Opinion ID: 2746137
Heading Depth: 1
Heading Rank: 5

Heading: Strict Scrutiny Application

Text: [¶99] Prior to the passage of H.B. 1297, medication abortions could be completed following the protocol for administration found on mifepristone’s FDA label, or they could be completed following the “off-label,” evidence-based regimen that has become standard practice in the medical community. The testimony indicated the evidence-based regimen had been used at the Clinic since 2007. The FDA label provision of H.B. 1297 takes the decision out of the hands of the woman and her doctor by requiring medication abortions to be performed in accordance with mifepristone’s FDA label. [¶100] When a state statute is alleged to burden a liberty right under the state constitution, this Court applies strict scrutiny. Hoff , 1999 ND 115, ¶ 13, 595 N.W.2d 285. “Where fundamental rights or interests are involved, a state regulation limiting these fundamental rights can be justified only by a compelling state interest and legislative enactments must be narrowly drawn to express only the legitimate state interests at stake.” Id. Generally, a statute is narrowly tailored, for purpose of determination whether it survives strict scrutiny review, only if it targets and eliminates no more than the exact source of the “evil” it seeks to remedy. As with the compelling interest determination, whether or not a regulation is narrowly tailored for purposes of a strict scrutiny analysis is evidenced by factors of relatedness between the regulation and the stated governmental interest. 16A Am. Jur. 2d Constitutional Law § 403 (2009). “The state, generally, has the burden of establishing that a state restriction which affects a fundamental right is necessarily related to a compelling interest.” Id. See Matter of K.A.S. , 499 N.W.2d at 565 (“[w]hen we use strict scrutiny, we do not defer to the legislative choice of classification but, instead, subject the classification ‘to close analysis in order to preserve substantive values of equality. . . .’”). Because H.B. 1297 burdens a woman’s liberty interest under the North Dakota state constitution, strict scrutiny applies to the determination of whether the challenged provisions of H.B. 1297 are constitutional. 1. Compelling State Interest [¶101] The State’s only expressed purpose for the off-label administration ban portion of H.B. 1297 is “to protect the health of women seeking abortions by regulating medication abortions.” (State’s Appellate Brief, 24). In passing H.B. 1297, the legislature treated the administration of medication abortions differently than any other medical procedure under North Dakota law. The justification was that abortion “is a very unique situation and sometimes in unique situations they call for unique remedies.” Hearing on H.B. 1297 Before the Senate Human Services Comm. , 62nd N.D. Legis. Sess. (March 15, 2011) (Senate Standing Committee Minutes) (testimony of Senator Spencer Berry). [¶102] Because prior to 1975 the state statutorily prohibited abortion, we must determine whether the state’s justifications in interfering with a woman’s liberty interest have changed over the years. The United States Supreme Court, in all decisions through Gonzales v. Carhart , instructs us that protection of unborn human life is not a sufficient justification to interfere with the liberty interest before viability. 550 U.S. 124, 146 (2007) (“Before viability, a State ‘may not prohibit any woman from making the ultimate decision to terminate her pregnancy.’”). [¶103] However, as noted by the Supreme Court of California, early anti-abortion legislation could be justified by the fact that abortion was dangerous. “When California’s first anti-abortion statute was enacted, any surgical procedure which entered a body cavity was extremely dangerous. Surgeons did not know how to control infection, and mortality was high.” People v. Belous , 458 P.2d 194, 200 (Cal. 1969). Although development was slow, techniques of antisepsis and asepsis became major general advances in surgery at and after the turn of the century. In due course safe procedures were developed for specific operations. Curettage, used for abortion in the first trimester, became a safe, accepted and routinely employed medical technique, especially after antibiotics were developed in the early 1940’s. (Douglas, Toxic Effects of the Welch Bacillus in Postabortal Infections (1956) 56 N.Y.State J.Med. 3673.) It is now safer for a woman to have a hospital therapeutic abortion during the first trimester than to bear a child. Id. at 200-01 (footnote omitted); accord Roe v. Wade , 410 U.S. at 149; Doe v. Bolton , 410 U.S. 179, 190-91 (1973). [¶104] The California court’s attention to the dangers of abortion is echoed in the North Dakota newspapers which reported death or near death by abortion in a roughly ten-year period near the time North Dakota enacted its first anti-abortion laws. See Revised Codes of the Territory of Dakota, Penal Code, §§ 337, 338 (1877); Compiled Laws of the Territory of Dakota, Penal Code, §§ 6538, 6539 (1887); Revised Codes