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Bernard v. Individual Members of Indiana Medical Licensing Board

United States District Court, S.D. Indiana, Indianapolis Division

June 28, 2019

CAITLIN BERNARD M.D., Plaintiff,
v.
INDIVIDUAL MEMBERS OF THE INDIANA MEDICAL LICENSING BOARD in their official capacities, et al. Defendants.

          ORDER ON PLAINTIFF'S MOTION FOR A PRELIMINARY INJUNCTION (DKT. 6)

          SARAH EVANS BARKER, JUDGE

         In recent years, several states have adopted statutes prohibiting an abortion procedure known to medicine as “dilation and evacuation” (“D&E”) and referred to by its political opponents as “dismemberment abortion.” Among these statutes is Indiana's House Enrolled Act 1211 (“HEA 1211”), enacted on April 24, 2019. We begin by noting that every federal court to consider these prohibitions have preliminarily or permanently enjoined them as violations of the Due Process Clause of the Fourteenth Amendment. Today, we join them, for the reasons given below.

         Background

         Our analysis commences with (I) a review of HEA 1211, followed by (II) an examination of the provision of D&E in Indiana and (III) a general overview of second trimester abortion methods, including (A) D&E, (B) induction of labor, and (C) hysterotomy. Thereafter, we review (IV) methods for inducing fetal demise before a D&E, including (A) injections of digoxin, (B) injections of potassium chloride, and (C) umbilical cord transections. We conclude by recapitulating (V) the posture of the instant motion.

         I. HEA 1211

         HEA 1211 creates a new statutory term “dismemberment abortion” and defines it as follows:

(a) “Dismemberment abortion” means an abortion with the purpose of killing a living fetus in which the living fetus is extracted one (1) piece at a time from the uterus through clamps, grasping forceps, tongs, scissors, or another similar instrument that, through the convergence of two (2) rigid levers, slices, crushes, or grasps a portion of the fetus's body to cut or rip it off.
(b) “Dismemberment abortion” does not include an abortion that uses suction to dismember a fetus by sucking fetal parts into a collection container.

Act of April 24, 2019, Pub. L. 93-2019, § 1, 2019 Ind. Acts-, 2019 Ind. Legis. Serv. P.L. 93-2019 (West) (to be codified at Ind. Code § 16-18-2-96.4) [hereinafter HEA 1211]. This term is original to this statute and its out-of-state companions.

         Effective July 1, 2019, “knowingly or intentionally” performing a “dismemberment abortion” will be a Level 5 felony, see Ind. Code § 16-34-2-7(a), punishable by up to six years' imprisonment and a $10, 000 fine, id. § 35-50-2-6(b), unless the “reasonable medical judgment” of the physician performing the abortion “dictates that performing the dismemberment abortion is necessary[] to prevent any serious health risk to the mother” or “to save the mother's life.” HEA 1211, § 3 (internal subdivisions omitted) (to be codified at Ind. Code § 16-34-2-1(c)).

         II. D&E in Indiana

         All agree that HEA 1211 by its terms prohibits D&E, which is “the usual abortion method” in the second trimester of pregnancy in the United States, Gonzales v. Carhart, 550 U.S. 124, 135 (2007), and “the predominant method of second trimester abortion in many parts of the world.” Dkt. 29 Ex. 1, at 3. D&E is performed from early in the second trimester, beginning approximately 15 weeks after the patient's last menstrual period (LMP). Dkt. 9 Ex. 1, ¶ 22 [hereinafter Pl. Decl.]. Through 10 weeks LMP, abortions may be performed medically through administration of the chemical abortifacients mifepristone and misoprostol. Id. ¶ 12. Aspiration and curettage procedures are also commonly employed through the first trimester, but cease to be effective by the beginning of the second trimester. Id. ¶¶ 12, 16. Thus, a woman seeking a second-trimester abortion receives a D&E or one of its two alternatives, which are discussed in more detail below.

