IN THE SUPREME COURT OF OHIO

NANCY H. ROGERS, OHIO ATTORNEY GENERAL, et al., : Case No. 2008-1234

:
Petitioners, : On Review of Certified
: Questions from the U.S.
v. : Court of Appeals for the
: Sixth Circuit
PLANNED PARENTHOOD CINCINNATI REGION, et al., :
: U.S. Court of Appeals Case
Respondents. : Nos. 06-4422/06-4423

BRIEF OF AMICI CURIAE MEMBERS OF THE U.S. CONGRESS

IN SUPPORT OF PETITIONERS
______________________________________________________________________________

Counsel for Respondents: Counsel for Petitioners:

JENNIFER L. BRANCH (0038893) BENJAMIN C. MIZER (0083089)
ALPHONSE GERHARDSTEIN (32053) Solicitor General
Gerhardstein & Branch Co., LPA STEPHEN P. CARNEY (0063460)
617 Vine Street, Suite 1409 Deputy Solicitor
Cincinnati, OH 45202 ANNE BERRY STRAIT (0012256)
513.621.9100 SHARON A. JENNINGS (0055501)
DAVID C. GREER (009090) Assistant Attorneys General
Bieser, Greer & Landis LLP 30 East Broad Street, 17th Floor
400 National City Center, 6 North Main Columbus, OH 43215
Dayton, OH 45402 614.466.8980
937.223.3277 JOSEPH T. DETERS (0012084)
HELENE T. KRASNOFF Hamilton County Prosecutor
Planned Parenthood Federation of America MICHAEL G. FLOREZ (0010693)
1780 Massachusetts Avenue, NW ROGER E. FRIEDMAN (0009874)
Washington, DC 20036 230 E. Ninth Street, Suite 4000
202.973.4800 Cincinnati, OH 45202
513.946.3229
ROGER K. EVANS
Planned Parenthood Federation of America Counsel for Amici Curiae:
434 West 33rd Street JOEL J. KIRKPATRICK (0071924)
New York, NY 10001 Kirkpatrick Law Offices PC
212.541.7800 Counsel of Record
31800 Northwestern Highway, Suite 350
B. JESSIE HILL (0074770) Farmington Hills, MI 48334
Case Western University School of Law 248.855.6010
11075 East Blvd.
Cleveland, OH 44106 MAILEE R. SMITH
216.368-.0553 Americans United for Life
310 S. Peoria St., Suite 500
JEFFREY M. GAMSO (0043869) Chicago, IL 60607
ACLU of Ohio Foundation, Inc. 312.568.4700
4506 Chester Avenue
Cleveland, OH 44103
216.472.2220
 TABLE OF CONTENTS

TABLE OF AUTHORITIES .......................................................................................................... ii

STATEMENT OF INTEREST OF AMICI CURIAE ......................................................................1

STATEMENT OF FACTS ..............................................................................................................3

ARGUMENT ...................................................................................................................................3

Proposition of Law No. I: OHIO REV. CODE § 2919.123 clearly encompasses the FDA
approval letter and the mifepristone drug label in requiring abortionists to follow “federal
law”..................................................................................................................................................4

A. Ohio and federal court jurisprudence support common sense interpretation of laws .........4

1. Ohio Court Precedent .............................................................................................. 5

2. U.S. Supreme Court and Lower Federal Court Precedent .......................................7

B. The common sense interpretation of “federal law” includes the 49-day gestational limit in
the FDA approval letter and the treatment protocols and dosage indications described in
the drug’s final printed labeling ..........................................................................................9

Proposition of Law No. II: The severe medical risks inherent in the use of mifepristone and
its off-label use underscore the necessity of including the FDA approval letter and the
mifepristone label in the definition of “federal law” ................................................................13

A. The use of mifepristone presents significant medical risks to women ..............................14

1. Death by C. sordellii bacterial infection ................................................................14

2. Other life-threatening infections ............................................................................18

3. Massive hemorrhage ..............................................................................................18

4. Further dangers specifically associated with off-label use ....................................19

B. Mifepristone offers no net therapeutic benefits over the safer alternatives .......................20

1. Risk of death from C. sordellii bacterial infection elevated in mifepristone use ..20

2. Risk of hemorrhage elevated in mifepristone use ..................................................20

CONCLUSION .............................................................................................................................22

i
 TABLE OF AUTHORITIES

CASES

City of Norwood v. Horney, 853 N.E.2d 1115 (Ohio 2006). ..........................................................5

Doe v. Bolton, 410 U.S. 179 (1973). .....................................................................7, 8, 9, 11, 12, 13

Fargo Women’s Health Org. v. Schafer, 18 F.3d 526 (8th Cir.

1994). ..............................................................................................................................................9

Founder’s Women’s Health Center v. Ohio State Department of Health,

2002 Ohio App. LEXIS 4345 (Ohio Ct. App. 2002). .................................................................6, 9

Grayned v. City of Rockford, 408 U.S. 104 (1972). .............................................................4, 5, 12

Greenville Women’s Clinic v. Comm’r, S.C. Dep’t of Health &

Envtl. Control, 317 F.3d 357 (4th Cir. 2002). ................................................................8, 9, 11, 12

Karlin v. Foust, 188 F.3d 446 (7th Cir. 1999). ...............................................................8, 9, 11, 12

Leon v. Ohio St. Bd. of Psychology, 590 N.E.2d 1223 (Ohio 1992). ..............................................6

Planned Parenthood Cincinnati Region v. Taft, 459 F. Supp. 2d 626

(S.D. Ohio 2006). ....................................................................................................................10, 11

Planned Parenthood of Minn./S.D. v. Rounds, 372 F.3d 969 (8th Cir.

