Advice Abortion

Ohio Supreme Court Prohibits Off-Label Use of RU-486 and Denies Release of Clinic Records

Jodi Jacobson

Two court cases were decided today by the Ohio Supreme Court, one limiting off-label use of RU 486 and the other protecting confidentiality by denying access by parents of one girl who received an abortion at a Planned Parenthood clinic to the records of other girls receiving services.

With thanks to our colleague Jill Zimon for passing along info on two important decisions by the Ohio Supreme Court.

First, as reported on the website of the Ohio Supreme Court and Justice System, today, July 1, 2009, the Court ruled against off-label use of RU-486:

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.

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The FDA approved mifepristone, commonly referred to as RU-486, for manufacture and use in the United States in September 2000. The FDA’s approval of RU-486 was based on clinical trials involving patients no more than 49 days pregnancy, and who received an oral dose of 600 mg of RU-486, followed two days later by an oral dose of 0.4 mg of misoprostol.  Clinics in Ohio, however, were using the drug for terminations of pregnancies of longer duration based on additional clinical evidence, but not approved by FDA.

Off-label use of drugs is common.  As noted in the original report:

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.

A law passed by the Ohio General Assembly enacted in 2004 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.”

That law 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 this 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.  They recieved an injunction preventing state officials or local prosecutors from enforcing the original statute.   Then, 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 of Ohio then 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 the law 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?”

“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 yes to both questions, stating that the:

“provisions of R.C. 2919.123 are not ambiguous.  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.’”

In a second decision, the Ohio Supreme Court on Wednesday ruled that Cincinnati Planned Parenthood would not have to release records to an attorney who contended that the Planned Parenthood affiliate “engaged in a pattern of abuse by failing to report to state officials cases of statutory rape.”

According to the Columbus Dispatch:

The court denied a request from the parents of a 14-year-old Cincinnati girl for records of other girls who obtained abortions from the Planned Parenthood of Southwest Ohio clinic.

The parents sued after the girl received an abortion in 2004 under false pretenses. She had been
sexually abused and impregnated by her 21-year-old soccer coach, a police investigation revealed.
The coach impersonated the girl’s father in order to give her permission for the abortion.

The parents accused Planned Parenthood of negligence and of a pattern of ignoring evidence of
abuse. They sought records from the abortion provider to establish their claim.

In a split decision, the Supreme Court said Planned Parenthood could not be compelled to turn
over confidential medical records, but the parents still can pursue their legal claims against the
clinic.

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