Opinion ID: 4538315
Heading Depth: 4
Heading Rank: 1

Heading: Digoxin Injections

Text: The first fetal-demise method the Secretary identifies is digoxin injections. As the district court explained, “[t]o inject digoxin, physicians begin by using an ultrasound machine to visualize the woman’s uterus and the fetus. The physician then inserts a long surgical needle through the patient’s skin, abdomen, and uterine muscle, to inject digoxin into the fetus” or the amniotic fluid. Meier, 373 F. Supp. 3d at 818. Because digoxin can take up to twenty-four No. 19-5516 EMW Women’s Surgical Center, et al. v. Friedlander, et al. Page 14 hours to work, physicians generally must administer this injection the day before performing a D&E. Id. at 818–19. The district court found that digoxin injections were not a feasible method for inducing fetal demise for five reasons. First, with between a 5% and 20% failure rate, digoxin injections do not reliably induce fetal demise and so patients may require a second injection, the effects of which have not been studied. Id. at 818. Second, digoxin injections are also insufficiently studied when administered before eighteen weeks LMP, and would therefore essentially be experimental for the approximately 50% of patients who would receive injections before this point. Id. Third, various factors make it difficult or impossible for many patients to receive a digoxin injection prior to a D&E. Id. Fourth, digoxin injections expose patients to substantial added health risks. Id. Finally, digoxin injections subject patients to additional logistical and emotional burdens by requiring them to undergo a risky and invasive procedure and by requiring them to invest resources in making a visit to their physician to have the injection twenty-four hours before receiving a D&E. Id. at 818–19.5 Much of the Secretary’s argument pertaining to digoxin injections amounts to an attempt to relitigate factual issues. He contends that digoxin injections do not fail as frequently as the district court found, that receiving multiple injections is safe, that receiving injections before eighteen weeks is safe, and that some of the risks identified by the district court are minimal or theoretical. In essence, the Secretary takes issue with the district court’s decision to credit Plaintiffs’ experts and cited studies over his own. 5 The district court found that digoxin injections are generally “not terribly difficult to perform,” but that they “still [are] not a feasible option for fetal-demise” for the five reasons indicated. Meier, 373 F. Supp. 3d at 818. Yet the dissent repeatedly asserts that the problem is simply that Plaintiffs do not desire to receive the training necessary to give the injections. This assertion has no grounding in the facts as the district court found them, and, as previously discussed, the dissent provides no support for it. In any event, the possibility that Plaintiffs could be trained to perform digoxin injections is irrelevant if digoxin injections are not otherwise a feasible workaround to H.B. 454. The evidence pointed to by the dissent provides no reason to question the district court’s conclusion that they are not. As detailed above, each of the factual findings relating to digoxin injection’s feasibility was a permissible view of the evidence. See Anderson, 470 U.S. at 574. Apparently recognizing this, the dissent does not suggest that any of the court’s findings were clearly erroneous. Instead, it simply asserts the facts as it sees them. But it is not our role to find facts, particularly in the absence of evidence, when we have no basis to reverse the district court’s permissible findings. See id. No. 19-5516 EMW Women’s Surgical Center, et al. v. Friedlander, et al. Page 15 The Secretary’s strategy is misguided. Even if we were inclined to disagree with the district court’s factual findings, we may not reverse those findings merely because we are “convinced that had [we] been sitting as the trier[s] of fact, [we] would have weighed the evidence differently.” Anderson, 470 U.S. at 573–74. As a federal appellate court, “we must let district courts do what district courts do best—make factual findings—and steel ourselves to respect what they find.” Taglieri v. Monasky, 907 F.3d 404, 408 (6th Cir. 2018). In reviewing a grant of permanent injunction following a bench trial, we ask simply whether the district court’s view of the evidence was permissible. Anderson, 470 U.S. at 574. The record supports each of the district court’s factual findings. Expert testimony presented at trial, supported by medical studies, suggested that digoxin injections fail between 5% and 20% of the time.6 (Tr. Vol. I, R. 106 at PageID #4391; Tr. Vol. II, R. 107 at PageID ##4675–76; Tr. Vol. IV, R. 103 at PageID #3911.) We cannot override the district court’s decision not to credit competing evidence that suggested the lower bound of this failure rate is 2%, (e.g., Tr. Vol. I, R. 106 at Page ID #4391; Tr. Vol. III-B, R. 102 at PageID ##3737, 3743), and we would not be compelled to conclude that digoxin injections are feasible even if we could. As a legal matter, the Secretary also contends that Plaintiffs should be bound by the statement in their complaint that digoxin fails between 5% and 10% of the time. But “[i]n order to qualify as [a] judicial admission[], an attorney’s statement must be deliberate, clear and unambiguous.” MacDonald v. Gen. Motors Corp., 110 F.3d 337, 340 (6th Cir. 1997). The complaint’s statement that “digoxin simply fails to