In Planned Parenthood of Se. Penn. v. Casey, the Supreme Court reaffirmed the constitutional right to abortion established in Roe v. Wade, but changed the standard by which restrictions on the right were evaluated. In doing so, the Court authorized states to regulate abortion in order to protect the health and safety of women seeking abortions. In response, many states passed abortion laws that were allegedly aimed at protecting women’s health. However, medical evidence shows that many of these laws do not improve health outcomes for women, and in some cases harm women’s health. In 2016, the Supreme Court’s decision in Whole Woman’s Health v. Hellerstedt clarified that “health-justified” regulations on abortion must be supported by evidence showing that the law actually promotes improved health outcomes. Several common forms of abortion restrictions currently in effect fail to meet this standard, such as certain informed consent laws, restrictions on medication abortion, and laws limiting the performance of abortion to physicians only. This article analyzes the medical evidence (or lack thereof) behind such regulations, and argues that such restrictions fail to meet the evidence-based standard of Whole Woman’s Health.
Texas argues that H. B. 2’s restrictions are constitutional because they protect the health of women who experience complications from abortions. In truth, ‘complications from an abortion are both rare and rarely dangerous.’ Many medical procedures, including childbirth, are far more dangerous to patients, yet are not subject to ambulatory-surgical-center or hospital admitting-privileges requirements. Given those realities, it is beyond rational belief that H. B. 2 could genuinely protect the health of women, and certain that the law ‘would simply make it more difficult for them to obtain abortions.’1
The right to obtain an abortion has been controversial ever since the Supreme Court declared its constitutional protection in Roe v. Wade.2 In recent years, this controversy has gained new life, as the number of state-enacted restrictions on abortion have ballooned.3 Such laws were made possible in part by the Court’s post-Roe decision, Planned Parenthood of Southeastern Pennsylvania v. Casey, which reaffirmed the abortion right, but changed the standard by which restrictions on the right were evaluated.4 Moreover, the Court reaffirmed the State’s power to impose restrictions on abortion to protect the health and safety of women seeking abortions.5 In the years since Casey, many states have directed specific restrictions at abortion clinics and medical facilities, known as “Targeted Regulation of Abortion Providers” or “TRAP” laws. TRAP laws “single out abortion for onerous forms of regulation not applied to procedures of equivalent or greater medical risk.”6
Under Casey, federal courts disagreed on the proper way to evaluate TRAP laws, which led to confusion over the proper standard of review. Despite the Supreme Court’s recognition that courts “retain an independent constitutional duty to review factual findings where constitutional rights are at stake,”7 some state and federal courts have declined to inquire into the factual basis behind TRAP laws, which are purportedly justified by an interest in protecting women’s health.8 The willingness of courts to defer to states’ purported reasoning for passing TRAP laws allowed a record number of abortion restrictions to be passed in recent years.9
In its 2016 decision Whole Woman’s Health v. Hellerstedt, the Supreme Court clarified that health-justified regulations on abortion must be supported by evidence that the laws actually promote women’s health.10 The Court’s opinion made clear that lower courts must evaluate the factual bases for health-justified laws, and that such restrictions are subject to an evidence-based standard of review.11 Although Whole Woman’s Health struck down admitting-privileges and ambulatory-surgical-center requirements, several categories of TRAP laws remain in effect across the country. These laws are not based on empirical research or medical fact, and thus must fail the scrutiny required by the new evidence-based standard of review under Whole Woman’s Health.
Part II of this article describes how the standard of review for health-justified abortion regulations has become unclear since Casey was decided. As a result of the ambiguity in the law, many states enacted regulations purporting to protect women’s health, but which were actually motivated by moral disapproval of abortion. Part II also discusses how the Supreme Court’s lack of clarity on the standard of review, particularly in Gonzales v. Carhart, led to a division among the courts on whether or not to evaluate the factual basis for health-justified laws. Part III describes how Whole Woman’s Health clarified the applicable standard by stating that health-justified laws must be supported by medical evidence. Part III also explores the importance of this clarification as a tool for legal advocates to challenge abortion regulations that do not actually improve women’s health.
Parts IV through VI describe three categories of abortion regulations that this article argues would not survive a constitutional challenge under Whole Woman’s Health’s evidence-based standard: Part IV discusses informed consent provisions, Part V discusses restrictions on medication abortion, and Part VI discusses requirements that only physicians provide abortion care. Laws in these categories are purportedly justified by states’ interest in protecting women’s health, but such claims are not based on empirical evidence. In fact, these laws can often lead to adverse health outcomes for women seeking abortions.
II. Lesser Scrutiny and Blended Justifications: The Need to Clarify the Standard
A. From Roe’s “Fundamental Right” to Casey’s “Undue Burden” Standard
The Roe v. Wade decision clearly stated that the right to access abortion was included in the “fundamental right” to privacy12 and that it therefore was subject to strict scrutiny: “[w]here certain ‘fundamental rights’ are involved, the Court has held that regulation limiting these rights may be justified only by a ‘compelling state interest,’ and that legislative enactments must be narrowly drawn to express only the legitimate state interests at stake.”13 Additionally, Roe created a trimester framework, forbidding restrictions on access to abortion during the first trimester and permitting more stringent restrictions only as the pregnancy progressed.14 While Planned Parenthood v. Casey reaffirmed Roe, the language of the plurality decision, penned by Justice O’Connor, appeared to modify Roe significantly. Roe identified abortion as a “fundamental” right, suggesting the application of strict scrutiny,15 but Casey invoked language that suggested judges use a lesser level of scrutiny.
