1483
1 IN THE UNITED STATES
DISTRICT COURT
FOR THE DISTRICT OF NEBRASKA
2
LEROY CARHART, M.D., WILLIAM G. ) 4:03CV3385
3 FITZHUGH, M.D., WILLIAM H. KNORR,) April 8, 2004
M.D., and JILL L. VIBHAKAR, M.D.,) 9:00 a.m.
4 on behalf of themselves and the ) Lincoln, Nebraska
patients they serve, )
5 )
Plaintiffs, )
6 )
vs. )
7 )
JOHN ASHCROFT, in his official )
8 capacity as Attorney General of )
the United States, and his )
9 employees, agents and successors )
in office, )
10 )
Defendant. )
11 ---------------------------------
12
13
VOLUME VIII,
14 TRANSCRIPT OF TRIAL PROCEEDINGS,
BEFORE THE HONORABLE RICHARD G. KOPF,
15 UNITED STATES DISTRICT JUDGE
16
17 A-P-P-E-A-R-A-N-C-E-S:
18 FOR THE PLAINTIFFS: PRISCILLA J. SMITH
JANET CREPPS
19 NAN E. STRAUSS
Attorneys at Law
20 Center for Reproductive
Rights
21 120 Wall Street, 14th Flr.
New York, New York 10005
22
JERRY M. HUG
23 Attorney at Law
1823 Harney Street, #1004
24 Omaha, Nebraska 68102
25
1484
1 FOR DEFENDANT: ANTHONY
J. COPPOLINO
TERRY M. HENRY
2 PREEYA M. NORONHA
ANDREW I. WARDEN
3 U.S. Department of Justice
Civil Division - Federal
4 Programs Branch
P.O. Box 883
5 Washington, DC 20044
6 COURT REPORTER: DAVID C. FRANCIS, RMR
Official Ct. Reporter (Ret)
7 6300 Briar Rosa Drive
Lincoln, Nebraska 68516
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24 Proceedings recorded by manual stenograph, transcript
25 produced with computer.
1485
1 (Thursday, April 8, 2004, at 9:00 a.m.)
2 THE COURT: Good morning.
3 MR. COPPOLINO: Good morning, Your Honor.
4 THE COURT: Counsel, I would like to receive into
5 evidence the exhibits that I spoke about yesterday with Dr.
6 Cook. Court's Exhibit 1, which is my rather crude sketch.
7 Is there any objection to the Court receiving Court's
8 Exhibit 1?
9 MR. COPPOLINO: No objection.
10 MS. SMITH: No objection, Your Honor.
11 THE WITNESS: It's received. The second is Court's
12 Exhibit 2, little table regarding gestational age, length
13 and weight, from 12 weeks to 24 weeks. Is there any
14 objection?
15 MR. COPPOLINO: No objection.
16 MS. SMITH: No objection, Your Honor.
17 THE COURT: Received. And the third is Court's
18 Exhibit number 3 which is in the record or will be in the
19 record, Congressional Record, which is Darney's -- Phillip
20 Darney's letter to Senator Diane Feinstein dated March 12,
21 2003, and it's somewhat redundant to receive it, but to make
22 the record clear about what I was talking with this
23 particular doctor about, I think it would be helpful. I'm
24 not offering it for the truth of the matter asserted, simply
25 to understand my questions of the doctor.
Dr. Elizabeth Shadigian, Direct 1486
1 MR. COPPOLINO: No objection, Your Honor.
2 MS. SMITH: No objection.
3 THE COURT: All right. It's received. With regard
4 to Court's Exhibit 3, I want you to know that I intend to
5 ask the Government's OB/GYN witnesses today and tomorrow
6 questions regarding the two scenarios raised by Dr. Darney.
7 All right. Are you ready to proceed?
8 MR. COPPOLINO: Yes, Your Honor.
9 THE COURT: You're ready to proceed.
10 MR. COPPOLINO: Yes.
11 MR. COPPOLINO: The defendant calls -- Your Honor.
12 THE COURT: That's all right.
13 MR. COPPOLINO: The defendant calls Dr. Elizabeth
14 Shadigian.
15 DR. ELIZABETH SHADIGIAN, DEFENDANT'S WITNESS, SWORN
16 THE COURT: You may inquire.
17 DIRECT EXAMINATION
18 BY MR. COPPOLINO:
19 Q. Thank you, Your Honor. Good morning, Dr. Shadigian.
20 Would you please tell the Court what you do for a living?
21 A. I would be glad to. My name is Elizabeth Shadigian, and
22 I'm a practicing physician the State of Michigan. I'm an
23 obstetrician gynecologist, a generalist, and I practice at
24 the University of Michigan as a fulltime faculty member.
25 Q. Doctor, how long have you been on the faculty of
Dr. Elizabeth Shadigian, Direct 1487
1 University of Michigan?
2 A. I'll be completing my tenth full year this June.
3 Q. Doctor, I have put on the ledge near you where you're
4 standing, just the first document, please, which is marked
5 as Defendant's Exhibit 529. Do you see that?
6 A. Yes, I do.
7 Q. Is this a copy of your CV, Doctor?
8 A. Yes, it is.
9 Q. And did you create this document?
10 A. Yes, I did.
11 Q. And at the time you prepared it for us, does it
12 accurately reflect your education, work experience and
13 publications?
14 A. Yes.
15 MR. COPPOLINO: Your Honor, the Government moves to
16 admit Exhibit 529.
17 MS. CREPPS: No objection.
18 THE COURT: Received.
19 BY MR. COPPOLINO:
20 Q. Dr. Shadigian, why did you decide to specialize in
21 obstetrics and gynecology?
22 A. I was very interested in taking care of women throughout
23 their lifetimes, and especially interested in the issues
24 around reproductive health and reproductive choices, and why
25 women choose what they do.
Dr. Elizabeth Shadigian, Direct 1488
1 Q. Are you board certified as an OB/GYN?
2 A. Yes, I am.
3 Q. How long have you been so certified?
4 A. Since 1996.
5 Q. Are you a fellow of the American College of
6 Obstetricians and Gynecologists?
7 A. Yes, I am.
8 Q. Since when?
9 A. 1997.
10 Q. What does it mean to be a fellow of ACOG?
11 A. It means I have been accepted by my colleagues at a
12 national level. I have fulfilled all the requirements of
13 board certification, also on recommendations of other
14 fellows to be part of this college.
15 Q. Are you a member of an organization called -- tell me if
16 I don't get this straight, the American Association of
17 Pro-life Gynecologists, did I say that right?
18 A. AAPLOG, American Association of Pro-Life Obstetricians
19 and Gynecologists is actually not separate from ACOG. It's
20 actually a special interest group of ACOG, just like there
21 is another special interest group on various other topics in
22 ACOG.
23 Q. Could you tell the Court what the focus of the
24 organization, the Pro-Life Obstetricians and Gynecologists
25 is? What is that organization interested in?
Dr. Elizabeth Shadigian, Direct 1489
1 A. Right. About 900 to 1,000 full fellows of ACOG are
2 physicians who may have performed abortions in the past but
3 do not currently perform abortions, and they say that they
4 don't but the real focus is medical education. It's about
5 understanding women's health issues and obtaining
6 information to give to women.
7 Q. Let's just back up a little bit more on your personal
8 biography. Where did go to college?
9 A. I obtained my undergraduate degree, a bachelors of
10 science and chemistry from Purdue, University.
11 Q. Medical school?
12 A. The Johns Hopkins School of Medicine.
13 Q. Graduated what year?
14 A. I graduated in 1990 from Hopkins.
15 Q. Could you tell us when and where you did your residency
16 and in what specialty?
17 A. My specialty was and is obstetrics and gynecology. And
18 I took my training at the Franklin Square Hospital Center in
19 Baltimore, as well as Johns Hopkins.
20 Q. After your residency, you came to work for the
21 University of Michigan?
22 A. Yes. I started fulltime as a Clinical Assistant
23 Professor of Obstetrics and Gynecology after my residency.
24 Q. That was in 1994?
25 A. Correct.
Dr. Elizabeth Shadigian, Direct 1490
1 Q. Could you tell the Court, just briefly summarize what
2 you do on the faculty of the University of Michigan?
3 A. I'm a fulltime member, and I devote my time in three
4 areas. My biggest area is actually taking care of real
5 women patients. I also do research, and I teach both
6 medical students and residents from other specialties, as
7 well as especially our own OB/GYN specialty.
8 Q. Let's start with your clinical experience taking care of
9 patients. Could you tell the Court what types of OB/GYN
10 services you provide to your patients?
11 A. Yes. I'm a generalist, which means basically, I take
12 care of both pregnant women and women who aren't pregnant.
13 And in terms much pregnancy, I do both high risk obstetrics
14 as well as low risk obstetrics. I do have limits though,
15 because I'm a generalist not a maternal fetal medicine
16 specialist. So I take care of women with hypertension,
17 women with diabetes, women with connective tissue disorders,
18 or rheumatological disorders an neurological disorders, and
19 twins, but I don't take care of some kinds of the most sick
20 women. In addition, the low risks pregnancies I take care
21 of is an important part of my practice. I follow women over
22 time, not just in pregnancy, but outside of pregnancy, I
23 perform gynecological surgery on women and also do a lot of
24 well woman care and family planning.
25 Q. You also deliver babies too; is that correct?
Dr. Elizabeth Shadigian, Direct 1491
1 A. Yes, that's included in all that.
2 Q. All right. Doctor, what kinds of high risk
3 complications would you refer to a maternal fetal
4 specialist?
5 A. There are some complications that I might have had a
6 little bit of training on as a resident, but because I
7 didn't spend the additional three years necessary to be
8 board certified maternal fetal medicine, I refer most of my
9 patients with complex cardiac disease, patients with severe
10 connective tissue disease, such as lupus, and women who are
11 HIV positive, or have triplet or quad pregnancies are
12 usually referred to the maternal fetal specialists.
13 Q. Doctor, are there occasions when caring for a pregnant
14 woman, you have had to terminate a pregnancy before the due
15 date?
16 A. Yes.
17 Q. Could you tell the Court for what reasons you have had
18 to do that?
19 A. There are many different medical reasons that
20 necessitate us delivering a baby early, and there is a broad
21 range of them. But just to give a few examples:
22 Pre-eclampsia is a disease which is characterized by high
23 blood pressure, protein in the urine, and general swelling
24 of a woman. That is one of the diseases that could make us
25 have to deliver the baby early to protect the health of the
Dr. Elizabeth Shadigian, Direct 1492
1 mom. In addition, we have to deliver women early sometimes
2 if the baby is growth restricted or we are worried the baby
3 is not getting enough blood supply inside. And then there
4 can be other situations that necessitate earlier delivery.
5 For example, for twins, we think babies have better outcomes
6 if they are delivered a little earlier than full term
7 singleton pregnancies.
8 Q. Doctor, have you ever diagnosed fetal anomalies in
9 pregnant women you have treated?
10 A. Yes.
11 Q. How do you do that?
12 A. We generally perform a second trimester rule out
13 anomalies ultrasound.
14 Q. Which anomalies have you, in your experience, had
15 occasion to detect in women you have treated?
16 A. It has been a broad range over 14 years. Some examples
17 are women with babies who have Trisomies such as Trisomy 18,
18 21 or 13. Turner's Syndrome. There is also other moms who
19 have babies with omphalocele or gastroschisis, which are
20 problems with the gastrointestinal tract of babies.
21 Sometimes the twins I have taken care of have been stuck
22 together and not completely separated. That's called
23 conjoined twins.
24 Q. Doctor, in the curse of your medical training and
25 practice, have you become familiar with the different
Dr. Elizabeth Shadigian, Direct 1493
1 methods of terminating a pregnancy?
2 A. Yes, I have.
3 Q. In your current medical practice, which methods of
4 pregnancy termination have you had occasion to utilize?
5 A. Well, depending on the gestational age of the baby, I
6 have had to use D & Cs, D & Es, and medical induction of
7 labor.
8 Q. Just so the record is clear, could you just briefly
9 describe what a D & C is for the Court?
10 A. Right. D & C stands for dilation and curettage, which
11 is the French word to mean to scrape. But generally, a
12 first trimester D & C is anywhere -- the first trimester
13 starts at the woman's last menstrual period, when she gets a
14 positive pregnancy test about five weeks up to 12 weeks of
15 pregnancy. The cervix is dilated, and then using sharp or
16 suction curettage, all the contents of the uterus are
17 removed, including the baby and the placenta and the fluid.
18 Q. And I believe you mentioned -- did you mention the
19 dilation and evacuation method?
20 A. Yes the D & E is another method I'm well familiar with.
21 Q. Would you explain that for the Court briefly?
22 A. The dilation and evacuation method is generally used in
23 the second trimester of pregnancy where the cervix is
24 dilated over a series of days with laminaria or osmotic
25 dilators. In current use, sometimes we use medicine such as
Dr. Elizabeth Shadigian, Direct 1494
1 Misoprostol to dilate the cervix and prepare the cervix.
2 Then the woman is taken back to the operating room, the
3 laminaria are removed, and the amount of dilation may be
4 increased with more dilators in the operating room. Finally
5 traction is placed on the cervix, which straightens it out
6 from the cervix to the uterus. And then a series of
7 instruments are put inside the uterus to facilitate removal
8 of a larger baby.
9 Q. And how would you describe a medical induction?
10 A. A medical induction is a way of terminating a pregnancy
11 where we actually put medications, either in the uterus or
12 intravaginally, or in a woman's mouth, to help give her
13 contractions and to start the physiological process of
14 labor.
15 Q. Doctor, I would like to ask you some questions
16 specifically on your experience in performing abortions and
17 pregnancy terminations. Let's start with D & C. And could
18 you summarize for the Court your experience in performing D
19 & Cs? If it would be easier, you might start with your
20 experience in med school, residency, and then up to the
21 present?
22 A. Right. To be clear, except in some medically indicated
23 terminations of pregnancy, all the babies that I have taken
24 care of that I have performed abortions on were dead by the
25 time I actually took care of the baby. So in the first
Dr. Elizabeth Shadigian, Direct 1495
1 trimester, as a student -- you asked me to start with when I
2 was a student.
3 Q. D & C, give the Court your experience. You can go back
4 to med school, residency?
5 A. Right. So as a medical student, at that level, I
6 actually watched the performs of D & Cs on live babies but
7 never participated holding instruments with live babies, but
8 had helped with several of them, probably six or less as a
9 student. In residency, we had a very busy obstetrical
10 program, and I did literally hundreds of D & Cs on babies
11 that had expired. And then I also made it a point to
12 actually be present and see techniques to see if they were
13 different or not for people performing abortions on live
14 babies as well.
15 Q. And do you continue to perform D & Cs, in your current
16 practice?
17 A. Yes, I do.
18 Q. Let's go to dilation and evacuation starting in medical
19 school and up to your residency, and your current practice.
20 Would you describe to the Court your experience in either
21 performing or observing the dilation and evacuation method
22 of abortion?
23 A. So as a medical student, I probably watched six or less
24 D & Es, just getting an idea and flavor for what happens
25 during them. But during my residency, because it was such a
Dr. Elizabeth Shadigian, Direct 1496
1 busy program, I actually helped participate between 30 and
2 50 D & Es on babies that had died. Or if I decided to be
3 present in the room, I could also observe the techniques on
4 live babies as well, but I didn't participate holding
5 instruments.
6 Q. Since you have been at the University of Michigan, how
7 many times, on occasion, have you -- how many occasions have
8 you had to perform a D & E procedure on a fetus that had
9 already died?
10 A. Probably between ten and 20 times.
11 Q. Is there any change in the procedure of extraction that
12 you utilize in performing a D & E, when the fetus has died?
13 A. No, we use the same disarticulation, meaning pulling the
14 baby out in pieces. However, on a dead baby, it may be
15 easier to actually pull the baby apart because of the
16 process of death being initiated already.
17 Q. Up to what gestational age have you observed a D & E on
18 a living fetus?
19 A. Probably between 20 and 22 weeks.
20 Q. How many D & Es have you performed with the fetus
21 between 18 and 19 weeks?
22 A. Probably eight to ten.
23 Q. Have you terminated a pregnancy where the fetus was
24 alive, where the termination was necessary to treat a
25 maternal health complication?
Dr. Elizabeth Shadigian, Direct 1497
1 A. Yes, I have.
2 Q. And in such cases, what technique have you used?
3 A. I have used medical induction of labor to take care of
4 women who were very sick, who need to have their pregnancy
5 ended.
6 Q. So is it correct to say, Doctor, you will terminate a
7 pregnancy on a live woman in order to treat a woman facing a
8 serious health complication?
9 A. Yes, I will and I have.
10 Q. As an OB/GYN, do you have an understanding of how to
11 empty the uterus during a pregnancy, if necessary, before
12 the due date?
13 A. Yes, I do.
14 Q. When you were in medical school in Baltimore, did you
15 make a special effort to learn about abortion?
16 A. Abortion and women's health choices around abortion have
17 been a subject that have been very interesting to me for my
18 whole career. So I have paid a special attention to both
19 the techniques and the complications of abortion.
20 Q. What institutions did you work at in Baltimore that
21 provided abortion services that you were able to learn about
22 abortion?
23 A. In addition to Johns Hopkins, there was a very large
24 county hospital called Francis Scott Key Medical Center, and
25 they actually did quite a few elective terminations of
Dr. Elizabeth Shadigian, Direct 1498
1 pregnancy, both by D & E and by medical induction. In fact,
2 I think had the biggest service in the entire greater
3 Baltimore area. So I had access to those people who were
4 teaching me to actually ask questions, and they helped me
5 understand the procedures very well as a student.
6 Q. Why did you make a special effort to learn about
7 abortion procedures while you were at, in Baltimore for med
8 school and residency?
9 A. I just wanted to understand it. I wanted to be able to
10 be very clear with my own patients as I was going into
11 OB/GYN what the risks and techniques were. And I wanted to
12 be good at how to do the procedure, so I could actually
13 explain that to people, so I could provide those services to
14 women.
15 Q. Is it also the case you were involved in working on teen
16 pregnancy issues while you were in Baltimore?
17 A. Yes. In my residency program, we had one of the busiest
18 hospitals, Franklin Square Hospital, but we had a very big
19 teen clinic. Baltimore, unfortunately has one the highest
20 teen pregnancy rates in the country. So I had the
21 opportunity to take care of a lot of teenagers.
22 Q. Now, let's just touch on medical induction again. Could
23 you tell the Court what your experience has been in
24 observing and performing medical inductions? Let's just go
25 with med school and residency for now.
Dr. Elizabeth Shadigian, Direct 1499
1 A. In medical school, medical induction of labor was one of
2 the techniques used for elective terminations. So they had
3 a whole ward and area that they did every day, or three days
4 a week, medical inductions of labor for elective reasons.
5 So I got -- I saw probably more of those even than D & Es in
6 medical school. And then in residency, most of my
7 experience on medical inductions were for medical reasons
8 and/or fetal anomalies, but I didn't participate in medical
9 inductions for fetal anomalies but the techniques were the
10 same.
11 Q. And in your current practice, could you give the Court
12 an indication of the frequency with which you use medical
13 induction to terminate a pregnancy, prior to term?
14 A. Well, prior to term, there are a lot more indications
15 than prior to viability. So I would say on a weekly basis,
16 there would be people we're inducing for medical reasons
17 that need to get delivered.
18 Q. And why don't you give the Court an idea of your
19 experience in terminating a pregnancy using the induction
20 method prior to viability?
21 A. Those particular circumstances are a lot more rare, and
22 thank goodness, women generally get through pregnancy
23 without having such severe complications in the second
24 trimester. But there are such complications and the two,
25 most common ones I take care of are infections in the uterus
Dr. Elizabeth Shadigian, Direct 1500
1 called chorioamnionitis, which is an infection of the
2 membranes, the placenta, the baby, the uterus, and it can be
3 any variation therein. So that's one example of why I need
4 to use my medical induction techniques. And the other
5 common medical complication of pregnancy is severe
6 pre-eclampsia that I have the most experience with.
7 Q. Doctor, would you explain to the Court why it is you
8 need to be familiar with both surgical and medical forms of
9 abortion in your practice?
10 A. Well, babies that I take care of who have already died
11 inside their moms, I want to be able to provide that service
12 to offer the D & E, just like I do to my first trimester
13 patients. So I generally offer that myself. If I find
14 that's it's beyond my scope of practice and I feel like my
15 surgical skills aren't as good, then I have my maternal
16 fetal medicine colleagues, who are specialists, I can also
17 refer to.
18 Q. Why is it that you have occasion to perform more
19 inductions than D & Es in your practice?
20 A. It just so happens the way the system is at the
21 University of Michigan is I actually, when I take call, take
22 care of a greater number of women on call than I would in my
23 own sort of almost private practice. So I have all the
24 transfers of care patients from all around the southern part
25 of Michigan are transferred to University of Michigan. So
Dr. Elizabeth Shadigian, Direct 1501
1 we are supervising the residents and all the transfer
2 patients as well. So that's why medical induction is more
3 common for me.
4 Q. Is there a stage in gestation where medical induction
5 termination of a pregnancy is more common, in your practice?
6 A. It's most common 16 weeks and greater gestational age,
7 but even more so, 20 weeks and greater.
8 Q. All right. Doctor, you also have teaching
9 responsibilities at the University of Michigan?
10 A. Yes, I do.
11 Q. Could you just describe those responsibilities to the
12 Court, who do you teach, what do you teach and where do you
13 teach?
14 A. So I teach at the undergraduate, graduate level as well
15 as medical students. So undergraduate teaching, I teach in
16 women's studies. I teach about domestic violence and sexual
17 assault. That's my other area of expertise that I have
18 taught about for many, many years. And in addition to
19 undergraduate students and women's studies in psychology, I
20 also teach a graduate students and nurse midwifery programs
21 in sociology, I have. And then at the medical student
22 level, I teach sort of on three levels. I help run a course
23 could the Interpersonal Violence Course to second-year
24 students. We are just finishing that up this week actually.
