for in

comprehensive guidelines supported by the Health Resources and Services

Administration (‘HRSA’) for purposes of this paragraph.” See Patient Protection

and Affordable Care Act, Pub. L. No. 111-148, 124 Stat. 119 § 1001 (codified at

42 U.S.C. § 300GG-13(a)(4) (2010)). The HRSA Guidelines recommended

coverage of “[a]ll Food and Drug Administration approved contraceptive

methods [and] sterilization procedures.” See Women’s Preventive Services

Guidelines: Affordable Care Act Expands Prevention Coverage for Women’s

Health and Well-Being, U.S.

DEPT. OF HEALTH & HUMAN SERVS.,

http://www.hrsa. gov/womensguidelines/ (last visited Jan. 21, 2014) (on file with

the Washington and Lee Law Review). Relying on the HRSA Guidelines, the

Administration finalized rules requiring coverage of “preventive care . . .

provided for in comprehensive guidelines supported by HRSA.” Interim Final

Rule on Preventive Services Under the ACA, 76 Fed. Reg. 46621, 46623 (Aug. 3,

2011); Final Rule on Preventive Services under the ACA, 77 Fed. Reg. 8724,

8725 (Feb. 15, 2012). The Mandate does not include drugs that are known to

work after implantation as chemical abortions, like RU-486. RU-486 is

marketed under the tradename “Korlym” and “Mifeprex.” Orange Book:

Approved Drug Products with Therapeutic Equivalence Evaluations, F

OOD &

DRUG ADMIN. (2013), http://www.accessdata.fda.gov/scripts/Cder/ob/docs/temptn.

cfm (last visited Jan. 21, 2014) (on file with the Washington and Lee Law

Review).

For a synopsis of the Administration’s accommodations of religious non-profits,

see Robin Fretwell Wilson, Demagoguing Abortion (working title), in T

RIGHTS OF RELIGIOUS INSTITUTIONS (Zoe Robinson, Micah Schwartzman & Chad

Flanders eds., forthcoming 2014) (on file with author). For penalties imposed on

objecting, non-exempt, for-profit employers if they drop all coverage, see Robin

Fretwell Wilson, The Calculus of Accommodation: Contraception, Abortion,

Same-Sex Marriage, and Other Clashes Between Religion and the State, 53 B.C.

L. REV. 1417, 1489–1505 (2012) [hereinafter Wilson, The Calculus].

3. Complaint at 6, Wheaton Coll. v. Sebelius, 887 F. Supp. 2d. 102 (D.D.C.

July 18, 2012) (No. 1:12CV01169), http://www.becketfund.org/wp-content/

uploads/2012/07/Wheaton-Complaint-timestamped.pdf; see also Birth Control:

Medicines to Help You, F

OOD & DRUG ADMIN., http://www.fda.gov/forconsumers/

EMERGENCY CONTRACEPTIVES 1387

devices is tantamount to providing an “abortion on demand.”

The

Administration and Mandate supporters insist that “drugs that

cause abortion are not covered by [the Mandate].”

This firestorm

over such drugs and devices (together, emergency contraceptives

or EC) reverberates far outside the Washington Beltway, spilling

over to decisions facing women about whether to use EC after

“unanticipated sexual activity, contraceptive failure, or sexual

assault.”

This Article explores how it is possible that such wildly

different claims can be made about the same drugs and devices,

claims that create real confusion for real women who are deciding

whether to use EC. It shows that both sides—Mandate

supporters and opponents, family planning advocates and

opponents of abortion—use conclusory labels to shorthand an

extraordinarily complex and still-unfolding scientific

understanding about how different kinds of EC work.

Notwithstanding key differences in their mechanisms of action—

that is, how the drug acts in a woman’s body—supporters and

opponents alike lump all EC together as if they work by precisely

the same mechanism, glossing over important differences.

byaudience/forwomen/freepublications/ucm313215.htm (last updated May 2013)

(last visited Feb. 11, 2014) [hereinafter FDA Birth Control Guide] (describing

various types of birth control, their utility, and how they work) (on file with the

Washington and Lee Law Review).

4. Complaint at 7, Sharpe Holding v. U.S. Dep’t. of Health and Human

Servs., (E.D. Mo. 2012) (No. 2:12-CV-92), http://www.becketfund.org/wp-

content/uploads/2013/04/Sharpe-Holdings-complaint.pdf; see also Timothy

Dolan, HHS Contraception Mandate “Un-American”, USA

TODAY (Jan. 25, 2012,

2:04 PM), http://usatoday30.usatoday.com/news/opinion/ forum/story/2012-01-

25/dolan-hhs-health-contraceptive-mandate/52788780/1 (last visited Jan. 14,

2014) (“[T]he contraceptives mandated as ‘preventive services’ will include

abortifacients.”) (on file with the Washington and Lee Law Review).

5. Cecila Munoz, Health Reform, Preventative Services, and Religious

Institutions, T

HE WHITE HOUSE BLOG (Feb. 1, 2012, 6:35PM),

http://www.whitehouse.gov/blog/2012/02/01/health-reform-preventive-services-

and-religious-institutions (last visited Jan. 14, 2014) (on file with the

Washington and Lee Law Review). The Administration has consistently

maintained that the Mandate does “not include abortifacient drugs.” See infra

note 36 and accompanying text.

6. W

HAT YOU NEED TO KNOW: THE DIFFERENCE BETWEEN MEDICAL

ABORTION AND EMERGENCY CONTRACEPTIVE PILLS, ASS’N OF REPROD. HEALTH

PROF’LS 1 (Dec. 2010), http://www.arhp.org/uploadDocs/mifepristone_ecfact

sheet.pdf [hereinafter W

HAT YOU NEED TO KNOW].

7. See infra Part III.A and accompanying footnotes (discussing the

1388 71 WASH. & LEE L. REV. 1385 (2014)

Compounding the competing explanations about how EC

works is the fact that both sides mean very different things when

they claim something is or is not “abortion-causing.”

Mandate

supporters contend that pregnancy begins when “a pre-embryo

completes implantation,”

while objectors believe the “life of every

human being [begins at] the moment of conception/fertilization,”

making its destruction “the killing of an innocent person.”

For women contemplating EC, separating “fact from fiction”

is no easy task

: “Since the approval of [ella] . . . there has been

even more confusion and controversy.”

Precisely because of

“myths” swirling around “in the popular press and on the

internet,” some women are now asking “tough questions about

mechanisms of action.”

While some discount concerns about whether EC works after

fertilization as a form of “zygote worship”

shared only by

different likely mechanisms of action for Plan B and ella and how they affect the

female reproductive system).

8. See infra Part II (discussing the confusion over what is and is not an

abortion-causing drug).

9. What You Need to Know, supra note 6, at 1.

10. Complaint at 2, 9, 11–13, Tyndale House Publishers v. Sebelius,

(D.D.C. Dec. 3, 2013) (No. 1:12-CV-1635-RBW), http://www.adfmedia.org/files/

TyndaleComplaint.pdf.

11. Verified Complaint for Declaratory & Injunctive Relief at 3, QC Group,

Inc. v. Sebelius, (D. Minn. July 2, 2013) (No. 0:13-CV-01726), http://www.

becketfund.org/wp-content/uploads/2013/08/1-Verified-Complaint-for-Declara

tory-and-Injunctive-Relief-7-2-13.pdf. Like many Catholic groups that have sued

the Administration, QC also believes that:

God, the Creator of human life, does not condone the use of birth

control (which includes ella, Plan B, the Pill, and other forms of

contraceptive required by the HHS Mandate) in any form because

they interfere with God’s sovereign will regarding whether and when

human beings should be born.

Id. As one of the authors notes elsewhere, few Americans object to contraceptive

use. See Wilson, The Calculus, supra note 2, at 1454 n.134 (citing a CBS News

opinion poll).

12. Pelin Batur, Emergency contraception: Separating fact from fiction, 79

LEVELAND CLINIC J. OF MED. 771, 771 (2012), available at

http://www.ccjm.org/content/79/11/771.full.pdf+html.

13. See id. (identifying and explaining common misunderstandings about

ella).

14. Id. at 771, 774.

15. I am indebted to Professor Jacqueline R. Fox, University of South

Carolina, School of Law, for bringing this term to my attention at the August

EMERGENCY CONTRACEPTIVES 1389

religious zealots, many women of child-bearing age remain torn

over using EC.

For some, these qualms flow directly from their

belief that life begins at fertilization. Although not an universally

held view, deeply personal views about the beginning of life raise

the question: Shouldn’t doctors have an “open and honest

conversation[ ] in layman’s terms regarding EC, its benefits, and

its potential consequences and let the patient make her own

decision”?

This Article maintains that a physician’s “guidance on how

and when to use [EC]”

is necessary to equip women with the

information needed to make informed decisions about their bodies

and healthcare, guided by “their own moral or religious beliefs.”

Part II briefly recaps how the Mandate reinvigorated public

concerns about abortion. It shows that religious objectors lifted

their concerns about the contested drugs and devices directly

from each label approved by the Food and Drug Administration

(FDA)—as the Administration concedes in the litigation over the

2013 Southeastern Association of Law Schools conference.

16. See infra Part IV (discussing the ethical dilemma women often face in

deciding whether to use EC).

17. Jennifer L. Wallace, et al., Letters to the Editor, In Response, Does

Pregnancy Begin at Fertilization?, Author’s Response, 36 F

AM. MED. 690, 691

(2004), http://www.stfm.org/fmhub/fm2004/November/Walter690.pdf.

18. Batur, supra note 12, at 771. Plan B’s accessibility on the shelf presents

added complexity to this issue. See infra note 66 (discussing the availability of

Plan B without a prescription or required interaction with a pharmacist). Thus,

women may not consult a physician or other professional before taking Plan B.

Therefore, the drug’s label should reflect accurate, accessible, and up-to-date

information regarding the drug’s mechanism of action. See infra Part III

(discussing fourteen years of scientific evidence that Plan B does not act after

fertilization, despite disclosures on Plan B’s label). Furthermore, primary care

physicians may also want to inform women seeking contraceptives about how

specific kinds of EC work.

19. Charles J. Lockwood, OTC Emergency Contraception: The Right Choice,

CONTEMP. OB/GYN 12, 15 (2004). Other healthcare professionals, such as

pharmacists, also have a role to play in providing women with the necessary

information to make informed decisions regarding EC use. See generally

UROPEAN CONSORTIUM FOR EMERGENCY CONTRACEPTION, EMERGENCY

CONTRACEPTION GUIDELINES IN THE EUROPEAN UNION COUNTRIES (2014),

http://www.ec-ec.org/custom-content/uploads/2014/03/ECEC_EC-Guidelines-in-

EU-countries_Feb2014.pdf. Therefore, while this Article deals primarily with

informed consent law as applied to physicians, informed consent principles

should animate the responsibilities of other healthcare professionals as well.

1390 71 WASH. & LEE L. REV. 1385 (2014)

Mandate presently before the U.S. Supreme Court.

Part III then

assesses the conflicting claims made by both sides about how the

contested drugs and devices actually work, focusing on two: Plan

B and ella.

This Part shows that since Plan B’s approval in

1999, it has never been shown to work after fertilization—despite

statements on its own label.

By contrast, ella is believed to

“have an additional action of affecting the ability of the embryo to

either attach to the endometrium or maintain its attachment, by

a variety of mechanisms” after fertilization.

As Part IV

documents, significant numbers of women care deeply about

whether a given drug acts after fertilization to prevent or disrupt

implantation.

Part V turns to the two prevailing standards for determining

what patients should be told when providing fully informed

consent to a treatment—the professional standard and the

material risk standard. This Part concludes that under either

standard, doctors have a duty to help women decipher the dense,

technical explanations found on the FDA-approved labels if

women are to make informed decisions to use EC guided by their

own values.

In doing so, physicians can add much-needed clarity

to an issue muddied by political rancor, while enhancing the

autonomy of the very women the Mandate sought to empower

and assist.

20. See infra Parts II and III; Birth Control: Medicines to Help You, supra

note 3 (explaining various types of birth control).

21. See infra Part III.A (detailing how Plan B and ella work).

22. See infra notes 38–39 and accompanying text (comparing the drug

labels of ella and Plan B); infra Part III.A.1 (discussing when and how Plan B

works).

23. Batur, supra note 12, at 774; see also Part III.A.2.

24. See infra notes 118–21 and accompanying text.

25. See infra Part V.

26. See Coverage of Certain Preventive Services Under the Affordance Care

Act, 78 Fed. Reg. 39,870, 39,873 (July 2, 2013) (to be codified at 26 C.F.R. pt. 54;

29 C.F.R. pts. 2510, 2590; 45 C.F.R. pts. 147, 156) (“[B]oth existing health

coverage and existing preventive services recommendations often did not

adequately serve the unique health needs of women. This disparity placed

women in the workforce at a disadvantage . . . . [A]ccess to contraception

improves the social and economic status of women.”).

EMERGENCY CONTRACEPTIVES 1391

II. A Resurgent Abortion Debate

In the years before the Mandate entered the public psyche,

reporting about “abortion-inducing drugs” was minimal.

Figure 1 illustrates, after the Administration promulgated rules

requiring coverage of “all-FDA approved contraceptives” in

August 2011,

news reports about “abortion-inducing,”

“abortifacient,” and “abortion-causing” drugs spiked and brought

this concern fully into the American consciousness.