Casey’s characterization of the holding in Roe demonstrates how the Court changed the standard. The Casey Court articulated the “essential holding” of Roe as having three parts: first, the right of a woman to choose to have an abortion before fetal viability; second, the power of a state to restrict abortion after viability; and third, the legitimacy of a state’s interest in protecting the health and safety of the woman, as well as the potential life of the fetus, throughout the pregnancy.16 Casey rejected Roe’s trimester system and instead made viability of the fetus the critical point of development for abortion regulations.17 At the same time, by recognizing a legitimate state interest in both potential life and the woman’s health “throughout pregnancy,” Casey allowed states to pass regulations that restricted abortion prior to fetal viability so long as they did not constitute an “undue burden.”18 Describing this new standard, the Casey decision stated that “[a]n undue burden exists, and therefore a provision of law is invalid, if its purpose or effect is to place a substantial obstacle in the path of a woman seeking an abortion before the fetus attains viability.”19
The language of the undue burden standard in Casey suggested a lesser form of scrutiny than what was advanced in Roe. First, where Roe described the abortion right as a fundamental right, Casey replaced this language with that of a “liberty” interest.20 The opinion rejects several purported state interests, such as moral interests, which would have passed rational basis scrutiny, suggesting that infringements on a liberty interest are subject to some heightened form of scrutiny.21 However, the changed language appeared to lower the level of scrutiny that applies to restrictions; in fact, in his dissent to the Casey opinion Chief Justice Rehnquist derides the plurality opinion for departing from the established standard of Roe.22 Some legal scholars and lower court judges agree with Chief Justice Rehnquist and believe that Casey’s undue burden standard “effectively demote[d] abortion from the status of fundamental right to something less.”23
Second, while Casey allowed for abortion restrictions to affect earlier stages of pregnancy, the decision made clear that such restrictions must still be aimed at promoting one of the two legitimate state interests first iterated in Roe. First, states may enact regulations designed to “persuade [a woman] to choose childbirth over abortion,”24 which this article will refer to as “potential-life-justified” regulations.25 Casey made clear that restrictions motivated by the state’s interest in potential life “must be calculated to inform the woman’s free choice, not hinder it,”26 and will be upheld only if they are “reasonably related” to the goal of encouraging childbirth over abortion.27 Second, states may pass abortion restrictions that are justified by efforts to protect women’s health, which this article will refer to as “health-justified” regulations. In promoting this interest, “the State may enact regulations to further the health or safety of a woman seeking an abortion.”28 However, Casey made clear that “[u]nnecessary health regulations that have the purpose or effect of presenting a substantial obstacle to a woman seeking an abortion impose an undue burden on the right.”29 The undue burden standard permits states to pass laws “which serve a valid purpose, one not designed to strike at the right itself,”30 even where such laws “ha[ve] the incidental effect of making it more difficult or more expensive to procure an abortion.”31
By emphasizing the ability of states to pass abortion regulations for both of these purposes, Casey “expand[ed] the ability of states to promote fetal life in the context of women’s decision-making about whether to continue a pregnancy.”32 While the Casey opinion was clear that laws passed for this purpose “must be calculated to inform the woman’s free choice, not hinder it,”33 misapplication of the decision by lower courts allowed states to pass even more intrusive laws, which limited women’s decision-making and allowed TRAP laws to proliferate. “An unfortunate result was to encourage states to impose even more intrusive mandatory delays, ‘counseling,’ and testing requirements (such as mandatory ultrasounds) that increase costs and delays and stigmatize and demean women.”34 After Casey recognized the ability of states to pass laws for both of these purposes, anti-choice lawmakers began to pass potential-life-justified abortion restrictions beyond what was permissible, despite the fact that “[t]he Court was clear to treat separately regulations necessary to protect women’s health. Casey plainly does not allow states to discourage abortion or make it difficult to obtain under the guise of protecting women’s health.”35 However, until Whole Woman’s Health clarified the distinction between these two motivations, many states passed such laws, and many courts, including the Fifth Circuit Court of Appeals, used lesser scrutiny and allowed for the blending of these justifications.36
B. Gonzales v. Carhart Further Confuses the Standard
The Supreme Court’s decision in Gonzales v. Carhart also substantiated state governments’ perceived ability to pass more expansive restrictions meant to discourage abortion. First, the Court’s language further confused the proper level of scrutiny to apply to abortion restrictions. Rather than Roe’s fundamental rights language or Casey’s liberty interest, the Gonzales Court invoked the language of rational basis.37 Rational basis scrutiny, the least stringent standard of review, requires only that the law be rationally related to the government’s legitimate purpose.38 Typically courts will not do a full analysis of the state’s purpose under the standard,39 such as in Gonzales, where “the Court nonetheless determined that Congress articulated a legitimate purpose for the law without doing a full purpose analysis.”40 Thus, by equating the undue burden standard with a rational basis standard, Gonzales suggested that courts should accept a state’s purported reasons for passing abortion restrictions at face value.41 This opened the door to a blending of justifications and the proliferation of TRAP laws.
Gonzales involved a challenge to the federal “Partial-Birth Abortion Ban Act,”42 which prohibited the performance of abortions using the intact dilation and evacuation procedure, or “intact D&E.”43 Prior to Gonzales, intact D&E was the most popular method to perform second trimester abortions.44 In passing the Act, Congress expressed concern that the intact D&E procedure, during which a fetus is partially delivered before the pregnancy is terminated, was too similar to “infanticide,” and justified the Act as expressing “respect for human life.”45 In evaluating the potential-life-justified Act, the Court appeared to blend the undue burden standard with a rational basis standard:
Where it has a rational basis to act, and it does not impose an undue burden, the State may use its regulatory power to bar certain procedures and substitute others, all in furtherance of its legitimate interests in regulating the medical profession in order to promote respect for life, including life of the unborn.46
The Gonzales Court’s use of the language “legitimate interests” is also consistent with the application of the more deferential rational basis standard.47
The infusion of the rational basis standard is clear in Justice Kennedy’s majority opinion upholding the Act. Despite stating both that “[t]he Court retains an independent constitutional duty to review factual findings where constitutional rights are at stake,” and that “[u]ncritical deference to Congress’ factual findings in these cases is inappropriate,” Justice Kennedy demonstrated deference to the legislature in line with the rational basis standard.48 The opinion relied on conflicting expert testimony at the District Court level to conclude that there was “medical uncertainty” about whether or not prohibiting intact D&E would impose health risks on women.49 The Court stated that, in the face of such uncertainty, state and federal legislatures have wide discretion to regulate abortion, and concluded that the medical uncertainty “provides a sufficient basis to conclude . . . that the Act does not impose an undue burden.”50
While deference to the legislature may be appropriate where true medical uncertainty exists, this was not the case with respect to the intact D&E procedure. As Justice Ginsburg emphasized in her dissent, several of the premises on which the majority opinion rested were contradicted by evidence and medical consensus.51 While the majority invoked medical uncertainty, Justice Ginsburg pointed out that the physicians who testified in favor of the Act had limited experience with abortion.52 In contrast, nine professional organizations, including the American College of Obstetricians and Gynecologists (“ACOG”), and testifying physicians with significant experience performing the challenged procedure, all concluded that “intact D & E carries meaningful safety advantages over other methods,” particularly for women with complicated pregnancies.53
By failing to evaluate the credibility of the experts who testified before Congress and the District Court, the majority blindly accepted Congress’s fact-finding, even in the face of contradicting, better-supported evidence. As a result, Gonzales suggests to state governments and lower courts that, at least in the case of later-term abortions, the legislature’s judgment will be given broad deference, despite its statement that the courts have a “constitutional duty to review factual findings.”54 This presumption of deference has created a problematic jurisprudence where laws purportedly enacted to promote women’s health are not struck down even where they fail to achieve that purpose.55 The confusion caused by Gonzales’ addition of the rational basis test to the undue burden analysis also led to a lack of clarity over the proper standard to apply to abortion regulations generally.56 Though Casey’s undue burden standard is not the same as a rational basis standard,57 Gonzales’ discussion of these standards enabled courts to apply the less rigid test to abortion restrictions, “requiring only that Congress have had a ‘rational basis to act.’”58
Gonzales’ rationale also caused some courts and judges to disregard Casey’s “purpose prong” and fixate on its “effect prong,”59 which allows the application of “extravagant deference to the legislature.”60 The emphasis on the effect prong and disregard for the purpose prong is so strong in abortion jurisprudence that, during oral arguments in Whole Woman’s Health v. Hellerstedt, Chief Justice Roberts asked why the state’s purpose in enacting the law was even relevant to the determination of its constitutionality.61 Lower courts have echoed the Chief Justice’s thinking, permitting states to pass “health-justified” restrictions on abortion access that neither promote health outcomes nor explain the actual impetus for passage of the law.62 These courts have held that the undue burden standard does not require the court to inquire into the validity of the medical purpose, instead accepting at face value the legislature’s purported health justification for enacting the law.63 Conversely, other courts have more vigorously evaluated health justifications, resulting in a circuit split on the proper way to apply the undue burden standard to abortion regulations.64
Finally, although Gonzales involved a potential-life-justified restriction, courts have adopted its apparent rational basis standard in the context of health-justified restrictions as well, muddling the clear delineation between health- and potential-life-justified abortion restrictions that was drawn in Roe and reaffirmed in Casey.65 These cases clearly delineated between health- and potential-life-justified restrictions, holding that states may only promote their interest in potential life by means “calculated to informed the woman’s free choice, not hinder it.”66 As Linda Greenhouse and Reva B. Siegel phrase it, this means that “[u]nder Casey, states can protect potential life by persuading a woman to carry a pregnancy to term, but may not do so by obstructing her access to abortion.”67 However, courts have read Gonzales to permit the blending of the two justifications and analyzed dually-motivated statutes under a “fusion and scrambling of rationales.”68 This enabled states to pass laws like those at issue in Whole Woman’s Health, alleging that the law’s purpose includes the protection of future life, despite the fact that Casey clearly states that restrictions under this justification cannot hinder a woman’s access to abortion.69
