Opinion ID: 2746137
Heading Depth: 3
Heading Rank: 3

Heading: Every pregnant woman to whom a physician gives, sells, dispenses, administers, otherwise provides, or prescribes any abortion-inducing drug must be provided with a copy of the drug’s label.

Text: 4. Any physician who gives, sells, dispenses, administers, prescribes, or otherwise provides an abortion-inducing drug shall enter a signed contract with another physician who agrees to handle emergencies associated with the use or ingestion of the abortion-inducing drug. The physician shall produce the signed contract on demand by the patient, the department of health, or a criminal justice agency. Every pregnant woman to whom a physician gives, sells, dispenses, administers, prescribes, or otherwise provides any abortion- inducing drug must be provided the name and telephone number of the physician whom will be handling emergencies and the hospital at which any emergences will be handled. The physician who contracts to handle emergencies must have active admitting privileges and gynecological and surgical privileges at the hospital designated to handle any emergences associated with the use or ingestion of the abortion-inducing drug. 5. When an abortion-inducing drug or chemical is used for the purpose of inducing an abortion, the drug or chemical must be administered by or in the same room and in the physical presence of the physician who prescribed, dispensed, or otherwise provided the drug or chemical to the patient. 2011 N.D. Sess. Laws ch. 109, § 6. [¶44] Statutory interpretation is a question of law, fully reviewable on appeal. In re P.F. , 2008 ND 37, ¶ 11, 744 N.W.2d 724. In enacting a statute, it is presumed the legislation is intended to comply with the state and federal constitutions, the entire statute is intended to be effective, a just and reasonable result is intended, a result feasible of execution is intended, and public interest is favored over any private interest. N.D.C.C. § 1-02-38. Words in a statute are given their plain, ordinary, and commonly understood meaning unless defined by statute or unless a contrary intention plainly appears. N.D.C.C. § 1-02-02. Statutes are construed as a whole and are harmonized to give meaning to related provisions. N.D.C.C. § 1-02-07. If the language of a statute is clear and unambiguous, the letter of the statute must not to be disregarded under the pretext of pursuing its spirit. N.D.C.C. § 1-02-05. If the language of a statute is ambiguous, however, a court may resort to extrinsic aids to determine the intention of the legislation, including the object sought to be attained, the circumstances under which the legislation was enacted, and the legislative history. N.D.C.C. § 1-02-39. A statute is ambiguous if it is susceptible to different, rational meanings. State v. Meador , 2010 ND 139, ¶ 11, 785 N.W.2d 886. [¶45] The determination whether a statute is constitutional is a question of law, which is fully reviewable on appeal. State v. Holbach , 2009 ND 37, ¶ 23, 763 N.W.2d 761. All regularly enacted statutes carry a strong presumption of constitutionality, which is conclusive unless the party challenging the statute clearly demonstrates it contravenes the state or federal constitution. Teigen v. State , 2008 ND 88, ¶ 7, 749 N.W.2d 505. Any doubt about a statute’s constitutionality must, when possible, be resolved in favor of its validity. State v. M.B. , 2010 ND 57, ¶ 4, 780 N.W.2d 663. The power to declare a legislative act unconstitutional is one of the highest functions of the courts, and that power must be exercised with great restraint. Teigen , at ¶ 7. The presumption of constitutionality is so strong that a statute will not be declared unconstitutional unless its invalidity is, in the court’s judgment, beyond a reasonable doubt. In re Craig , 545 N.W.2d 764, 766 (N.D. 1996). The party challenging the constitutionality of a statute has the burden of proving its constitutional infirmity. State v. Brown , 2009 ND 150, ¶ 30, 771 N.W.2d 267. [¶46] In considering the challenged language in H.B. 1297, the State argues the district court erred in construing the legislation to ban all medication abortions. The State argues the language in H.B. 1297, when construed together to give meaning to each word and phrase, requires adherence to the FDA final-printed-label protocol for medication abortions. [¶47] The protocol for mifepristone’s FDA final-printed-label regimen and the off- label use for mifepristone for medication abortions require mifepristone to be used in conjunction with misoprostol. The parties do not dispute misoprostol has not been separately approved by the FDA for use in abortions and the FDA final-printed-label protocol for misoprostol authorizes use of misoprostol to treat ulcers but is silent on abortion-related uses. The medical evidence in this record reflects mifepristone by itself, completes a medication abortion in