Opinion ID: 2746137
Heading Depth: 1
Heading Rank: 6

Heading: Purpose—Women’s Health

Text: [¶120] Unlike Gonzales , in this case, the State’s expressed purpose for H.B. 1297 is “to protect the health of women seeking abortions by regulating medication abortions.” (State’s Appellate Brief, 24). Protecting women’s health can be a legitimate purpose for pre-viability abortion regulation. See Casey , 505 U.S. at 878 (plurality opinion). However, courts cannot simply take the legislature at its word that the law serves this interest. When conducting purpose prong analysis, courts must ensure that the state’s interest in women’s health is actually served by the legislation. See Gonzales , 550 U.S. at 158 (analyzing a law under the purpose prong of the undue burden test and concluding the law “further[ed] the Government’s objectives”); Humble , 753 F.3d at 913 (noting that a court must “ask[] whether and to what extent the challenged regulation actually advances the state’s interest”). In Casey , the Court reasoned that “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.” 505 U.S. at 877. “The same is true for laws purporting to protect women’s health: they ‘must be calculated’ to advance women’s health, ‘not hinder it.’” Humble , 753 F.3d at 913 (citation omitted). [¶121] The court in Humble was examining similar Arizona legislation that restricted medication abortions to FDA label protocols. As in this case, the state of Arizona was unable to demonstrate the legislation advanced maternal health. The Humble court, relying on Gonzales , 550 U.S. at 165-66, noted the critical judicial function is to examine both the rationale for the legislation and the burden it imposes, determining that uncritical deference is “inappropriate” where constitutional rights are at stake. Humble , 753 F.3d at 913. See also Planned Parenthood of Wisconsin, Inc. v. Van Hollen , 738 F.3d 786, 798 (7th Cir. 2013) (“The cases that deal with abortion-related statutes sought to be justified on medical grounds require not only evidence . . . that the medical grounds are legitimate but also that the statute not impose an ‘undue burden’ on women seeking abortions. The feebler the medical grounds, the likelier the burden, even if slight, to be ‘undue’ in the sense of disproportionate or gratuitous.” (Internal citations omitted)). [¶122] The Ninth Circuit was critical of the decisions in Planned Parenthood of Greater Texas Surgical Health Services v. Abbott , 748 F.3d 583 (5th Cir. 2014), and Planned Parenthood Southwest Ohio Region v. DeWine , 696 F.3d 490 (6th Cir. 2012), reh’g & reh’g en banc denied (Nov. 30, 2012), because of the failure in those cases to do a complete undue burden analysis as articulated and applied in Casey and Gonzales : “The Fifth and Sixth Circuits’ approach fails to recognize that the undue burden test is context-specific, and that both the severity of a burden and the strength of the state’s justification can vary depending on the circumstances.” Humble , 753 F.3d at 914. [¶123] The district court in this case took evidence which applied to both the State’s proffered rationale for the legislation and to the burden it imposed. The district court did a complete Casey / Gonzales analysis. 1. FDA Label Provision a. De Facto Ban [¶124] As discussed above, the testimony and evidence at trial shows that a de facto ban on medication abortions does not protect women’s health. b. Restriction to FDA Label [¶125] Analyzing the FDA label provision on its face, the voluminous record in this case supports the district court’s conclusion: requiring adherence to mifepristone’s FDA label does not protect women’s health. In order to conclude the FDA label provision of H.B. 1297 protects women’s health, there must be credible evidence that off-label abortions, which had become accepted practice in the medical community prior to this legislation, are more dangerous than abortions performed under the regimen described in the FDA label. Legislation for legislation’s sake that does not protect women’s health cannot be sustained applying either strict scrutiny or the undue burden standard of constitutional scrutiny under Casey . See Casey , 505 U.S. at 877-78. [¶126] There is no evidence in the record to support the theory that the medication abortion protocol approved by the FDA is safer for women than the evidence-based medication abortion protocol being used by MKB. Similarly, when passing H.B. 1297, the legislature itself recognized, “There was no testimony that indicated there was more risk with off label use.” Hearing on H.B. 1297 Before the Senate Human Services Comm. , 62nd N.D. Legis. Sess. (March 15, 2011) (Senate Standing Committee Minutes). [¶127] In its amicus brief, the North Dakota Medical Association described its opposition to H.B. 1297’s FDA label provision: The marketing, sale, and use of prescription medications in the United States are the subjects of a complex web of federal and state