25 So that's about 16 contact hours of both didactic lectures
Dr. Elizabeth Shadigian, Direct 1502
1 and small groups. And I have done that for ten years. In
2 addition, for the students, I give the third-year students
3 direct hands-on teaching both in my office and the
4 gynecology ORs, labor and delivery, just as they rotate
5 through our department. In addition, I give two didactic
6 lectures every six weeks. One on breast feeding and one on
7 issues around violence against women. And then, finally, I
8 run an elective called Primary Care in Obstetrics and
9 Gynecology, where I take the most senior medical students
10 who are interested in a variety of topics and let them sort
11 of see what it's like to become an attending, and a faculty
12 member, and all the range of what we do. We actually allow
13 them to choose the kinds of experiences they want. And
14 those are the medical students I teach.
15 Q. Okay. You talk a little faster than even I do.
16 A. Sorry.
17 Q. Make sure the reporter is getting it all. That's fine.
18 Now, let's talk about residents. To the extent you haven't
19 covered it, give the Court and idea of how you work with
20 residents?
21 A. The residents that I teach are mostly obstetrician
22 gynecology residents. We have a four-year program and have
23 at least 20 residents at all different stages. So I
24 supervise them directly in the inpatient care. They don't
25 come to our offices, however. They have their own clinics
Dr. Elizabeth Shadigian, Direct 1503
1 at the University. But any of the cases that come from the
2 clinics, I might be asked to help in. And in addition,
3 there are internal medicine seen and pediatrics residents,
4 and they are also asked to rotate with me to get special
5 examinations, and pelvic exams, because of the different
6 work I do in gynecology. And then there are family practice
7 residents who are learning about obstetrics and gynecology
8 too. We supervise them as they rotate on our service.
9 Q. Do you have occasion, then, in that context, to have
10 residents come with you and have you supervise them in the
11 performance of pregnancy termination?
12 A. Yes.
13 Q. Could you describe that to the Court both in terms of
14 the frequency of that and what procedures you're supervising
15 residents on?
16 A. Whenever a patient from my own practice needs to have
17 any kind of procedure and I'm available to do it, I'll do it
18 myself. In the course of that, we have residents and
19 sometimes medical students who will be participant. So
20 depending on the level of the resident, I will allow them to
21 participate up to the safe level of their learning. But I
22 will be the one supervising everything.
23 Q. Do you let the residents actually insert instruments,
24 say, in the performs of a D & E on fetal demise?
25 A. Yes.
Dr. Elizabeth Shadigian, Direct 1504
1 Q. But you take over the procedure, if it's necessary, for
2 the safety of the mother?
3 A. Absolutely.
4 Q. Could you explain to the Court the process of the
5 extraction during a D & E that you would -- that you would
6 teach the resident, as you're doing the procedure?
7 A. Yes, I would. Basically, in addition to actually giving
8 them the physical hands on skills, one of the other things
9 we do is we are teaching didactically as we are doing it.
10 So I might ask, well, should we use an ultrasound machine
11 while we do this, because then we can see where the
12 instruments are actually going. So we'll go over and
13 discuss should we use an ultrasound machine in this instance
14 or not. And then before a resident may even perform the
15 procedure such as a D & E, I'll start asking them questions.
16 So what is the first thing you're going to do before you do
17 it? I'm going to put the speculum in if vagina. I'm going
18 to pull out the laminaria. I'm going to check how dilated
19 it is, and then I'm going to decide which kind of instrument
20 for traction I'm going to use. I might quiz them. Do you
21 want to use one that is dull or sharp, and what will reduce
22 the amount of bleeding, and, you know, how hard do you want
23 to pull. So I'll go each step, I'm asking them questions to
24 see if they have been reading to see if they understand the
25 literature. So we'll sort of go through that as we go, and
Dr. Elizabeth Shadigian, Direct 1505
1 then I'll ask well what kind of forceps do you want to use
2 today to pull -- to disarticulate. Then we'll go through
3 what our choices are.
4 Q. About how many times a year will you be working with a
5 resident in performing D & E on fetal demise?
6 A. Depends on the year because most of those patients are
7 actually from my practice. So it could be zero to two per
8 year.
9 Q. About how many times a year will you have a resident
10 with you while you're performing a D & C?
11 A. In almost every D & C I do, but I do so many more of
12 those.
13 Q. You also supervise residents in the performance of
14 medical induction?
15 A. That's correct. When a woman needs to have a medical
16 induction, whether they are before viability or after, the
17 residents will be participant fully in the decision making
18 and also the actual putting in the medications and figuring
19 out how often to dose the medications.
20 Q. Do you also teach about abortion complications?
21 A. Yes, I do.
22 Q. Would you describe, first of all to the Court, why you
23 have developed an interest in abortion medical
24 complications?
25 A. Yes. In the course of taking care of well women,
Dr. Elizabeth Shadigian, Direct 1506
1 abortion is a very common procedure. It has been estimated
2 up to 43% of American women will have an elective abortion
3 or a medically necessary abortion by the time they are age
4 45. So it's just a very common thing that women decide to
5 have. So I want to know how to best take care of those
6 women, if they have had an abortion or they haven't. And
7 sometimes, when we look at individual studies, I can't make
8 heads or tails out of what I should advise women based on
9 one study. So I have been become very involved in something
10 called systematic reviews, where we do a whole literature
11 search on a whole topic. And I have done this on several
12 different topics now, where we look at the world's
13 literature on a certain topic, and then we try to make sense
14 of what we find. Because as an individual physician, it's
15 very difficult to make good value and medical judgments,
16 just based on one or two articles you may know. So I found
17 taking care of women, I couldn't answer these questions by
18 just looking at one or two articles and just looking at
19 guidelines. I wanted to actually get down to the actual
20 articles and read them myself.
21 Q. What types of abortion complications have you seen and
22 treated in your practice?
23 A. Well, there are a whole range of them. The most common
24 once are things like infections or lots of blood loss after
25 an abortion procedure. But I have also had occasion to take
Dr. Elizabeth Shadigian, Direct 1507
1 care of women who have had scar tissue in their uterus,
2 because of their procedures, and women who have actually had
3 early births the next time after an induced abortion. There
4 is a big range.
5 Q. Besides your duties as a professor and your clinical
6 practice, have you had time to do research in areas related
7 to your practice?
8 A. Well, even when I was a resident, I did a research
9 project every year. And that has sort of been my way of
10 approach important things, is that I try to concurrently do
11 research as I find either clinical problems in my practice,
12 or if there is issues around care of women that are
13 important. For example, I just got published in the
14 International Journal of OB/GYN about how to take care of
15 women in pregnancy who have domestic violence issues in
16 looking at homicide data, for example. So that's another
17 area that I look at as well.
18 Q. Now, I noticed in your CV and from your testimony this
19 morning, that not all of the areas that you research may
20 seem to be directly related to obstetrics such as violence
21 against women. Why don't you explain to the Court how you
22 feel those topics, such always violence against women,
23 sexual assault, do relate to your practice of obstetrics.
24 A. Just because I take care of general women coming to my
25 office, they just have lots of histories of domestic
Dr. Elizabeth Shadigian, Direct 1508
1 violence and sexual assault. And, unfortunately, between a
2 fourth and a third of all women have been sexually assaulted
3 or molested sometime in their life. So I'm going to be
4 doing surgical procedures, for example, on women who have
5 been violated. So if I can understand that that happened,
6 and I can explain to women that they are giving their bodies
7 over to someone like myself and they need to trust me, and
8 they need to be able to feel safe, I can actually explain to
9 women what's going to happen very succinctly, and also help
10 them feel reassured that it's their choice to have this
11 done, and that we will do everything we can to make it feel
12 better for them, even if they have had a traumatic
13 experience.
14 Q. Doctor, I would like you to, have -- I would like you to
15 tell the Court about your experience in testifying in other
16 judicial proceedings concerning the issue of abortion.
17 A. I have been asked by several different states to help
18 them in different legislation around informed consent for
19 abortion. In addition, parental consent for abortion, and
20 there have been a couple of other kinds of topics, but those
21 are the two other topics I have been asked to offer opinions
22 on.
23 Q. Right. And what, just generally, are the issues
24 involving informed consent and parental consent involving
25 abortion that you have testified in, and what has been the
Dr. Elizabeth Shadigian, Direct 1509
1 nature of your opinion in those matters?
2 MS. CREPPS: Your Honor, I'm going to object on
3 relevance grounds at this point.
4 THE COURT: That will be overruled. You may
5 answer.
6 THE WITNESS: I think my varied experience in
7 explaining things to people, I have sort of honed those over
8 the years. So just as I gave the example of trying to
9 really explain procedures on people who have had sexual
10 assault, as part of their history, I make it a very big
11 point to be able to really explain how we do procedures on
12 women and what complications there are in plain language to
13 women, so that they can actually understand it. That's part
14 of my role as a physician and surgeon. But I think because
15 the women I really take care of have such varied
16 experiences, you know, in my office, I have made that a
17 special kind of area that I'm very explicit with them.
18 BY MR. COPPOLINO:
19 Q. All right. A little more specifically, what issues, in
20 the cases in which you have testified concerning informed
21 consent, what issues specifically have you testified about
22 and what opinions have you rendered?
23 A. Right. One other thing that I have done is tried to
24 explain that it's not good enough just to tell people about
25 the short-term complications on abortion consent forms, but
Dr. Elizabeth Shadigian, Direct 1510
1 that there are well studied and well documented long-term
2 complications, and women have the right to know what those
3 are too. It may not change their thinking about a procedure
4 in front of them, but they should know what could happen to
5 them later on, and their doctor should know that too.
6 Q. Doctor, you understand this case concerns a
7 Partial-Birth Abortion Act, Ban Act of 2003, correct?
8 A. Yes.
9 Q. What study have you undertaken of that procedure, in
10 connection with your testimony here today?
11 A. When I was asked to see if I would like to be an expert
12 in this case, I was actually asked about studies on D & X.
13 So I didn't really know if there had been studies done on D
14 & X or not. I hadn't heard of any, but what I did was using
15 the other techniques I had used to look at long term
16 complications of abortion, and homicide, and suicide, and
17 pregnancy; all the same techniques. I went to the library
18 and it said this is the topic. These are the words we need
19 to use, and then performed a systematic review.
20 Q. If you will just slow down for the reporter.
21 THE COURT: Trust me, he's ornery enough if he
22 can't take it, he'll tell you. And if he starts getting
23 tired, he'll tell you repeatedly.
24 BY MR. COPPOLINO:
25 Q. Doctor, what is your understanding of the term
Dr. Elizabeth Shadigian, Direct 1511
1 partial-birth abortion?
2 A. Partial-birth abortion has been described in many
3 different ways. I generally use interchangeably the
4 partial-birth abortion term, the intact D & E term.
5 Q. All right. So what's your understanding of -- is it
6 also occasionally referred to as the D & X procedure?
7 A. And the D & X procedure, dilatation and extraction
8 procedure.
9 Q. What's your understanding -- let's pick one for today
10 for convenience. Let's pick D & X. What is your
11 understanding of the D & X procedure?
12 A. As I understand the D & X procedure, there is generally
13 considered four parts to it. One is dilating the cervix
14 over several days to accomplish an adequate amount of
15 dilation. The second part is the instrumental conversion of
16 a fetus from whatever position it's in initially to a
17 breech, and then it's delivering the fetus up into the head,
18 which is called a breech extraction, and then it's the
19 admitting of instruments into the base of the skull of the
20 fetus, and then extracting the contents of the skull to
21 facilitate delivery of the head.
22 Q. Doctor, in preparing for your expert testimony, you've
23 read the Partial-Birth Abortion Ban Act of 2003?
24 A. Yes, I have.
25 Q. Have you also read the report of the U.S. house of
Dr. Elizabeth Shadigian, Direct 1512
1 Representatives on the Partial-Birth Abortion Ban Act of
2 2003?
3 A. Yes, I have.
4 Q. Have you read the description of the D & X procedure
5 attributed to Dr. Haskell?
6 A. Yes, I have.
7 Q. Have you also read the description of the so-called
8 intact D & X procedure prepared by ACOG?
9 A. Yes, I have.
10 Q. Have you also read some of the declarations prepared by
11 a couple of the experts testifying in the three cases that
12 are pending on the partial-birth abortion?
13 A. Yes, I have.
14 Q. Do you agree, Doctor, that there are variations in the
15 various procedures referred to as intact D & E, D & X,
16 intact D & X?
17 A. Yes, there are several variations.
18 Q. Do you have a view as to whether the procedure could be
19 described as a D & X, if the baby was already in a breech
20 position, instrumental conversion was not required?
21 A. That would still, in my mind, fulfill the D & X
22 criteria.
23 Q. Doctor, you have been asked to testify about a couple of
24 topics in this case, I would just like to have you identify
25 those topics, and have you summarize your opinion for the
Dr. Elizabeth Shadigian, Direct 1513
1 Court. Do you have an opinion as to whether the D & X
2 procedure is ever medically necessary to properly treat
3 pregnant women suffering from high risk medical
4 complications?
5 A. I know circumstance in which the D & X is medically
6 necessary to treat women with medical problems.
7 Q. Do you have an opinion as to whether there is a basis on
8 which to conclude that the D & X procedure offers safety
9 advantages to women over other methods of abortion?
10 A. Since the D & X has never been studied in a formal way
11 in peer review literature, there is no basis to say the D &
12 X is safer than any other procedure.
13 Q. And so do you have an opinion as to the relative safety
14 of the D & X procedure, as compared to the induction method
15 of abortion?
16 A. Well, there is no sound basis on which to conclude the D
17 & X is safer than medical induction.
18 Q. Okay. I would like to talk first about the medical
19 necessity of partial-birth abortion, your opinion in
20 connection with that. I believe you testified earlier this
21 morning that it is sometimes necessary to terminate a
22 pregnancy for maternal health reasons; is that correct?
23 A. Yes.
24 Q. And you may have said this already, but just describe to
25 the Court how common that actually occurs with reference to
Dr. Elizabeth Shadigian, Direct 1514
1 both pre and post-viability?
2 A. Post-viability, there are several times that we need to
3 induce labor, and that's a very common thing that
4 obstetricians/gynecologists learn in their training; how to
5 do that safely for babies at different gestational ages.
6 It's uncommon to find a mom who has such a complication in
7 the second trimester, that it actually necessitates
8 termination of the pregnancy. But the two I take care of
9 most frequently are the chorioamnionitis and the severe
10 pre-eclampsia.
11 Q. Why don't we, then, just briefly restate for the record
12 what those two conditions are. I want to ask you about your
13 experience terminating pregnancy for those conditions.
14 Let's start with severe pre-eclampsia.
15 A. Severe pre-eclampsia is a medical condition that is
16 specific to pregnancy. We don't see it outside of
17 pregnancy. Where a woman's liver is affected, where a
18 woman's platelets are affected, and where a woman can get
19 swollen, and have their blood pressure go very high. And in
20 those situations, a woman can start getting so sick that
21 she's at risk of hemorrhaging and dying from the actual
22 medical condition.
23 Q. Chorioamnionitis?
24 A. Chorioamnionitis, again, is an infection in the fluid
25 around the baby. The baby itself, and it can extend into
Dr. Elizabeth Shadigian, Direct 1515
1 the mother's's uterus, and then into the mother. So that
2 it, in fact, affects both the baby and the mom.
3 Q. Now, when you are faced with a need to terminate a
4 presentation because of maternal health complication, is
5 that situation approached differently depending on whether
6 the baby is pre or post-viable?
7 A. In the situation in the late second trimester, we
8 basically don't do anything different. We don't try to make
9 the baby die but we accept that the baby could die as a
10 normal part of this physiological process of terminating the
11 pregnancy.
12 Q. When the fetus -- when you have judged that the fetus
13 has no chance of survival outside pregnancy, is there any
14 difference in the actual method of induction?
15 A. We can use higher dose medications that may cause the
16 uterus to have a higher rate of both rupture, and it also
17 may be a quicker process, if we use higher doses of
18 medications.
19 Q. And, Doctor, you personally have had to terminate a
20 pregnancy on a living fetus you knew was not likely to
21 survive the termination; is that correct?
22 A. Yes.
23 Q. How do you evaluate maternal health conditions during a
24 pregnancy to determine whether and when you should end the
25 pregnancy, because of a severe maternal complication?
Dr. Elizabeth Shadigian, Direct 1516
1 A. Those are tricky situations to make those sort of hair
2 line decisions. But basically we look at a lot of different
3 medical factors. So it's not enough that a woman would have
4 just premature rupture of membranes, say, as a precursor to
5 the chorioamnionitis. We actually have to find physical
6 signs and symptoms. So the uterus has to be tender, the
7 woman has to have a fever. It's not good enough just, for
8 example, the membranes are ruptured. So we have to see that
9 certain criteria are fulfilled. And in the severe
10 pre-eclampsia, it's not enough just that the blood pressure
11 is high. We can manage blood pressure independent. But
12 when we see the liver being affected, the kidneys being
13 affected, the platelets. When we see other organ systems
14 being affected by the process, then we make the call that
15 it's affecting the mother so much that she's in danger.
16 Q. In circumstances in which the baby is potentially
17 post-viable, is your approach to try to deliver the baby and
18 then turn the baby over to neonatologists for what they can
19 do?
20 A. We try to deliver the baby in the safest way to give the
21 baby the most chance of surviving, if the baby is in the
22 viability range.
23 Q. Now, in all these circumstances in which you have
24 terminated pregnancy prematurely, you have used the medical
25 induction method?
Dr. Elizabeth Shadigian, Direct 1517
1 A. Yes.
2 Q. When a pregnancy has to be ended pre-viability for a
3 maternal health reason, is it ever necessary to take a
4 destructive act directly against the fetus, in order to
5 protect the health interests of the mother?
6 A. I have never needed to use such an act.
7 Q. And why not?
8 A. It's just not necessary.
9 Q. What is necessary to serve the health interests of the
10 mother, when she needs her pregnancy to end pre-viability?
11 A. The most important thing is ending the pregnancy, which
12 means delivering the baby and the placenta. Once that's
13 accomplished, then the mom will get well spontaneously.
14 Q. In your opinion, Doctor, would there ever be a medical
15 need to use the D & X procedure to terminate a pregnancy,
16 specifically, because of a particular type of health
17 condition that the mother is facing in the pregnancy?
18 A. I can't think of a situation.
19 Q. Are there, in your opinions, save and effective ways to
20 terminate a pregnancy for maternal health reasons without
21 the D & X procedure?
22 A. Yes. We have the disarticulation D & E procedure, and
23 we have the medical induction procedure with many different
24 kinds of medicines that have both been well studied.
25 Q. Would a D & X procedure ever be an appropriate procedure
Dr. Elizabeth Shadigian, Direct 1518
1 to terminate a pregnancy in the circumstance in which
2 maternal health is deteriorating rapidly?
3 A. No, that would be a circumstance that it would not be
4 good, because it takes so many days to treat the cervix a
5 head of time and get the body prepared for the actual
6 procedure itself.
7 Q. I would like to turn back to the subject of fetal
8 anomalies. You testified you had some involvement with
9 that. What happens when one of your patients is diagnosed
10 with a fetal anomaly?
11 A. When I get the ultrasound report, many times I almost
12 get it at the same time they are doing it. The radiologist
13 will call me. It's our practice that after the ultrasound,
14 the woman comes up to my office and talks to me or my nurse
15 practitioner. So in those situations, I explain what the
16 anomaly is. I explain if it's a kind of what we call
17 fixable or something that we can treat after the baby is
18 born, or even during the course of the pregnancy. And then
19 tell them what the likely outcome is. In addition to that,
20 I think it's always in one of these situations that it's
21 complicated, I most generally get a consultation from our
22 maternal fetal medicine colleague, so they can give their
23 opinion to the patient. Many times after that, they want to
24 call me back and see me again or go over things again,
25 because I do have a long-term relationship with most of my
Dr. Elizabeth Shadigian, Direct 1519
1 patients.
2 Q. Just to be clear, you diagnosis the anomalies in your
3 patients?
4 A. Yes.
5 Q. And how do you do that?
6 A. Well, I order a second trimester ultrasound, and then I
7 get to explain what it means to the patient. And sometimes
8 I have to order additional tests like a fetal echocardiogram
9 or a second ultrasound a few weeks later, if they couldn't
10 see all the parts.
11 Q. In cases involving a fetal anomaly, can there be a
12 maternal health problems that's associated with the woman
13 carrying the anomalous fetus that might independently
14 justify terminating the pregnancy?
15 A. Usually, they are two separate situations. Either mom
16 is sick and has her own issues around being sick, or that
17 the baby has problems, and the fetus is anomalous, but
18 rarely would they be, if at all, connected in any way.
19 Q. Do you have knowledge of the procedures that may be used
20 to terminate a pregnancy for a fetal anomaly?
21 A. Yes.
22 Q. What types of abortions are offered for patients at the
23 University of Michigan for fetal anomalies?
24 A. Generally, at the University of Michigan, D & Es are
25 offered to women 20 weeks and before. After 20 weeks, they
Dr. Elizabeth Shadigian, Direct 1520
1 may be offered, but the general trend is that we are doing
2 almost exclusively medical inductions of labor after 20
3 weeks.
4 Q. So what method of pregnancy would you recommend for
5 termination of pregnancy involving a fetal anomaly after 20
6 weeks?