cause demise in approximately 5–10% of cases,” (Compl., R. 1 at PageID #8 (emphasis added)), leaves ample room for Plaintiffs to show that the failure rate is higher. Likewise, evidence supports the district court’s conclusion that performing successive digoxin injections would amount to an experimental medical procedure, because no medical literature identifies the correct dose for or the risks of a second digoxin injection. (See, e.g., Tr. 6 The Secretary also argues that even a 20% failure rate does not make H.B. 454 facially invalid because this does not constitute an undue burden on the requisite large fraction of individuals for whom the restrictions are relevant. As this argument goes to the appropriateness of facial relief, we address it in considering what relief Plaintiffs are due. But at this juncture, it is worth noting that digoxin injections’ failure rate is not the only thing that makes them an infeasible workaround to H.B. 454. Thus, we need not consider whether this failure rate, standing alone, would be sufficient to suggest that H.B. 454 unduly burdens a large fraction of the population it restricts. No. 19-5516 EMW Women’s Surgical Center, et al. v. Friedlander, et al. Page 16 Vol. I, R. 106 at PageID ##4395–96; Tr. Vol. II, R. 107 at PageID #4678; Tr. Vol. III-B, R. 102 at PageID #3792.) The court’s conclusion regarding the use of digoxin injections before eighteen weeks LMP is also well grounded: according to witness testimony, no studies have been performed on the efficacy, dosage, or safety of digoxin injections before seventeen weeks, and just one study includes a few individuals at seventeen weeks’ pregnancy. (Tr. Vol. I, R. 106 at PageID ##4396–97; Tr. Vol. IV, R. 103 at PageID ##3984–85.) The court’s conclusion that digoxin injections are not available to many patients also is not clearly erroneous. Multiple experts testified that factors including placental positioning, fetal positioning, obesity, the presence of uterine fibroids, and the presence of cesarean-section scars can interfere with or prevent the successful administration of a digoxin injection. (Tr. Vol. I, R. 106 at PageID ##4387–88; Tr. Vol. III-B, R. 102 at PageID ##3793–94; Tr. Vol. IV, R. 103 at PageID ##4000–01.) Moreover, expert testimony and studies suggested that patient contraindications—including multiple gestations, fetal abnormalities, digoxin or cardiac glycoside sensitivities and allergies, cardiac abnormalities, renal failure, bleeding disorders, and use of certain medications—may prevent the safe administration of a digoxin injection. (Tr. Vol. I, R. 106 at PageID ##4388–90.) Despite the Secretary and the dissent’s assertions otherwise, the district court’s finding that digoxin injections are not generally technically difficult to perform does not remotely conflict with its conclusion that they cannot successfully be performed on all patients or that they are technically difficult to perform in some situations. In the event that an individual cannot receive a digoxin injection for any of these reasons, H.B. 454 could prevent her from receiving a D&E. There is no exception to H.B. 454’s restrictions for those who cannot undergo one of the proposed fetal-demise procedures.7 While the district court’s opinion did not include specific record citations to support its conclusion that that digoxin injections subject patients to additional health risks, Meier, 373 F. Supp. 3d at 818, this too is supported by the evidence. Expert testimony suggested that digoxin 7 The only exception to H.B. 454’s prohibition is for instances of “medical emergency.” (H.B. 454, R. 43- 1 at PageID #244.) The unavailability of a digoxin injection generally does not “so complicate[] the medical condition of a pregnant female as to necessitate the immediate abortion of her pregnancy to avert her death or for which a delay will create a serious risk of substantial and irreversible impairment of a major bodily function.” (Id.); Ky. Rev. Stat. § 311.720(9). On appeal, the Secretary does not argue that this medical exception covers any of the situations in which a fetal-demise procedure would be unavailable. No. 19-5516 EMW Women’s Surgical Center, et al. v. Friedlander, et al. Page 17 injections may increase patients’ risk of vomiting, infection, bowel or intestinal rupture, sepsis, and general hospitalization. (Tr. Vol. I, R. 106 at PageID ##4400–06; Brady Dep., R. 112-1 at PageID #5242.) Digoxin injections can also lead to extramural delivery, meaning delivery outside a clinic environment, which further increases medical risks (including the risk of hemorrhaging) and may also be painful and emotionally traumatic. (Tr. Vol. I, R. 106 at PageID ##4405–09; Brady Dep., R. 112-1 at PageID #5242.) The Secretary says that these negative effects rarely occur and dismisses them as “marginal or insignificant risks generalized to the entire population of women seeking . . . abortions [at the relevant time].” (Def. Br. at 35 (alterations in original) (quoting Women’s Med. Prof’l Corp. v. Taft, 353 F.3d 436, 447 (6th Cir. 2003)).)8 The Secretary draws this language from Women’s Medical Professional Corp. v. Taft, in which this Court considered whether a state could forbid D&X abortions if the statute doing so provided for a health exception. 