27. Prior to the Mandate, it was healthcare providers who principally

asserted religious objections to EC. See Robin Fretwell Wilson, The Limits of

Conscience: Moral Clashes over Deeply Divisive Health Care Procedures, 34 A

J.L. & MED. 41, 52–54 (2008) [hereinafter The Limits] (discussing refusals from

healthcare facilities to perform abortions and prescribe EC, which resulted in

the development of a private clinic industry); Robin Fretwell Wilson, The

Erupting Clash Between Religion and the State Over Contraception,

Sterilization, and Abortion, in R

ELIGIOUS FREEDOM IN AMERICA: CONSTITUTIONAL

ROOTS AND CONTEMPORARY CHALLENGES (Allen D. Hertzke, ed., Univ. of Okla.

Press 2014) (forthcoming) (discussing recent clashes over providing EC and

abortions by nurses at two major medical centers); see also G

UTTMACHER

INSTITUTE, STATE POLICIES IN BRIEF: REFUSING TO PROVIDE HEALTH SERVICES 3

(Dec. 1, 2013), http://www.guttmacher.org/statecenter/spibs/spib_RPHS.pdf

(charting “policies allowing providers to refuse” to provide abortion,

contraception, and sterilization).

28. See supra note 2 (charting the evolution of the regulations requiring

expanded coverage in accordance with HRSA Guidelines).

29. Three “All News” searches on Lexis for U.S. news pieces containing the

terms “abortion-inducing,” “abortifacient,” or “abortion-causing” are telling:

TERM FREQUENCY OF TERM IN A GIVEN YEAR

1999

2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

2013

“abortion-inducing” 43 73 31 8 20 3 46 33 6 5 12 20 125 1193 1225

“abortifacient” 36 30 34 26 22 30 79 116 49 64 64 56 143 816 428

“abortion-causing” 6 5 5 1 7 2 16 12 11 6 11 14 28 125 91

TOTAL 85 108 70 35 49 35 141 161 66 75 87 90 296 2134 1744

1392 71 WASH. & LEE L. REV. 1385 (2014)

Reporters quickly spotlighted the controversy. Headlines

routinely touted one perspective or another: “Obamacare

Mandates (Free) Coverage of Abortion Drug”

and “Emergency

Contraception Is Not Abortion.”

Mandate supporters and opponents staked out opposing,

public positions. In “Six Things Everyone Should Know About the

HHS [Department of Health and Human Services] Mandate,” the

United States Conference of Catholic Bishops, a Mandate

opponent, forcefully asserted: “[B]y including all drugs approved

by the FDA for use as contraceptives, the HHS mandate includes

drugs that can induce abortion, such as ‘ella,’ a close cousin of the

abortion pill RU-486.”

Supporters, like the American Congress

30. See Jeffrey Anderson, Obamacare Mandates (Free) Coverage of Abortion

Drug, THE WEEKLY STANDARD: THE BLOG (Aug. 4, 2011, 6:00 AM),

http://www.weeklystandard.com/blogs/obamacare-mandates-coverage-abortion-

drug_581969.html (last visited Jan. 21, 2014) (criticizing the Mandate) (on file

with the Washington and Lee Law Review).

31. See Amanda Marcotte, Emergency Contraception Is Not Abortion,

LATE: THE XX FACTOR (June 6, 2012, 12:53 PM), http://www.slate.com/blogs/

xx_factor/2012/06/06/the_new_york_times_confirms_that_emergency_contracept

ion_only_works_by_suppressing_ovulation_.html (last visited Jan. 21, 2014)

(discussing a recent New York Times article on EC) (on file with the Washington

and Lee Law Review).

32. Six Things Everyone Should Know About the Health and Human

Services Mandate, U.S.

CONFERENCE OF CATHOLIC BISHOPS (Feb. 6, 2012),

http://www.usccb.org/news/2012/12-021.cfm (last visited Dec. 29, 2013) (on file

500

1000

1500

2000

2500

Figure 1. Reporting About

"Abortion-Inducing" Drugs by Year

EMERGENCY CONTRACEPTIVES 1393

of Obstetricians and Gynecologists, came to the Mandate’s

defense: “Abortion coverage is not required to be part of a

minimum benefits package, and no federal funds or tax credits

may be used to pay for abortions, except for abortions in case of

rape, incest, and when the pregnancy puts the mother’s life in

danger.”

Although the better news reports and public statements

unpacked exactly what they meant by “abortifacient” or

“abortion-causing drug,”

many did not.

Even the

Administration could have shed more light than it did. An HHS-

drafted Factsheet about the Mandate flatly declared that

“[a]bortifacient drugs are not included.”

After exempting

nonprofit religious objectors, the Administration continued to

with the Washington and Lee Law Review).

33. A

M. CONG. OF OBSTETRICIANS AND GYNECOLOGISTS, ACOG’S HEALTH

CARE REFORM FAQS FOR WOMEN 1–2 (May 2010), available at

http://www.acog.org/~/media/Departments/Health%20Care%20Reform/201005H

CRFAQsForWomen.pdf?dmc=1&ts=20131211T1254164769. The American

Congress and the American College of Obstetricians and Gynecologists are

companion entities. Id.

34. See Marcotte, supra note 31 (“[A]bortion terminates pregnancy, which

begins at implantation.”); Anderson, supra note 30 (stating that abortifacients

work by “by keeping a fertilized egg (or a newly conceived being) from

implanting in the uterine wall”); Six Things Everyone Should Know, supra note

32 (noting that the HHS Mandate included coverage of ella, which the

Conference considered to be an abortion-inducing drug).

35. See, e.g., Steven Ertelt, Obama Revises Mandate: Free Abortion-

Causing Drugs for Women, L

IFENEWS.COM (Feb. 20, 2012, 12:55 PM),

http://www.lifenews.com/2012/02/10/obama-revises-mandate-free-abortion-

causing-drugs-for-women/ (last visited Jan. 31, 2014) (“The Obama

administration has revised its controversial mandate that had forced religious

employers to pay for health insurance coverage that includes birth control and

drugs like Plan B, the morning after pill, and ella that can cause abortions.”) (on

file with the Washington and Lee Law Review); Paige Winfield Cunningham,

White House: Insurers Must Cover Abortion Pill, T

HE WASH. TIMES (Aug. 1,

2011), http://www.washingtontimes.com/news/2011/aug/1/white-house-insurers-

must-cover-abortion-pill/?page=all (last visited Jan. 31, 2014) (failing to define

“abortion” in distinguishing required coverage of Plan B, but not RU-486) (on

file with the Washington and Lee Law Review).

36. Factsheet: Affordable Care Act Rules on Expanding Access to Preventive

Services for Women, on file with the author. HHS appears to have taken down

the Factsheet, but a search now leads to this: Affordable Care Act Rules on

Expanding Access to Preventive Services for Women, U.S.

DEP’T. OF HEALTH &

HUMAN SERVS., http://www.hhs.gov/healthcare/facts/factsheets/2011/08/womens

prevention08012011a.html (last updated Jun. 2013) (last visited Mar. 5, 2014)

(on file with the Washington and Lee Law Review).

1394 71 WASH. & LEE L. REV. 1385 (2014)

summarily dismiss concerns that mandated drugs in fact cause

abortions: “[T]he regulations do not violate federal restrictions

relating to abortion because FDA-approved methods, including

Plan B, ella, and IUDs, are not abortifacients within the meaning

of federal law.”

Ironically, the FDA labels for each contested drug supplied

the basis for objectors’ concerns. The label for Plan B One-Step

reads:

Emergency contraceptive pills are not effective if a woman is

already pregnant. Plan B One-Step is believed to act as an

emergency contraceptive principally by preventing ovulation

or fertilization (by altering tubal transport of sperm and/or

ova). In addition, it may inhibit implantation (by altering the

endometrium). It is not effective once the process of

implantation has begun.

The label for ella says: “When taken immediately before ovulation

is to occur, ella postpones follicular rupture. The likely primary

mechanism of action of [ella] for emergency contraception is

therefore inhibition or delay of ovulation; however, alterations to

the endometrium that may affect implantation may also

contribute to efficacy.”

While both drugs indicate that they may function

postfertilization, the fine print in their package inserts—for those

who bother to read them

—would only muddy the question of

whether the drug acts as an abortifacient.

For example, in

37. Coverage of Certain Preventive Services Under the Affordable Care

Act, 78 Fed. Reg. 39,870 (July 2, 2013) (to be codified at 26 C.F.R. pt. 54; 29

C.F.R. pts. 2510, 2590; 45 C.F.R. pts. 147, 156) (quoting 62 Fed. Reg. 8611 (Feb.

25, 1997) (“Emergency contraceptive pills are not effective if the woman is

pregnant[.]”); 45 C.F.R. § 46.202(f) (“Pregnancy encompasses the period of time

from implantation until delivery.”).

38. F

OOD & DRUG ADMIN., PLAN B ONE-STEP PRESCRIBING INFORMATION,

http://www.accessdata.fda.gov/drugsatfda_docs/label /2009/021998lbl.pdf (listing

drug information for Plan B)

(emphasis added).

39. See F

OOD & DRUG ADMIN., ELLA PRESCRIBING INFORMATION,

http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022474s000lbl.pdf

(listing drug information for ella) (emphasis added).

40. See infra Part V (detailing that drug inserts are designed for physicians

who act as an intermediary).

41. See The FDA Announces New Prescription Drug Information Format,

FOOD & DRUG ADMIN, http://www.fda.gov/Drugs/GuidanceCompliance

RegulatoryInformation/LawsActsandRules/ucm188665.htm (last visited Dec. 30,

EMERGENCY CONTRACEPTIVES 1395

highly technical language,

Plan B One-Step’s label says: “Plan B

One-Step is believed to act as an emergency contraceptive

principally by preventing ovulation or fertilization (by altering

tubal transport of sperm and/or ova). In addition, it may inhibit

implantation (by altering the endometrium).”

Even though the

label recognizes the possibility that Plan B One-Step may act

postfertilization—a time that some would consider during

“pregnancy”

—the label elsewhere flatly says it “is not effective

in terminating an existing pregnancy.”

Implicit in both disclosures is a central claim: a woman is not

“pregnant” until “implantation” occurs. Skeptics dismiss concerns

that EC may destroy a zygote after fertilization but before

implantation as just so much religious gibberish: “There’s no

reason to think [the anti-choice movement will] suddenly grow

respectful of actual science now that it has shown that emergency

contraception has no effect on egg cells who’ve had their good

Christian souls injected into them by those emissaries of the Lord

known as sperm.”

Religious concerns about destroying a life, however,

animate the Hobby Lobby Store, Inc. v. Sebelius

and Conestoga

Wood Specialties Corp. v. Sebelius

cases challenging the

2013) (“By improving the package insert to make it more useful for healthcare

providers in their day-to-day clinical practice, we are making it easier for them

to explain the benefits and risks of medications for their patients.” (quoting

Health and Human Services Secretary Mike Leavit)) (on file with the

Washington and Lee Law Review).

42. Generally, informed consent forms should be understandable by people

with an eighth grade or lower reading level. See C

ARL H. COLEMAN, JERRY A.

MENIKOFF, ET AL., THE ETHICS AND REGULATION OF RESEARCH WITH HUMAN

SUBJECTS 181 (LexisNexis 2005).

43. P

LAN B ONE-STEP PRESCRIBING INFORMATION, supra note 38, at 4.

44. See infra Part III.A.1.

45. P

LAN B ONE-STEP PRESCRIBING INFORMATION, supra note 38, at 2. Plan B

One-Step’s label also says it does not work “once the process of implantation has

begun.” Id. at 4. By contrast, ella’s label provides no such assurance. But see

LLA PRESCRIBING INFORMATION, supra note 39, at 5 (stating that ella “postpones

follicular rupture”).

46. Marcotte, supra note 31.

47. Hobby Lobby Stores, Inc. v. Sebelius, 723 F.3d 1114 (10th Cir. 2013) (en

banc), appeal docketed, No. 13-354 (S. Ct. Sept. 19, 2013).

48. Conestoga Wood Specialties Corp. v. Sebelius, No. 13-1144 (3d Cir.

2013), appeal docketed, No. 13-356 (S. Ct. Sept. 19, 2013).

1396 71 WASH. & LEE L. REV. 1385 (2014)

Mandate,

which are now set before the United States Supreme

Court for argument on March 25, 2014.

In that litigation, the

plaintiffs object to “drugs or devices that may cause the demise of

an already conceived but not yet attached human embryo,”

although they assert no objection to drugs that prevent

fertilization.

The en banc United States Court of Appeals for the

Tenth Circuit chose not to “wade into scientific waters,” noting

that “the government and the medical amici supporting the

government concede that at least some [EC] to which the

plaintiffs object have the potential to prevent uterine

implantation.”

Given the parties’ agreement that some forms of

EC function in a manner that the plaintiffs “find morally

problematic,” the en banc court found “no material dispute” about

the science. Apart from the other issues those cases raises, the

49. See Hobby Lobby Stores, Inc. v. Sebelius, 723 F.3d 1114, 1120 (10th Cir.

2013) (en banc) (challenging the Mandate). The plaintiffs sought declaratory

and injunctive relief, alleging that the Mandate violated the Free Exercise

Clause and the Religious Freedom Restoration Act. Id. The court held that the

plaintiffs had standing, that the Anti-Injunction Act did not bar the action, that

corporations constituted “persons” within the meaning of the Religious Freedom

Restoration Act, that corporations had rights under the Free Exercise Clause,

that the plaintiffs showed a likelihood of success on the merits, that the

Administration’s interests in public health and gender equality do not constitute

compelling interests, that the plaintiffs satisfied the irreparable injury prong for

the preliminary injunction test, and that the case required remanding for

consideration of the remaining preliminary injunction factors. Id. at 1121, 1129,

1143–47; see also Conestoga Wood Specialties Corp. v. Sebelius, 724 F.3d 377,

380 (3d Cir. 2013) (challenging aspects of the Mandate). A corporate employer

and five owners brought an action for declaratory and injunctive relief, alleging

that the Mandate violated the Religious Freedom Restoration Act, the First and

Fifth Amendments, and the Administrative Procedure Act. Id. The court held

that a for-profit, secular employer could not assert claims under the Free

Exercise Clause or the Religious Freedom Restoration Act. Id. at 388. The court

further held that the shareholders probably did not have a viable claim under

the Free Exercise Clause. Id. at 389.