7 A. I generally would recommend the medical induction.
8 Q. And why?
9 A. Well, there as few reasons. Basically because the
10 safety data is so much better on medical inductions,
11 especially with the newer Prostaglandins. It used to take
12 much longer to induce labors and it was more distasteful for
13 women and even more difficult to manage people over three
14 days. But now, we have Misoprostol and we can actually
15 deliver babies within four to 24 hours with the new
16 medication. So it's safer. And, also, the older studies
17 show that there is a lot less maternal mortality for medical
18 inductions for 21 weeks and later.
19 Q. Doctor, I believe you testified that you'll treat a
20 patient, maybe you did -- let me just ask it directly. Do
21 you ever continue to treat your patients after they have had
22 a termination for a fetal anomaly?
23 A. I treat most of my patients afterwards, if they choose
24 to come back. I specifically tell my patients, whether they
25 choose to abort their baby or not, I'm willing to take care
Dr. Elizabeth Shadigian, Direct 1521
1 of them later. In fact, I do, in most of their subsequent
2 pregnancies.
3 Q. I was going to ask. You anticipated my next question.
4 Have you delivered some babies for your patients after
5 terminations they have had?
6 A. Yes.
7 Q. And that's also in the case involving fetal anomalies,
8 have you delivered babies for patients after they have had a
9 termination for a fetal anomalies?
10 A. Yes. Both for fetal anomalies and other reasons.
11 Q. In your opinion, Doctor, is the D & X procedure ever
12 necessary to terminates a presentation in which there is a
13 fetal anomaly?
14 A. No.
15 Q. Why not?
16 A. It's just not necessary, because we have such other well
17 studied techniques that work very effectively; both the D &
18 E, and the medical induction are very well studied, and we
19 know where the lines are that there are increased risks with
20 one or the other.
21 Q. In your experience, Doctor, in being involved with
22 pregnancies involving fetal anomalies, is there anything
23 unique about fetal anomalies that would require an intact
24 extraction provided by the D & X procedure?
25 A. Not that I can think of. Even with anomalies that are
Dr. Elizabeth Shadigian, Direct 1522
1 very large -- I mean what's really, what we are really
2 talking about is are there babies where their parts are so
3 big that we actually have to decompress them first to do a
4 good job for mom. And there are only a couple of thoughts I
5 have. One, is if the head is very big with hydrocephaly,
6 there is actually a procedure we can do to draw off the
7 fluid around the baby's head, for the head to get a little
8 bit smaller and make it easier to have the baby come out.
9 And I had my own experience with a set of conjoined twins,
10 which are twins that are connected together, and they were
11 actually connected from the chest all the way down to the
12 abdomen. There were two heads and two sets of shoulders.
13 And we safely at University of Michigan used a medical
14 induction after 20 weeks and the babies didn't have to be
15 destroyed in any way. They just naturally died in the labor
16 process.
17 Q. In that case of conjoined twins, was there a subsequent
18 pregnancy outcome for the mother?
19 A. Yes, the mom had a term birth, I believe, about a
20 year-and-a-half later under my care.
21 Q. Doctor, I would like to turn now to some of the safety
22 issues involving the D & X procedure. You stated an
23 opinion, I believe, that there was no basis to conclude that
24 the D & X procedure is safer than other methods of abortion.
25 Would you tell the Court what the basis of your opinion is
Dr. Elizabeth Shadigian, Direct 1523
1 on that?
2 A. Well, I did do this literature search, looking at both
3 the international and domestic literature to see if there
4 were any studies whatsoever on D & X. And there are no
5 studies that tell us what the correct indication should be
6 for a D & X. We don't know what the short-term
7 complications are. We don't know the long-term
8 complications. And because it hasn't been studied at all,
9 we can't really even compare it to a D & E or to a medical
10 induction of labor.
11 Q. And in your opinion, Doctor, what does that lack -- what
12 is the significance of this lack of formal study of the D &
13 X procedure tell you?
14 A. Just tells me, I don't know if it's safe or not. I
15 don't know if it's going to cause women even more problems
16 in the end or less problems. And when something is so
17 unstudied and -- I'm just not willing to, you know, put my
18 patients own reproductive health on the line for something
19 that I know we already have good data on D & E procedures
20 and medical induction procedures.
21 Q. Doctor, the Court has heard from doctors who perform
22 abortion procedures with a fair degree of frequency, and
23 perform some variation of the D & X procedure. And the
24 Court has heard them testify that it's safe, based on their
25 experience. What is your opinion, with respect to
Dr. Elizabeth Shadigian, Direct 1524
1 assertions that the D & X procedure is intuitively safe,
2 based on the experience of practitioners who are performing
3 it?
4 A. Well, I know those practitioners have their best
5 intellectual judgment in mind. And I know they want to be
6 honest and truthful in what they are saying, but really it's
7 just anecdotal evidence they have that they think it's safe.
8 They don't have any long-term studies or even a comparison
9 of the D & X to another kind of procedure. So I don't
10 question that they really believe that, but really without
11 data, we can believe a lot of things, but medicine is based
12 on evidence. It's based on doing studies. It's based on
13 comparison of what we know to what we don't know. And in
14 the absence of that, those are just anecdotal thoughts or
15 feelings that a physician may have.
16 Q. Okay.
17 THE COURT: Can I see the lawyers at the bench here
18 just briefly? I want to ask you a question.
19 (Side bar)
20 THE COURT: She's not worried about copyright
21 protection. Can you provide it to your witness?
22 MR. COPPOLINO: It has been provided, but I have
23 not discussed that issue as to whether or not she should
24 alluded to it because when she wrote her expert report, it
25 became available subsequently, and Ms. Crepps will have that
Dr. Elizabeth Shadigian, Direct 1525
1 issue that they had before.
2 THE COURT: I'm not being critical. I just didn't
3 know.
4 MR. COPPOLINO: She has reviewed it, but I don't
5 know if I'm going to inquire of that. She hadn't examined
6 it.
7 THE COURT: I'm not being critical. I just wasn't
8 certain how those things were being handled. I didn't know
9 if she refused to sign it.
10 THE COURT: No, she's signed it.
11 THE COURT: Okay. Thank you. That's all I wanted.
12 (End of side bar)
13 THE COURT: Pardon me for interrupting, Doctor. I
14 just wanted to ask the lawyers a legal question. And I'm
15 sorry that I interrupted counsel's interrogation. Go ahead,
16 counsel.
17 BY MR. COPPOLINO:
18 Q. I would like to then ask you about a couple of specific
19 assertions as to the safety of the procedure, the D & X
20 procedure. For example, it has been asserted the D & X
21 procedure offers a safety advantage because it involves
22 fewer instrument passes and involves the extraction of fewer
23 sharp fetal fragments. What is your view as to whether that
24 is a sufficient basis on which to evaluate the safety of
25 this procedure?
Dr. Elizabeth Shadigian, Direct 1526
1 A. Well, that's a very good theory that may describe what
2 might happen. I don't know if that's actually true; if it's
3 actually safer to pull the baby through the cervix. It
4 actually involves more dilation. On the other side, I could
5 say, well, the cervix is more dilated. You're pulling the
6 baby through rather than letting a physiological process
7 happen. So for every example that people can say they think
8 this is safer, because there is less passes, there is
9 another way you can look at it. That it might be less safe,
10 because the cervix is dilated differently or more than in a
11 medical induction.
12 Q. Do you agree, Doctor, that specifically with respect to
13 sharp fetal fragments, that removing the fetus intact would
14 reduce the risk of laceration or perforation, as a result of
15 sharp bony fragments?
16 A. It should.
17 Q. Would you agree that -- that the procedure, as designed,
18 does have fewer instrument passes than a dismemberment D & E
19 procedure?
20 A. Yes, it does have less passes.
21 Q. Do those, in your opinion, do those potential benefits
22 of the procedure provide the whole picture as to the safety
23 of the procedure?
24 A. It doesn't to me, and it doesn't because of both
25 short-term complications and long-term complications. Many
Dr. Elizabeth Shadigian, Direct 1527
1 of the people performing the D & X procedure don't actually
2 see the patients back later, so they don't actually know if
3 they had complications outside a certain number of -- a
4 certain number of hours that they may be observing the
5 patient. So it's hard to say what those outcomes would be.
6 Q. What's your basis for that last assertion as to the
7 follow-up of the abortion practitioners with their patients?
8 A. Well, there have been several studies. One, I quote
9 specifically which is the Picker study from 1999, and they
10 actually asked women about the quality of their abortion
11 care, because this is such an important issue. And, in
12 fact, it turns out that only about 29% of women actually
13 follow up with their abortion provider afterwards. So it's
14 hard for me to understand how abortion providers, in quotes,
15 know their complications, if they don't even see their
16 patients back later.
17 Q. I believe you testified you have reviewed Dr. Haskell's
18 1992 paper, the National Abortion Federation Regarding the D
19 & X Procedure?
20 A. Yes, I have.
21 Q. Would you agree that in that paper, Dr. Haskell reported
22 on the results of cases he had undertaken to date using that
23 procedure, and that he had found no complications?
24 A. That's what he said.
25 Q. Okay. Isn't that a case review that provides some
Dr. Elizabeth Shadigian, Direct 1528
1 evidence of the procedure's safety?
2 A. Well, the problem I have with Dr. Haskell's report is he
3 said there weren't complications, but he actually never
4 called the patients to find out. He doesn't describe
5 finding out actually about complications. These are just
6 ones that he knows about from his practice.
7 Q. Let's just assume for a moment that his conclusions with
8 respect to complications are accurate. Isn't it the case
9 that understanding the safety of a procedure starts with
10 case reviews such as the kind Dr. Haskell presented to the
11 National Abortion Federation?
12 A. Certainly, we do start with case reviews and
13 correlations. We look, at first, to see new procedures by a
14 short case review.
15 Q. In your opinion, is it sufficient to rely on such
16 self-reported case reviews of physicians who are reporting a
17 procedure and evaluating the safety of the procedure?
18 A. It's not enough. It's not sufficient.
19 Q. Why not?
20 A. Because the person has an invested interest in their, in
21 quotes, new technique they designed themselves. They want
22 to -- they have a feeling and desire that they want it to be
23 safer. And they have no other comparison group that they
24 use to compare the two groups, if there isn't one.
25 Q. What about if a physician who is performing this
Dr. Elizabeth Shadigian, Direct 1529
1 procedure talks and confers and meets with other physicians
2 that he knows perform this procedure, and, collectively,
3 it's their experience that the procedure is safe. I'm
4 referring to the D & X procedure. Isn't that common
5 experience an indication as to the safety of the procedure?
6 A. Again, these are the very initial steps people should
7 take to discuss in academic settings or national meetings
8 about a new procedure. But it's the very first step in
9 evaluating procedures. After that happens, there is a
10 series of evidence-based studies that need to happen for us
11 to make any conclusions about the general safety or unsafety
12 of a procedure.
13 Q. Doctor, now this Court has heard some testimony that
14 there are now some medical schools in the United States
15 purportedly starting to teach the D & X procedure. And
16 assuming that's true, wouldn't that be some indication that
17 the procedure has certain potential safety advantages?
18 A. I don't think it says anything about safety.
19 Q. Why not?
20 A. Because it doesn't evaluate safety. Just because I talk
21 to a group of students about a personal experience I have
22 doesn't mean that it's the way it should be done.
23 Q. Just hold on for one second, Doctor.
24 A. Um-hm.
25 Q. I would just like to talk about some of the specific
Dr. Elizabeth Shadigian, Direct 1530
1 concerns that you have with the D & X procedure itself, and
2 as sort of a foundation for that, I would like you to just
3 describe what your understanding is of how dilation is
4 typically achieved for the D & X procedure.
5 A. Dilation is typically achieved over a set of two days
6 where laminaria or osmotic dilators are placed in the
7 cervix. Sometimes the cervix needs to be straightened out
8 before those are placed. Sometimes they can be placed
9 directly. And then overnight, the dilators expand, the
10 cervix dilates more. A woman comes back the next day. They
11 put even more dilators in and let those expand. And then on
12 the following day, a procedure such as the D & E is then --
13 or D & X is then started.
14 Q. I may have missed this if you said this and I apologize,
15 but is it your understanding Misoprostol can be used in
16 conjunction with the dilation process?
17 A. Yes, Misoprostol is now being used by many practitioners
18 in conjunction with laminaria.
19 Q. In the process of dilation necessary for the performance
20 of a D & X procedure have consequences on a woman's health?
21 A. Could you restate that question?
22 Q. Could the process of dilation for the D & X procedure,
23 in your opinion, have any consequences on a woman's health
24 short-term or long-term?
25 A. Yes. How many dilators are put in. If they are put in
Dr. Elizabeth Shadigian, Direct 1531
1 gently or forced into the cervix. Also, we know we can put
2 dilators in the wrong place. Sometimes the cervix may be
3 stenotic or have some scar tissue on there. You can create
4 a false tract, if you are not careful. All the things that
5 actually manipulate a woman's body, such as dilation, can
6 have longer term effects.
7 Q. Now, in an induction termination, is it the case that
8 the cervix is ultimately dilated to the full size of the
9 fetus coming out? Is that the case?
10 A. Yes, it is in medical induction.
11 Q. And is that -- why isn't that as potentially as harmful,
12 in your view, as the consequences of the dilation achieved
13 using the methods utilized in the D & X procedure?
14 A. Again, the D & X procedure uses those laminaria or
15 osmotic dilators whereas in the medical induction procedure,
16 it's only medications that actually have the woman's body
17 start a physiological process of contraction. So there is
18 no laminaria put in in a medical induction, except in very,
19 very rare circumstances.
20 Q. Just to summarize for the Court, what are your specific
21 concerns with respect to the dilation procedure utilized in
22 the D & X procedure?
23 A. The concerns are how many times the woman's cervix is
24 dilated over so many days, and how far it's dilated with the
25 number of laminaria. So no one has ever done a study to
Dr. Elizabeth Shadigian, Direct 1532
1 show what the optimum dilation is of the cervix to reduce
2 trauma. And what we are really talking about is how do we
3 safely reduce trauma to a woman's cervix so they don't go on
4 and have problems with their cervix later.
5 Q. Doctor, is it your position that there has to be a
6 prospective randomized controlled study, in order to
7 evaluate this procedure?
8 A. There are many different epidemiological studies that
9 could be performed. And they don't all have to be the ones
10 you described. The prospective randomized blinded trial.
11 Q. What other ways are there for evaluating the safety of
12 this procedure other, than a randomized prospective
13 controlled trial?
14 A. So there are other studies such as retrospective case
15 controlled studies.
16 Q. What is a retrospective case controlled study?
17 A. That's when there is something called a case and a
18 control. A case is whatever you're trying to study. So in
19 this case, it would be a D & X procedure. Then you decide
20 what kind of control group to compare it to. So you could
21 say I'm going to compare the D & X to a medical induction of
22 labor at the same gestational age. I'm going to compare the
23 D & X to a D & E at the same gestational age. It's where we
24 try to control for many, many factors that would be the same
25 in all the groups, but then have one factor different. And
Dr. Elizabeth Shadigian, Direct 1533
1 then we can head-to-head look at what the differences are
2 between the groups.
3 Q. What is your response to the assertion that in trying to
4 compare, say, a D & X to a dismemberment D & E in a study,
5 in a prospective study, it would be difficult to do because
6 it will be -- some women will simply choose not to undergo
7 the dismemberment procedure when there is an intact
8 alternative available?
9 A. Well, I think we have examples where women know that
10 there may be more risk with one procedure or another, but
11 they are willing to have themselves in a trial. One example
12 would be the term breech trial. We had the experience in
13 the United States where we really didn't know if it was
14 safer to have a baby deliver vaginally who is breech or
15 bottom first, versus shall we do the C section on those
16 patients. So some doctors would say one thing and some
17 doctors would say another. And all we had was retrospected
18 or looking backwards data. Instead, we did this new term
19 breech trial a few years ago looking prospectively. In
20 other words, we said to women, we don't really know what's
21 the safest procedure. We would like you to please be
22 randomized to one of these two groups. Either trying a
23 vaginal birth or going for a C section. And women would do
24 it. I had three of my own patients in my own practice say,
25 yes, I'll put myself into your care, the trial's care. That
Dr. Elizabeth Shadigian, Direct 1534
1 we will randomize you then we are going to find out what the
2 data shows. And I'm sure women undergoing the D & E or D &
3 X or medical induction would, with good informed consent, be
4 able to say, you know, Doctor, if you don't know what's
5 safer, I want my care to be part of something bigger than
6 myself, so I can help other women.
7 Q. And would those same views hold true with an effort to
8 compare D & X to medical induction?
9 A. Yes.
10 Q. Do you feel that if there is any question as to whether
11 one procedure is safer than the other, the informed consent
12 process would assist in having women choose one or the
13 other, in order to evaluate the two procedures?
14 A. Yes. And there are institutional review boards at major
15 medical institutions that actually check those things to
16 make sure they are even, and make sure women really get
17 informed consent, when they are enrolled in prospective
18 trials.
19 Q. Do you have any doubt that for the women who chose
20 medical induction terminations after 18 or 20 weeks, that
21 they would be undergoing a safe and effective procedure for
22 termination?
23 A. It would be safe and effective.
24 Q. I would like to talk to you a little bit now
25 specifically about potential long-term complications of the
Dr. Elizabeth Shadigian, Direct 1535
1 D & X procedure. Have you had occasion to study the
2 literature concerning abortion in order to assess its
3 potential long-term complications?
4 A. Yes, that's one of the papers I have recently published
5 in the last year-and-a-half.
6 Q. I think I have put it there on the ledge, Doctor. It's
7 Defendant's Exhibit 631. Would you identify Defendant's
8 Exhibit 631 for the Court, Doctor?
9 A. Yes. This is the review article I referred to,
10 Long-term Physical and Psychological Health Consequences of
11 Induced Abortion Review of the Evidence.
12 Q. And you are a co-author of this article; is that
13 correct, Doctor?
14 A. Yes.
15 Q. You, in fact, participated in this systematic review of
16 the literature?
17 A. Yes.
18 Q. And you relied on this article in providing your
19 opinions today?
20 A. Yes.
21 Q. And you identified this article in the expert report
22 that you provided to the plaintiffs in this case?
23 A. Yes, I did.
24 Q. What does this article address, Doctor?
25 A. This article looks at seven different possible physical
Dr. Elizabeth Shadigian, Direct 1536
1 and psychological health consequences that occur after six
2 weeks after the termination of pregnancy.
3 Q. How did you go about preparing and writing this article?
4 A. Well, we did what we call our own research using the
5 computers to look at different databases that contained
6 medical and psychological literature. So we asked with key
7 words what -- basically, what are the articles out there if
8 we do a literature search? So it started with a literature
9 search then we honed it down to different topics.
10 Q. Did you call this a systematic review of the literature,
11 Doctor?
12 A. It is a systematic review, because we have inclusion
13 criteria and exclusion criteria.
14 Q. What are inclusion criteria and exclusion criteria?
15 A. Inclusion criteria were that we had specific ways of
16 including a study or excluding it. For example, because we
17 wanted to just look at the bigger studies and not look at
18 just anecdotal case reports in such a systematic review, we
19 limited it to having at least 100 subjects and a follow-up
20 of two months or longer after an elective abortion.
21 Q. What other inclusion exclusion criteria, if you would
22 recall? If you would like to refer to the article --
23 A. Right. We also looked at publications in English, so we
24 didn't have any foreign publications translated for this
25 particular systematic review. And then we did restrict it
Dr. Elizabeth Shadigian, Direct 1537
1 to the med line database as well.
2 Q. Doctor, what is the -- you may have already touched on
3 this. So we are clear on the record, what is the purpose
4 and the benefit of this kind of a review?
5 A. Well, again, individual doctors don't have time to do
6 this. This is so we can look at data in an aggregate,
7 meaning we can combine things either by looking at
8 individual articles next to each other, or we can see the
9 limitations of individual articles next to each other.
10 Q. Now, Doctor, this article, your article here, looked at
11 seven potential complications of abortion; is that correct?
12 A. Yes.
13 Q. Could you identify, for the record, what those
14 complications were that you looked at?
15 A. Yes. We looked at seven complications, three of them
16 showed no effect between.
17 Q. Let's just identify the complications right now.
18 A. The seven complications that we looked at are subsequent
19 spontaneous miscarriage, subsequent infertility, and a
20 subsequent ectopic or tubal pregnancy. In addition, we
21 looked at breast cancer, placenta previa, pre-term birth and
22 psychological effects.
23 Q. Doctor, what are some of the limitations in to trying to
24 determine what the health effects of an abortion are?
25 A. Some of the limitations would include how do we actually
Dr. Elizabeth Shadigian, Direct 1538
1 ascertain if a woman has had an abortion or not. So there
2 may be some records that are hospital based records or data
3 registry from national databases. Other times, women just
4 report if they have had an abortion or not, and that might
5 be one what we call ascertainment by us -- where we find out
6 -- how did we find out if the actual event happened, such as
7 an induced abortion.
8 Q. With respect to follow-up, is the extent of follow-up a
9 potential limitation in trying to determine the health
10 effects of an abortion?
11 A. Yes. People move quite a bit both in the United States
12 and abroad. So sometimes, we don't have follow up on a
13 particular woman. The other thing is sometimes when we go
14 back to look, someone might have died from some other kind
15 of reason, or maybe lost a follow up because her name
16 changed or she has other reasons to not be in the area
17 anymore.
18 Q. Is the adequacy of any reported data or statistics on
19 abortion a potential limitation, on trying to evaluate the
20 health effects of abortion?
21 A. It is.
22 Q. Why so?
23 A. Unless someone is actively looking for long-term
24 complications, it may not be clear that they even correlate
25 with them. That's why the long-term studies are so helpful,
Dr. Elizabeth Shadigian, Direct 1539
1 because one can't always know a head of time if, say, a
2 certain cancer might be related to a surgical procedure or
3 if another kind of complication, such as pre-term birth,
4 might be related to something that happened a year or two
5 ago.