2004). ........................................................................................................................................9, 11

Roe v. Wade, 410 U.S. 113 (1973). .................................................................................................7

State v. Dorso, 446 N.E.2d 449 (Ohio 1983). .................................................................................5

State v. McKnight, 837 N.E.2d 315 (Ohio 2005). .......................................................................4, 5

State v. Williams, 728 N.E.2d 342 (Ohio 2000). .............................................................................5

U.S. v. Vuitch, 402 U.S. 62 (1971). .......................................................................................7, 9, 11

STATUTE

OHIO REV. CODE § 2919.123. ...............................................................2, 3, 4, 5, 10, 11, 12, 13, 14

ii
OTHER RESOURCES

Calhoun & Harrison, Challenges to the FDA Approval of

Mifepristone, ANNALS OF PHARM. 166 (Jan. 2004). .........................................................15, 19, 20

Emerging Clostridial Disease Workshop (CDC-FDA-NIH

Transcript May 11, 2006), at: http://www.fda.gov/cder/meeting/clostridia_disease.htm
(last visited Sept. 26, 2008). .................................................................................14, 15, 16, 17, 18

Fischer et al., Fatal Toxic Shock Syndrome Associated with

Clostridium sordellii after Medical Abortion, N.E. J. MED.
353:2352-60 (2005). .........................................................................................................15, 17, 20

Gary & Harrison, Analysis of Severe Adverse Events Related to

the Use of Mifepristone as an Abortifacient, ANNALS OF
PHARM. (Feb. 2006). .............................................................................................15, 16, 17, 18, 19

Greene, Fatal Infections Associated with Mifepristone-Induced

Abortion, N.E. J. MED. 353; 22 (Dec. 1, 2005). ............................................................................20

Jensen et. al, Outcomes of Suction Curettage and Mifepristone

Abortions in the United States: A Prospective Comparison
Study, CONTRACEPTION 59-153-59 (1999). ..................................................................................21

Letter from Donna Harrison, M.D., to Mark E. Souder, Chairman,

Subcommittee on Criminal Justice, Drug Policy and Human
Resources. .........................................................................................................................17, 20, 21

McGregor, Response to letter to the editor, CONTRACEPTION 74, 174-77

(2006). ...........................................................................................................................................16

Medical Management of Abortion, ACOG Practice Bulletin:

Clinical Management Guidelines for Obstetrician Gynecologists
26(4):1-20 (2001). .........................................................................................................................19

Medwatch Adverse Event Reports, Individual Safety Report nos.

3806144-7, 3803789-5, 4327968-6, 4411599-3, 4199811-X,
3915940-9, & 3943786-2 (FDA Office of Postmarking Drug
Risk Assessment). ...................................................................................................................18, 19

Miech, Patholphysicology of Mifepristone-Induced Septic Shock

Due to Clostridium sordellii, ANNALS OF PHARM. (Sept. 2005). ............................................15, 16

MIFEPREX™ (mifepristone) Tablets, 200 mg For Oral Administration

Only (mifepristone label), at: http://www.fda.gov/Cder/foi/label/2000/20687lbl.htm
(last visited Sept. 26, 2008). .........................................................................................................10

iii
Paul et al., A Clinician’s Guide to Medical and Surgical Abortion (1999). .................................19

Sepsis and Medical Abortion, at: http://www.fda.gov/cder/drug/advisory/mifeprex.htm

(last visited Sept. 26, 2008). .........................................................................................................14

Spitz et al., Early Pregnancy Termination with Mifepristone and Misoprostol

in the United States, N.E. J. MED. 338:1241 (1998). ....................................................................20

Statement by Donna Harrison, M.D., for RU-486: Demonstrating

a Low Standard for Women’s Health?, Hearing before the
Committee on Government Reform, House of Representatives
(May 17, 2006), Serial No. 109-202, at: http://www.gpoaccess.gov/congress/index.html
(last visited Sept. 26, 2008). ...........................................................................15, 16, 17, 18, 19, 20

Sternberg, Proceedings of the Nat’l Acad. Sci. 86: 2374-78 (1989). ............................................17

Webster & Sternberg, Role of the Hypothalamic-Pituitary-Adrenal

Axis, Glucocorticoids and Glococorticoid Receptors in Toxic Sequelae
of Exposure to Bacterial and Viral Products, J. ENDOCRIN. 181, 207-21
(2004). ...........................................................................................................................................16

iv
 STATEMENT OF INTEREST OF AMICI CURIAE

The constitutionality of the Food & Drug Administration’s (FDA) protocol for the

administration of RU-486, or mifepristone, has been called into question in this case. Amici

Curiae Representatives Roscoe Bartlett (MD),1 John A. Boehner (OH),2 Dan Burton (IN),3 Steve

Chabot (OH), Trent Franks (AZ), Jim Jordan (OH), Robert E. Latta (OH), Joseph R. Pitts (PA),

Jean Schmidt (OH),4 and Chris Smith (NJ)5 are members of the United States Congress who

support adherence to the FDA protocol, at a minimum, for the administration of mifepristone.

Amici have a strong interest in the proper interpretation and administration of a federal law.

Additionally, Amici Representatives Burton and Schmidt have a particular interest in

ensuring that adolescents and adult women are protected from the medical risks associated with

mifepristone. These Amici participated in the May 17, 2006, hearing before the House

Subcommittee on Criminal Justice, Drug Policy and Human Resources, which heard extensive

evidence demonstrating the life-threatening risks associated with mifepristone. The Committee’s

October 2006 Staff Report, which concluded that mifepristone should be withdrawn from the

market because of its substantial health risks, is attached as an Appendix to this brief.

The other Amici, though not members of the House Subcommittee, share their

colleagues’ interest in the enforcement of the FDA protocol and their interest in ensuring that

1
Lead Sponsor of H.R. 63, the RU-486 Suspension and Review Act.
2
House Minority Leader.
3
Member of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources.
4
Member of the House Subcommittee on Criminal Justice, Drug Policy and Human Resources.
5
Chairman of the House Pro-Life Caucus.

1
women are protected from the medical risks, and especially those additional risks incurred by

off-label use, of mifepristone.

Amici are deeply concerned that abortionists are admittedly not administering or

dispensing mifepristone in accordance with the FDA protocol as outlined in the FDA’s approval

letter and in the drug’s label. As explained herein, adherence to both the FDA’s approval letter

and the drug’s label is clearly required under OHIO REV. CODE § 2919.123.