of the State of North Dakota, Penal Code, §§ 7177, 7178 (1895). See An Abortion Murder , Bismarck Tribune, Nov. 18, 1878; A Strange Case , Bismarck Tribune, May 6, 1881; Condensed Telegraph , Bismarck Tribune, April 28, 1882; Telegraphic Ticks , Bismarck Tribune, October 20, 1882; Death Caused by an Abortion , Bismarck Daily Tribune, October 9, 1891; Bowman Arraigned , Bismarck Daily Tribune, Oct. 16, 1891. The state’s interest in maternal health has, in fact, changed with the advances of medical practice. [¶105] In 1969, the Supreme Court of California invalidated a criminal abortion statute requiring certainty of a woman’s impending death before abortion could be performed by a doctor. In so holding, the court noted “a definition requiring certainty of death would work an invalid abridgment of the woman’s constitutional rights.” Belous , 458 P.2d at 199. The court reasoned: The fundamental right of the woman to choose whether to bear children follows from the Supreme Court’s and this court’s repeated acknowledgment of a “right of privacy” or “liberty” in matters related to marriage, family, and sex. That such a right is not enumerated in either the United States or California Constitutions is no impediment to the existence of the right. It is not surprising that none of the parties who have filed briefs in this case have disputed the existence of this fundamental right. The critical issue is not whether such rights exist, but whether the state has a compelling interest in the regulation of a subject which is within the police powers of the state, whether the regulation is “necessary . . . to the accomplishment of a permissible state policy” and whether legislation impinging on constitutionally protected areas is narrowly drawn and not of “unlimited and indiscriminate sweep.” Id. at 199-200 (citations omitted). [¶106] Belous pre-dated Roe v. Wade , but Roe is consistent with the strict scrutiny applied to the abridgements of fundamental rights under state constitutions. Although Roe recognized states may “properly assert important interests in safeguarding health, in maintaining medical standards, and in protecting potential life,” the state’s interest under Roe was minimal early in pregnancy. 410 U.S. at 154. [¶107] The evidence in this case shows that medication abortions are in no more need of regulation than the multitude of other pharmaceutical drugs and medical procedures left unregulated by the legislature. As noted by the district court, the safety of medication abortions was a substantial focus of the trial, and the district court made findings based upon the evidence introduced. (Footnotes to the district court’s opinion appear in an Appendix to this opinion.). The district court summarized: 1. Safety and Efficacy of Medical Abortions The threshold issue is whether some compelling justification for regulation exists. Absent such need, even the most benign forms of infringement would be constitutionally infirm. Certainly no medical procedures performed in the United States have been subject to more criticism, opposition or scrutiny than those performed to electively terminate a pregnancy. Medical abortions are no exception. At the same time, elective abortion is a very common procedure. 3 For example, an estimated 1.75 million medical abortions have been performed in the United States since Mifeprex was first approved for marketing and distribution in 2000. R. at 209. A wealth of solid medical evidence regarding safety and efficacy exi[s]ts, particularly regarding the procedures commonly performed in the first trimester. This was a substantial focus of the trial. a. MKB’s Record During the first several months of gestation, abortion is most commonly performed surgically, using a variation of the vacuum aspiration technique. Most clinics also offer patients the option of a medical abortion. MKB has been providing medical abortions since 2007. R. at 14. This option is generally offered through 63 days of gestation, as measured from the first day of the last menstrual period (LMP). R. at 21-22. It is selected by approximately 20% of patients. 4 R. at 19. As of March 31, 2013, a total of 1,417 medical abortions had been performed in Fargo. R. at 127. Medical abortion patients of MKB are provided with detailed aftercare instructions. Exs. 30 and 31; R. at 133-34. They are also provided with a number they can call should they experience complications, or otherwise have questions or concerns. This phone service is provided on a continuous (24/7) basis, and is staffed by well qualified individuals. R. at 84. Patients are also instructed to return to the clinic two to three weeks following the initiation of the procedure. Approximately 75% of MKB’s patients comply with this instruction, and return for a follow-up evaluation. R. at 45-46. Therefore, MKB certainly has knowledge of the vast majority of any adverse events associated with the medical abortions it has performed. To the best of its knowledge, no patient of MKB has died following a medical abortion. Furthermore, no patient has experienced an infection