6 Q. I'm going to call your attention to a couple of
7 statements or passages in your article, Doctor. The first
8 one I want to call your attention to is on page 74, just a
9 sentence. You state on the right-hand column, on page 74.
10 That the long-term health consequences of elective abortion
11 have been highly politicized. What do you mean by that?
12 A. It's just that people who actually are trying to do
13 studies about long-term effects or any short-term effects on
14 induced abortion -- that you always have this -- there is
15 basically a fear on both sides. People -- that their own
16 personal opinions about abortion will somehow in influence
17 what their research shows about abortion. So this is caused
18 -- instead of people on both sides of this argument saying
19 women's health is really important and we are both for
20 healthy women and we need to, you know, make some kind of
21 collaborative effort to study long-term effects, it has been
22 polarized instead.
23 Q. The very next sentence goes on to state those who would
24 grant a moral status to an embryo or fetus, and thus limit
25 elective abortion, often use adverse health consequences,
Dr. Elizabeth Shadigian, Direct 1540
1 adverse health consequence claims as a tool to further their
2 moral agenda. Has that been your experience in researching
3 the issue of abortion?
4 A. Well, both of the thoughts -- may I actually say, I
5 don't know where you are, so I'm having a hard time
6 following.
7 Q. Page 74.
8 A. Right.
9 Q. Right-hand column.
10 A. Okay.
11 Q. Top of the page. Let me just read it all for the
12 record. First there is a sentence which begins, the
13 long-term health consequences of elective abortion have been
14 highly politicized. Those who would grant a moral status to
15 an embryo or fetus and thus limit elective abortion, often
16 use adverse health consequence claims as a tool to further
17 their moral agenda. While those who support no restriction
18 on abortion access are, at times, unwilling to consider that
19 pregnancy interruption could affect future and mental and
20 physical health. That's a statement in your article. Is
21 that right, Doctor?
22 A. Yes.
23 Q. Do you hold that opinion?
24 A. Yes, that. In fact, the research is always being
25 questioned because of all the other political statements
Dr. Elizabeth Shadigian, Direct 1541
1 that research can be used for.
2 Q. Doctor, just so we are clear, was this article that you
3 co-authored, was this article motivated to exaggerate the
4 health consequences of abortion?
5 A. No.
6 Q. What was it motivated by?
7 A. The whole point of this article is to let women know
8 what the long-term possible consequences might be for their
9 health, so that we can actually take care of women better.
10 Q. If you look a little bit further down on that page,
11 Doctor, page 74, near the very end of the right-hand column
12 where it says women deserve to be fully and accurately
13 informed. Do you see that?
14 A. Yes.
15 Q. Could you just, why don't you read it this time for the
16 record. Could you read that last sentence?
17 A. Sure. Women deserve to be fully and accurately informed
18 about potential health effects of elective abortion,
19 preferably in a health education context separate and
20 distinct from the time frame of actually being faced with
21 making difficult decisions about whether to continue or end
22 a pregnancy.
23 Q. And does that statement reflect your views and opinions
24 as to the need to inform women about the health consequences
25 of abortion?
Dr. Elizabeth Shadigian, Direct 1542
1 A. Yes.
2 Q. And just so we are clear, why do you think that's an
3 important thing to do?
4 A. Women need to know, before they are faced with a crisis
5 pregnancy, what would happen if they chose one path or
6 another in their lives. It's not just about what's going to
7 happen to that baby or potential baby. It's about what's
8 going to happen to her possibly for the rest of her life.
9 That she needs to have that information even before there is
10 a crisis pregnancy. This is the kind of stuff that should
11 be taught to teen-age girls. But the other thing is the
12 doctor should understand this, and this is not previously
13 been well understood.
14 Q. Doctor, which conditions, in your systematic review of
15 the literature on this topic, which conditions did you find
16 there was insufficient evidence of adverse consequences from
17 a prior abortion? In other words, the ones that you showed,
18 there was not sufficient evidence to show that abortion led
19 to an adverse consequence?
20 A. Right. Three different topics that were researched and
21 several articles were pulled on each of the topics. An
22 induced abortion was not associated in the aggregate with
23 ectopic pregnancy, tubal pregnancy that is, subfertility or
24 difficult time getting pregnant the next time, and
25 subsequent spontaneous miscarriages.
Dr. Elizabeth Shadigian, Direct 1543
1 Q. You used the term abortions. What do you mean in the
2 context of your study?
3 A. The way it's actually done in this study is this was
4 done before first trimester medical inductions, meaning are
5 you 486. So these are mostly all surgical abortions, and
6 because surgical abortion is much more common the first
7 trimester, it focuses on that, but also includes all comer
8 abortion.
9 Q. Sometimes we talk about the induction method and
10 sometimes we talked about induced abortions. In the context
11 of your article, does induced abortion mean all methods of
12 abortion that were utilized as -- that were utilized in the
13 studies that you studied?
14 A. Yes, it's elective termination of pregnancy.
15 Q. Does that include surgical and medical induction?
16 A. Yes.
17 Q. Which finding, in your review, do you think is the most
18 relevant to the partial-birth abortion debate?
19 A. The one finding that is the most striking, in fact, will
20 have the most impact on women, is that about induced
21 abortion in subsequent pre-term birth. So pre-term birth in
22 the next pregnancy.
23 Q. All right. Now, I just want to do this a couple of
24 times. I realize it's a little tedious, but I would like
25 you to turn to page 75.
Dr. Elizabeth Shadigian, Direct 1544
1 MR. COPPOLINO: May I approach the witness, Your
2 Honor?
3 THE COURT: Sure. If you want to put that on the
4 screen, Mr. Coppolino, that might help.
5 MR. COPPOLINO: Why don't we try to do that. That
6 way everyone can see it.
7 THE COURT: Perhaps your assistant could help you
8 or Ms. Beran can: I shamelessly promote this.
9 THE WITNESS: Thank you.
10 THE COURT: I appreciate this is not an eye test,
11 so you're going to have to focus in on the sentence that Mr.
12 Coppolino -- or the paragraph he wants to talk about.
13 MR. COPPOLINO: Thank you, Your Honor. The left
14 side of the page, the first column and just move it up just
15 a little. I'm going to have her read a portion for the
16 record, Your Honor.
17 THE COURT: Go ahead
18 BY MR. COPPOLINO:
19 Q. Doctor, I would like you to read basically the first
20 half of the second, of the left-hand column which begins
21 abortion is a procedure.
22 A. Certainly.
23 Q. Down to the word prematurely about halfway down?
24 A. Right.
25 Q. You can read it off the text -- you can read it off the
Dr. Elizabeth Shadigian, Direct 1545
1 paper. Whatever is easier.
2 A. Abortion is a procedure most used by women at the outset
3 of their reproductive life. Most women having an induced
4 abortion are under 30 years old. Pre-term birth is common
5 affecting around 10% of deliveries in the western world, and
6 is the leading cause of infant morbidity and mortality.
7 Despite substantial investigative effort, primary preventive
8 measures to lower the rate of pre-term births have proven
9 futile, and rates have been steady or increased over the
10 past two decades. The population based studies we reviewed
11 suggest that induced abortion increases the risk of pre-term
12 birth in subsequent pregnancies. Moreover, these reports
13 suggest that a dose-responsive effect is present with
14 increasing numbers of abortions associated with increasing
15 risk. And that the linkage is most strong with extremely
16 premature deliveries, less than 32 weeks, which is the
17 population of newborns that experiences the bulk of
18 morbidity and mortality that occur from being born
19 prematurely.
20 Q. Okay. Let's just hold it right there, Doctor. Those
21 statements you just read appeared in the study that you
22 co-authored. Is that correct?
23 A. Yes.
24 Q. Those statements reflect -- they reflect the results of
25 the research you undertake in helping to prepare this
Dr. Elizabeth Shadigian, Direct 1546
1 article?
2 A. Yes.
3 Q. Would you explain to the Court what dose-response effect
4 means?
5 A. Certainly. That means when you have one time something
6 happens you get one kind of effect. So for this particular
7 example, when women had one abortion, then they had a
8 premature risk that was, say, one-and-a-half times greater.
9 When they had two abortions, then they had two times greater
10 the risk. And when they had three abortions, they may have
11 had five times greater risk. So as you increase the number
12 of abortions, the amount of risk for pre-term birth
13 increases.
14 Q. All right. Doctor, I would like you to summarize for
15 the Court what you found, as a result of your review of the
16 literature, as to what studies indicated as to the effect of
17 induced abortion on pre-term risk -- on pre-term -- let me
18 just start that one over. I completely bungled that. Would
19 you summarize for the Court what your article summarizes
20 with respect to the connection between induced abortion and
21 pre-term birth and subsequent pregnancies?
22 A. Yes. Pre-term birth, especially in the most modern of
23 these studies, and the most recent ones, showed an increased
24 risk in pre-term birth with induced abortion; between 1.3 --
25 meaning 30% higher to double the amount.
Dr. Elizabeth Shadigian, Direct 1547
1 Q. Okay. I would like to just approach for a second, Your
2 Honor. Page 70. All right, Doctor. I would like to call
3 your attention to a passage on page 70 of your paper.
4 A. Yes.
5 Q. This is on the right-hand column, lower right-hand
6 column under the caption induced abortion and subsequent
7 pre-term birth. A little higher. All right. Doctor, would
8 you read into the record the sentence beginning the portion
9 beginning 12 studies down to the words a dose-response
10 effect?
11 A. Yes. 12 studies found an association between these two
12 phenomena, which is the pre-term birth and the induced
13 abortion actually. I'll start again. 12 studies found an
14 association between these two phenomena with consistent
15 results in risk ratio elevation of 1.3 to 2.0. Moreover,
16 seven of the 12 identified a, in quotes, dose-response
17 effect, end quote, with risk estimates rising action a woman
18 had more induced abortions. Also notable is the increased
19 risk of very early deliveries at 20 to 30 weeks gestation
20 after induced abortion, first noted by write Campbell and
21 Beazley in 1972. Seven subsequent articles displayed this
22 phenomena of mid pregnancy pre-term birth associated with
23 induced abortion, which is especially relevant because these
24 are the infants with the most risk of morbidity and
25 mortality upon which society expends so many resources. Of
Dr. Elizabeth Shadigian, Direct 1548
1 particular note are the three large cohort studies done in
2 the 1990s, 20 to 30 years after legalization. Each shows
3 elevated risk and a dose-response effect.
4 Q. Doctor, the passages you have just read are from the
5 study that you co-authored here at what's the exhibit
6 number? At exhibit number?
7 THE COURT: Should be 531 or pardon me. Yes, 631
8 BY MR. COPPOLINO:
9 Q. At Exhibit 631. Correct, Doctor?
10 A. Yes.
11 Q. And the information you just read in the record
12 summarizes part of the results of your research; is that
13 correct?
14 A. That is correct.
15 Q. All right. Now, also in the passage you just read, you
16 omitted footnotes numbers, but the numbers in the
17 parentheticals are the references to numbers contained at
18 the article?
19 A. Yes. It lets other people look at the exact article and
20 know what we are talking about.
21 Q. What I would like you to do is now that we have read the
22 passage, if you could summarize, in your own words here in
23 court, what the results of your research were, with respect
24 specifically to the relationship between prior abortion and
25 pre-term birth?
Dr. Elizabeth Shadigian, Direct 1549
1 A. The results show that many of the studies looking at
2 induced abortion and pre-term birth do show an elevation in
3 pre-term birth. What that exactly means is women deliver
4 before 37 weeks of pregnancy more often up to a doubling of
5 that effect, when they have had induced abortion, or what we
6 call abortion here.
7 Q. Yeah. And is this a risk of pre-term birth a risk that
8 is beyond the normal risk of pre-term birth in a pregnancy?
9 A. Yes. This is when all the other risk factors for
10 pre-term birth have already been looked at and controlled
11 for during these studies.
12 Q. All right. Now, in your opinion, what does this --
13 these findings with respect to pre-term birth indicate, with
14 respect to the potential long-term risks of the D & X
15 procedure?
16 A. The concern is this: The studies we looked at looked
17 mostly at first trimester abortions, and some second
18 trimester, but even with these abortions in these studies,
19 that there is an almost doubling effect of pre-term birth.
20 And now, in the D & X procedure, we are talking a much
21 greater size of the baby, and this baby being pulled through
22 a partially open cervix such that the mechanism for injury
23 which is purported to be both damage to the cervix, as well
24 as possibly infections. That the potential for damage to
25 the cervix is much greater in a D & X procedure than it
Dr. Elizabeth Shadigian, Direct 1550
1 would be in a simple first trimester procedure.
2 Q. Now, Doctor, is it fair to say that your study and the
3 studies that you rely upon don't say that abortion causes
4 pre-term birth; is that right?
5 A. It does not show that. It says that there might be a
6 correlation between the two.
7 Q. In your opinion, Doctor, what should women undergoing an
8 abortion be told about the potential long-term complications
9 of the procedure?
10 MS. CREPPS: Your Honor, I'm going to object on
11 relevance, and I don't feel this was disclosed as within the
12 scope of the opinions the doctor would be offering.
13 THE COURT: Well, what relevance does this have to
14 anything we are talking about?
15 MR. COPPOLINO: Your Honor, first of all, this
16 article was disclosed and it was inquired of at her
17 deposition.
18 THE WITNESS: I'm not talking about the article.
19 MR. COPPOLINO: Right.
20 THE COURT: There is no consent issue in this case,
21 it seems to me directly. I think that issues of consent, as
22 the doctor has spoken about, about people need to know risk
23 that sort of thing. And that's why she is particularly
24 interested in risk, and how it's explained in common terms
25 is perfectly appropriate background. But you're getting
Dr. Elizabeth Shadigian, Direct 1551
1 much more specific here, and I don't understand the
2 relevance.
3 MR. COPPOLINO: Well, I'll just briefly explain it.
4 The point -- the question goes to the doctor has offered an
5 opinion on the potential long-term complications of this
6 procedure.
7 THE COURT: Sure.
8 MR. COPPOLINO: I think it's relevant for you to
9 understand why she thinks that is important. And her desire
10 to inform her patients about why that is important, I think,
11 is relevant to helping you understand why she thinks it's
12 important. If you are not interested in the answer to the
13 question, Your Honor, I'll just move past it.
14 THE COURT: And I know you didn't mean it in the
15 sense, but I don't determine relevance on whether I'm
16 interested. As a matter of fact, I find the most
17 interesting questions frequently the most irrelevant. So in
18 any event, we won't get into that rather philosophical
19 debate. I'm going to sustain the objection.
20 MR. COPPOLINO: That's fine, Your Honor. Your
21 Honor, this would be a good breaking point. I don't have
22 much more to do, but probably we should take a break now, if
23 that's okay with the Court.
24 THE COURT: Is that agreeable, counsel.
25 MS. CREPPS: Yes, Your Honor.
Dr. Elizabeth Shadigian, Direct 1552
1 THE COURT: All right. We'll take a 15-minute
2 break now. Doctor, you may stand down.
3 THE WITNESS: Thank you, very much.
4 (Recess from 10:31 to 10:50 a.m.; all parties present).
5 THE COURT: Doctor, if you will retake the witness
6 stand, please.
7 (Dr. Shadigian resumed the witness stand).
8 THE COURT: You may proceed.
9 BY MR. COPPOLINO:
10 Q. Thank you, Your Honor. Doctor, if you still have your
11 article, I would just like to ask you about one additional
12 sentence in the article. It's on page 75, and we'll forego
13 the technology, Your Honor. It's just one sentence for this
14 one?
15 THE COURT: Sure.
16 BY MR. COPPOLINO:
17 Q. Page 75, left-hand column, last sentence of the middle
18 paragraph. And I'll just read it, Doctor. It says for
19 those women -- are you with me?
20 A. Yes.
21 Q. For those women who choose abortion techniques that, in
22 theory, protect the cervix from trauma such as laminaria or
23 pre-abortion cervical ripening should be used. Is that a
24 sentence in your article, Doctor?
25 A. Yes.
Dr. Elizabeth Shadigian, Direct 1553
1 Q. Now, in your opinion, would the use of such techniques
2 reduce or even eliminate the potential long-term risks of
3 pre-term birth from abortion?
4 A. It may.
5 Q. And is that something you believe requires further study
6 before we know that?
7 A. Yes.
8 Q. Why is that the case?
9 A. Theoretically, by using laminaria or Misoprostol, these
10 other cervical ripening techniques, we may reduce trauma to
11 the cervix. And that may be the postulated mechanism of why
12 pre-term birth is higher, especially in first trimester
13 abortion where it's not used as often.
14 Q. Given the stage in gestation when D & X might be
15 performed, and the amount of dilation that's typically
16 utilized, will we know the answer to that question until the
17 issue is studied?
18 A. That's the whole point is we need to study it to know if
19 the laminaria actually help or not.
20 Q. Doctor, do you have an opinion as to whether the safety
21 of the D & X procedure should be evaluated in some way by
22 reliance on data demonstrating the safety of the D & E
23 procedure?
24 A. The D & X procedure is really a separate procedure from
25 the D & E, and it cannot be relied upon -- the data on D &
Dr. Elizabeth Shadigian, Direct 1554
1 E cannot form the opinion for D & X complication safety
2 rates.
3 Q. Why, specifically, do you think that's the case?
4 A. Just like a D & C is considered a separate procedure as
5 a D & E, that they are different complications in the first
6 trimester, there are different complication the D & E
7 procedure, so it is with D & X. It is a different
8 procedure. It may use similar techniques at the beginning
9 of the procedure but it really has a different set of ways
10 of going about delivering the infant.
11 Q. What is it about some of the differences between the
12 procedures, either with reference to gestational age or
13 amount of dilation, that you feel it cannot be judged based
14 on the safety of the D & E procedure?
15 A. Without head-to-head studies, we cannot conclude
16 anything about the D & X procedure. Specifically, because
17 it was purportedly initially used for babies at different
18 gestational ages, in fact, greater gestational ages than
19 usually use the procedure D & E was used for, and that the
20 cervix is more dilated to accomplish an intact procedure.
21 Q. Doctor, do you have an opinion as to whether the safety
22 of the D & X procedure, as compared to current induction
23 procedures, should be evaluated by reliance on data
24 comparing D & E to prior methods of induction?
25 A. Again, can I not rely on D & E data versus medical
Dr. Elizabeth Shadigian, Direct 1555
1 induction to form an opinion on D & X, because it really is
2 a separate procedure, so can't draw a conclusion of the
3 safety of D & X to medical induction.
4 Q. In particular, do you think studies that compare D & E
5 to prior methods of induction provide any information that
6 the Court could look to in attempting to evaluate or compare
7 D & X to medical induction?
8 A. The older methods of medical induction are what we have
9 the most data on, unfortunately. We don't have much data on
10 the Misoprostol, although that is safer in the newer
11 studies. So we can't use old data well, but that's all we
12 have sometimes. So looking at medical induction numbers, we
13 can compare them head-on-head with D & E, when there are
14 such studies, but we can't head on head compare them to D &
15 X.
16 Q. Even if we were to rely on prior studies comparing prior
17 methods of D & E or -- let me rephrase that. Even if we
18 rely on prior studies comparing D & E to prior methods of
19 induction, what would that tell us with respect to the
20 relative safety of D & E and prior methods of medical
21 induction such as installation saline, installation.
22 A. We do have some head-to-head steady studies looking at
23 that. One thing people should know that at 21 weeks and
24 greater, that the mortality data, meaning moms dying later,
25 is actually less for medical induction as compared to D & E
Dr. Elizabeth Shadigian, Direct 1556
1 at 21 weeks gestation and greater. It's about the same
2 around 20 weeks. But the medical induction and D & E are
3 safe procedures, especially in the 16 to 20-week range.
4 Q. Doctor, are you familiar with an article recently
5 written by Drs. Autry, et al., entitled A Comparison of
6 Medical Induction and Dilation and Evacuation for Second
7 Trimester Pregnancy. Are you aware of that article?
8 A. Yes, I am.
9 Q. If you look at placed on the desk there, Exhibit 545,
10 Defendant's Exhibit 545. I believe that's what it says. Is
11 that what it says at the bottom?
12 A. Yes.
13 Q. Do you recognize this article, Doctor?
14 A. Yes.
15 Q. Did you have occasion to review this article?
16 A. Yes.
17 Q. Did you review it in connection with preparing your
18 expert record in this case?
19 A. Yes, I did.
20 Q. I believe you cited this article in the appendix of your
21 expert report?
22 A. Yes, I did.
23 Q. Doctor, this article appears to conclude the D & E
24 method of abortion is safer, based on mortality or morbidity
25 statistics than the induction method of abortion; is that
Dr. Elizabeth Shadigian, Direct 1557
1 correct?
2 A. Their conclusion is that D & E is safer for women but I
3 don't think they looked at mortality.
4 Q. Okay. Let me ask you then, why don't you summarize what
5 this article concludes instead of me, and then I want to ask
6 you questions about what you think about it.
7 A. This article concluded that dilation evacuation was the
8 safest method of second trimester abortion but that the
9 Misoprostol was safer than other abortion methods.
10 Q. All right. Now, to what extent do you agree with the
11 conclusions set forth in this article?
12 A. Well, I had several problems with this article. One is
13 the biggest complication they talk about is retained
14 placenta. Retained placenta is when the baby comes out and
15 the placenta remains inside the woman's uterus after a
16 period of time. They don't actually define what a retained
17 placenta is. They don't say it's two minutes or 20 minutes
18 or two hours. So one of my biggest complaints is they never
19 define how long it is to have, in quotes, a retained
20 placenta. At term, we wait up to 30 minutes for a placenta
21 to come out, but usually in the second trimester, we wait at
22 least two hours. But they never define that here and I
23 don't even know what their criteria is. So the first thing
24 is they don't define what a retained placenta really is. In
25 addition, they don't tell you why women were chosen for
Dr. Elizabeth Shadigian, Direct 1558
1 either group. It wasn't randomized. You don't know why
2 some people had a medical induction or underwent a D & E
3 procedure. And it doesn't say if the people writing the
4 article were actually blinded as to who was in what group.