III. Whole Woman’s Health: Clarification of the Standard and Strategy for Advocates
Perhaps the best demonstration of the differing applications of the undue burden standard can be seen by comparing the district and circuit court opinions for Whole Woman’s Health,70 the case in which the Supreme Court finally clarified how health-justified abortion restrictions should be evaluated.71 The cases involved two health-justified abortion restrictions enacted by the State of Texas after the passage of House Bill 2 (“HB 2”).72 One provision, the “admitting-privileges requirement,” mandated that “[a] physician performing or inducing an abortion must, on the date the abortion is performed or induced, have active admitting privileges at a hospital that is located not further than 30 miles from the location at which the abortion is performed or induced.”73 The other provision, the “ambulatory-surgical-center (“ASC”) requirement,” asserted that “the minimum standards for an abortion facility must be equivalent to the minimum standards adopted under [Texas Health & Safety Code] Section 243.010 for ambulatory surgical centers.”74
A. Disagreement over the Standard in the Lower Courts
The district court opinion in Whole Woman’s Health is representative of courts that understood the undue burden standard to require the evaluation of whether the proffered health-related purpose of the law has beneficial effects for women’s health. Although it applied rational basis review, citing Gonzales,75 the district court’s opinion, written by Judge Yeakel, found the two provisions violated the Constitution. Judge Yeakel did not accept that disagreement between expert witnesses constituted “medical uncertainty,” and thereby required deference to the legislature and upholding the law.76 Rather, the court rejected the State’s proffered purpose of protecting women’s health, emphasizing that “before the act’s passage, abortion in Texas was extremely safe.”77 Evaluating the ambulatory-surgical-center requirement, Judge Yeakel noted that “risks are not appreciably lowered for patients who undergo abortions at ambulatory surgical centers as compared to nonsurgical-center facilities,”78 and pointed out that the law would likely make abortion less safe, as the law caused many clinics in Texas to close, greatly increasing women’s travel time and delaying their ability to access a legal abortion provider.79 With respect to the admitting-privileges requirement, the court concluded that because physicians are often “denied privileges for reasons not related to clinical competency. . . . the heavy burden imposed on the women . . . is not appropriately balanced by a credible medical or health rationale.”80
In addition to independently evaluating the factual basis for the law, the district court questioned and rejected the State’s purpose in enacting HB 2, concluding that the law violated both the purpose and effect prongs of the undue burden standard. The court pointed to the State’s more lenient treatment of ambulatory surgery centers outside of the abortion context as suggestive that the State intended to reduce the number of abortion providers rather than promote health.81 Additionally, the Court emphasized a point undermining the State’s purpose argument that would later prove contentious during the Supreme Court oral argument.82 In defending the law, the State of Texas argued that residents faced with increased travel distances could obtain abortions in New Mexico.83 However, New Mexico did not have an analogous ambulatory-surgical-center requirement, leading the court to conclude that “it is disingenuous and incompatible with [the goal of protecting women’s health] to argue that Texas women can seek abortion care in a state with lesser regulations.”84 Following this evaluation, the court rejected the State’s purported reason for the law’s passage, concluding “that the ambulatory-surgical-center requirement was intended to close existing licensed abortion clinics,” and found the provision constituted an undue burden.85
In contrast, the Fifth Circuit’s ruling found that the undue burden standard did not require courts to evaluate the factual basis for a health-justified abortion restriction. On appeal, the Fifth Circuit vacated the District Court of Western Texas’ ruling that had enjoined both the admitting-privileges requirement and the ambulatory-surgical-center requirement.86 In so ruling, the appellate court not only declined to scrutinize the factual basis behind the State’s purpose in enacting the law, but reprimanded the district court for doing so, stating that “the district court erred by substituting its own judgment for that of the legislature.”87 The Fifth Circuit found that “legislatures have ‘wide discretion to pass legislation in areas where there is medical and scientific uncertainty’”88 and that courts should “not assume unconstitutional legislative intent even when statutes produce harmful results.”89 In evaluating the effects of the law, the Fifth Circuit rejected the district court’s conclusion that the law was unconstitutional because it did not actually further the state’s purported interests.90 The court wrote:
It is not the courts’ duty to second guess legislative factfinding, improve on, or cleanse the legislative process by allowing regulation of the facts that led to the passage of a law. Under rational basis review, courts must presume that the law in question is valid and sustain it so long as the law is rationally related to a legitimate state interest. As the Supreme Court has often stressed, the rational basis test seeks only to determine whether any conceivable rationale exists for an enactment. Because the determination does not lend itself to an evidentiary inquiry in court, the state is not required to prove that the objective of the law would be fulfilled.91
B. The Supreme Court Provides Clarification
In addition to clarifying the undue burden standard in its final opinion, the Supreme Court hinted at the need to investigate actual outcomes under health-justified abortion restrictions during oral argument. In a notable exchange, Justice Breyer asked Texas Solicitor General Keller to provide an example of women whose health and safety would be protected by the law.92 Mr. Keller was unable to provide such an example.93 Justice Breyer echoed this concern about the lack of health benefits promoted by the “health-justified” law in his majority opinion.
Justice Breyer began his analysis by clarifying Casey’s undue burden standard and stated that the Fifth Circuit’s articulation of the standard, which could “be read to imply that a district court should not consider the existence or nonexistence of medical benefits when considering whether a regulation of abortion constitutes an undue burden” was “incorrect.”94 The Justice clarified that the undue burden standard demands such an analysis, stating that Casey “requires that courts consider the burdens a law imposes on abortion access together with the benefits those laws confer.”95 The Court appeared to reject Gonzales’ call for rational basis scrutiny, stating that the Fifth Circuit incorrectly evaluated the restriction of the constitutional right to abortion under “the less strict review applicable where, for example, economic legislation is at issue.”96 The Court additionally rejected Gonzales’ call for deference in the face of medical uncertainty, instead emphasizing the part of the opinion stating, “the ‘Court retains an independent constitutional duty to review factual findings where constitutional rights are at stake.’”97 While rejecting the Fifth Circuit’s view about the role of courts in evaluating the health justifications for a law, the Supreme Court explicitly stated that the district court acted properly in evaluating the evidence for and against the law.98
Under this clarified standard, the Court struck down both the admitting-privileges and ambulatory-surgical-center requirements of the Texas law.99 With respect to the admitting-privileges requirement, the Court found that, despite the claimed purpose of “ensur[ing] that women have easy access to a hospital should complications arise during an abortion procedure,” the law “brought about no such health-related benefit.”100 Relying on the collection of evidence from peer-reviewed studies and expert witnesses presented to the district court at fact finding,101 Justice Breyer concluded that there is “nothing in Texas’ record evidence that shows that . . . the new law advanced Texas’ legitimate interest in protecting women’s health.”102 Similarly, the Court found that the evidentiary record provided significant support for the district court’s conclusion that the ambulatory-surgical-center requirement “does not benefit patients and is not necessary.”103 The Court emphasized that prior to enactment of the ambulatory-surgical-center requirement, Texas already held abortion facilities to such high health and safety standards that the new law did not make the facilities safer for abortion patients, and may have actually increased the risk of danger to women’s health.104 Additionally, the Court found that many of the requirements for ambulatory surgical centers were “inappropriate” for abortion facilities and that some of the rules “ha[d] such a tangential relationship to patient safety in the context of abortion as to be nearly arbitrary.”105
The lack of factual justifications for the “health-justified” provisions of HB 2 was further emphasized in Justice Ginsburg’s short, blunt concurring opinion. Citing amicus briefs from several medical organizations, including the American College of Obstetricians and Gynecologists (“ACOG”), Justice Ginsburg concluded that, given the realities of abortion care, “it is beyond rational belief that H. B. 2 could genuinely protect the health of women, and certain that the law ‘would simply make it more difficult for them to obtain abortion.’”106 Her concurrence concluded with a warning to states enacting laws analogous to Texas’ statute: “Targeted Regulation of Abortion Providers laws like H. B. 2 that ‘do little or nothing for health, but rather strew impediments to abortion,’ cannot survive judicial inspection.”107
C. The Practical Importance of Whole Woman’s Health’s Evidence-Based Standard
Whole Woman’s Health’s discussion of the proper standard of review for abortion regulations is significant because it clarified to the lower courts how to analyze such restrictions, and corrected courts that were applying an incorrect standard. After the decision was released, it was instantly useful to strike down similar admitting privilege and ambulatory surgical center requirements in other states.108 However, the value of the decision goes beyond legal clarity. Whole Woman’s Health also emphasized the importance of evidence-based laws and directed lower courts to actually analyze and interrogate the legislature’s purpose in determining whether abortion restrictions can stand. The decision’s critical interrogation of health justifications shows the Court’s willingness to accept medical and purpose-determinative evidence as relevant to legal analysis. Thus, the decision provides a litigation strategy for advocates who seek to strike down other laws restricting abortion access. Now, advocates can expect the courts to be responsive to arguments showing the actual purpose behind regulations, comparisons between regulations on abortion and those on other medical treatments, and evidence from peer-reviewed research and professional medical organizations.