50. S

UPREME COURT OF THE UNITED STATES, OCTOBER TERM 2014: FOR THE

SESSION BEGINNING MARCH 24, 2014, 1 (2014), http://www.supremecourt.gov/

oral_arguments/argument_calendars/MonthlyArgumentCalMar2014.pdf.

51. Complaint at 10, Conestoga Wood Specialties Corp. v. Sebelius, 917 F.

Supp. 2d 394 (E.D. Penn. 2013) (No. 12-6744); see also Complaint Paragraph at

24, Hobby Lobby Sores, Inc. v. Sebelius, 870 F. Supp. 2d 1278 (W.D. Okla. 2012)

(No. CIV-12-1000-HE) (“Plan B, Ella, and certain IUDs can cause the death of

the embryo.”).

52. Hobby Lobby Stores, Inc. v. Sebelius, 723 F.3d 1114, 1123 n.3 (10th Cir.

2013) (en banc).

EMERGENCY CONTRACEPTIVES 1397

science remains deeply contested by many, in part because of

where different parties draw the line for when they believe life

begins.

The next Part evaluates the factual claim that neither Plan

B nor ella act after fertilization.

III. Factual Basis for Religious Concerns

The claim that EC does not cause abortion rests on two

notions: (1) that EC works only as a contraceptive to prevent

fertilization and never functions afterwards; and (2) that even if a

drug worked postfertilization, nobody could possibly believe that

a pregnancy—or a life—exists in the hours and days after

fertilization, so any drug that works at this time cannot induce an

“abortion” by definition.

This Part shows first that in the fifteen years since its

approval, Plan B has never been shown to work after fertilization.

Since ella’s approval in 2010,

however, more than one expert

has posited that ella not only works before fertilization but it may

work after fertilization as well—in ways that would give some

women pause about whether to use ella.

Second, this Part

53. Id.

54. Nobody disputes that an abortion ends a pregnancy. See Abortion, T

FREE DICTIONARY, http://www.thefreedictionary.com/abortion (last visited Feb.

11, 2014) (defining abortion as “[i]nduced termination of a pregnancy with

destruction of the embryo or fetus”) (on file with the Washington and Lee Law

Review).

55. News Release, Food & Drug Admin., FDA Approves ella Tablets for

Prescription Emergency Contraception (Aug. 13, 2010) (on file with the

Washington and Lee Law Review), available at http://www.fda.gov/

NewsEvents/Newsroom/PressAnnouncements/ucm222428.htm (announcing

FDA approval of ella for use as emergency contraception).

56. See infra Part III.A.2 (describing how ella may work). This Article does

not examine the science behind the other contested drugs and devices because

the contrast between Plan B and ella sufficiently illustrates the factual debate

over how different ECs work. Although not necessary to this Article, the IUD

labels contain similar disclosures to those for ella. For a discussion of copper

IUDs, see Batur, supra note 12, at 774 (explaining that “the copper IUD also

prevents implantation after fertilization, which likely explains its high

efficacy”). For further discussion, see generally Kristina Gemzell-Danielsson,

Cecilia Berger & P.G.L. Lalitkumar, Review Article: Emergency Contraception—

Mechanisms of Action, 87 C

ONTRACEPTION 300 (2013) (discussing mechanisms of

action of IUDs and their physiological effects). For a searchable database of FDA

1398 71 WASH. & LEE L. REV. 1385 (2014)

documents that—although a handful of medical organizations

and federal regulators share the same view of when pregnancy

begins—medical treatises, dictionaries, and practicing Ob/Gyns

are all over the map on the question of when pregnancy—or for

that matter, when life—begins. More fundamentally, women

themselves have strikingly different views about when life

begins—and what would count as ending it.

Ultimately, what

matters is their view as to whether a given drug constitutes an

abortion.

A. Contraceptives or Abortifacients?: Unraveling Science and

Semantics

Nearly everyone—from the Administration to religious

objectors to the New York Times—lumps all EC together,

charging that they do or do not cause abortions.

As Part II

drugs, see FOOD & DRUG ADMIN., DRUGS AT FDA: FDA APPROVED DRUG

PRODUCTS (2013), available at http://www.accessdata.fda.gov/scripts/cder/drugs

atfda/.

57. See infra Part IV.

58. See Editorial, How Morning After Pills Really Work, N.Y.

TIMES, June

8, 2012 at A20, available at http://www.nytimes.com/2012/06/09/opinion/how-

morning-after-pills-really-work.html (referring to all EC as simply the “the

pill”); What You Need to Know, supra note 6, at 1 (stating that “[a]ccording to

the best scientific evidence available, all FDA-approved emergency

contraceptive pills work by interfering with ovulation or fertilization before

pregnancy begins and are not so-called ‘abortion pills’”); Q&A with Dr. Cullins:

Emergency Contraception, PLANNED PARENTHOOD, http://www.planned

parenthood.org/health-topics/ask-dr-cullins/cullins-ec-5360.htm (last visited Dec.

20, 2013) (discussing the mechanism of action of EC as if all EC is the same,

stating “EC works by stopping ovulation or fertilization . . . it could interfere

with the implantation of a fertilized egg, but there is no scientific proof that this

happens”) (on file with the Washington and Lee Law Review); Complaint at 5,

La. Coll. v. Sebelius, (W.D. La. Feb. 18, 2012) (No. 12-cv-463),

http://www.adfmedia.org/files/LouisianaCollegeComplaint.pdf

In the category of “FDA approved contraceptives” included in this

Mandate are several drugs or devices that may cause the demise of

an already-conceived but not-yet implanted human embryo. . . .

Likewise in that category are “emergency contraception” or “Plan B”

(the “morning after” pill), and variations of oral contraceptives (“birth

control pills” or “the Pill”) taken regularly through a cycle. . . . The

FDA approved in this same category a drug called “ella” (the “week

after” pill), which studies show can function to kill embryos even after

they have implanted in the uterus, by a mechanism similar to the

EMERGENCY CONTRACEPTIVES 1399

illustrated, the FDA label disclosures lend to a singular narrative

about how these drugs work, but the science plainly does not.

Consider the 2013 review article, “Separating Fact from

Fiction,”

by the Independent Family Health Center at the

Cleveland Clinic, home of the third-ranked gynecology program

in the United States.

The review article surveyed dozens of

scientific, peer-reviewed articles across more than a decade,

including one meta-analysis of the literature. The author, Dr.

Pelin Batur, Education Director of Primary Care of Women’s

Health, concluded that both Plan B and ella “work[] primarily by

delaying or inhibiting ovulation and inhibiting fertilization.”

Nonetheless, important differences exist between Plan B’s and

ella’s mechanisms of action: “[Plan B] . . . would be unlikely to

have any adverse effects on the endometrium after fertilization,

since [it] would only serve to enhance the progesterone effect.

Therefore, [it is] unlikely to affect the ability of the embryo to

attach to the endometrium.”

By contrast, ella

can have just the opposite effect on the postovulatory

endometrium because of its inhibitory action on progesterone.

[Ella] is structurally similar to [RU-486], and its mechanism of

action varies depending on the time of administration during

the menstrual cycle. When unprotected intercourse occurs

during a time when fertility is not possible, [ella] behaves like

a placebo. When intercourse occurs just before ovulation, [ella]

acts by delaying ovulation and thereby preventing fertilization

(similar to [Plan B]). [Ella] may have an additional action of

affecting the ability of the embryo to either attach to the

endometrium or maintain its attachment, by a variety of

mechanisms of action.

abortion drug RU-486.

59. See infra note 77 and accompanying text (noting that ella can work

very differently from Plan B under certain circumstances).

60. Batur, supra note 12, at 771 (dispelling common misunderstandings

about EC).

61. Top-Ranked Hospitals for Gynecology, U.S.

NEWS AND WORLD REP.

(2013), http://health.usnews.com/best-hospitals/rankings/gynecology (last visited

Dec. 30, 2013) (on file with the Washington and Lee Law Review).

62. Batur, supra note 12, at 774.

63. Id.

64. Id.

1400 71 WASH. & LEE L. REV. 1385 (2014)

As the next subparts detail, our independent review of the

scientific literature reaches the same conclusion: in all

probability, Plan B does not work after fertilization, despite the

FDA-approved label, while ella may act after fertilization,

sometimes.

1. How Plan B Works

It is no surprise that many want to lump Plan B and ella

together: both work after unprotected sex to prevent “expected

pregnancy.”

At one point, both drugs required a prescription,

although Plan B can now be found on the shelf next to common

cold medicines, suppositories, and condoms.

While Plan B is effective for only 72 hours after sex,

ella

works over a longer time span. Ella remains effective up to 120

hours after sex.

Given the longer timespan, ella is much more

effective in preventing pregnancy than Plan B.

In one 2006

study, women who received ella experienced “about half the

number of pregnancies than in those treated with [Plan B], with

65. See PLAN B ONE-STEP PRESCRIBING INFORMATION, supra note 38, at 1

(stating that Plan B is intended for use as an EC after unprotected intercourse);

LLA PRESCRIBING INFORMATION, supra note 39, at 1 (noting the ella is also

intended for use after unprotected intercourse to prevent pregnancy).“Expected

Pregnancy” “calculate[es] the number of pregnancies that might have occurred

without use of the intervention.” Anna F. Glacier et al., Ulipristal Acetate Versus

Levonorgestrel for Emergency Contraception: A Randomised Non-Inferiority

Trial and Meta-Analysis, 375 L

ANCET 555, 555 (2010).

66. See Julie Rovner, Plan B to Hit Shelves, Protected from Generics, NPR

(July 24, 2013, 3:18 PM), http://www.npr.org/blogs/health/2013/07/24/

205182187/plan-b-to-hit-shelves-protected-from-generics (last visited Jan. 21,

2014) (“Plan B One-Step . . . will be available on pharmacy and other retail

shelves without restriction.”) (on file with the Washington and Lee Law

Review); Sydney Lupkin, Judge Orders “Morning-After” Pill Be Sold Over-the-

Counter to Those Under 17, ABCN

EWS (Apr. 5, 2013), http://abcnews.

go.com/Health/morning-pill-sold-counter/story?id=18889946 (last visited Jan.

21, 2014) (“The FDA allowed Plan B to become available without a prescription

to women 18 and over in 2006.”) (on file with the Washington and Lee Law

Review). Ella still requires a prescription. See News Release, supra note 55

(noting that ella is available “by prescription-only”).

67. P

LAN B ONE-STEP PRESCRIBING INFORMATION, supra note 38, at 1.

68. E

LLA PRESCRIBING INFORMATION, supra note 39, at 1.

69. See Batur, supra note 12, at 772 (noting that ella is the most effective

oral EC).

EMERGENCY CONTRACEPTIVES 1401

pregnancy rates of 0.9% vs 1.7%.”

A later study found that ella

prevented 85% of expected pregnancies compared to Plan B’s

69%.

Part and parcel of Plan B’s reduced efficacy are the

mechanisms by which it is now understood to work. Amassed

across fifteen years and thousands of articles,

authorities agree

that Plan B works

to delay or inhibit ovulation: “Early

treatment with [EC]s containing only the progestin

levonorgestrel [as Plan B does] has been shown to impair the

ovulatory process and luteal function.”

While a single study has

suggested that Plan B may affect receptivity of the endometrium,

two later studies directly designed to assess this possibility could

not confirm it.

All available evidence suggests Plan B acts prior

70. Id.

71. See Kristina Gemzell-Danielsson & Chun-Xia Meng, Emergency

Contraception: Potential Role of Ulipristal Acetate, 2 I

NT’L J. WOMEN’S HEALTH

53, 57 (2010) (comparing results in an efficacy study of ECs).

72. Two searches on ScienceDirect.com, one limited by “levonorgestrel,”

Plan B’s chemical name, and the other by “ulipristal acetate,” ella’s chemical

name, yield 7,815 journals, 627 books, and 43 reference works for Plan B and a

mere 114 journals, 29 book, and 0 reference works for ella. Review articles show

the same pattern. One review article of the mechanism of action for various EC

canvassed 28 studies of Plan B but included only 3 studies of ella. See Gemzell-

Danielsson, Berger & Lalitkumar, supra note 56, at 306–08 (listing references

for the article, including the studies on which the discussion was based).

73. At one time, some speculated that Plan B also impeded the sperm, but

authorities now agree that Plan B is not likely to work this way at commercially

available doses. See James Trussell, Elizabeth G. Raymond & Kelly Cleland,

Emergency Contraception: A Last Chance to Prevent Unintended Pregnancy 6

(Dec. 2013) (unpublished manuscript), http://ec.princeton.edu/questions/ec-

review.pdf

In a study conducted more than 30 years ago, levonorgestrel was

found to interfere with sperm migration and function at all levels of

the genital tract; however, a study designed to assess this issue found

that 1.5 mg levonorgestrel had no effect on the quality of cervical

mucus or on the penetration of spermatozoa in the uterine cavity.