5 Finally, one of the key points is the gestational age was
6 very different between the two groups for medical induction
7 and for the D & E. And I'm going to refer to a table, if
8 that's okay.
9 Q. Sure?
10 A. So in the surgical induction or in the surgical group,
11 the gestational age was two weeks less, so around
12 18-and-a-half weeks, as compared to 20-and-a-half weeks. So
13 that, in and of itself, just having a difference of two
14 weeks in gestational age, may account for the entire
15 difference scene in this article. And they even say this
16 was statistically a different set of populations, but they
17 still draw those conclusions. So I can't really -- because
18 I think this article is so flawed, I can't draw any
19 conclusions to help me because of these problems I have with
20 it.
21 Q. With respect to the last point you made on the
22 differences in gestational age, what is the significance of
23 that disparity in terms of evaluating the results of this
24 article?
25 A. We know from prior research that the farther along a
Dr. Elizabeth Shadigian, Direct 1559
1 woman goes in the pregnancy, the more complications there is
2 -- there are for terminating a pregnancy. And because in
3 the medical induction group, the women were at least two
4 weeks farther along in the pregnancy than the surgical
5 group, that may, in fact, account for all the complication
6 differences. I don't think it does 100%, because of the
7 retained placenta issue, but it certainly could account for
8 most of the differences. So, in other words, if we had the
9 exact same gestational age in both groups, then in this
10 article, I might be able to draw some kind of conclusion.
11 Q. With respect to the retained placenta issue, Doctor, you
12 mentioned, I believe, that your practice is to wait about
13 two hours for the placenta to pass after induction
14 termination, if it's not passed immediately?
15 A. Yes.
16 Q. And is that the case when there is no emergent
17 circumstances such as maternal bleeding?
18 A. That's correct.
19 Q. All right. And would an emergent circumstance such as
20 maternal bleeding constitute a true complication of the
21 induction procedure?
22 A. Yes. Maternal hemorrhage is a complication.
23 Q. All right. Now, how common a practice is it to wait up
24 to two hours for the placenta to pass after an induction?
25 A. Seems to be a fairly common practice, at least for my
Dr. Elizabeth Shadigian, Direct 1560
1 colleagues at U of M, University of Michigan.
2 Q. What is done to remove a retained placenta, when you
3 have to go back in and remove it?
4 A. Most of the time, we see if the cervix is dilated enough
5 to actually just put our gloved hand up inside the uterus
6 and gently pull away the placenta from the sidewall of the
7 uterus. Sometimes that's already happened a little bit. We
8 just further place our hand between the placenta and the
9 uterus. However, sometimes we have to do a curettage or a
10 scraping of the placenta to come out.
11 Q. Now, if you -- how different is the procedure for
12 removing a retained placenta after a medical induction from
13 a procedure for removing the placenta in a D & E abortion?
14 A. It's essentially the same procedure. It's removing the
15 placenta. It's just the timing of when the baby comes out
16 and when the actual placenta comes out that's different.
17 Q. In the Autry study, the removal of the retained placenta
18 was counted as a complication; is that correct?
19 A. That is right.
20 Q. Do you have an opinion as to whether counting the
21 retained placenta as a complication of medical reduction has
22 skewed the comparison between the safety of the two
23 procedures?
24 A. It has, in this study.
25 Q. Do you think that her statistical comparison of the
Dr. Elizabeth Shadigian, Cross 1561
1 safety of the two procedures is reliable because she's used
2 retained placenta as a complication of medical induction?
3 A. I think this is part of the flaw of the study that we
4 can't really use that as a true complication.
5 MR. COPPOLINO: Just one moment, Your Honor.
6 THE COURT: Sure.
7 MR. COPPOLINO: Your Honor, I have no further
8 questions at this time.
9 THE COURT: Counsel, you may inquire.
10 CROSS-EXAMINATION
11 BY MS. CREPPS:
12 Q. Thank you, Your Honor. Dr. Shadigian, can you tell me
13 who is the chair of your department at the University of
14 Michigan?
15 A. Yes. His name is Timothy RB Johnson.
16 Q. You respect Dr. Johnson as a physician; is that correct?
17 A. Yes, I do.
18 Q. And you're aware, aren't you, Doctor, that Dr. Johnson
19 is a plaintiff in the New York case challenging the
20 partial-birth abortion ban?
21 A. Yes, that's what I have been told.
22 Q. Doctor, you described, in some detail, the literature
23 search that you conducted in formulating your opinions and
24 preparing your expert report in this case?
25 A. Yes.
Dr. Elizabeth Shadigian, Cross 1562
1 Q. And you reviewed, I believe, in the conduct of that
2 literature search between 80 and 150 abstracts, is that
3 correct?
4 A. That's correct.
5 Q. And all of the articles that you felt were relevant to
6 your opinions from that search are cited in your expert
7 report; is that correct?
8 A. I believe they are.
9 Q. And in your report, you have cited ten journal articles
10 and book chapters; is that right?
11 A. I think. Yes, that's correct.
12 Q. And the sources you've cited have come from reputable
13 sources that physicians would, such as yourself, would rely
14 on in doing looking at issues in this field?
15 A. Yes. They were peer reviewed journals that we looked
16 at.
17 Q. Doctor, do you believe there is a substantial body of
18 medical opinion that induction is safer than D & E after 20
19 weeks?
20 A. Yes.
21 Q. Do you believe there is a substantial body of medical
22 opinion that D & E is safer than induction after 20 weeks?
23 A. There are some opinions that D & E is safer, such as the
24 Autry article that I just cited.
25 Q. But it's your opinion that there is not a substantial
Dr. Elizabeth Shadigian, Cross 1563
1 body of medical opinion that believes that D & E is safer
2 than induction after 20 weeks?
3 A. It depends on what you mean by body of opinion. If you
4 could define that, maybe I could explain.
5 Q. Well, let me go back a step then. When I asked you if
6 you believed that there was a substantial body of medical
7 opinion that induction is safer after -- safer than D & E
8 after 20 weeks, and you responded yes, what were you
9 referring to?
10 A. I was referring to the literature search I did and the
11 review of the articles that I did. And so it was my
12 opinion, plus the opinion of others that did review
13 articles, that brought that to light.
14 Q. All right. So it's your synthesis of the information
15 that's out there that leads you to conclude that there is a
16 substantial body of medical opinion?
17 A. Yes.
18 Q. Doctor, do you agree that the safest and most
19 appropriate abortion procedure for a particular woman
20 depends, in part, on the gestational age of the fetus?
21 A. Yes.
22 Q. And that the safest and most appropriate abortion
23 procedure depends, in part, on the woman's health?
24 A. Yes, it may.
25 Q. And that the safest and most appropriate abortion
Dr. Elizabeth Shadigian, Cross 1564
1 procedure for a particular woman depends, in part, on
2 medical contraindications to a particular procedure or part
3 of a procedure for that woman?
4 A. Yes.
5 Q. And do you agree that the safest and most appropriate
6 abortion procedure for a particular woman depends, in part,
7 on her history of gynecological surgery?
8 A. It may, yes.
9 Q. And that the safest and most appropriate abortion
10 procedure may also depend, in part, on the training, skill
11 and experience of the physician performing the abortion?
12 A. It may.
13 Q. You would agree, wouldn't you, Doctor, even if two
14 procedures are statistically similar in terms of risk, the
15 safety for each particular woman depends on her individual
16 circumstances?
17 A. Yes.
18 Q. Doctor, just to go back through some of your earlier
19 testimony. You do not perform abortions on live fetuses,
20 except when it's your belief the mother will die, if the
21 pregnancy is not terminated; is that correct?
22 A. That's correct.
23 Q. That is luckily a very rare occurrence; is that right?
24 A. Yes.
25 Q. And your best estimate is that you have had to terminate
Dr. Elizabeth Shadigian, Cross 1565
1 a pregnancy in that circumstance between 20 to 40 times in
2 your career?
3 A. Yes.
4 Q. And in every case in which that was necessary where the
5 fetus was alive, you did that by induction and not D & E; is
6 that correct?
7 A. That is correct. In my practice.
8 Q. And in your career, you have performed -- well, since
9 you have been at the University of Michigan, approximately
10 10 to 20 D & E procedures; is that correct?
11 A. I believe that's so. I never counted them.
12 Q. Okay. And the latest that you will -- that you've
13 performed a D & E procedure is approximately 20 weeks?
14 A. I would say 20 weeks in my residency, and probably up to
15 17 to 18 weeks in my practice at the University of Michigan.
16 Q. And in your capacity as a supervising physician, you
17 estimate that you supervise residents doing D & Es zero to
18 two times a year; is that right?
19 A. That's correct.
20 Q. And, again, these are -- you are supervising is also in
21 cases of fetal demise; is that right?
22 A. Yes, it would be only in case of fetal demise, because I
23 don't perform any on live babies.
24 Q. So you wouldn't supervise somebody else doing that?
25 A. Correct, because I'm considered the practitioner also,
Dr. Elizabeth Shadigian, Cross 1566
1 and I would be helping if I did it.
2 Q. Okay. And you supervise approximately two to five
3 inductions of labor per year, for the purpose of removing a
4 dead fetus; is that right?
5 A. No, that's not what I said.
6 Q. Okay. Can we -- in the second trimester, can you
7 estimate how many times a year you would supervise a
8 procedure to remove a dead fetus by labor induction?
9 A. Probably about two or three times per year.
10 Q. And you have never discussed, I think we are using the
11 term D & X for your testimony. You have never discussed the
12 D & X abortion procedure with Dr. Johnson; is that correct?
13 A. If we discussed it at all, it may have been in a
14 teaching situation, not one-on-one with somebody else there.
15 Q. And you have never discussed the D & X procedure with
16 any physician, any other physician who performs it; is that
17 correct?
18 A. That is correct.
19 Q. And you have never induced fetal demise by means of a
20 drug administered to kill the fetus; is that correct?
21 A. That is correct.
22 Q. At the University of Michigan, among the physicians who
23 perform abortions on live fetuses, the decision whether or
24 not to induce fetal demise, prior to the procedure, is left
25 to the individuals physicians; is that correct?
Dr. Elizabeth Shadigian, Cross 1567
1 A. That is correct.
2 Q. You do not give formal lectures to medical students at
3 the University of Michigan on the complications of abortion;
4 is that correct?
5 A. What do you mean by formal lectures.
6 Q. A scheduled classroom lecture.
7 A. No.
8 Q. Doctor, you testified on direct that you are a member of
9 the American Association of Pro-Life Obstetricians and
10 Gynecologists; is that correct?
11 A. Yes, it is.
12 Q. In fact, you have served on the executive board and are
13 currently secretary of that group?
14 A. That's correct.
15 Q. You've also received an award the Matthew J. Bulfin
16 Award for Research, and Matthew J. Bulfin was the founder of
17 the American Association of Pro-Life Obstetricians and
18 Gynecologists; is that correct?
19 A. Yes, and he's passed away now.
20 Q. And you are also -- and that award is based on the best
21 scientific project with respect for life and its origin; is
22 that correct?
23 A. It was the best -- it's a research award. It's based on
24 literature and research.
25 Q. But the award is given on the basis of scientific
Dr. Elizabeth Shadigian, Cross 1568
1 projects with respect for life and its origin; is that
2 correct?
3 A. I believe that's the subtitle of the award but I haven't
4 looked at that.
5 Q. And you're also a member of the Catholic Medical
6 Association and have lectured at meetings of that
7 organization; is that correct?
8 A. Yes.
9 Q. And it is the position of the Catholic Medical
10 Association that abortion is an unspeakable crime, and no
11 Catholic physician should cooperate formally or materially
12 in its performance; is that correct?
13 A. I don't know.
14 Q. And it's also correct, is it not, Doctor, that many of
15 the presentations listed under extra mural invited
16 presentations on your resume have been at meeting either at
17 the American Association of Pro-Life Obstetricians and
18 Gynecologists or the Catholic Medical Association?
19 A. I believe I have only lectured the Catholic Medical
20 Association one time, but I would lecture to anyone who
21 would invite me to come to their meeting.
22 Q. You have also given, as reflected on your resume,
23 presentations to the National Institute of Family and Life
24 Advocates; is that correct?
25 A. Yes.
Dr. Elizabeth Shadigian, Cross 1569
1 Q. And Right to Life of Michigan?
2 A. Yes.
3 Q. And the Baptists for Life in Grand Rapids?
4 A. Yes.
5 Q. And among some of the writing that's listed on your
6 resume, one is chapter entitled Breaking the Silence,
7 Long-term Physical Complications of Induced Abortion and
8 that appears in a book entitled Back to the Drawing Board,
9 the History of the Pro-Life Movement; is that correct?
10 A. Yes, it is. It's a summary of the article we just went
11 over.
12 Q. And in your prior work as an expert in other cases, you
13 have actually only testified in front of a judge on one
14 occasion; is that right?
15 A. That is correct.
16 Q. Doctor, in your expert report, I think as you have
17 testified here today, you have stated no comparisons between
18 medical induction of labor for termination of pregnancy and
19 D & X procedure have been done; is that that's correct?
20 A. To my knowledge, that is correct. Based on the
21 literature.
22 Q. You also state in your report medical induction is a
23 safer abortion procedure than D & X; is that correct?
24 A. That sentence may be in there, but it is based upon
25 another set of sentences with it.
Dr. Elizabeth Shadigian, Cross 1570
1 Q. Do you agree, Doctor, that medical induction -- is it
2 your opinion that medical induction has been established to
3 be a safer abortion procedure than D & X?
4 A. I would say it is the study and safer abortion
5 procedure, yes.
6 Q. And you hold that opinion, even though there are no
7 published peer review medical studies comparing D & X and
8 induction?
9 A. I believe you're taking the title of a section of my
10 expert report, and that is the title of a section of my
11 expert report. And then I have several paragraphs
12 explaining why I believe that.
13 Q. Well, Doctor, is that your opinion? Medical induction
14 is a safer abortion procedure than D & X?
15 A. Because we don't have any safety data on D & X, I would
16 say it is, yes.
17 Q. And you hold that opinion, even though there are no
18 published peer reviewed medical studies evaluating the D & X
19 procedure?
20 A. Yes.
21 Q. You also stated in your expert report, and I believe in
22 your testimony today, that in the absence of any published
23 peer reviewed medical studies, evaluating the indications
24 and complications of the D & X procedure, there is no sound
25 basis for concluding that the D & X procedure offers safety
Dr. Elizabeth Shadigian, Cross 1571
1 or clinical advantages over alternative abortion methods.
2 Is that your opinion, Doctor?
3 A. Yes.
4 Q. And is it your opinion, Doctor, that the clinical
5 experience of board certified OB/GYNs, who would routinely
6 perform second trimester abortions, is not a sound basis for
7 concluding that D & X offers safety or clinical advantages
8 over other methods of clinical abortions?
9 A. Correct.
10 Q. When you were discussing earlier -- I believe it was the
11 Haskell presentation, you indicated one of the problems with
12 this kind of a case report is that the physician has nothing
13 to compare it to. Am I characterizing that correctly?
14 A. Yes, I said there were no comparison or control groups
15 in such a study.
16 Q. For a physician practicing abortion, practicing doing
17 abortions in the second trimester on a routine basis who has
18 integrated attempts to remove fetuses intact into his
19 practice, isn't it true that that physician would have a
20 basis of comparison, which would be his earlier practice of
21 removing the fetus through dismemberment with his current
22 practice of attempting to remove the fetus intact?
23 A. The practitioner that you're describing would have a
24 basis to compare what's at hand in front of them but
25 wouldn't be able to necessarily talk to short or long-term
Dr. Elizabeth Shadigian, Cross 1572
1 complications.
2 Q. Doctor, I believe you testified that, in your opinion, a
3 partial-birth abortion is never medically necessary as a
4 procedure to terminate the pregnancy of a woman, in order to
5 preserve her life or health; is that correct?
6 A. Yes.
7 Q. And that one of the reasons supporting your opinion is
8 that the circumstances in which it's necessary to do a
9 termination to preserve a woman's life or health is very
10 rare; is that right?
11 A. That's part of it, yes.
12 Q. But the fact that it's rare doesn't change the fact that
13 the woman in that situation should have access to the safest
14 and most appropriate abortion procedure; isn't that right?
15 A. Yes, if they are well studied, we could see if something
16 is safe and effective.
17 Q. It's your opinion, Doctor, killing the fetus in these
18 circumstances is never necessary?
19 A. The baby dying would be a natural secondary result of
20 medical induction abortions, for example. But in an of
21 itself, killing the baby does not offer any health benefits
22 for a woman nor will it change her medical outcome.
23 Q. And that opinion would apply with equal force to D & E
24 procedures in the same circumstance; isn't that correct?
25 A. Yes, it would.
Dr. Elizabeth Shadigian, Cross 1573
1 Q. In your practice, you would never perform a D & E
2 procedure in that circumstance?
3 A. On a live baby, I would not. No.
4 Q. I believe you may have given some examples where you
5 felt that there were reasons why you would want to avoid a
6 surgical procedure for women in certain health situations;
7 is that right?
8 A. Yes.
9 Q. And, again, those opinions would apply with equal force
10 to whether the procedure was going to be done by D & E or by
11 D & X, as you understand that procedure; isn't that correct?
12 A. I would have to go back to the exact paragraph that
13 you're talking about.
14 Q. All right. We'll just move on then.
15 A. Okay.
16 Q. One of the differences, I think that you described in
17 your induction procedures for fetuses that have not obtained
18 viability or fetal -- let me start that over. One of the
19 differences, in the way you perform induction procedures for
20 fetuses that are dead is that you can give higher doses of
21 the medications that you use, because there is no concerns
22 about the fetus; is that right?
23 A. Yes.
24 Q. And I believe you testified that this can result in a
25 shorter time for the induction procedure?
Dr. Elizabeth Shadigian, Cross 1574
1 A. It may.
2 Q. Doctor, did I understand your testimony that you do not
3 personally perform amniocentesis your patients?
4 A. I did as a resident and as an early faculty member, but
5 now there is a whole unit that just does fetal diagnosis, so
6 I don't now.
7 Q. So you would refer your patients who needed that to that
8 unit?
9 A. At the University of Michigan, certainly. Yes.
10 Q. Doctor, when you perform D & C procedures, you use
11 mechanical dilation; is that correct?
12 A. Yes, I do.
13 Q. And when you perform vacuum aspiration procedures to
14 remove a dead fetus, you also would use mechanical dilation
15 as needed; is that correct?
16 A. Yes.
17 Q. And you have also used laminaria for some of your
18 abortion procedures; is that correct?
19 A. Yes, I have.
20 Q. And in some instances, that has included serial
21 laminaria, which by that, I mean more than one insertion of
22 laminaria?
23 A. That is correct.
24 Q. And you're also considering for future cases, or maybe
25 at the present time, adding Misoprostol with the laminaria
Dr. Elizabeth Shadigian, Cross 1575
1 for the D & E procedures that you use?
2 A. Yes.
3 Q. And you think that may hold safety advantages for the
4 dilation process?
5 A. It may.
6 Q. The patients who receive laminaria are allowed to leave
7 and return the next day for the procedure; is that correct?
8 A. Yes.
9 Q. Doctor, I think you testified that one of your concerns
10 about the D & X procedure is that the dilation process may
11 apply or result in a different or greater force being
12 applied to the cervix than in an induction procedure; is
13 that correct?
14 A. I don't think I used those words today.
15 Q. Is that a correct statement, though, that those are your
16 concerns -- let me restate the question. That the dilation
17 process for D & X may result in a greater or different type
18 of force being applied to the cervix than in induction
19 procedures?
20 A. I think it's not just -- may I clarify?
21 Q. Yes.
22 A. Thank you. I think the point that I was trying to make
23 -- it's not just the dilation that's different and greater,
24 but it's actually the nonphysiological process of bringing
25 the baby through the open cervix that is different in a
Dr. Elizabeth Shadigian, Cross 1576
1 medical induction versus a D & E, for example, or D & X.
2 I'm sorry, for example.
3 Q. But you can't quantify the differences there, in order
4 to express your concerns and how they might increase the
5 risks between the procedures; is that right?
6 A. That's exactly right. And that's why the studies need
7 to be done, so we can understand what those risks may or may
8 not be.
9 Q. Doctor, I meant to ask you, when you've used laminaria,
10 I believe it was your testimony that in some cases you also
11 would use additional mechanical dilation at the time that
12 the products of conception are removed; is that correct?
13 A. Sometimes.
14 Q. So just to be clear, Doctor, for example, there is no
15 way, at this point, for us to compare dilation that is
16 achieved over two days using laminaria with, for example, a
17 four-hour induction using Misoprostol alone; is that
18 correct? In terms of risks to the cervix?
19 A. There are ways to compare those things.
20 Q. Based on current studies?
21 A. I see what you're getting at, so could you restate the
22 question, please.
23 Q. Sure. It wasn't very artfully asked. At this point,
24 based on what we know now, there would be no way to compare,
25 for example, the effect on the cervix of two days of
Dr. Elizabeth Shadigian, Cross 1577
1 laminaria used to dilate the cervix with the use of
2 Misoprostol, which results in expulsion of the fetus in four
3 hours?
4 A. Exactly. That there are no head-to-head studies looking
5 just at how the cervix is dilated in a serial dilation over
6 several days versus how it's dilated over four hours. That
7 is correct.