For these reasons, Amici urge this Court to answer the certified questions in the

affirmative.

2
 STATEMENT OF FACTS

Amici adopt the statement of facts as outlined by the Petitioners. In summary,

abortionists, including Respondents, admittedly administer and dispense the abortion drug

mifepristone contrary to the protocol described in the FDA’s approval letter for the drug and

contrary to the dosage and administration instructions of the drug’s label. In response to the

dangers posed by the drug and especially by such off-label use, legislators in the State of Ohio

enacted OHIO REV. CODE § 2919.123, seeking to require abortionists to administer and dispense

the drug according to the protocol dictated by “federal law.” As this court is well aware,

Respondents argue that, where § 2919.123 requires them to follow “federal law,” they do not

know what “federal law” means. At the Sixth Circuit, Amici Curiae argued that, under

controlling Supreme Court and lower court federal jurisprudence, the use of the term “federal

law” clearly encompasses the FDA drug approval letter as well as the mifepristone drug label.

The Sixth Circuit certified two questions of state law interpretation by this Court. As

outlined in this Court’s order of September 10, 2008, this Court will answer the following two

questions:

1. Does R.C. 2919.123 mandate that physicians in Ohio who perform abortions using
mifepristone do so in compliance with the forty-nine-day gestational limit described in
the FDA approval letter?

2. Does R.C. 2919.123 mandate that physicians in Ohio who perform abortions using
mifepristone do so in compliance with the treatment protocols and dosage indications
described in the drug’s final printed labeling?

ARGUMENT

Amici urge this Court to answer the foregoing questions in the affirmative. As

demonstrated herein, OHIO REV. CODE § 2919.123 clearly encompasses the FDA approval letter

and the mifepristone drug label in requiring abortionists to follow federal protocol. This federal

3
protocol includes complying with the 49-day gestational limit described in the FDA approval

letter, as well as the treatment protocols and dosage indications in the drug’s final printed

labeling. The FDA’s protocol is clear to both parties, and physicians routinely prescribe

medications in accordance with federal law. In addition, a reading of the Act as a whole leads to

the FDA-approved mifepristone label, which sets out the FDA protocol.

In addition, the severe medical risks of mifepristone underscore the importance of §

2919.123. These risks demonstrate the danger of off-label use of mifepristone and the need for

the standard of care found in § 2919.123—including compliance with the FDA approval letter

and the drug’s label.

Proposition of Law No. I: OHIO REV. CODE § 2919.123 clearly encompasses the FDA
approval letter and the mifepristone drug label in requiring abortionists to follow “federal
law”

A. Ohio and federal court jurisprudence support common sense interpretation of laws

Respondents have argued that OHIO REV. CODE § 2919.123 is vague, particularly as it

requires physicians to follow “federal law,”6 and that they do not know what “federal law”

means. Yet both Ohio and U.S. Supreme Court jurisprudence support common sense

interpretation of laws. A statute must simply “give the person of ordinary intelligence a

reasonable opportunity to know what is prohibited, so that he may act accordingly.” Grayned v.

City of Rockford, 408 U.S. 104, 108 (1972); see also State v. McKnight, 837 N.E.2d 315, 352

(Ohio 2005) (stating that a criminal statute must only define a criminal offense with sufficient

clarity for an ordinary person to understand). Statutory language need not provide

6
OHIO REV. CODE § 2919.123(A) states that physicians must provide mifepristone “in
accordance with federal law.” “Federal law” is defined to mean “any law, rule, or regulation of
the United States or any drug approval letter of the food and drug administration of the United
States that governs or regulates the use of RU-486 (mifepristone) for the purpose of inducing
abortions.” Id. at § 2919.123(F)(1).

4
“mathematical certainty.” Grayned, 408 U.S. at 110; State v. Williams, 728 N.E.2d 342, 361

(Ohio 2000). Under both Ohio and federal court precedent, the common sense interpretation of

“federal law” in § 2919.123 includes the FDA approval letter as well as the mifepristone label.

1. Ohio Court Precedent

Under Ohio law, a criminal statute must simply give a person of ordinary intelligence

who seeks to avoid its penalties fair notice of the conduct required or prohibited. See, e.g.,

McKnight, 837 N.E.2d at 352; City of Norwood v. Horney, 853 N.E.2d 1115, 1142 (Ohio 2006);

State v. Dorso, 446 N.E.2d 449, 450 (Ohio 1983). Statutes need not define every word or phrase

used with “mathematical certainty;” instead, it is only necessary that a person of common

intelligence be able to determine what conduct is prohibited. Williams, 728 N.E.2d at 361.

In fact, a “legislative body need not define every word it uses in an enactment.” State v.

Dorso, 446 N.E.2d at 451. Further, “any term left undefined by statute is to be accorded its

common, everyday meaning.” Id. “Words in common use will be construed in their ordinary

acceptation and significance and with the meaning commonly attributed to them.” Id.

Examples in Ohio abound demonstrating that the law does not demand extreme

specificity in statutes, and that verbiage used which would not likely “confound the person of

ordinarily intelligence” is perfectly acceptable and should be given the meaning understood by

the community affected by the statute. In State v. Dorso, this Court examined a noise ordinance

which prohibited disturbing the peace and quiet in a neighborhood. Dorso, 446 N.E.2d at 450.

The appellee was charged with violating the rule and subsequently claimed he did not understand

the word “neighborhood.” See generally, id. The court disagreed, holding that the word

“neighborhood” should be given its ordinary meaning, and stating that the definition of

“neighborhood” was well within the appellee’s own comprehension. Id. at 451.

5
 Furthermore, when a statute is aimed at regulating the medical community, terminology

is to be given the meaning understood by the medical community—and the medical community

cannot claim it misunderstands words or phrases or instructions routinely used in the medical

community. For example, in Founder’s Women’s Health Center v. Ohio State Department of

Health, the court considered a dispute regarding whether certain abortion clinics constituted

“ambulatory surgical facilities” under state law. 2002 Ohio App. LEXIS 4345 (Ohio Ct. App.

