Amicus Curiae Brief — Gonzales v. Carhart

LEROY CARHART, et al.,

Respondents.

ON WRIT OF CERTIORARI TO THE

UNITED STATES COURT OF APPEALS

FOR THE EIGHTH CIRCUIT

BRIEF FOR STEPHEN CHASEN, M.D., MARK I. EVANS, M.D.,

CASSING HAMMOND, M.D., MARC HELLER, M.D., TIMOTHY

R.B. JOHNSON, M.D., GERSON WEISS, M.D., CAROLYN

WESTHOFF, M.D., M.SC., AND NATIONAL ABORTION

FEDERATION AS AMICUS CURIAE SUPPORTING

RESPONDENTS

A. STEPHEN HUT TALCOTT CAMP

KIMBERLY PARKER Counsel of Record

AMY KREIGER WIGMORE BRIGITTE AMIRI

KAREN C. DALY REPRODUCTIVE FREEDOM

JESSICA L. WATERS - PROJECT

WILMER CUTLER PICKERING AMERICAN CIVIL LIBERTIES

HALE AND DORR LLP UNION FOUNDATION

1875 Pennsylvania Ave., N.W.125 Broad Street

Washington, DC 20006 New York, NY 10004

(202) 663-6000 (212) 549-2633

LORIE A. CHAITEN ELISABETH RYDEN BENJAMIN

THE ROGER BALDWIN FOUN- GALEN LEIGH SHERWIN

DATION OF ACLU, INC. NEW YORK CIVIL LIBERTIES

180 N. Michigan Ave. UNION FOUNDATION

Suite 2300 125 Broad Street

Chicago, IL. 60601 New York, NY 10004

(312) 201-9740 (212) 344-3005

AUG 10 2006

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TABLE OF CONTENTS

Page

TT ce lee ili

I i l

INTRODUCTION AND SUMMARY OF ARGUMENT................ 3

STATEMENT OF RELEVANT FACTS FROM NEW

EEN MAT RIN MS Sebi IT ARNE, AAO OS oe aN RE 4

PROCEDURAL HISTORY OF THE NEW YORK LITIGATION................. 4

EXPERT WITNESSES IN THE NEW YORK CASE.....................000000000000D

NEW YORK TESTIMONY ON ABORTION METHODS ............-cecccceeeeeee 7

fg REE ACTS Mee NDE IRE RET Ie 10

LIKE THE TWO RECORDS BEFORE THIS COURT, THE

NEW YORK RECORD SHOWS THE IMPORTANCE OF

INTACT D&E TO WOMEN’S HEALTH. ........................0.00.000000 10

A. ON THE BASIS OF ABUNDANT EVIDENCE, THE

NEW YORK COURT REJECTED CONGRESS'S

DEMONSTRABLY INCORRECT FINDINGS. .........c.cc..e00000e- 10

1. CONTRARY TO CONGRESS’S FINDINGS,

THE NEW YORK RECORD ESTABLISHED

THAT THERE IS NO MEDICAL CONSENSUS

eT te i cetcccecliiccecsecittonescscncsctntnscoses 11

2. EVIDENCE AT THE NEW YORK TRIAL Dis-

PROVED CONGRESS'S FINDINGS REGARD-

ING THE HEALTH RISKS OF INTACT V&E. ............. 13

B. THE NEW YORK TRIAL RECORD, LIKE THE NE-

BRASKA AND CALIFORNIA RECORDS, AMPLY

DEMONSTRATES THE SAFETY ADVANTAGES OF

I i 15

ii

TABLE OF CONTENTS—Continued

Page

C. THE NEW YORK DISTRICT COURT'S CHARAC-

TERIZATION OF SOME OF THE EVIDENCE DOES

NOT UNDERMINE ITS CENTRAL CONCLUSION

THAT SUBSTANTIAL MEDICAL EVIDENCE SUP

PORTS THE SAFETY ADVANTAGES OF INTACT

—ERRRERE IRR CSTE em pey etree Act LORS PRI, er OOD 20

SRN IITT cctscansdseickesartniienteenitvisbapudpinileivalesialouipsuenitensetistiinttnes 25

iil

TABLE OF AUTHORITIES

CASES

Page(s)

Ayotte v. Planned Parenthood, 126 S. Ct. 961 (2006) ............. 5

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

ieee acssnesaceatninphietedieciiandinnttiashunidaiilgniniimieiniaainiden 4, 15, 24

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

cert. granted, 126 S. Ct. 1314 (2006) ............esceseseeceseeneeees 4

National Abortion Federation v. Ashcroft, 330 F.

Supp. 2d 436 (S.D.N.Y. 2004) ............cscscsssessssseseees passim

National Abortion Federation v. Gonzales, 437 F.

I ee at Se ceicrenniltetiesennnectertniiennions 1, 5, 20

Planned Parenthood Federation of America, Inc. v.

Gonzales, 435 F.3d 1163 (9th Cir.), cert.

gvastod, 196 S. OC. BECE CRBOG) ccscccesssnsscesesessnsscecesvscrecserees 4

Planned Parenthood Federation of America v.

Ashcroft, 320 F. Supp. 2d 957 (N.D. Cal. 2004)....4, 8, 19, 24

Planned Parenthood v. Danforth, 428 U.S. 52

ETI ccnchicccaiesieens leciidastbiiapsiiainssacianiiitehaaliniainnsitiataiaaninad th taasnaanandts 21, 22

Planned Parenthood v. Taft, 444 F.3d 502 (6th Cir.

a i atialiall 21

Stenberg v. Carhart, 530 U.S. 914 (2000) 20... eee 10, 20, 21

Turner Broadcasting Systems, Inc. v. FCC, 512

eae EE Ue iiaiitctliteedcinseliidinisdnedeinitiniticiattinienaitialianiniiasceauctaninn ll

Wynn v. Scott, 449 F. Supp. 1802 (N.D. Ill. 1978)...............00. 22

STATUTES AND LEGISLATIVE MATERIAL

Partial-Birth Abortion Ban Act of 2003, § 2(14) ......000... 12, 13

I a cece l

Hearing on H.R. 760; Hearing Before the Subcom-

mittee on the Constitution of the House Comm.

on the Judiciary, 108th Cong. 186 (20038) .........ccseeeeseees 12

Partial Birth Abortion: The Truth: Joint Hearing

on 8.6 and H.R. 929 Before the Senate Commit-

tee on the Judiciary and the Subcommittee on

the Constitution of the House Committee on

the Judiciary, 105th Cong. 23 (1997) .........cceccesseeseeseeeses 12

iv

TABLE OF AUTHORITIES—Continued

Page(s)

OTHER AUTHORITIES

A CLINICIAN’S GUIDE TO MEDICAL & SURGICAL

ABORTION (Maureen Paul et al., eds. 1999) .............00 13

Chasen, Stephen T., et al., Dilation and evacuation

at > 20 weeks: Comparison of operative tech-

niques, 190 Am, J. of Obstetrics & Gynecology

CI ccrensensccreresneesngscscnaninnniinciioenasiaiieliataaies 13, 14, 15, 18

Chasen, Stephen T., et al., Obstetric outcomes after

surgical abortion at > 20 weeks’ gestation, 193

Am. J. of Obstetrics & Gynecology 1161 (2005).............. 13

Grimes, David A., The Continuing Need for Late

Abortions, 2830 JAMA 747 (Aug. 26, 1998) .......eeeesesees 13

Stubblefield, Phillip G., et al., First and Second

Trimester Abortion, in GYNECOLOGIC, OB-

STETRIC AND RELATED SURGERY (David H.

Nichols & Daniel L. Clarke-Pearson eds. 2d ed.

Stubblefield, Phillip G., et al., Methods for Induced

Abortion, 104 Obstetrics & Gynecology 174

Berar Bs scenscversssnsecncesinspstnsinetineshhichiatsiiininigubiinaainenidiaaian 13

WILLIAMS OBSTETRICS (F. Gary Cunningham et al.

CR, TIE OE, GIGS ccccrcenscerersisinesisnastatnsnitietiinbidiaipeinasiibieiaiaiiias 13

INTEREST OF AMICI’

Amici are plaintiffs in National Abortion Federation v.

Gonzales, an action brought in the United States District

Court for the Southern District of New York challenging the

same statute under review here, the Partial-Birth Abortion

Ban Act of 2003, 18 U.S.C. § 1531 (the “Act”). Amici submit

this brief in support of Respondents and in support of affir-

mance.

Amici include seven individual physicians who are all

practicing obstetrician-gynecologists, fellows of the Ameri-

ean College of Obstetricians and Gynecologists (“ACOG”),

and professors in, or chairs of, the Obstetrics and Gynecol-

ogy Departments of leading teaching hospitals throughout

the country. Collectively, they have published over 600

peer-reviewed articles, served as editors of numerous medi-

cal journals, and received tens of millions of dollars in com-

petitive research grants from the National Institutes of

Health. These physician-plaintiffs perform and teach abor-

tion procedures that are banned by the Act:

e Stephen Chasen, M.D., is Associate Professor of

Obstetrics and Gynecology at the Weill Medical Col-

lege of Cornell University and Director of High-Risk

Obstetrics at New York Presbyterian-New York

Weill Cornell Medical Center.

e Mark I. Evans, M.D., is Professor of Obstetrics and

Gynecology and Director of Comprehensive Genetics

at Mount Sinai School of Medicine in New York; he is

' No counsel for a party authored this brief in whole or in part, and

no person or entity other than amzci and their counsel made any monetary

contribution toward the preparation or submission of this brief. Letters

indicating the parties’ consent to the filing of this amicus brief have been

submitted to the Clerk of this Court.

* National Abortion Fed'n v. Ashcroft, 330 F. Supp. 2d 436 (S.D.N.Y.

2004), affd National Abortion Fed’n v. Gonzales, 437 F. 3d 278 (2d Cir.

2006).

2

also President of the Fetal Medicine Foundation of

America.

e Cassing Hammond, M.D., is Assistant Professor in

Obstetrics and Gynecology and Director of the Pro-

gram and Fellowship in Family Planning and Con-

traception at the Northwestern University School of

Medicine.

¢ Mare Heller, M.D., is the Medical Director of

Planned Parenthood Mohawk Hudson in

Schenectady, New York, and a part-time Associate

Clinical Professor at the College of Physicians and

Surgeons of Columbia University, through his asso-

ciation with its affiliate, Bassett Healthcare.

¢ Timothy R. B. Johnson, M.D., a maternal-fetal

medicine specialist, is the Bates Professor of the Dis-

eases Of Women and Children and Professor and

Chair of the Department of Obstetrics and Gynecol-

ogy at the University of Michigan Medical School.

¢ Gerson Weiss, M.D., is Professor and Chair of the

Department of Obstetrics, Gynecology, and Women’s

Health at the UMDNJ-New Jersey Medical School

and Chief of Service of Obstetrics and Gynecology at

the UMDNJ-University Hospital.

¢ Carolyn Westhoff, M.D., M. Sc., is Professor of

Obstetrics and Gynecology in the College of

Physicians & Surgeons of Columbia University, as

well as Professor of Epidemiology and of Population

& Family Health in the Mailman School of Public

Health, also at Columbia University.

Amicus National Abortion Federation (“NAF”), a

non-profit organization founded in 1977, is the medical pro-

fessional association of abortion providers in North America.

Its members include over 400 non-profit and private clinics,

3

women’s health centers, hospitals, and private physicians’

offices in 47 states. NAF’s members care for over half the

women who obtain abortions each year in the United States,

and they perform and teach abortion procedures that are

banned by the Act. NAF is the lead plaintiff in NAF v. Gon-

zales.

INTRODUCTION AND SUMMARY OF ARGUMENT

Amici, plaintiffs in NAF v. Gonzales (“Plaintiffs”), chal-

lenged the Act because it is constitutionally deficient on nu-

merous grounds, including that it bans an array of safe abor-

tion procedures. But even if the Act prohibited only second-

trimester surgical abortions in which the fetus is removed

intact—as the government sometimes claims—it would still

unconstitutionally endanger women’s health. Amici refer to

these procedures as intact dilation and evacuation (“intact

D&E”), because they are among the variants of dilation and

evacuation (“D&E”), which collectively account for the vast

majority of second-trimester abortions.

Essentially ignoring the Act’s other flaws, the govern-

ment’s defense of the Act relies almost entirely on Con-

gress’s finding that intact D&Es are “never medically indi-

cated to preserve the health of the mother.” See Pet. Br. 2.

This claim—and Congress’s findings—were discredited by

overwhelming evidence presented at three separate federal-

court trials held simultaneously in the Spring of 2004. At

those trials, eminent experts from the faculties of leading

medical schools, who have years of experience both perform-

ing abortions and treating women facing high-risk pregnan-

cies, testified that D&E with intact removal offers signifi-

cant safety advantages over alternative methods of termi-

nating a pregnancy in the second trimester. These wit-

nesses testified to the considerable health benefits of remov-

ing the fetus as intact as possible, and to the particular bene-

fits of doing so for women in compromised medical states.

After hearing this evidence, all three district courts con-

cluded that banning such procedures without a health excep-

tion violates the Constitution and this Court’s clear com-

mands.

4

The New York district court, like the Nebraska and

California courts whose decisions are under review, con-

cluded that Congress’s legislative findings cannot withstand

even the most deferential review. NAF, 330 F. Supp. 2d at

488. The New York court found that there is “no consensus

that D&X is never medically necessary,” id. at 482, and that,

in fact, “there is a significant body of medical opinion that

holds the contrary,” id. The New York court’s conclusions

were based on a substantial record amassed from over

twenty witnesses, from twelve of the most acclaimed medi-

cal and academic institutions in the country, during a three-

week trial. The record in New York comports fully with

those under review in this case’ and in Planned Parenthood

Federation of America v. Ashcroft, 320 F. Supp. 2d 957

(N.D. Cal. 2004) (“PPFA”). That the New York court did

not credit certain of Plaintiffs’ evidence does not undermine

that court’s central and dispositive finding: that there is sub-

stantial medical authority supporting the proposition that

prohibiting intact D&E endangers women’s health. This

finding adds considerable further weight to support affir-

mance.

STATEMENT OF RELEVANT FACTS

FROM NEW YORK RECORD

Procedural History of the New York Litigation

In November 2003, roughly simultaneously with the fil-

ing of the two cases currently under review by this Court,

Plaintiffs brought suit in the United States District Court

for the Southern District of New York challenging the Act.

On November 6, 2003, the New York court issued a tempo-

rary restraining order and, with the consent of the govern-

ment, later extended the TRO pending final resolution of the

‘Carhart v. Ashcroft, 331 F. Supp. 2d 805 (D. Neb. 2004), aff'd

Carhart v. Gonzales, 413 F.3d 791 (8th Cir. 2005), cert granted 126 S. Ct.

1314 (2006).

* Affd Planned Parenthood Federation of America, Inc. v. Gonza-

les, 435 F.3d 1168 (9th Cir. 2006), cert. granted 126 S. Ct. 2901 (2006).

5

case. During a three-week trial in March and April 2004, the

court heard testimony from sixteen witnesses in person and

six by deposition. On August 26, 2004, the court issued a de-

cision permanently enjoining the Act as unconstitutional un-

der this Court’s precedents because it lacks a health excep-

tion. On January 31, 2006, the Second Circuit affirmed, hold-

ing that “the lack of a health exception renders the Act un-

constitutional.” NAF’, 437 F.3d at 281. The Second Circuit

deferred ruling on the appropriate remedy until supplemen-

tal briefs could be filed addressing this Court’s recent ruling

in Ayotte v. Planned Parenthood, 126 S. Ct. 961 (2006). That

briefing was thereafter stayed pending the outcome of this

case.

Expert Witnesses in the New York Case

The New York court recognized seven of Plaintiffs’ wit-

nesses (including the five Plaintiffs who testified at trial) as

experts in obstetrics and gynecology and abortion practice

and procedures. These experts are all professors in the ob-

stetrics and gynecology departments at leading medical

schools. See NAF, 330 F. Supp. 2d at 458-62. Dr. Timothy

Johnson is department chair at the University of Michigan;

Dr. Gerson Weiss is department chair at UMDNJ-New Jer-

sey Medical School; Drs. Amos Grunebaum and Stephen

Chasen teach at Cornell University; Drs. Cassing Hammond

and Marilynn Frederiksen teach at Northwestern Univer-

sity; and Dr. Carolyn Westhoff teaches at Columbia Univer-

sity. Collectively, they have extensive experience both per-

forming and teaching the abortion methods at issue in this

case. They have all performed first- and second-trimester

abortions, and have used both of the procedures commonly

used to terminate pregnancies in the second trimester, D&E

and induction. Each of these experts has either performed,

or personally observed, the variant of D&E involving intact

removal of the fetus. See Tr. 210:8-213:12, 307:17-308:4,

312:1-7 (Grunebaum); Tr. 526:1-530:8, 533:9-20 (Hammond);

Tr. 742:5-751:4 (Westhoff); Tr. 1043:5-1046:2 (Frederiksen);

Tr. 1311:1-1316:25, 1338:12-1340:11, 1341:7-21 (Weiss); Tr.

1551:12-1555:13 (Chasen); see also Tr. 396:4-400:11 (John-

6

son). These experts teach an array of obstetric and gyneco-

logical procedures, including abortion; most of them teach

D&F with intact removal.®

Five experts testified at trial for the government. Each

of the government’s experts had limited, if any, experience

with abortion practice. Tr. 1788:25-1789:21 (government’s

witness Lockwood); Tr. 2399:19-24 (government’s witness

Clark) (testifying that he considers himself only “moderately

skilled” in performing abortions); Tr. 2093:2-6 (government’s

witness Sprang) (testifying that he has performed abortions

“exceedingly rarely”); Tr. 1967:16-17 (government’s witness

Anand) (testifying that he has never performed any type of

abortion); Tr. 2487:21-2488:15 (government’s witness Cook)

(testifying that he has performed abortions by methods

other than induction only on “rare occasions” and that most

of the abortions he performed were to remove dead fetuses).