         Plaintiff Dr. Caitlin Bernard, M.D., has brought this lawsuit on behalf of her patients to challenge the restrictions imposed under HEA 1211. She is a board-certified ob/gyn in Indianapolis employed by the Indiana University Health physician network. Id. ¶¶ 1, 5. She practices at two Indianapolis hospitals, Methodist and Eskenazi. Dkt. 34, 8:3-4 [hereinafter Pl. Dep.]. Dr. Bernard also teaches at the Indiana University School of Medicine. Pl. Decl. ¶ 5. As part of her general ob/gyn practice at these hospitals, Dr. Bernard

provide[s] abortion services only for certain specified indications. The overwhelming majority of second-trimester [abortions] occurring in Indiana are because of fatal or serious fetal anomalies. The identification of many major genetic or anatomic anomalies in the fetus, including anomalies that may cause the death of the fetus at, or shortly after, birth, generally occur in the second trimester. These might include such things as an intracranial mass in the fetal brain, neural tube defects such as spina bifida and anencephaly, or other disorders related to autonomic function. The remainder are because of health risks to the mother or because the pregnancy is the product of rape.

Id. ¶ 15. At Methodist and Eskenazi, Dr. Bernard performs only second-trimester abortions before fetal viability and before 21 weeks 6 days LMP. Id. ¶ 8. These abortions are all performed by D&E unless the patient requests another procedure. Id. ¶¶ 17, 39.

         In addition to Dr. Bernard, only one other physician in Indiana performs D&E procedures: Dr. Hua Meng, Pl. Dep. 35:10-11, an ob/gyn also employed by the Indiana University Health physician network who practices at the same Indianapolis hospitals as Dr. Bernard. Dkt. 36, 7:21-22, 10:11-13 [hereinafter Meng Dep.]. Dr. Bernard is also aware that Dr. Katherine McHugh (formerly a plaintiff in this case, see Dkt. 21) has performed D&E in the past “and wishes to be able to do so in the future.” Pl. Decl. ¶ 40. Neither Dr. Bernard nor Defendants are aware of any other Indiana physicians who perform or have performed D&E.

         The Supreme Court in Gonzales described the D&E procedure as follows:

Although individual techniques for performing D & E differ, the general steps are the same.
A doctor must first dilate the cervix at least to the extent needed to insert surgical instruments into the uterus and to maneuver them to evacuate the fetus. The steps taken to cause dilation differ by physician and gestational age of the fetus. A doctor often begins the dilation process by inserting osmotic dilators, such as laminaria (sticks of seaweed), into the cervix. . . . [T]he length of time doctors employ osmotic dilators varies. Some may keep dilators in the cervix for two days, while others use dilators for a day or less.
After sufficient dilation the surgical operation can commence. The woman is placed under general anesthesia or conscious sedation. The doctor, often guided by ultrasound, inserts grasping forceps through the woman's cervix and into the uterus to grab the fetus. The doctor grips a fetal part with the forceps and pulls it back through the cervix and vagina, continuing to pull even after meeting resistance from the cervix. The friction causes the fetus to tear apart. For example, a leg might be ripped off the fetus as it is pulled through the cervix and out of the woman. The process of evacuating the fetus piece by piece continues until it has been completely removed. . . . Once the fetus has been evacuated, the placenta and any remaining fetal material are suctioned or scraped out of the uterus. The doctor examines the different parts to ensure the entire fetal body has been removed.
Some doctors, especially later in the second trimester, may kill the fetus a day or two before performing the surgical evacuation. They inject digoxin or potassium chloride into the fetus, the umbilical cord, or the amniotic fluid. Fetal demise may cause contractions and make greater dilation possible. Once dead, moreover, the fetus' body will soften, and its removal will be easier. Other doctors refrain from injecting chemical agents, believing it adds risk with little or no medical benefit.

Gonzales, 550 U.S. at 135-36 (citations omitted). Dr. Bernard and Defendants here describe the procedure in materially identical terms. Pl. Decl. ¶¶ 17-20; Dkt. 30, ¶¶ 10- 13 [hereinafter Francis Decl.].

         When Dr. Bernard performs D&E, she uses laminaria. Pl. Decl. ¶ 17. If the pregnancy is more than 17 weeks LMP, the procedure takes two days: Dr. Bernard inserts the laminaria on the first day; the patient leaves the hospital and returns on the next day for the procedure. Id. ¶ 18. If the pregnancy is less than 17 weeks LMP, dilation and evacuation happen on the same day. Id. Once the cervix is sufficiently dilated, evacuation “generally takes no more than 10-15 minutes.” Id. ¶ 20. Dr. Bernard uses ultrasound imaging to confirm the uterus has been completely evacuated. Pl. Dep. 19:1-4.