statutes, regulations, and oversight. The U.S. Food & Drug Administration (FDA) plays a prominent, but by no means exclusive role, in this web. The Act ham-handedly invokes the FDA’s role by incorporating the FDA’s medication marketing approval process, which the Act claims produces a “document that delineates how a drug is to be used according to the federal food and drug administration [sic].” H.B. 1297 § 1, 62[n]d N.D. Legis. Sess. (to be codified at N.D.C.C. § 14-02.1-02). The Act misconstrues the document at issue, the FDA’s role in its creation and distribution, and its meaning and effect in the practice of medicine. . . . . The Act’s required adherence to an outmoded protocol for administration of the drugs at issue is especially egregious because it forces North Dakota’s physicians to administer three times the clinically appropriate dose of Mifeprex. It forces physicians to set aside their medical knowledge, training, and experience and practice medicine in a manner not consistent with the prevailing standard of care. The Act thus compels a physician to violate his or her oath to “serve the highest interests of my patients through the practice of my science and my art.” (Footnotes omitted). [¶128] Testimony indicates that evidence-based, off-label medication abortion protocol is as safe as the FDA label protocol and, in fact, may even be more beneficial to women’s health. With respect to off-label use, the FDA itself notes: Once a product has been approved for marketing, a physician may prescribe it for uses or in treatment regimens or patient populations that are not included in approved labeling. Such . . . “unlabeled” uses may be appropriate and rational in certain circumstances, and may, in fact, reflect approaches to drug therapy that have been extensively reported in medical literature. The term “unapproved uses” is, to some extent, misleading. It includes a variety of situations ranging from unstudied to thoroughly investigated drug uses. Valid new uses for drugs already on the market are often first discovered through serendipitous observations and therapeutic innovations, subsequently confirmed by well-planned and executed clinical investigations. Before such advances can be added to the approved labeling, however, data substantiating the effectiveness of a new use or regimen must be submitted by the manufacturer to FDA for evaluation. This may take time and, without the initiative of the drug manufacturer whose product is involved, may never occur. For that reason, accepted medical practice often includes drug use that is not reflected in approved drug labeling . Use of Approved Drugs for Unlabeled Indications , FDA Drug Bulletin, Vol. 12 No. 1, April 1982 at 4-5 (emphasis added). [¶129] Dr. Eggleston, medical director of the Clinic, testified that they use an evidence-based protocol for medication abortions, rather than the FDA label protocol, because “numerous studies . . . have shown that the evidence-based method of medical abortion is safe and more effective [than the FDA label protocol] specifically up to 63 days gestational age.” “There’s been many evidence-based studies that show that the 600 milligrams, which is what was given—described in the [FDA label], is equivalent to 200 milligrams of the Mifepristone. And so there’s—they’re equally effective so there’s no reason to give more medication than needed. And it’s also three times as expensive.” Dr. Daniel Grossman noted that “one of the studies found an increased risk of nausea with women who received [the FDA label’s prescribed dosage] of Mifepristone compared to [the dosage given under evidence-based protocol].” Dr. Eggleston testified, “[T]here’s been numerous studies that have compared [evidence-based and off-label administration of misoprostol] and the—the [evidence-based administration] has been shown to be very safe and more effective especially in those women 50 to 63 days gestational age.” There are “no increase in serious complications” associated with the evidence-based administration of misoprostol. Dr. Eggleston also testified: A. . . . I can tell you in general we do not promote the FDA method because we use the evidence-based method which is safe and effective and is the standard of care in our region. Q. And when you say the evidence base is safe and effective, would you say the same thing about the FDA . . . protocol in terms of safety? A. Yes. It is safe and effective, yes. Q. It’s just less convenient, that’s what we’re talking about, right? A. No. The evidence base method is more effective especially in those women 50 to 63 days gestational age. Q. It’s more effective because it can’t be provided under the FDA, correct? A. And I think if you take—if you just compare the two regimens and take the FDA restriction out the evidence-based method that we give is more effective, especially between 50 and 63 days gestational age. Q. But under the FDA the 50 to 63 days isn’t even an