Not one of the government’s experts had any experience

with D&E involving intact removal. None had even person-

ally observed such a procedure. NAF, 330 F. Supp. 2d at

462-64.

*The portions of the trial transcript cited in this brief are repro-

duced in the accompanying Appendix.

*The New York record also included deposition testimony of Drs.

Mitchell Creinin and Maureen Paul, both of whom have extensive experi-

ence in obstetrics, gynecology, and abortion practice; Dr. Watson Bowes,

whom the government had designated as an expert but did not call at

trial; and representatives from three medical organizations opposing the

Act: Joanna Cain, M.D., chair of the ethics committee of the American

College of Obstetricians and Gynecologists (““ACOG”); Meghan Kissell,

Director for Communications and Advocacy for the American Medical

Women’s Association (“AMWA”); and Alan Baker, Chief of Staff for the

American Public Health Association (“APHA”). In addition, Dr. Rebecca

Baergen of Cornell-Weill Medical School testified for Plaintiffs as an ex-

pert in pathology and perinatal pathology, Tr. 1096:23-1097:5; Dr. Sherwin

Nuland of Yale University, a Pulitzer Prize-winning author and expert on

medical and surgical history, testified as an expert in the evolution of sur-

gical procedures, Tr. 69:8-14; and Dr. Joel Howell, Director of the Robert

Wood Johnson Clinical Scholars Program at the University of Michigan,

testified in rebuttal as an expert in evaluation of medical research, Tr.

2673:13-25.

7

New York Testimony on Abortion Methods

As the undisputed testimony showed and the New York

district court found, approximately 90% of all abortions oc-

cur during the first trimester of pregnancy, and approxi-

mately 10% during the second. NAF, 330 F. Supp. 2d at 464.

During the second trimester (which begins at thirteen to

fourteen weeks from the first day of the woman’s last men-

strual period before she became pregnant (“LMP”)), ap-

proximately 95% of abortions are performed using the D&E

method. Tr. 779:7-8, 802:9-14 (Westhoff).

D&E consists of dilating the cervix and evacuating the

uterus. Tr. 1552:19-21 (Chasen). Both Plaintiffs’ and the

government’s witnesses testified that the physician’s goal in

any D&E is to empty the uterus in the safest way possible

for the woman. See e.g., Tr. 2701:5-2703:13 (government’s

expert Bowes); Tr. 1363:21-1364:1 (Weiss).

In a D&E, the physician first dilates and softens the

cervix so that the uterus can be safely evacuated. NAF’, 330

F. Supp. 2d at 464 (quoting trial testimony). To achieve ade-

quate dilation, physicians typically place osmotic dilators in

the cervix, which expand slowly as they absorb moisture

from the cervix, thereby gradually opening it. Jd. at 464-65.

Once dilation is adequate, the physician inserts instruments

or his or her fingers through the dilated cervix and into the

uterus, to grasp the fetus. The physician then uses traction

(7.e., pulling) to remove the fetus from the uterus. Tr.

786:22-787:18 (Westhoff).

As the New York record demonstrates, during a D&E,

the fetus may be removed intact or in parts. Both parties’

experts testified that physicians performing D&Es seek to

minimize the number of times they insert instruments into

the uterus. They therefore try to remove as much of the fe-

tus as possible with each pass of an instrument. See Tr.

1849:23-1850:3 (government’s expert Lockwood); Tr. 2709:6-

2710:6 (government’s expert Bowes); Tr. 794:11-16 (West-

hoff); Tr. 479:18-23 (Johnson). In some cases, depending on

factors such as the degree of cervical dilation achieved, the

tensile strength of the fetal tissue, and the position of the

8

fetus, the physician is able to remove the fetus intact or rela-

tively intact with the first pass of instruments.’ See Tr.

1572:19-1574:4 (Chasen); see also Tr. 791:17-792:6, 786:22-

787:10 (Westhoff); Tr. 2696:4-10 (government’s expert

Bowes). The experts in New York testified, however, that

despite attempts to remove the fetus as intact as possible,

the ss often results in removal of the fetus in parts,

wit... physician reinserting instruments—and extracting

as much of the fetus as possible with each instrument pass—

until the evacuation is complete.” See Tr. 786:22-787:10

(Westhoff); Tr. 1454:14-19 (Paul); Tr. 1503:11-24 (Creinin);

_ Tr. 1573:23-1574:4 (Chasen).

A variety of terms—such as “intact D&E” or “D&X”—

were used throughout the New York trial to describe sec-

ond-trimester surgical abortions in which the fetus is re-

moved intact or largely intact. Regardless of the term em-

ployed, the New York experts testified that such a proce-

dure is “a variation of ... D&E.” Tr. 1065:6 (Frederiksen);

see also Tr. 212:4-6, 231:23 (Grunebaum); Tr. 1450:8-10

(Paul); Tr. 665:22-666:3 (Hammond).”

"The testimony in New York showed that physicians do not use a

different dilation protocol to achieve an intact extraction. Rather, the

same standard protocol may result in more dilation with a given patient,

increasing the possibility of a relatively intact extraction. See Tr. 597:10-

14 (Hammond) (physicians “do nothing differently before [their| intact

procedures”); see also PPFA, 320 F. Supp. 2d at 965 (physicians “cannot

... ascertain{]” the “potential for a largely intact removal” until the dila-

tors are removed and “the surgical procedure has already begun”).

* The fetal skull is the largest part of the normally developed fetus and

is typically too large Lo pass through the cervix during a D&E. Asa result,

whether the fetus is dismembered or removed intact, the physician must

reduce the size of the skull to complete the delivery. See Tr. 796:11-12,

797:25-798:14 (Westhoff); Tr. 643:8-11 (Hammond); Tr. 1573:7-13 (Chasen).

*The Act’s findings, and the government, attempt to define D&Es

with intact removal as if they were an entirely distinct procedure from

D&Es involving dismemberment. However, the record evidence in New

York showed that physicians who perform them “consider all D&E’s [sic]

part and parcel of the same procedure.” Tr. 597:10-15 (Hammond); see

also PPFA, 320 F. Supp. 2d at 966 (“{t}he only physicians who referred

9

The testimony in New York showed that virtually all of

the remaining second-trimester procedures (five percent)

are performed using the induction method. In an induction

abortion, which can last anywhere from fewer than twelve

hours to more than forty-eight hours, pre-term labor is initi-

ated with medication, the cervix dilates, and the fetus is

generally expelled through the labor process. NAF, 330 F.

Supp. 2d at 467. In some induction abortions, however, the

physician must intervene with surgical steps to complete the

evacuation as safely as possible for the woman. When this

happens, the physician uses the surgical techniques of D&E

to complete the procedure. /d. at 468-69.

The uncontested evidence presented in the New York

trial established that any D&E or induction—whether used

to induce aLortion or to treat pregnancy loss (sometimes

called “miscarriage”)—may fall within the definition of “par-

tial-birth abortion” contained in the Act. See Tr. 298:21-

299:8 (Grunebaum); 639:2-644:17 (Hammond); 854:3-862:20

(Westhoff); see also Tr. 1877:22-1878:18 (government’s ex-

pert Lockwood).

The remaining procedures for pregnancy termination in

the second trimester, hysterectomy (removal of the uterus)

and hysterotomy (essentially a pre-term cesarean section),

are rarely used to terminate pregnancies because of their

inherent risks and consequences for future reproduction.

They nonetheless remain legal and can be used in those un-

usual circumstances in which they may be the safest method

for a given patient with a critical medical condition. NAF,

330 F. Supp. 2d at 467 (quoting trial testimony).

to” intact procedures “as ... separate ... were witnesses who had never

performed the|m]”). Despite the fact that both variants are used at the

same point in pregnancy, the government seeks to stigmatize one as aber-

rant and to embrace the other as “standard.” Pet. Br. 11.

10

ARGUMENT

LIKE THE TWO RECORDS BEFORE THIS COURT, THE NEW

YORK RECORD SHOWS THE IMPORTANCE OF INTACT D&E To

WOMEN’S HEALTH.

The extensive evidence presented in New York is en-

tirely consistent with that presented in the Nebraska and

California cases under review. The New York court heard

“more evidence during its trial than Congress heard over

the span of eight years,” including testimony from a greater

number of physicians on the safety of D&E involving intact

removal. NAF, 350 F. Supp. 2d at 482. In addition to Plain-

tiffs’ highly credentialed experts, who testified to the signifi-

cant safety advantages of intact D&E, several of the gov-

ernment’s experts acknowledged that such procedures may

reduce the risk of dire complications and provide safety ad-

vantages for some patients. /d. at 461-73. That evidence

demonstrated that intact D&E is well within the standard of

care; that it is becoming ever more widely used as greater

numbers of physicians learn this approach to D&E anc read

about its benefits in the medical literature; and that a ban on

its use would harm women’s health.

Accordingly, like the courts whose decisions are under

review, the New York trial court found that “[t]here is no

consensus that D&X is never medically necessary, but there

is a significant body of medical opinion that holds the con-

trary.” Jd. at 482. This conclusion, affirmed by the Second

Circuit, places the New York decision in an unbroken line

that has struck down laws banning intact D&E since this

Court’s decision in Stenberg v. Carhart, 530 U.S. 914 (2000).

A. On the Basis of Abundant Evidence, the New

York Court Rejected Congress’s Demonstrably

Incorrect Findings.

Like the courts in Nebraska and California, the New

York court concluded that Congress's findings were belied

by both the congressional record itself and abundant trial

evidence. Having observed that “le]ven the government’s

own experts disagreed with almost all of Congress’s factual

ll

findings,” NAF, 330 F. Supp. 2d at 482, the court held that

those findings cannot satisfy even the highly deferential

‘ standard the government urged. The court, that is, found

that the findings do not even reflect “reasonable inferences

based on substantial evidence.” Turner Broad. Sys., Inc. v.

FCC, 512 U.S. 622, 666 (1994).

1. Contrary to Congress’s Findings, the New

York Record Established That There is No

Medical Consensus Against Intact D&E.

The New York court rejected Congress’s finding that

there is a “consensus” that D&E with intact removal “is

never medically necessary and should be prohibited.” Act

$ 2(1). In fact, as the court found, “{t/he congressional re-

cord itself undermines this finding.” NAF’, 330 F. Supp. 2d

at 488. The court likewise rejected the related findings that

Congress made in an attempt to circumvent Stenberg. As

the court observed, “[t]he face of the congressional record

[itself] rebuts” Congress’s finding “that D & X is a disfa-

vored medical procedure that is not embraced by the medi-

cal community, ‘particularly among physicians who routinely

perform other abortion procedures.” /d. at 490 (quoting Act

§$ 2(2) and citing id. §§ 13, 14(O)); see also id. $§ 13, 14(O)

(procedure “lies outside the standard of medical care” and

“is unrecognized as a valid abortion procedure by the main-

stream medical community”). The court found that:

First, the [congressional] record includes the

statements of nine associations, including ACOG

and APHA, which opposed the ban because they

believe that the procedure offers safety advantages

.... Second, the congressional record contains let-

ters from numerous individual physicians—whose

practices include performing abortions—stating

that maternal health would be jeopardized under

the Act. Third, medical textbooks, which were in-

cluded in the congressional record, discuss D&X as

a medically recognized means to terminate a preg-

nancy.

12

330 F. Supp. 2d at 490 (citations omitted); see also Hearing

on H.R. 760: Hearing Before the Subcomm. on the Constitu-

tion of the House Comm. on the Judiciary, 108th Cong. 186-

88 (2003); Partial-Birth Abortion: The Truth: Joint Hearing

on S.6 and H.R. 929 Before the Senate Comm. on the Judici-

ary and the Subcomm. on the Constitution of the House

Comm. on the Judiciary, 105th Cong. 23-35 (1997) (medi-

cally-based opposition to Act of Plaintiff NAF and of

Planned Parenthood, representing physicians who perform

an array of abortion procedures).

In addition to the congressional record, the New York

court found that the “|tjestimony adduced at trial bolsters

this conclusion” that Congress was “unreasonable to con-

clude that a consensus within the medical community” op-

poses intact D&E. 330 F. Supp. 2d at 489. That testimony

includes the concessions of the government’s own witnesses

that no such consensus exists. Id. at 443; see also Tr. 2700:2-

11, 2714:14-23 (government’s expert Bowes).

Abundant trial evidence likewise disproved Congress’s

other “findings.” For example, Congress asserted that in-

tact D&E was not taught at any medical schools, Act

§ 2(14)(B). Yet, “[tJestimony at trial adduced that, contrary

to Congress’s finding, the procedure is taught at leading

medical schools,” NAF, 330 F. Supp. 2d at 490, including, as

experts for both sides testified, Columbia, Cornell, New

York University, Northwestern, and Albert Einstein Col-

lege of Medicine. /d. at 479, 490 (citing testimony of, inter

alia, government’s experts Lockwood and Sprang). Dr.

Lockwood, a witness for the government and Chair of the

obstetrics and gynecology department at Yale Medical

School, testified that intact D&E was taught under his

chairmanship at New York University, Tr. 1794:4-1795:8,

and that he “intends to develop a program at Yale which

would teach the procedure.” NAF, 330 F. Supp. 2d at 479.

Currently, at least six additional medical! schools, including

Yale, provide instruction on this surgical technique. The re-

cord likewise reflects that authoritative medical textbooks

discuss intact D&E and its safety benefits. See id. at 471

13

(citing A CLINICIAN'S GUIDE TO MEDICAL & SURGICAL

ABORTION 136 (Maureen Paul et al., eds. 1999)); see also

WILLIAMS OBSTETRICS 243 (F. Gary Cunningham et al.

eds., 22d ed. 2005); Phillip G. Stubblefield, First and Second

Trimester Abortion, in GYNECOLOGIC, OBSTETRIC AND RE-

LATED SURGERY 1033, 1043 (David H. Nichols & Daniel L.

Clarke-Pearson eds. 2d ed. 2000).

The New York record similarly refuted Congress’s

claim that intact D&E has not been the subject of peer-

reviewed studies and articles. See Act $2(14)(B). The re-

cord includes the testimony of amicus Dr. Stephen Cha-

sen—Director of High-Risk Obstetrics at New York Presby-

terian-New York Weill-Cornell Medical Center, where he

also teaches—as well as the first of two articles Dr. Chasen

has published in an authoritative peer-reviewed journal

comparing D&E involving intact removal to D&E involving

dismemberment. See Stephen T. Chasen et al., Obstetric

outcomes after surgical abortion at = 20 weeks’ gestation,

193 Am. J. of Obstetrics & Gynecology, 1161-64 (2005);

Stephen T. Chasen et al., Dilation and evacuation at = 20

weeks: Comparison of operative techniques, 190 Am. J. of

Obstetrics & Gynecology, 1180-83 (2004). See discussion in-

fra at 18-19. Other peer-reviewed articles also discuss intact

D&E and its safety advantages. See, eg., Phillip G.

Stubblefield et al., Methods for Induced Abortion, 104 Ob-

stetrics & Gynecology 174-85 (July 2004); David A. Grimes,

The Continuing Need for Late Abortions, 280 JAMA 747-50

(Aug. 26, 1998).

2. Evidence at the New York Trial Disproved

Congress’s Findings Regarding the Health

Risks of Intact D&E.

The New York trial court correctly concluded that the

evidence presented at trial refuted Congress’s assertion that

“overwhelming evidence” demonstrates that D&E involving

intact removal presents serious increased risks to women.

Act §2(14)(A). The court concluded, for example, that

“[e)xperts for both sides labeled ... inaccurate” Congress's

finding that intact removal increases the risk of uterine rup-

14

ture, abruption, amniotic fluid embolus, and trauma to the

uterus. NAF’, 330 F. Supp. 2d at 489; see also, e.g., Tr.

2419:3-2420:13 (government’s expert Clark); Tr. 2706:19-

2707:17 (government’s expert Bowes); Tr. 1831:18-1832:10

(government’s expert Lockwood). Similarly, the trial court

found that experts for both sides agreed that intact D&E

“does not involve the capricious and erratic use of instru-

ments,” thus undercutting Congress’s finding that the pro-

cedure poses an increased risk of maternal laceration and

bleeding. 330 F. Supp. 2d at 489-90. The government’s own

experts agreed at the New York trial that there is simply no

evidence that performing a D&E with intact removal poses

greater safety risks than performing one involving dismem-

berment. See Tr. 2706:19-2707:17 (government’s expert

Bowes); Tr. 1880:2-5, 1880:23-1881:4; 1881:5-7 (government’s

expert Lockwood); Tr. 2151:23-25 (government’s expert

Sprang)."”

’ Evidence presented at the New York trial also contradicted Con-

gress’s finding that removing the fetus intact in a D&E increases a

woman’s risk of cervical incompetence, which can lead to pre-term birth in

subsequent pregnancies. See NAF, 330 F. Supp. 2d at 467 (citing West-

hoff). The district court incorrectly suggested that Dr. Chasen’s original

study indicates an increased risk of subsequent pre-term birth: as experts

from both sides explained, this difference between the two groups—

women who had received intact D&Es and women who had received

D&Es with more dismemberment—was statistically insignificant because

there were so few patients in this part of the study. 330 F. Supp. 2d at

467; Tr. 1629:15-1631:9 (Chasen); Tr. 2679:18-2680:11 (Howell); Tr. 2425:1-

25, 2429:16-2430:13 (government's expert Clark) (conceding that “one can

reach no conclusions” from the Chasen study about the procedure’s impact

on risk of subsequent pre-term birth). No less important, as the govern-

ment’s experts conceded, women in the intact group in the study had pre-

existing risk factors for pre-term delivery to a far greater degree than did

women in the dismemberment group. See Chasen et al., Dilation and

evacuation at >20 weeks: Comparison of operative techniques, 19) Am. J.

of Obstetrics & Gynecology, 1180, 1183 (2004); see also Tr. 2412:8-11,

2427:12-2429:1 (government's expert Clark); Tr. 2614:15-2615:6 (govern-

ment's expert Cook). Indeed, each of the two women from the intact

group who delivered a subsequent pregnancy pre-term had undergone the

abortion in the study specifically because she had begun to lose that ear-

lier pregnancy through premature rupture of the membranes or prema-

15

B. The New York Trial Record, Like the Nebraska

and California Records, Amply Demonstrates the

Safety Advantages of Intact D&E.

