Amicus Curiae Brief — Gonzales v. Carhart

Supreme Court brief2007

Ask Donna

What actually matters in this document.

Text

Sa FILED —

No. 05-380 2006

2 ean grap Bi COURT. US.

Supreme Court of the Anite ate

ALBERTO R. GONZALES, Attorney General,

Petitioner,

LEROY CARHART, et al.,

Respondents.

On Writ Of Certiorari To The United States

Court Of Appeals For The Eighth Circuit

BRIEF OF AMICI CURIAE AMERICAN

ASSOCIATION OF PRO LIFE OBSTETRICIANS

AND GYNECOLOGISTS (AAPLOG),

SENATOR TOM COBURN, M.D., CONGRESSMAN

CHARLES BOUSTANY, JR, M.D., CONGRESSMAN

MICHAEL BURGESS, M.D., CONGRESSMAN

PHIL GINGREY, M.D., CONGRESSMAN

DAVE WELDON, M.D., C. EVERETT KOOP, M.D.,

EDMUND D. PELLEGRINO, M.D.

IN SUPPORT OF PETITIONER

CLARKE D. FORSYTHE

(Counsel of Record)

DENISE M. BURKE

MAILEE R. SMITH

AMERICANS UNITED FOR LIFE

310 South Peoria Street, Suite 500

Chicago, Illinois 60607

312/492-7234

Counsel for Amici Curiae

COCKLE LAW BRIEF PRINTING CO (800) 225-6964

OR CALL COLLECT (402) 342-2831

TABLE OF CONTENTS

IE latcetiuicthisiicaisiegditipsnesdivabetitnisesneuiiiidliaiiaads

II.

III.

The Act Imposes No Undue Burden Under

Planned Parenthood v. Casey Because There Is

No Substantial, Reliable Evidence that the Act

Will Increase Medical Risks for Any Woman ....

There Is No Substantial, Reliable Evidence

That Any Maternal Or Fetal Condition Re-

CR Be i i ite stensitinsitetseninsteiensecnsstottins

A. The Record Demonstrates That D&X Is

Not Necessary for any Maternal Medical

i isdinistchcdtincnctendlapiipaiausipiiiaaitahpebeinienoe

B. The Record Demonstrates that D&X Is

Not Necessary for Any Fetal Anomaly .......

C. The ACOG Policy Statement Has No Basis

in Empirical Evidence and Is Not Reliable...

There Is No Substantial, Reliable Evidence

that D&X Is Safer than Existing Procedures....

A. Intuition and Personal Observation are

Not Reliable or Substantial Evidence of

B. No Empirical Data Demonstrate the

EN TE IIIA: cisnstcthndecicipasristenbbbakachaericitibteinsteagie

C. There Is Substantial, Reliable Evidence

that there are Well-Established Alterna-

ASE TETAS cS NR TS ate MERC

NY a inciisinnstveiiennnasatnstinnitanciendinniveietaeetedenhedbian

TABLE OF CONTENTS — Continued

Page

APPENDIX A: Index of Trial Testimony in Ne-

braska (Carhart v. Ashcroft), New York (National

Abortion Federation v. Ashcroft), and San Fran-

cisco (Planned Parenthood v. Ashcroft)..............000000008+

APPENDIX B: Excerpt from American College of

Obstetricians and Gynecologists (ACOG), Prac-

tice Bulletin No. 67 (October 2005), reprinted in

ACOG, Compendium of Selected Publications

2006; Excerpt from U.S. Preventive Services

Task Force, Guide to Clinical Preventive Services

ITED scctcsrecebasanspeadicensitasipinitlenidewasnpindedismnndesnierinmmauininenipiaiiieet

ill

TABLE OF AUTHORITIES

Page

CASES

American College of Obstetricians & Gynecologists

v. Thornburgh, 737 F.2d 283 (3d Cir. 1984), a/f’d,

Sy He IED Siilicn bie scaanseiiecttdcaeldnah dubictapilidsendeteainks 4

Carhart v. Ashcroft, 331 F.Supp.2d 805 (D. Neb.

ae isecibtaididsabeininsininiibbipailetebdvintsinclasvoncisaianbiaantbas passim

Carhart v. Gonzales, 413 F.3d 791 (8th Cir. 2005)........ 3, 26

Colautti v. Franklin, 439 U.S. 379 (1979)... 4

Doe v. Bolton, 410 U.S. 179 (1973)............ 0c ccc cceeccece eee es 4,5

National Abortion Federation v. Ashcroft, 330

F.Supp.2d 436 (S.D.N.Y. 2004)............... 12, 13, 18, 19, 25

National Abortion Federation v. Gonzales, 437 F.3d

Se SETI aks cbtlicchicctdecddpdinancéndentdveiaises 3, 18, 26, 27

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

aid acilenieticainciseliulinLestiicidusan stan 4-ebesdenithsleatebsioaoeunsisiddwoniioy 2, 3, 5, 27

Planned Parenthood v. Ashcroft, 320 F.Supp.2d 957

es a ID ai catidihcanidanabeaibncaienietenictitnetdinbabsinasendbabausiniis 8

Planned Parenthood v. Gonzales, 435 F.3d 1163

REET, PENI A OMAR ORS NO Pewee 3

Stenberg v. Carhart, 530 U.S. 914 (2000)..........0........ 20, 26

Women’s Medical Professional Corp. v. Taft, 353

ce REN ie pene eee 4

Women’s Medical Professional Corp. v. Voinovich,

130 F.3d 187 (6th Cir. 1997), cert. denied, 523

i eT inka tetiiniacdh slain d Lind captdnindacnipinsinaplinidiatahbboe 4

TABLE OF AUTHORITIES — Continued

STATUTES

Partial-Birth Abortion Ban Act of 2003, Pub. L. No.

108-105, 117 Stat. 1201, 18 U.S.C.S. $1531 (2006)......... 3

FA UBOD. FRR. CSG cre svectsnseceticcesovepinevticsonainoenpertions 6

OTHER AUTHORITIES

ST Chasen, RB Kalish, M Gupta, JE Kaufman, WK

Rashbaum, FA Chervenak, Dilation and evacua-

tion at > or = 20 weeks: comparison of operative

techniques, 190 Am. J. Ob. Gyn. 1180 (2004)................ 23

ST Chasen, et al., Obstetric Outcomes After Surgi-

cal Abortion at (greater than or equal to) 20

weeks’ gestation, 193 Amer. J. Ob. Gyn. 1161

Gee wiacdvtecniseindscepicnanititdiieiadeiianialaupiibdaindiammcea imine 25

Maureen Paul, M.D. et al., A Clinician’s Guide to

Medical and Surgical Abortion (1999)...........ccccceceseeeeee 23

Random House Webster’s Unabridged Dictionary

CEE GSN sce icnnccnesccetdesebiiinciictiadinibetidieichimada tia ctu ae 5

John Thorp, Katherine Hartmann and Elizabeth

Shadigian, Long-Term Physical and Psychologi-

cal Health Consequences of Induced Abortion:

Review of the Evidence, 58 Obstetrical & Gyneco-

SOIREE BRU SF GINO cevccesensncassvenssssectaestbigansnionisipiiivanns 6

. United States Department of Health & Human

Services, Food & Drug Administration, Guidance

for Industry: Providing Clinical Evidence of Ef-

fectiveness for Human Drugs and Biological

FOO Fic cenccsvidenesiieniettnesiniddistiantaatlatcusdiae 6

U.S. Preventive Services Task Force, Guide to

Clinical Preventive Services (2005) .........ccccccccccceeeeeeeeeeees 6

INTEREST OF AMICI CURIAE

Amicus American Association of Pro Life Obstetricians

and Gynecologists (AAPLOG) is a non-profit medical

organization currently consisting of over 2,000 obstetrician

and gynecologist members and associates.’ The American

College of Obstetricians and Gynecologists (ACOG) recog-

nizes AAPLOG as one of the largest special interest groups

within ACOG, as 2,200 Fellows of ACOG have joined

AAPLOG.’ AAPLOG affirms that the physician has two

patients and is caregiver to both mother and unborn child.

Senator Tom Coburn, M.D., Congressman Charles

Boustany, Jr, M.D., Congressman Michael Burgess, M.D.,

Congressman Phil Gingrey, M.D., and Congressman Dave

Weldon, M.D. are physicians and members of Congress who

voted for or support the Partial-Birth Abortion Ban Act of 2003.