(on file with the Washington and Lee Law Review); Gemzell-Danielsson, Berger

& Lalitkumar, supra note 56, at 302 (“In vitro data indicate that [Plan B] . . . in

doses relevant for EC has no direct effect on sperm function.”).

74. Trussell, Raymond & Cleland, supra note 73, at 6.

75. See id. (discussing studies on early treatment with EC pills). Further,

one study found no effect on the endometrium while the other found that Plan B

does affect concentrations of glycodelin, a molecule that “inhibits fertilization,

[and] may indicate an additional mechanism of action when ovulation is not

inhibited.” Id.

1402 71 WASH. & LEE L. REV. 1385 (2014)

to fertilization, as an ordinary contraceptive. In essence, the

sperm never meets the egg.

While Plan B’s mechanism of action has been extensively

studied, permitting experts to now rule out a postfertilization

mechanism of action,

ella lacks this depth of research.

Although nascent, a burgeoning literature seeks to pinpoint

precisely what explains ella’s “enhanced effectiveness.”

2. How Ella May Work

Leading authorities agree that, like Plan B, ella’s primary

mechanism of action is to prevent ovulation.

The key difference

76. See Batur, supra note 12, at 774 (finding Plan B unlikely to have any

effects after fertilization); Trussell, supra note 73, at 7 (noting Plan B has no

effect after fertilization), Gemzell-Danielsson, supra note 56, at 302 (finding no

effect after fertilization when using Plan B in studies with monkeys and rats).

Of course, no study can definitely, positively, absolutely exclude the possibility

of a postfertilization effect, even as to Plan B. Authors of the studies showing a

contraceptive effect acknowledge that “[i]t is unlikely that this question can ever

be unequivocally answered, and we therefore cannot conclude that [ECs] never

prevent pregnancy after fertilization.” James Trussell & Beth Jordan,

Mechanism of Action of Emergency Contraception Pills, 74 C

ONTRACEPTION 87,

87 (2006); see also Gabriela Noe et al., Contraceptive Efficacy of Emergency

Contraception with Levonorgestrel Given Before or After Ovulation, 81

ONTRACEPTION 414, 414 (2010) (conceding that studies of Plan B’s impact on

“endometrial receptivity,” a post fertilization effect, “are not consistent, and

current knowledge on cellular and molecular markers of endometrial receptivity

in the human is insufficient to resolve this controversy”).

As Jeffrey Keenan, a professor of obstetrics and gynecology and director of

the Division of Reproductive Endocrinology and Infertility at the University of

Tennessee Medical Center, explains, clinical studies of Plan B “were not

designed to assess this possibility.” Jeffrey Keenan, Ulipristal Acetate:

Contraceptive or Contragestive?, 45 A

NNALS OF PHARMACOTHERAPY 813, 814

(2011). To give of the kind of certainty that some would like to see, “each study

participant [would have had] to undergo laboratory evaluation and possibly

sonographic examination to determine whether ovulation had already occurred.”

Id. Asking women themselves may not be promising, given the fact that “over

30% of women presenting for [EC]s had inaccurately dated their own menstrual

cycles.” Trussell, Raymond & Cleland, supra note 73, at 3.

77. See supra note 72 (noting that available information on ella is

somewhat limited).

78. Keenan, supra note 76, at 814.

79. See Trussell, Raymond & Cleland, supra note 73, at 7 (discussing more

than a half dozen studies that indicated ella prevents ovulation); Gemzell-

Danielsson, Berger & Lalitkumar, supra note 56, at 302 (discussing the effect of

EMERGENCY CONTRACEPTIVES 1403

between the two: ella “is able to inhibit or signiﬁcantly delay

follicular rupture for over 5 days if given immediately before

ovulation by postponing the LH peak”—that is, the spike of the

hormone that triggers ovulation.

Thus, “when ovulation is

imminent, [ella] is more effective than [Plan B] in delaying

[ovulation].”

While authorities universally agree that ella delays

ovulation,

they are divided about whether ella may work by

other mechanisms as well, as ella’s label suggests. Some posit

that ella may work through a “contragestive” effect, in which

“only gestation (implantation and growth) of the embryo

[fertilized egg] is prevented.”

When would this occur?

It would occur if ella altered the endometrium and the

change “hamper[ed] implantation.”

In a 2010 study, Pamela

Stratton and colleagues examined the effects of three different

doses of ella on the endometrium and compared them to a

ella on ovulation); Ralph P. Miech, Immunopharmacology of Ulipristal as an

Emergency Contraceptive,

3 INT’L J. WOMEN’S HEALTH 391, 392 (2011) (noting

that ella acts by delaying ovulation); Keenan, supra note 76, at 813 (noting that

ella’s primary function is to prevent ovulation, and that ella is “significantly

more effective in this role than other forms of [EC]”).

80. See V. Brache et al., Immediate Pre-Ovulatory Administration of 30 mg

Ulipristal Acetate Significantly Delays Follicular Rupture, H

UM. REPROD. 2256,

2262 (2010) (concluding that “this study provides mechanistic evidence to

explain how [ella] could be more effective in preventing pregnancy than current

reference EC methods”).

As another review article puts it, the primary explanation for ella’s

increased effectiveness over Plan B is that ella is “effective even when

administered before ovulation, when LH has already started to rise, a time

period when [Plan B] is no longer effective.” Gemzell-Danielsson, Berger &

Lalitkumar, supra note 56, at 305.

81. Trussell, Raymond & Cleland, supra note 73, at 4.

82. See also Miech, supra note 79, at 392 (“[ella’s] effectiveness as an EC is

extended up to 120 hours after intercourse . . . and is [] effective as an EC if

taken during rising LH levels prior to ovulation.”); Keenan, supra note 76, at

813 (“There is good reason to believe that one mechanism of action for [ella] is

the inhibition of ovulation. In fact, it appears to be significantly more effective in

this role than other forms of [EC] such as [Plan B] . . . .”).

83. Keenan, supra note 76, at 814; see also E

LLA PRESCRIBING INFORMATION,

supra note 39, at 9 (noting that ella may work to prevent implantation).

84. Pamela Stratton et al., Dometrial Effects of a Single Early Luteal Dose

of the Selective Progesterone Receptor Modulator CDB-2914, 93 FERTILITY AND

STERILITY 2035, 2040 (2010).

1404 71 WASH. & LEE L. REV. 1385 (2014)

placebo.

The authors found “a significant reduction in

endometrial thickness among those subjects receiving [ella]

compared with those receiving placebo.”

They concluded that

“taken together, these endometrial effects in the absence of

ovarian and menstrual cycle effects suggest mechanisms by

which [ella] might be effective as an emergency contraceptive.”

Importantly, others caution that “whether this change would

inhibit implantation is unknown.”

A pair of experts has asked whether ella, if taken sufficiently

late, is in fact working after fertilization.

Ralph Miech, an

associate professor emeritus of molecular pharmacology,

physiology, and biotechnology at Brown University, contends that

ella has a “direct abortifacient effect” in a very narrow set of

circumstances.

He defines “abortifacient” to mean the “loss of

the embryo occurring either at the preimplantation stage or at

the post-implantation stage.”

According to Miech, this would

occur “[w]hen unprotected intercourse occurs within the fertility

window (i.e., less than 120 hours (5 days) before ovulation or not

more than 24 hours after ovulation) and [ella] is taken after

fertilization.”

He envisions a “host-versus-graft rejection

85. See id. at 2036 (examining whether ella, at any doses, delayed

endometrial maturation, reduced endometrial thickness, or affected the number

of progesterone receptors).

86. Id. at 2038.

87. Id. at 2040.

88. See Trussell, Raymond & Cleland, supra note 73, at 5 (discussing

Stratton’s findings). Gemzell-Danielsson, Berger, and Lalitkumar contend that

“the effect of lower doses equivalent to the 30 mg used for EC was similar to

that of placebo,” but this synopsis does not accord with the study findings

themselves. Gemzell-Danielsson, Berger & Lalitkumar, supra note 56, at 304.

Cf. Stratton et al., supra note 84, at 2038 tbl.1 (reporting the endometrial effects

of ella).

89. See supra note 79 (noting that both authorities, Miech and Keenan,

agree that ella works primarily to prevent ovulation).

90. Miech, supra note 79, at 392.

91. Id. (“This report [uses] the classical definitions of abortion and

contraceptive. Abortion is defined as the loss of the embryo occurring either at

the preimplantation stage or at the post-implantation stage and contraception is

defined as the prevention of fertilization.”). A post-implantation effect would be

an abortifacient under almost every medical definition and those Federal

regulations in place since the 1970s. See supra note 37 and accompanying text

(discussing the difference between contraception and abortifacient drugs).

92. Miech, supra note 79, at 392.

EMERGENCY CONTRACEPTIVES 1405

mechanism during the embryo’s attempt to implant into the

decidua.”

In other words, ella may actually operate on the

embryo during the implantation process.

In a 2011 article in the Annals of Pharmacotherapy, Jeffrey

Keenan, Professor of Obstetrics and Gynecology at the University

of Tennessee Medical Center in Knoxville, concluded that if a

woman takes ella within five days of unprotected sex and after

the fertilization, ella’s “mechanism of action is much more

accurately described as contragestive, since only gestation

(implantation and growth) of the embryo [fertilized egg] is

prevented.”

Keenan believes this action likely accounts for ella’s

“enhanced effectiveness” relative to Plan B.

Disclosures from

medical professionals and drug manufacturers should be

“provided according to the best evidence available,” as is the

standard in European Union countries.

Some scientists move

past the concern that any kind of EC might act as an

abortifacient—in the views of women using them—by noting that

ECs “do not interrupt an established pregnancy, defined . . . as

beginning with implantation.”

And as the next subpart

illustrates, even the meaning of pregnancy is deeply contested.

B. The Meaning of Life—Or at Least Pregnancy

Obviously, how one defines pregnancy determines whether a

given drug or device may induce an abortion in one’s view.

Some

93. Id. (emphasis added).

94. Keenan, supra note 76, at 814; see also E

LLA PRESCRIBING INFORMATION,

supra note 39, at 9 (noting that ella “may also work by preventing attachment”).

95. See Keenan, supra note 76, at 814 (noting that ella’s “contragestive

effect” is likely why it is so effective).

96. See generally E

UROPEAN CONSORTIUM FOR EMERGENCY CONTRACEPTION,

supra note 19.

97. Trussell, Raymond & Cleland, supra note 73, at 7.

98. Vivian W. Y. Leung, Marc Levine & Judith A. Soon, Mechanisms of

Action of Hormonal Emergency Contraceptives, 30 PHARMACOTHERAPY 158, 160

(2010) (“For people who define pregnancy as beginning at implantation, an

abortifacient is an agent that interferes with subsequent processes. . . . For

those who consider pregnancy to begin with the completion of fertilization, an

abortifacient is an agent that interferes with any postfertilization event,

including implantation.”).

Some people may believe that pregnancy begins at implantation, yet

1406 71 WASH. & LEE L. REV. 1385 (2014)

groups, like the Guttmacher Institute, assert that the medical

profession uniformly measures pregnancy from “implantation.”

The evidence for this proposition: “Major medical

organizations . . . as well as U.S. government policy, consider a

pregnancy to have begun only when the entire process of

conception is complete, which is to say after the fertilized egg has

implanted in the lining of the uterus.”

100

Despite this confident assertion, a quick review of medical

authorities reveals no unitary view. Some authorities measure

pregnancy from fertilization

101

and some from implantation.

102

Others measure pregnancy from an “established pregnancy,”

103

nonetheless believe that a drug that prevents implantation ends the existence of

either a living, human organism (short of a pregnancy) or destroys something

that has a special moral status. See infra notes 113–44.

99. See Sneha Barot, Past Due: Emergency Contraception in U.S.

Reproductive Health Programs Overseas, 13 G

UTTMACHER POL’Y REV. 8, 8 (2010),

available at http://www.guttmacher.org/pubs/gpr/13/2/gpr130208.html (noting

that “the Catholic Church and many antiabortion advocates” embrace a

definition of pregnancy “flatly rejected by the medical profession” and that

“under this definition, pregnancy begins with the ‘moment of fertilization’—the

union of an egg and sperm”).

100. Id. at 8–9. Guttmacher also asserts that the meaning of “abortifacient”

in federal law is clear; however, it is not as unambiguous as Guttmacher would

have people believe. See Wilson, The Calculus, supra note 2, at 1456, 1459

(reviewing federal guidance about what counts as an abortifacient under federal

regulations); Wilson, Demagoguing Abortion, supra note 2 (summarizing federal

hearings in 1975 over the classifications of diethylstilbestrol as a contraceptive,

a drug that studies in the Congressional Record indicated works on the

endometrial implantation site, but was later pulled from the market as a

teratogen). The FDA classified diethylstilbestrol as a contraceptive because it

“prevent[ed] implantation.” Id. Ella is posited to work, sometimes, during the

process of implantation itself, raising a thorny question of how to construe

FDA’s definition. Id.

101. See Grace S. Chung et. al, Obstetrician-Gynecologists’ Beliefs About

When Pregnancy Begins, 206 A

M. J. OBSTETRICS & GYNECOLOGY 132.e1, 132.e1

(2012), available at http://www.ajog.org/article/S0002-9378(11)02223-X/fulltext

(showing some measure pregnancy from fertilization).