         III. Second-Trimester Abortion Methods

         “Approximately 1 in 4 women [in the United States] obtain an abortion by the age of 45.” Dkt. 12 Ex. 1, ¶ 9 [hereinafter Davis Decl.]. Most are poor. Id. The risk of death from an abortion (less than 1 in 100, 000) is fourteen times lower than the risk of death from childbirth (8.8 in 100, 000) and “significantly lower” than the risk of death from common outpatient procedures such as colonoscopy (2.9 in 100, 000). Id. ¶ 10. These risks increase with time, however, from 0.1 in 100, 000 at 8 weeks LMP and earlier to 8.9 in 100, 000 at 21 weeks LMP and later. Dkt. 40 Ex. 11, at 25 [hereinafter ACOG Practice Bulletin No. 135].

         Approximately 90 percent of abortions are performed in the first trimester of pregnancy. See Id. at 22. Women obtain second-trimester abortions because they did not know they were pregnant in the first trimester; because they could not access an abortion provider or obtain funding for an abortion in the first trimester; and because, as Dr. Bernard explains supra, major anatomic or genetic abnormalities are most commonly detected in the second trimester. Id. “Poverty, lower education level, and having multiple disruptive life events[] have been associated with higher rates of seeking second-trimester abortion.” Id. See also Dkt. 30 Ex. 2, at 8 (“[T]he known risk factors associated with presenting for second trimester abortion include: adolescence, drug and alcohol addiction, poverty, difficulty obtaining funding for the abortion, and African-American race.”). Unprompted changes of heart are apparently not among the common motivators for seeking a second-trimester abortion. In any event, the factors that lead women to seek second trimester abortions “are all part of the complexity of women's lives, complexity that the pregnant woman herself best understands.” Dkt. 30 Ex. 2, at 8.

         A. D&E

         “Induced abortion is the second most common surgery for reproductive-aged women in the United States, after cesarean delivery.” Soc'y Family Planning, Clinical Guidelines: Induction of Fetal Demise Before Abortion, 81 Contraception 462, 462 (2010) [hereinafter Induction of Fetal Demise Before Abortion]. The “vast majority” of second-trimester abortions, as high as 95 percent, are performed by D&E. ACOG Practice Bulletin No. 135 at 22. See also Dkt. 29 Ex. 1, at 4 (“99% of abortions between 13-15 weeks, 95% between 16-20 weeks, and 85% at 21 weeks or later.”); Dkt. 40 Ex. 9, at 77 (“the majority of procedures performed between 14 and 20 weeks' gestation”). And the “vast majority” of D&Es are performed before 18 weeks LMP. Davis Decl. ¶ 21. Also Id. ¶ 29. D&E is generally recognized as the “fastest, safest, and most common method” of second-trimester abortion. Pl. Decl. ¶ 22. Also Davis Decl. ¶¶ 7, 15; Dkt. 40 Ex. 1, ¶ 9; Dkt. 40 Ex. 3, ¶ 26 [hereinafter Davis Reply Decl.]; Dkt. 40 Ex. 9, at 20, 78; ACOG Practice Bulletin No. 135 at 26.

         The complication rate ranges from 0.05 percent to 4 percent; the major-complication rate is approximately 1 percent. Dkt. 40 Ex. 9, at 78-79. Potential complications of D&E include hemorrhage requiring transfusion (0.1 to 0.6 percent of cases); retained products of conception in the uterus (less than 1 percent of cases); and uterine perforation (occurring when an instrument punctures the uterus, often a “sub- clinical” condition that may “resolve by [itself] and without any long-term damage[, ]” Dkt. 40 Ex. 10, ¶ 5. Accord Dkt. 42 Ex. 118:15-19:22 [hereinafter Second Francis Dep.]) (0.2 to 0.5 percent of cases); ACOG Practice Bulletin No. 135 at 25-26. Infection and cervical laceration may occur in any second-trimester abortion. ACOG Practice Bulletin No. 135 at 25-26.