By rejecting blind deference to the legislature, the Court’s decision reflected the way in which many abortion restrictions are actually enacted.109 Many state abortion restrictions are drafted by organizations whose purpose is to get rid of abortion, not to make it safer. The Texas law at issue in Whole Woman’s Health was drafted by Americans United for Life (“AUL”), an anti-abortion organization “dedicated to ending abortion through its incremental regulation,” and which “provides states model legislation that it claims will protect life and protect women’s health.”110 Legislators who share these anti-abortion sentiments promote the statutes through their state legislatures. On the day the Texas State Senate approved the admitting-privileges and ambulatory-surgical-center requirements, “then-Lieutenant Governor David Dewhurst tweeted a photo of a map that showed all of the abortion clinics that would close as a result of the bill. ‘We fought to pass S.B. 5 thru the Senate last night, & this is why!’”111 The Governor of Mississippi made a similar statement on the day the State enacted its own admitting-privileges requirement: “This is a historic day to begin the process of ending abortion in Mississippi.”112 These comments suggest that preventing abortion was the true impetus for the restriction, not protecting women’s health.113
Prior to Whole Woman’s Health, such evidence was insufficient to condemn anti-abortion regulations under the purpose prong. In Mazurek v. Armstrong,114 “[t]he Court rejected as insufficient to prove improper purpose the fact that an anti-abortion-rights group drafted the law, and that no evidence supported its patient-safety rationale.”115 But as scholar Caitlin Borgmann argues, stigma around the abortion right should make efforts to restrict it subject to more scrutiny, not less:
Four decades after Roe v. Wade, abortion remains a controversial constitutional right. Many state legislatures are eager to curb the procedure as much as possible. It stands to reason that some legislators will promote abortion restrictions on pretextual purposes. It is also predictable that their zeal to harass abortion providers or restrict abortion access will overwhelm their interest in the real facts.116
Without directly accusing the Texas legislature of enacting the law with an improper purpose, Justice Breyer’s opinion suggests that the law must have been motivated by an improper purpose by noting “the virtual absence of any health benefit.”117 Requiring that health-justified restrictions be supported by evidence will likely make it more difficult for states to blend health- and potential-life justifications, which was made easier by Gonzales. In requiring evidence to support a health-justified law, the Court treated abortion care as a form of health care, rather than a separate category that the legislature can regulate without regard to actual health outcomes.
Pro-choice scholars have labeled the willingness of legislatures and courts to treat abortion care differently than other forms of health care “abortion exceptionalism.”118 Gonzales shows a clear example of such exceptionalism, holding abortion care to a different standard than other medical care:
Gonzales v. Carhart was the first time in history the Court determined a physician could be prohibited from performing a medical procedure the physician found necessary to ensure the woman’s health. The longstanding tradition of the Court had been to defer to the medical profession to define what was medically necessary.119
In fact, the Gonzales Court specifically acted against ACOG’s recommendations, whose official “policy on abortion stated that only a physician, in consultation with a woman, could make the medical decision regarding the appropriate medical procedure to use to terminate a pregnancy.”120
The permissibility of blending health- and potential-life justifications left states free to practice abortion exceptionalism.121 In the context of health-justified exceptions, the permissibility of abortion exceptionalism represents a failure to treat abortion as what it is: an ordinary health care decision.122 Like other health decisions, both patients and physicians are better situated to make decisions that are best for a woman’s life and health. Allowing private health care decisions to be regulated because of the state’s interest in something other than health outcomes, such as potential life, clearly demonstrates how pregnant women are prevented from making their own medical decisions, a situation which is rare in the provision of other forms of health care.
The fact that special regulations on abortion providers represent a departure from standard medical practice is made more apparent by the safety of standard abortion procedures. Women are fourteen times more likely to die while carrying a pregnancy to term than from obtaining an abortion.123 Additionally, states already closely monitor and regulate abortion facilities, to the point that additional regulations do not improve outcomes for women’s health.124 An extensive report by Rewire, which drew on information from thirty-eight state attorneys general and thirty-two state health departments found “no support for . . . new restrictions on abortion.”125
The Court’s evidence-based standard repudiated such state actions, and instead treated abortion as a form of health care,126 and expressed an honest concern for the conditions in which women receive abortion care.127 Justice Ginsburg’s concurring opinion went a step further, recognizing that TRAP laws will not prevent women from having abortions, but will simply make abortion more dangerous: “When a State severely limits access to safe and legal procedures, women in desperate circumstances may resort to unlicensed rogue practitioners, faute de mieux [for want of a better alternative], at great risk to their health and safety.”128 A global study by the World Health Organization and the Guttmacher Institute supports this idea, finding that “the legal status of abortion does not influence a woman’s decision whether to have an abortion.”129 If lawmakers regulating abortion truly aim to protect women’s health, they must take this fact into consideration. The failure to do so, as the majority noted in Whole Woman’s Health, “would be harmful to, not supportive of, women’s health.”130 This harm has already been demonstrated: according to the Texas Policy Evaluation Project at the University of Texas, in Texas, which has passed several abortion restrictions over the last decade, at least 100,000 women have attempted to induce their own abortions.131 Lawmaker or voter disapproval of abortion does not justify making necessary medical care so unattainable that women resort to unsafe alternatives.132 Aside from the necessity of protecting recognized rights,133 “[i]t is the courts’ job to protect unpopular constitutional rights from legislative encroachment. They can only do this job well if they examine carefully the factual premises supposedly justifying burdensome abortion laws.”134
Whole Woman’s Health represents a step towards preventing moral opposition to abortion from swallowing up the constitutional right and condemning women to inferior health care options.135 The Court’s decision additionally provides a litigation strategy map for advocates seeking to challenge similar TRAP laws and expand access to abortion. The fact that Justice Breyer found it significant that other more dangerous medical procedures were less regulated than abortion indicates the Court’s responsiveness to arguments highlighting and challenging abortion exceptionalism. Additionally, the Supreme Court’s direction that lower courts must interrogate the factual bases for health-justified laws indicates that arguments couched in evidence for peer-reviewed research from professional organizations will be successful in challenging other restrictions.
As will be discussed in the following sections, “Justice Breyer’s unusually close examinations of the facts as he identifies and balances the benefits and burdens of the Texas law models a kind of scrutiny that few TRAP laws could withstand.”136 In the following sections, I describe three categories of abortion regulations that I argue are susceptible to challenge under Whole Woman’s Health’s evidence-based standard, and which can be challenged by utilizing medical studies and reports, as well as evidence of abortion exceptionalism. Not only will the use of these kinds of evidence allow advocates to strike at restrictive regulations, but it will also be a step towards treating abortion care like all other forms of health care.