requiring treatment, or required any form of follow-up surgery on an emergent basis. R. at 106. One patient did require a blood transfusion for hemorrhage. This is the only instance of emergency care known to MKB that may be associated with a medical abortion performed at its clinic. R. at 50. In terms of efficacy, approximately 2% of MKB’s medical abortion patients require a vacuum evacuation to complete the procedure. R. at 34. This additional treatment is provided at the clinic on a routine and non-emergent basis. R. at 51. It is usually performed at the time of the follow-up examination. R. at 35, 173. Furthermore, MKB’s results are completely consistent with the overwhelming medical evidence that is now available at the national and international levels. b. Credibility of Expert Testimony At trial, the primary experts regarding the safety and efficacy of medical abortions were Drs. Grossman and Harrison. From a standpoint of their training and experience, both of these experts are highly qualified. They are board certified in obstetrics and gynecology. Both have closely followed developments in the use of medication to perform abortions, and they have both done so since before Mifeprex was first approved for distribution in the United States. From an ideological standpoint, however, these two witnesses could not be more different. Dr. Grossman’s personal and professional bias is to increase access to abortions. R. at 183-84. Dr. Harrison is opposed to abortion in all forms. In 2000, she left her medical practice in order to devote all of her time and energy to the American Association of Pro-life Obstetricians and Gynecologists. Dr. Harrison is the executive director of that organization. She also serves as its director of research and public policy. R. at 374-80. It would be naive to assume that the opinions of either of these experts have not been influenced by their diametrically opposed convictions. At the same time, there are significant differences that should be noted. Dr. Grossman’s opinions were consistent and they were expressed with confidence. Those opinions are also supported by a very substantial body of medical evidence and literature. His answers were generally responsive, and appeared to be completely candid. By contrast, Dr. Harrison’s opinions have shifted dramatically over time, and appear to be shaped primarily by the position she is advocating at the moment. As a prime example, in 2002 she co- authored a “citizen petition” which urged the FDA to revoke its earlier approval of Mifeprex, and to conduct a comprehensive audit of the clinical studies commissioned by the drug’s sponsor. R. at 377. This petition argued vehemently that the performance of medical abortions in accordance with the FDA approved documents represented a substantial and unacceptable risk to women’s health. 5 In this litigation, Dr. Harrison supports the proposition that adherence to that same protocol should be legislatively mandated as a means of safeguarding women’s health. Furthermore, Dr. Harrison’s opinions lack scientific support, tend to be based on unsubstantiated concerns, and are generally at odds with solid medical evidence. To the extent she referenced published studies during her testimony, Dr. Harrison tended to present the results in an exaggerated or distorted manner. Finally, her demeanor on the stand was guarded and defensive. For all these reasons, it must be concluded that Dr. Grossman was a very credible witness, but the same cannot be said for Dr. Harrison. As Dr. Harrison was the state’s sole witness, this further detracts from any weight that can be given to the state’s evidence. c. Studies and Statistics In his testimony, Dr. Grossman provided a detailed analysis of the relative safety and efficacy of medical abortions. For comparison purposes, he relied primarily on morbidity and mortality statistics applicable to childbirth and early surgical abortions. 6 Before turning to any of this, however, a different and stark reality should be acknowledged. The alternative to safe and legal abortion is, of course, illegal abortion. When it is not performed by a skilled physician, utilizing acceptable medical techniques and procedures, abortion is a notoriously unsafe practice. According to the World Health Organization (WHO), on a global basis illegal abortions continue to result in an estimated 47,000 deaths each year. Approximately one- fourth of all women who survive such procedures are left with some form of disability. These realities fall disproportionately on the poor, who cannot afford to travel to places where abortions are legal. WHO, Safe Abortion: Technical and Policy Guidance for Health Systems , p. 1 (2d ed. 2012) (WHO, 2012 Guidance Document ). 