Cordray v. Planned Parenthood Cincinnati

911 N.E.2d 871

122 Ohio St.3d 361

2009-Ohio-2972

CORDRAY, Attorney General, et al. v. PLANNED PARENTHOOD CINCINNATI REGION et al.

No. 2008-1234.

Supreme Court of Ohio.

Submitted March 10, 2008.

Decided July 1, 2009.

Richard Cordray, Attorney General, Benjamin C. Mizer, Solicitor General, Stephen P. Carney and Elisabeth A. Long, Deputy Solicitors, and Anne Berry Strait and Sharon A. Jennings, Assistant Attorneys General, for petitioner.

Gerhardstein & Branch Co., L.P.A., Alphonse A. Gerhardstein, and Jennifer L. Branch, Cincinnati; and Bieser, Greer & Landis, L.L.P., and David C. Greer, Dayton, for respondents.

Planned Parenthood Federation of America, Helene T. Krasnoff, and Roger K. Evans, for respondents Planned Parenthood Southwest Ohio Region, Planned Parenthood of Central Ohio, Planned Parenthood of Northeast Ohio, Dr. Roslyn Kade, and Dr. Laszlo Sogor.

B. Jessie Hill, Case Western Reserve University School of Law, Cooperating Counsel for the ACLU of Ohio; and ACLU of Ohio Foundation, Inc., and Jeffrey M. Gamso, Cleveland, for respondent Preterm.

Kilpatrick Law Offices, P.C., and Joel J. Kirkpatrick; and Mailee R. Smith, Americans United for Life, for amici curiae members of the United States Congress, in support of the Ohio Attorney General.

O'DONNELL, J.

{¶ 1} The United States Court of Appeals for the Sixth Circuit has submitted the following two certified questions in accordance with Sup.Ct.Prac.R. XVIII, seeking our answer to these questions of Ohio law:

{¶ 2} "1) Does O.R.C. § 2919.123 mandate that physicians in Ohio who perform abortions using mifepristone do so in compliance with the forty-nine-day gestational limit described in the FDA approval letter?"

{¶ 3} "2) Does O.R.C. § 2919.123 mandate that physicians in Ohio who perform abortions using mifepristone do so in compliance with the treatment protocols and dosage indications described in the drug's final printed labeling?" Planned Parenthood Cincinnati Region v. Strickland (C.A.6, 2008), 531 F.3d 406, 412.

{¶ 4} The plain language of R.C. 2919.123 mandates that physicians providing mifepristone to patients for the purpose of inducing an abortion do so in accordance with the FDA drug approval letter and the final printed labeling it incorporates, including compliance with the 49-day gestational limitation and the treatment protocols and dosage indications expressly approved by the FDA. Accordingly, we answer these certified questions in the affirmative.

Facts and Procedural History

{¶ 5} In March 1996, the Population Council sponsored a new drug application with the Food and Drug Administration ("FDA") "for the use of [mifepristone] for the medical termination of intrauterine pregnancy through 49 days' pregnancy." In evaluating the safety and efficacy of mifepristone (a drug also known as "RU-486" and its trade name "Mifeprex") for inducing abortions, the FDA relied on clinical trials involving women with gestational durations of 49 days or less who took 600 mg of mifepristone followed in most cases by a dose of 400 μg of misoprostol two days later. In issuing its September 28, 2000 drug approval letter approving use of mifepristone, the FDA concluded that "adequate information has been presented to approve [mifepristone] for use as recommended in the agreed upon labeling text."

{¶ 6} Further, in its drug approval letter, the FDA, pursuant to 21 C.F.R. 314.520, imposed an additional restriction that mifepristone "be provided by or under the supervision of a physician who meets the following qualifications:

{¶ 7} "[1.] Ability to assess the duration of the pregnancy accurately.

{¶ 8} "[2.] Ability to diagnose ectopic pregnancies.

{¶ 9} "[3.] Ability to provide surgical intervention in cases of incomplete abortion or severe bleeding, or have made plans to provide such care through other qualified physicians, and are able to assure patient access to medical facilities equipped to provide blood transfusions and resuscitation, if necessary.

{¶ 10} "[4.] Has read and understood the prescribing information of [mifepristone].

{¶ 11} "[5.] Must provide each patient with a Medication Guide and must fully explain the procedure to each patient, provide her with a copy of the Medication Guide and Patient Agreement, give her an opportunity to read and discuss both the Medication Guide and the Patient Agreement, obtain her signature on the Patient Agreement and must sign it as well.