IV. Informed Consent: Challenging the Provision of Incorrect or Misleading Information to Abortion Patients
Currently, thirty-five states have laws requiring informed consent before an abortion is performed, with twenty-nine of these states specifically detailing the information that must be provided to abortion patients.137 Many of these laws depart from the medical doctrine of informed consent by requiring pregnant women to be provided with inaccurate or uncertain information designed to discourage abortion. This section will first introduce the legal background of informed consent and then describe how, in another incidence of abortion exceptionalism, standard medical practice has been distorted in an effort to prevent abortions. Finally, the section will describe various informed consent laws that are not supported by medical evidence and thus fail to satisfy the scrutiny required after Whole Woman’s Health.
A. Introduction to the Doctrine of Informed Consent
Based in tort law, the doctrine of informed consent was developed to protect patients’ bodily autonomy and ability to make their own decisions about their health care. This is evidenced by the first statement of the doctrine by then-Judge Cardozo in Schloendorff v. Society of New York Hospitals: “Every human being of adult years and sound mind has a right to determine what shall be done with his own body; and a surgeon who performs an operation without his patient’s consent commits assault.”138 In order for consent to medical treatment to be “informed,” health care professionals must provide sufficient information to patients “to allow them to make an intelligent decision as to whether to undergo a medical intervention.”139 The determination of what is “material,” and thus must be disclosed to the patient, varies by state, with about half of states defining the risks as “those that a reasonable person would likely find significant” and the other half defining them as “what a reasonable physician would disclose.”140
The rationale behind informed consent reasons that “patients who are unaware of the risks, benefits and alternatives to a particular treatment cannot effectively render their consent to treatment.”141 It is thus essential to informed consent that the information provided be medically accurate and unbiased.142 In fact, early informed consent cases explicitly stated that a physician is prohibited from “substitut[ing] his own judgment for that of the patient by any form of artifice or deception.”143
B. Distortion of Informed Consent in the Abortion Context
While the doctrine of informed consent is based on bodily autonomy, informed consent and counseling laws in the abortion context have clearly departed from this foundation.144 A study by Rutgers University concluded that one third of women who seek abortions are provided with misleading information.145 Misleading or flatly inaccurate information is commonly provided under informed consent laws requiring the provision of incorrect statements that abortion can be reversed if the woman acts quickly;146 inaccurate information about the risk to fertility from abortion;147 inaccurate information that abortion is linked to breast cancer;148 largely inaccurate or unproven information that abortion causes the fetus to experience pain;149 and misleading information about negative psychological effects for women who have abortions.150
Prior to Whole Woman’s Health, such provisions appeared to be supported by the case law, including Casey, which upheld a Pennsylvania informed consent requirement.151 The statute in Casey required that women be provided with information about “the nature of the procedure, the health risks of the abortion and of childbirth,” as well as information about services to support the woman if she chose to have the child rather than an abortion.152 In upholding the provision, the Casey Court permitted the future proliferation of biased informed consent laws, despite the presence of language that can be read to limit such laws.153
Comparing Pennsylvania’s informed consent law provision to the doctrine as applied to other medical procedures, specifically kidney transplants, the Casey Court concluded that the provision “conforms to the general regulation of the practice of medicine outside the abortion context.”154 Additionally, the Court emphasized the need for medically accurate informed consent, stating that “[i]f the information the State requires to be made available to the woman is truthful and not misleading, the requirement may be permissible.”155 At the same time though, Casey appeared to permit the blending of health and potential-life rationales for informed consent laws, noting that states may require the provision of information “relating to the consequences to the fetus, even when those consequences have no direct relation to her health.”156
In so ruling, the Court departed from general medical standards and permitted the use of informed consent laws to promote moral values rather than to assure informed medical choice. In fact, the Court even went so far as to suggest that biased informed consent provisions could promote women’s health by protecting against future mental health problems.157 However, the Casey Court did not base its reasoning on factual support, which opened the door for Gonzales to further depart from the established principles of informed consent.158 Although the case did not involve an informed consent provision, Gonzales invoked the concept of informed consent to justify the prohibition of the intact D&E procedure, reasoning that a woman who later regrets her abortion will “struggle with grief more anguished and sorrow more profound” when she learns the means by which the abortion was performed.159 Like in Casey, the Gonzales Court was permitted to reach such a conclusion without scrutinizing any medical evidence. In fact, the Court explicitly states that there was no support for Court’s speculations about harm.160
By divorcing informed consent in the abortion context from the generally applicable medical doctrine, Casey and Gonzales permit yet another form of abortion exceptionalism. While informed consent is rooted in respect for patient autonomy, in the abortion context, informed consent laws permit states to question the decision-making capacity of women seeking abortions, and allow biased, inaccurate information to persuade them against making their own medical decisions. While states are permitted to pass laws aimed at persuading women to choose childbirth over abortion, such laws must be defended by the potential-life justification, rather than by pretending that such laws are aimed at promoting women’s health or assuring accurately informed consent.161 Under Whole Woman’s Health’s evidence-based standard, health-justified informed consent provisions are unconstitutional if they are not supported by medical evidence.162
C. After Whole Woman’s Health: Application to Specific Informed Consent Provisions
Not all informed consent provisions are justified by protecting women’s health, and it is possible that potential-life-justified informed consent laws could continue to stand even after Whole Woman’s Health. However, health-justified informed consent provisions will fail to satisfy the clarified undue burden standard if empirical research does not support their purported health benefit. In addition, those that are justified by the state’s interest in potential life should be found unconstitutional if, rather than simply seeking to persuade women against seeking an abortion, they bar women’s access to abortion.