8 Q. Doctor, just a few questions on the review article that
9 you discussed, Defendant's 631. I don't think you'll need
10 to read out of it, but if you would like to have that in
11 front of you, that's fine. That article looked at 24
12 studies looking at an association between abortion and
13 pre-term birth; is that correct?
14 A. Yes, it did.
15 Q. And 12 of those studies, in other words, half of those
16 studies found no association; is that correct?
17 A. Yes, the older studies showed no association. There
18 happened to be 12 of them, yes.
19 Q. And even among the more current studies, isn't it
20 correct that not all of them found an association? I
21 believe, if you cut it off at about 1980, the six later
22 studies, four found an association but two did not; is that
23 correct?
24 A. That's correct. I didn't look at your numbers but I'm
25 going to assume you're right.
Dr. Elizabeth Shadigian, Cross 1578
1 Q. And your concern that there may be a correlation --
2 well, before I get to that question, let me just confirm.
3 You testified that most of these studies are looking at
4 first trimester abortions, or that's the majority of
5 abortions that are considered in those studies; is that
6 correct?
7 A. Yes, they were probably the majority of the abortions in
8 those studies, that's correct.
9 Q. And you believe that based on these studies, there may
10 be a correlation between greater dilation in the second
11 trimester and pre-term birth, based on studies showing an
12 association with dilation in the first trimester?
13 A. Well, my concern is just that really, it's a mixed bag
14 of first and second trimester basically in these studies,
15 and most of them didn't separate those out, unfortunately.
16 But the concern is you don't dilate as much in the first
17 trimester and you actually dilate more in the second
18 trimester. So the concern is, could there be even more
19 pre-term birth with second trimester abortions or later
20 gestational age ones.
21 Q. But because those studies are looking primarily at first
22 trimester abortions, in which the method of dilation was
23 most likely mechanical dilators, whereas abortions in the
24 second trimester are being done with laminaria or a
25 combination of laminaria and Cytotec, it's purely
Dr. Elizabeth Shadigian, Cross 1579
1 hypothetical that there might be a greater risk, based on
2 these studies?
3 A. Yes. That's the whole point is we don't have studies on
4 whether they use laminaria or not in whatever trimester, but
5 it is one of the concerns. But it is a theoretical concern,
6 rather than one based completely on solid evidence.
7 Correct.
8 Q. And Doctor, was -- did the studies that you included in
9 the review article include a study by Kalish at all, looking
10 at abortions from 14 to 24 weeks?
11 A. No, I don't believe it did.
12 Q. Doctor, it's your opinion, isn't it, that it's
13 impossible during a D & E procedure that most of the fetus
14 can be removed in a single pass?
15 A. I think I said it would be rare, unlikely.
16 Q. And that's based on your experience performing D & Es
17 and observing D & Es; is that correct?
18 A. Yes, and from reading reports, yes.
19 Q. And you agree that the fetus is more friable as a result
20 of demise and, therefore, disarticulation is more likely or
21 may be more likely with a dead fetus than a live fetus; is
22 that right?
23 A. Would be more likely or more easily performed.
24 Q. Well, more easily performed, I guess would be
25 appropriate, based on your prior answer?
Dr. Elizabeth Shadigian, Cross 1580
1 A. Yes.
2 Q. And Doctor, you believe the average time for the
3 surgical removal of the fetus during a D & E procedure under
4 normal circumstances is between 30 minutes and two hours; is
5 that correct?
6 A. I don't think I said that was the normal range. I think
7 probably the normal average is probably closer to 30
8 minutes. I think when the question was asked, I was being
9 asked about a full range.
10 Q. Doctor, let me have you take a look at your deposition
11 and we'll sort that out. May I approach, Your Honor?
12 THE COURT: Yes.
13 MR. COPPOLINO: I have got the deposition. Thank
14 you.
15 THE WITNESS: Thank you.
16 BY MS. CREPPS:
17 Q. Doctor, can you turn, please, to page 141 of your
18 deposition?
19 A. Yes. Just a second.
20 Q. And I'm looking at line 11, and I'm going to read my
21 question and your response and see if that's your opinion.
22 How long, on average, does a surgical removal of the fetus
23 take? Answer: Again, it depends on the gestational age and
24 other factors, meaning that if the woman has a uterine
25 anomaly, it may take longer or if there is a complication.
Dr. Elizabeth Shadigian, Cross 1581
1 However, in the basic usual circumstances, it can take
2 probably between 30 minutes and two hours. That was the
3 response to that question you gave in your deposition; is
4 that correct, Doctor?
5 A. It is.
6 Q. Thank you.
7 A. I think -- may I say something though or not?
8 THE COURT: Typically, Doctor, the lawyers will.
9 It puts them in an awkward position, because they are
10 supposed to ask the questions and not argue with you, but if
11 you can certainly add anything if you want -- if you think
12 that your answer is unclear, you feel free to do that. But
13 if it regards something else, then I would prefer that you
14 not. So if you think the answer you just gave is unclear
15 and you need to explain it, feel free to do that. If not,
16 wait for somebody to give you a question that will give you
17 an opportunity.
18 THE WITNESS: Okay. I'll wait.
19 THE COURT: Okay.
20 BY MS. CREPPS:
21 Q. And, Doctor, you acknowledge that it's theoretically
22 possible intact removal of the fetus could result in less
23 sharp bony fragments within the uterus; is that correct?
24 A. Yes.
25 Q. Some of the concerns you have indicated about insertion
Dr. Elizabeth Shadigian, Cross 1582
1 of laminaria were, I believe, the risk of infection or
2 trauma to the cervix; is that right?
3 A. Yes.
4 Q. And those risks are present whenever laminaria are
5 inserted, whether it's a single time or two times or more;
6 isn't that right?
7 A. Yes .
8 Q. Doctor, you do not believe there is a substantial body
9 of medical opinion that D & X may be the safest and most
10 appropriate procedure for some women in some circumstances;
11 is that correct?
12 A. Yes, based on the medical literature.
13 Q. And you believe there may be a substantial body of
14 personal opinion that D & X may be the safest procedure for
15 some women in some circumstances; is that correct?
16 A. I believe when I said that, I believe I meant
17 personal/medical anecdotal.
18 Q. Yes. I would like to have you take a look at
19 Plaintiff's Exhibit 5, which I'm going to come and get the
20 binder for you, and this is one of the ACOG statements of
21 policy.
22 A. Thank you. I'm there.
23 Q. You're familiar with this statement of policy; is that
24 correct, Doctor?
25 A. Yes, I am.
Dr. Elizabeth Shadigian, Cross 1583
1 Q. And I believe there is a description of intact dilation
2 and extraction on page two, which you indicated on direct,
3 you had reviewed in formulating your opinions in this case;
4 is that correct?
5 A. Yes.
6 Q. And according to the policies, to this policy statement,
7 the intact D & X procedure is one method of terminating a
8 pregnancy after 16 weeks; is that correct? I'm looking at
9 the last sentence on page two.
10 A. That's what the sentence says, yes.
11 Q. Now, if you will go to page three, Doctor, and in the
12 right-hand column, I'm going to read the second sentence.
13 An intact D & X, however, may be the best or most
14 appropriate procedure in a particular circumstance to save
15 the life or preserve the health of a woman, and only the
16 doctor in consultation with the patient, based upon the
17 woman's particular circumstances, can make this decision.
18 Do you agree with that statement, Doctor?
19 A. I'm just reading it again. I'm sorry.
20 Q. Take your time.
21 A. I would say that the person who is in front of the
22 woman, her physician at the time, is probably the best
23 person to make the decision, but it has to be based on not
24 just personal experience but on the medical literature too.
25 Q. Doctor, if a physician who routinely performs D & E
Dr. Elizabeth Shadigian, Cross 1584
1 procedures believes that intact removal of the fetus is the
2 safest and most appropriate procedure, is it your opinion
3 that that physician should, nonetheless, not do that
4 procedure?
5 A. I think the issue is around the belief. What
6 contributes to a belief about something and that's what the
7 whole issue is around this. So it's around that word belief
8 that I have the most hard time with.
9 Q. So would it be your opinion, Doctor, that physicians
10 should limit the amount of dilation they attempt to achieve
11 in a D & E procedure, in order to avoid the possibility of
12 intact removal of the fetus?
13 A. Not necessarily.
14 Q. And it's your opinion, Doctor, that this ACOG statement
15 of policy is simply a compilation of the personal opinions
16 of several physicians who sat on the executive board at the
17 time this statement was issued; isn't that correct?
18 A. It is correct that it was just approved by the executive
19 board, which is a small number of physicians, but they
20 didn't talk to any of the rest of the body of ACOG about any
21 of these issues.
22 Q. And so it's your feeling that this is simply a statement
23 of their personal opinions; isn't that correct?
24 A. It's a statement of their personal/medical, anecdotal
25 opinions, yes.
Dr. Elizabeth Shadigian, Cross 1585
1 Q. Doctor, one of the concerns that you've raised about D &
2 X procedure is that the indications for the procedures have
3 not been studied; is that correct?
4 A. Yes.
5 Q. By indications, you mean the reason why the procedure
6 would be performed?
7 A. The reason why that procedure would be performed over
8 other procedures.
9 Q. And, Doctor, in your report, you cite an article by
10 Epner, et al., entitled late term abortion. Is that
11 correct?
12 A. Yes.
13 Q. I would like to have you look at Plaintiff's Exhibit 41,
14 if you would, and I think that's in the same binder?
15 A. It is.
16 Q. And this article was published in the Journal of the
17 American Medical Association in August of 1998; is that
18 right?
19 A. Yes.
20 Q. You cite this article in your expert report for the
21 proposition that medical inductions after 21 weeks have
22 slightly lower mortality rates than D & E abortions at 21
23 weeks; is that correct?
24 A. Could you restate the question? I'm sorry.
25 Q. Sure. You cite this article in your expert report for
Dr. Elizabeth Shadigian, Cross 1586
1 the proposition that medical inductions after 21 weeks have
2 a slightly lower mortality rate than D & E abortion
3 procedures at 21 weeks and higher?
4 A. Right. It's inclusive of 21 weeks, correct.
5 Q. And I would like to have you look at page 727 of this
6 article on table four.
7 A. Yes.
8 Q. And this chart reports -- this reports the
9 abortion-related mortality rates for induced abortion
10 procedures at 13 weeks or later; is that correct?
11 A. Yes, that's in the title from 1974 to 1987.
12 Q. And the chart reports that for abortions performed at 21
13 weeks or greater, the mortality per 100,000 abortions is
14 11.9 for D & E; 10.3 for labor induction; and 274.3 for
15 hysterotomy or hysterectomy; is that correct?
16 A. Yes, that's the third column in that table.
17 Q. And the authors describe the rates of mortality for D &
18 E and labor induction at or after 21 weeks as comparable; is
19 that right?
20 A. Say that one more time. I'm sorry.
21 Q. The authors of this article describe the mortality rates
22 for D & E and labor induction at or after 21 weeks as
23 comparable; is that correct?
24 A. I don't know. If you show me the sentence, I'll
25 understand what you mean.
Dr. Elizabeth Shadigian, Cross 1587
1 Q. Okay. If you will look on the same page under the
2 heading of abortion related mortality and go to the last
3 sentence in that section, and I'll just read it out loud.
4 Mortality rates overall are higher for abortion related
5 labor induction than D & E (7.1 and 3.7 respectively) but
6 are comparable for induced abortions performed at 21 weeks
7 or more, 11.9 and 10.3 respectively. That's how the authors
8 characterize this information; is that right?
9 A. Yes. Without further analysis, that's what they did.
10 Q. Doctor, still on the same page now. I'm in the far
11 right column. I'm looking at the third paragraph in that
12 column, and I would like to read to you from that paragraph
13 and see if you agree with some of the statements here. The
14 paragraph states cervical incompetence and compromised
15 subsequent pregnancies are important but unresolved concerns
16 related to second or third trimester abortions. Little
17 research exists on whether those complications are more
18 likely to result from D & E (or intact D & X) or from labor
19 induction methods. You agree with those statements, don't
20 you, Doctor?
21 A. Yes.
22 MS. CREPPS: Your Honor, at this time, I would like
23 to move Plaintiff's Exhibit 41 into evidence for the reasons
24 that we have discussed previously.
25 THE COURT: The Government renews its objection.
Dr. Elizabeth Shadigian, Cross 1588
1 MR. COPPOLINO: We renew our objection, Your Honor.
2 THE COURT: Mr. Henry is nodding. I'm getting a
3 double objection. Mr. Henry is giving you the thumbs up.
4 MR. COPPOLINO: Speaking of Mr. Henry.
5 THE COURT: Yes, sir.
6 MR. COPPOLINO: We might even be able to address
7 this issue today. If you would like, after the witness is
8 concluded, this whole issue of what are we going to do with
9 these articles -- I think we are prepared to address that in
10 further detail.
11 THE COURT: I'll withhold ruling on 41. That's
12 also 561, I think of the defendant's as well.
13 MR. COPPOLINO: Yes, it is, Your Honor.
14 THE COURT: I'll withhold ruling. Go ahead.
15 MS. CREPPS: Your Honor, I'm close to being
16 finished. May I have just a moment.
17 THE COURT: Sure.
18 BY MS. CREPPS:
19 Q. Doctor, I believe it was your testimony that the
20 practice at the University of Michigan has shifted away from
21 doing D & E procedures after 20 weeks towards the
22 performance of induction; is that correct?
23 A. Yes.
24 Q. But you're not aware of the exact number of physicians
25 at the University of Michigan who perform abortions; is that
Dr. Elizabeth Shadigian, Redirect 1589
1 right?
2 A. I could count them up probably.
3 Q. Well, in your deposition, you estimated that it was five
4 or six; is that right?
5 A. Correct.
6 Q. And of those, you do not now how many perform abortions
7 after 20 weeks; is that correct?
8 A. I don't know specifics on cases, correct.
9 Q. In formulating your opinion regarding a practice at the
10 University of Michigan shifting away from D & E at 20 weeks
11 and towards induction, you did not speak with the chair of
12 your own department, Dr. Johnson; is that correct?
13 A. Correct. I talked to a different colleague.
14 Q. Doctor, it's fair to say, is it not, that your opinion
15 that induction is safer than D & X for abortions at 20 weeks
16 and later is a hypothesis you have developed from looking at
17 studies that don't look at D & X but look at other aspects
18 of abortion procedure?
19 A. That is correct.
20 Q. It would have been possible to make the same kind of
21 hypothetical comparison between D & X and D & E?
22 A. Yes, we could have done that as well. I could have done
23 that as well.
24 MS. CREPPS: I don't have any other questions, Your
25 Honor.
Dr. Elizabeth Shadigian, Redirect 1590
1 THE COURT: Redirect?
2 REDIRECT EXAMINATION
3 THE COURT: Mr. Coppolino, I have criminal matters
4 over the noon hour, but I'm okay to go into the noon hour a
5 little bit. But if you want to take a break and come back
6 at 1:30, if that's your preference, that's fine with me.
7 MR. COPPOLINO: Your Honor, I expect to have only
8 about five minutes maybe.
9 THE COURT: Oh, that's fine.
10 MR. COPPOLINO: Five or ten minutes then. If you
11 have questions, that may force us to go -- if we have to
12 leave right at noon, I suppose we would have to come back.
13 But if you had a few minutes, we could wrap this witness up
14 by 12:15 or so.
15 THE COURT: That would be fine.
16 BY MR. COPPOLINO:
17 Q. Doctor, on the last point Ms. Crepps was asking you
18 about, with respect to your opinion on the relative safety
19 of D & X and induction, is it in part because there was no
20 studies on D & X that you believe medical induction is a
21 safer procedure?
22 A. That's correct.
23 Q. Ms. Crepps asked you a question about reliance on
24 clinical experience by the doctors who perform abortions.
25 Is it your opinion that clinical experience alone is a sound
Dr. Elizabeth Shadigian, Redirect 1591
1 basis on which to evaluate the D & X procedure?
2 A. No, it is not.
3 Q. Ms. Crepps asked you about Dr. Johnson. He's your
4 chairman of the department at Michigan?
5 A. Yes, he is.
6 Q. And someone you respect?
7 A. Yes.
8 Q. You disagree with him on this issue?
9 A. Very much so.
10 Q. But he hired you; is that correct?
11 A. I have known Tim almost 20 years, yes.
12 Q. He's placed his trust in you to care for women at the
13 University of Michigan; is that correct?
14 A. Yes.
15 Q. Now, Doctor, you were asked about a reference on page
16 141 of your deposition. It was on page 141, line 11 and
17 your answer went down through line 17. Do you recall being
18 asked about that?
19 A. Yes.
20 Q. And I think you indicated that you wanted to add
21 something to put that answer into fuller context. So let me
22 just ask you -- I'll give you that opportunity now to put
23 that answer in a fuller context. Just for the record let's
24 make it clear. The question was, how long on average does
25 the surgical removal of the fetus take? Answer: Again, it
Dr. Elizabeth Shadigian, Redirect 1592
1 depends on the gestational age and other factors, meaning if
2 the woman has a uterine anomaly, it may take longer if
3 there's a complication. However, on the basic usual
4 circumstances, it can take between 30 minutes and two hours.
5 A. Yes. I think what I meant to say, and I didn't notice
6 this when I read the deposition again, but she asked about
7 you know what's normal, and then what's, you know, other
8 things that may take longer. So I said gestational age may
9 take longer, but I was also thinking of the abnormality of
10 uterine anomalies, which always take longer. So I said
11 however, in the basic usual circumstances, and I think I
12 meant to say in the basic and unusual circumstances.
13 Because we were talking about normal and abnormal. I think
14 I was just thinking normal and abnormal. So, you know, if I
15 was to say it better today, I would say in the normal and
16 abnormal and 30 to -- minutes to two hours. So in the basic
17 and unusual circumstances.
18 Q. Ms. Crepps asked you about the Epner article which is
19 Defendant's Exhibit 561. You have it up there. It's also a
20 Plaintiff's Exhibit.
21 A. I have it.
22 Q. I would like just to call your attention to a couple of
23 sentences at the end of 727. Ms. Crepps had asked you about
24 the sentences concerning abortion related mortality. The
25 Epner article also comments on abortion related morbidity.
Dr. Elizabeth Shadigian, Redirect 1593
1 Is that correct?
2 A. Yes.
3 Q. Just for the record, what's the difference between
4 complications from mortality and morbidity?
5 A. Mortality means when a woman dies as a direct result of
6 a procedure, and morbidity is when there are other
7 complications that don't cause her death but may cause
8 serious consequences such as infections or hemorrhages.
9 Q. Calling your attention to the bottom of page 727. There
10 is a sentence which reads -- would you just read where it
11 says abortion related morbidity. Would you read that over
12 to the conclusion of the paragraph on the next page?
13 A. I would be glad to. Abortion related morbidity is lower
14 for D & E procedures than for labor induction methods used
15 in second trimester abortions. However, the rates are
16 similar for procedures performed at 20 weeks gestation and
17 beyond. More research on complications and complication
18 rates associated with various procedures and by gestational
19 age is needed before firm conclusions about the relative
20 safety of procedures can be drawn.
21 Q. Now, do you agree with those statements in the Epner
22 article?
23 A. Yes.
24 Q. Ms. Crepps asked you if you have seen the Kalish and
25 Chasen article on subsequent relationship between dilation
Dr. Elizabeth Shadigian, Redirect 1594
1 and evacuation and subsequent pregnancy outcome?
2 A. Yes.
3 Q. Have you reviewed that article?
4 A. Yes, I have.
5 Q. I would like you to turn to Defendant's Exhibit 596.
6 Your Honor, can I assist the witness in finding the article?
7 THE COURT: Sure.
8 MR. COPPOLINO: Seem to be missing a notebook over
9 here.
10 THE COURT: Oh, my, somebody stole a notebook.
11 BY MR. COPPOLINO:
12 Q. Doctor, Defendant's Exhibit 596, is this the article by
13 Doctors Kalish and Chasen, et al., entitled Impact of Mid
14 Trimester Dilation and Evacuation on Subsequent Pregnancy
15 Outcome?
16 A. Yes.
17 Q. And have you read this article before?
18 A. Yes.
19 Q. What does this article conclude about pre-term birth as
20 a long-term complication of induced abortion?
21 A. May I read from it?
22 Q. Well, where are you going to read from? The conclusion?
23 A. Just the conclusion.
24 Q. Sure, you can read that.
25 A. Their conclusion was that second trimester D & E was not
Dr. Elizabeth Shadigian, Redirect 1595
1 a risk factor mid trimester pregnancy loss or spontaneous
2 pre-term birth.
3 Q. I would like you to -- well, first of all, having read
4 the article, does it change your view about the complication
5 of subsequent pre-term birth resulting from an abortion?
6 A. No, it did not.
7 Q. Why not?
8 A. There were several flaws in this study. I also did not
9 have too much time to look at that, but on the time that I
10 had -- would you like me to do an analysis of why I didn't
11 think it helped me?
12 Q. To the extent you can recall. And I have a specific
13 sentence that I want to call to your attention. Why don't I
14 do that first, and then we can go to your whatever thoughts
15 you have. Take a look at page 884. Under the caption
16 comment, starts on the bottom of the left-hand column.
17 A. Yes.
18 Q. Where it says our study reviewed the medical records of
19 600 patients.
20 A. Yes.
21 Q. Do you see that?
22 A. Yes.
23 Q. And it also indicates -- well, why don't you read that
24 over. Why don't you read from there. Just read it to
25 yourself to refresh your recollection on what they did in
Dr. Elizabeth Shadigian, Redirect 1596
1 this study in part.
2 A. Yes, I remember now.
3 Q. Over to the carryover paragraph on the right-hand
4 column.
5 A. Yes.
6 Q. And this section of the article talks about follow-up
7 with patients who were involved in the study; is that
8 correct?
