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New abortion protocol allowed

(This is another in a continuing series of reports on the impact that Supreme Court decisions have on later cases. The ruling discussed here is a sequel to the Court’s Jan. 18 ruling in the case of Ayotte v. Planned Parenthood of Northern New England [04-1144], limiting court orders in abortion cases.)

A new procedure for a medical abortion that does not involve surgery must be allowed later in pregnancy, the Sixth Circuit Court ruled Friday in a major new decision involving the drug known as “RU-486.” The decision can be found here. The ruling, however, requires a federal judge to reconsider an order totally barring the state of Ohio from restricting doctors’ use of RU-486.

This marks the second time a federal appeals court has applied the Court’s Ayotte decision. The Ninth Circuit, however, found that Ayotte did not require a narrower court order in a case where the Circuit Court had struck down the federal ban on so-called “partial-birth” abortions. In Friday’s Sixth Circuit ruling, however, the judges concluded that Ayotte did require a new look at a broad injunction against enforcement of the state law at issue.

RU-486, a French invention that brought a breakthrough in the medical technology of abortion because it allows termination of pregnancies without surgery, is now in wide use by doctors as a safe alternative procedure. The Food and Drug Administration had prescribed a protocol on when in pregnancy the drug could be used. Since then, a procedure known as “the Schaff protocol” (for Dr. Eric Schaff) has been adopted by more doctors, and it is the non-surgical method now recommended by major abortion provider organizations. The Sixth Circuit noted that this protocol “has come to be widely employed across the United States,” and has a success rate of at least 90 percent in terminating pregnancies.

One key difference between the Schaff protocol and the FDA version is that Dr. Schaff’s method allows the drug combination mifepristone (RU-486) and misoprostol to be administered up to 63 days in pregnancy — that is, nine weeks. The FDA protocol allows the procedure only up to 49 days — seven weeks.

Ohio’s legislature, concluding that there was some risk in the Schaff protocol, banned it in that state in a 2004 law restricting the use of RU-486 only under the FDA-approved approach. (An FDA-approved drug may be used by doctors for the purposes set out in an FDA protocol, but also may be applied in other situations — “off-label” use — unless a state has required otherwise. The Schaff protocol is an “off-label” use.)

Two doctors and a group of Planned Parenthood chapters in Ohio sued to stop the Ohio ban from taking effect, and a federal judge barred its enforcement, concluding that the challengers were likely to win ultimately with the claim that any abortion restriction must have an exception to allow its use when necessary to protect the health of pregnant women.

The Sixth Circuit, in a key constitutional part of its ruling Friday, declared that Supreme Court case law does not require that every law restricting abortion must have a health exception — a view that appears to contradict rulings by other appeals courts on the point. The Sixth Circuit said a health exception is necessary only when medical judgment shared by doctors suggests that a banned procedure would be safer than an alternative — that is, when a law’s ban on a procedure poses a significant health risk to women.

It went on to hold that Ohio’s ban on the Schaff protocol would pose a significant health risk, at least to women for whom alternative abortion methods would pose a risk into the ninth week of pregnancy — such as when a woman has a divided uterus, or there are other abornomalities in the uterus or the genital tract. For those women, the Circuit Court found, the evidence suggested that a surgical alternative would be significantly more risky.

“The medical authority available at the time of the preliminary injunction phase of this case permitted the finding that using mifepristone is the safest available method of medical abortion and that in some circumstances a medical abortion using mifepristone would pose significantly less risk to the health or life of a discrete class of women than a surgical abortion,” the Court concluded. “The evidence…does not adequately support the state’s claim that the act may constitutionally omit a health or life exception.”

Turning to the remedy, the Circuit Court applied the Supreme Court’s Ayotte decision, and ordered the trial judge to reconsider the sweep of the injunction barring any enforcement of the ban on the Schaff protocol. Ayotte, it said, holds that “when an abortion statute lacks a constitutionally necessary health or life exception, a narrow injunction prohibiting only unconstitutional applications of the statute should be employed where such an approach is not contrary to legislative intent.”

The proper course, the Court conlcuded, was to limit the injunction against the Ohio law to situations when the ban would be unconstitutional. It left the precise ruling on how to set that limit to the District Court judge, when the lower court considers the state legislature’s intent and other, not-yet-decided challenges to the state law.

(Thanks to Howard Bashman of How Appealing blog for the alert to the Sixth Circuit ruling, and for a link to it.)