C. Everett Koop, M.D., ScD., the former ‘Surgeon

General of the United States (1981-1989), is Senior

Scholar of the C. Everett Koop Institute and the Elizabeth

DeCamp MclInerny Professor of Surgery at Dartmouth

Medical School. Edmund D. Pellegrino, M.D. is Professor

Emeritus of Medicine and Medical Ethics and Adjunct

Professor of Philosophy at Georgetown University. He has

served as Director of the Center for Clinical Bioethics at

' This brief is filed with the written consent of the parties. Letters

of consent have been filed with the Clerk of this Court. No counsel for a

party authored this brief in whole or in part. No entities other than the

Amici or its counsel have made a monetary contribution to the prepara-

tion or submission of this Brief.

* Flizabeth Shadigian, M.D., the current President of AAPLOG,

Watson Bowes, M.D., Curtis Cook, M.D., and Leroy Sprang, M.D., are

or have been mernbers of AAPLOG and testified for the Government in

this case.

Georgetown University; head of the Kennedy Institute of

Ethics and director of the Center for the Advanced Study

of Ethics at Georgetown.

SUMMARY OF ARGUMENT

This brief summarizes the record testimony in the

Nebraska, New York, and San Francisco cases challenging

the Partial Birth Abortion Ban Act of 2003 and demon-

strates that “partial-birth abortion” as defined by the Act

(hereinafter D&X) is not necessary for any maternal or

fetal condition. There is no reliable evidence that any

maternal or feval medical condition requires the use of

D&X or that D&X is safer than existing procedures. In

contrast, there is substantial and reliable evidence that

there are well-established alternatives to D&X (namely,

dilation & evacuation (D&E) and medical induction).

Hence, there is no reliable evidence that a prohibition on

D&X will increase medical risk to any woman. Accordingly,

the Act’s prohibition of D&X creates no “substantial

obstacle” and thus no undue burden under Planned

Parenthood v. Casey, 505 U.S. 833 (1992).

ARGUMENT

I. THE ACT IMPOSES NO UNDUE BURDEN

UNDER PLANNED PARENTHOOD V. CASEY

BECAUSE THERE IS NO SUBSTANTIAL, RE-

LIABLE EVIDENCE THAT THE ACT WILL IN-

CREASE MEDICAL RISKS FOR ANY WOMAN.

The Partial-Birth Abortion Ban Act of 2003, Pub. L.

No. 108-105, 117 Stat. 1201, 18 U.S.C.S. §1531 (2006)

(hereinafter “the Act”) imposes no undue burden under

Planned Parenthood v. Casey, 505 U.S. 833 (1992), on a

woman’s ability to choose abortion because the Act will not

be a “substantial obstacle to the woman’s exercise of the

right to choose.” Jd. at 877.° Contrary to Casey, the lower

courts erred by applying a vague and subjective standard

(“medically necessary to preserve women’s health”) in

evaluating the evidence.‘ The terms “medically necessary”

and “health” have become terms of art with broad defini-

tions unique to abortion law. A “medically necessary”

abortion is whatever an abortion provider, in his/her

* The Act contains an express exception “to save the life of a

mother whose life is endangered by a physical disorder, physica! illness,

or physical injury, including a life-endangering physical condition

caused by or arising from the pregnancy itself,” which is sufficient to

cover a true life-threatening medical emergency. 18 U.S.C.S. §1531(a)

(2006).

* See e.g., Carhart v. Ashcroft, 331 F.Supp.2d 805, 1012 (D. Neb.

2004) (“there are times when the banned procedure is medically

necessary to preserve the health of a woman”); Carhart v. Gonzales, 413

F.3d 791, 795 (8th Cir. 2005) (“necessary, in appropriate medical

judgment, for the preservation of the health of the mother”); National

Abortion Federation v. Gonzales, 437 F.3d 278, 287 (2d Cir. 2006) (“the

procedure might sometimes be necessary to avoid risk to a woman's

health”); Planned Parenthood v. Gonzales, 435 F.3d 1163, 1171, 1172

(9th Cir. 2006) (“necessary, in appropriate medical judgment for the

preservation of the life or health of the mother.”).

subjective judgment, determines it to be.* Any use of the

term “health” in abortion law automatically incorporates

the definition of “health” in Doe v. Bolton, 410 U.S. 179,

192 (1973) (“all factors — physical, emotional, psychologi-

cal, familial, and the woman’s age — relevant to the well-

being of the patient. All these factors may relate to

health”).° When these two terms are combined — “medi-

cally necessary to preserve the health of the woman” —- a

“medically necessary” abortion means any abortion a

provider agrees to perform for any reason.’ The subjective

* See e.g., Women’s Medical Professional Corp. v. Voinovich, 130

F.3d 187, 209-10 (6th Cir. 1997) (“importance of giving the physician

discretion to decide whether an abortion is necessary”; finding health

exception unconstitutionally limited “the physician’s discretion to

determine whether an abortion is necessary to preserve the woman's

health . . . ”), cert. denied, 523 U.S. 1036 (1998).

* See e.g., American College of Obstetricians & Gynecologists v.

Thornburgh, 737 F.2d 283, 299 (3d Cir. 1984) (“It is clear from the

Supreme Court cases that “health” is to be broadly defined,” (citing Doe

v. Bolton)), aff'd, 476 U.S. 747 (1986). There is no indication in the

record in any of the cases challenging the Act that the doctors who

testified understood this unique definition of “health” in abortion law.

See Appendix A to this Brief for an Index of the testimony in the three

trials.

” See e.g., Colautti v. Franklin, 439 U.S. 379, 394 (1979) (“The

contested provisions in those cases [United States v. Vuitch and Doe v.

Bolton| had been interpreted to allow the physician to make his

determination in the light of all attendant circumstances — psychologi-

cal and emotional as well as physical — that might be relevant to the

well-being of the patient. The present statute does not afford broad

discretion to the physician.”); Women’s Medical Professional Corp v.

Taft, 353 F.3d 436, 462 (6th Cir. 2003) (Tarnow, J., dissenting) (“To

determine whether an abortion is medically “necessary,” ... that

“medical judgment may be exercised in the light of all factors — physical,

emotional, psychological, familial, and the woman’s age — relevant to

the well-being of the patient. All these factors may relate to health.”

[citing Doe] ... “a woman's mental health, in addition to her physical

health, must be considered in assessing whether an exception to an

(Continued on following page)

elasticity of the lower courts’ standard is compounded by

the courts’ loose reference to “risk.” Risk is simply “expo-

sure to the chance of injury or loss.” Random House

Webster’s Unabridged Dictionary 1660 (2d ed. 1998).

“Health risk” in abortion law, therefore, means the poten-

tial for exposure to the chance of a loss of “well-being”

under Doe v. Bolton. Because this standard contradicts

Casey, this Court should reject it and ask more precisely

whether there is substantial, reliable evidence that the

D&X procedure is necessary to successfully treat any

maternal or fetal condition or is significantly safer than

existing procedures. Casey, 505 U.S. at 880.

The extreme subjectivity of the lower courts’ standard

of review (“medically necessary to preserve women’s health”)

is magnified by the fact that the Respondents’ case against

the Act is based entirely on intuition and personal obser-

vation, not empirical evidence. There. was substantial

testimony, from witnesses on both sides, that intuition

is fallible and inferior to empirical evidence.’ Intuition

and personal observation alone are not “substantial

abortion regulation actually preserves the health of the pregnant

woman.”) (emphasis in original).

* The Nebraska trial transcript wil] be referenced as NE TR (page

number); the New York transcript as NY TR, and the San Francisco

transcript as SF TR. See NE TR 1353 (Cook) (intuition not enough); NE

TR 475 (Howell) (intuition often fallible); NE TR 1524 (Shadigian)

(assertions that D&X is intuitively safe is “just anecdotal evidence they

have that they think it’s safe”); NY TR 1882 (Lockwood) (contrasted

intuition with empirical evidence); NY TR 2389-91 (Clark) (medical

decisions based on intuition can often be wrong); NE TR 912-13 (Bowes)

(citing examples where intuition was wrong, including episiotomy); NY

TR 108 (Nuland); NY TR 1751 (Lockwood) (citing the use of DES, a

form of synthetic estrogen, to treat threatened miscarriage).

evidence.” The lower courts’ total reliance on intuition in

the absence of empirical evidence conflicts with objective

standards for evidence-based medicine adopted by the

American College of Obstetricians and Gynecologists

(ACOG) and contained in the U.S. Preventive Services

Task Force (USPSTF) standards (Appendix 2 to this

Brief)."° The USPSTF standards rank intuition as “poor”

evidence (Level C) of the acceptability of clinical practices

and innovations.’ Consequently, there is no reliable evi-

dence that the Act will deny any woman a safe procedure.”