9 A. Yes.
10 Q. How would you characterize the follow-up of the patients
11 who were involved in this study for purposes of evaluating
12 long-term risks of pre-term birth after their abortion?
13 A. Right, so what they did was they studied the medical
14 records of 600 patients in a particular institution and
15 found that there were 96 subsequent pregnancies just at that
16 institution. So they didn't bother to ask other
17 institutions, even in the same town, if women had delivered
18 there who had had prior procedures at this particular
19 institution. And this is part of an analysis of many of
20 these kinds of studies is, you know, you have to look bigger
21 than the one hospital that you practice at because people's
22 insurance change all the time. They have to go to the
23 hospital across the street. And, also, just in the greater
24 metropolitan area, or they could have called people later
25 and said, have you had another pregnancy or where. They had
Dr. Elizabeth Shadigian, Redirect 1597
1 other information. They could have gone and actually
2 followed women in those ways. And because they didn't do
3 that, it's hard to draw any conclusions because it's just
4 limited to one institution.
5 Q. Do you think the follow-up in this study is inadequate;
6 is that right?
7 A. Absolutely.
8 Q. All right. One last question, Doctor. Ms. Crepps
9 identified the ACOG statement. Take a look at where on page
10 three of the ACOG policy statement?
11 A. Yes.
12 Q. Ms. Crepps asked you to read a sentence on page three.
13 I would like you to read the sentence before it where it
14 begins a select panel convened by ACOG. Would you read that
15 sentence, please?
16 A. I would be glad to. A select panel convened by ACOG
17 could identify no circumstances under which this procedure,
18 as defined above, would be the only option to safe the life
19 or preserve the health of the woman.
20 Q. Do you agree with the conclusion of the select panel
21 with ACOG?
22 THE COURT: With that sentence --
23 BY MR. COPPOLINO:
24 Q. Let me rephrase the question. Can you identify any
25 circumstances in which the D & X procedure would be the only
Dr. Elizabeth Shadigian, Examination by Court 1598
1 option to save the life or preserve the health of the woman?
2 A. I cannot.
3 MR. COPPOLINO: Thank you, Your Honor.
4 EXAMINATION
5 THE COURT: Doctor, I have a few questions. The
6 first has to do with the 17th week of gestation. And assume
7 -- well, assume you have got a board certified OB/GYN or
8 well qualified surgeon who does abortions; typically does D
9 & Es, 17th week. He or she doesn't think they can use
10 Digoxin, at that point in time, to cause fetal demise,
11 because they have concerns about the safety of doing that
12 because of the small size of the fetus. This is done in a
13 clinic setting for a wide variety of reasons. Typically,
14 the doctor does an intact or pardon me, typically a D & E,
15 but there are a fair number in his or her practice of
16 circumstance at which at the 17th week, the doctor reaches
17 up and he has the fetus delivered to the point where the
18 cervix, where the calvarium lodges against the cervix.
19 Okay.
20 THE WITNESS: Yes.
21 THE COURT: Now, I realize, do we have the facts
22 pretty well. Do you understand the facts as I have given
23 them to you?
24 THE WITNESS: I think so.
25 THE COURT: Okay. What does the physician do at
Dr. Elizabeth Shadigian, Examination by Court 1599
1 that point?
2 THE WITNESS: Do you mean to try to get the rest of
3 the baby to deliver at that point?
4 THE COURT: Well, the physician's intent is to do
5 an abortion.
6 THE WITNESS: Right.
7 THE COURT: So I have given you the circumstance.
8 You have got the head lodged in the cervix. It may be
9 relatively uncommon, but that's the circumstance. What does
10 the physician do?
11 THE WITNESS: Well, the physician can use all their
12 other techniques in their armamentarium to continue the
13 procedure. So they may want to gently turn the baby's head
14 and try to change the angle of the head such that if it's
15 open enough to admit the rest of the body so quickly, as you
16 describe, then it may be just with these certain techniques
17 we have -- we use at term birth also. Pinard maneuvers and
18 some of these other maneuvers we use for breeches that they
19 could try those maneuvers and see if they could get the baby
20 to come. That would be the first thing I bet people would
21 do.
22 THE COURT: What if that doesn't work?
23 THE WITNESS: Then they may want -- they could
24 probably try to use medicine to try to increase the chance
25 that the uterine contractions themselves may help the baby
Dr. Elizabeth Shadigian, Examination by Court 1600
1 come out. And, in addition, there is medicine such as
2 Nitroglycerin that actually relaxes the cervix and the
3 uterus, and may with a single dose of Nitroglycerin, may, in
4 fact, have the baby get dislodged, and we have done that
5 before when necessary.
6 THE COURT: And what if that doesn't work, 15
7 minutes, 20 minutes passes, the woman is bleeding. What do
8 you do next.
9 THE WITNESS: Right. Another thing I didn't say,
10 you didn't initially say the woman was bleeding. You said
11 just that the head was lodged.
12 THE COURT: Well, are you telling me that in the
13 circumstance that I described it would be atypical to have
14 bleeding?
15 THE WITNESS: It would be less typical. It would
16 be. Another thing --
17 THE COURT: Uncommon?
18 THE WITNESS: It would be uncommon to have so much
19 bleeding that you have to necessitate a very quick delivery.
20 THE COURT: But there is bleeding going on,
21 generally speaking, at the 17th weak in the circumstance
22 that I have described; isn't that right.
23 THE WITNESS: Yes, there can be bleeding as the
24 baby is delivering and the placenta is coming out.
25 THE COURT: So we have gone through the
Dr. Elizabeth Shadigian, Examination by Court 1601
1 circumstance in which you try a physical manipulation, and
2 the Nitroglycerin or other labor-induction medicines. What
3 is the next step that the doctor should consider.
4 THE WITNESS: Well, the doctor could merely do a
5 disarticulation procedure, if they so chose to.
6 THE COURT: How would the doctor do that, at that
7 point?
8 THE WITNESS: They could just start pulling the
9 pieces out.
10 THE COURT: Pull read hard?
11 THE WITNESS: Yes, they could pull harder. What
12 might happen instead of using their hands, they may actually
13 use one of those Soffer forceps. Rather than grasp the
14 head, because again, if it's struck, it's not easy to put it
15 in there. But they could grasp a different part of the baby
16 try and change the angle and pull it as well.
17 THE COURT: Under any of that, in that circumstance
18 that I have described, are you telling me that it would
19 violate the standard of care to collapse the skull?
20 THE WITNESS: No, I didn't say that. Which
21 standard of care are we talking about?
22 THE WITNESS: Whatever standard of care you use at
23 the University of Michigan.
24 THE WITNESS: If the baby, if you really -- if
25 she's hemorrhaging and you need to get the baby out, that
Dr. Elizabeth Shadigian, Redirect 1602
1 could be possible to collapse the skull.
2 THE COURT: All right. I'm going to let the
3 lawyers follow up first for the Government, then the
4 defendant, then the Government. I mean the plaintiff.
5 You'll appreciate why I use the word defendant. Go ahead.
6 REDIRECT EXAMINATION
7 BY MR. COPPOLINO:
8 Q. Doctor, you characterize, can you characterize, for lack
9 of a better word, the malleability of the fetal head at 17
10 weeks?
11 A. At 17 weeks, there is less ossification so the head is
12 much softer and more cartilaginous rather than bony.
13 Q. And would that permit the physician to manipulate the
14 head a little easier than he could at later stages in
15 gestation?
16 A. Yes.
17 Q. Doctor, is the primary cause of bleeding or a primary
18 cause of bleeding in second trimester abortion the removal
19 of the placenta from the uterine wall?
20 A. Yes.
21 Q. If the placenta has not yet removed or been removed from
22 the uterine wall, how much bleeding is there typically at
23 that stage in gestation, at that point in the procedure?
24 A. Very little.
25 Q. Doctor, if the head is stuck solid in the cervical os at
1603
1 that stage of 17 weeks under the Judge's hypothetical, how
2 easy is it to get forceps in there to remove it? Would it
3 depend on how tight the head is against the cervix?
4 A. Yes, and you would maybe need to even push the head back
5 in to get your instrument in there.
6 MR. COPPOLINO: Thank you, Your Honor.
7 THE COURT: Plaintiffs?
8 MS. CREPPS: No questions, Your Honor.
9 THE COURT: All right. Thank you, Doctor. I found
10 your testimony very helpful. You may stand down.
11 THE WITNESS: Thank you, sir.
12 THE COURT: Counsel, it's now 10 after 12. Mr.
13 Henry, you have -- you want to talk about exhibits?
14 MR. COPPOLINO: If I could answer for Mr. Henry.
15 Do you want to do it now? If you have work to do in the
16 noon hour, we can come back. It could take a few minutes.
17 THE COURT: If you don't mind, that would be my
18 preference. If you would come back at 2:00 o'clock, that
19 would give me a chance to sentence two people and eat a
20 sandwich. I probably ought not to describe with that
21 connection. Doctor, you can step down.
22 MS. SMITH: Your Honor, could I do it tomorrow
23 morning?
24 MR. COPPOLINO: I'm a little reluctant to eat into
25 the witness time tomorrow morning.
Argument on exhibits 1604
1 THE COURT: You want to come back later this
2 afternoon?
3 MS. SMITH: That's fine. 2:00 o'clock is fine.
4 THE COURT: Come on back at the 2:00 o'clock.
5 We'll stand in recess.
6 (Recess from 12:10 to 2:00 p.m.; all parties present)
7 THE COURT: Please be seated. We are back on the
8 record now in Carhart versus Ashcroft. Counsel, I have
9 placed on your benches a list of exhibits which have been
10 offered but not received which we hope is accurate, and I
11 understand we are here now to discuss the question of those
12 exhibits and perhaps others. Who would like to go first?
13 MS. SMITH: I guess we are offering, so perhaps it
14 makes sense for me.
15 THE COURT: Well, actually, I'm not sure, but that
16 both sides -- It doesn't make any difference to me who goes
17 first.
18 MS. SMITH: Your Honor, with reference to the list,
19 plaintiffs were under the impression we had also offered
20 Exhibit 44, the Grimes article on, I believe that was on
21 April 1st in conjunction with Dr. Vibhakar's testimony.
22 THE COURT: Yes, I do show that is offered myself.
23 MS. SMITH: Okay.
24 THE COURT: Someone on my staff will be punished.
25 You see how fearful they are.
Argument on exhibits 1605
1 MS. SMITH: Your Honor, learned treatises such as
2 excerpts from medical texts are not inadmissible hearsay
3 where they are not offered for the truth, and, in fact,
4 courts have admitted scientific articles and medical
5 articles where they were offered not for the truth but for
6 existence of knowledge in the community, for example. In a
7 case in this circuit called, I don't know how to pronounce
8 it, Buttice or Buttice vs. --
9 THE COURT: Anybody who can say Henriet.
10 MS. SMITH: Henriet Buttice, I don't know. I'm
11 trying to make use of my high school French, and the only
12 thing I ever could do was the accent, so --
13 THE COURT: Very well done.
14 MS. SMITH: It's B-u-t-t-i-c-e, and the cite for
15 that is 938 F. Supp. 561. That's from the Eastern District
16 of Missouri. It's a 1996 case, and in that case, the Court
17 stated that the excerpts from medical texts were not
18 inadmissible hearsay because they weren't offered for the
19 truth. They were offered to establish the existence of
20 medical literature, and thus the knowledge of the medical
21 community concerning in that case IUD use and pelvic
22 inflammatory disease at a particular point in time.
23 Similarly, the Seventh Circuit case, it's 940 F.2d 207,
24 allowed design standards that were in existence at the time
25 of the manufacturing of a product to be offered for -- to
Argument on exhibits 1606
1 show the defendant's knowledge, actual and constructive
2 knowledge.
3 The Tenth Circuit at 866 F.2d 319 allowed scientific
4 articles to show defendant's notice that products posed a
5 certain health threat.
6 And the Fifth Circuit at 415 F.2d 1009, allowed medical
7 articles to show that defendants should have known of a
8 particular disease and its causation or products cause; and
9 in this case, we are offering these articles for existence
10 of the substantial body of medical opinion, perhaps to
11 support the reasonableness of that opinion, and also as
12 evidence of the debate in the community, and also for what
13 Congress should have known and considered at the time and
14 didn't. Courts in this Circuit, including the Eighth
15 Circuit have, while not ruling on the evidentiary issue,
16 have considered medical texts in determining knowledge of
17 the medical community concerning a particular issue and
18 that's the King versus Nashua case at 763 F.2d 332, and that
19 was a 1985 case, and I think all of those cases really
20 support our position here that we are offering them for
21 knowledge in the community, opinion in the community, even
22 less for the truth in some ways because it's just evidence
23 of opinion.
24 THE COURT: Well, I think the opinion in the
25 community, to be more precise is, what you're really talking
Argument on exhibits 1607
1 about is the community here are doctors.
2 MS. SMITH: Um-hm, yes.
3 THE COURT: So that's the community you're
4 referring to.
5 MS. SMITH: That's right, the medical opinion,
6 medical community, and that there is a debate about these
7 issues, and there is a substantial body that holds that the
8 intact D & Xs in some circumstances is safer.
9 THE COURT: Well, at least informs us as to whether
10 that's true or not.
11 MS. SMITH: That's right. I think it, at least,
12 even though the Chasen article is the only article that is
13 specifically on that issue, the other articles all inform
14 the debate, they establish, you know, we have heard a lot
15 about intuition and doctors' intuition about what is safer.
16 Well, if evidence of this intuition doesn't come from, you
17 know, Mother Nature or something, it doesn't come from some
18 amorphous source. It's really medical opinion based on
19 medical articles that are well respected in the community,
20 and that that means that that opinion carries weight.
21 It's not some, you know, one doctor. We talked at the
22 TRO hearing about could you just have one doctor who thought
23 something, and would that be a substantial body? No. But
24 it is a substantial body when you have a number of doctors,
25 especially now that we have seen people at medical schools
Argument on exhibits 1608
1 all over the country teaching intact D & X.
2 We also have, you know, articles that support --
3 THE COURT: Who said that?
4 MS. SMITH: Well, actually, Your Honor, in the
5 testimony that you'll receive from Dr. Chasen, Dr. Westhoff,
6 Dr. Frederiksen, Dr. Hammond, their teaching, and actually
7 Dr. Lockwood tomorrow, they are teaching and doing intact D
8 & Xs at very well-respected institutions.
9 THE COURT: I haven't been presented with that yet.
10 MS. SMITH: No, that's right, Your Honor. That's
11 right.
12 THE COURT: Well, and I take it you also offer it
13 because, whether it's right or not, your view is to the
14 extent the Congressional Record does not make an effort to
15 examine these papers which were in existence at the time of
16 the Congressional findings, that informs me whether I'm
17 persuaded that the articles are correct or not, about the
18 degree of deference that I ought to give Congress.
19 MS. SMITH: That's right, Your Honor.
20 THE COURT: All right. Now, I take it that you
21 think the articles that the defendant are offering ought to
22 be received in the same fashion?
23 MS. SMITH: Yes.
24 THE COURT: Okay.
25 MS. SMITH: They ought to be received in the same
Argument on exhibits 1609
1 fashion, Your Honor.
2 THE COURT: For example, fetal pain articles.
3 MS. SMITH: May I consult for one moment, Your
4 Honor?
5 THE COURT: Sure.
6 MS. SMITH: Yes, Your Honor. As long as they are
7 being offered with the same limitations. They are not
8 offered for the truth. They are offered for evidence of a
9 debate in the medical community or opinions in the medical
10 community.
11 THE COURT: Mr. Henry?
12 MR. HENRY: Thank you, Your Honor. Your Honor,
13 just for clarification, although the defendant's case is
14 still open, I don't believe that we have offered fetal pain
15 articles. I think the only thing on the list that you
16 provided that we have offered is up till now is that
17 American College of Surgeons' statement toward the very end.
18 I think the fetal pain articles were offered by plaintiffs
19 as part of their cross-examination of Dr. Anand.
20 THE COURT: Well, okay. Let me hear you and then
21 I'll ask -- I'll ask if you -- Well, let me hear what your
22 position is, and perhaps that will better inform me. Go
23 ahead.
24 MR. HENRY: Your Honor, based on even the -- Ms.
25 Smith's comments today, I think they are attempting to have
Argument on exhibits 1610
1 these articles admitted for the truth of the matters
2 asserted therein.
3 There is basically no distinction between offering them
4 to show a debate in the medical community and offering them
5 for the truth. If an article or any other statement that's
6 otherwise hearsay is not offered for its truth, then the
7 significance lies in the fact that the statement was made,
8 the credibility of the whoever made the statement.
9 Credibility of the statement itself is just not an issue,
10 but here that's not the case. The materials that we are
11 talking about, they are being offered, indeed, they are
12 really only relevant as proof that the authors, as experts,
13 you know, as doctor, physicians, whatever, believe that
14 something is safe or not or needed or not.
15 I believe Ms. Smith made multiple references to there
16 being a body of medical authority, a substantial body of
17 medical authority, and that all goes to the truth, the
18 weight or however you want to put it, of what is contained
19 in those articles. It's just the same as what went on with
20 respect to the experts the defendant offered and the
21 plaintiffs offered. We put them on the stand, we asked them
22 about their views as to whether some particular issue was
23 safe or needed or not, and these articles are basically
24 being offered for that very same point.
25 The debate issue basically becomes just a shorthand for
Argument on exhibits 1611
1 the truth of what's contained in the articles.
2 THE COURT: I don't think that's what the Justice
3 meant when he wrote it. Do you think that's what Justice
4 Breyer meant to say?
5 MR. HENRY: Well, Your Honor, you mean in the prior
6 Stenberg case?
7 THE COURT: Yes. I think what the Justice was
8 saying, far be it from me to put words in Justice Breyer's
9 mouth or anybody else's, but in essence, I think what he was
10 saying was that at least where you have a debate among
11 experts, you may never ever know what the truth is, and so
12 the question becomes, then, what do you do in a circumstance
13 when it may never be possible to prove the existence of an
14 ultimate fact; in other words, one may never know whether
15 this procedure is safe or not safe if the community that
16 deals with that issue is uncertain as well, so I don't think
17 -- I don't think that they are one and the same things.
18 MR. HENRY: Well, if I may, Your Honor, I think the
19 issues are quite different because in the prior Stenberg
20 case, the materials that were before this Court and before
21 the Supreme Court were basically admitted for -- as I
22 recall, by stipulation on a lot of things, most
23 particularly, the ACOG policy statement, those kind of
24 things.
25 THE COURT: Um-hm.
Argument on exhibits 1612
1 MR. HENRY: And Justice Breyer of the Supreme Court
2 relied upon those in saying, well, this procedure may be
3 appropriate in some circumstance, and then there was a
4 competing statement, I think, from the AMA where they said
5 something a little different, so those, that evidence was
6 being considered for the truth of the matter asserted, and
7 it showed a debate, and I guess what I'm saying is that in
8 this case --
9 THE COURT: But let's assume -- Let me interrupt
10 you for a moment.
11 MR. HENRY: Sure.
12 THE COURT: Let's assume that it is relevant to
13 prove a debate. Let's assume that at least you and I can
14 agree that the Justice said the existence of the debate is
15 relevant.
16 MR. HENRY: Yes.
17 THE COURT: Are you saying that the only way you
18 can prove the existence of that debate is with a witness?
19 MR. HENRY: I'm saying that while the existence of
20 the debate is relevant, any evidence that this Court takes
21 in regarding that issue or any other issue has to be
22 according to the Federal Rules of Evidence, and that means
23 that with respect to expert testimony and those sort of
24 things, it would have to be through an expert witness, and
25 that's what's been done here. Witnesses have been on the
Argument on exhibits 1613
1 stand, they have talked about the literature, you know, they
2 have quoted from it, they have done things in accordance
3 with the learned treatise exception to the hearsay rule.
4 THE COURT: We have got far beyond that today with
5 this young woman who testified. I mean, we were reading
6 huge portions of the thing into evidence.
7 MR. HENRY: That's what the rule contemplates, Your
8 Honor.
9 THE COURT: I have read the rule. I understand the
10 rule, but go ahead.
11 MR. HENRY: Okay. The point is, is that with under
12 plaintiffs' proposal, we are moving far beyond that. They
13 want to admit articles in their entirety beyond what was
14 read into the record through an expert witness talked about
15 through an expert witness, that sort of thing, and our
16 position remains that that is inappropriate, that the
17 hearsay rule says what it says, the articles are hearsay
18 unless there is an exception, and the learned treatise
19 exception is the only one we are dealing with here, and the
20 point that I was trying to make starting out was that we
21 really are dealing with a truth issue. I mean, basically,
22 the plaintiffs want the Court to look at these articles to
23 establish that the authors are halfway credible and believe
24 something, and that's a truth issue.
25 If I could go back to the Court's comment from a few
Argument on exhibits 1614
1 days ago, you were concerned about the parties kind of
2 eliminating any kind of fringe, or I believe you used the
3 term goof ball articles.
4 THE COURT: Um-hm.
5 MR. HENRY: That, I think, makes evident that we
6 are dealing with a truth issue because --
7 THE COURT: I think that's more foundational. It
8 seems to me that, obviously, you can have a debate under --
9 if it is a relevant question to prove the existence of a
10 debate, then we get into the question of what does that
11 debate mean. What are the parameters of that debate, and
12 what I was suggesting is I could conceive of some
13 circumstances where the foundation for an article is not
14 sufficient either from its face or from collateral evidence
15 to conclude that it is a part of some alleged debate, a
16 reasonable part of it. It seems to me, one doesn't -- one
17 is not asked to determine whether or not what the article
18 says is accurate or not, but rather that the speaker is a
19 participant in the debate, and that's where I think you and
20 I disagree about whether we are talking about the truth or
21 something else.