issue, correct? A. It is not. They don’t comment on that in the FDA protocol. Q. Okay. For the protocol up to the 50 days, to the 49th day, are both methods of medication abortion equally safe? A. They’re both safe, yes. [¶130] Dr. Grossman testified that a study conducted at National Abortion Federation member clinics the year after mifepristone was approved by the FDA found that only 4% of facilities surveyed were administering medication abortions in accordance with the FDA label protocol; “the vast majority of providers were using evidence-based regimens.” Dr. Grossman also testified that this immediate shift away from the FDA label protocol indicated that protocol was “obsolete about the same time it was authorized.” Dr. Grossman noted that, under the 2005 American College of Obstetrician’s and Gynecologists (“ACOG”) guidelines on medication abortions: [T]he FDA approved protocol [for medical abortions] is safe and effective for medical abortion through 49 days of gestation. . . . [C]ompared with the FDA approved [protocol], [evidence-based protocols] are associated with a decreased rate of continuing pregnancies, decreased time to expulsion, fewer side [e]ffects, improved complete abortion rates, and lower cost for women with pregnancies up to 63 days of gestation based on last menstrual period. Dr. Grossman testified the ACOG reaffirmed its findings in 2011, and noted that, “compared to the FDA regimen, the evidence-based regimen . . . is essentially more effective and associated with a lower cost and can be used up to 63 days gestation.” Dr. Grossman concluded: There is no medical benefit [to the FDA label dosage of Mifepristone]. As I mentioned, you know, the studies that have done direct randomized controlled trials, or 4 studies that have looked comparing the 200 to 600-milligram doses of Mifepristone, show no differences in efficacy. There’s certainly ample safety data also with the 200-milligram regimen. [¶131] The testimony of the State’s only witness supports the conclusion that the off-label protocol for medication abortions is no more dangerous than administration pursuant to the FDA label protocol. Dr. Donna J. Harrison, Executive Director of the American Association of Pro-life Obstetricians and Gynecologists, testified: So when we look at this and you say is there a concern about 3,200 milligram tabs versus 1,200 milligram tabs, well, you’re getting more of the Mifepristone. Is that a concern? It depends on what you mean by a concern. It’s not been shown to be any different in any of the studies that have been done so in and of itself that’s not a concern. There’s not been shown to be a difference with 200 versus 600 as has been amply testified. Dr. Harrison also acknowledged that the ACOG concluded, “Multiple large studies in the United States have demonstrated that a patient can safely and effectively administer the Misoprostol, paren, orally or vaginally in her home.” Dr. Harrison also acknowledged that the World Health Organization concluded, “Home use of Misoprostol is a safe option for women.” Dr. Harrison did not provide an explanation as to why regulation of medication abortions should be limited to the FDA label, rather than the evidence-based protocol, instead stating that her opinion is that the FDA should revoke all approval of mifepristone. [¶132] The evidence at trial supports the district court’s conclusions that there was no evidence the FDA label protocol was beneficial or advantageous in protecting women’s health, when measured against the evidence-based, medically-preferred, off-label protocol. [¶133] In other areas of our statutes, the North Dakota legislature has recognized the importance of allowing physicians to prescribe medications based on best practices and their own medical judgment, rather than adhering to a drug’s FDA label. N.D.C.C. § 26.1-36-06.1 controls health insurance coverage for off-label uses of drugs. That statute requires health insurance providers to provide coverage for drugs administered off-label “if the drug is recognized for treatment of the indication in one of the standard reference compendia or medical literature.” Id. In passing this statute, the North Dakota legislature recognized that “[f]or [the FDA] to go back and reassign the drugs is very costly and through usage of drugs more advantages are found.” Hearing on H.B. 1428 Before the Senate Human Services Comm. , 55th N.D. Legis. Sess. (March 5, 1997) (Senate Standing Committee Minutes). They also recognized that medical doctors were in a better position to make judgments regarding the use of off-label drugs. Hearing on H.B. 1428 Before the House Industry, Business and Labor Comm. , 55th N.D. Legis. Sess. (Jan. 27, 1997) (written testimony of Rep. Ralph Kilzer). No other statutes have been passed by the legislature to ban off-label administration in other areas of medicine. [¶134] Off-label treatment is common in other medical contexts, such as the treatment of cancer: