MKB Mgmt. Corp. v. Burdick, No. 20130259.

• Court: United States State Supreme Court of North Dakota
• Writing for the Court: PER CURIAM.
• Citation: 855 N.W.2d 31 (Mem)
• Parties: MKB MANAGEMENT CORP., d/b/a Red River Women's Clinic, Tammi Kromenaker, Kathryn L. Eggleston, M.D., Plaintiffs MKB Management Corp., d/b/a Red River Women's Clinic, Kathryn L. Eggleston, M.D., Appellees v. Birch BURDICK, in his official capacity as State Attorney for Cass County, Terry Dwelle, M.D., in his official capacity as the chief administrator of the North Dakota Department of Health, Defendants Terry Dwelle, M.D., in his official capacity as the chief administrator of the North Dakota Department of Health, Appellant.
• Decision Date: 28 October 2014
• Docket Number: No. 20130259.

855 N.W.2d 31 (Mem)

MKB MANAGEMENT CORP., d/b/a Red River Women's Clinic, Tammi Kromenaker, Kathryn L. Eggleston, M.D., Plaintiffs
MKB Management Corp., d/b/a Red River Women's Clinic, Kathryn L. Eggleston, M.D., Appellees
v.
Birch BURDICK, in his official capacity as State Attorney for Cass County, Terry Dwelle, M.D., in his official capacity as the chief administrator of the North Dakota Department of Health, Defendants
Terry Dwelle, M.D., in his official capacity as the chief administrator of the North Dakota Department of Health, Appellant.

No. 20130259.

Supreme Court of North Dakota.

Oct. 28, 2014.
Rehearing Denied Jan. 5, 2015.

Joseph A. Turman (appeared), Katrina A. Turman Lang (on brief), Fargo, N.D., Autumn Katz (argued), David Brown (appeared), Jennifer Sokoler (on brief), New York, N.Y., and Carmen Bremer (on brief), Dallas, TX, for plaintiffs and appellees MKB Management Corp., d/b/a Red River Women's Clinic and Kathryn L. Eggleston, M.D.

Douglas A. Bahr (argued), Solicitor General, and Douglas B. Anderson (appeared), Assistant Attorney General, Bismarck, N.D., for appellant.

Christopher T. Dodson, Bismarck, ND, Thomas Brejcha, Chicago, IL, and Paul B. Linton, Northbrook, IL, for amicus curiae North Dakota Catholic Conference.

Don R. Grande, Fargo, N.D., and Mailee R. Smith, Washington, DC, for amicus curiae North Dakota Legislators.

Sarah A. Herman, Fargo, N.D., for amicus curiae North Dakota Medical Association.

LaRoy Baird III, Bismarck, N.D., for amicus curiae Steven R. Morrison, Professor of Constitutional Law, North Dakota Women's Network, and North Dakota Council on Abused Women's Services.

Opinion

PER CURIAM.

¶ 1] Article VI, § 4 of the North Dakota Constitution requires the agreement of at least four members of this Court to declare a statute unconstitutional. Justice Kapsner and Surrogate Judge Maring have concluded that H.B. 1297 is unconstitutional under the North Dakota Constitution, Chief Justice VandeWalle and Justice Sandstrom have concluded that H.B. 1297 is constitutional under the state constitution, and Justice Crothers has concluded that the state constitutional issue need not be decided. Justices Kapsner and Crothers and Surrogate Judge Maring have concluded that H.B. 1297 is unconstitutional under the federal constitution, Chief Justice VandeWalle has concluded that H.B. 1297 is constitutional under the federal constitution, and Justice Sandstrom has concluded the federal constitutional issue is not properly before this Court. Justice Kapsner and Surrogate Judge Maring have concluded that H.B. 1297 has been declared unconstitutional under the federal constitution by a sufficient majority. Chief Justice VandeWalle and Justices Sandstrom and Crothers, however, have concluded that H.B. 1297 has not been declared unconstitutional under the federal constitution by a sufficient majority. The

[855 N.W.2d 32

effect of the separate opinions in this case is that H.B. 1297 is not declared unconstitutional by a sufficient majority and that the district court judgment permanently enjoining the State from enforcing H.B. 1297 is reversed.

¶ 2] GERALD W. VANDE WALLE, C.J., MARY MUEHLEN MARING, S.J., CAROL RONNING KAPSNER, DANIEL J. CROTHERS, and DALE V. SANDSTROM, JJ., concur.

[¶ 3] The Honorable LISA FAIR McEVERS was not a member of the Court when this case was heard and did not participate in this decision. Surrogate Judge MARY MUEHLEN MARING, sitting.

VANDE WALLE, Chief Justice.