2002). The Department of Health had visited and determined that the appellant clinics did in fact

constitute ambulatory surgical centers that must be licensed as such. See generally, id. At issue

was whether the clinics were “offices of private physicians” under OHIO REV. CODE § 3702.30,

because, the clinics claimed, if they were considered offices of private physicians, they could not

be regulated as ambulatory surgical centers. Id. In litigating this argument, the clinics claimed

that, because the statute did not define “offices of private physicians,” the phrase was vague. Id.

“Offices of private physicians” was not defined under OHIO REV. CODE § 3702.30. In

determining its meaning, the appellate court first quoted Ohio Supreme Court precedent for the

rule of construction that terms used in a statute must be given their usual and ordinary meaning.

Id. at *32 (citing Leon v. Ohio St. Bd. of Psychology, 590 N.E.2d 1223 (Ohio 1992)). The court

also reiterated the standard: men of common intelligence must not be left to guess at a term’s

meaning. Id. at *33. However, the court specifically applied this standard to the context of the

medical profession, holding that members of the medical profession should understand what is

meant by the phrase “offices of private physicians.” Id. at **33-34. Thus, when determining the

meaning of a word or phrase used in a statute, the community affected by the statute is the

appropriate community to use in evaluating the meaning of that statute. In other words, in

examining a law aimed at the medical profession, the proper evaluation is what definition a

6
person in the medical profession would assign to a given word or phrase, as is routinely used by

the medical community.

2. U.S. Supreme Court and Lower Federal Court Precedent

Because the questions before this court concern the interpretation of a phrase in an

abortion-related statute, it is instructive to examine how the U.S. Supreme Court has interpreted

words and phrases in abortion-related legislation. In U.S. v. Vuitch, the Court heard the appeal of

a defendant who had been indicted for producing and attempting to produce an abortion in

violation of a D.C. statute. 402 U.S. 62, 67 (1971). A district judge ruled the law

unconstitutionally vague, in part because of the “ambivalent and uncertain word ‘health’” in the

statute’s exception clause. Id. at 68. The judge stated that there was “no indication whether it

include[d] varying degrees of mental as well as physical health.” Id. at 71.

The Supreme Court disagreed. Id. at 71-72. While the legislative history and House

Report provided no guidance, one district court judge had construed the word to also include

mental health. Id. The Court concluded that that construction accorded with the general usage

and modern understanding of the word “health,” noting that the consideration of “whether a

particular operation is necessary for a patient’s physical or mental health is a judgment that

physicians are obviously called upon to make routinely ….” Id. at 72 (emphasis added).

The Court affirmed this position in Doe v. Bolton, 410 U.S. 179 (1973), the companion

case of Roe v. Wade, 410 U.S. 113 (1973). The appellants challenged as vague a provision

making it a crime to perform an abortion unless the abortion was “necessary.” Bolton, 410 U.S.

at 191. The Court stated, “[w]hether, in the words of the Georgia statute, ‘an abortion is

necessary’ is a professional judgment that the Georgia physician will be called upon to make

routinely.” Id. at 192 (emphasis added). Further, interpreting the law in such a way

7
“operate[ed] for the benefit, not the disadvantage, of the pregnant woman.” Id. (emphasis

added).

In interpreting other abortion-related statutes, lower federal courts have also stated that

physicians are uniquely suited to understand what is required of them under medically-related

laws. For example, in Karlin v. Foust, the Seventh Circuit took special note that physicians are

highly trained, intelligent persons, and that it was “simply not that difficult” to ascertain what

information the informed consent law at issue required them to disseminate. 188 F.3d 446, 477

(7th Cir. 1999). With a “minimum amount of diligence,” a physician would have no difficulty

complying. Id.7

In upholding abortion clinic regulations in Greenville Women’s Clinic v. Commissioner,

S.C. Department of Health and Environmental Control, the Fourth Circuit concluded that a

“reasonable person, reading the regulation in its entirety and in the context of South Carolina

statutes, would be able to interpret the regulation and determine what is required and what

conduct is prohibited.” 317 F.3d 357, 366 (4th Cir. 2002), cert. denied, 538 U.S. 1008 (2003).

For example, in examining a provision requiring physicians performing abortions to be “properly

qualified,” the court outlined that physicians routinely hold themselves out as trained and

experienced in given areas, and that such a standard is routinely applied in the medical field. Id.

The court added, “we can expect abortion clinics to consult relevant legislation in advance of

action or to seek clarification from appropriate administrative sources when necessary.” Id. at

367.

7
See also Karlin, 188 F.3d at 464-68 (finding that an informed consent regulation provided “fair
warning” to physicians and “fair enforcement” by authorities in part because physicians are
accustomed to having their medical decisions judged under an objective standard).

8
 Finally, in Fargo Women’s Health Organization v. Schafer, the Eighth Circuit analyzed

the term “medical emergency” in a South Dakota informed consent statute. 18 F.3d 526 (8th Cir.

1994). The court explained that, when the phrase “medical emergency” was viewed in light of

the purpose section of the act, it was clear that the state intended to protect maternal health. Id.

at 535. The court’s “common sense interpretation” of the statute “easily” led it to conclude that

physicians were fully capable of understanding the statute’s requirements. Id.8

B. The common sense interpretation of “federal law” includes the 49-day gestational
limit in the FDA approval letter and the treatment protocols and dosage indications
described in the drug’s final printed labeling

Under the guidance of the aforementioned Ohio and federal court jurisprudence, the

“common sense interpretation” of “federal law” is clear. See Fargo, 18 F.3d at 535. All that is

asked of the legislature is that persons of ordinary intelligence—and in this case, physicians of

ordinary intelligence—be able to ascertain what is meant by “federal law.” See, e.g., Founder’s

Women’s Health Center, 2002 Ohio App. LEXIS 4345, *33. Moreover, this ordinary

intelligence must be taken in context with the whole of the physicians’ highly trained medical

practice, including those tasks which physicians perform routinely. See, e.g., Vuitch, 402 U.S. at

72; Bolton, 410 U.S. at 192; Karlin, 188 F.3d at 464-65, 477; Greenville Women’s Clinic, 317

F.3d at 366. Thus, “federal law” is to be assigned that commonsense meaning which would be

generally understood by these highly trained professionals and used routinely in their practices.