         B. Induction

         The only nonsurgical alternative to D&E in the second trimester is abortion by inducing delivery of a previable fetus, or “induction abortion.” “Labor induction abortion affects expulsion of the fetus from the uterus without instrumentation.” Dkt. 31 Ex. 1, at 2 [hereinafter Society of Family Planning Guidelines]. This procedure, like its first-trimester analogue, is also sometimes called a “medical abortion, ” but we will use “induction” only to distinguish the procedures. Accord Id. “Under this method a physician uses medications to induce labor and delivery.” Pl. Decl. ¶ 23. Common agents include mifepristone, misoprostol, oxytocin, and ethacridine lactate. Society of Family Planning Guidelines at 3. Induction is generally “safe” but takes longer, costs more, and “is associated with a greater risk of complications” than is D&E. ACOG Practice Bulletin No. 135 at 23.

         As for timing and duration, relative to induction “[t]he timing of D&E is predictable, and although it may require preoperative outpatient visits for cervical preparation, the procedure usually is faster . . . .” ACOG Practice Bulletin No. 135 at 26. Induction abortion “may take 2-3 days to occur, during which time the woman has to be hospitalized as an inpatient. Moreover, the woman has to go through labor, which may involve hours of pain requiring significant medication or anesthesia.” Pl. Decl. ¶ 23. Accord Davis Decl. ¶ 17. However, induction may take significantly less than two or three days, particularly if mifepristone and misoprostol are used in conjunction, which “reduce[s] the median induction-to-abortion interval to as low as six hours[.]” Dkt. 32 Ex. 1, at 9 [hereinafter Complications After Second Trimester Abortion].

         As for cost, D&E “may be more cost-effective than [induction] abortion.” ACOG Practice Bulletin No. 135 at 26. “An induction abortion may cost more than $20, 000 in Indiana, and a D&E may cost less than half of that.” Pl. Decl. ¶ 24. Private insurance coverage of abortion costs is variable and state and federal public insurance coverage is unavailable. Id.

         As for complications, “[a] comparison of D&E and induction mortality rates from 1972 to 1987 showed that D&E had lower death rates under 20 weeks of gestation, while induction had lower rates after 20 weeks.” Society of Family Planning Guidelines at 4. “Retained [products of conception] or incomplete abortion has been reported in less than 1% of cases of D&E, but occurs in at least 8% of cases of medical abortion that involve use of the mifepristone regimen[, ]” and “[i]n several cohort studies, incomplete abortion was significantly more common after medical abortion with misoprostol” as well. ACOG Practice Bulletin No. 135 at 25. See also Complications After Second Trimester Abortion at 7-8. The rate of retention may be as a high as 10 to 33 percent. Davis Decl. ¶ 18. In Dr. Bernard's experience, “following an induction a significant percentage of women have a retained placenta and must undergo an additional surgical procedure to have it removed.” Pl. Decl. ¶ 25. The “additional procedure” is aspiration, sharp curettage, or D&E, in cases of completely failed induction (“when the fetus is not expelled within a specific timeframe, ” Society of Family Planning Guidelines at 2). Davis Decl. ¶ 18. Dr. Meng estimates that 40 percent of his patients require additional intervention following induction of labor. Meng Dep. 24:2.

         Other complications include hemorrhage requiring transfusion at a rate roughly comparable to D&E (0.7 of cases versus 0.1 to 0.6 percent of cases, respectively), but cf. Complications After Second Trimester Abortion at 8 (“The higher proportion of women requiring blood transfusion after medical induction compared to D&E is concerning and deserves further study.”), and uterine rupture at an unknown rate. ACOG Practice Bulletin No. 135 at 25. (“[T]here is much debate about whether women who have had a prior caesarean delivery are at higher risk for this complication. Complications After Second Trimester Abortion at 9.) In Dr. Bernard's experience, uterine rupture is “rare” but “can be life threatening” when it occurs. Pl. Decl. ¶ 25. Accord Davis Decl. ¶ 18. Again, infection and cervical laceration may occur in any second-trimester abortion. ACOG Practice Bulletin No. 135 at 25-26. Overall, D&E is “associated with fewer complications (up to 4%) than [induction] abortion involving misoprostol[-only] regimens (up to 29%)[.]” Id. at 26. Induction using both misoprostol and mifepristone may narrow this gap, id., though does not eliminate it. Complications After Second Trimester Abortion at 7. (As a general matter, “[t]he only large trials comparing [induction] and [D&E] were carried out . . . prior to the availability of mifepristone” in the United States, necessitating further research comparing D&E with modern induction methods. Dkt. 32, at 9.)