102. See id. (“Since 1965, the American College of Obstetricians and

Gynecologists (ACOG) has defined pregnancy as beginning with implantation of

the embryo in the uterine wall. This definition is used also by the Guttmacher

Institute, Planned Parenthood, and some textbooks.” (footnotes omitted)).

103. See A

M. COLL. OF OBSTETRICS AND GYNECOLOGY, STATEMENT ON

CONTRACEPTIVE METHODS 1 (1998) (listing the “[e]ssential steps necessary for

pregnancy” as ending with “implantation of the blastocyst into the lining of the

uterus at the conclusion of which pregnancy is established”).

EMERGENCY CONTRACEPTIVES 1407

positive pregnancy test,

104

and the first heartbeat,

105

among

others.

106

Clearly, however, the two leading contenders for the

beginning of pregnancy are “implantation”

107

and

“fertilization.”

108

Medical professionals themselves split on what marks the

start of pregnancy. Fifty-seven percent of U.S. Ob/Gyns said

pregnancy begins at “conception,” by which the study authors

believed respondents meant fertilization.

109

Twenty-eight percent

of Ob/Gyns said pregnancy begins at implantation, and sixteen

percent were “not sure which statement comes closest to their

beliefs.”

110

Those surveyed brought preconceived notions to the

question. The strongest predictors of how Ob/Gyns defined

pregnancy were the importance of religion in their lives and their

own views on abortion.

111

104. See Keenan, supra note 76, at 814 (attributing to ACOG a definition of

pregnancy that “begin[s] not with fertilization of the egg, but advancing

implantation as demonstrated by a positive pregnancy test” (footnote omitted)).

105. Chung et. al, supra note 102, at 132.e5.

106. See id. (noting that “a significant percentage of Ob/Gyn physicians

(16%) [who completed the questionnaire] marked ‘not sure’ when asked to

indicate when pregnancy begins”). The two primary options were “conception”

and “implantation.” Id. at 132.e1. Given the percentage of “not sure” responses,

“it is possible that a significant minority of physicians have not made up their

minds or that they believe that their views could not be reduced to either of the

2 options that were offered.” Id. at 132.e5.

107. See John K. Jain, When Does Pregnancy Begin?, S

HARECARE,

http://www.sharecare.com/health/prior-to-conception/when-does-pregnancy-beg

in;jsessionid=787ABB31090D6282CC87D03389AE56BD (last visited Jan. 31,

2014) (concluding that “pregnancy officially begins at the time of implantation

but is usually not detectable until the pregnancy hormone shows up in the blood

and urine”) (on file with the Washington and Lee Law Review).

108. See Walter L. Larimore, Joseph B. Stanford & Chris Kahlenborn,

Letters to the Editor: In Response: Does Pregnancy Begin at Fertilization?, 36

AM. MED. 690, 690 (2004) (stating that many maintain pregnancy starts the

“instant that a spermatozoon enters an ovum and forms a viable zygote”).

109. Chung et. al, supra note 102, at 132.e6.

110. Id.

111. See id. at 132.e3–e4 (“[R]eligious doctors and those who objected to

abortion were less likely to be ‘not sure’. . . . [B]elieving that pregnancy begins at

implantation rather than conception (excluding those who were ‘not sure’) was

associated with religious affiliation, the importance of religion, and objections to

abortion.”).

1408 71 WASH. & LEE L. REV. 1385 (2014)

Just as important as this split, pregnancy is often a proxy for

measuring the “onset of life.”

112

Fertilization and implantation

are not the only two markers for measuring the “onset of life,” as

Dr. Maureen Condic, Associate Professor of Neurobiology and

Anatomy at the University of Utah School of Medicine, explains:

Recently, it has been asserted that the life and moral status of

the embryo begin at the eight-cell stage, because zygotic

transcription (the active utilization of embryonic genes)

commences at this time; and prior to this moment, whatever is

happening in the “fertilized egg” is being driven by maternal

factors. Some push the onset of life to even later, to the

formation of speciﬁc structures or the onset of speciﬁc

developmental processes.

113

Philosophers, theologians, ethicists, and others have devoted

thousands of pages to whether “personhood determines the

beginning of human life,” whether “rationality is necessary for

personhood,” and whether personhood begins with the “active

potential for further development as a person,” the “development

of the primitive streak,” or when the organism becomes a

“unique” individual.

114

Some ask whether, even absent

personhood, the “embryo has a significant moral status” worthy of

respect.

115

While the Guttmacher Institute, the Administration, and

others rely on the Code of Federal Regulations

116

in dismissing

religiously grounded concerns, individual women follow their

personal moral codes, as the next Part explains.

112. See Condic, supra note 101, at 1–2 (describing various ways to

biologically define when life begins). For a general discussion of the beginning of

life, whether at pregnancy or other points or whether a potential life is due

special consideration, see the excellent book, D

EFINING THE BEGINNING AND END

LIFE: READINGS ON PERSONAL IDENTITY AND BIOETHICS (John. P. Lizza ed.,

2009).

113. Condic, supra note 101, at 1 (footnotes omitted).

114. See John P. Lizza, Introduction to D

EFINING THE BEGINNING AND END OF

LIFE: READINGS ON PERSONAL IDENTITY AND BIOETHICS 1, 5 (John. P. Lizza ed.,

2009) (summarizing various theories included in the book on when life begins).

115. See id. (noting that “most Jewish thinkers” believe an embryo does not

become a “person” until birth but is nonetheless entitled to protection during

“gestation”).

116. See supra note 37 (showing reliance by the Administration on

regulatory definitions of pregnancy in other contexts); see also supra note 100

and accompanying text (discussing the definition of pregnancy).

EMERGENCY CONTRACEPTIVES 1409

IV. Women Care About Mechanisms of Action

Caught in the midst of an argument by label, women are now

no more informed about how EC works than before the

Mandate.

117

But they still care.

Physicians have long recognized that “the majority of

women . . . want to be informed . . . about mechanisms of action

taking place after fertilization and implantation, regardless of

their religiosity or whether they believed that human life begins

at fertilization or implantation.”

118

In 2004, when the FDA made

Plan B available over the counter, the scientific advisory

committee to the FDA urged the FDA to include appropriate

disclosures on Plan B’s label precisely “so that women could make

an informed choice about its use and avoid inadvertently

violating their own moral or religious beliefs.”

119

Disclosures from

medical professionals and drug manufacturers should be

“provided according to the best evidence available,” as is the

standard in European Union countries.

120

Empirical studies of women’s attitudes across the United

States, in both urban and suburban settings, confirm the

importance that women place on information. A 2005 study of

women 18–50 seen in Utah and Oklahoma family practices and

Ob/Gyn clinics found that 53% would not use a birth-control

method that acts after fertilization but before implantation.

121

117. Supra Part II.

118. Cristina Lopez-del Burgo et al., Knowledge and Beliefs About

Mechanism of Action Birth Control Methods Among European Women, 85

CONTRACEPTION 69, 75 (2012); see also Christy A. Sherman, S. Marie Harvey,

Linda J. Beckman & Diana B. Petitti, Emergency Contraception: Knowledge and

Attitudes of Health Care Providers in a Health Maintenance Organization, 11

OMEN’S HEALTH ISSUES 448, 452 (2001) (surveying San Diego County,

California healthcare providers including Ob/Gyns and reporting that “[n]early

all (99.4%) of the providers surveyed reported they agreed with the statement

‘Women who specifically ask for information about emergency contraceptive

pills should be given information,’ with 85% of providers indicating strong

agreement”).

119. See Lockwood, supra note 19, at 15 (noting that “[m]any on the FDA

panel perceived that a contragestive effect [e.g., an effect after fertilization

occurs] was possible and we recommended that the package labeling should

describe the drug’s potential mechanism of action”).

120. See generally E

UROPEAN CONSORTIUM FOR EMERGENCY CONTRACEPTION,

supra note 19.

121. Huong M. Dye et al., Women and Post-Fertilization Effects of Birth

1410 71 WASH. & LEE L. REV. 1385 (2014)

Seventy-four percent would not use a method that acts after

implantation.

122

When asked if they would change their own birth

control method if told that “there was a remote possibility” that it

acted after fertilization but before implantation, 44% “would stop

using it,” while 69% “would stop using it” if there was a “remote

possibility” of it acting after implantation.

123

For many of these women, their reticence directly reflects

their beliefs about when life begins. Forty-eight percent of women

“reported the personal belief that human life begins at

fertilization” and another 5% answered that “life begins after

fertilization, but before implantation.”

124

Of all women surveyed,

34% answered that “life begins at fertilization and [that they]

would not use a birth control method that acts [after

fertilization]”—while 3% answered that life starts at fertilization

but they would nonetheless use a birth control method that acts

after fertilization.

125

Women in the southeastern United States also expressed deep

discomfort with EC that acts after fertilization. In an anonymous

2008 questionnaire of women seen at two academic family

medicine clinics, 38% of all respondents said they would use EC

but only if “it worked before fertilization or implantation,”

126

—

Control: Consistency of Beliefs, Intentions and Reported Use, 5 BMC WOMEN’S

HEALTH, Nov. 29, 2005, at 4, http://www.biomedcentral.com/content/pdf/1472-

6874-5-11.pdf. For a description of the study sites, see id. at 2–3 (noting that the

Oklahoma site was “a teaching clinic associated with a family medicine

residency program sponsored by a Protestant religious organization” and that

“[n]one of the clinics in Utah were religiously affiliated or sponsored”).

122. Id. at 4.

123. Id. No EC required by the Mandate is presently understood to act after

implantation. See supra Part III (discussing RU-486, which is not mandated).

Surveys of women who are not faced directly with the possibility of pregnancy

after unprotected sex may not capture the views of women faced with that

possibility. Choices presented in a vacuum might look very different if a woman

suddenly finds herself in need of EC.

124. Dye et al., supra note 111, at 5.

125. Id. at 5–6.

126. See John W. Campbell III et al., Attitudes and Beliefs About Emergency

Contraception Among Patients at Academic Family Medicine Clinics, 6

ANNALS

FAM. MED. S23, S23 (2008) (utilizing a “convenience sample [size of 178] of

female patients aged 18 to 50 years.”). Researchers asked: “Pregnancy begins

when[:] A. Sperm and egg join within the female reproductive tract. B.

Implantation occurs. C. The heart starts beating. D. Unsure. E. Other.” Id. at

S24.

EMERGENCY CONTRACEPTIVES 1411

admittedly an inartful question.

127

Nearly half, 47%, “believed that

pregnancy begins with fertilization.”

128

Isolating the impact of

socioeconomic factors, only annual household income of less than

$40,000 correlated with a woman’s belief that life begins at

fertilization—with those under $25,000 most likely to believe the

life begins at fertilization.

129

Strength of religious beliefs, age,

race, and level of education were irrelevant.

130

Ironically, the

women whose life chances are likely to be most impacted by an

unintended pregnancy—poorer women with fewer resources—

were precisely the ones most likely to believe that life begins at

fertilization.

131

Researchers for John W. Campbell III and colleagues also

gauged knowledge of EC’s mechanism of action. A “majority of

women surveyed did not know that one possible mechanism of

action of EC is to prevent implantation of a fertilized ovum.”

132

Although “women aged 25 years or younger were more likely to

think that EC works before the egg and sperm join than older

women[,] [t]here w[ere] no significant differences in the

perception . . . based on age, race, income, education, or strength

of religious beliefs.”

133

The authors’ takeaway message was that

“m[a]ny women are uninformed about the possible mechanisms of

action of EC, and we found no reliable predictors for those who

were better informed.”

134

Better knowledge would not matter to

everyone—42% were unsure whether better knowledge of a drug’s

127. The inartfully drafted “fertilization or implantation” question is not as

probative as it would have been if it had separated views about prefertilization

methods from postfertilization, pre-implantation methods.

128. Campbell et al., supra note 126, at S23. Although 47% of respondents

indicated that “pregnancy begins with fertilization,” only 30% believed that “life

begins with fertilization” even if pregnancy was not present. Id. (emphasis

added).

129. See id. at S25 (“Women with incomes of less than $40,000 [per year]

were more likely to believe that life begins at the joining of sperm and egg than

women with higher incomes.”).

130. Id. at S25–S26.

131. See generally N

AOMI CAHN & JUNE CARBONE, RED FAMILIES V. BLUE

FAMILIES: LEGAL POLARIZATION AND THE CREATION OF CULTURE (2010).

132. Campbell et al., supra note 126, at S26.

133. Id. at S25–S26.

134. Id. at S23.

1412 71 WASH. & LEE L. REV. 1385 (2014)

mechanism would change their practices.

135

Nonetheless, the

authors stressed the “need to better educate [women] about

[EC’s] possible mechanisms of action.”

136

In a 2004 study of Latino women seen at two reproductive

health clinics in southeast Texas, “women who believed that EC

worked mainly by preventing implantation were significantly less

willing to use it than those who believed that it prevented

ovulation.”

137

Religious background did not affect this

willingness,

138

although factual misconceptions about EC did.

139

As the authors noted, “EC reduces the risk of pregnancy by

preventing or delaying ovulation, inhibiting fertilization, and

possibly inhibiting implantation. However, a belief that

implantation is the primary mechanism or that EC interrupts

gestation would not be correct.”

140

The authors found “the odds of

being unwilling to use EC were roughly six times higher among

women who believed that EC prevents pregnancy at implantation

when compared to women who believed that EC affects ovulation

processes.”

141

The researchers chalked up unwillingness to use

EC to “misinformation about the mechanism of action.”

142

Education to correct misconceptions about the mechanism of

action of EC would “help alleviate [Latino women’s] concerns,

which in turn may increase their willingness to use EC.”

