Okla. Coal. for Reprod. Justice v. Cline

• Court: Oklahoma Supreme Court
• Writing for the Court: PER CURIAM.
• Citation: Okla. Coal. for Reprod. Justice v. Cline, 441 P.3d 1145 (Okla. 2019)
• Decision Date: 30 April 2019
• Docket Number: No. 116,603,116,603
• Parties: OKLAHOMA COALITION FOR REPRODUCTIVE JUSTICE, on behalf of itself and its members; and Nova Health Systems, d/b/a Reproductive Services, on behalf of itself, its staff, and its patients, Plaintiffs/Appellees, v. Terry L. CLINE in his official capacity as Oklahoma Commissioner of Health, Defendant, and Lyle Kelsey, in his official capacity as Executive Director of the Oklahoma State Board of Medical Licensure and Supervision, Defendant/Appellant, and Preston L. Doerflinger, in his official capacity as Oklahoma Interim Commissioner of Health, Appellant.

441 P.3d 1145

OKLAHOMA COALITION FOR REPRODUCTIVE JUSTICE, on behalf of itself and its members; and Nova Health Systems, d/b/a Reproductive Services, on behalf of itself, its staff, and its patients, Plaintiffs/Appellees,

v. Terry L. CLINE in his official capacity as Oklahoma Commissioner of Health, Defendant,andLyle Kelsey, in his official capacity as Executive Director of the Oklahoma State Board of Medical Licensure and Supervision, Defendant/Appellant,andPreston L. Doerflinger, in his official capacity as Oklahoma Interim Commissioner of Health, Appellant.

No. 116,603

Supreme Court of Oklahoma.

FILED APRIL 30, 2019

Mithun S. Mansinghani, Solicitor General, Michael K. Velchik, Assistant Solicitor General, State of Oklahoma, Oklahoma City, Oklahoma, for Defendants/Appellants.

J. Blake Patton, Oklahoma City, Oklahoma, for Plaintiffs/Appellees.

PER CURIAM:

¶1 We decided OklahomaCoalitionforReproductiveJustice v. Cline, 2016 OK 17, 368 P.3d 1278 (Cline III) on February 23, 2016, which addressed whether House Bill (H.B.) 2684 violated two provisions of the Oklahoma Constitution. The provisions in question were art. 5, § 1, delegation of legislative authority¹ and art. 5, § 59 prohibition of special laws.² We held that neither provision was violated, and we remanded the cause to the trial court for a determination of the bill's validity under other state and federal constitutional provisions. The trial court held a hearing on October 6, 2017, and on November 9, 2017, it granted summary judgment and declared H.B. 2684 "unconstitutional in all applications" and "therefore void and of no effect." The State appealed on December 8, 2017, and we retained the cause on January 2, 2018.

¶2 On June 4, 2018, we stayed resolution of this cause pending the outcome of an Arkansas case, PlannedParenthoodArkansas&EasternOklahoma v. Jegley, 2016 WL 6211310 (E.D. Ark. 2016), which involved a similar statute. The Arkansas case concluded with a dismissal by the appealing parties, thus rendering it ineffective to persuasively apply to this cause.³ We hereby vacate the stay and hold that: 1) decisions from the United States Supreme Court are binding on this Court, and because the United States Supreme Court has spoken, this Court is bound by its pronouncements;⁴ and 2) the Legislature's requirement that physicians adhere to the Federal Drug Administration's (FDA) 2000 label protocol for medication-induced abortions, rather than the more effective current 2016 label protocol places a substantial obstacle in the path of a woman's choice and imposes an undue burden on the woman's rights pursuant to United States Supreme Court precedent as it currently exists.

FACTS AND PROCEDURAL HISTORY

¶3 The undisputed facts in this appeal which are supported by competent evidentiary materials which are nearly identical to those in Cline III, supra, ¶¶9-11, and are summarized here. Cline III, supra, also discussed the procedural history of both the caselaw and legislation leading up to the enactment of H.B. 2684 in ¶¶2-7. (We summarize that history here as well as previously stated in Cline III, supra.)

¶4 Medication terminated pregnancy is a procedure for terminating a pregnancy using medications alone, generally following a protocol using both Mifeprex and misoprostol, which are taken one after the other respectively. Methotrexate is used to terminate or treat ectopic pregnancies. In 2011, the Oklahoma Legislature enacted H.B. 2684's predecessor, H.B. 1970, ch. 216, 2011 Okla. Sess. Laws 821-23 (codified at 63 O.S.Supp. 2011, § 1-729a ), which prohibited the off-label use of Mifeprex (generally known as mifepristone or RU-486) and misoprostol (brand name Cytotec ) for use in treatment. The effect of H.B. 1970 was to ban medication terminated pregnancies in Oklahoma.⁵

¶5 In the first challenge to H.B. 1970, this Court followed PlannedParenthoodofSoutheasternPennsylvania v. Casey, 505 U.S. 833, 112 S.Ct. 2791, 120 L.Ed.2d 674 (1992), and affirmed the district court's decision that H.B. 1970 was unconstitutional.⁶ The appellees filed a petition for certiorari in the United States Supreme Court.⁷ The U.S. Supreme Court granted the petition and certified two questions to this Court: whether H.B. 1970 prohibits "(1) the use of misoprostol to induce abortions, including the use of misoprostol in conjunction with mifepristone according to a protocol approved by the Food and Drug Administration; and (2) the use of methotrexate to treat ectopic pregnancies."⁸

¶6 In our second pronouncement, we answered both questions affirmatively and the United States Supreme Court then dismissed the petition for certiorari as improvidently granted, leaving our decision intact.⁹ In 2014, in response to our second decision, the Legislature passed H.B. 2684, amending Title 63, Section 1-729a of the Oklahoma Statutes. H.B. 2684, ch. 121, 2014 Okla. Sess. Laws 375-80. H.B. 2684 was approved by the Governor and became effective on November 1, 2014.

