Planned Parenthood of Cincinnati v. Strickland

531 F.3d 406

PLANNED PARENTHOOD CINCINNATI REGION; Planned Parenthood Of Greater Cleveland; Planned Parenthood Of Central Ohio; Preterm; Dr. Roslyn Kade; and Dr. Laszlo Sogor, Plaintiffs-Appellees, v. Ted STRICKLAND, Governor of the State of Ohio, Defendant Nancy H. Rogers, Interim Attorney General of the State of Ohio^*; and Joseph T. Deters, Hamilton County, Ohio, Prosecuting Attorney as representative of a class of all Prosecuting Attorneys in Ohio, Defendants-Appellants.

No. 06-4422.

No. 06-4423.

United States Court of Appeals, Sixth Circuit.

Argued: April 23, 2008.

Decided and Filed: June 23, 2008.

ARGUED:

Anne Berry Strait, Office of the Attorney General, Columbus, Ohio, for Appellants. Mimi Y.C. Liu, Planned Parenthood Federation of America, Washington, DC, for Appellees.

ON BRIEF:

Anne Berry Strait, Office of the Attorney General, Columbus, Ohio, for Appellants. Alphonse A. Gerhardstein, Gerhardstein & Branch Co. LPA, Cincinnati, Ohio, Helene T. Krasnoff, Planned Parenthood Federation of America, Washington, DC, Roger K. Evans, Planned Parenthood Federation of America, New York, New York, B. Jessie Hill, Case Western Reserve University, Cleveland, Ohio, Jeffrey M. Gamso, American Civil Liberties Union of Ohio Foundation, Cleveland, Ohio, for Appellees. Mailee R. Smith, Denise M. Burke, Clarke D. Forsythe, Americans United for Life, Chicago, Illinois, for Amici Curiae.

Before: MOORE, ROGERS, and McKEAGUE, Circuit Judges.

ORDER OF CERTIFICATION TO THE SUPREME COURT OF OHIO

McKEAGUE, Circuit Judge.

On remand from this court's decision in Planned Parenthood v. Taft, 444 F.3d 502 (6th Cir.2006), the district court permanently enjoined the enforcement of Ohio Revised Code ("O.R.C.") § 2919.123 on the basis that it is unconstitutionally vague. The defendants-appellants, Interim Ohio Attorney General, Nancy H. Rogers, and Hamilton County, Ohio, Prosecuting Attorney, Joseph T. Deters, as representative for a class of all Ohio county prosecutors (collectively referred to in this order as the "State"), appealed.¹ On appeal, both the State and Planned Parenthood have presented this court with contrary, yet plausible, interpretations of O.R.C. § 2919.123 that they respectively believe would save the statute from unconstitutionality.

Because neither side addressed the issue of certification in their briefs, we instructed them to discuss at oral argument the propriety of certifying the question of O.R.C. § 2919.123's scope and meaning to the Supreme Court of Ohio. When asked about certification at oral argument, both Planned Parenthood and the State encouraged this court to speculate on how the Supreme Court of Ohio would interpret the statute as opposed to seeking an authoritative interpretation from the Ohio high court via certification. In our opinion, however, the interests of judicial federalism and comity strongly counsel in favor of providing the Supreme Court of Ohio with the opportunity to interpret O.R.C. § 2919.123. Accordingly, we sua sponte CERTIFY the questions set forth in § II, B of this order to the Supreme Court of Ohio pursuant to Rule XVIII of the Rules of Practice of the Supreme Court of Ohio. See generally Elkins v. Moreno, 435 U.S. 647, 662, 98 S.Ct. 1338, 55 L.Ed.2d 614 (1978) (certifying, sua sponte, a question of state law to the Maryland Court of Appeals).

I. BACKGROUND

A. Factual History

This court's previous opinion set forth the relevant facts as follows:

Until 2000, most first trimester abortions in this country were surgical abortions performed by vacuum aspiration or curettage. In September of 2000, the Food and Drug Administration ("FDA") approved mifepristone [commonly referred to as RU-486], a pill used to induce an abortion without surgical intervention, for manufacture and use in the United States. This approval was based on clinical trials which involved the oral ingestion of 600 mg of mifepristone followed two days later by the oral ingestion of 0.4 mg of misoprostol.²

Absent state regulation, once a drug has been approved by the FDA, doctors may prescribe it for indications and in dosages other than those expressly approved by the FDA. This is a widely employed practice known as "off-label" use. Off-label use does not violate federal law or FDA regulations because the FDA regulates the marketing and distribution of drugs in the United States, not the practice of medicine, which is the exclusive realm of individual states. As a result of this research, an off-label protocol was developed consisting of 200 mg of mifepristone administered orally followed one to three days later by 0.8 mg of misoprostol administered vaginally. This regimen is employed up to sixty-three days' gestation and is known as the Schaff protocol after the doctor whose research primarily led to its development.