7 If medical abortions are no longer legal, safe and available in North Dakota, it must be assumed some women will feel compelled to resort to self- help. Although this is neither safe nor legal, virtually any medication is now readily available over the Internet. R. at 232, 354-55. By comparison, when performed by physicians in accordance with the evidenced-based protocol followed by MKB, medical abortion is an extremely safe and effective procedure. The risk of a significant adverse event is so low it becomes hard to quantify. A very recent study analyzed data from 233,805 medical abortions performed by Planned Parenthood affiliates in 2009 and 2010. Almost all of those procedures utilized the same protocol followed by MKB. The overall incidence of significant adverse events was very low. Emergency room treatment was required in only 0.10% of all cases. The hospitalization rate was even lower—0.06%. R. at 240. The study also confirmed that the evidence-based regimen is more effective through 63 days LMP than the FDA approved protocol was through 49 days LMP. 8 The revised and updated guidance document released by the WHO in 2012 is an excellent summary of current medical evidence and standards. R. at 197. It reports the evidence-based regimens have “been proven highly effective, safe and acceptable” for abortions up to 63 days LMP. WHO, 2012 Guidance Document , p. 44. It goes on to indicate that efficacy rates up to 98% are achieved, and that only a small percentage of patients require surgical intervention to complete the procedure or to control bleeding. Id. d. The State’s Arguments The state failed to effectively refute any of this. It was suggested not all adverse events resulting from medical abortions may be reported, but this is certainly true of any medical procedure. R. at 264-78. Moreover, due to the intense scrutiny medical abortions receive, under-reporting should be a relatively insignificant concern in this case. R. at 317-18. The state also suggests that most of the data regarding medical abortions does not come from closely controlled medical trials, and therefore may not have comparable reliability. R. at 381-87. This criticism is equally unavailing. Because adverse events are so rare, any clinical study designed to analyze or quantify the risks would necessarily require a huge number of cases—a very unfeasible proposition. R. at 311. Dr. Harrison’s opposition to medical abortions has largely focused on her concern that this procedure may somehow be associated with an extremely rare and usually fatal form of bacterial infection. In her affidavit, she claimed that: “The death rate from C. sordellii infection alone in medical abortions is ten times the death rate from all causes in surgical abortion at a comparable gestational age.” Harrison aff., ¶ 12. The evidence introduced at trial painted a very different picture. The FDA has analyzed the adverse incident reports submitted in connection with the use of Mifeprex through the end of April 2011. This reflects data from an estimated total of 1.52 million cases. Ex. 6. Fourteen post-procedure mortalities have been reported. Some of those deaths were clearly unrelated. Seven cases tested positive for Clostridium sordellii , and one case tested positive for Clostridium perfringens . Id. fn. 1. The eight deaths that appear to be the result of bacterial infection have been the subject of intense scrutiny and debate. Dr. Harrison theorizes that the combination of mifepristone and misoprostol, when administered in accordance with the evidence-based protocol, may impair or interfere with natural immune systems or clotting mechanisms. R. at 395-97, 418. She provided no credible, scientific support for this theory. Despite the continued and concerted efforts of abortion opponents, the FDA continues to indicate that no causal connection has been established between medical abortions and the reported Clostridium deaths. The same is true for the CDC. R. at 446-47. Furthermore, deaths from the same bacterial infection have been reported following other medical events, including childbirth and surgical abortions, which suggests the absence of a causal link to medical abortions. R. at 210. Even if some causal connection is ultimately established, this concern has already been addressed by changes to the evidence-based protocol. Before these deaths were reported, most centers were instructing patients to self-administer the misoprostol vaginally. Seven of the reported fatal sepsis cases involved vaginal misoprostol use. Only one such death followed the buccal administration of this drug. Id. , fn. 1. The vast majority of providers, including MKB, now recommend the buccal administration of misoprostol, and prescribe an antibiotic on a prophylactic basis. R. at 283. On a national basis, perhaps 750,000 medical abortions have now been performed utilizing the current, evidence-based protocol. R. at 315. Even if the one fatality due to a bacterial infection is related, the mortality rate is infinitesimal. e. Risk Comparisons In comparative terms, childbirth is far more likely to result in death or significant complications. Dr. Grossman’s testimony underscores this reality. He cited a recent study which indicates a live birth is 12.5 times more likely to result in maternal mortality than a medical abortion. R. at 208-09. A comparison of morbidity rates also results in large disparities. For example, a blood transfusion is 10 times more likely following childbirth, and the risk of serious infection is increased by a factor of 5.2. R. at 205-06. Because all the rates are so low, it is more difficult to compare the potential risks associated with a medical abortion to those associated with an early surgical abortion. Dr. Grossman testified that, based on his thorough knowledge of the relevant studies, the overall risks are very comparable. 