Days before taking recess, the Supreme Court granted cert in a case that, with all the noise over the Voting Rights Act, Affirmative Action, and same sex marriage, skipped right past most of us. The case, Cline v. Oklahoma Coalition for Reproductive Justice, deals with a sloppily-drafted Oklahoma law that bans off-label use of two drugs to perform medical abortions.
Proponents of the law argue that sticking to the on-label treatment procedure, or using surgical procedures, is safer for the patient, while opponents argue that this is an unconstitutional restriction on abortion. The Oklahoma Supreme Court, in an opinion shorter than this blog post, found the law unconstitutional per Planned Parenthood v. Casey.
And the Supreme Court, when granting certiorari, certified two questions to the Oklahoma Supreme Court because the language of the statute was so grossly unclear.
The vocabulary is perhaps the most confusing part of this case. Here is a quick primer on terms that will resurface repeatedly:
- Off-label -- Any treatment protocol not specifically preapproved by the FDA. According to Professor Hank Greely, the Director of Stanford's Center For Law and the Biosciences, off-label treatments are extremely common in medical practice, and as far as he can recall, the only legislative ban on an off-label treatment to date has been Congress' ban and controlled substance scheduling of anabolic steroids.
- On-label -- The exact treatment protocol approved by the FDA and printed on the drug's accompanying label.
- methotrexate -- A drug originally approved as chemotherapy, according to WebMD, it is now used off-label, in combination with misoprostol, for medical (non-surgical) abortions, or, also off-label, as the only non-surgical treatment for ectopic pregnancies.
- mifepristone - an on-label abortifacient mentioned in the statute, also used with misoprostol. According to Wikipedia, it is also known as RU-486 or mifeprex
- misoprostol -- A medicine originally approved to treat stomach ulcers, it is now used, off-label, in combination with either methotrexate or mifepristone for medical (non-surgical) abortions.
- medical abortion -- A drug-induced, rather than surgical, abortion. The FDA has approved the combination of methotrexate and misoprostol, according to a specific treatment regimen, for abortions up to seven weeks.
The issue, which necessitated the certified questions, is the language of the statute, which appears to ban any off-label use of the two drugs used in medical abortions, period. Then again, it allows on-label use of the drugs, per the FDA approved protocol, as a pair.
The Supreme Court's first certified question was whether the law bans misoprostol use, even as part of the FDA treatment, due to the vague language. Second, does it ban the off-label, yet very common, use of methotrexate for ectopic pregnancies?
Next week, we'll take a look at the amicus briefs submitted, so far, to the Oklahoma Supreme Court, as well as the exact language of the statute at issue.
- Mechanism of Action and Pharmacology of Mifepristone, Misoprostol, and Methotrexate (Medscape)
- How Justice Ginsburg Struck Out in the Pro-Choice Movement (FindLaw's U.S. Supreme Court Blog)
- SCOTUS May Settle Circuits in Obamacare Mandate (FindLaw's U.S. Supreme Court Blog)