As defined in the statute, “federal law” means “any law, rule, or regulation of the United

States or any drug approval letter of the food and drug administration of the United States that

governs or regulates the use of RU-486 (mifepristone) for the purpose of inducing abortions.”

8
See also Planned Parenthood of Minn./S.D. v. Rounds, 372 F.3d 969, 974 (8th Cir. 2004)
(“When both sides agree to the meaning of a particular word, we do not see how either side can
say, in good faith, that it was unable to understand the meaning of that word.”).

9
OHIO REV. CODE § 2919.123(F)(1). As this Court is well aware, the Respondents claim that it is

unclear “whether the Act’s inclusion of the FDA approval letter in the definition of federal law

renders it illegal for a physician to prescribe” the protocol they prefer to prescribe. See Planned

Parenthood Cincinnati Region v. Taft, 459 F. Supp. 2d 626, 631 (S.D. Ohio 2006). Specifically,

Respondents claim it is unclear whether “federal law” includes the 49-gestational limit in the

FDA approval letter and the protocol delineated in the mifepristone label.

First, the common sense interpretation of “federal law”—which unambiguously includes

“any drug approval letter” of the FDA—includes the 49-day gestational limit in that FDA

approval letter. To claim otherwise is contrary to any person’s common sense interpretation of

the law.

Moreover, the mifepristone label9 accompanying the drug explains in unambiguous

words that it “is indicated for the medical termination of intrauterine pregnancy through 49 days’

pregnancy.”10 Under the heading “Dosage and Administration,” the label explains that treatment

requires three office visits by the patient and may only be administered in a clinic, medical

office, or hospital under the supervision of a physician. The label then states that on Day One,

three 200 mg tablets are taken in a single oral dose; on Day Three, the patient returns and, unless

an abortion has occurred and is confirmed, the patient takes two more tablets orally. The label

also provides that on Day 14, the patient is to return for a follow-up visit in order to confirm that

9
The federal district court refers to this label as the “final printed labeling instructions,” or
“FPL.” See Taft, 459 F. Supp. 2d at 635.
10
MIFEPREX™ (mifepristone) Tablets, 200 mg For Oral Administration Only (mifepristone
label), at: http://www.fda.gov/Cder/foi/label/2000/20687lbl.htm (last visited Sept. 26, 2008).
This label is easily accessible on the FDA’s website.

10
a complete termination has occurred. In addition, the label’s title states “for oral administration

only.”

The Respondents are not “confused” by the FDA’s protocol. Even the federal district

court explicitly stated that the FDA protocol “that the FDA tested and on which it based its

approval of mifepristone consisted of three oral doses of 200 mg of mifepristone followed by a

single dose of .4 mg misopristol also taken orally, through 49 days LMP.” Id. at 630 n.7. Thus,

the Respondents are not confused with regard to the exact protocol outlined by the FDA. See

Rounds, 372 F.3d at 974 (stating that when both sides agree to a meaning of a word, neither side

can argue it is vague). Instead, the Respondents only argue that it is unclear whether the Act

includes the FDA protocol, including the 49-day gestational limit and dosage and administration

instructions in the label, in its definition of “federal law.” As is demonstrated below, the

Respondents are merely grabbing at straws in order to defend their preferred—and untested and

unapproved—protocol.

Physicians are called upon on a daily basis to provide prescriptions for a variety of

medications. Likewise, physicians routinely provide those prescriptions in accordance with

federal guidance and FDA-approved labeling. It is not confusing that FDA protocol and labeling

for any drug would be included in a definition of federal law. The “routineness” of a practice is

constantly cited in decisions upholding challenged abortion laws. See Bolton, 410 U.S. at 192;

Vuitch, 402 U.S. at 72; Greenville Women’s Clinic, 317 F.3d at 366; Karlin, 188 F.3d at 464-65.

In the same way, “federal law” includes the mifepristone label, because the routine nature of

consulting drug labels negates any claims to the contrary.

Furthermore, § 2919.123 is to be examined in light of the ordinary person’s reading of

the Act. Here, the “ordinary person” is a physician, called upon routinely to prescribe

11
medications in accordance with FDA guidelines. As noted in Greenville Women’s Clinic, we

can expect a physician to consult relevant legislation and FDA protocol in advance of an action,

or to seek clarification from appropriate administrative sources when necessary. See Greenville

Women’s Clinic, 317 F.3d at 367. Physicians are intelligent and highly trained and should have

no difficulty complying with § 2919.123 after a “minimum amount of diligence.” See Karlin,

188 F.3d at 477.

Even if physicians routinely fail to follow the protocol outlined in FDA-approved labels,

the provisions of § 2919.123 itself provide guidance as to what is included in “federal law.”

Section 2919.123(B) provides that no physician “shall knowingly fail to comply with the

applicable requirements of any federal law that pertain to follow-up examinations….” OHIO

REV. CODE § 2919.123(B) (emphasis added). As demonstrated above, the mifepristone label

unambiguously pertains to follow-up care. Thus, when taken “as a whole,”11 the text of §

2919.123 points to the mifepristone label, which clearly sets forth the required FDA protocol.

In examining the whole of the law, it is also important to note that the law is aimed at the

protection of women. See Part II., infra. Because of its protective purpose, the law “operates for

the benefit, not the disadvantage,” of women. Bolton, 410 U.S. at 192. Likewise, in order for

this court to interpret the subject provisions in light of the statute’s intent, those provisions

should be interpreted for the protection of women. Here, it is clear that mifepristone was only

tested and approved through 49 days gestation, and only in accordance with the protocol outlined

in the drug’s label. This Court should give deference to the legislature’s intent in protecting

women, and interpret the phrase “federal law” to include the protocol that will be most protective

of women. Defining “federal law” to include the 49-day gestational limit in the FDA approval

11
See Grayned, 408 U.S. at 110; Greenville Women’s Clinic, 317 F.3d at 366.

12
letter and the protocol outlined in the mifepristone label simply “operates for the benefit, not the

disadvantage, of the pregnant woman.” Id.