9 R. at 200. In its 2012 guidance document, the WHO concludes “complications are impressively rare and the risk of death is negligible” with any modern abortion procedure. WHO, 2012 Guidance Document , p. 47. This quote accurately captures the overall record. f. Conclusion In short, the record establishes, in a very convincing manner, medical abortions are very safe and effective through 63 days LMP, when performed in accordance with current standards. Accordingly, the state has failed to demonstrate any need to regulate this procedure, much less a compelling need. The district court’s findings accurately reflect the testimony given. The evidence establishes that there is no safety reason based on maternal health to limit medication abortions to the FDA label. [¶108] The findings of the district court on this issue are supported on appeal by the amicus brief filed by the North Dakota Medical Association in support of affirmance, which urges this Court: The [challenged portions of H.B. 1297] intrude[] on the patient-physician relationship in three concrete ways. First, following the Act’s treatment protocol, a physician is required to administer three times more medication than a patient needs. Second, the physician is required to instruct the patient to appear at the clinic during a time when it is safer for the patient to remain at home. Third, the physician is required to give the patient erroneous and dangerous instructions regarding what the patient should do if she experiences a medical emergency. All of these intrusions force a physician to violate prevailing standards of medical care and good medical judgment. [¶109] In Doe v. Bolton , the United States Supreme Court, applying strict scrutiny, struck down Georgia statutes regulating the manner in which abortions could be performed in that state as a constitutionally impermissible interference with the woman’s right to receive medical care and the doctor’s right to practice medicine. 410 U.S. at 197, 199. Criminal sanctions were imposed on the doctor for violations of the statute. Id. at 188. “Viewing the Georgia statute as a whole, we see no constitutionally justifiable pertinence in the structure for the advance approval by the abortion committee. . . . We are not cited to any other surgical procedure made subject to committee approval as a matter of state criminal law. The woman’s right to receive medical care in accordance with her licensed physician’s best judgment and the physician’s right to administer it are substantially limited by this statutorily imposed overview.” Id. at 197. “Required acquiescence by co-practitioners has no rational connection with a patient’s needs and unduly infringes on the physician’s right to practice.” Id. at 199. [¶110] The State cannot establish that the legislation serves the purpose of protecting maternal health, let alone a compelling interest. Since the decision of the district court, other states have failed to provide evidence that similar legislation restricting the use of off-label, evidence-based protocols for medication abortions protects maternal health. Planned Parenthood Arizona v. Humble , 753 F.3d 905, 916 ( 9th Cir. 2014), petition for cert. filed , 2014 WL 4467076 (U.S. Sept. 2, 2014) (No. 14-15624) (“Plaintiffs have introduced uncontroverted evidence that the Arizona law substantially burdens women’s access to abortion services, and Arizona has introduced no evidence that the law advances in any way its interest in women’s health.”). [¶111] Like the California Supreme Court in Belous , we conclude that considerations of maternal health do not provide a compelling state interest to support the constitutionality of the challenged legislation. 2. Narrowly Tailored [¶112] Even where the State has a compelling interest in the regulation of medication abortions, the State has an additional burden to show that state legislation limiting the exercise of fundamental rights is narrowly tailored to address its compelling interest. See Hoff , 1999 ND 115, ¶ 13, 595 N.W.2d 285. Evidence in this case shows the challenged legislation is not narrowly tailored. As discussed below, the provisions of H.B. 1297 at issue do not satisfy the less-stringent, undue burden analysis’s requirement that the challenged legislation further the State’s purpose. These provisions do not promote women’s health in any way, let alone in the most narrowly tailored way. Because we hold below that these provisions cannot stand under the less-stringent undue burden standard, we do not repeat the analysis here. The challenged provisions of H.B. 1297 are not narrowly drawn to address the State’s proffered interest. [¶113] We agree