353 F.3d at 446–47. Noting that Supreme Court precedent required exceptions for “when the procedure is necessary to prevent a significant health risk,” this Court concluded that the Supreme Court did not intend to require medical exceptions to include “marginal or 8 In his reply brief, the Secretary contends for the first time that whether the three fetal-demise procedures pose significant risks is a constitutional fact subject to de novo review. A constitutional fact is one “upon which the enforcement of the constitutional rights of the citizen depend.” Crowell v. Benson, 285 U.S. 22, 56 (1932); see also Henry Paul Monaghan, Constitutional Fact Review, 85 Colum. L. Rev. 229, 230, 254–55 (1985) (describing constitutional fact review as “judicial review of the adjudicative facts decisive of constitutional claims” and summarizing Crowell). To be sure, this Court has explained, in the context of abortion cases, that “an appellate court is to conduct an independent review of the record when constitutional facts are at issue.” Voinovich, 130 F.3d at 192; see also Women’s Med. Prof’l Corp. v. Taft, 353 F.3d at 442. But we have not clarified what that “independent review” means, nor have we identified any constitutional facts to which we apply that independent review. See, e.g., Voinovich, 130 F.3d at 192; Women’s Med. Prof’l Corp. v. Taft, 353 F.3d at 442. In both of the cases the Secretary cites to support his argument, the Court reviewed legal questions pertaining to statutory construction, including how a health exception in a statute regulating abortion should be interpreted. Voinovich, 130 F.3d at 208–10; Women’s Med. Prof’l Corp. v. Taft, 353 F.3d at 443–51. This Court did not hold in either case that the existence of a significant health risk is a constitutional fact. The Secretary’s argument turns on his assertion that a law “imposes an undue burden only when the regulation creates a substantial obstacle to previability abortion by ‘creat[ing] significant health risks’ for women,” implying that the undue burden analysis turns exclusively on whether a law presents significant health risks. (Def. Reply Br. at 10–11 (quoting Gonzales v. Carhart, 550 U.S. 124, 162 (2007)).) Of course, in balancing the benefits and burdens H.B. 454 imposes, we consider more than just health risks alone. We consider the question of whether a procedure poses a significant health risk a mixed question of fact and law. What risks a procedure poses is a question of fact, and whether those risks are significant is a question of law. Accordingly, we apply clear error review to the former question and de novo review to the latter question. No. 19-5516 EMW Women’s Surgical Center, et al. v. Friedlander, et al. Page 18 insignificant risks generalized to the entire population of women seeking late second-trimester abortions.” Id. We found it significant that the law in question “specifically exclude[d]” D&Es from its restrictions, as D&Es provided a safe alternative to the D&X procedure. Id. at 438, 451–53. As the Supreme Court later explained, in comparing D&X and D&E abortions, there was substantial medical uncertainty “over whether the barred procedure [i.e., D&X] is ever necessary to preserve a woman’s health, given the availability of other abortion procedures that are considered to be safe alternatives [i.e., D&E].” Gonzales, 550 U.S. at 166–67. By contrast, under H.B. 454, an individual is left with no safe alternative to undergoing a fetal-demise procedure, and the record shows, with no medical uncertainty, that a D&E without a fetal-demise procedure may be necessary to preserve an individual’s health. Indeed, in every circumstance, a fetal-demise procedure poses additional health risks beyond those present with a D&E alone, and so it always places an individual’s health in jeopardy. Accordingly, every court to consider the question has found that digoxin injections pose impermissible, significant risks to those who would be compelled to undergo them. See, e.g., Williamson, 900 F.3d at 1323–24, 1327; Bernard, 392 F. Supp. 3d at 949, 960; Yost, 375 F. Supp. 3d at 858; Paxton, 280 F. Supp. 3d at 949; Hopkins, 267 F. Supp. 3d at 1039, 1060–61; Evans, 977 F. Supp. at 1301, 1318; Schmidt, 368 P.3d at 678; see also Farmer, 220 F.3d at 145–46 (discussing digitalis, another cardiac glycoside); Verniero, 41 F. Supp. 2d at 500 (same), aff’d sub nom. Farmer, 220 F.3d 127; accord Meier, 373 F. Supp. 3d at 818. We agree. Finally, the district court found that digoxin injections impose additional logistical and emotional burdens on patients because they may increase the length of the D&E procedure by a day and because they require patients to undergo an additional invasive, painful, and likely scary procedure. Meier, 373 F. Supp 3d at 818–19. The Secretary’s argument that D&E procedures regularly take two days anyway is unavailing; even if he is correct, the record suggests that an additional day may be required for some patients to undergo a digoxin injection. (See Tr. Vol. I, R. 106 at PageID ##4396, 4432; Tr. Vol. II, R. 107 at PageID #4768.) In sum, we see no error in the district court’s analysis of the feasibility of using digoxin injections to induce fetal demise prior to a D&E. Digoxin injection is an unreliable procedure that may not effectively cause fetal demise, presents unknown risks when administered multiple No. 19-5516 EMW Women’s Surgical Center, et al. v. Friedlander, et al. Page 19 times or before eighteen weeks, may not be administrable at all based on the patient’s health history and characteristics, increases medical risks under any circumstance, and creates additional emotional and logistical challenges for patients. Based on these findings of fact, digoxin injections are not a safe or effective workaround to H.B. 454.