* Under federal law, “substantial evidence” of safety and effective-

ness is “evidence consisting of adequate and well-controlled investiga-

tions, including clinical investigations, by experts qualified by scientific

training and experience to evaluate the effectiveness of the drug

involved. ...” 21 U.S.C.S. §355(d) (2006). “The usual requirement for

more than one adequate and well-controlled investigation reflects the

need for independent substantiation of experimental resu!ts.” US HHS,

FDA, Guidance for Industry: Providing Clinical Evidence of Effective-

ness for Human Drugs and Biological Products 4 (May 1998) (emphasis

in original).

*° Evidence-based medicine has become “increasingly adopted” in

“all specialities and areas of medicine.” NY TR 1464-65 (Paul); NY TR

107 (Nuland). ACOG has adopted the USPSTF standards (Appendix B).

Since 1997, the National Abortion Federation (NAF) purports to adhere

to evidence-based medicine in its abortion standards. NY TR Exh. K-4

at LNAF 019321.

" Innovations in medicine should be subjected to rigorous study.

First with retrospective study and then with randomized clinical trials.

NY TR 1750-51 (Lockwood). Respondents’ expert Maureen Paul agreed

that ideally, a procedure should be subject to controlled studies. NY TR

1464 (“I would never argue against evidence-based medicine.”) Respon-

dents’ expert Carolyn Westhoff favored the use of clinical trials with

external monitoring as a way to assess medical procedures. NY TR 968.

" Safety is inherently a relative term in medicine. Amici do not

concede that elective abortion is safe. Current collection and

analysis of data in the U.S. is inadequate, and the focus on immedi-

ate complications ignores long-term complications. See John Thorp,

Katherine Hartmann and Elizabeth Shadigian, Long-Term Physical

(Continued on following page)

Il. THERE IS NO SUBSTANTIAL, RELIABLE

EVIDENCE THAT ANY MATERNAL OR FETAL

CONDITION REQUIRES THE USE OF D&xX.

A. The record demonstrates that D&X is not

necessary for any maternal medical condi-

tion.

Several experts on both sides testified that D&X is not

necessary for any maternal medical condition, because

well-established alternative procedures exist.” A mater-

nal-fetal medicine specialist, Dr. Steven Clark, testified

that “[uJnder no circumstance would the abolition of this

procedure in any way jeopardize the life or health of any

mother regardless of what medical condition she may

have.” Carhart v. Ashcroft, 331 F.Supp.2d 805, 931 (D.

and Psychological Health Consequences of Induced Abortion: Review of

the Evidence, 58 Obstetrical & Gynecological atin 67 (2003) (NE TR

Defendants’ Exhibit).

" See NE TR 897-98, 920 (Bowes) (never seen a situation where

D&X is necessary or advantageous); NE TR 1098, 1102, 1162 (Sprang)

(“never seen a situation where a D&X would be the safest, the best, or

the only procedure to use to protect the health of the mother”); SF TR

1112 (Sprang) (“never seen a situation where an intact D&X method

was necessary; AMA “task force ... could not find any medical condi-

tions that would require an intact D&X”"). NE TR 1255, 1299, 1327; NY

TR 2532 (Cook) (D&X is never medically necessary); NE TR 1513, 1517,

1572, 1597-98 (Shadigian) (knows of no circumstance where D&X is

medically necessary); NY TR 491 (Johnson) (no maternal complication

that would require D&X or make it only procedure that could be

performed); NY TR 261 (Grunebaum) (D&X “absolutely not” the only

method of abortion in any given circumstance); NY TR 1369 (Weiss)

(could not think of circumstance where D&X required for maternal

health condition); NY TR 1683 (Chasen) (agreeing that his study

showed that D&X “is rarely used in cases of a maternal medical

problem”).

Neb. 2004)."* Dr. Charles Lockwood, Chairman of the Yale

Department of Obstetrics and Gynecology and a maternal-

fetal medicine specialist, testified that he could not “envi-

sion a circumstance in which the D&X procedure would be

required.... ” NE TR 895, 940. Respondents’ witness Dr.

Doe could not “identify a specific maternal physical health

indication for which an intact D&E [D&X] would be

necessary because of that physical health condition,” as

the district court noted. Carhart, 331 F.Supp.2d at 935.

Furthermore, there are no medical studies supporting

the claim that D&X is medically necessary. Carhart, 331

F.Supp.2d at 894, 931 (Clark). After doing a systematic

review of the medical literature on D&X, Dr. Shadigian

concluded that there is no substantial body of medical

opinion that D&X is the safest and most appropriate

procedure for some women in some circumstances. NE TR

1510, 1582. The district courts erred by dismissing the

testimony of certain experts simply because they do not do

abortions on live fetuses.”

“ Clark testified that it is “very rare” that it would be necessary to

terminate a pregnancy to treat a woman’s medical condition. And, in

those rare cases, D&X is never necessary to effectively treat the

woman's condition, because maternal fetal medicine has established

alternative procedures to treat all conditions that are as safe or safer

than D&X. NY TR 2315 (Clark) (no cases where D&X is preferable to

D&E or induction).

* Two district courts dismissed the testimony of some of the

Government's experts for the sole reason that they did not do “abor-

tions” on live fetuses. Planned Parenthood v. Ashcroft, 320 F.Supp.2d

957, 980 (N.D. Cal. 2004); Carhart v. Ashcroft, 331 F.Supp.2d at 1011.

In addition to compounding the misunderstanding that personal

experience is decisive, the courts overlooked the fact that maternal-fetal

medicine and ob-gyn experts have experience doing comparable

techniques (D&E, labor induction, and variations thereof) involving live

and dead fetuses to treat women with high risk pregnancies, or

(Continued on following page)

In addition, experts on both sides testified that D&X is

not necessary for specific maternal conditions: diabetes,”

renal conditions,” breast cancer,” infection or sepsis,”

leukemia,” chorioamnionitis (uterine infection), hyperthy-

roidism,” uncontrolled blood pressure,” acute fatty liver,“

pregnancies in which it is necessary to deliver a fetus early (such as

pre-eclampsia). NE TR 904, 920-21 (Bowes) (describing comparable

procedures to D&E and D&X where the fetus is already dead and the

procedure is used to complete or terminate the pregnancy).

* NE TR 286 (Fitzhugh) (D&E safe); Carhart, 331 F.Supp.2d at

901 (Knorr) (refers patients to hospital if uncontrolled).

" NE TR 287 (Fitzhugh) (D&E safe); NE TR 1311 (Cook) (D&X not

necessary); Carhart, 331 F.Supp.2d at 901-02 (Frederiksen) (induction

and D&E both safe); NY TR 2368-69 (Clark) (not a medical indication

for abortion and D&E or induction appropriate); NY TR 1229-30

(Frederiksen) (can be managed to term and D&E or induction appropri-

ate).

* NE TR 287 (Frederiksen) (D&E safe); NE TR 1322-23, 1408-09

(Cook) (D&X never necessary).

* NE TR 287 (Fitzhugh) (D&E safe); id. at 1320 (Cook) (D&X

never necessary).

* NE TR 1319 (Cook) (D&X never medically necessary in case of

leukemia, other safer alternatives available).

" Carhart, 331 F.Supp.2d at 893 (Shadigian) (uses induction); id.

at 901 (Frederiksen) (induction or D&E appropriate); NY TR 2347

(Clark) (women with this condition easily induced because the infection

starts the process, and either D&E or induction safe and acceptable); id.

at 2347-48 (Clark) (if infection is severe, a physician would not do

surgical procedure); id. at 1227-28 (Frederiksen) (no particular method

of abortion required).

* NE TR 901 (Knorr) (hospitalization preferable).

* Id. (Clark) (D&E appropriate).

* NY TR 2342-44 (Clark) (acute fatty liver occurs in the third

trimester, at which time he uses induction to live birth); NY TR 2344-45

(Clark) (in an extreme situation where the liver is failing, surgical

procedures such as D&X are contraindicated and induction is prefer-

able); id. at 1226 (Frederiksen) (D&E appropriate).

autoimmune disorders,” cancer,” cardiac disease,” includ-

ing cardiomyopathy,” fluid shifts,” pulmonary hyperten-

sion,” a history of classical caesarean section,” HELLP

syndrome,” hypertension or severe pre-eclampsia, lung

* NY TR 2348-49 (Clark) (generally not indications for abortion

and D&E or induction appropriate).