The New York trial record supports the safety advan-

tages of intact D&E based on three demonstrated facts: (1)

D&Es of all variations have safety advantages over induc-

tion abortions, (2) D&Es with intact removal have safety

advantages over D&Es with dismemberment, and (3) these

safety advantages are especially important for women who

are particularly vulnerable to catastrophic complications by

virtue of their already compromised medical states.

First, it is uncontested that prohibiting D&Es in gen-

eral would endanger women’s health. At the New York

trial, all parties’ experts agreed that, while D&E and induc-

tion are both extremely safe procedures, D&E is generally

safer than induction at certain stages of pregnancy. NAF,

330 F. Supp. 2d at 467-68 (citing testimony of government’s

experts Lockwood, Sprang, and Clark, and Plaintiffs’ expert

Frederiksen). [t was also undisputed that for numerous

women, induction is dramatically less safe than D&E. These

patients include, for example, women at high risk of uterine

rupture during an induction, due to prior scarring from pro-

cedures such as high (also known as “classical”) cesarean

sections or from the surgical removal of uterine fibroids. See

Tr. 1817:24-1818:8, 1818:19-22 (government’s expert Lock-

wood); Tr. 2358:22-2359:17, 2407:21-2408:7, 2408:18-24 (gov-

ernment’s expert Clark); Tr. 1584:22-1585:9 (Chasen); Tr.

1080:1-4 (Frederiksen); Tr. 223:25-224:16 (Grunebaum).

Second, the evidence presented in New York showed

that numerous physicians believe that, among D&E vari-

ture cervical dilation. Both those events are known risk factors for pre-

term delivery in future pregnancies. See Chasen et al., Dilation and

evacuation at > 20 weeks: Comparison of operative techniques, at 1183.

For this reason, the California and Nebraska courts both found that the

Chasen study does not support the claim that intact D&E may increase

the risk of subsequent pre-term birth. See Carhart, 331 F. Supp. 2d at

1022; PPF'A, 320 F. Supp. 2d at 1001.

16

ants, D&E involving intact removal may be the safest way—

although not the only way—to terminate a pregnancy in the

second trimester. See, e.g., Tr. 1588:23-1589:5, 1632:3-1633:4

(Chasen); Tr. 563:15-23 (Hammond); Tr. 824:12-17, 840:4-12,

841:20-22 (Westhoff); Tr. 1439:1-6, 1445:10-21, 1451:9-1452:9

(Paul); Tr. 1321:10-16, 1388:1-11, 1345:23-1346:2, 1421:2-12

(Weiss); Tr. 453:19-21 (Johnson); Tr. 1053:7-20, 1161:21-24

(Frederiksen); Tr. 1503:25-1504:2 (Creinin). Even the gov-

ernment’s experts agreed that there are intuitive advan-

tages to intact removal. Tr. 1828:4-14 (government’s expert

Lockwood); Tr. 2708:19-22, 2709:6-2710:6 (government’s ex-

pert Bowes). Indeed, government witness Dr. Lockwood

conceded that, compared to dismembering the fetus, intact

removal might carry lower risks of injury to the woman. Tr.

1880:6-8. This is so for several reasons, as the evidence pre-

sented in New York showed:

e By reducing the number of times a physician must

insert instruments through the cervix and into the

uterus, intact removal reduces the risk of what gov-

ernment expert Dr. Lockwood called the most feared

complication of D&E with dismemberment—uterine

perforation. 330 F. Supp. 2d at 471 (citing testimony

of government’s experts Lockwood and Cook and of

Plaintiffs’ experts); Tr. 1765:21-1766:1, 1822:16-

1823:1, 1823:14-1824:6 (government’s expert Lock-

wood); Tr. 2548:5-23 (government’s expert Cook).

The government’s experts agreed that it is medically

appropriate to attempt to make as few instrument

passes as possible, Tr. 1825:12-16 (government’s ex-

pert Lockwood); Tr. 2708:19-22, 2709:18-2710:6 (gov-

ernment’s expert Bowes), and Dr. Lockwood testi-

fied that making fewer passes with instruments also

reduces the risk of infection. Tr. 1825:9-20

(government’s expert Lockwood). Testimony from

ACOG (presented by deposition of its representative,

Dr. Joanna Cain) showed that ACOG viewed reduced

instrumentation as a significant reason why D&E

with intact removal may be the best or most appro-

17

priate abortion method to save the life or preserve

the health of a woman. Tr. 185:2-18 (Cain).

e Removing the fetus intact virtually eliminates the

risk that fetal,tissue will be left in the uterus. Re-

tained tissue increases the likelihood of infection,

hemorrhage, and infertility. NAF, 330 F. Supp. 2d at

472; Tr. 248:13-249:9 (Grunebaum); Tr. 570:8-571:18

(Hammond); Tr. 824:18-825:7 (Westhoff); Tr. 1045:13-

22, 1053:7-20, 1060:8-1064:18 (Frederiksen); Tr.

1322:25-1324:3, 1421:2-12 (Weiss); Tr. 1441:10-16

(Paul); Tr. 1590:21-24, 1593:2-9 (Chasen). The gov-

ernment’s expert Dr. Lockwood agreed that intact

removal logically lowers the risk of retained tissue.

Tr. 1769:3-4.

¢ D&E with intact removal takes less operating time

than D&E with dismemberment, and may thus re-

duce bleeding, the risk of infection, and exposure to

anesthesia. 330 F. Supp. 2d at 472 (citing trial testi-

mony of government’s experts Bowes and Lockwood

and Plaintiffs’ experts Grunebaum, Hammond,

Westhoff, Weiss, and Chasen). The government’s

experts agreed that a shorter procedure time is

medically advisable for these reasons. Tr. 1825:21-

1826:9 (government’s expert Lockwood); Tr. 2709:6-

16 (government’s expert Bowes)."'

‘' Contrary to the New York district court’s suggestions and the

government's claims here, see Pet. Br. 37 n.12, Dr. Chasen’s origina! com-

parison study of D&E variants does not belie this evidence. While the

procedure times for the two study groups was the same, the intact D&E

group Was, on average, two weeks further along in pregnancy, meaning

that their procedure times were expected to be longer than the times for

the group that had D&Es with dismemberment. See Tr. 1628:13-1629:19,

1634:5-16, 1680:2-6 (Chasen); Tr. 884:17-885:21 (Westhoff); Tr. 289:14-

291:14 (Grunebaum). The fact that they were not longer indicates that the

intact approach does reduce procedure time for D&E.

18

e Intact removal is less likely to expose the uterus and

cervix to sharp fetal bone and skull fragments. 330

F. Supp. 2d at 471; Tr. 1825:17-20 (government’s ex-

pert Lockwood); Tr. 447:4:-448:19 (Johnson); Tr.

565:7-566:2, 568:19-570:7, 592:2-9 (Hammond); Tr.

1053:11-18, 1058:10-1059:10 (Frederiksen); Tr.

1330:25-1332:8 (Weiss); Tr. 1590:1-17, 1592:9-15,

1611:11-1612:2 (Chasen); Tr. 793:2-794:5, 824:18-825:2

(Westhoff). The government’s experts agreed that

cervical laceration and uterine perforation are risks

of dismemberment D&E. Tr. 2411:9-12 (govern-

ment’s expert Clark); Tr. 1825:9-20 (government’s

expert Lockwood); Tr. 2548:5-23 (government’s ex-

pert Cook). And the evidence showed that sharp fe-

tal fragments are the leading cause of this complica-

tion. Tr. 1058:10-23 (Frederiksen).

The New York record also included testimony regard-

ing Dr. Chasen’s original study, the first peer-reviewed

Study specifically comparing dismemberment and intact re-

moval in D&Es, See Chasen et al., Dilation and evacuation

at > 20 weeks: Comparison of operative techniques, 1180-83,

supra at 13. Experts testified that the study demonstrated

that intact removal is at least as safe as, and probably safer

than, dismemberment in a D&E. Tr. 1612:22-1614:13,

1625:21-1629:14, 1632:3-1633:4, 1634:3-16, 1679:12-1681:8,

1694:18-1695:16 (Chasen); Tr. 838:18-25, 884:17-885:21

(Westhoff); Tr. 289:14-291:14 (Grunebaum); Carhart, 331 F.

Supp. 2d at 962 (government’s expert “Dr. Lockwood testi-

fied that the Chasen study ‘suggests [the intact D&E

method of abortion is] safe” (alteration in original)).

The two patient groups in the study—those who had

relatively intact procedures at a median gestational age of 23

weeks LMP, and those who had dismemberment procedures

at a median gestational age of 21 weeks LMP—experienced

comparable bleeding, procedure times, and complication

rates (although all of the serious complications occurred in

the dismemberment group). Chasen et al., Dilation and

evacuation at > 20 weeks: Comparison of operative tech-

19

niques, at 1182-83 supra at 13. The fact that the complica-

tion rates were comparable was significant because, as Dr.

Chasen and other experts testified, the patients in the intact

group were at greater risk of complications because they

were two weeks further along in pregnancy and the risks of

abortion increase as pregnancy advances. Tr. 805:2-7

(Westhoff). Thus, the intact group would have been ex-

pected to have worse outcomes. Tr. 1625:21-1630:1, 1632:3-

1633:4, 1634:3-16, 1679:12-1681:8, 1694:18-1695:16 (Chasen);

Tr. 884:17-885:21 (Westhoff); Tr. 289:14-291:14 (Grunebaum).

The fact that they did not “provide[s] medical support for

the conclusion that intact D&E is a safe, and sometimes nec-

essary, procedure.” PPFA, 320 F. Supp. 2d at 1034.

Third, the New York record also included abundant

evidence that intact removal may be the safest option for

women with certain medical conditions who are terminating

their pregnancies. In such cases, the benefits described

above are particularly important given the patient’s already

compromised medical state and increased vulnerability to

catastrophic complications. These conditions include, for ex-

ample, being prone to or having infection, NAF’, 330 F. Supp.

2d at 473; Tr. 1826:16-1827:9 (government’s expert Lock-

wood); experiencing, or being at risk for, chorioamnionitis, a

potentially deadly infection of the amniotic fluid and mem-

branes that, among other things, increases the risk of uter-

ine perforation, NAF’, 330 F. Supp. 2d at 473; Tr. 1825:9-20,

1826:16-1827:20 (government’s expert Lockwood); Tr.

588:19-590:7 (Hammond); being otherwise at risk of hemor-

rhage, NAF’, 330 F. Supp. 2d at 473 (citing Hammond); hav-

ing compromised immune systems, id.; and being prone to

perforation or having uterine scarring, id. (citing inter alia

government’s expert Lockwood); Tr. 1335:18-1336:5 (Weiss);

see also Tr. 1056:14-24 (Frederiksen). In addition, ACOG’s

expert panel pointed to numerous such conditions that make

intact D&E the safest abortion method for certain patients.

See, e.g., Tr. 153:10-20, 154:16-23, 158:13-21, 185:2-18 (ACOG

representative Cain). In addition to these conditions, there

was also testimony in New York that D&E with intact re-

moval could benefit women carrying fetuses with certain

20)

anomalies, such as hydrocephaly (which greatly enlarges the

fetal head), NAF, 330 F. Supp. 2d at 473 (citing govern-

ment’s and Plaintiffs’ experts), and that it may also help in

the post-abortion pathological diagnosis of certain fetal con-

ditions. See id. (citing Westhoff).

BS * *

In sum, there was ample evidence in New York from

highly credentialed experts on both sides to support the con-

clusion that banning intact D&E without a health exception

creates “unnecessary risk of tragic health consequences.”

Stenberg, 530 U.S. at 937. The evidence showed that the

unique advantages of intact removal—reduction of instru-

ment passes, fetal fragmentation, and procedure time—

minimize the likelihood of complications that, while perhaps

infrequent in an absolute sense, are potentially catastrophic

in the very real cases when they do occur. The potential

consequences of these complications include hemorrhage,

overwhelming and systemic infection, and infertility. NAF,

330 F. Supp. 2d at 471-72; supra at 16-18 Such potentially

catastrophic complications are no less constitutionally cogni-

zable simply because they are, fortunately, rare."

C. The New York District Court’s Characterization

of Some of the Evidence Does Not Undermine Its

Central Conclusion That Substantial Medical

Evidence Supports the Safety Advantages of In-

tact D&E.

Contrary to the government’s suggestion, see Pet. Br.

40-41, the New York court did not reject the essential safety

benefits on which Plaintiffs’ case rested. While the court

opined that certain of Plaintiffs’ proffered reasons for their

belief in the safety advantages of intact D&E were “not

credible” or even “false,” the court did not so characterize

"This court's precedent offers no support for the suggestion in

Chief Judge Walker’s Second Circuit concurrence that procedures that

reduce such complications offer only “marginal” and constitutionally in-

significant benefits. NAF, 437 F.3d at 291.

21

the health benefits described above. Moreover, the court

. also found that Congress was “unreasonable” in concluding

that there is “no credible medical evidence” that intact

D&Es offer safety advantages. 330 F. Supp. 2d at 489. In so

holding, the court necessarily found that credible medical

evidence disproved Congress’s false “findings.”

The New York court did not state that any specific rea-

son Plaintiffs offered in support of the medical advantages of

intact procedures was “false” or “not credible.” Instead, it

merely noted that these advantages were “theoretical” or

“hypothetical” because they were based on physician ex-

perience, and had not yet been proven by controlled stud-

ies—studies this Court has made clear are not necessary to

support the need for a health exception.

As this Court held in Stenberg, the “absence of con-

trolled medical studies” cannot defeat the need for a health

exception. See 530 U.S. at 936-37. This Court, and lower

courts, have never required that medical benefits be proven

through studies as a prerequisite to invalidating bans on

abortion procedures. In fact, banning a procedure would

perversely preclude such studies ever being conducted. As

this Court explained in Stenberg, “[mJedical treatments and

procedures are often considered appropriate (or inappropri-

ate) in light of estimated comparative health risks (and

health benefits) in particular cases.” Jd. at 937 (emphasis

added); see also Planned Parenthood v. Danforth, 428 U.S.

52, 77-78 (1976) (invalidating ban on saline abortions despite

absence of studies demonstrating comparative benefits of

saline versus prostaglandin induction); Planned Parent-

The trial court in Danforth heard testimony from two plaintiff-

physicians and from four physicians who supported the ban. See Brief of

John C. Danforth, Attorney General of Missouri, Danforth, 428 U.S. 52

(1976) (No. 74-1151, 74-1419), at 58-68; Brief for Planned Parenthood of

Central Missouri, David Hall, M.D., and Michael Freiman, M.D., Danforth,

428 U.S. 52 (1976), (No. 74-1151, 74-1419), at 123-25; see also Brief as

Amici Curiae for Planned Parenthood Federation of America, Inc., Asso-

ciation of Planned Parenthood Physicians, Ine. and Certain Medical School

22

hood v. Taft, 444 F.3d 502, 513 (6th Cir. 2006) (invalidating

ban on alternative protocol for administering abortion drug

after concluding that “studies are not necessary where there

is expert testimony that a restricted procedure is safer than

the alternatives”); Wynn v. Scott, 449 F. Supp. 1302, 1326

(N.D. Ill. 1978) (invalidating saline abortion ban on the basis

of physician affidavits and drug manufacturer’s description

without studies in the record).

Evidence presented in the New York trial explained

why requiring definitive controlled studies of intact D&E at

this point would be unreasonable and at odds with the way

medical innovations typically develop. Dr. Sherwin Nuland,

formerly a practicing surgeon and now a professor of bio-

ethics and medical history at Yale Medical School, testified

that innovative surgical techniques such as intact D&E arise

through a “process bf evolution,” proceeding from the initial

flash of insight, then spreading within the profession by

word of mouth, and moving gradually to scientific study with

retrospective peer-reviewed reports and case studies (the

current status of research relating to intact D&E), and only

much later (and only if possible) to controlled experimenta-

tion. Tr. 69:21-73:2. Controlled studies require a sufficient

sample size, which might be difficult to achieve here given

the relative infrequency of second-trimester abortion by any

method, and, in particular, the relative rarity of complica-

tions. Jd. at 79:25-80:7. This limitation exists for any study

of second-trimester abortion. See, e.g., Tr. 1822:12-15 (gov-

ernment’s expert Lockwood).'* Given this limitation, the

New York court's criticism of Plaintiffs’ failure to provide

controlled studies demonstrating that D&E with intact re-

Deans, Professors and Individual Physicians, Danforth, 428 U.S. 52 (1976),

(No. 74-1151, 74-1419), at Point I.

'* For example, the government’s expert Dr. Lockwood was unable

to identify any randomized, controlled studies supporting his opinion that

there may be safety advantages Lo induction abortion over surgical abor-

tion after 20 weeks LMP.

23

moval lessens the risk of already-rare complications is mis-

placed.

The New York court also inappropriately relied on the

views of a single government witness, Dr. Clark, to discredit

Plaintiffs’ experts’ testimony supporting the safety advan-

tages of intact D&E. Dr. Clark, who admitted to being only

moderately skilled in performing abortions, Tr. 2399:19-24,

contended that certain specific health conditions would not

“necessitate” a D&E with intact removal. However, the

conditions on which his testimony focused were not among

those Plaintiffs had offered to support the greater safety of

intact D&E. Instead, they included conditions Plaintiffs had

offered as examples of why women obtain second-trimester

abortions generally, or of why surgical D&E offers advan-

tages over induction abortion.'’ Even the government’s own

witness, Dr. Lockwood, agreed that there may be advan-

tages to intact removal over dismemberment in some cases.

Dr. Lockwood specifically noted such potential advantages

for women suffering from chorioamnionitis, a potentially

deadly infection of the amniotic fluid and membranes that,

among other things, increases the risk of uterine perforation.

Tr. 1826:16-1827:18 (government’s expert Lockwood). Dr.