with Minnesota, Montana, California, Alaska, New Jersey, Tennessee, and other courts that the State must establish a compelling interest to interfere with a woman’s fundamental right to an abortion prior to viability and must establish a narrow means of addressing its interest. The challenged legislation fails both tests. The decision of the district court permanently enjoining enforcement of H.B. 1297 should be affirmed. V. Undue Burden Analysis [¶114] Although the district court determined the challenged portion of H.B. 1297 was unconstitutional under a strict scrutiny analysis, it also determined the challenged portion of H.B. 1297 was unconstitutional under the undue burden standard of analysis developed in federal caselaw. The district court’s undue burden analysis is required under both the federal and our state constitution. We interpret our state constitution in light of the text and history of that document. “[W]e cannot interpret our state constitution to grant narrower rights than guaranteed by the federal constitution.” Southeast Cass Water Res. Dist. v. Burlington N. R.R. Co. , 527 N.W.2d 884, 890 (N.D. 1995). Plaintiffs brought this action under several sections of the state constitution, primarily article I, sections 1 and 12. Although, as discussed above, the language in section 1 is more expansive than language in the federal constitution, section 12 virtually mirrors the language of the Fifth and Fourteenth Amendments to the federal constitution. Decisions arising under the comparable provision of the federal constitution must inform our decisions under the same language of our state constitution. Federal decisions interpreting and applying the Fourteenth Amendment become a minimum to our interpretation of section 12 of the state constitution in this context. Our own constitution requires this. See N.D. Const. art. I, § 23. We must therefore, at a minimum, consider the constitutionality, under our state constitution, of legislation regulating abortion under the undue burden standard developed in federal caselaw. [¶115] In 1973, in Roe v. Wade , 410 U.S. at 117-18, the United States Supreme Court considered a federal constitutional challenge to Texas statutes prohibiting abortions except for the purpose of saving the mother’s life. The Court concluded an individual’s right to privacy under the Fourteenth Amendment’s concept of personal liberty was broad enough to cover the abortion decision. Id. at 152-55. The Court concluded, however, an individual’s right to an abortion was not absolute and was subject to some limitations, and at some point, the state’s interest in the protection of a woman’s health, medical standards, and the potential for prenatal life became dominant. Id. The Court explained “[w]here certain ‘fundamental rights’ are involved, . . . regulation[s] limiting these rights may be justified only by a ‘compelling state interest,’ and that legislative enactments [regulating those fundamental rights] must be narrowly drawn to express only the legitimate state interests at stake.” Id. at 155 (citations omitted). The Court balanced the respective interests and announced a trimester framework for evaluating abortion regulations. Id. [¶116] In 1992, in Casey , 505 U.S. at 844, the United States Supreme Court considered a federal constitutional challenge to several provisions of the Pennsylvania Abortion Control Act of 1982. In Casey , a plurality of the Supreme Court reaffirmed the “essential holding” in Roe that the right to terminate a pregnancy before viability is a liberty interest under the Fourteenth Amendment’s due process clause: First is a recognition of the right of the woman to choose to have an abortion before viability and to obtain it without undue interference from the State. Before viability, the State’s interests are not strong enough to support a prohibition of abortion or the imposition of a substantial obstacle to the woman’s effective right to elect the procedure. Second is a confirmation of the State’s power to restrict abortions after fetal viability, if the law contains exceptions for pregnancies which endanger the woman’s life or health. And third is the principle that the State has legitimate interests from the outset of the pregnancy in protecting the health of the woman and the life of the fetus that may become a child. Id. at 846. [¶117] In Casey , 505 U.S. at 852, 871-72, the plurality discussed the practical difficulty in applying strict scrutiny to abortion regulations because of a state’s important and legitimate interests in a woman’s health and in potential life. The plurality opinion abandoned the trimester framework from Roe and instead applied an “undue burden” standard under the federal constitution to evaluate the constitutionality of abortion regulations before viability. Id. at 869-79. The plurality decision described the undue burden standard: A finding of an undue burden is a shorthand for the conclusion that a state regulation has the purpose or effect of placing a substantial obstacle in the path of a woman seeking an abortion of a nonviable fetus. A