In summary, this is not a case where an ordinary citizen is called upon to understand that

he or she must comply with federal law. This is a case where highly-trained physicians are

instructed to comply with federal law in prescribing and dispensing a medication. This is an

action undertaken routinely by physicians, and physicians routinely check and abide by protocols

approved in FDA letters and drug labels. The statute itself defines “federal law” to include drug

approval letters, and the drug approval letter includes the 49-day gestational limit. Moreover, the

statute states that physicians must comply with any federal law that pertains to follow-up care,

and the mifepristone label clearly pertains to follow up care. And finally, in order for this Court

to honor the legislature’s intent in protecting women under this statute, this Court should

interpret “federal law” to include those provisions which will best protect women against the

dangerous off-label effects of mifepristone. See Part II, infra. For each of these reasons,

“federal law” must be interpreted to include the 49-day gestational limit in the FDA approval

letter as well as the protocol clearly delineated in the mifepristone label.

Proposition of Law No. II: The severe medical risks inherent in the use of mifepristone and
its off-label use underscore the necessity of including the FDA approval letter and the
mifepristone label in the definition of “federal law”

OHIO REV. CODE § 2919.123 was enacted for the protection of women. As detailed

below, even when physicians and patients abide by the federal protocol outlined in the FDA’s

approval letter and the drug’s label, use of mifepristone poses significant risks for women. And

as this Court is fully aware, the United States Supreme Court has affirmed time and time again

that states have significant—even compelling—interests in protecting women from the harms

and risks of abortion.

13
 To date, at least eight American women have died from mifepristone abortions. The

dangerous risks of mifepristone demand strict adherence to the FDA-approved protocol. Off-

label use of mifepristone is deadly, and the necessity of § 2919.123—and Ohio’s compelling

interest—is obvious.

The medical evidence examined below, along with the discussion presented in the

Appendix, demonstrates that the federal protocol—including the 49-day gestational limit in the

FDA approval letter and the treatment protocols and dosage indications in the drug’s label—

makes sense medically and serves to protect women’s health and establish a uniform standard for

the administration of mifepristone. Section 2919.123 is thus directly and strongly related to

protecting women’s health by requiring that Ohio providers follow the standard of care in the

federal protocol.

A. The use of mifepristone presents significant medical risks to women

1. Death by C. sordellii bacterial infection

From September 2003 through June 2005, the FDA reported four U.S. deaths due to C.

sordellii bacterial infection in women, ages 18-34, who had undergone mifepristone abortions.12

All four patients were two months pregnant and received the off-label dosages and vaginal

administration preferred by the Respondents. All died within five to seven days following

receipt of mifepristone, with identical clinical signs of shock, absence of fever, increase in

leukocytes and red blood cells, and decrease in plasma volume. The time from hospital

12
Sepsis and Medical Abortion, at: http://www.fda.gov/cder/drug/advisory/mifeprex.htm (last
visited Sept. 26, 2008); Emerging Clostridial Disease Workshop (CDC-FDA-NIH Transcript
May 11, 2006), at: http://www.fda.gov/cder/meeting/clostridia_disease.htm (last visited Sept. 26,
2008) (CDC Workshop).

14
admission to death was a matter of hours, and one woman collapsed and died before reaching the

hospital.13

These deaths demonstrated that severe infection occurs unpredictably, is difficult to

identify, and is difficult to treat due to the absence of usual symptoms of infection (e.g., fever).

Once identified, it can result in death in a matter of hours.14

Multiple species of Clostridium, including sordellii (C. sordellii), are found in 8-18

percent of all women.15 Yet C. sordellii is usually suppressed by a normally functioning immune

system, and therefore infection in healthy, young women is very rare and “occurs primarily

among patients with serious underlying immunoconditions.”16 However, these four U.S. women

were reported by the Centers for Disease Control (CDC) and FDA as having been previously

healthy, without any underlying immunoconditions.17 They had no risk factors predisposing

13
Fischer et al., Fatal Toxic Shock Syndrome Associated with Clostridium sordellii after Medical
Abortion, N.E. J. MED. 353:2352-60 (2005); CDC Workshop, supra, at 79-82, 104-105; Gary &
Harrison, Analysis of Severe Adverse Events Related to the Use of Mifepristone as an
Abortifacient, ANNALS OF PHARM. (Feb. 2006).
14
Miech, Patholphysicology of Mifepristone-Induced Septic Shock Due to Clostridium sordellii,
ANNALS OF PHARM. (Sept. 2005); Statement by Donna Harrison, M.D., for RU-486:
Demonstrating a Low Standard for Women’s Health?, Hearing before the Committee on
Government Reform, House of Representatives (May 17, 2006), Serial No. 109-202, at:
http://www.gpoaccess.gov/congress/index.html (last visited Sept. 26, 2008); Fischer, supra, at
2356, 2358; Gary-Harrison, supra.
15
Fischer, supra, at 2358; CDC Workshop, supra, at 93, 107.
16
CDC Workshop, supra, at 76-77, 93, 115; Meich, supra, at 1484; Harrison, supra, at 139;
Calhoun & Harrison, Challenges to the FDA Approval of Mifepristone, ANNALS OF PHARM. 166
(Jan. 2004); Fischer, supra, at 2356.
17
Fischer, supra, at 2352-53, 2356; CDC Workshop, supra, at 79; Harrison, supra, at 139.

15
them to infection or death—especially from a bacterium that rarely affects humans with a normal

immune system.18

Medical literature explains that this phenomenon occurs because mifepristone can

prevent the proper functioning of the immune system and cause fatal toxic shock.19 Mifepristone

blocks receptors that play a necessary role in the immune system’s response to bacteria.

