Cline v. Oklahoma Coalition for Reproductive Justice

Supreme Court of Oklahoma · 2013 · Administrative Law

Administrative LawCertified QuestionsStatutory Interpretationcertified questionstatutory interpretationplain languagedisjunctive orFDA-approved label

Facts

H.B. 1970 provides that no physician who provides RU-486 (mifepristone) or any abortion-inducing drug may knowingly or recklessly fail to provide or prescribe it according to the protocol tested and authorized by the FDA and as authorized in the drug label. The statute separately defines "abortion-inducing drug" to include off-label use of drugs known to have abortion-inducing properties, such as misoprostol and methotrexate, when prescribed with the intent of terminating a clinically diagnosable pregnancy. Misoprostol is used with mifepristone in both the FDA-labeled protocol and evidence-based regimens, but misoprostol's own FDA-approved label does not approve abortion-related uses. Methotrexate is also used off-label both in abortion-related regimens and to treat ectopic pregnancies, and its FDA-approved label is likewise silent on those uses.

Issue

Does H.B. 1970 prohibit (1) the use of misoprostol to induce abortions, including in conjunction with mifepristone according to an FDA-approved protocol, and (2) the use of methotrexate to treat ectopic pregnancies? More specifically, does the statute's requirement that physicians follow the FDA-approved label for any "abortion-inducing drug" bar these off-label uses?

Rule

When interpreting H.B. 1970, the court applies the statute's plain language. Because the statute uses the disjunctive phrase "RU-486 (mifepristone) or any abortion-inducing drug," each term must be treated separately, and any drug that falls within the statute's definition of "abortion-inducing drug" must be provided or prescribed according to that drug's own FDA-approved label; thus, off-label uses of such drugs are prohibited.

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In Tulsa, Dr. Nina Patel prescribes Drug A, a tablet whose FDA-approved label authorizes use for ending early pregnancies. She also instructs the patient to take Drug B two days later, even though Drug B's own FDA-approved label approves only ulcer treatment and says nothing about pregnancy termination. A state statute provides that no physician who provides "Drug A or any abortion-inducing drug" may knowingly or recklessly fail to provide or prescribe it according to the FDA-authorized protocol and as authorized in the drug label for "Drug A or any abortion-inducing drug."

Under the majority's reading of that statute, is Dr. Patel's use of Drug B permitted?

Explanation. The majority applied the statute's plain language and gave independent effect to the disjunctive word "or." That means the named drug and "any abortion-inducing drug" are separate categories. If Drug B qualifies as an abortion-inducing drug, it must be prescribed according to Drug B's own FDA-approved label, not merely as part of Drug A's labeled regimen. General FDA tolerance of off-label use does not alter the statute's command. (Derived from Cline v. Oklahoma Coalition for Reproductive Justice (n.d.).)