* NY TR 2372 (Clark) (not a medical indication for abortion, most

forms do not require chemotherapy that is harmful to the fetus, and

either D&E or induction appropriate).

*” NY TR 2328-29 (Clark) (inductions are safe and “under most

circumstances preferable,” and it would be “irresponsible” in such

situations to perform D&X); NY TR 2540, 2542 (Cook) (no circum-

stances where D&X necessary to preserve the health of a cardiac

patient, and the controlled approach of induction is better than the

uncontrolled surgical approach); NE TR 1311-12 (Cook); NE TR 1313-16

(Cook) (D&X not necessary); Carhart, 331 F.Supp.2d at 901 (Knorr)

(refers heart conditions to hospital); id. at 953 (Clark) (D&X offers no

benefit; D&E or induction appropriate).

* NY TR 2331-34 (Clark) (D&E or induction appropriate).

* NY TR 2324-25 (Clark) (occurs after birth and is irrelevant to

the selection of abortion method).

* NY TR 1229 (Frederiksen) (D&E appropriate); id. at 2326

(Clark) (dramatic increased risk of death when a mother with this

condition is delivered surgically instead of medically).

* Td. at 1230 (Frederiksen) (D&E appropriate); id. at 436 (John-

son) (recommends D&E); id. at 2357-58 (Clark) (not medical indications

for abortion).

* NY TR 2341-42 (Clark) (D&E and inductions appropriate, and if

a woman's platelets are really low, induction vastly preferable to

surgical manipulation); NE TR 1317 (Cook) (D&X not necessary).

* NY TR 2370-71 (Clark) (the majority occur near term and D&E

or induction is appropriate); NY TR 2537-39 (Cook) (physicians want to

avoid surgical procedures when a woman has low platelets or other

clotting abnormalities); id. at 1228 (Frederiksen) (no particular

abortion method needed); NE TR 287 (Fitzhugh) (D&E safe); id. at 327

(Vibhakar) (performs D&E); id. at 1308 (Cook) (D&X not necessary);

Carhart, 331 F.Supp.2d at 893 (Shadigian).

disease,“ organ transplants,” placenta previa,” throm-

boembolic disease,” or hemophilia.” D&X is medically

contraindicated for: a bleeding brain, vaginal hemorrhag-

ing,” or other bleeding.“ Other conditions, such as placen-

tal insufficiency,” lung disease,” and prior organ

transplantation do not require termination of pregnancy.

Moreover, D&X is contraindicated in true emergency

situations because the dilation of the cervix takes too

long.“ Carhart, 331 F Supp.2d at 934-35.

Coupled with the lack of necessity for D&X is the fact

that Respondents’ witnesses admitted that they generally

do not know what abortion procedure they will use and

that a number of factors, other than the woman’s health,

* NY TR 2337-38 (Clark) (D&E and induction safe and accepted).

* NY TR 2374-75 (Clark) (not an indication for abortion and D&E

or induction appropriate).

“ NY TR 2352, 2354 (Clark) (never a medical indication for

abortion and D&E appropriate).

* NY TR 2362-63, 2367-68 (Clark) (not an indication for abortion

because it can be successfully treated and, if a woman is on blood

thinners, induction and not surgical] abortion is preferable).

* NY TR 2349-50 (Clark) (not indications for abortion and D&E or

induction appropriate); id. at 2350 (Clark) (if condition is severe and

the woman has bad bleeding tendency, induction is preferable).

* Id. at 1405 (Cook).

” Carhart, 331 F.Supp.2d at 923 (Cook).

" NE TR 1341 (Cook).

“ Carhart, 331 F.Supp.2d at 900 (Clark).

“ Id. (Clark).

“ NE TR 1327-2 (Cook); id. at 1517-18 (Shadigian); Carhart, 331

F.Supp.2d at 934 (Cook); id. at 936 (Shadigian); see also id. at 892-93.

determine which procedure is ultimately used.“ Dr.

Chasen testified that the method chosen is “not dependent

upon the medical condition . . .” Carhart, 331 F.Supp.2d at

869. The presence of maternal medical conditions does not

affect his choice of abortion method. NY TR 1683. Instead,

several of Respondents’ experts testified that they perform

D&X procedures when possible — not because it is ever

“medically necessary.”

The court in National Abortion Federation v. Ashcroft

(hereinafter NAF) concluded that some of the alleged

reasons necessitating D&X were “incoherent” or “merely

theoretical.” 330 F.Supp.2d 436, 479-80 (S.D.N.Y. 2004).

The court concluded: “the Court does not believe that

many of Plaintiffs’ purported reasons for why D&X is

medically necessary are credible; rather they are theoreti-

cal or false.” Jd. at 480.

This was supported by abundant testimony in the

record. Dr. Clark testified that “under no circumstance is

D&X abortion necessary to preserve the life or health of

the mother” and that banning D&X would not jeopardize

the life of any woman. NY TR 2311. The Government’s

witnesses, Dr. Lockwood” and Dr. Cook,” concurred.

“ See, e.g., NE TR 346 (Vibhakar); NE TR 517, 557 (Knorr); NE TR

211-12, 246, 250-51, 256 (Fitzhugh) (stating his amount of sleep impacts

which procedure he uses).

“ Id. at 1683-84 (Chasen); id. at 675 (Hammond); id. at 1438-39

(Paul).

“ NY TR 1760 (Lockwood) (could think of no circumstance where

D&X would be necessary).

“ NY TR 2532-33 (Cook) (could think of no maternal medical

condition where D&X medically necessary).

The testimony of Respondents’ seven doctors who have

actually used D&X echoed this testimony. Doctors Chasen,

Westhoff, Grunebaum, Frederiksen, Weiss, Paul, and

Hammond could not recall or identify even one case in

which they used D&X for a maternal health condition. NY

TR 1684-85 (Chasen); NY TR 1007-11 (Westhoff); NY TR

691-92, 695-96, 707-11 (Hammond); NY TR 261, 345

(Grunebaum);” NY TR 1037, 1082, 1138, 1237 (Frederik-

sen); NY TR 1305-1426, 1369 (Weiss),° NY TR 1448-49,

1463 (Paul). Neither Creinin (NY TR 1512-1513) nor

Johnson (NY TR 476) perform D&X abortions.” None of

the nine physicians presented by Respondents could

identify a single case in which D&X was needed for a

maternal medical condition.

All of this testimony led the court to conclude:

In no case involving these or other maternal

health conditions could Plaintiffs point to a spe-

cific patient or actual circumstance in which

D&X was necessary to protect a woman’s health.

NAF, 330 F.Supp.2d at 480.”

“” NY TR 261 (Grunebaum) (D&X “absolutely not” the only method

for abortion in any given circumstance).

” NY TR 1369 (Weiss) (could think of no circumstance where D&X

required).

" NY TR 491 (Johnson) (no maternal complication requires D&X

or makes it the only procedure performable).

(Lockwood); id. at 487-90 (Johnson).

B. The record demonstrates that D&X is not

necessary for any fetal anomaly.

Several witnesses on both sides confirmed that abor-

tions for fetal anomalies are elective, not necessitated by

maternal health reasons, and that no fetal anomaly

requires the use of D&X. Carhart, 331 FSupp.2d at 906

(citing Dr. Doe’s testimony). D&X is never necessary for

hydrocephaly, one of the most often-cited fetal anomalies.

See Carhart, 331 F.Supp.2d at 936 (citing Cook). Respon-

dents’ witnesses testified that D&E can be safely used for

hydrocephaly and that the procedure need not be modified.

NE TR 288 (Fitzhugh); NE TR 385 (Vibhakar); NE TR

554-55 (Knorr). For example, while the occurrence of

hydrocephalus is “very rare,” a procedure can be per-

formed to take abnormal fluid off of the head, and induc-

tion or D&E is “appropriate.” NY TR 2379-80 (Clark); NY

TR 1687-88 (Chasen). See also NE TR 1335 (Cook); NE TR

1522 (Shadigian). D&X is never necessary. Jd. at 2512

(Cook); see also id. at 1461-62 (Paul) (stating that most of

her abortions for anomalies are by induction).” D&E can

” See NE TR 386 (Vibhakar); id. at 1330, 1334 (Cook); id. at 1521

(Shadigian).