22 MR. HENRY: Your Honor, if I could, let me just
23 bring the Court's attention to a case.
24 THE COURT: Sure.
25 MR. HENRY: And I have a couple of copies if you
Argument on exhibits 1615
1 want.
2 THE COURT: That would be great.
3 MR. HENRY: I have already given that to opposing
4 counsel.
5 THE COURT: If you'll give that to Ms. Beran.
6 She'll make certain I get a copy.
7 MR. HENRY: The case is --
8 THE COURT: I'm going to tease you now for just a
9 minute. I just love the fact you have cited a Ninth Circuit
10 case to me. I'm just so pleased.
11 MR. HENRY: It was late at night. I was running
12 out of time.
13 THE COURT: Certain instructions my law clerks have
14 and they'll take particular -- Pardon me. Go ahead.
15 MR. HENRY: It is a case from the Ninth Circuit,
16 United States vs. An Article of Drug, 661 F.2d 422, Ninth
17 Circuit, 1981. Your Honor, this was a case involving the
18 Food, Drug and Cosmetic Act. It involved an issue as to
19 whether the drug that was actually being seized in this case
20 was generally recognized by experts as safe and effective.
21 It had that recognition, and it was being legally marketed
22 or whatever.
23 If you look on page 745 under the paragraph that's
24 headnote 5, the Court stated, said the district court
25 allowed expert witnesses to read excerpts from treatises
Argument on exhibits 1616
1 into evidence during the course of their testimony but
2 refused to admit the treatises themselves as exhibits, this
3 following the learned treatises to the hearsay rule, F.R.E.
4 803(18). The defendant in that case contends, however, that
5 the mere existence of the published studies and
6 investigations regarding the drugs involved was probative,
7 and therefore the treatises were not hearsay. That, I
8 submit, is similar to the situation we are in here. The
9 defendants in this case thought that the existence of these
10 articles, these treatises was probative on the issue of
11 whether experts generally thought something was safe and
12 effective. I think that's analogous to a debate situation.
13 Then the Court went on to say --
14 THE COURT: No, no, no. It's analogous to safe --
15 MR. HENRY: Safe and --
16 THE COURT: What's the magic language?
17 MR. HENRY: Safe and effective.
18 THE COURT: Yeah. I mean, if it was relevant that
19 the FDA wanted to know if there was a debate, that's a
20 different question. Here these folks were offering these as
21 back door experts.
22 MR. HENRY: Well, they were, and the Court goes on
23 to say, the treatises were relevant only as proof that the
24 authors as experts believed the drugs were safe and
25 effective or for the fact of things being safe or effective,
Argument on exhibits 1617
1 but the Court said --
2 THE COURT: For the purpose that it was offered.
3 Here, the question before the Court was whether it was safe
4 and effective. That is one of the questions before me, and
5 I think Breyer said one of the other questions is, if you
6 don't know but there is a debate in the community,
7 Government loses, so counsel says as to the second point,
8 not whether it's safe because it can't prove that with an
9 expert who is not here and subject to cross-examination. I
10 can prove it by showing the debate, and one of the ways you
11 show a debate is in the medical journals.
12 MR. HENRY: Your Honor, if I could respectfully
13 disagree. In this case, the United States versus An Article
14 of Drug case, if you look in the first column of page 745,
15 the end of the first full paragraph, the Court says, the
16 sole issue for trial, therefore, was whether the drugs were
17 generally recognized by experts as safe and effective. The
18 issue was not whether it was safe and effective. The issue
19 is whether experts generally recognized it as safe and
20 effective.
21 THE COURT: Where does it say that? Pardon me.
22 MR. HENRY: On the first column on page 745, and
23 the first full paragraph, at the very end of that paragraph.
24 THE COURT: Okay.
25 MR. HENRY: And so I submit to you that that is
Argument on exhibits 1618
1 analogous to the situation we have here. The plaintiffs
2 purport not to offer the materials for the truth of the
3 matter asserted or for the truth of whether any particular
4 procedure is, you know, safe or whatever, but for the
5 existence of a debate. Here we had this same issue. It was
6 whether experts in the field generally recognize something
7 as safe and effective, and I think that would be implied in
8 that is whether there was a substantial body of experts who
9 thought drugs were safe and effective.
10 And the Ninth Circuit, again going back to the last
11 paragraph on page 745 where it's talking about the
12 defendant's desire to have these studies in, it says the
13 treatises were relevant only as proof that their authors as
14 experts believed the drugs were safe and effective or for
15 the actual fact there, and then it concludes that paragraph
16 by saying either way, they were hearsay, and we have that
17 same situation here. We have had experts on the stand
18 talking about the medical literature, so with respect to a
19 debate or the lack thereof, the Court has been presented
20 with evidence, and it will be presented with more as the
21 parties submit the trial testimony and that sort of thing.
22 THE COURT: Pardon me for interrupting you.
23 MR. HENRY: Yes.
24 THE COURT: Has this issue arose in San Francisco
25 or New York?
Argument on exhibits 1619
1 MR. HENRY: The issue of admissibility of articles,
2 it has arisen. There were briefs filed yesterday on it. To
3 my knowledge, Judge Hamilton has not ruled.
4 THE COURT: And Judge Casey has not made a --
5 MR. HENRY: May I consult?
6 THE COURT: Sure.
7 MR. HENRY: Your Honor, our understanding is Judge
8 Casey in New York has rejected the admission of medical
9 articles, but don't hold me to that. I'm not exactly sure.
10 THE COURT: Do the plaintiffs know?
11 MS. SMITH: I don't know, Your Honor.
12 MR. HENRY: So again, we believe we are dealing
13 with a truth issue here, and that the articles are hearsay,
14 and basically what we are doing or what the plaintiffs are
15 proposing is to create an exception that goes way beyond the
16 learned treatise exception that's stated in the rule, and we
17 don't believe that's appropriate.
18 If I could just talk briefly about the case that Ms.
19 Smith brought to the Court's attention.
20 THE COURT: The IUD case?
21 MS. SMITH: Could I give you a copy, Your Honor?
22 THE COURT: You haven't, but I would like to see
23 one, sure.
24 MS. SMITH: I have one.
25 THE COURT: Who is the judge in the IUD case? I'll
Argument on exhibits 1620
1 find it. That's fine.
2 MR. HENRY: Did you ask the judge?
3 THE COURT: Yeah.
4 MR. HENRY: It was Judge Shaw from the Eastern
5 District of Missouri.
6 THE COURT: Thank you. Go ahead.
7 MR. HENRY: Yes, sir. That case is distinguishable
8 to my understanding the other cases that the plaintiff has
9 mentioned are distinguishable in that those situations
10 involved products liability cases where the issue, either in
11 this Eastern District of Missouri case, the issue was
12 statute of limitations and whether the plaintiff had notice
13 of IUD problems.
14 THE COURT: I think they are different too. I
15 think the products cases are different. I tried enough of
16 those to understand that's a slightly different issue,
17 although frankly, the whole question of a state-of-the-art
18 defense in a products liability case or a notice defense in
19 a products liability case, we go through this same thing
20 about whether this stuff is really going to a poor jury who
21 is trying to be, you know, you instruct them about
22 state-of-the-art or notice, and it's not offered to prove X
23 or Y but whether somebody was placed on notice. I mean, you
24 run into this same analytic question about what are you
25 really trying to prove, but go ahead.
Argument on exhibits 1621
1 MR. HENRY: I think, as Your Honor said the other
2 day, I'm not sure anyone understands the hearsay rule.
3 THE COURT: There is a law professor at Creighton
4 whose brother is a federal judge down in Western Missouri
5 who gives the funniest lecture that there just really is no
6 hearsay rule because no one understands it, and if you don't
7 understand a rule, it can't exist, and it's his conclusion
8 after 25 years of studying it that no one understands it,
9 but go ahead.
10 MR. HENRY: Well, I'm doing my best here today,
11 Judge.
12 THE COURT: You're doing fine. Go ahead.
13 MR. HENRY: I think we have pretty much made our
14 points.
15 THE COURT: You wanted to distinguish this IUD case
16 though.
17 MR. HENRY: Yes, sir, and as I mentioned, in this
18 particular case we were dealing with a statute of
19 limitations, a time barred situation where the issue was did
20 the plaintiff have notice that there may have been problems
21 caused by these IUFDs (sic), and so the state of the medical
22 literature was relevant whether it was true or not as to the
23 notice the plaintiff should have had under, you know, the
24 applicable products liability cases or case law.
25 And with respect to other products liability cases
Argument on exhibits 1622
1 including some of the ones the plaintiff cited, it does deal
2 with this state-of-the-art defense, and so the issue is not
3 really is it true or not so much as the manufacturer's on
4 notice one way or the other and has to react in some fashion
5 or another.
6 THE COURT: Tell me how something can be the state-
7 of-the-art and not be true.
8 MR. HENRY: Well, Your Honor, I think it's a
9 situation of is it right, is it wrong? We don't know but
10 the manufacturer had notice that at least some people
11 thought it was right and needed to react in some fashion to
12 that as far as the design of the product.
13 THE COURT: Well, I understand what the theory is.
14 But just think about it. If it is the state-of-the-art that
15 you design something this way, and there is nothing to
16 contradict it's the state-of-the-art, is it not true?
17 MR. HENRY: Well, perhaps not because the state-of-
18 the-art changes, so you know.
19 THE COURT: Does truth change?
20 MR. HENRY: Truth, as men understand it, does, I
21 suppose, when you're dealing with factual situations.
22 THE COURT: Yeah.
23 MR. HENRY: And that's one of the reasons, you
24 know, the parties bring in experts. We put on the evidence,
25 we try to get them to walk the Court through the literature
Argument on exhibits 1623
1 to understand what the literature says what its strengths
2 are, what its weaknesses are, and the evidence in this case
3 should be limited to that and not to just kind of doing away
4 with the constraints of the learned treatise rule and just
5 bringing in all these medical articles without the benefit
6 of experts on the stand guiding the Court as to, you know,
7 whether those articles do reflect the truth of what's
8 asserted therein or reflect the legitimate debate or
9 whatever, so Your Honor, we are constrained to stand on our
10 objection with respect to the exhibits.
11 THE COURT: Let me ask you sort of a silly
12 hypothetical, but let's assume Congress banned this
13 partial-birth abortion technique, and it relied on the
14 statement of one physician that it called to testify, and
15 then we know that there are ten physicians who were not
16 called who say the exact opposite thing. Congress didn't
17 call them, and I want to know whether Congress was serious
18 about its effort to determine whether physician one was
19 correct or not. Are you telling me that if I want to know
20 the existence of that fact that I have got to call all 11
21 physicians and talk to them in a courtroom?
22 MR. HENRY: I don't believe the plaintiffs would
23 have to do that, Your Honor. I mean, they could have their
24 own expert, one expert, I assume, if that expert had a
25 sufficient knowledge base to say that there are, you know,
Argument on exhibits 1624
1 11 or 100 or two, how many ever doctors that believe this,
2 and they published articles on it, and these are things that
3 Congress did not consider. I think it's gone on to some
4 degree in this trial, but going beyond that and just saying
5 that the plaintiffs can come in and put in, you know, all
6 these articles without, in their entirety without
7 appropriate testimony from an expert witness, I think is
8 kind of beyond the appropriate confines of what the Court
9 can do within the rules of evidence.
10 Now, the issue of deference to Congress is, you know,
11 that's kind of a different issue in that, you know, the
12 Court can look at what Congress did and give Congress
13 whatever level of deference is appropriate under the case
14 law, but as far as taking in the evidence to determine, you
15 know, for example, if the evidence you take in, you can use
16 in that determination of whether you think Congress's
17 findings are based on substantial evidence or any other kind
18 of evidence, I think in taking in that evidence, the Court
19 has to do it through the courtroom as constrained, rather,
20 by the rules of evidence.
21 THE COURT: Oh, sure.
22 MR. HENRY: That's all we are asking for here.
23 THE COURT: You'll agree with me that the rules of
24 evidence are inclusive, not exclusive. That's the general
25 proper way to look at the rules of evidence; right?
Argument on exhibits 1625
1 MR. HENRY: I'm afraid to say yes, but I think
2 generally that is correct.
3 THE COURT: And the reason why that is is because
4 the rules of evidence really try to help us do two things to
5 get at the truth but do it in a way that's fair to both
6 sides, and there is, sometimes, in order to make things fair
7 to both sides that you've got to -- you've got to limit the
8 truth-seeking effort because, I mean, you just can't beat
9 the confession out of somebody, even though it might be
10 truthful. That's the sense, and so I appreciate what you're
11 saying, and the question here is for me to puzzle through
12 the question of whether this is really back door hearsay or
13 whether it truly is something different.
14 MR. HENRY: Well, Your Honor, the only thing I
15 would say in response is that, yes, sometimes the truth-
16 finding function has to be adjusted to account for things,
17 and that's what the exceptions to the hearsay rule, for
18 example, do.
19 THE COURT: Right.
20 MR. HENRY: All we are asking for is that with
21 respect to the potentially applicable exceptions, which
22 would be the learned treatise rule, that that be adhered to
23 because that's what Congress and the Supreme Court
24 determined the rule to be, and that's all we are seeking
25 here.
Argument on exhibits 1626
1 THE COURT: And categorically, if it's not hearsay,
2 then we don't have to worry about whether the exception
3 applies.
4 MR. HENRY: That's true.
5 THE COURT: The other thing is, the other question
6 I have for you is what about -- Well, I think you've
7 answered it. Thank you.
8 MR. HENRY: Thank you.
9 THE COURT: Well, I'm prepared to rule to admit
10 these things in a general way for two reasons: Not to prove
11 that these articles are true or not true, but one, to prove
12 or disprove the existence of a substantial body of medical
13 opinion or to prove or disprove questions related to the
14 Congressional effort to ascertain the true facts. Now, that
15 doesn't mean that each of these articles is admissible, but
16 I think it means that most of them are.
17 Now, let me ask the plaintiffs, are you offering all of
18 the exhibits on the exhibits-offered-but-not-received list
19 that I gave you, including Exhibit 44, given the limitations
20 that I've just stated?
21 MS. SMITH: Yes, Your Honor.
22 THE COURT: Now, that includes the fetal pain stuff
23 and everything else?
24 MS. SMITH: Yes. Yes.
25 THE COURT: All right. Do the parties want any
Argument on exhibits 1627
1 further ruling? In a minute I'll identify what's coming
2 into the record. Do the parties want any further ruling?
3 MR. HENRY: No, Your Honor. I think that's
4 sufficient.
5 THE COURT: I receive into evidence Exhibits 3, 4,
6 5 which is also defendant's 652, 6, 651 -- 6 and 651 which
7 are the same thing, 7 and 653 which are the same thing, 8
8 and 672 which are the same thing, 9 and 673 which are the
9 same thing, 10 and 669 which are the same thing, 44, 11 and
10 670 which are the same thing, 13, 14, 15, 16, 17, 178, 19
11 and 545 which are the same thing, 25, 26, 27, 28, 30, 38, 39
12 and 650 which are the same thing, 41 and 561, 40, 42, 45, 46
13 and 577 which are the same thing, 55 and 596 which are the
14 same thing, 64 and 608 which are the same thing, 114, 538,
15 544, 563, 566, 609, 625, 633, 648, and once again, I receive
16 those not for -- to prove that what is said in those
17 articles are true but for the limited purposes I have
18 previously explained.
19 Now, to make it clear to the defendant, I will receive
20 into evidence similar exhibits offered subject to the
21 limitation that I have admitted these articles on and other
22 things without, from my perspective, thinking that you've
23 waived your objection. Now, I don't know what some other
24 court will make of that, but from my perspective I won't
25 feel whipsawed if you get before the Court of Appeals and
Argument on exhibits 1628
1 say that idiot shouldn't have received these and we put this
2 other junk in simply because he forced us into that
3 circumstance, but I'll leave that to your tactical judgment
4 about what you want to do.
5 All right. Is there anything further that we should
6 take up at this time?
7 MS. SMITH: Your Honor, with respect to rebuttal.
8 THE COURT: Um-hm.
9 MS. SMITH: At this point there is one issue which
10 has arisen recently with two of the defendant's attorneys
11 that we may want to put some live rebuttal testimony on
12 about, and I wanted to raise --
13 THE COURT: About two of the defendant's attorneys?
14 MS. SMITH: I'm sorry. Two of the defendant's
15 witnesses.
16 THE COURT: Okay.
17 MS. SMITH: And I wanted to raise with the Court if
18 the Court would at all be open to a telephonic, a very short
19 telephonic rebuttal rather than live-witness-sitting-in-the-
20 chair rebuttal.
21 THE COURT: If you all, you know, and you run into
22 problems with that, but if you all can work it out, I'm not
23 opposed. We do have video conference capacity, not in this
24 courtroom, although we do have video conferencing capacity
25 in the courtrooms in Omaha, I think. Is that right,
Argument on exhibits 1629
1 Colleen? I think in at least two of the courtrooms in Omaha
2 we do, and we do have video conferencing capacity here in
3 another room although it's not in the courtroom. We can
4 pipe telephone into this courtroom. I mean, if the other
5 side has the appropriate switching equipment, they can be
6 speaking and we can be speaking. I just don't know how that
7 can be set up, but I'm not opposed to doing that by phone,
8 but there are legitimate logistic problems such as, I think
9 Mr. Coppolino said once he had a concern about exhibits.
10 MS. SMITH: Exhibits, yeah. Well, I will discuss
11 it with counsel and I didn't mean to, you know, surprise
12 them, but I just wanted to raise it because it just came up.
13 THE COURT: Who is the witness?
14 MS. SMITH: It might be Dr. Vibhakar, but it would
15 be very limited.
16 THE COURT: Call her in rebuttal?
17 MS. SMITH: It would be a very, very limited point,
18 15 minutes at most, but I don't know how things are going to
19 go tomorrow. I don't know if I'm going to feel that I need
20 it, but I wanted to raise it today at least to give you a --
21 find out if you are open to it before, and then we'll
22 discuss it with counsel and see if they have an objection.
23 THE COURT: Yeah. I mean, you run into some
24 mechanical questions about how you swear the witness.
25 MS. SMITH: Right.
1630
1 THE COURT: Although that's never been in a case
2 like this something that I'm terribly concerned about. We
3 could have somebody --
4 MS. SMITH: We could get a court reporter in Iowa
5 or something.
6 THE COURT: Perhaps. We could do it that way, and
7 then the question is how do you know it's a court reporter
8 in Iowa? All right. You visit with Mr. Ashcroft's lawyers
9 and see if you can't work something else. Anything else?
10 MS. SMITH: That's it.
11 THE COURT: Anything else, counsel?
12 MR. HENRY: No, Your Honor.
13 THE COURT: Thank you. We stand in recess.
14 (Recess at 2:46 p.m.)
15 C E R T I F I C A T E
16 I, David C. Francis, certify that the foregoing is an
17 accurate transcription of the record of proceedings made in
18 the above-entitled matter.
19 /S/ David C. Francis Date: April 8, 2004
20 Official Court Reporter
21 INDEX
22 DEFENDANT'S WITNESSES:
23 Dr. Elizabeth Shadigian
Direct by Mr. Coppolino.....1486
Cross by Ms. Crepps.........1561
24 Redirect by Mr. Coppolino...1589
Examination by Court........1598
25 Redirect by Mr. Coppolino...1602
1631
1 Argument on exhibits previously offered.................1604
2
3 EXHIBITS: Offered Received
4 Court 1. Sketch 1485 1485
5 Court 2. Gestational age table 1485 1485
6 Court 3. Feinstein letter 1485 1486
7 3. ACOG Statement Previously 1627
8 4. ACOG on subject of PBA Previously 1627
9 5/652. ACOG Abortion Policy Previously 1627
10 7/653. ACOG Fact Sheet Previously 1627
11 8/672. ACOG Task Force Mtg. Agenda Previously 1627
12 9/673 ACOG Technical Bulletin 109 Previously 1627
13 10/669. ACOG Task Force Report 12/2/96 Previously 1627
14 11/670. ACOG Frigoletto Memo to ACOG Previously 1627
15 13. AMA Seward Memo 5/19/97 Previously 1627
16 14. AMWA letter to Nadler Previously 1627
17 15. AMWA letter to Chabot Previously 1627
18 16. AMWA's response to documents Previously 1627
19 17. APHA letter to House of Reps. Previously 1627
20 18. APHA Attachment A Previously 1627
21 19/545. Autry, et al., article Previously 1627
22 25. Chasen article, draft one Previously 1627
23 26. Chasen article, draft two Previously 1627
24 27. Chasen article Previously 1627
25 28. Chasen: Chart rep'g. data Previously 1627
1632
1 30. Cornell U. Letter to Chasen Previously 1627
2 38. Defendant's document subpoena Previously 1627
3 39/650. Henry letter to Edelman Previously 1627
4 40. DOJ Memo Previously 1627
5 41/561. Epner: Late-term abortion Previously 1627
6 42. FBI Memo re: Civil Rights Program Previously 1627
7 45. Grimes article Previously 1627
8 46/577. Grimes Morbidity & Mortality Previously 1627
9 55/596. Kalish article Previously 1627
10 64/608. McMahon article Previously 1627
11 114. Article on Routine Morphine Infusion Previously 1627
12 529. Dr. Shadigian's CV 1487 1487
13 538. Arnand: Fetuses, fentanyl, etc. Previously 1627
14 544. Audu: Diagnostic Features... Previously 1627
15 563. Fisk: Effect of direct fetal... Previously 1627
16 566. Giannakoulopoulos article Previously 1627
17 609. Modi article Previously 1627
18 625. Smith: Pain and Stress Previously 1627
19 633. Vanhatalo: Fetal pain Previously 1627
20 648. ACOG: Statement on Issues... Previously 1627
21
22
23
24
25