Off-label therapy with cancer drugs is common in practice. When there is no established therapy for a cancer, or stage of cancer, it is common for oncologists to try different regimens or combinations of established drugs. . . . In their daily practice, many oncologists treat cancer patients with regimens that include off-label use of drugs. They evaluate the published data and past clinical experience to assess the risk of such treatments. Guidance for Industry IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer , U.S. Department of Health and Human Services, 4 (Jan. 2004). [¶135] The restrictions at issue beg the question: would the legislature ban off-label treatment for other medical conditions? For example, use of off-label drugs is prevalent in the treatment of prostate cancer. See Zosia Chustecka, Significant Off- Label Use of Chemo in Elderly Cancer Patients , Medscape (June 13, 2013), http://www.medscape.com/viewarticle/805748 (noting there are 33 “unapproved” drugs used in the treatment of prostate cancer). [¶136] Evidence at trial was consistent with our statutory recognition of off-label use. When asked whether Dr. Grossman was “aware of any other areas of medical practice where physicians are restricted from prescribing drugs off-label where such off-label use has been documented as safe either in published medical journals or as consistent with the standard of care,” Dr. Grossman testified that he was “not aware of any other example.” 2. Emergency Contract Provision [¶137] The testimony and evidence at trial supports the conclusion that the emergency contract provision of H.B. 1297 does not protect women’s health, is unnecessary, is burdensome, can result in confusing instructions to patients, and is impossible to fulfill. The State argues that H.B. 1297 does not require physicians to direct patients to go to a specific physician and hospital if they have complications. Even assuming such an interpretation is plausible, it does not support the constitutionality of the challenged provision. The legislation provides: 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 who will be handling emergencies and the hospital at which any emergencies 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 emergencies associated with the use or ingestion of the abortion-inducing drug. 2011 N.D. Sess. Laws ch. 109, § 6. [¶138] The district court described the required contract as an exclusive contract. The language of the legislation supports this description. From the perspective of the physician agreeing to take on the responsibilities, it would certainly be perceived as an exclusive contract requiring continuous availability to meet the needs of patients coming from North Dakota, South Dakota, and Minnesota. The legislation requires that this physician have privileges at “the hospital designated to handle any emergencies associated with the use or ingestion of the abortion-inducing drug.” 2011 N.D. Sess. Laws ch. 109, § 6. The district court found, with support in the record, that these conditions were impossible to fulfill. As the testimony indicated, in the event of a medical emergency, patients have been regularly told to refer to the nearest medical center. Even if the State’s interpretation of the contract is correct, by requiring the physician to give the patient a copy of the contract indicating the “name and telephone number of the physician who will be handling emergencies and the hospital at which any emergencies will be handled,” id. , the State’s interpretation, at best, allows for confusing information to be provided to the patient. This is not in the interest of maternal health and is not supported by the language of the legislation. [¶139] The district court found that the emergency contract provision did not advance maternal health because it was unnecessary. The district court noted the complications associated with miscarriage and medication abortion are identical and so is the treatment. The difference is that complications associated with a miscarriage often arise later in the pregnancy when the fetus is more developed. Treating complications associated with miscarriage is a common medical event as the evidence established that one in seven pregnancies ended in spontaneous abortion. Complications associated with childbirth are also common medical events treated regularly throughout the medical community. Forty-three medical facilities distributed throughout North Dakota are capable of providing emergency care if complications arise from an abortion. The evidence before the district court established that MKB was only aware of one emergent situation for the Clinic patients which required a blood transfusion which was given in Minnesota. [¶140] The district court’s findings accurately reflect the evidence and testimony. Even under the State’s more forgiving interpretation, the emergency contract provision of H.B. 1297 does not protect women’s health.