about seven percent of cases, and misoprostol is necessary to complete the medication abortion in the remainder of cases. As construed in conjunction with the FDA final-printed-label protocol, those definitions suggest a complete prohibition of medication abortions using misoprostol. See Cline , 2013 OK 93, ¶¶ 15-17, 313 P.3d 253 (construing abortion-inducing drug under Oklahoma statute to include misoprostol; citing statutory definition of abortion-inducing drug as including misoprostol). Unlike the statutory definition of abortion-inducing drug at issue in Cline , however, H.B. 1297 does not specifically define abortion-inducing drug to include misoprostol, and other provisions in H.B. 1297 require that medication abortions follow the FDA final-printed-label protocol for the abortion-inducing drug. Mifepristone is an abortion-inducing drug and incorporates the use of misoprostol in that regimen. When read together, the amendments are not clear about whether H.B. 1297 was intended to include misoprostol as an abortion inducing drug and to prohibit all medication abortions or to require medication abortions to follow the FDA final-printed-label protocol for mifepristone. I therefore consider extrinsic aids in construing H.B. 1297, including the legislative history. [¶48] The legislative history for H.B. 1297 does not include any references to a total ban on all medication abortions; rather, the legislative history manifests that the legislation was intended to permit medication abortions under the protocol tested and authorized by the FDA final-printed-label protocol. See Hearing on H.B. 1297 Before House Human Servs. Comm. , 62nd N.D. Legis. Sess (Jan. 31, 2011) (testimony of Representative Betty Grande that legislation uses FDA guidelines for definitions and safe practices; written testimony of Christopher T. Dodson, Executive Director of North Dakota Catholic Conference that use of abortion-inducing drug is in manner authorized by FDA in accordance with manufacturer’s instructions; and written testimony of Amy Jacobson, North Dakota Public Affairs Manager for Planned Parenthood of Minnesota, North Dakota, and South Dakota that bill would require physicians to follow outdated protocol for medication abortion instead of best standard available). Nothing in the legislative history indicates H.B. 1297 was intended to prohibit all medication abortions and the history of the legislation supports an interpretation that H.B. 1297 requires adherence to the FDA final- printed-label protocol, which authorizes the use of mifepristone and incorporates the use of misoprostol for medication abortions according to the FDA final-printed-label protocol for mifepristone. I construe H.B. 1297 to permit medication abortions under the FDA final-printed-label protocol for mifepristone, which employs the administration of mifepristone and misoprostol up to 49 days after a woman’s last menstrual period and requires the misoprostol to be administered orally at the clinic. I conclude the district court erred in interpreting H.B. 1297 to ban all medication abortions. [¶49] I also construe the plain language of H.B. 1297 to require a physician prescribing, giving, administering, or otherwise providing an abortion-inducing drug to enter a signed contract with another physician for emergencies associated with the use or ingestion of the abortion-inducing drug and to require the pregnant woman be provided with the name and telephone number of the other physician who will be handling emergencies and the hospital at which any emergencies will be handled. Moreover, the plain language of the amendments requires the other physician to have admitting privileges and gynecological and surgical privileges at the designated hospital. The district court construed the provisions for the emergency services contract to require the prescribing or providing physician to enter an “exclusive” contract with another physician. Although the language of H.B. 1297 requires a physician prescribing or providing an abortion-inducing drug to enter a written contract with another physician for emergency services, the plain language does not require an exclusive contract and does not preclude the prescribing or providing physician from giving a pregnant woman other additional information for dealing with emergencies, such as going to the nearest available hospital for an emergency. Moreover, I also note the plain language about the emergency services contract does not include any geographical limitations like the admitting and staffing privileges requirement in the 2013 amendments in S.B. 2305. [¶50] Finally, the plain language of H.B. 1297 requires an abortion-inducing drug used for the purpose of inducing an abortion to be administered in the same room and in the physical presence of the prescribing or dispensing physician. The State contends misoprostol, the second drug employed in the off-label protocol and the FDA final-printed-label protocol for medication abortions, is not an “abortion- inducing drug” prescribed or dispensed with the intent of causing an “abortion” when used after mifepristone because misoprostol expels the contents of the uterus and does not cause or induce the death of an unborn child, as those terms are defined in the legislation. I agree with the State’s interpretation of H.B. 1297 that misoprostol is not an abortion-inducing drug under the language in H.B. 1297, but I nevertheless recognize the FDA final-printed-label protocol requires misoprostol to be administered orally at the clinic two days after mifepristone. 