“ NY TR 821 (Westhoff) (prefers D&E for large abnormalities); id.

at 2378-80 (Clark) (induction and D&E acceptable); id. at 440 (Johnson)

(D&E beneficial).

“ Evidence was presented that for pathological diagnoses, induc-

tion — and not D&X — is preferred. NY TR 438, 485, 487 (Johnson); id.

at 951 (Westhoff) (stating that an induction is advantageous); id. at

1462 (Paul) (stating that an intact fetus is an advantage of induction).

To obtain a “truly intact fetus,” induction is necessary. Jd. at 1220

(Frederiksen). Brain defects cannot be confirmed after D&X. /d. at 1221

(Frederiksen). While an intact fetal brain, face, and back of head and

base of skull are advantageous, such features are destroyed by D&X. /d.

at 1123-29 (Baergen).

also be used for genetic defects,” Trisomy 21,” Trisomy 13

or Trisomy 18 or spina bifida,” neural tube defects,”

chromosomal defects,” organ malformations,” and anen-

cephaly.” Medical induction has been used safely after 20

weeks to remove conjoined twins. NE TR 1522

(Shadigian).

Likewise, D&X is not necessary for pathological

diagnoses of fetal anomalies. Carhart, 331 F.Supp.2d at

906 (recounting Chasen’s testimony); Jd. at 937 (restating

Clark testimony). Respondents’ witnesses testified that

“(tlhe intact D&E procedure makes it more difficult to

diagnose brain abnormalities.” Jd. at 905 (citing testimony

of Baergen, Broekhuizen, Frederiksen). A medical induc-

tion usually results in a completely intact fetus. Jd. at 905,

906 (citing Frederiksen and Baergen testimony). Finally,

‘|t]here are no studies or literature comparing the method of

abortion with the ability to diagnose fetal anomalies.... ”

Id. at 906. Respondents could not identify a single situa-

tion where D&X was necessary to preserve maternal

health in the case of a fetal anomaly.

“ NE TR 287 («itzhugh).

” Jd. (Frederiksen); Carhart, 331 F.Supp.2d at 903 n.65 (citing

Clark testimony).

* NE TR 288 (Fitzhugh); NY TR 714-15 (Hammond) (no complica-

tions with other methods).

® Id. at 384 (Vibhakar).

” Id. (Vibhakar).

“ Jd. (Vibhakar).

“ NE TR 355 (Knorr); NY TR 713-14 (Hammond) (no complications

with other methods).

C. The ACOG Policy Statement has no basis

in empirical evidence and is not reliable.

The ACOG “select panel” met for only two days to

draft the organization’s 1997 policy statement on D&X. NY

TR 2235." The panel did not identify or examine ary

studies regarding the safety of D&X and other abortica

methods. NY TR 153-54, 2457. Any written materials were

reviewed only for “issue spotting,” and the panel failed to

discuss D&X with any other physicians. NY TR 2438-42.

The panel then sent a draft statement to the ACOG

executive board with the following conclusion: it could

identify no circumstances under which [D&X] would be the

only option to save the life or preserve the health of the

woman. NY TR 153-54, 2461 (emphasis added).™

Without consulting the panel, the ACOG executive

board unilaterally added the statement that D&X “mav be

the best or most appropriate procedure in a particular

circumstance to save the life or preserve the health of a

woman....” NY TR 2460-62. The statement was never

discussed or voted upon by ACOG’s fellows or membership.

NY TR 2221-22, 2229. Due to the executive board’s unilat-

eral addition of a statement unsupported by empirical

evidence, the ACOG statement cannot be relied upon for

the proposition that D&X is necessary for any maternal or

fetal condition.

* Dr. Joanna Cain, who was deposed, was ACOG’s president and a

select panel member.

“ See also NE TR 1098-1102 (Sprang) (ACOG “couldn’t come up

with a single example where it would be .. . the best, most appropriate

alternative to save the health of the mother”).

Ill. THERE IS NO SUBSTANTIAL, RELIABLE

EVIDENCE THAT D&X IS SAFER THAN EX-

ISTING PROCEDURES.

A. Intuition and personal observation are not

reliable or substantial evidence of safety.

In addition to relying on intuition alone, Respondents’

witnesses consistently used general and vague assertions

about the utility or safety of D&X." The claims of intuition

were made to support the vague standard that D&X may

be “medically necessary to preserve a woman’s health

under some circumstances.” When tested against a clear,

definite standard, however, Respondents’ experts conceded

that D&X was not the “only method available for perform-

ing abortions in any given circumstance.”

For example, Respondents’ first intuition claim is that

less instrumentation reduces risk -to women. This is

countered by several factors. First, doctors who do D&X

“do not count or keep track of how may instrument passes

they use.” NY TR 1206 (Frederiksen); NY TR 678

(Hammond). Second, none of the large retrospective

studies on D&E (let alone D&X) have actually studied

“ See e.g., Creinin deposition testimony read into the record, NY

Day 9 (“when looking at the risks and the benefits of the different

procedures, a procedure which is designed to remove the fetus intact

could have a lower risk of complications or difference, a change in the

ratio of risks to benefit”); SF TR 839-840 (Westhoff) (“possibility that

those boney fragments can lacerate,” have observed laceration from

instrumental passes; “blind use of instruments which has more

potential for perforation”), NY TR 252-54 (Grunebaum) (D&X “offers

advantages over D&E”); NY TR 691 (Hammond) (D&X “offers advan-

tages” lo women).

“ NY TR 261 (Grunebaum); NY TR 444, 491 (Johnson); NY TR

1369 ( Weiss).

whether the introduction of instrumentation affects risk.

Third, there are no studies published comparing D&E and

D&X on the number of instrument passes. NY TR 678

(Hammond); NY TR 1461 (Paul); NY TR 1411 (Weiss).

Fourth, practitioners of D&X only observe women for a

very short time and do no long-term follow-up. NE TR

1527 (Shadigian).”

Respondents’ second intuition claim is that an intact

delivery will eliminate dismemberment in the uterus,

thereby reducing the risk of lacerations or puncture.

Plaintiffs’ expert Frederiksen was aware of no studies that

support this theory in the case of D&E or D&X. N¥ TR

1214.% Judge Straub concluded that the trial evidence

showed that “plaintiffs failed to establish that D&X

lessened the chance of retained fetal parts,” (National

Abortion Federation v. Gonzales, 437 F.3d 278, 308 (2d Cir.

2006)), and concluded “the plaintiffs were unable to

‘explain the medical reasons supporting’ the proposition

that D&X is medically necessary.” 437 F.3d at 300 (quoting

330 F.Supp. 2d at 479).

The district court in NAF concluded that expert

witnesses “reasonably and effectively refuted Plaintiffs’

proffered bases for the opinion that D&X has safety

advantages over other second-trimester abortion proce-

dures.” 330 F.Supp.2d at 479. The court in NAF did “not

” NE TR 1527 (Shadigian: “hard ... to understand how abortion

providers ... know their complications, if they don’t even see their

patients back later” (citing Picker Institute, From the Patient's Perspec-

tive: Quality of Abortion Care (1999) (found that only about 29% of

women actually follow up with their abortion provider afterwards))).

* See also NY TR 1527 (Weiss); NY TR 2114-15 (Sprang) (called

laceration from bony fragments is a “very, very theoretic possibility”).

believe that many of Plaintiffs’ purported reasons for why

D&X is medically necessary are credible; rather they are

theoretical or false.” 330 F.Supp.2d at 480, and found that

the “Government’s experts, especially Dr. Clark, demon-

strated that some of the Plaintiffs’ reasons necessitating

D&X are incoherent; other reasons were shown to be

merely theoretical.” 330 F.Supp.2d at 479-80.

If intuition is to be considered, intuition supports

multiple possible dangers from D&X, as much as it does

its theoretical safety, for several reasons: heightened risk

of placenta previa and preterm birth (prematurity) in

future pregnancies,” heightened risk of maternal lacera-

tion from crushing the fetal skull or puncturing the fetal

neck, increased risk of infection from extended dilation,”

and heightened risk of uterine trauma from internal

rotation (version) of the fetus during D&X.” First, to the

extent that D&X requires that the cervix is more dilated,

it logically could entail greater risk. NAF, 330 F.Supp.2d

at 466.” The Chasen study suggests a nearly “threefold

“ NY TR 1752-53 (Lockwood) (citing studies).