Clark’s testimony notwithstanding, the New York court

clearly recognized that the evidence demonstrated “a divi-

sion of medical opinion” regarding the advantages of intact

D&E for women with certain health :onditions, such as

“uterine scarring, placenta previa, preeclampsia, bleeding

disorders, and infections”—a division that requires an ex-

ception to preserve women’s health. NAF, 330 F. Supp. 2d

at 481.

* See e.y., Tr. 1017:11-21 (Westhoff) (peripartum cardiomyopathy as

example of condition that prompts some women to terminate pregnancy in

the second trimester); Tr. 594:10-17 (Hammond) (Von Willebran’s disease

as example of condition that makes surgical approach (i.e., D&E) far pref-

erable to induction abortion); Tr. 2332:20-2334:5; 2349:24-2350:14 (govern-

ment’s expert Clark opining that that neither peripartum cardiomyopathy

nor Von Willebran’s disease necessitates intact D&E).

24

Finally, the Nebraska and California courts, both of

which heard the same evidence, were untroubled by the ab-

sence of controlled studies or the consequently “theoretical”

nature of the proffered health advantages of intact D&E,

which advantages they found compelling. After hearing the

testimony of substantially the same witnesses who testified

in New York, both the California and Nebraska courts

“flou)nd[] that intact D&E is in fact the safest medical option

...in some circumstances and is significantly safer than in-

duction, hysterotomy, or hysterectomy for terminating a

second trimester pregnancy, and under certain circum-

stances, also significantly safer than D&E by disarticula-

tion.” PPFA, 320 F. Supp. 2d at 1002; see also Carhart, 331

F. Supp. 2d at 1018. Both courts also found that Plaintiffs’

witnesses’ “expertise in recommending and performing

D&E and intact D&Es is unassailable ....” PPFA, 320 F.

Supp. 2d at 1001 (“(T)he court accepts their testimony over

that of the government witnesses, who... were not qualified

to testify as experts on the practice.”); see also Carhart, 331

F. Supp. 2d at 1025 (“In order to find that” D&E with intact

removal does not bring safety advantages, “one would have

to dismiss the views of highly trained and very experienced

physicians . . . who have detailed knowledge of the surgical

methods under discussion [and] would have to accept the

contrary views of doctors ... who have virtually no experi-

ence with abortions. Choosing... this nadir of inexperience

... would be plainly unreasonable.”) These contrary findings

cast serious doubt on the New York court’s view of some

aspects of the evidence.

CONCLUSION

For the reasons set forth above, and in the Brief for the

Respondents, the Court should affirm the judgment of the

court of appeals.

A. STEPHEN HUT

KIMBERLY PARKER

AMY KREIGER WIGMORE

KAREN C. DALY

JESSICA L. WATERS

Respectfully submitted,

TALCOTT CAMP

Counsel of Record

BRIGITTE AMIRI

REPRODUCTIVE FREEDOM

PROJECT

WILMER CUTLER PICKERING AMERICAN CIVIL LIBERTIES

HALE AND DORR LLP

UNION FOUNDATION

1875 Pennsylvania Ave., N.W.125 Broad Street

Washington, DC 20006

(202) 663-6000

LORIE A. CHAITEN

THE ROGER BALDWIN

FOUNDATION OF ACLU, INC.

180 N. Michigan Ave.

Suite 2300

Chicago, IL 60601

(312) 201-9740

AUGUST 2006

New York, NY 10004

(212) 549-2633

‘ELISABETH RYDEN BENJAMIN

GALEN LEIGH SHERWIN

NEW YORK CIVIL LIBERTIES

UNION FOUNDATION

125 Broad Street

New York, NY 10004

(212) 344-3005

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APPENDIX

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF NEW YORK

03 Civ. 8695 (RCC)

NATIONAL ABORTION FEDERATION, MARK I.

EVANS, M.D., CAROLYN WESTHOFF, M.D., MSC;

CASSING HAMMOND, M.D., MARK HELLER, M.D.,

TIMOTHY R.B. JOHNSON, M.D., STEPHEN CHASEN,

M.D., GERSON WEISS, M.D., ON BEHALF OF THEMSELVES

AND THEIR PATIENTS,

Petitioners,

V.

JOHN ASHCROFT, IN HIS OFFICIAL CAPACITY AS

ATTORNEY GENERAL OF THE U.S., ALONG WITH HIS

OFFICERS, AGENTS, SERVANT, EMPLOYEES, AND

SUCCESSORS IN OFFICE,

Defendants.

New York, N.Y.

Before:

HON. RICHARD CONWAY CASEY

District Judge

TRIAL TRANSCRIPT EXCERPTS

MARCH 29, 2004

[69:8-14] (Nuland)

MS. WIGMORE: Your Honor, | think we would be comfort-

able in offering him as an expert in the evolution of surgical

procedures, if counsel for the defense has no objection.

MR. LANE: We have no objection.

THE COURT: Their having no objection, he will be ac-

knowledged as an expert in that limited field.

2a

[69:21-73:2] (Nuland)

Q. Have you formed an opinion regarding how surgical pro-

cedures change and develop?

A. Yes.

Q. What is your opinion?

A. Surgical! procedures by their very nature historically and

[70] currently come to be by a process of evolution. What

essentially happens is that based on the technology of the

particular era in which surgeons are working, one or two or

several begin to conceive that a certain procedure might

make some sense. It might make sense physiologically,

might make sense therapeutically, might make sense techni-

cally, and might perhaps be done with a significant degree of

safety.

They begin doing those procedures primarily, histori-

cally, on human beings rather than animals. They may test

the technique itself on animals, but the important thing is

that the physiological results can only be tested on humans.

So that will be done.

When word gets out by word of mouth, medical meet-

ings, perhaps a letter, perhaps a phone call, perhaps a very

preliminary report in a journal, others will come to watch

what they are doing, will meet with them at medical meet-

ings, decide whether these procedures have the merit that

the originators claim, and then go back to their own institu-

tions and do those things.

Ordinarily, it is customary to keep scrupulous records of

the way these new procedures are being done so that in

time, when there is a sufficient number of them to judge

whether they have true value and are truly safe, in time

there will be a publication.

Q. Doctor, can you give us any examples of surgical tech-

niques [71] that have evolved in the manner you have de-

scribed.

A. Virtually every surgical technique has evolved precisely

that way. We can take something as large as cardiac sur-

gery in general, but we don’t we restrict it to open-heart

3a

surgery, which I had the opportunity to be involved with at

the very beginning, so that I can speak not only as an ob-

server but as a participant.

Q. Can you describe for us how that developed.

A. The notion had long been about that if one could simply

prevent blood from getting into the heart, certain diseased

parts of the heart, whether they were congenital disease or

acquired disease, could be treated. A valve, for example,

could be repaired or a hole between the two sides of the

heart could be closed. But for that to happen, it was neces-

sary that the heart be emptied of blood, then one could open

it and do what was needed.

Of course, for that to happen, a big piece of technology

was required. Someone had to invent and build what is

called a heart-lung machine, a machine that could both pump

the blood and oxygenate it at the same time, so that one

could remove the blood from the body before it got to the

heart, then return it beyond the anatomical point where the

heart is and pump it at the same time.

That took many years in the development. Actually,

there is one single person who eventually developed that

[72] technology, a man named John Gibbon in Philadelphia.

His progress was watched by a lot of others. When that ma-

chine was satisfactorily conceived and built and he had oper-

ated on a few patients, others began to engineer their own

modifications of that equipment, go back to their own insti-

tutions, and operate on patients.

Some of those patients had been operated on before the

machine was generally available. With so-called cross-

circulation techniques, you would use another person’s heart

to pump the blood, another person’s lungs to oxygenate it.

But essentially what we were really waiting for was this

heart-lung machine.

So Gibbon creates it, engineers it, designs it, and every-

body copies it. I well remember, as a young fellow in train-

ing, a fellow in the cardiac laboratory at that time, visiting

other institutions to watch their innovations, before we in

4a

our institution—actually I can tell you the date, it was De-

cember 8, 1956—finally went ahead and did our first proce-

dure.

At that point there were short papers—well, there were

also long papers, but there were short groups, rather small

groups of patients that had been operated on at different

centers. The primary center at that time was the University

of Minnesota under the leadership of pioneers in this field.

THE COURT: Under who?

[73] THE WITNESS: The leadership of certain pioneers in

the field.

[79:25-80:7] (Nuland)

Q. In your opinion, would it be reasonable to require a con-

trolled study demonstrating the safety of a surgical tech-

nique before allowing that technique to be widely used on

human patients?

A. I consider that a contradiction in terms, because how can

in surgery a controlled study be done unless there have been

a statistically significant number of people who have under-

gone that procedure?

[153:10-20] (Cain)

“Q. What did the tax force discuss with respect to safety?

“A. Numerous examples were raised by the members of the

task force regarding different procedures and specific cases

and issues of safety. For example, in GYN oncology the

most pertinent example would be triploidy, which is a form

of cancer of the placenta often diagnosed in the second tri-

mester with severe preeclampsia. In that case, the least

amount of instrumentation possible of the uterine wall is de-

sirable. So it is much safer for the woman to have an intact

D&X to remove the pregnancy. So multiple issues were

used to explore issues of safety at the time and in compari-

son to other procedures.

[154:16-23] (Cain)

“Q. Well, if you want to look at Exhibit 7, I'll go a little

above that, “Terminating a pregnancy is indicated in some

5a

circumstances to save the life or preserve the health of the

mother.’ This was obviously a conclusion of the select panel,

is that correct?

“A. That is correct, and we could identify numerous circum-

stances in which this might be the best procedure for that.

Rare, but still numerous.

{158:13-21] (Cain)

“Q. Are you aware of any analysis or study—let’s strike that

and say, are you aware of any study which supports the con-

clusion that intact D&X may be the best or most appropriate

procedure in certain circumstances?

“A. I'm not aware of a study. I am well aware of multiple

circumstances that an expert panel could identify at the time

of the task force, where it was clearly the best choice, includ-

ing in my field, where the other options led to a higher like- .

lihood of death or recurrence of disease.

[185:2-18] (Cain)

“Q. Okay. And what are some aspects of the D&X proce-

dure that might lead a physician to conclude that D&X is the ,

best or most appropriate abortion procedure to save the life

or preserve the health of a woman?

“A. One of the elements that came up among the different

and numerous examples was the decreased instrumentation

and ability to preserve relatively intact fetus for evaluation,

particularly for some genetic-based congenital anomalies.

“Q. Why would less instrumentation be beneficial?

“A. It depends on the circumstance. In the circumstance of

septic abortions, any increase in instrumentation might in-

crease the ability of bacteria to enter the blood stream.

In the case of tropoblastic disease, increased

instrumentation is likely to transport tropoblastic disease,

which is a form of cancer, to other areas such as the lung.

MARCH 30, 2004

[210:8-213:12] (Grunebaum)

6a

Q. Approximately how many abortions have you performed

throughout your career?

A. I started with my medical school in 1968, and attended

abortions throughout my medical school and after I finished

medical school. So it’s about 36 years that I have been doing

them, probably about a thousand abortions just as a ball-

park. But it is difficult to be very precise.

Q. Of the abortions that you perform in your current prac-

tice, approximately what percentage of those are abortions

regarding wanted pregnancies?

A. The majority of the abortions that I perform in my prac-

tice over the last three years are wanted pregnancies,

probably well over 95 percent.

Q. What types of abortions have you performed?

A. I have performed different kinds of abortions. We just

described a dilatation and curettage, which is the form of

abortion done in the first trimester. That procedure be-

comes more dangerous as pregnancy progresses, usually af-

ter 12 weeks. [211] At that time the options for abortions at

that point are usually induction abortions or an abortion

called D&E, dilatation and evacuation.

Q. What is an induction abortion?

A. An induction abortion is a type of abortion where labor is

being induced, and after the woman has gone through a pe-

riod of labor the cervix dilates and the fetus and the placenta

are being expelled.

Q. Doctor, you have used the term “die-latation,” “di-

latation.” What does that refer to?

A. “Dilatation” stands for opening. In the case of the cervix,

it is the opening of the cervix by different means.

Q. Is that ever referred to as “dilation”?

A. Yes.

Q. You mentioned that you perform dilation and evacuation,

or D&E’s. What are those procedures?

A. A D&E is a form of abortion which is usually done in the

second trimester of the pregnancy, which usually begins

Ta

around 13 to 14 weeks of the pregnancy. In a D&E, as the

first word refers, the cervix is being dilated. What we do

now days is we dilate the cervix with small laminaria, we call

them, small sticks about a couple of millimeters thick and

probably an inch or so long, which we insert into the cervix

and leave in the cervix overnight. And sometimes we repeat

that procedure the next day.

[212] Q. Are you familiar with the term “intact D&E”?

A. Yes, I am.

Q. What is an intact D&E?

A. As I explained before, D&E is a form of a termination of

a pregnancy, an abortion, in the second trimester. The in-

tact D&E is one version how to perform a D&E.

Q. How does that version proceed?

A. In an intact D&E the fetus is removed intact, as the

word says. As compared to the other version of the D&E,

where the fetus is removed in portions, and the medical term

for that is dismemberment”.

Q. Dr. Grunebaum, have you performed intact D&E’s?

A. Yes, I did.

Q. How did you learn to perform intact D&E’s?

A. I saw my first intact D&E’s shortly after I arrived at

New York Hospital, I believe in the year 2001, when I first

saw them. And I learned them in the year 2002.

Q. Is New York Hospital affiliated with New York-

Presbyterian Hospital?

A. It is one hospital system, but there are two hospitals that

have merged several years back. One is called Presbyterian,

the other one is called New York Hospital.

Q. Is New York Hospital affiliated with any medical school?

A. Yes, it is.

Q. With what medical school?

{213} A. Cornell.

Q. Did you receive training in the intact D&E procedure

while you were working at Cornell?

8a

A. Yes, I did.

Q. Approximately how many D&Es have you performed

since joining the faculty at New York Presbyterian hospital?

A. I have performed or performed myself approximately 15

to 20 D&E’s.

Q. 15 to 20 intact?

A. Intact D&E’s, correct.

Q. How many D&E’s of all types have you performed?

A. Approximately 100.

[223:25-224:16] (Grunebaum)

Q. Doctor, do you have an opinion as to whether D&E offers

any [224] safety advantages over induction?

A. Yes: It does.

Q. What are those advantages?

A. Let me first start with contraindications for induction

termination of pregnancy. The contraindications for induc-

tion termination of pregnancy include a prior scar in the

uterus, specifically if the scar is from what we call a classical

Cesarean section, is if a woman in a pregnancy has had a

classical Cesarean section.

It is called “classical” because that is the first form of

Cesarean section, which we started to do approximately 150

years ago. That is an incision in the uterus which is vertical

in the top of the uterus. The reason why we cannot do an

induction in those women is because a vertical uterine inci-

sion is more likely to rupture when a woman goes into labor.

And if it ruptures, she can die, bleed out.

{231:23] (Grunebaum)

A. The intact D&E is just one variation of the D&E per se.

(235:18-23] (Grunebaum)

Q. What are those advantages, Doctor?

A. The major advantage that you really don't have to use

much instruments. Every time you place an instrument into

the uterus, you increase the risk of perforating the uterus.

9a

It is always easier in most or in many medical procedures to

remove something you want to remove in an intact way.

[248:13-249:9] (Grunebaum)

Q. Are there any other advantages of intact D&E over dis-

memberment D&E?

A. Yes. When you break off portions of the fetus you need

to ensure that at the end of the procedure all portions have

been removed from the uterus.

The reason why that is important is that if you leave

anything behind it increases the risk of an infection. You

want to ensure at the end of the procedure one of the most

important things you do at the end of a, as a dismemberment

D&E proceeds and that’s actually the part which takes the

longest, is to ensure that even the small portions are being

removed. :

So, you need to go in again and again and again with in-

struments to make sure that all of these portions are re-

moved [249] to decrease the risk of infection and of potential

risk of bleeding because retained fetal portions can lead to

infection and can lead to bleeding. And, at its worse, they

can lead to a woman’s infertility.

So that actually, that portion of ensuring completeness

with the dismemberment D&E takes up a good portion of

the procedure.

_ And then, after you finish with that part you need to

remove the placenta too.

[289:14-291:14] (Grunebaum)

Q. Dr. Grunebaum, are you aware of any studies comparing

the relative safety of intact D&E with dismemberment

D&E?

A. Yes, I am.

Q. Which study are you aware of?

A. There is a study about to be published with Dr. Chasen

as the lead author, I believe.

Q. Could you please describe for us that study generally.

10a

A. That study in general looked retrospectively at women

who underwent dilatation and evacuation for termination of

pregnancy. It then compared the dismemberment variant to

the intact D&E variant.

Q. When you say the study looked retrospectively, what do

you [290] mean?

A. Retrospectively is you identify people who undergo a

certain procedure or who are under certain situations. Then

you abstract information from those medical records and

then you compare them with each other.

Q. In the course of your medical practice, have you relied on

retrospective studies?

A. All the time.

Q. What were the results of Dr. Chasen's study regarding

the comparison of intact D&E and dismemberment D&E?

A. I can give you the general gist. My understanding from

the study is that both forms of D&E are safe.

Q. What, if any, impact does Dr. Chasen’s study have on

your opinion concerning the relative safety of intact D&E

and D&E involving dismemberment?

A. It confirms what I said previously, that the intact D&E is

as safe or even safer than the dismemberment D&E.

Q. Did Dr. Chasen’s study conclude that there was any dif-

ference in complication rates for D&E versus intact D&E?

A. Not that I can recall. :

Q. What is your basis for concluding that intact D&E offers

safety advantages over dismemberment D&E?

A. The study shows that both dismemberment D&E and

intact D&E have similar outcomes. But the groups that

have been compared in that study are slightly different

groups and they differ [291] mostly as to the gestational age

of the pregnancies. The average gestation age of the pa-

tients in the intact D&E group were slightly more advanced.

THE COURT: Slightly more what?

lla

A. More advanced in pregnancy. I believe they were 23

weeks on average as compared to 21 weeks in the dismem-

berment D&E.

Q. Do the risks of abortion change at all with the advance-

ment of gestational age?