¶7 In 2000, based on previously conducted clinical trials, the FDA approved Mifeprex's final printed label (FPL) protocol for marketing and distribution by the manufacturer. The approved use is for up to the first 49 days of gestation as measured from the first day after a woman's last menstrual period¹⁰ and it requires:

(1) Mifeprex distribution only to doctors who have read and understand the prescribing information.

(2) Three office visits for patients.

(3) Administration of Mifeprex only in a clinic, medical office, or hospital, by or under the supervision of a physician able to assess the gestational age of an embryo and to diagnose ectopic pregnancies.

(4) Patients to read the medication guide and read and sign the patient agreement before treatment.

(5) Administration of one dose of 600 milligrams(mg) of Mifeprex.

(6) Oral administration of 400 micrograms (g) of misoprostol given two days later unless an abortion has been confirmed.

(7) A follow-up visit about fourteen days after the administration of the Mifeprex to confirm complete termination of the pregnancy.

(8) Warning to patients that some women may experience vaginal bleeding or spotting up to sixteen days.

(9) Warning to patients that heavy or moderate bleeding is an indication of an incomplete termination.

It is uncontested that the FDA's requirements apply to the manufacturer and are marketing restrictions and other special distribution conditions, but the requirements do not restrict or control a doctor's practice of medicine or the use of medication once it is distributed.

¶8 Within a year of the FDA's approval of Mifeprex in 2000, ninety-six percent of medically terminated pregnancies did not follow the FPL protocol used in the clinical trials on which the FPL's approval was based.¹¹ The American College of Obstetricians and Gynecologists (ACOG) materials state that the off-label protocol actually used by most doctors is more effective with fewer adverse effects.

¶9 Plaintiff Nova Health Services (plaintiff/Nova) followed an off-label protocol which is endorsed by the ACOG. The ACOG recommended off-label, or "evidence-based," protocol is based on "good and consistent scientific evidence" and includes vaginal, buccal, and sublingual administration of misoprostol by the patient away from a clinic. The ACOG off-label protocol provides for administration of one 200 milligram dose of Mifeprex, compared to the 600 milligrams of FDA on-label protocol, followed by 800 micrograms of misoprostol to be patient self-administered, compared to FDA's protocol of 400 milligrams to be doctor administered. The ACOG materials provide that medication terminations can be provided safely through nonphysician clinicians and that the protocol can be used for up to 63 days of gestation (calculated from the last menstrual period). ¶10 H.B. 2684 restricts Mifeprex and misoprostol use for treatment to the FDA-approved final Mifeprex label, prohibits methotrexate use for treatment except to treat ectopic pregnancies, provides for liability of physicians who knowingly or recklessly perform a termination in violation of H.B. 2684, and makes doctors subject to discipline and actual and punitive damages for violating H.B. 2684. Title 63 O.S. § 1-729a(C)-(H). Because the Mifeprex label only allows its use for 49 days after the last menstrual period and Mifeprex off-label use allows for its use up to 63 days, the effect of H.B. 2684 is to ban the use of the Mifeprex and misoprostol drugs for pregnancies between 49 and 63 days from the last menstrual period.

¶11 On September 30, 2014, the Oklahoma Coalition for Reproductive Justice and Nova filed a challenge to H.B. 2684's prohibition of the off-label use of Mifeprex in the district court against the Oklahoma Commissioner of Health and the Executive Director of the Oklahoma State Board of Medical Licensure and Supervision (State). Nova challenged H.B. 2684 as violating rights guaranteed by the Oklahoma Constitution, including the right to due process by limiting women's rights to choose to terminate a pregnancy, to bodily integrity, and to equal protection; violating the Oklahoma constitutional prohibition against special laws; and improperly delegating legislative authority.

¶12 The district court rendered summary judgment in favor of the plaintiffs, finding that H.B. 2684 is a special law in violation of art. 5, § 59 of the Oklahoma Constitution.¹² The State appealed, raising only the questions of issue preclusion, unauthorized delegation of legislative authority, and special law. We retained the appeal for disposition and decided OklahomaCoalitionforReproductiveJustice v. Cline, 2016 OK 17, 368 P.3d 1278 (Cline III) on February 23, 2016, in which we reversed the district court and remanded for disposition of plaintiff's remaining challenges.

¶13 After our opinion in Cline III, supra, was decided, the FDA approved a new FPL protocol for Mifeprex on March 29, 2016. However, in Cline III, supra, we upheld H.B. 2684's constitutionality under the improper delegation of...