3 [¶51] Having construed the challenged provisions in H.B. 1297, I consider that legislation under the undue burden standard. The federal courts that have considered challenges to state laws regulating medication abortions have reached varying results under the undue burden standard. See DeWine , 696 F.3d at 513-18; Planned Parenthood of Greater Texas Surgical Health Servs. v. Abbott , 748 F.3d 583, 600-05 (5th Cir. 2014); Planned Parenthood Ariz., Inc. v. Humble , 753 F.3d 905, 911-18 (9th Cir. 2014). [¶52] In DeWine , 696 F.3d at 513-18 (opinion by McKeague, J.), the Sixth Circuit Court of Appeals, in a 2-1 decision, affirmed a summary judgment dismissing a challenge to an Ohio statute requiring adherence to the dosage requirements and gestational time limits in the FDA final-printed-label protocol for medication abortions. The court held the statute did not have the effect of creating a substantial obstacle to a woman’s right to an abortion and did not impose an undue burden on a woman’s ability to make the decision to have an abortion. Id. The court explained the ban on medication abortions from 50 to 63 days after a woman’s last menstrual period was not an undue burden because the ban on that method of abortion for that time frame did not preclude a surgical abortion, which was the most common method of abortion for that time period. Id. at 514-16. The court said a woman’s right to choose an abortion did not encompass the right to choose a particular method of abortion. Id. The court explained the right to abortion under federal jurisprudence protects the freedom to decide whether to terminate a pregnancy, but has not been extended to a woman’s preferred method of terminating a pregnancy. Id. at 516. The court concluded in the absence of any evidence the statute created a substantial obstacle to the ultimate abortion decision, any conclusion about what a woman might prefer did not create a disputed issue of material fact. Id. The court also determined the increased costs associated with increased or different dosages of medication under the FDA final-printed-label protocol did not create an undue burden on a woman’s right to an abortion. Id. at 516. The court cited Casey for the proposition that although at some point increased costs could become a substantial obstacle to a woman’s right to obtain an abortion, increased costs associated with additional trips to an abortion clinic did not constitute an undue burden on a woman’s right to an abortion for a large fraction of affected women. 696 F.3d at 517. The court concluded the provisions for medication abortions at issue in that case did not constitute an undue burden on a woman’s right to an abortion before viability. Id. at 514-17. [¶53] In Abbott , 748 F.3d at 600-05, the Fifth Circuit Court of Appeals considered a facial challenge to a Texas statute requiring medication abortions follow the FDA final-printed-label protocol for mifepristone and concluded the statute was constitutional. In the context of that facial challenge, the court applied Gonzales to analyze whether restrictions on medication abortions from 50 to 63 days after a woman’s last menstrual period facially imposed an undue burden on the abortion right of women who, because of gynecological abnormalities, cannot safely undergo a surgical abortion during that time period. Abbott , at 600-05. The court concluded the Texas statute’s requirement for adherence to the FDA final-printed-label protocol for medication abortions did not facially require a court imposed exception for the life or health of a woman. Id. The court explained the Texas statute did not ban an entire abortion method; rather, it shortened the window during which a woman may elect to have a medication abortion. Id. The court held the statute, on its face, did not impose an undue burden on the life and health of a woman and explained that its decision did not detract from the requirement in Casey regarding abortion restrictions where the abortion is necessary to preserve the life of the mother. Id. [¶54] In Humble , 753 F.3d at 907, 911-18, the Ninth Circuit Court of Appeals reversed a federal district court decision denying a motion to preliminarily enjoin enforcement of Arizona regulations restricting medication abortions