A. Absolutely. They increase as the gestational age ad-

vances. For example, an abortion done at 20 weeks is less

risky than that done at 21 weeks, 22 weeks. The reason for

that is as we explained before. The fetus is bigger, the pla-

centa is bigger, and the uterus is more distended, so you

would expect at a more advanced gestation age more com-

plications.

[298:21-299:8] (Grunebaum)

Q. Dr. Grunebaum, I want to focus your attention now on

D&E’s involving dismemberment. Do you have any fear of

prosecution under the Act if you were to perform a D&E

involving dismemberment?

A. Yes, I have.

[299] Q. Why is that the case?

A. Because in a dismemberment procedure, more or less the

same as is described under what this Act calls a partial-birth

abortion, and I can only read again, “The term ‘partial-birth

abortion’ means an abortion in which a person deliberately

performing the abortion deliberately and intentionally vagi-

nally delivers a living fetus.” That is what I do in a partial-

birth abortion, in a dismemberment D&E also.

[307:17-308:4] (Grunebaum)

Q. Doctor, are you familiar with the term “spontaneous

abortion”?

A. Yes. The other word for spontaneous abortion is also a

“miscarriage.”

Q. What is a miscarriage?

A. A miscarriage is when a woman loses her pregnancy

without any act of intervention by anyone.

Q. Do physicians have any role in treating miscarriages?

12a

A. That is one of our major jobs, treating women who have a

[308] miscarriage.

Q. Doctor, do you have any fear of prosecution under the

Act associated with your treatment of miscarriages?

A. Yes, I do.

[312:1-7] (Grunebaum)

Q. Doctor, in terms of the patients whom you have seen

were having spontaneous abortions, do any of them come in

when the fetus is still living?

A. Yes.

Q. Have you ever had to perform any medical procedures to

manage that process?

A. Yes.

MACH 31, 2004

{396:4-400:11] (Johnson)

Q. Do you perform abortion procedures, Doctor?

A. I do; yes, sir.

Q. What types of abortion procedures do you do?

A. Currently I am involved, because of my call schedule,

only in medical induction procedures.

Q. Do you have privileges to perform surgical procedures?

A. Yes, sir.

Q. And what about your call schedule involves you only in

medical induction procedures?

A. Well, currently because of my administrative and day-

time duties | take call usually on, on the evening or on week-

ends. I don’t cover the operating rooms or the units during

the daytime, which is the time that surgical procedures are

carried out.

So, because of that the patients that I see are patients

who are admitted for medical induction during my time on

call.

Q. Prior to your current schedule and in the past, what

types of abortions have you performed?

18a

A. Both medical and surgical abortions, first and second

trimester.

Q. And by medical abortions in the second trimester, can

you [397] again tell the Court what you mean?

A. I am talking about abortion inductions that are induced

using medications, using drugs to induce labor and to cause

delivery.

Q. And by surgical procedures in the second trimester, what

do you mean by that, sir? .

A. Surgical procedures would be operative procedures to

perform evaluation of the uterus, so, D&E procedures.

Q. Do you manage spontaneous abortions in the course of

your practice?

A. Yes, sir.

Q. How do you do those procedures?

A. Those patients present to the emergency department—

generally occasionally to labor and delivery—but to one of

our acute triage units, and they’re evaluated and then I

would participate in their management.

Q. Have you had any training, Dr. Johnson, in abortion pro-

cedure?

A. Yes, sir.

Q. Could you describe it for the Court, please?

A. Well, as a resident and as a fellow I received didactic—

THE COURT: Can you tell us where it occurred and when

it occurred?

THE WITNESS: Sure. As a resident from 1975 to 1979 we

had lectures, [898] directed readings and were involved in

abortion procedures at University Hospital. Those were—

THE COURT: That was in Virginia?

THE WITNESS: No, that was at the University of Michi-

gan.

THE COURT: University of Michigan.

THE WITNESS: When I was a resident between ’75 and

79; so at that time most of those procedures were mid-

l4a

trimester procedures because of the practice in the hospital.

I had some experience at Planned Parenthood with first tri-

mester procedures as a resident.

Subsequently, from 1979 to 1981, at Hopkins, I received

further training. At the time, from 1979 to 1981, Hopkins

had a large abortion research unit and the fellows, including

myself, were responsible for managing the complications in

that unit, managing the problems in that unit, doing any

procedures that needed to be done in that unit at night when

we were in-house managing those patients.

Since then I have continued reading the medical litera-

ture and attending conferences, attending quality assurance

meetings, departmental meetings, and continued to be in-

volved in the education and training of our residents who

participate in abortion training in our institution.

Q. You made reference in that answer, Dr. Johnson, to the

mid-trimester, I’m not sure we have heard that word, what

is [399] the mid-trimester of pregnancy?

A. Considered generally from 12 to 24 weeks, but often in

terms of the management we are talking more like 14, 15

weeks until 24 weeks.

Q. And the mid-trimester is synonymous with the second

trimester, is that correct?

A. Correct, yes.

Q. Are you familiar with a variation of the D&E procedure

known as the intact dilation and evacuation, or intact D&E?

A. Yes, sir.

Q. Have you observed performance of the intact variation of

D&E?

A. Yes, sir.

Q. Where did that occur?

A. At affiliated—at training sites that we have a relation-

ship with at our institution.

Q. With respect to—

THE COURT: Where, specifically, Doctor?

15a

THE WITNESS: Well, I’m afraid to identify that place be-

cause I’m concerned that my residents and my colleagues

who are working there could be identified and targeted as -

if that were, became widely known.

MR. HUT: Your Honor, would it be possible at this point

perhaps to approach and have the court reporter, if this

would be satisfactory to Dr. Johnson, transcribe it only in

the [400] presence of the Court and the government, rather

than in the full courtroom?

THE COURT: Before we do that, let me understand your

concern about the safety of your colleagues.

THE WITNESS: Yes, sir. We have a very smal! commu-

nity—

THE COURT: I didn’t ask you—

THE WITNESS: I am afraid that my colleagues could be

identified if it were known where they were doing their

training in their abortions.

THE COURT: All right, I will take it at sidebar.

[421:4-6] (Johnson)

A. Yes. I think that D&E procedure compares favorably to

medical induction, especially in the period from 16 to 20

weeks. It has relative safety benefits and other benefits.

[447:4-448:19] (Johnson)

Q. Dr. Johnson, what is uterine perforation?

A. Uterine perforation describes a condition where an in-

strument or an object goes through the uterine muscle.

Q. What, if any, health risks are associated with uterine per-

foration, in your judgment?

A. Well, the risks would be either bleeding or infection.

Perforation site can lead to bleeding, the bleeding can be ei-

ther intraperitoneal bleeding or intrauterine vaginal bleed-

ing, infection.

Perforation can either introduce infection into the

uterus or introduce infection outside the uterus into the

peritoneal cavity.

16a

Those would be the major complications of uterine per-

foration.

Q. As between the intact variation of D&E and the dismem-

berment variation, do you have an opinion which, if involve

less risk of uterine perforation?

A. Yes.

It would be my opinion that the intact procedure would

carry less risk.

Q. What causes the lesser risk in your opinion, Doctor?

A. Well, there are two potential items that can perforate the

[448] uterus during a D&E procedure. One would be the

instruments themselves and those instruments, with each

passage into the uterus have a, have the potential to perfo-

rate the uterus so that an intact procedure would reduce the

number of passes of the instruments and reduce the risk of

perforation with the instruments.

In addition, the dismemberment procedure leads to fetal

parts, bony parts, the head, various other body parts that

can, themselves, cause perforation.

Long bones, sharp bones can actually perforate the

uterus, can go al] the way through the uterus either to the

broad ligament, to the round ligament, or to the abdominal

cavity during the course of the procedure.

So, in addition, as one attempts to get those uterine

parts, extra passages with the instruments can lead to fur-

ther risk. So, it’s repetitive passages of the instruments to

complete the procedure to retrieve parts that may be miss-

ing, and then finally those parts themselves that can move

outside the uterus as part of the process.

[453:19-21] (Johnson)

A. Yes. | think there are a substantial number of practicing

OB-GYNs who believe that the intact D&E procedure has

benefits compared to the traditional dismemberment proce-

dure.

[479:18-23)} (Johnson)

—_—_—_—— ee ss Oe - - ——_- ——_—_—_— —— eae aS eee —___> -——- s + — = —

17a

THE WITNESS: What I mean by that is that the people:

who do our D&E procedures try to deliver the fetus as in-

tact as possible with as few procedures as possible. So if, as

they do the procedure, if they are able to deliver the fetus

intact, that would be fine. The fewer number of passes to do

a dismemberment D&E is always our goal.

{526:1-530:8] (Hammond)

Q. And you have testified that you perform abortions; how

long have you been performing abortions?

A. I began providing pregnancy terminations in the first

year of my residency. I have continued since that time, so

approximately 15 years.

Q. And what types of abortions have you performed over

the course of your career?

A. I have provided both medical abortions and also surgical

abortions.

Q. Can you describe for me what you mean by medical and

surgical abortions, please?

A. Well, medical abortion involves giving some kind of

medication or drug to induce abortion. So, in the first tri-

mester of pregnancy you are inducing something akin to a

In the second trimester of pregnancy you are, in es-

sence, inducing labor to cause a patient to deliver.

For surgical abortions, typically in the first trimester

this involves suction curettage where we vacuum the uterine

lining.

In the second trimester pregnancy it involves a per-

formance of the procedure dilation and evacuation, com-

monly abbreviated D&E.

Q. Doctor, do you currently perform each of these types of

abortions?

[527] A. Yes, I do.

Q. And approximately how many abortions have you per-

formed in your career?

18a

A. I have performed at least approximately 3,000 abortions

since beginning my residency and probably a thousand or

more D&Es.

Q. How frequently do you currently perform abortions?

A. I am currently scheduled to perform abortions each

Tuesday and also each Friday; they are referred to the fam-

ily planning service.

We often have to add extra procedures in because of the

nature of our practice, so we will occasionally add them in

that have to be done sooner and other times of the week, or

even the weekend.

Q. What type of abortions are you currently providing in

your practice?

A. Really ali types I have been trained to do, so both medi-

cal and surgical abortions in the first as well as the second

trimester.

Q. So that would include the procedures you have described

for us a few minutes ago, the suction curettage and the

medica! abortion in the first trimester, and the dilation and

evacuation and labor induction procedure in the second tri-

mester; is that correct?

A. That is correct.

[528] Q. Doctor, what gestational ages do you perform abor-

tions?

A. We currently provide abortions from very early in gesta-

tion, really as early as the pregnancy is diagnosed. So, ap-

proximately five weeks until 24 weeks.

Q. Do you have formal training in providing abortion care?

A. Yes, I do.

Q. Can you describe that for us?

A. Well, 1 received training when I was a resident in obstet-

rics and gynecology.

When | was at the University of Rochester obtaining

training abortion training was optional but was routinely

provided to residents, and I chose to learn how to do this.

19a

So, I was trained in my residency program to provide surgi-

ca] abortion through approximately 20 weeks’ gestation.

THE COURT: Ms. Chaiten, is this a convenient time to take

our afternoon break? Or do you have a little bit more you

would like to do on this?

MS. CHAITEN: Your Honor, if I might just ask one follow

up question and then it would be a fine time to take a break.

THE COURT: Of course. Go ride ahead.

BY MS. CHAITEN:

Q. Have you received any additional training in abortion

care?

A. Yes, I have. After I finished residency I continued to

provide [529] abortion care, but when I moved to North-

western University had really only been trained through

approximately 20 weeks’ gestation.

At that point my boss was Dr. Marilyn Frederikson, she

needed something to be able to assist with these procedures

because there is a lack of people out there who are actually

trained to do them. And she—in essence I was an appren-

tice to her as I gradually advanced the gestational age at

which I was comfortable to 22 weeks.

And then, after approximately 2001, gradually advanced

my comfort level, had advanced my comfort level to 24

weeks.

MS. CHAITEN: Your Honor, this would be a fine time to

take a break.

THE COURT: Fine. The Court will stand in recess.

(Recess)

THE COURT: Before we continue I thought I would just

tell all of you that having experienced two days of listening

to this testimony, I would tell you in advance that when the

hearing or trial was concluded I still want summations but

I’m going to require written submissions on findings of fact

and conclusions of law, which I am going to--at the time, I

won't set a date of course—but it will be at the moment 10

.

days after the conclusion of the hearing, all right? Ms.

Chaiten, you may inquire.

MS. CHAITEN: Thank you, your Honor.

[530] BY MS. CHAITEN:

Dr. Hammona, you testified earlier that you performed pro-

cedures called D&E, is that correct?

A. That is correct.

Q. Approximately how many D&E procedures have you

performed throughout your career?

A. At least a thousand.

[533:9-20] (Hammond)

Doctor, in the context of your practice, approximately how

many times have you performed an intact approach to D&E?

A. That’s really hard for me to say because, again, we are

dealing with this continuum of procedures where you're

really looking at how intact constitutes an intact D&E. And,

to be honest, we don’t really think much about how intact we

are doing it at the time. It’s not something that we record or

that we note or keep track of.

Now, I can tell you that in those procedures that I do

between 20 and 24 weeks’ gestation I am probably, in about

half of all of those cases, able to extract a part of the fetal

torso intact to the level of the fetal navel or above.

[563:15-23] (Hammond)

Q. Do you have an opinion regarding the safety of intact

D&E?

A. I think it is a very safe procedure.

Q. Do you have an opinion as to the comparative safety of

intact D&E to other second trimester abortion termination

procedures?

A. I think D&E’s generally are very safe procedures. But I

think the more inteet you can do a D&E, the safer it is for

the patient. So I think intact D&E’s are really the safest

type, the safest variation, the safest evolution of D&E’s.

[565:7-566:2] (Hammond)

2la

Q. Dr. Hammond, I believe you were talking about the rea-

sons why it is your opinion that the intact approach to D&E

is the safest way to perform a D&E. I think you mentioned

the decrease in the number of passes of instruments into the

uterus. Would you continue with your answer, please.

A. Like I was saying, there are many other reasons that I

think that it is safer to use *he intact procedures. Another

reason is simply that there is less of a chance to lacerate or

to make a cut in the cervix. If you are doing this relatively

intact, you have fewer bony parts of the fetus that are ex-

posed that can cut into the cervix as you remove them from

the patient. So the more intact the fetus, the less chance

there is for those to cut the cervix and injure the patient.

Another reason is simply the degree of surgical control

that we have. With very intact procedures, when I have

control over the fetus external to the cervix, I can see a

large portion of the procedure that I am doing. I am not

having to blindly grope inside the uterus like I am with a

more disarticulated or dismembered D&E, and therefore

have a [566] drastically lower likelihood of perforating the

uterus and injuring the cervix, because it is all exposed.

[568:19-571:18] (Hammond)

Q. Why does intact D&E reduce the risk of uterine perfora-

tion?

A. Again, there are several reasons. First of all, I am just

not reaching into the uterus as frequently. Secondly, when I

am reaching in, I am not having to rely solely on feel. I have

greater control of the fetus, often operating almost directly

in front of me external to the cervix. So I am not reaching

into the uterus as frequently, I don’t have dismembered fetal

[569] parts in the uterus that can poke through the uterus,

and | have far better surgical contro] throughout the proce-

dure.

Q. Doctor, you also testified that one of the advantages of an

intact D&E is recucing the risk of cervical laceration or

uterine perforation due to the fact that the presence of sharp

22a

bony fetal parts is reduced. First of all, can you tell us, what

is cervical laceration?

A. It is a cut or a tear in the cervix, a scrape in the cervix.

Q. What causes the presence of sharp bony parts in the first

place?

A. Disarticulation or dismemberment of the fetus.

THE COURT: Have you ever lacerated a cervix?

THE WITNESS: I am sure at some point that I have, your

Honor. I don’t specifically recall a circumstance right now.

Q. Doctor, why is the presence of sharp bony fetal parts as-

sociated with laceration and perforation?

A. In terms of perforation, obviously if you have a sharp ob-

ject that is inside of the uterus and you are reaching in

somewhat blindly into the uterus to grasp that sharp object,

you can either directly push that object through the uterine

wall or indirectly do so as whatever other parts jostle that

object inside the uterus.

In terms of cervical laceration, if you have exposed

[570] bony fragments and you are extracting them through

this ring-like structure, which is what the cervix is, they can

scrape against the cervix as you remove them and lacerate

the cervix.

Q. Why does intact D&E reduce this risk?

A. If you are doing the procedure intact, again, you don't

expose those bony fragments, the fetus remains intact. It is

more akin in many degrees of intactness to a standard deliv-

ery.

Q. Another advantage that you mentioned earlier was the

reduction of retained fetal tissue or parts. What does that

mean?

A. Retained parts just means that we leave something be-

hind. It can be either the placenta or it can be part of the

fetus. As I was indicating earlier, one of the things we do at

the end of the procedure is to make a mental note as to

whether we think that we have extracted everything that

might have been inside.

23a

In some of the cases that I have seen, that is not nearly

as easy as it would seem. I have seen patients referred in

because they have fetal anomalies. So I have cases where

the baby doesn’t have much of its head or may be lacking

extremities or any of the other landmarks that we commonly

use to tell us whether we have extracted everything that we

need to extract.

So if I have done this intact and have an intact fetus in

front of me, then I know that I have done at least an intact

[571] extraction of the fetus and have nothing else that I

need to look for.

Q. Why is it important to make sure that you have removed

all the fetal tissue and parts from the uterus?

A. With respect to both the fetus and the placenta, if you

leave tissue inside of the uterus, the patient is at an in-

creased risk for coming back with either an infection or a

hemorrhage. Most of the time the patient will simply pass

the tissue and will be fine, but many patients don’t, and we

eventually have to evacuate that material under less than

optimal circumstances.

Q. Why does intact D&E reduce the risk of retained fetal

tissue or parts?

A. As I had just indicated, because we have seen the fetus

delivered. We now at that point that there is nothing that

we have dismembered or disarticulated that could be re-

maining behind inside of the uterus. It is all at that point

present and accounted for.