* NE TR 1098-1174 (Sprang); SF TR 1083-85 (Sprang).

" NY TR 1766-67 (Lockwood); SF TR 444 (Doe) (potential risk of

perforation or laceration of cervix or lower uterine segment from getting

forceps around the feta! skull during D&X); SF TR 1085-87 (Sprang)

(increased risk from internal podalic version, “basically forcing [the

fetus) to do a somersault within the uterine cavity”); SF TR 1411 (Cook)

” NE TR 1148 (Sprang) (dilating the cervix over two days); NE TR

1530-32 (Shadigian) (D&X requires a greater degree of cervical dilation

than D&E, involving longer multiple-day dilations; “D&X procedure

uses those laminaria or osmotic dilators whereas in the medical

induction procedure, it’s only medications that actually have the

woman's body start the physiological process of contraction ... the

concerns are how many times the woman’s cervix is dilated over so

many days and how far it’s dilated with the number of laminaria”); SF

TR 744 (Creinin).

increased risk of premature birth [for women undergoing

D&X] along with a plausible biologic explanation for why

that might occur, namely, twice the cervical dilation... . ”

NY TR 2386 (Clark).” Second, there was significant

testimony, from experts on both sides, that internal

podalic version of the fetus carries risks of uterine rup-

ture, abruption, and trauma to the uterus.” Thus, contrary

to this Court’s statement in Stenberg v. Carhart, 530 U.S.

914 (2000), that “division of medical opinion ... signals

the presence of risk, not its absence.... ” (Jd. at 937), a

division of medical opinion based on intuition, in the

absence of empirical evidence, signals uncertainty as to

whether D&X involves a greater or lesser risk than well-

established procedures for abortion.

B. No empirical data demonstrate the safety

of D&X.

All of Respondents’ evidence about the safety of D&X

amounted to assertions of the intuitive safety of the

procedure from the few who do it; no reliable empirical

evidence was presented, with the sole exception of the

Chasen study, published after the trials, which is seriously

flawed (as outlined below). Several of Respondents’ experts

conceded the lack of any empirical studies testing the

* See also NY TR 1752-54, 1844 (Lockwood) (concerned about

prematurity after D&X, needs additional study); NY TR 2121 (Sprang);

NY TR 2546-47 (Cook) (Chasen study showed a disturbing trend toward

increased risk of preterm deliveries specifically as a result of |D&X)”).

* NY TR 375 (Grunebaum); NY TR 508 (Johnson); NY TR 1766-67

(Lockwood); NY TR 2108 (Sprang); NY TR 1415-16 (Weiss); NY TR

2545-46 (Cook).

providers’ intuition.” Frederiksen could identify no studies

comparing blood loss or risk of injury from “bony parts”

between D&X and D&E. Carhart, 331 F.Supp.2d at 928.”

The Government’s experts also emphasized that no em-

pirical data existed.” Even if (as Respondents claim) it is

generally true that the safety for each particular woman

depends on her individual circumstances when two proce-

dures are statistically similar in terms of risk, there is no

data indicating that D&X can be so compared because

there is no data to show that it is statistically similar in

terms of risk.”

The absence of empirical evidence to support the

safety of D&X is reflected in the three papers on which

Respondents rely for all their “data” to support D&X:

* NY TR 1523 (Creinin) (no published peer reviewed studies); NY

TR 1408 (Weiss) (no published studies evaluating the potential risks or

benefits). Of the Government’s experts, see NY TR 1751-1752, 1885

(Lockwood).

* 331 F.Supp.2d at 935 (citing Clark (no studies concerning

relative risk of D&X)); NY TR 2386 (Clark) (risks of D&X are “abso-

lutely unknown”).

” “Since the D&X has never been studied in a formal away in peer

review literature, there is no basis to say that D&X is safer than any

other procedure.” NE TR 1513 (Shadigian). “|T]here is no sound basis

on which to conclude the D&X is safer than medical induction.” Jd. NE

TR 932 (Bowes) (claims of safety can’t be supported by evidence-based

medicine) NE TR 922 (no published peer reviewed studies evaluating

safety of an intact D&E versus a disarticulation D&E and none

comparing safety of intact D&E with labor induction abortion); NE TR

1352 (Cook) (no peer-reviewed studies).

* NE TR 1523 (Shadigian) (the short-term complications are not

known, the long-term complications are not known; “no studies that tell

us what the correct indication [the reason why the procedure would be

performed over other procedures] should be for a D&X”; “and because it

hasn't been studied at all, we can’t really even compare it to a D&E or to

a medical induction of labor .. . when something is so unstudied. . . . ”).

Haskell’s (not peer-reviewed), McMahon’s (not peer-

reviewed), and Chasen’s.” Haskell’s 1992 paper was

neither peer-reviewed nor controlled; it was simply a

compiled series of his own personal experience.” Back in

1997, when Respondents’ expert Westhoff testified in court

against state prohibitions on D&X and relied on the

Haskell and McMahon papers, she believed that D&X

“deserved formal clinical comparative evaluation as the

best way to evaluate its risks and benefits for the future.”

NY TR 964-965, 967-68 (Westhoff). There is no evidence

that Haskell or McMahon ever “followed up with patients

to determine complications.” NE TR 1528 (Shadigian);”

NE TR 1343 (Cook). By contrast, in a related context —

regarding the utility of administering “parenteral or

additional oral antibiotic therapy” — Haskell himself noted

that “there are no data to confirm the necessity of this

” There is evidence in the record that women undergoing D&X

never received informed consent for this untested procedure by D&X

practitioners or by Haskell, McMahon, and Chasen in their papers.

Informed consent specifically for D&X was required by the serious risk

to the mother from increased cervical dilation, internal podalic version,

and the insertion of scissors in the back of the fetal skull, which are not

components of D&E.

“ NE TR Defendant’s Exh. 580. There was “no comparison

comparable or concurrent control group. They simply stated their

results but didn’t compare it to a group that they had matched with

similar kinds of patients ... so it’s a case series and it was not peer

reviewed, so we don’t know whether there was selection bias in

selecting the patients for the study; don’t know how many patients were

lost to follow-up.” NE TR 923-24 (Bowes).

* “(SJelf-reported case reviews” are “not sufficient.” NE TR 1528

(Shadigian). “[I)t’s the very first step in evaluating procedures” to

discuss the procedure with others who do it. “After that happens, there

is a series of evidence-based studies that need to happen for us to make

any conclusions about the general safety or unsafety of a procedure.”

NE TR 1529 (Shadigian). See also SF TR 1233, 1236-38 (Shadigian);, SF

TR 895 (Bowes).

practice.”” Likewise, McMahon’s paper was self-reported

and not peer-reviewed.” Respondents’ expert Westhoff

admitted that McMahon’s data was self-reported and

testified that McMahon admitted that his results were

“inconclusive.” NY TR 965-967."

The only peer-reviewed study on D&X ever published

is the Chasen study,” an observational, retrospective

cohort study which compared a group of women who had

D&E abortions (263) with a group that had D&X abortions

(120) at or beyond 20 weeks gestation. NY TR 1624-26. All

were performed in the same hospital, not an outpatient

clinic. NY TR 1628 (Chasen).“ The Chasen study has

* Maureen Paul, A Clinician’s Guide to Medical and Surgical

Abortion 129 (1999) (Chapter 10) (emphasis added) (a book developed

by the National Abortion Federation, NY TR Day 4 (April 1, 2004)

(Hammond)).

*® JT McMahon, Intact D&E: the first decade, Presented at the

NAF conference, New Orleans, April 2, 1995 (NE TR Defendant's

Exhibit 608; cited in Carhart, 331 F.Supp.2d at 1021 n.149.

“ See also NY TR 2513, NE TR 1343 (Cook critique of study); NE

TR 1343 (Cook critique of McMahon); NE TR 924 (Bowes critique of

McMahon).

* ST Chasen, RB Kalish, M Gupta, JE Kaufman, WK Rashbaum,

FA Chervenak, Dilation and evacuation at > or = 20 weeks: comparison

of operative techniques, 190 Am. J. Ob. Gyn. 1180 (2004). There was no

pre-existing published data addressing the comparison of D&E and

D&X before Chasen’s. NY TR 1614-15. Judge Casey found Chasen to be

the only study to compare D&E and D&X. NAF, 330 F.Supp.2d at 476.

NY TR 370-371 (Grunebaum) (other than Chasen study, no published

studies of D&X).