         Given a choice, most women prefer D&E to induction. ACOG Practice Bulletin No. 135 at 26-27; Complications After Second Trimester Abortion at 9; Davis Decl. ¶ 18; Davis Reply Decl. ¶ 25; Pl. Decl. ¶ 26; Dkt. 29 Ex. 1, at 4. A need for fetal autopsy, ACOG Practice Bulletin No. 135 at 26, or a desire to “bond[] with the fetus after delivery, ” Dkt. 29 Ex. 1, at 5, may render induction the preferred method, however. Also Meng Dep. 12:12 (“If the patient wants the fetus intact.”).

         One study designed to compare outcomes of midtrimester D&E versus induction “failed to recruit its target sample size because most potential study participants strongly preferred D&E and declined to be randomized.” ACOG Practice Bulletin No. 135 at 26. Another study found that women who had undergone D&E “reported less pain and were more likely to say they would opt for the same procedure again compared with those who underwent induction with mifepristone and misoprostol[.]” Id. Accord Dkt. 29 Ex. 1, at 4; Complications After Second Trimester Abortion at 4 (“significantly more pain” reported for induction versus D&E). Further, “many patients” view D&E as “less emotionally challenging than induction.” ACOG Practice Bulletin No. 135 at 26-27. Induction abortions “are often performed in a labor and delivery area, which can be psychologically challenging for some women, especially those who are obtaining an abortion after learning of a devastating fetal diagnosis.” Davis Decl. ¶ 17. “Several authors agree that D&E is emotionally easier for a patient [than induction] because she does not have to deliver a fetus that may show signs of life.” Dkt. 31, at 1.

         “But though the emotional trauma of the [D&E] experience is reduced for the patient [relative to induction], it is increased for those who perform the abortion.” Id. Physicians, therefore, may prefer induction to D&E for emotional or other personal reasons, as Dr. Christina Francis, M.D., a board-certified ob/gyn in Fort Wayne, explains with reference to herself and the physicians with whom she is personally familiar. Francis Decl. ¶ 15. (Some physicians may conflate their views with their patients'. See ACOG Practice Bulletin No. 135 at 28 (“Although many obstetric providers believe that women terminating a pregnancy for fetal anomalies and fetal demise prefer induction of labor to D&E, this may not be the case.”).) Indeed, “much of the emotional burden of the [D&E] procedure is borne by the physician.” Dkt. 32 Ex. 1, at 10. See also Dkt. 30 Ex. 2 (discussing emotional and moral burdens of second-trimester abortions on physician; acknowledging risk that discussion would be “taken out of context and used as evidence for further abortion practice restrictions”).

         Physicians also may prefer induction to D&E because they view D&E as “barbaric.” Francis Decl. ¶ 16. Setting aside private religious or philosophical opinions on zygotic, embryonic, or fetal personhood, see Dkt. 40 Ex. 2 60:17-20 [hereinafter First Francis Dep.]; Second Francis Dep. 56:10-58:22; see generally John J. Miklavcic & Paul Flaman, Personhood Status of the Human Zygote, Embryo, Fetus, 84 Linacre Q. 130 (2017), some physicians may decline to perform D&E because they believe “a fetus is likely able to feel pain[.]” Francis Decl. ¶ 17.

         However, this opinion is contrary to the great weight of current medical evidence.

A [2005] multidisciplinary review of the medical evidence concluded that a fetus cannot experience pain until 29 weeks of gestation at the earliest, when thalamocortical connections are first present. . . . This review shows evidence that both withdrawal reflexes and hormonal stress hormones can be elicited by nonpainful stimuli and can occur without conscious cortical processing. Therefore, the best indicator as to when a fetus has potentially the capacity to experience pain is the development of the thalamocortical axons, which do not occur until at least 29 weeks of gestational duration; however, their functionality within the intrauterine environment has not been determined. With the difficulty of establishing any clear way to measure fetal pain and the lack of specific markers for fetal pain, any potential pain of the means of inducing fetal demise cannot be assessed either.