1. Mental-Health-Justified Informed Consent Laws
Informed consent provisions justified by the concept of “abortion regret,” while impliedly authorized by Casey, fail the standard of review established in Whole Woman’s Health. The rationale that women come to regret their abortion has been used to justify abortion restrictions for many years. However, empirical research does not support this conclusion.163 In 2008, the American Psychological Association (“APA”) released a detailed report after its Task Force on Mental Health and Abortion collected and examined seventy-three peer-reviewed studies on the subject.164 The report ultimately concluded that “among women who have a single, legal, first-trimester abortion of an unplanned pregnancy for nontherapeutic reasons, the relative risks of mental health problems are not greater than the risks among women who deliver an unplanned pregnancy.”165
Two additional studies published in the last few years have found that the overwhelming majority of women who obtain abortions do not regret their decision. One of these is a recent longitudinal study conducted by researchers at the University of California, San Francisco (“UCSF”) and the associated organization Advancing New Standards in Reproductive Health (“ANSIRH”).166 They surveyed women having either first-trimester abortions or abortions within two weeks of the facility’s gestational age limit. Over the course of three years, 99% of women in both groups consistently reported that having an abortion was the right decision.167 The study also concluded that the women thought about their abortions less over time, with both negative and positive emotional responses decreasing as the study went on.168
Another study conducted by researchers at UCSF reached similar conclusions.169 Researchers at UCSF collected information both from women who obtained abortions and from women who were denied them because their pregnancies had progressed beyond the gestational age at which their states banned abortions. In addition to concluding that “abortion does not adversely affect women’s mental health over five years,” the researchers found that being denied an abortion leads to greater mental health issues than having one.170 Where the study authors saw “a general improvement in women’s mental health and well-being over time” after having an abortion, “[t]he women who were turned away and ultimately did give birth reported the most anxiety, and lowest self-esteem and life satisfaction one week after being denied an abortion.”171 The study authors concluded that informed consent laws seeking to protect women from the emotional distress that supposedly results from having an abortion are unjustified.172
Based on this empirical research, state laws requiring the provision of inaccurate information about abortion regret are not evidence-based. The standard delineated in Whole Woman’s Health also suggests that prior court decisions upholding informed consent provisions with dubious information about mental health outcomes could be overturned.173
2. Physical-Health-Justified Informed Consent Laws
In addition to informed consent laws that purportedly seek to protect women’s mental health, several states require physicians to provide women with inaccurate information that abortion is linked to detrimental physical health results, such as breast cancer or infertility.174 In many cases, such laws rely on debunked or methodologically problematic studies.175 While some states only require the provision of information about abortion and fertility when it is medically accurate, other states do not limit the impact of their informed consent laws.176
Links between abortion and breast cancer have been repeatedly rejected by the scientific community.177 The American Cancer Society explains the correlation between pregnancy and breast cancer risks on its website, explaining that a woman’s risk of breast cancer decreases as the number of full-term pregnancies she experiences increases.178 Additionally, women who have more menstrual periods over their lifetime have a slightly elevated risk of breast cancer, and pregnancy causes a woman to have fewer menstrual periods.179 Despite these connections, the American Cancer Society concludes that there is no causal link between abortion and breast cancer risk, as do the National Cancer Institute and the American College of Obstetricians and Gynecologists.180
Similarly, there is no empirical evidence to support informing women that abortion is linked to future fertility problems. A literature review of studies on this subject concluded that “there is no association between induced abortion and later infertility.”181 Specifically for the most common first trimester abortion procedure, vacuum aspiration, “[t]he overwhelming scientific consensus” is that the procedure “poses virtually no long-term risk of infertility,” or other negative reproductive health outcomes.182 While complications from abortion “may implicate future reproduction,” such complications are rare, particularly when abortions are performed at an early gestational age.183
Based on these conclusions, informed consent laws linking abortion with negative health outcomes like breast cancer and infertility are unconstitutional under Whole Woman’s Health’s evidence-based standard. One particularly ripe target for challenge is Texas’ “A Woman’s Right to Know” packet, which women in the state must receive twenty-four hours prior to an abortion being performed.184 After the state published the packet online, it immediately came under fire for its fear-inducing and misleading claims, particularly those linking breast cancer and abortion.185
3. Factually Dubious Claims about Abortion in Informed Consent
Finally, some states require women be provided with information that is factually disputed or flatly incorrect. The most common of these provisions are “fetal pain laws,” which require physicians to tell a woman that her fetus will experience pain from her abortion.186 Because the vast majority of abortions occur in the first trimester, this information is inaccurate with respect to most abortion patients, but states frequently do not limit this instruction to situations in which it may possibly be accurate.187
The statement that fetuses can experience pain is based on scientific studies indicating that the neural pathways which allow fully developed humans to experience pain form in the fetus as early as the twentieth week of pregnancy.188 However, other studies suggest that these pathways form as late in the pregnancy as thirty weeks.189 Additionally, other scientists argue that the formation of these structures alone is not enough to suggest that pain can be experienced.190 According to a literature review of studies on this subject published in the Journal of the American Medical Association, there is “limited” evidence that fetuses have the capacity to feel pain, and it is “unlikely before the third trimester.”191
While scientists may be in dispute about the later stages of pregnancy, it is clear that information about fetal pain is not factually supported prior to twenty weeks of pregnancy. Thus, requiring that informed consent laws include information about fetal pain will likely violate the Whole Woman’s Health evidence-based standard as applied to the vast majority of abortion patients. In addition, laws requiring doctors to administer anesthesia in order to perform abortions after 20 weeks, such as the law passed in Utah in 2016, may be ripe for challenge for lack of medical or factual support.192
V. Medication Abortion: Challenging Abortion Exceptionalism in the Regulation of Abortion Medication
A. Introduction to Medication Abortion
Medication abortion is usually performed via the prescription of two medications, mifepristone and misoprostol.193 Mifepristone, which is commonly referred to by its trade name, Mifeprex, functions by blocking the hormone progesterone, without which a pregnancy cannot continue.194 Six to forty-eight hours after taking mifepristone, a woman takes the second medication, misoprostol, which causes contractions and expels the contents of the woman’s uterus.195 It is worth noting that even when abortion medications are administered by a physician or in a clinic, the actual abortion will take place several hours later; according to the Mifeprex label, “most women will expel the pregnancy within 2 to 24 hours of taking misoprostol,” the second medication.196
While misoprostol has been used for years to complete spontaneous miscarriage or induce labor,197 its pairing with mifepristone was revolutionary for abortion care. When Mifeprex, also known as RU-486, was first approved by the FDA in 2000, it was heralded as “‘the little white bombshell’ that ‘may well reconfigure the politics and perception of abortion.’”198 Activists hoped that the option for women to be prescribed a pill and have an abortion in the privacy of their own homes would reduce the ability of states to block access to abortion care. It was believed that the drug would be particularly beneficial for women living in rural areas, who often lack access to a physician of any kind, particularly one who is willing to perform an abortion.199
Since its approval by the FDA, Mifeprex has largely changed the way in which abortion care is delivered, and medication abortions are now nearly as common as surgical abortions.200 In addition, Mifeprex and the increased use of medication abortion has been credited with the trend of abortions being performed earlier in pregnancy, thus making abortion care safer and more affordable.201 The full potential of Mifeprex came another step closer to being realized in 2016, when the FDA updated its prescription protocol, allowing for the drug to be prescribed further into pregnancy and lowering the recommended dosage for the drug in light of information about its safety and effectiveness.202 Public health experts lauded this decision, noting that the update brought the FDA protocol in line with evidence and clinical practice.203
Unfortunately, the benefit of medication abortion has been limited by several categories of state abortion regulations restricting the utilization of Mifeprex as it was originally imagined. Thirty-four states require that abortion medication only be administered by physicians.204 As will be discussed below, this physician-only requirement prohibits the prescription of Mifeprex by medical professionals such as physician’s assistants and nurse practitioners, both of whom are allowed to prescribe a wide range of medications, including controlled substances, in other contexts, and do so safely.205 Additionally, nineteen states require that the physician be physically present when the medication is administered.206 These requirements prevent medication abortion from being prescribed remotely via telemedicine, which most directly affects women living in rural areas.207 Finally, three states, North Dakota,208 Ohio,209 and Texas,210 require that Mifeprex is prescribed with strict adherence to the FDA approved label,211 despite the fact that many prescription medications are commonly prescribed “off label.”212 This leniency allows physicians to prescribe medication according to the most recent standards of practice, rather than based on rigid rules that are infrequently updated.213
In light of the evidence-based standard from Whole Woman’s Health, limitations on medication abortion prescriptions that are not based on medical evidence must be found unconstitutional. In particular, evidence suggests that medication abortion, and even later forms of abortion, can safely be performed by non-physicians and outside of a health care facility, as will be discussed in Part VI. In addition, state requirements that require physicians to prescribe Mifeprex according to an outdated FDA protocol are not supported by sufficient evidence under Whole Woman’s Health.