* After criticism from a peer-reviewer at the ACOG journal

Obstetrics & Gynecology, which rejected the study for publication,

Chasen changed his paper NY TR 1658-1660. The reviewer criticized

Chasen’s original conclusion that “[djilation and evacuation with intact

extraction is as safe as dilation and extraction with disarticulation after

20 weeks gestation,” on the basis that the retrospective study showed

only that there were no obvious differences between the two procedures,

(Continued on following page)

several limitations that render it unreliable for assessing

the relative safety of D&X and D&E. First, there were so

few patients that no conclusions could be reached with any

statistical validity. Carhart, 331 F.Supp.2d at 962 (citing

criticism by Bowes, Sprang, Lockwood); NY TR 2126

(Sprang); NY TR 2689 (Howell). Second, the authors did

not document their follow-up procedure, preventing them

from reliably documenting complications.” Third, the

patients in the two groups were not randomized and were

very different in important characteristics: in age, in

gestational duration of pregnancy at which the proce-

dures were done, and in the indications for which the

abortions were performed. No regression analysis was

employed to take account of these differences and adjust

for them. The authors did not identify the criteria for

deciding which patient would have what procedure; thus,

the operators were inherently “biased” in determining

what procedures they would use. NY TR 1523-24 (Cre-

inin). On the critical issue of subsequent pre-term birth

(PTB), the authors followed only 62 pregnant women (of

363 patients) who happened to return to that hospital for

prenatal care. NY TR 1662. The study suggests greater

cervical and genital tract trauma with D&X (though not

not that D&X was safe. NY TR 1659. Chasen then made two changes to

his paper: changing his abstract conclusion to state that “outcomes

appear similar between patients undergoing dilation and evacuation

and dilation and extraction after 20 weeks gestation,” and changing the

conclusion from “lo)ur data affirmed that D&E, after 20 weeks gesta-

tion with intact extraction when performed by experienced physicians,

is as safe as D&E with disarticulation,” to “jolur data affirmed that

abortion after 20 weeks gestation with intact D&X appears to have

similar complication rates as dilation and evacuation when performed

by experienced physicians.” NY TR 1660-61.

*” SF 752 (Creinin); SF 1794 (Chasen).

statistically significant due to the lack of statistical

power).” These trends contradict the study’s conclusion

that the outcomes are similar in the two groups.”

Chasen admitted, based on the data in his retrospec-

tive study, that (1) he could not state that one technique is

superior to the other (D&X v. D&E) (NY TR 1661) and (2)

that the major complications that occurred in the D&E

group could not have been avoided by doing a D&X abor-

tion. NY TR 1665. The Chasen study does not show any

improvement in outcomes between D&E and D&X. NY TR

2393-94 (Clark).” The district court in NAF concluded that

“the Chasen Study itself found no difference between D&X

and D&E in procedure time or estimated blood loss... . ”

330 F.Supp.2d at 472. No additional data on D&X has been

published in the two years since the Chasen study.”

For all these reasons, the claims of D&X’s safety

cannot be supported by evidence-based medicine. NE TR

* Genital tract lacerations occurred in 3.3% of the D&X cases and

1.5% of the D&E cases; cervical lacerations occurred in 2.4% of the D&X

cases and in 0.8% of the D&E cases. NY TR 2124 (Sprang).

NY TR 2125 (Sprang); NE TR 926-33 (Bowes).

” See also NE TR 1595 (Shadigian critique of Chasen); NE TR

1158-61, 1222-26 (Sprang critique).

* A follow-up study by Chasen et al., looking at obstetric outcomes

after D&E or D&X at >20 weeks gestation, was published in 2005,

using the previous dataset but somehow finding twice as many prenatal

patients. Chasen, et al., Obstetric Outcomes After Surgical Abortion at

(greater than or equal to) 20 weeks’ gestation, 193 Amer. J. Ob. Gyn.

1161 (2005). No valid safety or preterm birth conclusions can be drawn

from this study, because the D&X data were excluded when D&X was

performed in the presence of premature preterm ruptured membranes

andWor advanced cervical dilation.

932 (Bowes).” Six years after Stenberg v. Carhart, “[(nJo

studies support the contention that the D&X abortion

method is safer than other abortion methods.” Stenberg,

530 U.S. 914, 966 (2000) (Kennedy, J., dissenting).

C. There is substantial, reliable ovidunss that

there are well-established alternatives to

D&X.

For women seeking abortion, there are two well-

established alternatives to D&X: medical induction and

D&E. They have been the subject of many peer-reviewed

studies over the past 20 years, and these are widely consid-

ered to be “safe.” SF TR 103 (Paul); SF TR 846 (Westhoff); SF

TR 430 (Doe); SF TR 705, 718, 748-49 (Creinin); SF TR 194

(Sheehan); SF TR 1819 (Chasen). No empirical evidence

exists that these are les: safe than D&X.

For the pregnant woman who develops a medical

emergency, there are safe alternatives. Maternal-fetal

medicine has established alternative procedures to treat

all maternal medical conditions and fetal anomalies. NY

TR 1760, 2311, 2313-14 (Clark). Several experts from both

“@ The 8th Circuit concluded that, after the Chasen study, “there

are still no medical studies addressing the medical necessity of the

banned procedures.” Carhart v. Gonzales, 413 F.3d 791, 803 (8th Cir.

2005) (“There is a dearth of studies on the medical necessity of the

banned procedures.”). ACOG acknowledged that “ACOG is unaware of

any comparative maternal morbidity studies specifically evaluating

Intact D&E procedures with other methods of abortion.” NAF, 437 F.3d

at 307 (quoting ACOG President that “there is no data to say that one

of the procedures is safer than the other”). As Judge Straub noted, “it is

undisputed that no peer-reviewed studies or data exists [sic] showing

that D&X is either safe or safer than abortion procedures.” 437 F.3d at

307.

sides testified that at 20-24 weeks gestation, medical

induction and D&E are comparable for safety and are

established alternatives to D&X."” NY TR 1632-33 (Cha-

sen). As Judge Walker noted, the district court in NAF

concluded, from a review of the Congressional and trial

record, that there is “substantial evidence that, even if the

D&X procedure is wholly prohibited, a woman can obtain a

safe abortion in almost every conceivable situation.” 437

F.3d at 296. Although Respondents give the impression

that D&X just might be useful in some emergency, the

truth is quite opposite: because the dilation required for

D&X takes so long to complete, D&X can never be used

properly in a true emergency to treat a woman.

Because there are well-established alternatives to

D&X, the Act imposes no “substantial obstacle,” Casey, 505

U.S. at 877, and imposes no “significant threat to the life

or health of a woman.” Jd. at 880. The Act “in no real sense

deprives women of the ultimate decision.” Jd. at 875. The

Act therefore imposes no undue burden in violation of

Casey.

“ NY TR 1743, 1749-50 (Lockwood); NY TR 2306 (Clark); NY TR

541 (Hammond); NY TR 810 (Westhoff) (both induction and D&E “are

very safe”); NY TR 1426 (Weiss); NY TR 422, 423, 500-501 (Johnson);

NE TR 1534 (Shadigian); NE TR 1174, 1213 (Frederiksen); NE TR 504,

579-80 (Broekhuizen); NE TR 2306 (Clark); NE TR 1423 (Cook); NE TR

1129 (Sprang). See Carhart, 331 F.Supp.2d at 941-42 (surveying

testimony).

CONCLUSION

The judgment of the court of appeals should be re-

versed.