Combined with the mifepristone effects of a softened, open cervix and lack of protective

mucous, this impairment of the immune system allows C. sordellii to enter the uterus and

multiply. Once established in the uterus, it secretes lethal toxins, which break down G-proteins,

the molecular switches that activate the functions necessary for cellular immune responses.20

In addition, mifepristone blocks the hypothalamic-pituitary-adrenal (HPA) axis, which

controls an essential aspect of the body’s immune system. When the proper functioning of the

HPA axis is prevented, dangerous levels of excess cytokines, or proteins, are released.21 The

combined entrance of excess cytokines and lethal toxins into the circulatory system causes toxic

shock syndrome, multiple organ failure, and, ultimately, death.22 This causal chain between

mifepristone and death by toxic shock syndrome has been demonstrated in multiple animal

18
Harrison, supra, at 135.
19
Webster & Sternberg, Role of the Hypothalamic-Pituitary-Adrenal Axis, Glucocorticoids and
Glococorticoid Receptors in Toxic Sequelae of Exposure to Bacterial and Viral Products, J.
ENDOCRIN. 181, 207-21 (2004); Miech, supra; Gary-Harrison, supra; Harrison, supra; CDC
Workshop, supra, at 76-121.
20
Miech, supra, at 1484; CDC Workshop, supra, at 109.
21
McGregor, Response to letter to the editor, CONTRACEPTION 74, 174-77 (2006).
22
CDC Workshop, supra, at 108-10, 115, 118; Miech, supra; Gary-Harrison, supra; Webster-
Sternberg, supra.

16
models of septic shock,23 where the mortality rate increased from 13 percent to 100 percent in

mifepristone-treated animals.24

In the deaths of the four U.S. women, the symptoms appeared four to five days after

receipt of mifepristone.25 While most drugs are metabolized and eliminated from the body in a

few hours, mifepristone has an unusually long half-life of 30 hours. It thus takes four to five

days to remove 95 percent of mifepristone from the body, and in some women, it can take up to

18 days.

Furthermore, because mifepristone abortions typically involve severe cramping, women

are frequently prescribed codeine. Codeine competes with mifepristone for the enzyme that

breaks down mifepristone, thereby prolonging the drug’s lengthy presence in the uterus. C.

sordellii then has enough time to establish itself, multiply, and secrete lethal, immunity-

impairing toxins, contributing to the onset of fatal toxic shock. 26

Medical scholarship, scientific data, and cases of recent fatalities in the U.S. support the

conclusion that abortion by mifepristone presents a significant risk of death.27 In short,

mifepristone’s anti-progesterone mechanism makes the uterus “a fertile medium of dead fetal

tissue surrounded by an endometrium that lacks normal innate immune responses”28 and an

23
CDC Workshop, supra, at 91, 108, 115.
24
Sternberg, Proceedings of the Nat’l Acad. Sci. 86: 2374-78 (1989); Harrison, supra, at 135,
138.
25
Fischer, supra, at 2352-53.
26
CDC Workshop, supra, at 79, 89, 105-06.
27
Letter from Donna Harrison, M.D., to Mark E. Souder, Chairman, Subcommittee on Criminal
Justice, Drug Policy and Human Resources, at Q.1(b) (Souder letter); Harrison, supra, at 138-39.
28
Gary-Harrison, supra, at 109.

17
“ideal bacterial culture for C. sordellii.”29 Mifepristone’s blockage of the HPA axis, combined

with exposure to C. sordellii, places women in a vulnerable state. The blockage of

glucocorticoid receptors prohibits the body from protecting itself from the lethal toxins and

excess cytokines. As a result, the body undergoes fatal toxic shock.

2. Other life-threatening infections

Through July 2005, the FDA reported at least 46 cases of life-threatening infections

requiring hospitalization. Reported cases included septic shock, toxic shock syndrome, adult

respiratory distress syndrome from sepsis, Escheria coli sepsis, group B Streptococcus

septicemia, disseminated intravascular coagulopathy (DIC) with heptic and renal failure, and

severe pelvic infection. Four of these cases required ICU hospitalization. An additional 14

patients were treated for pelvic infections as outpatients. Severe pelvic infection also presents an

increased risk of subsequent ectopic pregnancy, tubal occlusion with subsequent infertility, and

chronic pelvic pain from adhesive disease.30

3. Massive hemorrhage

The FDA has reported that at least 116 women have required blood transfusions for

massive bleeding after mifepristone abortions, with at least 54 losing over one-half of their blood

volume. These women would have died without immediate access to sophisticated emergency

facilities equipped to perform large blood transfusions. Medical research has shown that one to

two of every 1,000 women who undergo mifepristone abortions will require emergency blood

29
CDC Workshop, supra, at 109.
30
Gary-Harrison, supra, at 192-93; Harrison, supra, at 141; Medwatch Adverse Event Reports,
Individual Safety Report nos. 3803789-5, 4327968-6, 4411599-3, 4199811-X, 3915940-9, &
3943786-2 (FDA Office of Postmarking Drug Risk Assessment).

18
transfusion for massive hemorrhage. Because no risk factors have been identified, it is

impossible to predict or prevent massive hemorrhage from mifepristone abortion.31

4. Further dangers specifically associated with off-label use

Ectopic pregnancy is an absolute contraindication to mifepristone,32 and the only way it

can be discovered is by ultrasound.33 Because symptoms of ectopic pregnancy mimic the

symptoms of completed mifepristone abortions, ectopic pregnancies go easily undiagnosed.34

Improper screening and failure to follow FDA protocol requiring follow-up care place the

lives of women with unknown ectopic pregnancies at even greater risk of death by ruptured

ectopic pregnancy. The FDA has reported that at least 17 women have had undetected ectopic

pregnancies during mifepristone administration, eleven of which resulted in ectopic rupture. One

of these eleven women bled to death—a death which would not have occurred if the ectopic

pregnancy had been properly diagnosed.35 The absence of ultrasound use and follow-up care

also increases the risk of retained tissue, thereby increasing the risk of infection.36

In addition, disregard for mifepristone’s failure rate increases medical risk. It is generally

understood that the percentage of incomplete mifepristone abortions requiring emergency

surgical intervention increases with gestational age. Mifepristone’s failure rate is 8 percent at 49

31
Harrison, supra, at 136, 141-42; Gary-Harrison, supra, at 192; Paul et al., A Clinician’s Guide
to Medical and Surgical Abortion 202 (1999).
32
Gary-Harrison, supra, at 195.
33
Calhoun-Harrison, supra, at 165.
34
Medical Management of Abortion, ACOG Practice Bulletin: Clinical Management Guidelines
for Obstetrician Gynecologists 26(4):1-20 (2001); Calhoun-Harrison, supra, at 165.
35
Gary-Harrison, supra, at 192-93; Medwatch, supra, Individual Safety Report no. 3806144-7.
36
Calhoun-Harrison, supra, at 165.