143

Although the researchers surveyed women in 2004—long before

ella came on the scene—the general proposition stands. For many

women, EC that “affects fertilization or implantation” is morally

objectionable.

144

135. Id. at S25.

136. Id.

137. Laura F. Romo et al., The Role of Misconceptions on Latino Women’s

Acceptance of Emergency Contraceptive Pills, 69 C

ONTRACEPTION 227, 233

(2004).

138. Id.

139. Id.

140. Id. at 229 (endnote omitted).

141. Id. at 232.

142. Id. at 233 (“Specifically women who believed that EC prevents

pregnancy at ovulation reported less moral objections to its use than women

who believe that EC affects fertilization or implantation.”).

143. Id.

144. Id.

EMERGENCY CONTRACEPTIVES 1413

While there is good reason to worry about the

representativeness of these studies, women in Europe,

145

Mexico,

146

and Spain

147

also communicate uneasiness about drugs

that may act after fertilization. As the next Part argues, women

can vindicate their own beliefs and values only if informed, in

layman’s terms, about how these drugs may act in their own

bodies.

V. The Duty of Informed Consent

Aimed at autonomy, individual rights, and self-

determination,

148

informed consent fits naturally with American

145. See Lopez-del Burgo et al., supra note 118, at 69 (randomly surveying

women in “Germany, France, the UK, Sweden, and Romania” and finding that,

“[r]egardless of [participants’] sociodemographic characteristics and their belief

about when human life begins,” the “majority [of women surveyed, 75%,] want

to be informed about possible postfertilization effects [of contraceptive

methods]”).

146. See Heather Gould, Charlotte Ellertson & Georgina Corona, Knowledge

and Attitudes About the Difference Between Emergency Contraception and

Medical Abortion Among Middle-Class Women and Men of Reproductive Age in

Mexico City, 66 C

ONTRACEPTION 417, 423 (2002) (“Because one possible

mechanism of action involves impeding implantation of a fertilized egg, some

participants continue to equate EC with abortion.”).

147. See Cristina Lopez-del Burgo et al., Spanish Women’s Attitudes Toward

Post-Fertilization Effects of Birth Control Methods, 151

EUR. J. OBSTETRICS &

GYNECOLOGY AND REPROD. BIOLOGY 56, 57 (2010) (finding that “45% of women

[surveyed] . . . would not consider using a [contraceptive] method that may work

after fertilization and 57% would not consider using one that may work after

implantation”).

148. See J

ESSICA W. BERG ET AL., INFORMED CONSENT: LEGAL THEORY AND

CLINICAL PRACTICE 14 (2d ed. 2001) (noting the values that guide informed

consent). As Bernard Lo notes, “participation in decisions generally has other

beneficial consequences for patients, such as increased sense of control, self-

efficacy, and adherence to plans for care.” B

ERNARD LO, RESOLVING ETHICAL

DILEMMAS: A GUIDE OF CLINICIANS 21 (2d ed. 2000). Not all patients want this.

See Cathy J. Jones, Autonomy and Informed Consent in Medical

Decisionmaking: Toward a New Self-Fulfilling Prophecy, 47

WASH. & LEE L.

REV. 379, 419 (1990) (surveying evidence that “in many cases patients do

request or allow physicians to make decisions for them” (footnote omitted)); see

also infra note 166 and accompanying text (describing the “model of shared

decision making” between patients and doctors as responding to the desire of

some patients to provide input but not necessarily to make a decision on their

own).

1414 71 WASH. & LEE L. REV. 1385 (2014)

values and culture.

149

As Justice Cardozo famously observed in

1914, “[e]very human being of adult years and sound mind has a

right to determine what shall be done with his body.”

150

For much

of our history, however, informed consent played little to no role

in the doctor–patient relationship. In an era of paternalism,

“simple consent” sufficed before a physician treated a patient.

151

Not surprisingly, “simple consent” sometimes amounted to no

consent at all.

152

By the late 1950s, courts began to require meaningful

consent by patients. In Salgo v. Leland Stanford Junior

149. See BERG ET AL., supra note 148, at 14 (explaining that such values are

“deeply embedded in American culture” and thus “[i]t is not surprising that

informed consent is a cornerstone of contemporary medical ethics and health

law in the United States”).

150. Schloendorff v. Soc’y of N.Y. Hosp., 105 N.E. 92, 93 (N.Y. 1914).

151. See BERG ET AL., supra note 149, at 43 (noting that historically “courts

have generally agreed that the patient has, by speaking some phrase,

authorized the physician to proceed and thereby provided the physician with a

defense to an action for battery”). We refer to this as a “simple consent”

requirement. Id.

152. See id. (noting that in early- to mid-twentieth-century cases courts

often found consent even when patients had expressly told the doctor not to

render treatment) (citing Markart v. Zeimer, 227 P. 683 (Cal. Ct. App. 1924);

Meek v. City of Loveland, 276 Pac. 30 (Colo. 1929); Corn v. French, 289 P.2d 173

(Nev. 1955)).

As late as the 1950s, a Nevada trial court granted a defendant-doctor’s

motion to dismiss even though the plaintiff-patient maintained that the doctor

deliberately deceived her into consenting. See Corn, 289 P.2d at 281–82 (noting

trial court’s grant of involuntary dismissal and plaintiff’s assignments of error).

There, Ruth Corn visited Dr. James French about a lump under her right

breast. Id. at 174–75. Suspecting breast cancer, Dr. French indicated that the

breast may need to be removed and began making arrangements over the phone

for a procedure at a hospital, including a request for particular tools. Id. Ruth

immediately told Dr. French, “If that’s my breast you are talking about, you are

not going to remove it.” Id. at 175. Doctor French responded, “I have no

intentions of removing your breast. I wouldn’t think of doing so without first

making a test,” explaining that the test required the same tools. Id. When Ruth

arrived at the hospital for the procedure, she signed a form “giv[ing] [her]

consent to James B. French, M.D., to perform an operation for mastectomy . . .

upon [her], and to do whatever may be deemed necessary in his judgment.” Id.

Ruth had never heard of a mastectomy and Dr. French never explained what

mastectomy meant. Id. Ruth told Dr. French a second time that he only was to

conduct a test. Dr. French removed Ruth’s breast anyway. Id. Although the

Supreme Court of Nevada ultimately reversed the decision and remanded it for

a new trial on a claim of negligence, id. at 182, the trial court’s decision

exemplifies the historical resistance to imposing duties of informed consent.

EMERGENCY CONTRACEPTIVES 1415

University Board of Trustees,

153

a California appellate court

imposed on doctors an affirmative duty of honest and meaningful

disclosure.

154

Fleshing out the contours of informed consent, the

Salgo court noted that “[a] physician violates his duty to his

patient and subjects himself to liability if he withholds any facts

which are necessary to form the basis of an intelligent consent by

the patient to the proposed treatment.”

155

A. Two Approaches to Informed Consent

Today, as a result of judicial decisions or state legislation, all

fifty states require physicians to secure informed consent.

156

But

states differ in how they determine what must be disclosed to

patients.

157

Under the earliest test, the professional standard,

physicians must disclose only that “which a reasonable medical

practitioner would [disclose] under the same or similar

circumstances.”

158

This standard offered physicians, as a group,

the freedom to define appropriate disclosure based on medical

knowledge,

159

giving them considerable certainty about what

needed to be disclosed.

160

Clearly, the professional standard gives

physician’s substantial control over what is disclosed and,

153. 317 P.2d 170 (Cal. Dist. Ct. App. 1957).

154. See id. at 181 (noting that despite this duty, the trial court’s jury

instruction on the physician’s duty to disclose was “rather broad” and explaining

the duty in detail).

155. Id.

156. See Jaime Staples King & Benjamin W. Moulton, Rethinking Informed

Consent: The Case for Shared Decision-Making, 32 A

M. J.L. & MED. 429, 493

(2006) (providing appendix of state laws and key cases).

157. See BERG ET AL., supra note 149, at 46–51 (discussing the differences

between the “professional” and “patient-oriented” standards of informed

consent). “[I]n practice the boundary between these two standards is often

blurred.” Id. at 52.

158. Natanson v. Kline, 350 P.2d 1093 (Kan. 1960).

159. See BERG ET AL., supra note 148, at 46 (recognizing the “maintenance of

the medical profession’s freedom . . . to shape the contours of appropriate

disclosure” as an advantage of the professional standard).

160. Id. at 46–47 (noting that “the professional standard places no extra

burden on physicians to conform to an externally imposed standard, since they

presumably already know about and observe professional norms,” but there may

be instances in which no “professional custom of disclosing,” or an inadequate

custom, exists).

1416 71 WASH. & LEE L. REV. 1385 (2014)

therefore, over the ultimate decision whether to proceed with a

treatment.

161

Roughly half the states continue to follow this

standard.

162

The more patient-centered material risk standard emerged to

“safeguard the patient’s interest in achieving his own

determination on treatment.”

163

The material risk standard

generally requires the physician “to disclose all information about

a proposed treatment that a reasonable person in the patient’s

circumstances would find material to a decision either to undergo

or forgo treatment.”

164

Although the material risk standard

imposes a significantly greater burden on physicians,

165

“[i]ndividuals place different values on health, medical care, and

risk,” preferences that “physicians cannot accurately predict.”

166

161. See id. at 47 (“[E]ven where professional standards exist, they may be

set too low to satisfy the needs of patients who wish to participate in medical

decision making in accord with the idea of informed consent.”).

162. See David M. Studdert et al., Geographic Variation in Informed Consent

Law: Two Standards for Disclosures of Treatment Risks, 4 J.

EMPIRICAL LEGAL

STUD. 103, 105 (2007) (noting that “23 states have maintained the professional

standard”).

163. See Canterbury v. Spence, 464 F.2d 772, 786–87 (D.C. Cir. 1972)

(explaining why the court declined to adopt a standard for disclosure “framed

with reference to prevailing fashion within the medical profession” and instead

defined the contours of what is disclosed by “the patient’s right of self-decision”).

164. BERG ET AL., supra note 149, at 48. A handful of jurisdictions “take an

even more protective approach, requiring disclosure of information that a

particular patient (as contrasted with a [reasonable] patient) would have

wanted to make his or her decision.” H

ALL ET AL., HEALTH CARE LAW AND ETHICS

204 (7th ed. 2007). Clearly, what the reasonable person finds material and what

an individual patient finds material may differ. Berg offers the example of a

watch repairer who would be interested in knowing that a particular medication

can cause a fine tremor, a risk most patients may not find material. See B

ERG ET

., supra note 149, at 50.

165. This is especially true when the law requires physicians to divine what

individual patients would want to know. See Robert Gatter, Informed Consent

and the Forgotten Duty of Physician Inquiry, 31 LOY. U. CHI. L.J. 557, 596 (2000)

(arguing that “physicians [should] reasonably inquire about the subjective

treatment goals of patients” and that “[w]ithout an objective limitation to a

physician’s inquiry, physicians could be held liable for failing to ask the one

question that, in hindsight, would have brought forth key information about the

patient’s treatment goals”); see also L

O, supra note 149, at 24 (discussing how

problematic a subjective standard is in malpractice litigation).

166. Id. at 20. Over the last decade, healthcare professionals have embraced

a model of shared decision making, which some describe as the “process of

interacting with patients who wish to be involved in arriving at an informed,

values-based choice among two or more medically reasonable alternatives.”

EMERGENCY CONTRACEPTIVES 1417

Under both standards for disclosure, patients must be

informed of “the nature of the intervention, the expected benefits,

the risks, and the likely consequences.”

167

Under both, physicians

have a duty to apprise patients of alternatives to treatment,

168

well as the risk of “doing nothing.”

169

Under both, physicians are

not absolved of a duty to discuss the risks of a medication with

patients even if those risks are disclosed on a drug’s labeling. The

drug’s label is intended for consumption by the physician, who

must independently explain its importance to patients.

170

Annette O’Connor, Hilary A. Llewellyn-Thomas & Ann Barry Flood, Modifying

Unwarranted Variations in Health Care: Shared Decision Making Using Patient

Decision Aids, H

EALTH AFFAIRS 63, 64 (2004), http://geiselmed.dartmouth.edu/

cfm/education/PDF/shared_decision_making.pdf. One impetus for the model is

studies showing while that a significant number of patients (a fourth in one

study) want physicians to make the decision for them, a significant majority,

roughly one-half in one study and 68% in another, wanted to select the

treatment option together with their physician. Deber RB, Kraetschmer N,

Irvine J., What Role Do Patients Wish to Play in Treatment Decision-Making?,

154 A

RCHIVES INTERNAL MED. 1414, 1414–20 (1996); see also Dennis J. Mazur &

David H. Hickam, Patients’ Preferences for Risk Disclosure and Role in Decision

Making for Invasive Medical Procedures, 12

J. GEN. INTERNAL MED. 114, 115

(1997) (studying patient attitudes about the role they desire to have in medical

decision-making). For a critique of shared decision making, arguing that “the

skimpiest reflection reveals that [shared decision making] is ambiguous unto

incoherence,” see Carl E. Schneider, Void for Vagueness, 37

HASTINGS CTR. REP.

10, 10–11 (2007); see also Simon N. Whitney et al., Beyond Shared Decision

Making: An Expanded Typology of Medical Decisions, 28 MED. DECISION MAKING

699, 701–02 (2008) (discussing situations in which one viable treatment option

exists and contrasting these with situations in which patients and doctors

disagree about treatment options).

167. See L

O, supra note 149, at 21 (laying out requirements for informed

consent).