APRIL 1, 2004

(588:19-590:7) (Hammond)

Q. Doctor, you also mentioned that patients with chorio-

amnionitis would be offered particular advantages by un-

dergoing an intact approach to D&E, is that correct?

A. Yes, that’s correct.

Q. Just remind us briefly [589] what chorioamnionitis is. |

know we have defined it before, but there are a lot of medi-

24a

cal terms here. Just for the benefit of the rest of us, can you

briefly remind us what that is.

A. It is an infection of the fetal membranes and also the am-

niotic fluid. We commonly, in case I lapse into this, will ab-

breviate it “chorio” for short.

Q. Why is it that a patient with chorioamnionitis would

benefit from an intact approach to D&E?

A. There are a couple of reasons. First of all, these are pa-

tients who are already at higher risk of uterine perforation.

If the uterus is infected, the wall doesn't have the usual tur-

gor, the rigidity that it would have if it were not infected.

Because of that, because of doing the procedure, as I testi-

fied, more intact decreases the likelihood of perforation, it is

even more important in this kind of patient who is at higher

risk.

There is another even more compelling reason, though.

The more you manipulate the inside of the uterus when it is

an infected environment, the more likely you are to seed the

- infection from the uterine lining into the blood and take a

localized infection like chorio and make the patient septic,

which I testified yesterday is a more disseminated infection

and vastly more dangerous to the patient.

So when I am doing a D&E on somebody who has

chorio, | am going to try to do the procedure with the mini-

mum number of passes, the least intrauterine instrumenta-

tion that I can, so that I don’t make the patient sicker in the

process of doing [590] this.

Q. Does a patient who has chorioamnionitis have to termi-

nate the pregnancy?

A. The pregnancy must be delivered, yes.

Q. Why is that?

A. Because it is the only way that you are really going to

eventually treat the infection. You must evacuate the

uterus.

[592:2-9] (Hammond)

25a

Q. What are the benefits of that control of an intact proce-

dure? :

A. The benefits of the control are that I am not reaching

into the uterus and having to somewhat blindly go after dis-

articulated or dismembered parts. I can see and feel every-

thing that I am doing, because it is closer to me. So I am

never at as heightened a risk of perforating the uterus or

lacerating the cervix.

[594:10-17] (Hammond)

Also, one of the more common clotting factor problems,

you had asked about these, is something called von Wille-

bran’s disease. It is a problem with, I won’t belabor this, but

the factor 8 complex, which is also involved in hemophilia. It

is much more common, it is much more common in women.

We do see this. And there is a drug called DDAVP, which

they can actually give nasally immediately beforehand when

we know exactly when the patient is going to deliver.

[597:10-15] (Hammond)

Q. Doctor, do you do anything different when dilating for an

intact D&E than when you dilate for any other D&E?

A. Again, as I testified, I consider all D&E’s part and parcel

of the same procedure. The truth is we do nothing differ-

ently before our intact procedures, our relatively intact

procedures, than for those that are done by dismemberment.

(639:2-644:17] (Hammond)

You testified earlier that the word “intact” does not ap-

pear in the Act’s definition of partial-birth abortion, is that

correct?

A. That is correct.

Q. Is that a concern for you?

A. Yes, it is.

Q. And why is that?

A. Well, as I think I mentioned earlier, I believe that many

of even the dismemberment D&Es that I performed eventu-

ally fall within the scope of the ban.

26a

Q. The statute says, partially vaginally deliver a living fe-

tus; does that help you to understand better whether dis-

memberment procedures would be covered by the ban?

A. Well no, it doesn’t, because it’s possible, as I was testify-

ing, to have started this delivery, have dismembered part of

the fetus, and yet the fetus could still have a sign of life such

as a heartbeat, and | could then deliver the remaining part of

' the fetus above the level of the navel and I believe sweep

into, and I believe in those circumstances could potentially

have violated the ban.

Q. In that situation, would you have partially delivered a

living fetus—I'm sorry—partially vaginally delivered a liv-

ing fetus?

A. Yes, I would.

[640] Q. And would you have delivered it to a level past the

umbilicus, or the navel?

A. Yes.

Q. And, in doing so, would you then take steps that you

know would kill the fetus?

A. Many of the steps that we take during the abortion know

that the fetus will not survive.

Q. And would—

THE COURT: The moment you dismember it it is going to

bleed to death, isn’t it?

THE WITNESS: But we don’t know exactly when demise

is going to occur, your Honor.

THE COURT: But start it.

THE WITNESS: Yes.

BY MS. CHAITEN:

Q. In taking those steps, in partially delivering the living

fetus to a point past the umbilicus, would your purpose be to

enable yourself to take steps that you know will kill the fe-

tus?

27a

A. Well, my purpose is to evacuate the uterus and complete

the procedure. It’s not specifically to do those portions of

the procedure you described.

Q. Doctor, you mentioned that you were concerned that

some of the induction termination procedures that you per-

form could come within the scope of this ban, is that correct?

[641] A. That is correct.

Q. Can you explain how that could happen?

A. Well, I can certainly describe some scenarios which could

potentially trip the ban.

Let’s say that you had initiated an induction procedure.

Keep in mind that an induction procedure is not a, quote un-

quote, natural event, it is a deliberate and intentional act

with the prospect, eventually, of a vaginal delivery.

But let’s say that the fetus starts to deliver but delivers

such that the calvarium, the head, is entrapped behind the

cervix. That isn’t a preposterous kind of assumption or sce-

nario because if you were inducing, let’s say an infant with

hydrocephalous or any kind of enlargement or disproportion

of the head and the rest of the body, the head is the yet

part and could get stuck at the cervix.

Now, what do you do under those circumstances? Well,

this kind of scenario could result in an obstetrician who

really has had—has tried in good faith not to violate what

they might perceive this ban to be to now have to try to as-

sist the patient in completing this process.

And what we usually would do is analogous to a D&E.

It’s one of the reasons why the National Abortion Federa-

tion clinical policy guidelines are if you do a medical induc-

tion abortion you are supposed to have the instruments for

D&E on [642] hand also in case you get stuck and have to

finish the procedure surgically.

But let’s say that the person doing the procedure didn’t

know how to, with the entrapped calvarium, with the en-

trapped head to reach up, perform a decompression proce-

dure and complete the process as I have already described.

Well, they might, in the process of trying to even just do a

28a

delivery, do an act which could be interpreted as the overt

act.

Let’s say they try to deliver a 20 week gestation where

the neck is simply not as.stable as what you might think with

a full-term baby. We’ve had cases where people have - we

being at Northwestern where people have attempted to do

these deliveries and have evulsed, they have basically torn a

great deal of the neck if not tearing it off just trying to de-

liver the rest of the baby.

And so, in that case that person could have violated the

Act because they know the fetus isn’t going to survive that

act.

Q. Doctor, in that example what would have to be done in

order to then deliver the fetal head?

A. Well, you would have to do it instrumentally, just like we

do for a D&E.

You need to reach in with one of the forceps that we use

and do an act that would collapse the calvarium.

[643] Now, again, because we have been talking about

collapsing the head in many ways that doesn’t always in-

volve putting scissors in and, certainly, if it has been disar-

ticulated we wouldn’t do that. We would reach in with our

forceps and take the head out.

Q. And in order to do that you would have to collapse the

head?

A. Oh, you always have to collapse the head with the D&E

procedures to get the head out.

Q. In every D&E?

A. That’s correct.

Q. Doctor, in performing an intact D&E, do you deliver the

fetus to a certain point for the purpose of performing an act

that you know will kill the fetus?

A. No, I—in any D&E, including intacts, I deliver the fetus

as intact as possible to get the operation over with.

Q. Doctor, in the induction example that you gave us where

the head got stuck and you needed to proceed in the same

29a

way that you might with an intact D&E, are the steps that

you take deliberate and intentional?

A. Yes, they are.

Q And, in that scenario, do you deliberately and intention-

ally vaginally deliver the fetus?

A. Yes, I do.

Q. And what is the deliberate and intentional act that begins

[644] the delivery of the fetus into the vagina in an induc-

tion?

A. Giving the medicine that starts the delivery process.

Q. Do you deliberately and intentionally deliver the fetus to

a point past the navel?

A. In many cases, yes, because the uterus itself is going to

start that process and effect that delivery. And if it’s incom-

plete we are going to have to help the delivery process con-

tinue.

Q. And what would the overt act be, in that scenario?

A. It could be, in the scenario where you described where

the fetus becomes stuck, it could be any act that can result in

the demise as I extricate the baby, anything from disarticu-

lating at the neck to collapsing the calvarium and so forth.

Q. Do you deliberately and intentionally perform the overt

act in this situation?

A. Every act that I do in most abortions is deliberate and

intentional.

[665:22-666:3] (Hammond)

Q. What’s the dose of propofol given to a patient who is un-

dergoing intact D&E, Doctor?

A. I would—I think they give the same dose to all of our—

the same appropriate dose to our patients and don’t change

the [666] dose based on whether we are performing the

D&E any differently. Because, like I said, a D&E is pretty

much a D&E to me.

(742:5-751:4) (Westhoff)

Q. And do you, yourself, perform abortions, Dr. Westhoff?

30a

A. Yes, I do.

Q. For about how long have you been doing so?

A. I started performing abortions during my residency

training at Kings County Hospital and there have been, over

all these years, changes in the scope of practice. So I started

providing abortion in the late 1970s and continued to do so

today but there have been a few, several years in between

where I was not providing abortion care because my ener-

gies were focused elsewhere.

Q. But for most of the time since 1978 can you give the

Court an approximation of how many abortion procedures

you’ve performed?

A. I’m sure it’s more than several thousand and I would

need to think year by year what I was doing to try to add up,

but.

Q. I think we probably don’ t need—

A. Okay.

Q. I don’t think we need that unless the Court would like to

inquire. Do you currently perform abortion procedures?

A. Yes, I currently do provide abortion procedures.

[743] Q. Is that at the specialty services, at Allen Pavilion?

A. Yes, at special GYN services and in private practice.

Q. Approximately how many abortion procedures are per-

formed at the special GYN services unit each year?

A. The unit, overall, provides abortion care for about 2,000

patients per year.

Q. And you don’t do all of those?

A. I do not do all of those.

Q. What type of abortion procedures are performed at spe-

cial GYN services?

A. We provide, in the first trimester, both surgical abortion,

vacuum aspiration abortions, and also medical abortion using

mifepristone and misoprostol. And in the second trimester

we provide surgical] abortion, D&E.

3la

Q. And in the past, Dr. Westhoff, what other abortion pro-

cedures, if any, have you performed?

A. In past years I also performed second trimester induc-

tion abortion and particularly used the saline installation

method, although I have in the past done other kinds of in-

duction abortions as well. But that's not currently part of

my practice.

Q. Have you, in the past, Dr. Westhoff, performed hystero-

tomies?

A. I have, on a few occasions, performed hysterotomy for

abortion.

[744] Q. How many induction procedures have you per-

formed over your career, Dr. Westhoff?

A. It certainly has been several hundred. I don’t know the

exact number.

Q. Are you familiar with the use of prostaglandins to induce

preterm uterine contractions?

A. Yes, I am.

Q. Have you authored any publications or instructional ma-

terials concerning that use?

A. Yes. On behalf of the American College of OB/GYN I

helped prepare a teaching tape for doctors to learn about the

method of emptying the uterus with using prostaglandins.

Q. Do you remain current, Dr. Westhoff, on literature in the

field regarding induction procedure?

A. I try to remain familiar with the literature.

Q. At about what gestational age, Dr. Westhoff; does your

service perform suction curettage procedures?

A. We perform suction curettage starting from the, what-

ever early gestational age a woman might present seeking

such a treatment. We don’t have a lower limit as long as we

can make a diagnosis of pregnancy, and we continue using

the suction curettage technique through the first three

months of pregnancy. So, certainly up to 12 or 13 weeks.

[745] And there are some patients where suction curettage

is successful even early in the second trimester.

32a

Q. At about what gestational age does the special GYN ser-

vice perform medical abortions?

A. We perform medical abortions just through nine weeks,

until nine weeks after the last menstrual period.

Q. You made reference.in an earlier answer, I think to the

use of mifepristone in the medical abortions that you do?

A. Yes.

Q. Does that go by another name?

A. Mifepristone is formerly known as RU-486.

Q. At what gestational age does your service perform D&E,

Doctor?

A. We perform D&E throughout the second trimester, from

the beginning of the second trimester about 14 weeks’ gesta-

tion through 23 weeks and six days’ gestation.

Q. Does the service perform the variation of D&E known as

intact D&E?

A. Yes, we do.

Q. At about what gestational age do you begin to do that?

A. In general we use that approach in the later part of the

second trimester, perhaps starting around 18 or 19 weeks,

but there are—it’s not an exact threshold. Each case is dif-

ferent.

Q. How many D&E procedures, approximately, of any

variation, [746] does your service perform each year?

A. In 2003 our service performed about 250 D&Es.

Q. You said 250?

A. I think so.

Q. And approximately how many of those involve or in-

volved, in 2003, if you know, intact D&E?

A. We haven't had the practice of keeping any kind of cen-

sus where we distinguish what kind of D&E we did, so I

don’t have any sort of statistics to support that number. But

my general recollection is that it would be at least 50 of the

D&Es last year would have been intact D&Es.

33a

THE COURT: Is there any time when you did keep such a

record at your institution as to what type of D&E was done

at the institution?

THE WITNESS: No, your Honor. We have not kept re-

cords with that kind of breakdown.

Q. Can you explain for the Court the basis for your judg-

ment not to keep those sorts of breakdowns?

A. Well, all of these cases are variation on D&E. The main

fact for us is that we did perform a D&E and I think a lot of

documentation sometimes is driven by requirements to

match the coding that exists, the procedure coding, diagnosis

coding and so on, and there exists no special coding for dif-

ferent variations on D&E. They’re all coded the same.

Q. In addition to the procedures, the D&E procedures that

you [747] personally performed, what is the basis for your

general recollection that the order of number of D&Es that

you do each year is about 50, or that did you in 2003, per

haps? |

A. One reason I have for giving that number is just the way

our week is structured. We perform our D&Es on Fridays,

which means we do cervical preparation with laminaria on

Wednesdays and Thursdays. I have assigned myself to see

patients on Wednesday on this service so that that means

I’m likely to see most of these patients when they have,

when they begin their cervical preparation, they begin get-

ting ready for the D&E. And so, that just gives me a sense

of who the patients are going to be and it gives me a sense

that probably every week we have at least one such patient.

In addition, I just discuss with all of my colleagues who

share the coverage of the operating room on Friday what

their impression is about doing these cases.

Q. Of the types of abortion procedures performed at the

personal GYN service, which do you currently perform, Doc-

tor?

A. I perform all of the—some—I take care of some cases for

all of the types of treatments that we offer, although I don’t

currently perform tubal ligations.

34a

Q. And with respect to those treatments, can you give the

Court an idea of how many are involved, say, with respect to

suction curettage, for example?

[748] A. Sure. In the year 2003 I probably performed, per-

sonally, about 500 suction curettage, some give or take a

hundred. And I probably personally performed or person-

ally supervised, in the operating, room about 50 D&E cases.

THE COURT: You supervised or you performed?

THE WITNESS: Well, since we’re a teaching institution we

often will have more than one doctor in the operating room

at the same time, and so sometimes I’m right there working

with another doctor but I might not be the main person who

actually has my hands on the patient.

THE COURT: How many times do you have your hands on

the patient in that setting in that procedure?

THE WITNESS: I haven’t thought about distinguishing

that previously so I just need to think about my answer

and—

THE COURT: Well, I would think you know what you did

last year. I mean, roughly. I’m not asking you for an exact

count.

THE WITNESS: No. Because an important part of my role

in taking care of patients is also to teach other doctors. I

want the doctors working with me to provide as much of the

direct hands-on care as they are competent to do. And often

my role there is to help or guide them rather than to carry

out the case alone and so I would—

THE COURT: Would it be fair to say then that you [749]

supervised them all but you do the hands-on?

THE WITNESS: In the majority—yes. And I mean I will

be there with my gloves on so-to-speak, but in the majority

of cases it will be the other doctors I'm working with who

are actually doing more than I am.

[750] THE COURT: You are primarily the supervisor then,

is that correct, fair to say?

THE WITNESS: Yes, that is fair, your Honor.

35a

BY MR. HUT:

Q. Approximately how many D&E procedures, Dr. West-

hoff, have you performed throughout your career?

THE COURT: Could we have this clarified that we are talk-

ing about supervising or actually performing them hands-on,

if you could break that out.

Q. If you could distinguish that for the Court and answer

my question, please do so.

A. Until we started this service three years ago at the Allen

Pavilion, I was performing only a small number of D&E's.

We didn’t have a service at our hospital. Since we started

the service, it is more cases, and I would say in the—again,

looking back just at 2003, I was probably in the operating

room helping take care of about 50 patients having D&E’s.

But, as I said a moment ago, that is a mixture of hands-on

and supervisory care, which is the nature of a teaching ser-

vice.

Q. If you extend that back beyond 2008, going back to the

time you first began to perform D&E, can you give us an ap-

proximation of the number of times you performed D&E?

A. Our service was a little less busy in 2001 and 2002, so I

think the numbers were a little less in those years. And

prior to 2001 the numbers would have been much smaller,

because [751] we didn’t actually have a whole service of our

own

Q. Does the number of D&E that you indicated you per-

formed or supervised in 2003 include the intact variation?

A. Yes, it does.

APRIL 2, 2004

[779:7-8] (Westhoff)

A. The CDC reports that in the United States about 95 per-

cent of all second trimester abortions are performed using

D&E.

[786:22-787:18] (Westhoff)

36a

But once the cervix is stabilized we will then insert fin-

ger or uterus—finger or instrument into the uterine cavity

to begin to pull down fetal parts. In general, in our cases, we

have a sonography unit in [787] the room with us standing

by but we decide on a case-by-case basis how much we want

to use sonography during the case.

THE COURT: That’s a sonogram?

THE WITNESS: Sonogram, ultrasound, yes; to take, to im-

age the fetal portion, the fetal parts and position.