19
days gestation, 17 percent at 50-56 days gestation, and 23 percent at 57-63 days gestation.

Abdominal pain, nausea, diarrhea, and vaginal bleeding also increase with increasing gestational

age.37 Despite these known statistics, the Respondents continue to advocate use of mifepristone

past the FDA’s 49-day protocol.

B. Mifepristone offers no net therapeutic benefits over the safer alternatives

1. Risk of death from C. sordellii bacterial infection elevated in mifepristone use

In 30 years, there have been no reported deaths from C. sordellii following surgical

abortion. At less than eight weeks gestation, it has been reported that the rate of death from

infection by all causes, except C. sordellii, is 0.1 per 100,000 surgical abortions, which means

that the risk of death from C. sordellii after a mifepristone abortion is at the very least ten times

the risk of death from all other types of bacterial infection in surgical abortion procedures.38 In

addition, the risk of death from C. sordellii after mifepristone abortion is fifty times the risk of

death from C. sordellii after surgical abortion.39

2. Risk of hemorrhage elevated in mifepristone use

The risk of hemorrhage from mifepristone is much greater than the risk of hemorrhage

from surgical abortion.40 A study specifically comparing the outcomes of surgical and

mifepristone abortions found that, of the women who required surgery to complete an abortion

after receiving mifepristone, 12.5 percent also underwent emergency surgery for acute bleeding.

37
Calhoun-Harrison, supra, at 165; Spitz et al., Early Pregnancy Termination with Mifepristone
and Misoprostol in the United States, N.E. J. MED. 338:1241-47 (1998).
38
Calhoun-Harrison, supra, at 165; Greene, Fatal Infections Associated with Mifepristone-
Induced Abortion, N.E. J. MED. 353; 22 (Dec. 1, 2005).
39
Harrison, supra, at 135, 141; Fisher, supra, at 2358; Souder Letter, supra, at Q.1(b).
40
Harrison, supra, at 136, 142-44; Souder Letter, supra, at Q.1(b), 2, 5, 7.

20
In contrast, no women in the surgical abortion group required emergency surgery for acute

bleeding.41

***

Statistics demonstrate that both surgical abortion and childbirth are safer alternatives to

mifepristone abortion. One scientific study has also revealed that mifepristone abortions fail

more often than surgical abortion, have more subsequent bleeding for a longer duration of time,

require more emergency surgical intervention, and are more painful than surgical abortions.42

Thus, mifepristone does not offer women any net therapeutic benefit; rather, it exposes women to

greater medical risk.

41
Jensen et. al, Outcomes of Suction Curettage and Mifepristone Abortions in the United States:
A Prospective Comparison Study, CONTRACEPTION 59-153-59 (1999).
42
Id.; Souder Letter, supra, at Q.5.

21
 CONCLUSION

Amici urge this court to answer both certified questions in the affirmative.

Respectfully Submitted,

__________________________________
Kirkpatrick Law Offices PC
Joel J. Kirkpatrick (0071924)
Counsel of Record
31800 Northwestern Highway, Suite 350
Farmington Hills, MI 48334
248.855.6010 (t)
866.241.4152 (f)

Americans United for Life

Mailee R. Smith, Of Counsel
310 S. Peoria St., Suite 500
Chicago, IL 60607
312.568.4700 (t)
312.568.4747 (f)

Counsel for Amici Curiae

 CERTIFICATE OF COMPLIANCE

I certify that this Brief of Amici Curiae was sent on October _____, 2008, by ordinary U.S. mail
to counsel of record for Petitioners and Respondents at the following addresses:

Counsel for Respondents: Counsel for Petitioners:

JENNIFER L. BRANCH (0038893) BENJAMIN C. MIZER (0083089)
ALPHONSE GERHARDSTEIN (32053) Solicitor General
Gerhardstein & Branch Co., LPA STEPHEN P. CARNEY (0063460)
617 Vine Street, Suite 1409 Deputy Solicitor
Cincinnati, OH 45202 ANNE BERRY STRAIT (0012256)
513.621.9100 SHARON A. JENNINGS (0055501)
DAVID C. GREER (009090) Assistant Attorneys General
Bieser, Greer & Landis LLP 30 East Broad Street, 17th Floor
400 National City Center, 6 North Main Columbus, OH 43215
Dayton, OH 45402 614.466.8980
937.223.3277 JOSEPH T. DETERS (0012084)
HELENE T. KRASNOFF Hamilton County Prosecutor
Planned Parenthood Federation of America MICHAEL G. FLOREZ (0010693)
1780 Massachusetts Avenue, NW ROGER E. FRIEDMAN (0009874)
Washington, DC 20036 230 E. Ninth Street, Suite 4000
202.973.4800 Cincinnati, OH 45202
513.946.3229
ROGER K. EVANS
Planned Parenthood Federation of America
434 West 33rd Street
New York, NY 10001
212.541.7800
B. JESSIE HILL (0074770)
Case Western University School of Law
11075 East Blvd.
Cleveland, OH 44106
216.368-.0553
JEFFREY M. GAMSO (0043869)
ACLU of Ohio Foundation, Inc.
4506 Chester Avenue
Cleveland, OH 44103
216.472.2220

______________________________
Joel J. Kirkpatrick