Induction of Fetal Demise Before Abortion at 464. Accord Dkt. 40 Ex. 1, ¶¶ 38-49 (“[A] widespread consensus exists in the medical and scientific community that fetal pain is not possible before at least 24 weeks LMP.”) [hereinafter Ralston Decl.]; Dkt. 42 Ex. 1, at 38 (“[T]he fetus does not even have the physiological capacity to perceive pain until at least 24 weeks of gestation.”).

         In all, D&E is regarded as the preferred method of second-trimester abortion unless trained D&E providers are unavailable. ACOG Practice Bulletin No. 135 at 26; Davis Reply Decl. ¶ 26; Dkt. 31 Ex. 2, at 3; Complications After Second Trimester Abortion at 3 (“Current evidence suggests that, given trained providers and where otherwise feasible, D&E is preferable to medical induction.”); Dkt. 40 Ex. 9, at 23 (“When abortion by aspiration is no longer feasible, D&E and induction methods are used. D&E is the superior method; in comparison, inductions are more painful for women, take significantly more time, and are more costly.”). Dr. Bernard “certainly would not recommend that [her] patients undergo an induction rather than a D&E unless the patient requested an induction[, ]” Pl. Decl. ¶ 39, though she “[a]lways” offers both options to her patients. Pl. Dep. 25:25. Accord Meng Dep. 12:1-8 (“If the patient does not want [D&E] done, we do not do it. . . . [But, in general, if] the patient wanted the termination of the pregnancy in the second trimester, I would recommend the safest route, safest procedure, and that would be the D&E.”).

         C. Hysterotomy

         The only surgical alternative to D&E in the second trimester is a hysterotomy abortion. “A hysterotomy is an incision in the abdomen and uterus similar to what is performed during a caesarean section and other uterine surgeries.” Dkt. 40 Ex. 10, ¶ 4. This major surgical procedure is “associated with a much higher risk of complication than D&E or [induction] abortion and should only be performed when the latter two procedures are contraindicated.” ACOG Practice Bulletin No. 135 at 24. There is no evidence that any physician recommends hysterotomy over D&E, as a general matter.

         IV. Fetal Demise

         All agree that, because HEA 1211 applies only to a “living fetus, ” HEA 1211 does not prohibit D&E when fetal demise has been induced before the evacuation and any concomitant disarticulation.

         A recent survey of abortion providers' fetal-demise practices cited by Defendants notes that “[i]nducing fetal demise is not without controversy, as it involves risks to patients without associated medical benefit, making it difficult to justify from an ethical standpoint.” Colleen C. Denny et al., Induction of Fetal Demise Before Pregnancy Termination: Practices of Family Planning Providers, 92 Contraception 241 (2015) [hereinafter Induction of Fetal Demise Before Pregnancy Termination]. The survey found that, of the 105 responding abortion providers (62 percent of 169 eligible respondents), 55 (52 percent) attempted to induce fetal demise before performing the abortion. Id. Seventeen respondents indicated their decision to induce demise was made on a case-by-case basis. Of the 38 remaining respondents, physicians who attempted to cause demise beginning at a specific gestational threshold (36 percent of all respondents), none attempted to induce fetal demise prior to 17 weeks LMP; one attempted demise beginning at 17 weeks LMP; five beginning at 18 weeks; three at 19 weeks; 16 at 20 weeks; none at 21 weeks; five at 22 weeks; and four at 23 and 24 weeks and later.[1] Id. (The remaining four respondents' practices do not appear to be accounted for.)

         A larger and more recent survey found that “‘74% (123/167) of clinicians who reported performing D&Es at 18 weeks LMP or greater did not routinely induce preoperative fetal demise,' and among the minority (26%) who do use demise procedures, the vast majority (70%) do so only for procedures at 20 weeks LMP or greater.” Davis Reply Decl. ¶ 15 (emphasis omitted) (citing Katharine O. White et al., Second-Trimester Surgical Abortion Practices in the United States, 98 Contraception 95 (2018)). These data support Dr. Bernard's characterizations of inducing pre-D&E fetal demise as a “minority” practice. Pl. Decl. ¶ 28. Also Davis Decl. ¶ 21; Davis Reply Decl. ¶ 15.