Respectfully submitted,

CLARKE D. FORSYTHE

(Counsel of Record)

DENISE M. BURKE

MAILEE R. SMITH

AMERICANS UNITED FOR LIFE

310 South Peoria Street, Suite 500

Chicago, Illinois 60607

312/492-7234

Counsel for Amici Curiae

May 22, 2006

APPENDIX A

INDEX TO TRIAL TESTIMONY

Nebraska (Carhart v. Ashcroft)

NE Day One (March 29, 2004), vol. I

Opening statements pp. 158-203

Plaintiff Dr. William Fitzhugh pp. 203-226

NE Day Two (March 30, 2004), vol. II

Plaintiff Dr. William Fitzhugh pp. 229-306

Plaintiff Dr. Jill Vibhakar pp. 306-410

NE Day Three (March 31, 2004), vol. III

Plaintiff's witness Dr. Joel Howell pp. 414-495

Plaintiff Dr. William Knorr pp. 495-575

NE Day Four (April 1, 2004), voi. IV

Plaintiff Dr. Leroy Carhart pp. 582-749

Plaintiff rests pp. 787

NE Day Five (April 5, 2004), vol. V

Defendant's witness Dr. George Marzariegos pp. 793-888

Defendant’s witness Dr. Watson Bowes pp. 897-993

NE Day Six (April 6, 2004), vol. VI

Defendant’s witness Dr. Kanwaljeet Anand pp. 1000-1094

Defendant’s witness Dr. Leroy Sprang pp. 1098-1248

NE Day Seven (April 7, 2004) vol. VII

Defendant’s witness Dr. Curtis Cook pp. 1254-1478

NE Day Eight (April 8, 2004), vol. VIII

Defendant’s witness Dr. Elizabeth Shadigian pp. 1486-1604

NE Day Nine April 9, 2004, vol. IX

Defendant’s witness Dr. Charles Lockwood pp. 1639-1771

NE June 2, 2004, vol. X

Oral arguments on briefs pp. 1830-1950

Questions of Court 1830-1912

Final Arguments 1913-1950

New York (National Abortion Federation v. Ashcroft)

NY Day One (March 29, 2004)

Opening statements pp. 1-52

Plaintiff’s witness Dr. Sherwin Nuland pp. 52-107

Deposition testimony of Dr. Joanna Cain pp. 122-187

NY Day Two (March 30, 2004)

Plaintiff’s witness Dr. Amos Grunebaum pp. 202-384

NY Day Three (March 31, 2004)

Plaintiff’s witness Dr. Timothy Johnson pp. 388-516

Plaintiff’s witness Dr. Cassing Hammond pp. 517-576

NY Day Four (April 1, 2004)

Plaintiff’s witness Dr. Cassing Hammond pp. 579-728

Plaintiff’s witness Dr. Carolyn Westhoff pp. 730-773

NY Day Five (April 2, 2004)

Plaintiff’s witness Dr. Carolyn Westhoff pp. 777-954

NY Day Six (April 5, 2004)

Plaintiff's witness Dr. Carolyn Westhoff

Plaintiff's witness Dr. Marilyn Fredriksen

NY Day Seven (April 6, 2004)

Plaintiff's witness Rebecca Baergen

Plaintiff's witness Dr. Marilyn Frederiksen

NY Day Eight (April 7, 2004)

Plaintiff's witness Dr. Gerson Weiss

Maureen Pau! ‘estimony read into record

Creinin dep. testimony read into record

NY Day Nine (April 8, 2004)

Plaintiff's witness Dr. Mitchell Creinin

testimony read into record

Plaintiff's witness Dr. Stephen T. Chasen

NY Day Ten (April 12, 2004)

Defendant's witness Dr. Charles Lockwood

NY Day Eleven (April 13, 2004)

Defendant's witness Dr. Kanwaljeet Anand

Defendant's witness Laureen Tews

NY Day Twelve (April 14, 2004)

Defendant's witness Dr. LeRoy Sprang

Plaintiff's witness Dr. Joanna Cain’s

deposition testimony read into record

Pp.

PP.

Pp.

959-1036

1037-1082

. 1089-1138

1138-1237

. 1305-1426

. 1426-1465

. 1468-1491

. 1500-1540

. 1540-1701

. 1706-1892

. 1898-2023

. 2024-2058

2065-2213

2213-2266

NY Day Thirteen (April 15, 2004)

Defendant’s witness Dr. Steven Clark

Dr. Joanna Cain’s deposition

testimony read into record

NY Day Fourteen (April 16, 2004)

Dr. Joanna Cain deposition testimony

read into record

Defendant's witness Dr. Curtis Cook

NY Day Fifteen (April 19, 2004)

Plaintiff’s witness Dr. Joel Howell

Defendant's witness Dr. Watson Bowes

testimony read into record

pp. 2270-2430

pp. 2431-2470

pp. 2475-2479

pp. 2479-2622

pp. 2661-2690

pp. 2691-2714

San Francisco (Planned Parenthood v. Ashcroft)

SF Day One, March 29, 2004 (vol. 1, pp. 1-174)

Plaintiff’s witness Dr. Maureen Paul

Plaintiff’s witness Suellen Craig

Plaintiff’s witness Katharine Sheehan

pp. 5-127

pp. 128-131

pp. 132-174

SF Day Two, March 30, 2004 (vol. 2, pp. 175-373)

Plaintiff's witness Katherine Sheehan

Plaintiff’s witness Eleanor Drey

pp. 178-273

pp. 274-376

SF Day Three, April 1, 2004 (vol. 3, pp. 374-477)

Plaintiff’s witness Dr. John Doe

pp. 377-462

SF Day Four, April 5, 2004 (vol. 4, pp. 478-696)

Plaintiff's witness Dr. Fredrik Broekhuizen

Plaintiff's witness Dr. Mitchell Creinin

pp. 481-638

pp. 645-697

SF Day Five, April 6, 2004 (vol. 5, pp. 697-868)

Plaintiff's witness Dr. Mitchell Creinin pp. 700-789

Plaintiff’s witness Dr. Carolyn Westhoff pp. 791-864

SF Day Six, April 8, 2004 (vol. 6, pp. 869-992)

Defendant’s witness Dr. Watson Bowes pp. 872-986

SF Day Seven, April 9, 2004 (vol. 7, pp. 993-1176)

Defendant’s witness Dr. LeRoy Sprang pp. 999-1170

SF Day Eight, April 12, 2004 (vol. 8, pp. 1177-1342)

Defendant’s witness Dr. Elizabeth Shadigian pp. 1187-1330

SF Day Nine, April 13, 2004 (vol. 9, pp. 1343-1536)

Defendant’s witness Dr. Curtis Cook pp. 1345-1530

SF Day Ten, April 15, 2004 (vol. 10, pp. 1537-1693)

Defendant’s witness Dr. Kanwaljeet S. Anand pp. 1540-1686

SF Day Eleven, April 16, 2004 (vol. 11, pp. 1694-1930)

Plaintiff's witness Dr. Stephen T. Chasen pp. 1708-1830

Closing Arguments pp. 1833-1930

APPENDIX B

Excerpt from ACOG Practice Bulletin No. 67 (included in

all ACOG Practice Bulletins):

“Studies were reviewed and evaluated for quality accord-

ing to the method outlined by the US Preventive Services

Task Force:

I Evidence obtained from at least one properly

designed randomized controlled trial.

II-1 Evidence obtained from well-designed controlled

trials without randomization.

IIl-2 Evidence obtained from well-designed cohort or

case-control analytic studies, preferably from more

than one center or research group.

II-3 Evidence obtained from multiple time series with

or without the intervention. Dramatic results in

uncontrolled experiments also could be regarded as

this type of evidence.

Ill Opinions of respected authorities, based on clinical

experience, descriptive studies, or reports of expert

committees.

Based on the highest level of evidence found in the data,

recommendations are provided and graded according to

the following categories:

Level A — Recommendations are based on good and

consistent scientific evidence.

Level B — Recommendations are based on limited or

inconsistent scientific evidence.

Level C - Recommendations are based primarily on

consensus and expert opinion.”

American College of Obstetricians and Gynecologists,

Medical management of abortion, ACOG Practice Bulletin

No. 67, 106 Obstetrics & Gynecology 882 (October 2005)

(reprinted in ACOG, 2006 Compendium of Selected Publi-

cations 705 (2006))

U.S. Preventive Services Task Force,

Guide to Clinical Preventive Services (2005)

“The USPSTF grades the quality of the overall evidence for

a service on a 3-point scale (good, fair, poor).

Good: Evidence includes consistent results from well-

designed, well-conducted studies in representative popula-

tions that directly assess effects on health outcomes.

Fair: Evidence is sufficient to determine effects on health

outcomes, but the strength of the evidence is limited by the

number, quality or consistency of the individua! studies,

generalizability to routine practice, or indirect nature of the

evidence on health outcome.

Poor: Evidence is insufficient to assess the effects on health

outcomes because of limited number or power of studies,

important flaws in their design or conduct, gaps in the

chain of evidence, or lack of information on important

health outcomes.”

U.S. Preventive Services Task Force, Guide to Clinical

Preventive Services: Recommendations of the USPSTF 164

(2005) (Appendix A).

The current Guide to Clinical Preventive Services 2005:

Recommendations of the USPSTF is available on the Web

at http://www.ahrq.gov/clinic/pocketgd. pdf.

This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.