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State Law Restricts Administration of Abortion Drug to FDA-Approved Gestational Limit, Delivery Protocol

2008-1234.  Cordray v. Planned Parenthood Cincinnati Region, Slip Opinion No. 2009-Ohio-2972.
Certified Questions of State Law, United States Court of Appeals for the Sixth Circuit, Nos. 06-4422 and 06-4423.  Certified questions answered in the affirmative.
Lundberg Stratton, O'Donnell, and Cupp, JJ., concur.
Moyer, C.J., concurs in syllabus and judgment.
O'Connor and Lanzinger, JJ., concur in part and dissent in part.
Pfeifer, J., dissents.
Opinion: http://www.supremecourt.ohio.gov/rod/docs/pdf/0/2009/2009-Ohio-2972.pdf Adobe PDF Link opens new window.

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(July 1, 2009) The Supreme Court of Ohio ruled today that a state law enacted in 2004 mandates that Ohio physicians providing the drug mifepristone (RU 486) to patients for the purpose of inducing an abortion must do so in accordance with the approval letter and final printed labeling for the drug issued by the U.S. Food and Drug Administration (FDA), which includes compliance with the 49-day gestational limit and with the treatment protocols and dosage indications expressly approved by the FDA.

The Court’s 4-3 majority decision was authored by Justice Terrence O’Donnell.

Today’s ruling does not address the constitutionality of the state law in question, R.C. 2919.123, but only interprets  the language of the statute in response to a request by the U.S. Sixth Circuit Court of Appeals.  The Sixth Circuit requested today’s ruling in connection with an ongoing federal lawsuit in which Planned Parenthood and other Ohio providers of abortion services have challenged the constitutionality of R.C. 2919.123. That lawsuit remains pending in the federal courts.

In September 2000, the FDA approved mifepristone, commonly referred to as RU-486, for manufacture and use in the United States. RU-486 is a pill used in combination with another drug, misoprostol,  to induce an abortion without surgical intervention. The FDA’s approval was based on clinical trials in which patients whose pregnancies had advanced no longer than 49 days received an oral dose of 600 mg of RU-486, followed two days later by an oral dose of 0.4 mg of misoprostol. 

After a drug has been approved by the FDA, in the absence of additional state-level regulation, doctors are permitted to prescribe that drug in different medical situations and to employ different dosages and delivery protocols for the drug than those initially approved by the FDA. This practice, known as “off-label” use, is not barred by federal law or FDA regulations. As a result of research conducted following FDA approval of RU-486, an off-label protocol was developed in which doctors administer a 200 mg oral dose of RU-486  followed three days later by 0.8 mg of misoprostol to patients whose pregnancies have progressed as long as 63 days. This off-label regime was adopted by the Planned Parenthood clinics in Cleveland, Columbus and Cincinnati and by other providers of abortion services in Ohio.

In 2004, the Ohio General Assembly enacted R.C. 2919.123, a new section of state law that barred Ohio physicians from administering or prescribing RU-486 to induce an abortion unless the drug was provided to a patient “in accordance with all provisions of federal law that govern the use of RU-486.” The statute defined “federal law” as “any law, rule or regulation of the United States or any drug approval letter of the (FDA) ... that governs or regulates the use of RU-486 for the purpose of inducing abortions.” Under R.C. 2919.123, the prescription or administration of RU-486 by a doctor to a patient in a manner not consistent with  “federal law” is a criminal offense punishable as a felony.

Before the new law took effect, Planned Parenthood of Southwest Ohio and other plaintiffs filed suit in federal district court asserting  four different legal bases on which the statute was unconstitutional and therefore unenforceable. The district court granted a temporary injunction preventing state officials or local prosecutors from enforcing the statute. In 2006, while the temporary injunction  remained in place, the U.S. District Court for the Southern District of Ohio granted summary judgment in favor of Planned Parenthood, holding that R.C. 2929.123 was unconstitutionally vague and permanently enjoining enforcement of the entire statute.

The state appealed that ruling to the U.S. Sixth Circuit Court of Appeals. Prior to ruling on the state’s appeal, the Sixth Circuit asked the Supreme Court of Ohio to review and interpret R.C. 2929.123 and to  answer two certified questions: “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?” and  “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?”