Q. Does that conclude the description, Doctor?

A. At this point we will begin the extraction of the fetus or

the evacuation of the fetus, and we can do this with a combi-

nation of traction with instruments or digital traction, until

we remove the entire fetus from the uterus. When we have

removed the entire fetus, if it is in parts we do enumerate

the parts to feel confident that all the fetus has been re-

moved. And then we will remove placenta and membranes

using a combination of suction curettage and sharp curet-

tage.

Q. You mention traction in your answer, Dr. Westhoff; what

is traction?

A. Traction just means pulling.

[791:17-792:6] (Westhoff)

Q. In your D&E practice, Dr. Westhoff, how much of a fetus

may be removed by the physician with the [792] first pass of

instruments during a D&E?

THE COURT: Meaning herself.

Q. Herself or her service; to the extent she is familiar with

it.

A. Myself, that’s fine. In my own experience, my own per-

sonal experience there is a very wide range of possibility

where sometimes with the first pass of instruments in fact

we do not succeed in removing any fetal parts so we can

have an unsuccessful pass. And we can introduce instru-

ments and remove the entire fetus at the first pass of the

instruments. And of course every possibility in between

-

37a

those two extremes, which have all in fact occurred in my

very own practice.

(793:2-794:5] (Westhoff)

Q. Have doctors performing D&E in your service, under

your supervision, had uterine perforations during the course

of D&Es they have performed, Doctor?

A. Yes. As I was saying yesterday, I’m responsible for as-

sessing all of our complications in order to make sure that

we’re taking good care of our patients and see what’s going

on. In the last three years on our service we have had one

cervical laceration and we have had three perforations of the

uterus during D&E procedures.

THE COURT: Were these done by interns or residents?

THE WITNESS: They were done by other attending physi-

cians or—

THE COURT: I didn’t ask you that, Doctor. My questions

are very simple.

THE WITNESS: No.

THE COURT: They were not done by residents.

THE WITNESS: They were not done by interns or resi-

dents.

THE COURT: Either one.

THE WITNESS: I know who was involved in each of these

cases and it was not interns and residents.

BY MR. HUT:

These perforations and lacerations occur in D&Es that were

[794] effected with dismemberment or more relative intact,

Doctor?

A. Each of these cases I am referring to occurred during a

dismemberment type of D&E. We have had no lacerations

or perforations on my service with the use of an intact vari-

ant of D&E.

[794:11-16] (Westhoff)

My preference is to minimize the passes of instruments

into the uterine cavity and my corollary preference is to re-

38a

move as much of the fetus in each pass as possible and the,

sort of logical goal of that is if I can remove the fetus intact I

will do so. But we have to see each step of the way as we

proceed, if that’s possible.

(797:25-798:14] (Westhoff)

Q. During the midtrimester, Dr. Westhoff, what is usually

the [798] largest part of the fetus?

A. The largest part is the skull itself and, in particular, we

pay attention to the diameter across the skull.

Q. When any part of the fetus is too large to pass through

the cervix during the course of a surgical abortion in the

midtrimester, how do you remove the part in question?

A. For any fetal part that’s too large to fit through the cer-

vix we attempt to remove—reduce the diameter of the fetal

part by severing, crushing it, or collapsing it.

Q. How often will it be necessary to collapse the fetal skull

during D&E whether the D&E proceeds by a dismember-

ment or more relatively intact, Doctor?

A. For the vast majority of D&Es it will be necessary to

either crush or collapse the fetal skull.

[802:9-14] (Westhoff)

Q. Based on your review of and familiarity with CDC statis-

tics, Dr. Westhoff, what percentage of second trimester

abortions are performed using the procedures you have just

identified?

A. The best estimate is about 95 percent are D&E and

about 5 percent are induction.

[805:2-7] (Westhoff)

Q. Without delving into the relative safety of different

methods of abortion, do you have an opinion on the impact of

increased gestational age of the relative safety of abortion?

A. Yes, sir. Abortion is safest in the early weeks of preg-

nancy, and as the gestational age advances, the risks and

complications increase as well.

[810:16-811:11] (Westhoff)

39a

A. Both approaches are very safe. In the earlier part of the

second trimester, up to 16 weeks or so, the uterus is less

sensitive to the induction drugs, and so I think D&E is sub-

stantially safer because it is more likely to be successful in

the earlier part of the second trimester.

In the later part of the second trimester, in general,

D&E and induction are similar. However, that depends on

the resources available when taking care of the patient, be-

cause they are not going to be equal in all hands.

Q. With respect to the later part of the second trimester, do

[811] you have an opinion why D&E is the more common in

that portion if, as you have testified, the procedures are,

subject to your testimony, approximately comparable in

safety?

A. Yes. An induction abortion involves hospitalization for a

period of several days, during which a woman goes through

essentially the experience of labor. This is painful and diffi-

cult for all women. In particular, my patients find that

would be very distressing when they are ending a wanted

pregnancy, and they would prefer to have a D&E with less

time in the hospital and the opportunity to undergo the

abortion itself in a very short period of time while they are

asleep.

[824:12-825:7] (Westhoff)

Q. Do you have an opinion, Dr. Westhoff, regarding the

safety of the intact variation of D&E?

A. Yes, I do.

Q. What is your opinion, Doctor?

A. My opinion is that the intact variation is safer for the

woman than the dismemberment variation of D&E.

Q. Why in your opinion is the intact variation safer than the

dismemberment variation for the woman?

A. Because we minimize the number of passes of instru-

ments into the uterus, we can reduce or possibly eliminate

the risk of perforation of the uterus or laceration of the cer-

vix that is directly due to the instrument itself. Also, be-

40a

cause in dismemberment D&E the fetus is removed in parts,

there are bony fragments, and it is possible for the bony

fragments to cause [825] perforation or laceration. With the

intact variation, that risk is decreased or eliminated. Also,

with the dismemberment D&E there is a risk of small por-

tions of the fetus remaining behinu .n the uterus, and that

can lead to hemorrhage or infection of the uterus subsequent

to the procedure. When the fetus is removed intact, that

risk is reduced or eliminated.

[838:18-25] (Westhoff)

Q. —do you recall the names of any of the other investiga-

tors associated with Dr. Chasen in the study?

A. Yes. I don’t know all of them. Do you want me to tell

you the names of the ones I know?

Q. Yes, and their affiliations, to the extent you know those

as well, please.

A. Sure. Dr. Frank Chervenak, who is chairman of obstet-

rics and gynecology at the Cornell campus of the New York

Presbyterian Hospital is one of the authors; Dr. Bill

Rashbaum who is an attending physician there; Dr. Jane

Kaufman who did her training the Cornell campus of New

York Presbyterian and who now is attending physician on

my service at Presbyterian. And I think there are one or

two additional authors but I don’t know those individuals.

[840:4-12] (Westhoff)

Q. Dr. Westhoff how, if at all, does the study performed by

Dr. Chasen and its conclusions, affect your view of the intact

variation of D&E as compared to dismemberment variation?

A. The results of Dr. Chasen’s study confirm my impression

that intact D&E is a safe alternative for my patients and is

less likely to result in serious complications than a dismem-

berment D&E. So, his results from his patients conforms to

my clinical experience.

[841:20-22] (Westhoff)

4la

A. Among the range of alternatives I usually think, for most

of my patients, that intact D&E offers safety advantages

compared to those alternatives.

[854:3-862:20] (Westhoff)

As in the case we were discussing previously where the

fetus was entirely intact, subsequent steps would include

cutting the umbilical cord and collapsing the skull, either one

of which would be more rapidly lethal.

Q. And why is it that you would perform such acts?

A. In order to continue the procedure and to empty the

uterus safely.

Q. And at the time that you would collapse the skull or cut

the cord, is the fetus still living? _ 5

A. Yes. It would be likely to still be living.

Q. And as with the last example, is the cutting of the cords

or the collapsing of the skull an act that you know is lethal?

A. Yes.

Q. Are the steps that you have just described in performing

the variation of dismemberment D&E discussed, performed

by you deliberately and intentionally?

A. Yes.

Q. What is your purpose in performing a D&E involving

dismemberment such as the one you have just described?

A. It is to, as safely as possible, complete the abortion.

Q. Doctor, would you fear prosecution under the Act for

D&E by dismemberment and the way you just described it?

A. Yes, I would.

[855] Q. Do you have any other examples or scenarios of the

way D&E with dismemberment might proceed given its

variability that would involve vaginal delivery of a living fe-

tus until a point at which any part of the fetal trunk, past the

navel, is outside the body of the woman?

A. Yes. Certainly, I can. An example that I have in fact

experienced myself in taking care of the patient in the recent

past involved not being able to start the procedure by bring-

42a

ing the feet down, using forceps and in fact first delivering

part of the fetal back entirely separate from the patient. So,

that is a part of the fetal trunk above the navel that was de-

livered outside of the woman’s body as a separate piece of

the fetus. We were then able to continue bringing the fetus

down and bring the legs down and ultimately completed the

abortion. I don’t remember in that case all the exact subse-

quent steps, but we did bring out a piece of the trunk first

while the fetus was still living. So, I fear that that particular

sequence of events would also violate the ban.

Q. And in the sequence that you described, did you perform

an overt act after the evacuation of the portion of the fetal

trunk above the navel and while that portion was outside the

body of the woman?

[856] A. Yes. And in that case, as it evolved, we also cut the

cord and collapsed the skull, both of which are lethal acts.

Q. Again, why did you perform those lethal acts in the situa-

tion you just described?

A. In order to continue emptying the uterus and in order to

continue the abortion.

Q. And at the time you performed the first of the cutting of

the cord or the collapsing of the skull, was the fetus still liv-

ing?

A. Yes.

Q. And at the time you performed either the first of the cut-

ting of the cord or collapsing of the skull, did you know that

such act, as performed, would be lethal?

A. Yes.

Q. Did you perform the acts, in the abortion you just de-

scribed, deliberately and intentionally?

A. Yes.

Q. Now, in a dismemberment D&E, do you deliver the fetus

to a certain point for the purpose of performing an act that

you know would kill a fetus?

A. I go step by step for the purpose of completing the entire

abortion and I know that in the course of proceeding step by

step I will perform a lethal act, but—

Q. Is that step-by-step process the same for an intact D&E,

[857] Dr. Westhoff?

A. Yes, it is.

Q. Now, Doctor, I would like to turn your attention or have

you turn your attention to the applicability of the Act to the

induction. Does vaginal delivery—

MS. GOWAN: Object to the form of the question.

THE COURT: What’s your objection?

MR. HUT: I will rephrase it, your Honor.

Q. Does vaginal delivery occur, Dr. Westhoff, in an induc-

tion?

A. Yes; vaginal delivery occurs during an induction abor-

tion.

Q. When you perform an induction abortion, is the fetus liv-

ing when you commence the vaginal delivery?

A. Yes, it is.

Q. Based on your experience in performing an induction, has

it ever occurred that you have vaginally delivered a living

fetus until a point at which any part of the fetal trunk, past

the navel, is outside the body of the mother?

A. Yes.

Q. Now, directing your attention to the phrase, “an overt

act that the person knows will kill the partially-delivered

living fetus,” does it ever occur, in the course of an induction

procedure, thet a physician must perform an overt act that

he or she knows will kill the fetus?

A. Yes.

[858] In an induction in the midtrimester it is very like-

ly that the fetus will present in the breech position to start

out with, as | said earlier.

And so, as the induction proceeds, the fetus may in fact

deliver feet-first. And typically the cervix will not yet be

44a

sufficiently dilated for the larger parts of the fetal body to

pass readily through. It is common for there to be some ten-

sion on the cord which may be wrapped around the body.

So, a very common occurrence during an induction de-

livery of a breech would be to cut the cord along the way.

And in the case of a midtrimester abortion, that would be a

lethal act.

Q. And when you would cut the cord in the situation you

just described, would there be a part of the fetal body past

the navel—excuse me, part of the fetal trunk, past the navei,

outside the body of the woman at the time that you per-

formed the lethal act?

A. Yes, it would be.

Q. And at the time you performed the lethal act, would the

fetus still be living?

A. Yes, it would be.

Q. And would the cutting of the cord, as you just described

it, be an act that a physician knows will kill the fetus?

A. Yes.

Q. In the type of induction that you just described, [859] Dr.

Westhoff, are steps taken deliberately and intentionally?

A. The overall plan of the induction is deliberate and inten-

tional and if the fetus delivers to that position, any subse-

quent action by the physician is deliberate and intentional;

yes.

Q. Dr. Westhoff, will you explain why it is that physicians

have a role in treating spontaneous abortions?

A. Spontaneous abortion or miscarriage can occur through-

out gestation, and many spontaneous abortions do not com-

plete on their own, the patient requires physician assistance

to complete the emptying of the uterus.

And there is some portion of cases where women might

complete the delivery entirely without intervention, but I

would say in the majority of miscarriages, of which there are

about 800,000 per year in the United States, in at least 75

percent some medical intervention is required.

45a

In particular, in the second trimester the cervix may be

open and the patient may be bleeding or may have infection,

and this can only stop or be remedied through the comple-

tion of emptying the uterus. And so, a physician must take

some action to help the miscarriage be completed.

Q. And is the action the physician may take in emptying the

uterus something that involves vaginal delivery?

A. Yes, it does.

Q. And when a physician may treat spontaneous abortion,

may [860] the fetus be still living when you commence with

the vaginal delivery?

A. Yes, it may.

Q. Based on your experience, Dr. Westhoff, in managing.

spontaneous abortion, has it ever occurred that you have

vaginally delivered a living fetus at the point at which any

part of the feta] trunk, past the navel, is outside the body of

the mother?

A. Yes, I have.

Q. Directing your attention to the phrase “overt act the per-

son knows will kill the partially-delivered living fetus,” does

it ever occur, in the course of treating a spontaneous abor-

tion, that the physician must perform an overt act that she

knows would kill the fetus?

A. Yes, it does.

Q. Can you provide us with an example?

A. Well, there are two patients very recently taken care of,

both of whom were miscarrying wanted pregnancies.

In one case the cervix started to dilate and the patient

was around 20 to 22 weeks. I don’t remember the gesta-

tional age exactly, but the cervix started to open and the

amniotic membranes became infected, so she had a condition

called chorioamnionitis, and that is dangerous to the woman

she can become septic. Her entire body can become infected

if all the infected tissue is not removed from the uterus.

46a

[861] Because her cervix started to dilate she didn’t

need any laminaria treatment, for instance, but we took her

to the OR for a D&E in order to complete the miscarriage.

In another recent patient, the membranes ruptured

prematurely and the fetus, while still alive, was not growing

further. And after three weeks it became clear that ulti-

mately the prognosis for the fetus was fatal, it was not going

to be able to grow and survive this.

So, we dilated the patient’s cervix with laminaria and

went to the OR to perform a D&E. So, these were both mis-

carriages that did not complete on their own and we needed

to take care of the patient to complete the miscarriage.

Q. In these or any other cases that you have seen, does it

occur that there is a part of a navel—excuse me—a part of

the fetal trunk past the navel that is outside the body of a

woman at a time that the physician must perform an overt

act that is lethal?

A. Yes.

THE COURT: Keep your voice up, Mr. Hut, please?

MR. HUT: Sure, your Honor.

Q. And in those situations or any other, what type of overt

act might a physician have to perform?

A. Certainly it may be cutting the umbilical cord, and also in

these cases the collapse of the skull.

Q. And at the time of the collapse of the skull was the fetus,

[862] in these cases, still living?

A. Yes, it was.

Q. And why did you perform the collapsing of the skull in

these cases, or why do you perform collapsing of the skull

and the cutting of the cord and any other treatment in the

case of spontaneous abortion, Doctor?

A. In order to continue the procedure and accomplish the

goal of emptying the uterus I need to proceed step by step

and cannot complete it without carrying out those maneu-

vers.

47a

Q. Is the collapsing of the skull or the cutting of the cord in

such cases an act that the physician knows will kill the fetus?

A. Yes, it is.

Q. Are the steps taken by physicians in managing spontane-

ous abortion deliberate and intentional?

A. Yes, they are.

Q. What is the physician’s purpose in managing a spontane-

ous abortion in the ways you have just described?

A. Overall, the main purpose is to maximize the health and

safety of the woman and it is necessary to empty the uterus

to

[884:17-885:21] (Westhoff)

Q. Doctor, with respect to test:mony from you in the morn-

ing, why is it that the Chasen study confirms your view re-

specting the safety of intact D&E?

A. There are two reasons Dr. Chasen’s results confirm my

view. One is that among the complications that he reports

on in his study, about 5 percent of patients in the intact

group and 5 percent of the patients in the dismemberment

group experienced complications. But in fact, on reading the

details, all of the serious complications he reported, the most

serious [885] complications were in the dismemberment

group, and those actually are entirely analogous to the com-

plications that we have observed in our own patient practice

at Presbyterian.

Second, his overall conclusion is that the complication

rates are the same in the two groups. But in his study the

patients who underwent an intact D&E had a gestational

age that was about two weeks greater than the gestational

age of patients undergoing dismemberment D&E. Since we

do know based on other existing data that the risk of compli-

cations increases with advancing gestational age, I would

expect to see more complications in the subgroup that had a

more advanced gestational age. The fact that they had the

same overall rate of complications is, I think, something that

favors intact D&E as being a safer technique.

48a

I think that supports—

THE COURT: Does that mean you disagree with Dr. Cha-

sen’s report?

THE WITNESS: I think Dr. Chasen—

THE COURT: Do you disagree, ma’am?

THE WITNESS: I agree with his results. I think his con-

clusions are too conservative.

APRIL 5, 2004

[1017:11-21] (Westhoff)

A. “Some women require abortions because their pregnan-

cies compromise their health. In some instances the patient

has a pre-existing medical condition that is exacerbated by

her pregnancy. For instance, women with certain kinds of

heart disease are at increased risk during pregnancy with

the risk of maternal and fetal death as high as 50 percent.

Women who develop peripartum cardiomyopathy, a condi-

tion in which the heart muscle does not pump blood suffi-

ciently are at sufficient risk of cardiac failure. Women with

conditions such as kidney and liver disease may experience

exacerbation of those diseases as a result of the pregnancy.”