         Where physicians induce demise before performing a D&E, it is not done to increase the safety of the procedure. “No evidence currently supports the use of induced fetal demise to increase the safety of second-trimester [induction] or surgical abortion.” ACOG Practice Bulletin No. 135 at 24. “To demonstrate whether second-trimester abortion is made safer by [inducing prior fetal demise], additional [randomized controlled trials] are necessary. . . . To justify the harm of the documented increase[s] [in complication rates], a significant increase in D&E safety would seem warranted.” Induction of Fetal Demise Before Abortion at 470, cited at inter alia Davis Decl. ¶ 20. Also Dkt. 40 Ex. 9, at 234 (“Research is limited, but the few existing comparative studies suggest that [the most commonly used methods of inducing fetal demise before a D&E] do not confer a clinical benefit and may increase risks.”).

         Where fetal demise is induced, “[t]he reasons most frequently cited for this practice are avoiding prosecution, facilitation of D&E abortion, patient preference and avoiding extramural [i.e., outside the healthcare facility] abortion with signs of life.” Dkt. 33, at 1. Also Dkt. 40 Ex. 9, at 234 (“Fetal demise is induced before dilation and evacuation . . . by some abortion providers in the belief that it facilitates an easier, faster and safer evacuation. Other frequently cited reasons for this practice are patient preference, avoiding prosecution, and avoiding extramural delivery with signs of life.”). The last of these reasons will be addressed relative to each method of causing fetal demise, discussed below.

         As for avoiding prosecution, “[p]assage of the Partial-Birth Abortion (PBA) Ban Act in 200[3], ” sustained by the Supreme Court in Gonzales v. Carhart, 550 U.S. 124 (2007), “resulted in a change in U.S. abortion practice for legal reasons without medical indication.” Id. The federal statute prohibits a variant of D&E known as “intact” D&E. See Gonzales, 550 U.S. at 136-37, 146-47. Though not required to do so by the statute, abortion providers may induce prior fetal demise as a prophylactic against liability. Induction of Fetal Demise Before Abortion at 462; Induction of Fetal Demise Before Pregnancy Termination at 241; Dkt. 33, at 1; Dkt. 40 Ex. 9, at 234.

         As for facilitation of the D&E procedure, prior demise does not in fact appear to make D&E faster or easier for the physician. ACOG Practice Bulletin No. 135 at 24; Society of Family Planning Guidelines at 11; Dkt. 35 Ex. 1, at 5-6. But see Dkt. 40 Ex. 9, at 238 (nonrandomized study finding reduction in mean procedure time with prior demise).

         As for patient preference, one study of inducing demise to facilitate D&E found that 92 percent of study participants preferred to induce demise before undergoing the procedure. Dkt. 35 Ex. 1, at 2. But the authors of that study recommended interpreting this data “cautiously because only patients who were willing [to have the demise procedure performed] entered the trial.” Id. at 6. “This question was posed to patients within the context of a clinical trial in which many of them believed the injection might make their abortion safer[, ]” though the trial found it did not. Induction of Fetal Demise Before Abortion at 464. “Also, the social acceptability of a positive response may have skewed the results.” Id. “[B]y contrast, in a different study when patients were offered the option not to undergo digoxin injections, the vast majority-81%-declined.” Davis Reply Decl. ¶ 13 (citing Aileen M. Gariepy et al., Transvaginal Administration of Intraamnniotic Digoxin Prior to Dilation and Evacuation, 87 Contraception 76 (2013), Dkt 33.).

         The parties discuss three specific methods for causing fetal demise: injecting digoxin intrafetally (that is, into the fetal body) or intra-amniotically (that is, into the amniotic sac, the sac containing amniotic fluid in which the fetus gestates); injecting potassium chloride (KCl) intracardially (that is, into the fetal heart) or intracranially (that is, into the fetal head); ...


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