Writing for the majority in today’s Supreme Court decision, Justice O’Donnell answered both certified questions in the affirmative. “The provisions of R.C. 2919.123 are not ambiguous,” he wrote.  “It allows physicians to provide or prescribe mifepristone to a patient to induce an abortion only if ‘the physician provides the RU-486 (mifepristone) ...  in accordance with all provisions of federal law that govern the use of RU-486 (mifepristone) for inducing abortions.’  Pursuant to R.C. 2919.123(F)(1),  ‘Federal law’ means ... 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.”

“The FDA drug approval letter states that the ‘new drug application provides for the use of [mifepristone] for the medical termination of intrauterine pregnancy through 49 days’ pregnancy.’ ...

Administering mifepristone to induce an abortion beyond the 49th day of pregnancy would not be in accordance with the drug approval letter. Similarly, the drug approval letter, by incorporating the labeling text, provides a specific dosage indication and treatment protocol: 600 mg of mifepristone, taken orally, followed when necessary by an oral dose of 400 µg of misoprostol two days later.  Using any other dosage indication or treatment protocol would not be in accordance with the drug approval letter. ... Because the FDA does not approve the use of mifepristone beyond the 49th day of pregnancy or using any other dosage amount or treatment protocol, providing mifepristone for the purpose of inducing an abortion beyond the 49th day or using any other dosage indications or treatment protocols would not be in accordance with the drug approval letter and is therefore prohibited by R.C. 2919.123.”

Justice O’Donnell’s opinion was joined by Justices Evelyn Lundberg Stratton and Robert R. Cupp.  Chief Justice Thomas J. Moyer concurred in judgment and in the syllabus holding.

Justice Maureen O’Connor entered an opinion, joined by Justice Judith Ann Lanzinger, in which she concurred with the majority’s holding that R.C. 2919.123 limits the lawful use of U-486 to patients whose pregnancies have progressed no longer than 49 days, but disagreed that the statute also prohibits all off-label uses of the drug. Citing the FDA’s requirement that a patient who is prescribed RU-486 must certify in writing that she believes she is no more than 49 days pregnant, Justice O’Connor wrote: “In requiring a patient to sign the patient agreement, the FDA prohibits the use of mifepristone outside of the 49-day gestational period. It is the requirement of the patient agreement that indicates the limitation on the use of mifepristone. I thus concur with this result reached by the majority.” 

In rejecting the majority’s holding with regard to other off-label use of the drug, she wrote: “It is well accepted that after the FDA approves a drug for use, doctors may prescribe the drug for off-label uses. ... The law recognizes that medical judgments are best left to the sound discretion of those with the education, training, and experience to make the best-informed decisions – physicians. ... Although doctors and other health-care professionals are not immune from valid limitations on the practice of medicine, those limitations must be imposed properly. ... If the legislature intended to forbid all off-label uses of mifepristone, it could have expressly done so.  Instead, it limited the use of the drug to those uses that are in accordance with federal law. Thus, I would hold that although R.C. 2919.123 restricts the delivery of the drug to women no more than 49 days pregnant because of the FDA’s required patient agreement, I do not agree that the statute prohibits all off-label use of mifepristone.”

Justice Paul E. Pfeifer dissented from both parts of the majority decision.  He wrote: “First, and obviously, the plain language of R.C. 2919.123 does not mention a 49-day gestational limitation. Second, federal law does not specifically limit the use of mifepristone, because the FDA does not regulate the practice of medicine. ...   The drug-approval letter in this case, which is defined by R.C. 2919.123(F)(1) as “federal law,” states that mifepristone is approved for use and that its use is indicated ‘for the medical termination of intrauterine pregnancy through 49 days’ pregnancy.’  Neither the approval letter nor any other federal law prohibits the off-label use of mifepristone. ...

Third, the General Assembly could have specifically banned the off-label use of mifepristone, as it banned particular off-label uses of certain steroids.  See R.C. 3719.06(B).  But it didn’t. Nothing in the plain language of R.C. 2919.123 mandates that the use of mifepristone be limited to the first 49 days of pregnancy. I dissent.”

Contacts
Jennifer L. Branch, 513.621.9100, for Planned Parenthood of Southwest Ohio et al.

Benjamin C. Mizer, 614.466.8980, for the State of Ohio.