{¶ 12} "[6.] Must notify the sponsor or its designate in writing as discussed in the Package Insert under the heading DOSAGE AND ADMINISTRATION in the event of an ongoing pregnancy, which is not terminated subsequent to the conclusion of the treatment procedure.

{¶ 13} "[7.] Must report any hospitalization, transfusion or other serious events to the sponsor or its designate.

{¶ 14} "[8.] Must record the [mifepristone] package serial number in each patient's record."

{¶ 15} The FDA labeling text referred to in the drug approval letter states, "Mifepristone is indicated for use in the termination of pregnancy (through 49 days' pregnancy) and has no other approved indication for use during pregnancy." (Emphasis added.) It also explains that treatment with mifepristone requires three office visits by the patient. On day one, the patient takes a single oral dose of 600 mg of mifepristone. On day three, the patient returns to the provider for an oral dose of 400 μg of misoprostol, unless the physician confirms that the abortion has already occurred. On day 14, the patient again returns for a follow-up visit to ensure that termination of the pregnancy has occurred.

{¶ 16} The FDA-mandated final printed labeling also includes a "Patient Agreement" that requires the patient to affirm that she "believe[s] [that she is] no more than 49 days (7 weeks) pregnant" and a "Prescriber's Agreement" by which the physician is to indicate that he has met the qualifications for providing mifepristone imposed by the drug approval letter and to agree to administer the drug consistently with listed guidelines.

{¶ 17} Since issuing the drug approval letter in September 2000, the FDA has revised it and has twice revised the labeling text for mifepristone. However, none of those revisions or any other action of the FDA has altered the 49-day gestational limitation for administration of mifepristone or modified any of the dosage indications or treatment protocols originally approved by the FDA.

{¶ 18} In general, after the FDA approves a drug for use and absent any state regulation to the contrary, doctors may prescribe that drug for indications, in dosages, and following treatment protocols different from those expressly approved by the FDA in its approval letter, a practice commonly known as "off-label" use. See, e.g., Planned Parenthood Cincinnati Region v. Strickland (C.A.6, 2008), 531 F.3d 406, 408; Planned Parenthood Cincinnati Region v. Taft (C.A.6, 2006), 444 F.3d 502, 505. Off-label use of drugs approved by the FDA does not violate federal law or FDA regulations, because the FDA regulates the marketing and distribution of drugs, not the practice of medicine. Id. Continuing research on the use of mifepristone for inducing abortions led to the development of evidence-based regimens for off-label use of mifepristone in lower dosages (200 mg rather than 600 mg) and beyond the 49-day gestational limitation (up to 63 days of pregnancy) contained in the approval letter and the labeling text it incorporates, as well as varying the route of administration, timing, and dosage of misoprostol. The FDA has not, however, issued a new drug approval letter approving these uses.

{¶ 19} In 2004, the Ohio General Assembly enacted R.C. 2919.123(A), which 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 in any person or enabling the other person to induce an abortion in any person, unless the person who gives, sells, dispenses, administers, or otherwise provides or prescribes the RU-486 (mifepristone) 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." R.C. 2919.123(F)(1) defines "federal law" to mean "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." (Emphasis added.)

{¶ 20} Prior to the effective date of R.C. 2919.123, respondents, Planned Parenthood Cincinnati Region and various other abortion providers that use mifepristone to perform abortions in Ohio (collectively, "Planned Parenthood"), filed a complaint in the United States District Court for the Southern District of Ohio challenging the constitutionality of the statute on the grounds that it is void for vagueness, violates their patients' rights to bodily integrity, lacks an exception to protect the life or health of their patients, and unduly burdens their patients' right to an abortion. Planned Parenthood sought preliminary and permanent injunctions restraining the state of Ohio from enforcing R.C. 2919.123 and a declaration that the statute violates the right to due process of law.

{¶ 21} The district court determined that Planned Parenthood had shown a strong likelihood of success on the merits of its claim that R.C. 2919.123 unconstitutionally omitted an exception for the health or life of the woman. On appeal, the Sixth Circuit affirmed in part, but, relying on Ayotte v. Planned Parenthood of N. New England (2006), 546 U.S. 320, 126 S.Ct. 961, 163 L.Ed.2d 812, the...