to the FDA final-printed-label protocol. The Ninth Circuit Court of Appeals concluded Abbott and DeWine were inconsistent with the undue burden test articulated in Casey and Gonzales , stating the Fifth and Sixth Circuits’ approach failed to recognize the undue burden test is context-specific and both the severity of a burden and the strength of the state’s justification can vary depending on the circumstances. Humble , at 914-15. The Ninth Circuit Court of Appeals adhered to its approach in Tucson Woman’s Clinic v. Eden , 379 F.3d 531, 539 (9th Cir. 2004), which the court explained required weighing the extent of the burden against the strength of the state’s justification in the context of each individual state regulation. Humble , at 914-15. The court concluded the Arizona regulation, on the record before the court for the preliminary injunction, appeared wholly unnecessary for a woman’s health. Id. In reversing the denial of a preliminary injunction, the court said the plaintiffs had provided uncontroverted evidence Arizona’s regulation of medication abortions substantially burdens a woman’s access to abortion services and Arizona provided no evidence the law advances its interest in a woman’s health. Id. at 916-17. [¶55] I recognize the split in the federal circuits on issues relating to medication abortions, which ultimately may require resolution by the United States Supreme Court. I agree, however, with the application of the undue burden standard by the Fifth and Sixth Circuits because I conclude those decisions reflect the proper deference to a state’s interest in a woman’s health and in potential life under Gonzales and Casey . [¶56] During the legislative process, the proponents of H.B. 1297 provided the legislature with information describing dangers of abortion-inducing drugs and the need for regulation. See Hearings on H.B. 1297 Before House and Senate Human Servs. Comms. , 62nd N.D. Legis. Sess. (Jan. 31, 2011 and March 14, 2011) (prepared testimony of Christopher T. Dodson, Executive Director of North Dakota Catholic Conference with attached exhibit). The legislature was also provided with contrary information describing the efficacy of a medication abortion at the Clinic under the off-label protocol. See Hearing on H.B. 1297 Before Senate Human Servs. Comm , 62nd N.D. Legis. Sess. (March 14, 2011) (testimony of Tammi Kromenaker, Director of Red River Woman’s Clinic). [¶57] On its face, H.B. 1297 reflects a legitimate purpose to protect women from asserted dangers of off-label use of an abortion-inducing drug for a medication abortion while permitting surgical abortions and medication abortions using the FDA final-printed-label protocol. “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.” Gonzales , 550 U.S. at 158. The plaintiffs have presented evidence reflecting medication abortion is extremely safe and the off-label protocol used by the Clinic has advantages over the FDA final-printed-label protocol. I am not persuaded, however, that the evidence suggests there is no basis for the regulations in H.B. 1297. A legislature need not legislate the best means to achieve a goal and it is not for this Court to “improve” or “cleanse” the legislative process. See Abbott , 748 F.3d at 594. [¶58] I have construed H.B. 1297 to permit medication abortions under the FDA final-printed-label protocol for mifepristone and to not require an exclusive contract with another physician for emergency services. As I have construed H.B. 1297, I am not persuaded the purpose or effect of the legislation imposes a substantial obstacle on a woman’s right to an abortion before viability under federal precedent. To the extent the district court made contrary determinations about the effect of H.B. 1297, the court’s findings were based on its erroneous interpretation of the language of H.B. 1297 and the court’s erroneous application of strict scrutiny to the legislation. We have often said findings of fact based on an erroneous conception of the law are not entitled to deference under the clearly erroneous standard of review. See, e.g. , MayPort Farmers Coop. v. St. Hilaire Seed Co., Inc. , 2012 ND 257, ¶ 4, 825 N.W.2d 883. [¶59] I agree with the ultimate conclusions in DeWine and Abbott that statutes requiring adherence to the FDA final-printed-label protocol for medication abortions are rational regulations related to the regulation of the medical profession to promote a woman’s health and respect for life, including the life of the unborn, and do not constitute an undue burden on a woman’s right to an abortion before viability. I conclude the rationale of DeWine and Abbott is persuasive for assessing H.B. 1297 under applicable federal precedent. I conclude the challenged provisions of H.B. 1297, on their face and as I have construed them, do not constitute an undue burden on a woman’s right to abortion before viability under applicable federal precedent.