In 2004, the Ohio General Assembly enacted H.B. 126 ("the Act") to regulate the use of mifepristone in Ohio. Specifically, the Act provides:

No person shall knowingly give, sell, dispense, administer, otherwise provide, or prescribe RU-486 (mifepristone) to another for the purpose of inducing an abortion ... unless the person ... is a physician, the physician satisfies all the criteria established by federal law that a physician must satisfy in order to provide RU-486 (mifepristone) for inducing abortions, and the physician provides the RU-486 (mifepristone) to the other person for the purpose of inducing an abortion in accordance with all provisions of federal law that govern the use of RU-486 (mifepristone) for inducing abortions.

Ohio Rev.Code Ann. § 2919.123(A). The Act defines "federal law" as, "any law, rule, or regulation of the United States or any drug approval letter of the food and drug administration of the United States that governs or regulates the use of RU-486 (mifepristone) for the purpose of inducing abortions." Ohio Rev.Code Ann. § 2919.123(F). This arguably requires doctors who prescribe mifepristone for the purpose of inducing an abortion to do so only in accordance with the indication, regimen and distribution restrictions approved by the FDA. In other words, the Act arguably prohibits the "off-label" use of mifepristone.

According to the State, the Act was passed because abortion providers in Ohio were openly using the Schaff protocol and "because legislators became aware that several women had died or been severely injured recently as a result of their use of mifepristone." The State further suggests that Ohio legislators concluded that the FDA had only approved one specific protocol for the administration of mifepristone because that was the only safe and effective protocol. Accordingly, the State argues that [it] banned all other uses of mifepristone to protect Ohio women from unsafe and ineffective mifepristone protocols.

Taft, 444 F.3d at 505-06.

While Planned Parenthood previously instructed its doctors that mifepristone could be administered up to sixty-three days' gestation, its instructions now provide that mifepristone only be administered up to fifty-six days' gestation. Thus, there can be no debate that physicians in Ohio continue to administer mifepristone beyond the FDA-approved use of forty-nine days' gestation. These doctors also continue to perform medical abortions using doses of mifepristone that are lower than those approved by the FDA.

B. Procedural History

Section 2919.123 was scheduled to go into effect on September 23, 2004. But, prior to the effective date, Planned Parenthood filed a complaint in United States District Court for the Southern District of Ohio alleging that the statute: (1) is void for vagueness; (2) violates a woman's constitutional right to bodily integrity by forcing her to undergo a surgical abortion where a medical abortion using mifepristone would be more desirable; (3) lacks the constitutionally-mandated exception for the life and health of the woman; and (4) imposes an undue burden on a woman's right to an abortion in violation of Supreme Court precedent. On September 22, 2004, the district court issued a preliminary injunction against the State's enforcement of O.R.C. § 2919.123. See Planned Parenthood v. Taft, 337 F.Supp.2d 1040, 1041 (S.D.Ohio 2004). The district court issued the injunction based on its belief that Planned Parenthood would likely succeed on the merits of its claim that O.R.C. § 2919.123 lacked the constitutionally required exception for the life or health of the woman and that irreparable harm would result from enforcement of the law. Id. at 1047-48. The State appealed.

On appeal, we held that the district court erroneously determined that every abortion statute must contain an exception for the life or health of the woman. Taft, 444 F.3d at 511. We explained that neither the United States Supreme Court nor this court have announced a per se rule requiring all abortion statutes to contain a life or health exception; rather, each case must be considered on its facts. Id. In our prior decision, we went on to examine whether, under the facts of this specific case, the statute was constitutionally infirm because it lacked a health or safety exception. Id. at 511-12. With regard to that issue, we agreed with the district court that the record contained "substantial medical authority" in support of Planned Parenthood's contention that the strictures imposed by O.R.C. § 2919.123 could endanger the life or health of the woman. Id. at 513. Relying on the Supreme Court's recent decision in Ayotte v. Planned Parenthood of Northern New England, 546 U.S. 320, 126 S.Ct. 961, 163 L.Ed.2d 812 (2006), we determined that the absence of a life or health exception did not necessarily justify an injunction against the entire statute. Id. at 516-17. Therefore, we remanded the matter to the district court for a determination of the proper scope of the preliminary injunction in light of Ayotte, which explained that "we prefer ... to enjoin only the unconstitutional applications of a statute while leaving...