statute with this purpose is invalid because the means chosen by the State to further the interest in potential life must be calculated to inform the woman’s free choice, not hinder it. And a statute which, while furthering the interest in potential life or some other valid state interest, has the effect of placing a substantial obstacle in the path of a woman’s choice cannot be considered a permissible means of serving its legitimate ends. . . . Understood another way, we answer the question, left open in previous opinions discussing the undue burden formulation, whether a law designed to further the State’s interest in fetal life which imposes an undue burden on the woman’s decision before fetal viability could be constitutional. The answer is no. Some guiding principles should emerge. What is at stake is the woman’s right to make the ultimate decision, not a right to be insulated from all others in doing so. Regulations which do no more than create a structural mechanism by which the State, or the parent or guardian of a minor, may express profound respect for the life of the unborn are permitted, if they are not a substantial obstacle to the woman’s exercise of the right to choose. See [505 U.S.] at 899-900 (addressing Pennsylvania’s parental consent requirement). Unless it has that effect on her right of choice, a state measure designed to persuade her to choose childbirth over abortion will be upheld if reasonably related to that goal. Regulations designed to foster the health of a woman seeking an abortion are valid if they do not constitute an undue burden. . . . . We give this summary: (a) To protect the central right recognized by Roe v. Wade while at the same time accommodating the State’s profound interest in potential life, we will employ the undue burden analysis as explained in this opinion. An 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. (b) We reject the rigid trimester framework of Roe v. Wade . To promote the State’s profound interest in potential life, throughout pregnancy the State may take measures to ensure that the woman’s choice is informed, and measures designed to advance this interest will not be invalidated as long as their purpose is to persuade the woman to choose childbirth over abortion. These measures must not be an undue burden on the right. (c) As with any medical procedure, the State may enact regulations to further the health or safety of a woman seeking an abortion. Unnecessary 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. (d) Our adoption of the undue burden analysis does not disturb the central holding of Roe v. Wade , and we reaffirm that holding. Regardless of whether exceptions are made for particular circumstances, a State may not prohibit any woman from making the ultimate decision to terminate her pregnancy before viability. (e) We also reaffirm Roe ’s holding that “subsequent to viability, the State in promoting its interest in the potentiality of human life may, if it chooses, regulate, and even proscribe, abortion except where it is necessary, in appropriate medical judgment, for the preservation of the life or health of the mother.” Id. at 877-79 (citations omitted). [¶118] In Gonzales , 550 U.S. at 129, 132-33, the United States Supreme Court considered the validity of the Partial-Birth Abortion Act of 2003, 18 U.S.C. § 1531, a federal statute regulating certain partial-birth abortion procedures in the second trimester, passed with the purpose of respecting the life of the fetus. The Court described “assume[d]” principles from Casey for purposes of its decision: Before viability, a State “may not prohibit any woman from making the ultimate decision to terminate her pregnancy.” 505 U.S., at 879 (plurality opinion). It also may not impose upon this right an undue burden, which exists if a regulation’s “purpose or effect is to place a substantial obstacle in the path of a woman seeking an abortion before the fetus attains viability.” Id. , at 878. On the other hand, “[r]egulations which do no more than create a structural mechanism by which the State, or the parent or guardian of a minor, may express profound respect for the life of the unborn are permitted, if they are not a substantial obstacle to the woman’s exercise of the right to choose.” Id. , at 877. Casey , in short, struck a balance. Id. at 146. [¶119] In Gonzales , the Court construed the Partial-Birth Abortion Act and concluded it prohibited intentionally performing an intact dilation and evacuation procedure, but did not prohibit a standard dilation and evacuation procedure in which the fetus was removed in parts. 550 U.S. at 150-67. The Court compared the two procedures and determined the regulation furthered the government’s interest in promoting respect for life. Id. at 156-58. The Court also determined there was disagreement whether the prohibited procedure was safer than the allowed procedure, therefore the challengers had not met their burden of proving that the regulation had the effect of imposing an undue burden by requiring women to undergo a less safe procedure. Id. at 161-63.