B. Applying the Evidence-Based Standard to Medication Abortion Restrictions
1. Medication Abortion without Physicians Physically Present
Requirements that physicians prescribe or be present for the administration of medication abortion pills were purportedly passed to protect women’s health. However, this insistence is disingenuous, particularly given the safety of Mifeprex and the ability of non-physicians to prescribe medication outside the abortion context.214 In most states, physician assistants and registered nurses are permitted to prescribe drugs that are far more dangerous than abortion medication, such as narcotics and stimulants.215 Additionally, professional medical organizations such as the ACOG, World Health Organization (“WHO”), the American Public Health Association (“APHA”), and the American Medical Women’s Association have all argued that non-physicians, such as nurse-midwives and nurse practitioners, should be permitted to provide medication abortion pills to women.216
Support for the safety of medication abortion without having a physician physically present can also be found in the utilization of telemedicine for other forms of medical treatment, such as in Alaska, where rural health providers send test results to doctors in large cities for diagnosis and treatment plans.217 According to medical ethicist Arthur Caplan of the University of Pennsylvania: “No one has ever said a negative word about the merits of telemedicine until Planned Parenthood used the technology to remotely open a drawer that contained abortion drugs.”218 Further, the FDA recently approved a new study in which abortion pills will be sent by mail to women seeking abortion, showing that the organization is open to the possibility of the medication being administered outside the presence of a physician.219
Finally, the consequences of laws limiting medication abortion clearly rebuff arguments that such laws are designed to protect women’s health. It is well documented that stigma around abortion has led to a deficit of physicians willing to provide abortions, particularly in rural states. When states mandate that abortions only be performed by physicians, it is inevitable that “a woman seeking a medication abortion may have to wait a long time for an appointment and travel long distances to visit the clinic attended by a physician. The situation is made worse by provisions that require that physician to be physically present during the procedure.”220 These delays cause women to obtain abortions later in their pregnancy, when abortion is more dangerous.
The demonstrated safety of non-physician provision of abortion medication and the fact that laws prohibiting such administration decrease women’s access to early, safe abortion provide empirical evidence that medication abortion restrictions do not actually promote women’s health. As a result, such laws are unconstitutional under Whole Woman’s Health. This argument was made recently in a lawsuit filed by the American Civil Liberties Union (“ACLU”) Reproductive Freedom Project and ACLU of Hawaii seeking to expand access to Mifeprex outside the presence of a physician.221 In Chelius v. Wright, the ACLU is challenging the FDA’s application of a Risk Evaluation and Mitigation Strategy (“REMS”) to Mifeprex, which requires that abortion patients “must be handed the medication at a clinic, medical office, or hospital under the supervision of a health care provider” who must first register with drug manufacturers, stock the drug, and meet other requirements.222 Noting that FDA REMS may be imposed “when, and only when, necessary to ensure that a drug’s benefits outweigh its risks,”223 the ACLU points to the safety of Mifeprex to argue that “this restriction is neither motivated nor supported by science.”224
While the Chelius Complaint specifically emphasizes the inappropriate application of a REMS to Mifeprex, its comments about the safety of the medication provide a compelling constitutional argument against laws requiring medication abortion pills be provided to a woman in the presence of a physician. At the outset, the Complaint notes that Whole Woman’s Health held that “an abortion restriction purportedly designed to protect patient health and safety must actually do so, and the medical benefit must outweigh the burden on patient access, or else the law is constitutionally invalid.”225 Ultimately, the ACLU argues that because the FDA protocol fails to satisfy this standard, it violates “patients’ right to liberty and privacy as guaranteed by the due process clause of the Fifth Amendment to the U.S. Constitution by imposing significant burdens on abortion access that are not justified by the law’s purported benefits, thereby imposing an undue burden on a woman’s right to abortion.”226
In support of this argument, the Complaint details conclusions of the medication’s safety, including by the FDA itself: “By the FDA’s own admission, major adverse events associated with Mifeprex are ‘exceedingly rare, generally far below 0.1% for any individual adverse event.’”227 In addition, the Complaint cites a letter from advocates such as ACOG, the American Public Health Association, the National Abortion Federation, and other medical professionals calling to end the Mifeprex REMs and allow its administration through retail pharmacies.228
In addition to demonstrating that the FDA rule is not justified by health outcomes, the Complaint also points out how requiring the provision of Mifeprex in the presence of a physician actually causes negative health implications by delaying access to abortion to later in the pregnancy, which increases the associated risks.229
Further, the Complaint demonstrates how the FDA’s purported justification for the rule is indicative of abortion exceptionalism, rather than actual concern for women’s health. The Complaint notes that the exact same medication, mifepristone, “is also FDA-approved under the brand name Korlym in 300 mg tablets for daily use by patients with endogenous Cushing’s syndrome to treat high blood sugar,” but that Korlym “is not subject to a REMS.”230 As ACLU Reproductive Freedom attorney Julia Kaye notes, “[t]he FDA’s unique restrictions on medication abortion are not grounded in science—this is just abortion stigma made law.”231 In addition, the Complaint describes several drugs which are more likely to cause adverse health outcomes than mifepristone—including Viagra—but which nonetheless are not subject to comparably strict FDA requirements.232
2. Laws Requiring Adherence to Outdated FDA Protocols
Because the FDA recently updated its recommended protocol for prescribing Mifeprex, the requirements in North Dakota,233 Ohio,234 and Texas235 that the drug be prescribed according to FDA protocols do not currently pose a risk to women’s health. However, the state laws “do not allow for additional improvements in practice if further advances are made to the medication abortion regimen.”236 As a result, women in these states will not benefit from future developments on the safest and most effective ways to prescribe Mifeprex. For example, there is some evidence that abortion medication can be used to facilitate some second trimester abortion procedures.237 States with laws requiring adherence to FDA protocols will not be able to benefit from such advances in medical knowledge, and women in those states will be prescribed medication under older standards of practice, which could cause harm to women seeking abortion.
The fact that adherence to outdated FDA protocols causes harm was clearly established by the effects of a 2011 Ohio state statute, which required Mifeprex be prescribed according to the FDA protocol. The law held physicians to the pill’s regime as approved in 2000, which required 600 milligrams of mifepristone followed two days later by 400 micrograms of misoprostol.238 The 2000 protocol also limited the use of Mifeprex to the first forty-nine days, or seven weeks, of pregnancy.239 (The 2016 update to the FDA protocol, which “aligned [the label] with standard medical practice, which has been proven safe and effective,”240 decreased the mifepristone dosage to 200 milligrams, and allowed Mifeprex to be prescribed up to 70 days into gestation.241)
A detailed study of 2,783 women who obtained medication abortions in Ohio showed the harm of following an old protocol when new medical standards had developed.242 According to the UCSF research team, women who obtained medication abortions after Ohio’s law went into effect were “three times as likely to need additional interventions to complete their abortion compared to women in the prelaw period.”243 The study’s principal author noted that the unnecessarily high dose of the medication caused almost double the amount of negative side effects, to the extent that “[w]omen got out to the parking lot, and they were vomiting and they had to come back [to the clinic] and take the dosage again.”244 The researchers cautioned that the updated FDA protocol may become outdated in the future, and that laws such as Ohio’s will prevent abortion providers from using the most up-to-date, evidence-based standards for Mifeprex.245
The medical evidence seems to clearly suggest that state laws requiring adherence to outdated FDA protocols do not further women’s health. As a result, the laws of North Dakota, Ohio, and Texas would likely fail to meet the Whole Woman’s Health standard if they required doctors to prescribe medication abortion “on label” after medical practice had developed beyond the 2016 FDA protocol.
