4-3 Split Ohio Sup Ct: No Off-Label Uses of Mifepristone

The Ohio Supreme Court consists of seven elected Republicans.  It is so Republican that Justice Pfeifer — formerly in the GOP leadership of the Ohio Senate — is the most-often-Left-ish member of the court.

As such, ideological 4-3 splits are rare.  Today, such a split happened in Cordray v. Planned Parenthood Cincinnati Region, 2009-Ohio-2972 (pdf).  The U.S. Sixth Circuit Court of Appeals certified two questions about mifepristone — commonly known as the abortion pill — to the Ohio Supreme Court for clarification about Ohio law.

The one — resulting in a 6-1 opinion (Pfeifer, J., dissenting) — asked whether Ohio law “mandate[s] 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.”  The court answered that question, “Yes.”

The 4-3 result came from the second question, asking whether Ohio law “mandate[s] 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.”  Two of the three the dissenting justices asserted that the court’s “yes” answer was a holding that Ohio law “prohibits all off-label uses of the drug.”  Justice O’Connor, joined by Justice Lanzinger, dissented, accusing the majority of coming between doctors and their patients:

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.  “Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgment.”  United States Food and Drug Administration, Information Sheet:  Guidance for Institutional Review Boards and Clinical Investigators 1998 Update, available at http://www.fda.gov/oc/ohrt/irbs/offlabel.html.  Although doctors and other health-care professionals are not immune from valid limitations on the practice of medicine, those limitations must be imposed properly.

Because the FDA’s approval of the use of mifepristone within the 49-day gestational limit does not prohibit off-label use of the drug, other uses are also in accordance with federal law.  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.  Accordingly, I concur in part and dissent in part.

Justice Pfeifer dissented seperately, concluding simply: “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.”

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