[¶ 4] Terry Dwelle, M.D., in his official capacity as chief administrator of the North Dakota Department of Health, appealed from a judgment permanently enjoining the State from enforcing 2011 amendments to the North Dakota Abortion Control Act, N.D.C.C. ch. 14–02.1, regulating medication abortions (“H.B. 1297”) and from an order preliminarily enjoining the State from enforcing 2013 amendments to the Abortion Control Act requiring physicians performing abortion procedures to have admitting and staffing privileges at a hospital within thirty miles of the abortion facility (“S.B. 2305”). The parties have stipulated to dismiss the claim to enjoin enforcement of S.B. 2305, and we dismiss the State's appeal from the order preliminarily enjoining enforcement of S.B. 2305. The State argues the district court erred in construing H.B. 1297 as a ban on all medication abortions and erred in determining a fundamental right to an abortion exists under the North Dakota Constitution and in applying strict scrutiny to the challenged provisions of H.B. 1297. I conclude the district court erred in determining a fundamental right to an abortion exists under the North Dakota Constitution and in applying strict scrutiny to the challenged provisions in H.B. 1297. I further conclude the court erred in construing the challenged provisions in H.B. 1297 as a ban on all medication abortions, and as construed, I conclude the challenged provisions do not constitute an undue burden on the right to an abortion under federal precedent. I would reverse the judgment permanently enjoining the State from enforcing H.B. 1297.

I

[¶ 5] In July 2011, MKB Management Corporation, doing business as the Red River Women's Clinic, and Kathryn L. Eggleston, a physician licensed in North Dakota and the medical director at the Clinic, sued Dwelle and Birch Burdick, in his official capacity as State's Attorney for Cass County, for a declaration that certain provisions in H.B. 1297 for medication abortions violate the North Dakota Constitution. The plaintiffs alleged the Clinic is the only abortion provider in North Dakota and serves women residing in North Dakota, as well as women who travel to the Clinic from Minnesota and South Dakota. The plaintiffs alleged the Clinic offers both surgical and medication abortions and performed a total of about 1,300 abortions in 2010. According to Eggleston, in 2007 the Clinic began offering medication abortions using two prescription drugs, mifepristone and misoprostol, and about 20 percent of the Clinic's patients choose a medication abortion and about 80 percent of the patients choose a surgical abortion. According to Tammi Kromenaker, a director at the Clinic, the Clinic performs surgical abortions through 16 weeks of a woman's pregnancy and performs medication abortions up to 9 weeks or 63 days after a woman's last

[855 N.W.2d 33

menstrual period using an “off-label” or “evidence-based” protocol rather than a “final-printed-label” protocol for administering the medication.

¶ 6] To understand the issues raised in the plaintiffs' lawsuit and this appeal, I briefly describe the differences between the “final-printed-label” protocol and the “off-label” or “evidence-based” protocol for medication abortions:

Before 2000, most first-trimester abortions were surgical, performed by a procedure commonly known as vacuum aspiration or suction curettage.... Briefly, a surgical abortion is performed by inserting a speculum into the woman's vagina, dilating the cervix, and then inserting a tube into her uterus that empties the contents by suction.....

In 2000, the Food and Drug Administration (“FDA”) first approved the distribution and use of mifepristone in the United States. Mifepristone, also called RU–486, is a medication that “terminates the pregnancy by detaching the gestational sac from the uterine wall.” Approximately 24 to 48 hours later, the woman takes a second medication, misoprostol, which is “a prostaglandin which induces the contractions necessary to expel the fetus and other products of conception from the uterus.”...

A U.S. manufacturer first filed a New Drug Application for mifepristone in 1996. Consistent with the three clinical trials submitted in support of the application, ... the “FDA labeling and approval letter indicated that the appropriate treatment regimen was to administer 600 mg of mifepristone orally followed by 0.4 mg of misoprostol administered orally two days later and that mifepristone was not to be administered after forty-nine days' gestation.” ...

Following FDA approval, additional clinical trials led to the development of new protocols for administering the drugs, one of which called for “200 mg of mifepristone administered orally followed one to three days later by 0.8 mg of misoprostol administered vaginally” and could be “employed up to sixty-three days' gestation.” This new [off-label] protocol ... changed (1) the dosage amounts of the drugs, lowering the amount of mifepristone from 600 mg to 200 mg and increasing the amount of misoprostol from .4 mg to .8 mg; (2) the number of days between the drugs, from two days to between one and three; (3) the method of administering the misoprostol, from orally at the clinic to vaginally at home; and (4) the number of days' gestation up to which the protocol could be successfully performed, from 49 to 63 days after the woman's last menstrual period (“LMP”)....

In 2006, ... a variation of the [off-label] protocol called for self-administration of the misoprostol buccally, i.e., via gum absorption.... By 2010, additional trials had demonstrated the safety and efficacy of buccal absorption up to 63 days LMP....

Once a drug has been approved, the FDA does not ban ... “off-label use” [ ] i.e., prescribing the drug for uses or in doses not identified in the approved labels.

Planned Parenthood Sw. Ohio Region v. DeWine, 696 F.3d 490, 494–96 (6th Cir.2012) (citations and footnotes omitted). See also Cline v. Oklahoma Coal....