168. See generally John H. Derrick, Annotation, Medical Malpractice:

Liability for Failure of Physician to Inform Patient of Alternative Modes of

Diagnosis or Treatment, 38 A.L.R.4th 900 (originally published in 1985)

(collecting and discussing physician liability for failing to disclose alternative

methods of treatment to patients under both standards).

169. See Wecker v. Amend, 918 P.2d 658, 661 (Kan. Ct. App. 1996)

(concluding that a physician should inform a patient of the option of forgoing

treatment “in situations where no treatment at all is a reasonably medically

acceptable option” under the professional standard); Truman v. Thomas, 611

P.2d 902, 906–07 (Cal. 1980) (explaining that “if the recommended test or

treatment is itself risky, then the physician should always explain the potential

consequences of declining to follow the recommended course of action” since it

would be material to a reasonable patient).

170. See Niemiera ex rel. Niemiera v. Schneider, 555 A.2d 1112, 1119 (N.J.

1989) (holding a prescription drug maker did not owe a duty to warn of side-

1418 71 WASH. & LEE L. REV. 1385 (2014)

Under both, physicians must disclose not only “biomedical

risks” but “psychosocial” harms as well.

171

Indeed, sometimes the

psychosocial harms are the ones that matter most. As the medical

ethicist Bernard Lo notes: “[For HIV] and genetic testing, the

pertinent risks are not the risks of venipuncture, but the risks of

stigma and discrimination in employment or health insurance.

Many states have enacted special provisions requiring written

informed consent and pretest counseling for HIV testing.”

172

Neither standard, however, requires physicians to inform patients

of things that patients already know or reasonably should know.

173

effects because of the “learned intermediary” doctrine and noting that “[t]he

duty of the manufacturer of the vaccine is to warn the learned intermediary who

passes it on to the patient through informed consent” (internal quotation marks

omitted)).

171. See L

O, supra note 148, at 21 (explaining the types of information

physicians must discuss with patients to obtain informed consent). Some

question whether the information provided to women, or all patients, should be

limited to medical information. For example, family practitioners might choose

to disclose to women risks to their children from cohabiting with someone other

than the child’s legal parent. For a discussion of risks to children cohabiting

with mother’s boyfriends, in particular, see generally Robin Fretwell Wilson,

Trusting Mothers: A Critique of the American Law Institute’s Treatment of De

Facto Parents, 38 HOFSTRA L. REV. 1103 (2010); Robin Fretwell Wilson,

Undeserved Trust: Reflections on the ALI’s Treatment of De Facto Parents, in

RECONCEIVING THE FAMILY: CRITICAL REFLECTIONS ON THE AMERICAN LAW

INSTITUTE’S PRINCIPALS OF THE LAW OF FAMILY DISSOLUTION 90 (Robin Fretwell

Wilson ed., 2006); Robin Fretwell Wilson, Children at Risk: The Sexual

Exploitation of Female Children After Divorce, 86 C

ORNELL L. REVIEW 251

(2001).

172. L

O, supra note 148, at 21 (citation omitted).

173. Physicians may also be excused “from a duty to disclose information

concerning dangers related to proposed treatment of which patients of average

sophistication would already be aware, apparently without a requirement that

any given patient actually be ‘of average sophistication.’” Jones, supra note 148,

393–94 (quoting Canterbury v. Spence, 464 F.2d 772, 788 (D.C. Cir. 1972)). Five

general exceptions exist to the duty to provide informed consent: “threats to

public health, medical emergency, therapeutic privilege, waiver of informed

consent by the patient, and a patient’s lack of competence to make decisions.”

HOMAS MAY, BIOETHICS IN A LIBERAL SOCIETY: THE POLITICAL FRAMEWORK OF

BIOETHICS DECISION MAKING 21 (paperback ed. 2009). Today, the therapeutic

privilege has fallen into disfavor as too easily leveraged to “overrid[e] a patient’s

values.” Id. at 21–22, 26–30 (explaining how the therapeutic privilege was relied

upon to preclude disclosure of alternative treatments to patients who would

rather let the doctor decide); see also Nathan A. Bostick, Robert Sade, John W.

McMahon & Regina Benjamin, Report of the American Medical Association

Council on Ethical and Judicial Affairs: Withholding Information from Patients:

Rethinking the Propriety of “Therapeutic Privilege,” 17 T

HE J. OF CLINICAL

EMERGENCY CONTRACEPTIVES 1419

In short, then, “all risks potentially affecting the decision must be

unmasked.”

174

B. Abortion Cases

A pair of recent cases brought by women after abortions they

later regretted affirms that, under both standards, patients must

be informed about factual information like gestational stage.

In the past few years, state courts in New Jersey and Illinois

have grappled with the limits of disclosure provided to women

seeking an abortion. In both, the plaintiffs lost.

175

The plaintiffs

maintained—in virtually identical terms

176

—that they should

ETHICS 302 (2006) (concluding that withholding information is unethical and

early communication should only be avoided if early communication is “clearly

contraindicated”).

174. Canterbury v. Spence, 464 F.2d 772, 787 (D.C. Cir. 1972) (footnote

omitted). Of course, disclosure does not always work this way on the ground. See

ERG ET AL., supra note 148, at 147 (noting that some proponents of informed

consent “are troubled by the failure of the current law to protect [patient]

autonomy as fully as it might and by what they see as a consistent pattern of

subordinating patient autonomy to the interests of the medical profession”

(endnotes omitted)).

175. See Doe v. Planned Parenthood/Chi. Area, 956 N.E.2d 564, 574 (Ill.

App. Ct. 2011) (affirming lower court’s dismissal of complaint that included

claim for lack of informed consent); Acuna v. Turkish, 930 A.2d 416, 428 (N.J.

2007) (“We . . . reinstate the order dismissing plaintiff’s lack-of-informed-consent

and emotional distress claims, which were the only remaining claims in this

case.”).

To succeed on a claim of a breach of the duty to provide informed consent,

plaintiffs must demonstrate three elements: failure to disclose a specific risk in

violation of the applicable standard, the materialization of the specific risk, and

that had the risk been disclosed, the patient, or a prudent person in the

patient’s position, would not have proceeded as she did. See H

ALL ET AL, supra

note 164, at 215 (laying out elements of a cause of action for nondisclosure).

On causation, the dominant standard is the prudent person standard, but a

handful of jurisdictions follow a subjective standard. Compare Canterbury, 464

F.2d at 791 (establishing the objective “reasonable person” test for causation

and noting that “[t]he [particular] patient’s testimony is relevant on that score

of course but it would not threaten to dominate the findings”), with Scott v.

Bradford, 606 P.2d 554, 559 (Okla. 1979) (rejecting the Canterbury “‘reasonable

man’ standard” and opting instead for a test that places significant weight on

the testimony of the particular patient).

176. The striking parallels between the plaintiffs’ complaints are not

surprising because both cases were brought by the same counsel. See Doe, 956

1420 71 WASH. & LEE L. REV. 1385 (2014)

have been told the procedure would terminate a “complete,

separate, unique and irreplaceable human being,” and so would

“kill[] an existing human being.”

177

In Acuna v. Turkish,

178

the court accepted as true the

plaintiff’s allegations that she had asked whether it was a “baby

in there.”

179

In Doe v. Planned Parenthood/Chicago Area,

180

plaintiff alleged she asked if a “life of a human being in the

biological sense” would be terminated.

181

In both, the patients

said the provider assured them that no life was at stake. In

Acuna, the doctor allegedly said “don’t be stupid, its only

blood,”

182

and in Doe, plaintiff alleged Planned Parenthood’s

counselor told her that “an abortion did not terminate the life of a

human being.”

183

Both later learned, as Acuna says in her words,

that there “‘was a baby and not just blood’ inside of her.”

184

Both

wanted to be told far more than they say they were—in extremely

explicit terms. Acuna claimed that the physician failed to inform

her that “[Andres] Acuna [(The name she gave to her terminated

“child”)], although a person unborn, was a complete, separate,

unique[,] and irreplaceable human being.”

185

Doe charged that

N.E.2d at 571 (“The remarkable similarity with the instant case may be

explained by the statement at oral argument of plaintiff’s counsel that he

represented Acuna before the New Jersey Supreme Court.”)

177. Acuna, 930 A.2d at 418 (internal quotations omitted).

178. 930 A.2d 416 (N.J. 2007).

179. Id. at 419.

180. 956 N.E.2d 564 (Ill. App. Ct. 2011).

181. Id. at 567.

182. Acuna, 930 A.2d at 419. “Defendant could not recall how he responded

but believes he likely would have told her that a ‘seven-week pregnancy is not a

living human being,’ but rather it ‘is just tissue at this time.’” Id.

183. Doe, 956 N.E.2d at 567. It is unclear whether the defendant disputes

this allegation. See id. (accepting the plaintiff’s facts as true). The plaintiff

further contended “the defendants had a duty to inform her there is a greater

risk of death, depression, suicide and breast cancer in women who undergo an

abortion than in those who give birth.” Id.

184. Acuna v. Turkish, 930 A.2d 416, 419 (N.J. 2007). Acuna says that after

experiencing vaginal bleeding as the result of “incomplete abortion,” a nurse told

her that “the doctor had left parts of the baby inside of her.” Id. (footnote

omitted).

185. Id. at 420. Acuna also claimed the physician failed to inform her that

. . . (2) there existed the potential risk that Andres “was capable of

experiencing pain” at eight weeks gestation; (3) abortion involved

“actually killing an existing human being”; (4) she would be at risk of

EMERGENCY CONTRACEPTIVES 1421

Planned Parenthood failed to “inform her that an abortion

‘procedure would terminate the life of a second patient, a living

human being as a matter of biological fact.’”

186

Both courts made short work of the duty to be so explicit. In

Acuna, the court first noted that the plaintiff “must demonstrate

that a physician withheld medical information that a reasonably

prudent pregnant woman in like circumstances would have

considered material before consenting to a termination of

pregnancy.”

187

The court held it would “not place a duty on doctors when

there is no consensus in the medical community or among the

public supporting plaintiff’s assertions.”

188

Indeed, “the

knowledge that plaintiff sought from defendant cannot be

compelled from a doctor who may have a different scientific,

moral, or philosophical viewpoint on the issue of when life

begins.”

189

The court refused to use “the engine of the common

law” to “drive public policy in one particular direction” on an

issue on which there is a “deep societal and philosophical divide:”

“the profound issue of when life begins.”

190

The common law

requires that physicians “provide their pregnant patients seeking

an abortion only with material medical information, including

gestational stage and medical risks.”

191

Evaluating Planned Parenthood’s disclosures by “that of the

reasonable physician,”

192

the Doe court also rejected the patient’s

suffering from “post-abortion syndrome,” a form of a post-traumatic

stress disorder; and (5) she would come to realize that she “was

responsible for killing her own child” and bear a weight of guilt for

the rest of her life.

Id.

186. Doe v. Planned Parenthood/Chi. Area, 956 N.E.2d 564, 567 (Ill. App. Ct.

2011).

187. Acuna, 930 A.2d at 425 (citation omitted).

188. Id. at 428.

189. Id. The defendant and amici argued: “[M]andating that a physician

express a non-medical and value-laden viewpoint conflicting with the

physician’s own strongly held personal and moral beliefs violates his First

Amendment right to the exercise of free—not coerced—speech.” Id.

190. Acuna v. Turkish, 930 A.2d 416, 427 (N.J. 2007).

191. Id. at 427–28.

192. Doe v. Planned Parenthood/Chi. Area, 956 N.E.2d 564, 570 (Ill. App. Ct.

2011) (citing Weekly v. Solomon, 510 N.E.2d 152 (Ill. App. Ct. 1987)).

1422 71 WASH. & LEE L. REV. 1385 (2014)

informed consent claim.

193

It cited the Acuna court’s description

of the common law with approval, namely that it “requires

doctors to provide their pregnant patients seeking an abortion

only with material medical information, including gestational

stage and medical risks involved in the procedure.”

194

It added

that “[n]o court, regardless of where it sits, has found a common

law duty requiring doctors to tell their pregnant patients that

aborting an embryo, or fetus, is the killing of an existing human

being.”

195

The court then rejected the “plaintiff’s claims that the

defendants owed her disclosures under Illinois common law that

reflected something other than the scientific, moral, or

philosophical viewpoint of Planned Parenthood as an abortion

clinic.”

196

C. The Disclosure Owed to Women

As these cases illustrate, a sensible line can be drawn

between disclosure of factual medical information that would be

material to the prudent patient, as the Acuna court did, and

weighing in on the ultimate issue of when life begins. In this

context, doctors owe women factual disclosures faithful to the

science around EC. Physicians should give each woman specific,

fact-based information on when a given form of EC likely works

(pre-fertilization, post-fertilization but pre-implantation, or

during implantation) so that she can make decisions based on her

own views of when life begins—or whether that question even

matters to her.

The juncture at which EC works is material to many

patients. Ordinary women care deeply about how EC functions.

Likewise, medical providers—from family practitioners and

members of the FDA scientific panel to academic researchers and

women’s health educators—recognize that women should be told

far more than they are told now.

197

The need for factual

193. See id. at 573 (“Illinois common law does not compel the disclosures the

plaintiff claims should have been made to her . . . .”).

194. Id.

195. Id. at 572 (citing Acuna v. Turkish, 930 A.2d 416, 418 (N.J. 2007)).

196. Id. at 573.

197. Supra Part IV.

EMERGENCY CONTRACEPTIVES 1423

information is especially compelling because many women labor

under misconceptions about how EC functions. Without better

information, some women will make choices that may

“inadvertently violat[e] their own religious or moral values.”