VI. Physician-Only Requirements: Emphasizing the Safety of Non-Physician Abortion Providers
A. Applying the Evidence-Based Standard to Physician-Only Requirements
Recent scholarship also suggests that non-physicians can safely perform abortions later in pregnancy, such as aspiration abortions. Thus, state laws prohibiting medical professionals other than physicians from performing later abortions may not be supported by health outcomes, and therefore could be challenged under Whole Woman’s Health. In response to concerns about the lack of abortion providers, organizations such as the ACOG,246 the American Public Health Association,247 the World Health Organization,248 and the National Abortion Federation249 have called for medical professionals, such as nurse-midwives, nurse practitioners, and physician assistants to be trained to provide abortions. Even the FDA recognizes the safety and allows non-physician providers acting within their scope to dispense abortion medication.250 Some organizations have responded to these findings by seeking to train more abortion providers: the National Abortion Federation and Advancing New Standards in Reproductive Health, a program located at UCSF, have jointly created a toolkit to teach such professionals how they can expand their practice to include abortion care.251 The toolkit emphasizes its evidence-based approach, and notes that when properly trained, the provision of abortion services by these clinicians results in improved patient safety, integration of abortion care into early pregnancy care, and reduced delays in obtaining abortions.252
A recently published six-year study demonstrates the safety of permitting non-physicians to perform non-medication-based abortions.253 In that study non-physician health care providers—nurse practitioners, certified nurse midwives, and physician assistants—were granted legal waivers to perform aspiration abortions in California.254 The study concluded that “[f]irst trimester abortions are just as safe when performed by trained nurse practitioners, physician assistants and certified nurse midwives as when conducted by physicians.”255 Emphasizing that minority and low-income women are more likely to obtain primary care from one of these non-physican professionals, the study’s authors concluded that allowing non-physicians to perform aspiration abortions would likely improve health outcomes for women by expanding access to abortion providers and moving abortions earlier in the pregnancy, thus “significantly decreasing the overall risk of complications, which increases with gestational age.”256
In addition to the value of showing that non-physician practitioners can just as safely perform abortions, the study is ground-breaking “because it provides an example of how research can be used to answer relevant health care policy issues” says one of the co-authors, Diana Taylor, of UCSF School of Nursing.257 That is the goal of a recent lawsuit co-filed by the ACLU Reproductive Freedom Project and Planned Parenthood that seeks to reject the reasoning of lawmakers who claim that physician-only requirements protect women’s health.258 The ACLU’s Press Release about the case, Jenkins v. Almy, notes the significance of the study’s findings in light of the Supreme Court’s decision in Whole Woman’s Health, “which emphasized that states cannot burden patient access to abortion without proof of a valid medical justification.”259
Jenkins v. Almy challenges the state of Maine’s physician-only law which “prohibits, under threat of criminal prosecution, anyone other than a licensed physician from providing abortion services.”260 Much of the argument against the law’s constitutionality relies on showings that the physician-only law is “medically unjustified.”261 The filed Complaint cites medical and public health studies spanning several decades, including the study described above, demonstrating the safety of non-physician practitioners providing both medication and aspiration abortions.262 In addition, the Complaint references policy statements by numerous professional medical organizations in support of expanding who can provide abortions, including ACOG, the APHA, the WHO, and the FDA.263
The challenge also points out abortion exceptionalism in Maine’s laws to demonstrate that the physician-only requirement is not supported by medical evidence. The Jenkins Complaint highlights the inconsistency of the law with standard medical practice, pointing out that Maine “does not single out any other health care service as beyond an [advanced practice registered nurse’s] [“APRN”] scope of practice.”264 It also notes that such practitioners can legally perform similar tasks outside of the abortion context; in Maine, “APRNs may ‘prescribe, administer, dispense, or distribute any drug that is in the Maine formulary and that is ‘related to the the[ir] specialty area of certification,’”265 and “are authorized to prescribe potentially dangerous and addictive substances such as oxycodone, methadone, morphine, and codeine.”266 In fact, APRNs are legally permitted to perform the exact same procedure as aspiration abortion when a patient is experiencing a miscarriage, but may not perform that procedure in the often safer situation of a woman seeking an abortion.267 The law also allows APRNs to provide the medications misoprostol and mifepristone for miscarriage treatment, but not to induce abortion.268 The Jenkins Complaint utilizes both studies and evidence of abortion exceptionalism to show that the purpose is not medically justified and thus, under the clarified standard of Whole Woman’s Health, the law is an unconstitutional undue burden.269
B. Addressing Mazurek v. Armstrong
Arguments that physician-only requirements violate the undue burden standard will have to contend with the Supreme Court’s 1997 opinion in Mazurek v. Armstrong,270 which upheld a Montana law limiting performance of abortion to licensed physicians. However, an argument can be made that Whole Woman’s Health’s clarification of the standard has opened the door to a different result today. In Mazurek, the Ninth Circuit Court of Appeals struck down Montana’s physician-only requirement after finding that the law was passed for an improper purpose.271 Emphasizing the need to analyze the state legislature’s purpose in order to determine the law’s constitutionality, the court concluded that “[a] determination of purpose in the present case, then, may properly require an assessment of the totality of the circumstances surrounding the enactment of [the law], and whether that statute in fact can be regarded as serving a legitimate health function.”272 While this inquiry seems to be in line with what the Supreme Court would later hold to be required analysis in Whole Woman’s Health, the Supreme Court’s decision in Mazurek rejected this analysis, suggesting that the holding now rests on uneven footing.273 Reversing the Ninth Circuit, the Court “called into question whether an invalid purpose alone can constitute a justification for declaring a law unconstitutional.”274 In doing so, the Court rejected arguments that “the Montana law must have had an invalid purpose because ‘all health evidence contradicts the claim that there is any health basis for the law.’”275 The Court did so based on an understanding that Casey “‘reflect[s] the fact that the Constitution gives the States broad latitude to decide that particular functions may be performed only be licensed professionals, even if an objective assessment might suggest that those same tasks could be performed by others.’”276 However, given the discussion of health-justified abortion restrictions in Whole Woman’s Health, the Mazurek decision appears to rest upon a misunderstanding of the scrutiny Casey requires. In fact, Whole Woman’s Health seems to support the view put forward by Justice Stevens in his Mazurek dissent, in which he suggested that the lack of health benefits from the law suggested that it was passed for an improper purpose, and thus unconstitutional.277
This analysis is in fact supported by Justice Thomas’ dissent in Whole Woman’s Health, where he emphasized that Mazurek may not be able to stand under the clarified standard. Justice Thomas noted that Mazurek “had no difficulty upholding” the Montana law “even though no legislative findings supported the law and the challengers claimed that ‘all health evidence contradict[ed] the claim that there is any health basis for the law.’”278 In Justice Thomas’ view, this is because Casey and Gonzales made clear that “[w]henever medical justifications for abortion restriction are debatable, that ‘provides a sufficient basis to conclude in [a] facial attack that the [law] does not impose an undue burden.”279 However, in light of the Whole Woman’s Health decision, particularly the majority’s “refus[al] to leave disputed medical science to the legislature”280 and “require[ment that] laws . . . have more than a rational basis even if they do not substantially impede access to abortion,”281 Justice Thomas believes that “the majority’s undue burden balancing approach risks ruling out even minor, previously valid infringements on access to abortion.”282 In particular, Justice Thomas emphasizes that “by second-guessing medical evidence and making its own assessments of ‘quality of care’ issues . . . the majority reappoints this Court as ‘the country’s ex officio medical board with powers to disapprove medical and operative practices and standards throughout the United States.’”283
While advocates challenging physician-only requirements will have to contend with Mazurek’s precedent, challengers can point to Justice Thomas’ dissent to support an argument the decision relied on a misunderstanding of the undue burden standard. Now that Whole Woman’s Health has clarified that courts should inquire into the evidentiary support for laws regulating medical practices, challenges to the constitutionality of physician-only law could be successful despite Mazurek.
While Casey and Gonzales confused the standard of review for health-justified abortion restrictions, Whole Woman’s Health made it clear that courts must evaluate the factual basis for such laws. Where empirical evidence does not support the health justification, courts must strike down the law as violating the undue burden standard. Under this evidence-based standard, states are clearly not permitted to pass laws that claim to seek to protect women’s health, but actually make abortion more dangerous and difficult to access. Many existing informed consent provisions will fail this standard, as will limitations on the provision of medication abortion and who may provide abortion care. While abortion rights have been under particularly vigorous attack in recent years, the Supreme Court’s most recent abortion decision is a powerful tool for advocates seeking to protect safe and legal access to abortion. By requiring that health-justified laws actually promote health outcomes, the Court rejects abortion exceptionalism and affirms that the controversial nature of abortion does not mean that women’s health can be endangered—or that women’s choices may be stifled under the pretext of protecting their health.
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