[1043:5-1046:2] (Frederiksen)

Q. You mentioned that you do. D&E’s and the intact varia-

tion, and earlier you mentioned that you provided abortion

service. Can you describe to me the scope of your abortion

practice.

A. I provide abortion services from approximately 4 or 5

weeks of gestation through 23 5/7 weeks of gestation.

THE COURT: 23 what?

THE WITNESS: And five-sevenths.

Q. What procedures do you perform?

A. I do first trimester dilatation and evacuation, or suction

curettage. I provide second trimester terminations by lami-

naria and dilatation evacuation as well as the intact varia-

tion. I also do induction medical abortions in the second tri-

49a

mester, and I provide medical abortion medications for the

induction of early first trimester terminations.

Q. Approximately how many abortions have you performed

in your career?

A. Thousands.

Q. Currently, how many do you perform per year?

A. Approximately 100 to 125 per year.

Q. Do you have specific training in abortion practice?

A. Yes, I do.

[1044] Q. Can you describe that, please.

A. During my residency, there was an abortion service at

the Boston Hospital for Women, and all residents rotated

through that. We received training in dilatation and evacua-

tion as well as abortion induction in the second trimester.

Q. Have you had any additional abortion training since your

residency?

A. Formal training, not per se. It is a matter of evolution of

the existing procedures and extension of their services be-

yond what it was during my residency.

Q. How does that evolution occur?

A. It is a process by which we communicate with other phy-

sicians or have availability of better equipment or better

pharmacological means to attempt different techniques as

we provide abortion services.

Q. You mentioned that you perform a procedure known as

dilation and evacuation, or D&E, is that correct?

A. Yes.

Q. Approximately how many D&E procedures have you

performed throughout your career?

A. I really don’t know, but probably thousands.

THE COURT: Thousands, plural?

THE WITNESS: Thousands, plural.

Q. You also mentioned a variation of D&E known as intact

dilation and evacuation or intact D&E, is that correct?

50a

[1045] A. Yes.

Q. Briefly explain what that term means as you understand

it.

A. It is a procedure by which you use serial laminaria in the

cervix over a period of time, after which there is adequate

dilatation to allow extraction of the fetus relatively intact.

Q. Can you also assure that the fetus will be removed in-

tact?

A. No, I can’t.

Q. Why is that?

A. During the process of doing those techniques, you. may

encounter, resistance to the cervix. The fetal tissues are

relatively fragile, and you can’t guarantee getting the fetus

out totally intact.

Q. Do you ever perform a D&E using the intact approach?

A. Yes.

Q. Do you do those as part of your regular practice?

A. Since my training in the seventies, I have gradually

changed the protocol under which I operate and have found

that when I can get the fetus out relatively intact, I can en-

sure that there is no retained fetal tissue within the uterus,

decreasing the risk of infection. The procedures are gener-

ally shorter, and the blood loss and the anesthesia time is

less for the woman, so that it is a safer procedure.

Q. Approximately how many times have you performed an

intact D&E?

A. I don’t know.

[1046] Q. Why can’t you tell us?

A. Ihave no mechanism. I don’t keep track of it.

[1053:7-20] (Frederiksen)

Q. Dr. Frederiksen, does your opinion regarding the safety

of second trimester D&E procedures include an approach

that would be the intact approach to D&E?

A. Yes.

5la

Q. Do you have an opinion as to whether intact D&E is ever

safer than other abortion procedures?

A. An intact D&E is always safer because the fetus comes

out relatively intact, involving less passes of the instruments

into the uterus. It also has no ability to leave fetal parts

within the uterus. There are less bony parts or bony frag-

ments which can lacerate or cut the cervix as they are deliv-

ered from the uterus. And there is less blood loss overall.

Because the procedure is with the intact delivery of the

fetus, the placenta usually delivers intact as well.

[1056:14-24] (Frederiksen)

Q. Dr. Frederiksen, how is it that uterine perforation occurs

during a D&E in the second trimester?

A. Perforation is much more common with forcible dilata-

tion of the uterus, but it can be an inadvertently happened

when you are using forceps to grab tissue. There can be ir-

regularities in the uterine wall which make you think there

are fetal] parts there and there are not. There can be irregu-

larities in the thickness of the uterine wall, including with a

scarred uterus, where you can very easily go through the

scar, the prior scar, or have the scar open, and you then have

a chance of delivering anything from the maternal abdomen.

[1058:10-1059:10] (Frederiksen)

Q. Doctor, you also testified that intact D&E can reduce the

risk of cervical laceration. Why is that?

A. Cervical laceration can actually nick an internal branch of

the cervical artery as well as lacerate the endocervical canal

and cause bleeding. The leading cause for this is bony

pieces, pieces of bony parts of the fetus which can be very

sharp, and when you pull them through the cervix can lacer-

ate the cervix and cause hemorrhage.

Q. What causes the presence of sharp bony parts in the first

place?

A. The dismemberment process that is necessary to empty

the uterus.

Q. Are these fragments present in an intact evacuation?

52a

A. No, they are not.

Q. Why not?

A. Because the fetus is delivered almost or virtually intact,

[1059] and thereby you don’t have those bony fragments.

Q. Dr. Frederiksen, is there a high risk of cervical] laceration

or uterine perforation from bony fragments during a D&E?

A. If you end up having a situation where you end up having

multiple fetal parts, there is always a risk of cervical lacera-

tion.

Q. Is that why you try to control for this risk?

A. We decrease that risk by doing an intact or near intact

procedure.

[1060:8-1064:18] (Frederiksen)

Q. You testified that intact D&E can also produce the risk

that fetal tissue or parts can remain behind in the uterus.

How is it that fetal tissue or parts can remain behind doing

an D&E?

A. If you do a D&E where the fetus doesn’t come out intact,

you are making an assumption or you make your best clinical

estimation that the uterus is entirely empty. Unfortunately,

we are not very good at that, and we can leave either frag-

ments of the fetus in the uterus or fragments of the placenta

in the uterus, and there can be a nidus for infection and

there can be the cause of a post-abortal hemorrhage.

Q. Used the word “a nidus.” What is that?

~A. Like a focus.

Q. So it would be a location of, a point of infection?

A. Yes.

Q. What is post-abortal hemorrhage?

A. Post-abortal hemorrhage is hemorrhage which occurs

after the abortion has occurred. It can be episodic or you

can get a [1061] hemorrhage and then find no evidence for

the bleeding by examining the patient. That is characteristic

of a cervical artery laceration of the internal os or the inter-

53a

nal os of the cervix, where bony fragments can lacerate that

‘branch of the cervical artery.

Or they can be caused by the uterus failing to contract

or maintain a contraction after the delivery of the fetus and

the majority of the pregnancy. That is called uterine atony,

and that may necessitate reexploration of the uterus or use

of medications.

Q. Why are you concerned about the uterus failing to con-

tract? What purpose does that serve?

A. The physiological changes of pregnancy increase the car-

diac output proportion that goes to the uterus during preg-

nancy. That is maintained in the post-partum stage. So an

obstetrical post-partum hemorrhage or a post-abortal hem-

orrhage—

THE COURT: Doctor, can you slow down a little bit?

The reporter has to get it all.

THE WITNESS: Yes.

A. I don’t know where I was.

Q. I had asked you about why you were concerned about the

uterus being able to contract after an abortion procedure.

A. During pregnancy a higher proportion of the cardiac out-

put is directed to the uterus, and that is maintained in the

post-pregnancy termination period, whether that be at 24

weeks [1062] or 22 weeks or 17 weeks. It takes approxi-

mately 12 weeks after pregnancy termination for the card

cardiovascular changes to go back to normal.

During that period of time, if the uterus failed to con-

tract, the contraction of the uterus stops the arterials from

bleeding into the cavity of the uterus. Atony, or failure of

the uterus to contract, increases the amount of blood flow

which can then accumulate in the uterus and then be passed

vaginally. So obstetrical hemorrhages post-abortion or post-

delivery can be very heavy.

Q. So failure of the uterus to contract impedes stopping of

the bleeding? Is that sort of a basic way to say that?

A. Yes.

54a

Q. You talked about some of the complications from having

retained fetal tissue or parts in the uterus. Can those com-

plications affect future reproductive health?

A. When you develop an infection in the uterus, you can de-

velop something called Asherman’s syndrome. It is usually

associated with multiple curettage of the endometrial tissue,

and it is also usually thought to be associated with infection.

So yes you can develop a condition in which you don’t have

menstrual periods because the lining of the uterus has been

damaged.

There can also intrauterine synechiae. That is a big

term. It is basically internal scar tissue which go from one

[1063] side of the uterus to another side of the uterus, and

therefore impede implantation and development of the sub-

sequent pregnancy. You can also get infection that is so se-

vere that you can get blockage of your tubes.

Q. Why is it that the intact D&E retains the risk of retain-

ing fetal tissue or parts?

A. Ensuring that the fetus delivered intact or virtually in-

tact decreases the chances that there can be amounts of tis-

sue in the uterus that are left. Also, when you do an intact,

D&E you usually get the placenta out as more of a discoid

organ rather than in bits and pieces.

Q. Doctor, I apologize if I maybe didn’t hear you. When I

asked you why it is that fetal tissue or parts—let me start

over. I apologize.

When I asked you why intact D&E reduces the risk of

fetal tissue and parts remaining in the uterus, I think you

said that intact D&E reduces the risk of fetal tissue or parts

remaining in the uterus. I would like you to explain why

that is.

A. Because the fetus comes out intact or virtually intact,

there are no fetal pieces of tissue left within the uterus. As

such, when you deliver the fetus intact or virtually intact,

the placenta can come out also virtually intact, thereby en-

suring that the uterus contracts and there is no retained

55a

products of conception within the uterus, which is the lead-

ing [1064] cause of infection in the post-abortal period.

Q. Dr. Frederiksen, can you assure that all fetal tissue and

parts have been removed by scanning with ultrasound fol-

lowing the procedure?

A. You can if you don’t think that you haven’t completed the

procedure. Ultrasound is usually available to scan the pa-

tient. But then if you don't have an intact fetus or you are

questioning whether the uterus is really empty or not, if you

actually have some left, you have to go back and continue the

procedure.

Q. Does that lengthen the procedure?

A. Yes.

Q. Can you always visualize remaining tissue with an ultra-

sound?

A. No, because you lose the contrast of the amniotic fluid as

you empty the uterus, and fetal parts are the same density

sometimes as blood clots. Therefore, you may not be able to

see them.

[1065:6] (Frederiksen)

A. Intact D&E is a variation of D&E.

[1080:1-4] (Frederiksen)

A. A D&E in the second trimester is not usually associated

with uterine rupture and is actually safer for a woman who

has undergone a caesarian section or any classical incision on

her uterus, or even a myomectomy.

APRIL 6, 2004

[1096:23-1097:3] (Baergen)

MS. STERNBERG: Your Honor, we tender Dr. Baergen as

an expert in pathology and perinatal pathology pursuant to

Federal Rule of Evidence 702.

[1097] MR. PANTOJA: No objection, your Honor.

THE COURT: The Doctor will be so recognized by the

Court.

[1161:21-24] (Frederiksen)

56a

Q. Dr. Frederiksen, is intact D&E the only technique avail-

able to terminate pregnancy in the second trimester?

A. It is not necessarily the only technique but it is the saf-

est.

APRIL 7, 2004

{1311:1-1316:25] (Weiss)

Q. Dr. Weiss, do you currently treat patients?

A. I do.

Q. In what settings do you treat patients?

A. I treat patients in an office setting in New Jersey, in

Hasbruck Heights, in an office called University Reproduc-

tive Associates. I also take patients who are in-patient both

in Hackensack University Medical Center and University

Hospital in Newark. I sometimes see patients in consulta-

tion with Newark as well.

Q. What type of patients do you see?

A. By and large, I take care of patients with problems in

gynecology. I am frequently referred to complex problems

from other gynecologists, and I see a full range of reproduc-

tive endocrinology and infertility cases as well.

). Do you perform surgery?

A. Ido.

Q. How often do you perform surgery?

A. Roughly 50 times a year.

Q. What types of surgeries do you perform?

A. I perform a fairly broad gamut of surgery in gynecology

and in my subspecialty. These include office surgical proce-

dures as well as hospitalized procedures, including repara-

tive procedures, endoscopies, laparoscopies, hysteroscopies,

vaginal and abdominal hysterectomies.

Q. You mentioned hysteroscopies. Can you explain what

those [1312] are.

A. A hysteroscopy is an operative procedure where the cer-

vix is dilated and then the inside of the uterus is evaluated

57a

with a telescope put into the uterus through the cervix. In

doing so, we can diagnose the presence of fibroids that are

impinging on the cavity, occasionally observe a malignancy,

observe polyps, adhesions, scars, and anomalies and things

that interfere with fertility. They can frequently be cor-

rected at the same time through instruments put into the

scope.

Q. You also mentioned laparotomies. Can you explain what

that is.

A. A laparotomy is an operation where the abdomen is

opened. It is a generic term for any time the abdomen is

opened. Specifically in gynecology, laparotomies, hysterec-

tomies, abdominal hysterectomies, removal of cysts, tubal

repair, tubal ligation, or removal of ovarian cysts and other

things that need to be done through an open incision.

Q. Have you ever performed an abortion?

A. Yes.

Q. Approximately how many times in your career have you

performed an abortion?

A. Approximately 1500 to 2,000.

Q. What types of abortions have you performed?

A. I have performed D&C abortions, including both sharp

curettage and dilatation and suction. I performed D&E

[1313] procedures later on in pregnancy. I have performed

an occasion hysterotomy. I have performed instillations. I

think that completes it.

Q. Do you currently perform abortions?

A. Ido.

Q. Dr. Weiss, how did you first learn to do abortions?

A. When I was a resident, abortions were not permitted and

were illegal. When I was a chief resident in 1969 and the end

of 1968, the law had softened somewhat in New York State

and there was the ability to do abortions for women whose

lives were endangered by the process.

Before that time, what we would see in my training at

Bellevue Hospital were the referred complications of crimi-

58a

nally induced abortions throughout the city. So every week,

especially as a first-year resident, | would have to deal with

completion of abortions of first and second trimester proce-

dures, many times in women who had infected uteri and

multiple problems. This is where I learned the techniques of

finishing the abortion process, in dealing with the issues, in

dealing with the complications and the trouble caused when

procedures are not performed accurately and adequately.

When I was a chief resident, I had 12 individuals who,

for medical or psychiatric reasons, were deemed by an inde-

pendent committee of physicians and other members of the

community that an abortion was appropriately required.

These [1314] women were in their second trimester. Be-

cause the process was a long one and even if they presented

at 8 weeks, which would be usual—because you could rarely

in those days diagnose a pregnancy before 6 or 7 weeks—

they would have to go through a committee and they would

be in their second trimester.

Using the skills that I had developed as a junior resi-

dent dealing with the many hundreds of abortions that were

in various stages of completion, I trained myself to perform

these abortions, because no one had done them beforehand

and there was no one that could teach the procedure. The

skills are not that much different from the skills I already

had. So I learned really in a way being self-taught at that

time.

Q. What were some of the consequences of the illegal in-

abortions that you described?

MR. LANE: Objection, your Honor.

THE COURT: What, pray tell, has this got to do with this

case?

MS. PARKER: Your Honor, may I?

THE COURT: Yes.

MS. PARKER: He is just describing the way he learned

abortions and some of the consequences.

THE COURT: I think you are going far beyond that.

59a

MS. PARKER: I will move on, your Honor.

THE COURT: Sustained.

Q. Dr. Weiss, approximately how many D&E procedures

have you [1315] performed throughout your career?

A. I would estimate 20 percent of the total, so that would be

somewhere around 3 to 500.

Q. In conjunction with your work at the hospital and the

medical school, do you supervise other physicians’ abortion

practices?

A. Yes. I am required to do quality control for all proce-

dures in the hospital. There was a period of time when the

abortion service, for varying reasons, was actually not part

of the obstetrics and gynecology department. But even at

that time I was responsible for the oversight of the proce-

dures, the quality assurance, and the evaluation of the pro-

cedures hy morbidity and mortality conferences.

I now see that residents are trained in these procedures

and evaluate the process. Specifically, we have generic

screens, such as readmission to the hospital for removal of

structures not planned for, readmission within a month after

procedure, that trigger what is called the morbidity mortal-

ity conference, which is an evaluation of the problem, why it

occurred, what could be done to prevent it from occurring

again.

We have now established, I have hired someone to es-

tablish, an abortion service. She has received a national

grant from the Ryan Foundation for I guess it is $450,000

the first year to set up training programs to teach individu-

als all [1316] aspects of contraception and abortion. This is

to teach residents as well as medical students and other—

THE COURT: What foundation is this?

THE WITNESS: The Ryan Foundation.

THE COURT: How do you spell that?

THE WITNESS: R-Y-A-N. It is named after Kenneth

Ryan, who was the chairman of obstetrics and gynecology at

60a

Harvard Medical School for many years and the chairman of

I believe it was President Nixon’s ethics committee.

Q. Dr. Weiss, how many D&E procedures have you super-

vised your career?

A. It would have to be thousands.

Q. Are you familiar with a variation of the D&E procedure

sometimes known as intact D&E?

A. Yes.

Q. Have you ever delivered a fetus intact in a D&E proce-

dure that you have performed?

A. Yes.

Q. Do you have any responsibility for training other physi-

cians?

A. Yes. Part of my job as the chairman of the medical

school department is to see that we train other physicians in

the subspecialty. We specifically through this grant are re-

quired as a department, as recipients of this, to train indi-

viduals as well.

[1321:10-16] (Weiss)

Q. Do you have an opinion regarding the safety of removing

the fetus intact in a D&E procedure?

A. Yes, I do.

Q. What is that opinion?

A. My opinion is that removing the fetus intact is a safer

procedure than disarticulating or breaking the fetus into

parts before removing it.

[1322:25-1324:3] (Weiss)

Q. Doctor, you were describing why it is that you thought

that [13823] removing the fetus intact in a D&E procedure

was safer. Did

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