198

Of equal force is the fact that some women will choose not to

use EC,

199

believing all forms of EC work after fertilization—

when, for Plan B, that is highly unlikely. In one study of “never-

users” of EC in Canada, researchers found that “[n]ever-users

who had believed [EC] to be an abortifacient said that they would

be more likely to consider using it, if the need arose, now that

they understood how it functions.”

200

Nonetheless, concerns about compelled speech need to be

taken seriously. Doctors cannot—and should not—be compelled

to express an ultimate conclusion about whether “pregnancy” or

“life” begins at one junction or another. Conversely, doctors

should not be asked to express an opinion on the ultimate

decision of whether a given drug acts as an “abortifacient.” As the

Acuna court noted, “it would be bad public policy, and probably

unconstitutional, under the banner of the law of informed

consent, to compel obstetricians to voice plaintiff’s non-medical

and ideologically-driven viewpoint in the ongoing debate on

abortion.”

201

Both courts made clear, however, that factual,

scientific disclosure required by the duty to provide informed

consent does comport with the First Amendment.

D. Practical Considerations

198. Lockwood, supra note 19, at 15.

199. Gemzell-Danielsson, Berger & Lalitkumar, supra note 56, at 300

(arguing that “an increased knowledge about the mechanisms of action and

safety of EC is essential for the development of new methods as well as for

optimizing the use of those already available”). “This knowledge may also

influence individual and cultural acceptability of EC use.” Id. Another article

argues that in order “[t]o make an informed choice, women must know that

[EC] . . . prevent[s] pregnancy primarily by delaying or inhibiting ovulation and

inhibiting fertilization.” Trussell, Raymond & Cleland, supra note 73, at 7.

200. Jean Shoveller et al., Identifying Barriers to Emergency Contraception

Use Among Young Women from Various Sociocultural Groups in British

Columbia, Canada, 39 P

ERSP. ON SEXUAL & REPROD. HEALTH 13, 16 (2007).

201. Acuna, 930 A.2d at 424.

1424 71 WASH. & LEE L. REV. 1385 (2014)

The aspiration for informed consent, as guidance to federal

family planning agencies under Title X encapsulates the duty, is

to have “individualized dialogue[s] with a client.”

202

In the fast-

paced medical practices of today, physicians sometimes see

informed consent as a “nuisance.” The impulse may be to deal

with it “in relatively mechanical ways, such as making sure

patients sign consent forms before major procedures.”

203

Paper consent is not likely to advance women’s

understanding.

204

As many have recognized, patients are no more

likely to read long consent forms than they are to read the FDA

insert. And unless explained in more accessible, nonspecialized

terms, patients are no more likely to understand the content of a

consent form without a physician’s guidance than they are the

FDA label.

True, providing informed consent is not without costs.

205

Doctors face enormous time constraints in daily practice.

206

202. U.S. DEP’T OF HEALTH & HUMAN SERVS., PROGRAM GUIDELINES FOR

PROJECT GRANTS FOR FAMILY PLANNING SERVICES 18 (2001), http://www.hhs.

gov/opa/pdfs/2001-ofp-guidelines-complete.pdf.

203. T

OM L. BEAUCHAMP & JAMES F. CHILDRESS, PRINCIPLES OF BIOMEDICAL

ETHICS (3d ed. 1989).

204. A rich literature exists on the failings of paper consent. See e.g., Carl E.

Schneider, Void for Vagueness, H

ASTINGS CTR. REPORT 11 (2007) (“The long-

standing principle—informed consent—is administratively practical but a paper

tiger.”).

205. See Peter H. Schuck, Rethinking Informed Consent, 103 YALE L.J. 899,

904 (1994) (footnotes omitted)

The realists—primarily practicing physicians—harbor a different

vision of informed consent. Although they emphatically do not contest

the principle and goals of informed consent, they do question whether

most patients really desire the kind of dialogue that the idealists

propose. They also question whether, whatever patients desire, the

gains in patient autonomy and improved outcomes produced by the

dialogue are worth the additional time, money, and needless patient

anxiety and confusion that informed consent may entail.

206. See generally Andrew Gottschalk & Susan A. Flocke, Time Spent in

Face-to-Face Patient Care and Work Outside the Examination Room, 3

ANNALS

FAM. MED. 488 (2005); David Mechanic, Physician Discontent Challenges and

Opportunities, 7 J. AM. MED. ASS’N 941 (2003); Jerome P. Kassirer, Doctor

Discontent, 339

NEW ENG. J. MED. 1543 (1998).

For example, as of 1997, 41% of physicians reported a decrease in the

amount of time devoted to face-time with patients. KAREN SCOTT COLLINS, CATHY

SCHOEN & DAVID R. SANDMAN, THE COMMONWEALTH FUND, THE COMMONWEALTH

FUND SURVEY OF PHYSICIAN EXPERIENCES WITH MANAGED CARE 5 (1997). While

EMERGENCY CONTRACEPTIVES 1425

Mounting administrative responsibilities tied to navigating

payment by insurers, like authorization requests and utilization

review, take time away from interaction with patients.

207

Moreover, keeping up with the dense literature on mechanisms of

action of various forms of EC takes time, and demystifying it for

patients will take more time. In the best of circumstances,

patients often do not understand what a physician means.

208

Here, easy-to-follow summaries by

the Cleveland Clinic and

others can facilitate these conversations, making conversations

less taxing for all. Doctors need only give a snapshot of the

literature drawn from quick summaries of the maturing evidence

about how Plan B and ella work.

209

many say that “visit rates above three to four per hour are associated with

suboptimal visit content,” in the U.S., visit lengths were “10 to 20 minutes or

more” in 1999, and are likely more crunched today. See David C. Dugdale,

Ronald Epstein & Steven Z. Pantilat, Time and the Patient-Physician

Relationship, 14 J.

GEN. INTERNAL MED. S34, S34 (1999) (“[I]n Great Britain,

average visit lengths for general practitioners are between 5 and 8 minutes,

whereas in the United States and Sweden, they are 10 to 20 minutes or more.”).

207. See David C. Dugdale, Ronald Epstein & Steven Z. Pantilat, Time and

the Patient-Physician Relationship, 14 J.

GEN. INTERNAL MED. S34, S34 (1999)

(“[P]hysicians face mounting demands on their time. Increasing administrative

requirements for health care delivery (e.g., service and authorization requests,

utilization review processes) encroach on time spent with patients.”).

208. See, e.g., Pauline W. Chen, Do You Know What Your Doctor Is Talking

About?, N.Y.

TIMES (Apr. 2, 2009), http://www.nytimes.com/2009/04/02/health/

02chen.html (last visited Jan. 15, 2014) (discussing the problems presented by

patients’ lack of health literacy) (on file with the Washington and Lee Law

Review); Omri Ben-Shahar & Carl E. Schneider, The Failure of Mandated

Disclosure, 159 U.

PA. L. REV. 647, 651 (2013) (arguing that “mandated

disclosure . . . chronically fails to accomplish its purpose” of enlightening

patients so that they can participate meaningfully in decision-making processes

with professionals).

209. Physicians’ prescribing of EC to patients may change with updated

information, as well. Some physicians hesitate to prescribe EC on religious

grounds. See Jennifer L. Wallace et al., Emergency Contraception: Knowledge

and Attitudes of Family Providers, 36 F

AM. MED. 417, 421 (2004) (identifying a

“subset of physicians who would not prescribe under any circumstance . . .

[because of] feeling uncomfortable with EC secondary to religious/ethical

beliefs”). This reluctance may be allayed as to Plan B with better information.

See supra Part III.A.1 (discussing how Plan B works). Citing a “lack of

knowledge,” physicians are understandably hesitant to prescribe to adolescents.

Neville H. Golden et al., Emergency Contraception: Pediatricians’ Knowledge,

Attitudes, and Opinions, 107 P

EDIATRICS 287, 291 (2001). In 2001, “most

pediatricians did not feel comfortable prescribing EC and cited lack of

knowledge as the main concern for lack of comfort,” although this may have

1426 71 WASH. & LEE L. REV. 1385 (2014)

Physicians do have to “remember[] to discuss EC during

routine visits,” which is not the easiest thing to do in a crush of

patients and is “one of the most significant barriers” to EC use.

210

To some extent, operationalizing informed consent falls not solely

on the doctor but can be facilitated by good practices and good

office staff. Videos and print brochures can introduce the patient

to the needed information, supplementing the interactions

between doctor and patient. Perhaps more for this topic than

most, a visual will go a long way towards illuminating the

junctures at which a particular form of EC may work—whether

(a) before fertilization, (b) after fertilization and before

implantation, or (c) during implantation. A visual would also

assist a woman who did not already have a set notion about when

pregnancy begins to decide, for herself, among competing medical

understandings. In studies of video consent, some patients better

understand and are more satisfied with their treatments when

medical professionals supplement their verbal interaction with

audio-visual aids.

211

changed. Id.

Twelve percent cited moral or religious reasons and [seventeen

percent] were concerned about teratogenic effects. There were no

differences in comfort level based on age, gender, or practice type.

Twenty-two percent of respondents believed that providing EC

encourages adolescent risk-taking behavior and 52.4% would restrict

the number of times they would dispense EC to an individual

[adolescent] patient.

Id. at 287. Better information may again allay physician concerns, an important

benefit since girls need this information as much as women—or perhaps even

more. See

CAHN & CARBONE, supra note 131, at 20–24 (discussing teen

pregnancy and life chances).

210. See Wallace et al., supra note 209, at 421 (discussing “[b]arriers to EC

use identified by physicians”).

211. See Michael Migden, Arianne Chavez-Frazier & Tri Nguyen, The Use of

High Definition Video Modules for Delivery of Informed Consent and Wound

Care Education in the Mohs Surgery Unit, 27 SEMINARS CUTANEOUS MED. &

SURGERY 89, 92 (2008) (“Increased patient understanding was demonstrated in

our assessment of the wound care video group, with patients scoring 91.6% on

the multiple-choice quiz compared with a score of 84% in the group with only

nurse demonstration of wound care.”); E. Tompsett, R. Afifi & S. Tawfeek, Can

Video Aids Increase the Validity of Patient Consent, 32

J. OBSTETRICS &

GYNAECOLOGY, 680, 680–82 (2012) (offering evidence that patient understanding

of methods and purpose of treatment was significantly enhanced by using

videos).

EMERGENCY CONTRACEPTIVES 1427

Some states provide legal safe harbor protections that

immunize physicians who follow “stock” disclosures about the

risks of a particular treatment, an approach that could be used

here to reduce the transaction costs of providing informed consent

(as well as liability risks). Texas provides one example of such a

safe harbor protection.

212

Texas physicians may use off-the-rack

disclosure forms to provide information to patients about risks

inherent in particular procedures.

213

One form is very general and

may be adapted to any procedure.

214

Other forms have been

developed for specific procedures, listing their particular risks

and unique concerns.

215

The patient signs the form prior to

undergoing treatment. The patient’s signature triggers a legal

presumption that the duty of informed consent was satisfied.

216

The form supplements, but does not replace, the discussion that

must occur between physician and patient to otherwise fulfill the

doctor’s disclosure obligations.

217

The safe harbor approach, like good office procedures, can

significantly reduce the burden on physicians of meeting their

legal duties to empower women to decide for themselves.

VI. Conclusion

Like so much of the country’s continuing clash over abortion,

the dispute over whether Plan B and ella act as ordinary

contraceptives, before fertilization—or whether they “violate[] the

212. For a general discussion of Texas’s safe harbor protections, see

generally Informed Consent, TEXAS MED. ASS’N (Feb. 2012), http://www.

texmed.org/Template.aspx?id=6049#Proper (last visited Feb. 8, 2014) (on file

with the Washington and Lee Law Review).

213. See id. (explaining how and when disclosure forms are used); see also 22

EX. ADMIN. CODE § 165.6 (2014); 25 TEX. ADMIN. CODE §§ 601.4, 601.5, 601.7,

601.8, 601.9 (2014) (discussing consents and disclosures required in various

procedures).

214. 25 T

EX. ADMIN. CODE §§ 601.4, 601.5, 601.7.

215. 22 T

EX. ADMIN. CODE § 165.6; see also 25 TEX. ADMIN. CODE §§ 601.4,

601.5, 601.7, 601.8, 601.9 (discussing consents and disclosures required in

various procedures).

216. See Informed Consent, supra note 212 (stating that once risks are

disclosed and consent is given, a legal presumption is established).

217. Id.

1428 71 WASH. & LEE L. REV. 1385 (2014)

Commandment against murder”

218

—generates more heat than

light.

Clearly, “women should be informed that the best available

evidence is that the ability of [both to] prevent pregnancy can be

fully accounted for by mechanisms that do not involve

interference with post-fertilization events.”

219

While hundreds of

studies over fifteen years demonstrate that the chances that Plan

B ever acts after fertilization are vanishingly small, the same

cannot be said of ella.

While many women have no moral qualms about using EC,

whether it acts before or after fertilization, others do. For them,

the fact that a drug may act after fertilization means that it is

morally off limits. Equipping women with the factual information

necessary for them to make their own moral judgments falls

squarely within the commitment we have made to patients in

matters affecting their bodies and health: patients decide.

218. Complaint at 10, Geneva Coll. v. Sebelius, 929 F. Supp. 2d 402 (W.D.

Penn. 2013) (No. 2:12-cv-00207).

219. Trussell, Raymond & Cleland, supra note 73, at 7.