Just before recessing for the summer, the Supreme Court issued an unusual order in Cline v. Oklahoma Coalition for Reproductive Justice.  The Court’s order reads, in full:

The petition for a writ of certiorari is granted.

This Court, pursuant to the Revised Uniform Certification of Questions of Law Act, Okla. Stat., Tit. 20, §1601 et seq. (West 2002), respectfully certifies to the Supreme Court of Oklahoma the following question: Whether H.B. No. 1970, Section 1, Chapter 216, O.S.L. 2011 prohibits: (1) the use of misoprostol to induce abortions, including the use of misoprostol in conjunction with mifepristone according to a protocol approved by the Food and Drug Administration; and (2) the use of methotrexate to treat ectopic pregnancies.

Further proceedings in this case are reserved pending receipt of a response from the Supreme Court of Oklahoma.

The Supreme Court Background

First, what does this mean?  Well, federal courts often have to pass on the constitutionality of state laws, but sometimes the meaning of the state laws isn’t very clear.  Determining the meaning of a state law is something that, in general, the federal courts would rather leave to the courts of the relevant state.  After various troublesome cases in 1967 the National Conference of Commissioners on Uniform State Laws proposed a Uniform Certification of Questions of State Law Act, which, when adopted by a state, allow federal courts to certify questions to that state’s courts. Between that Act, and other methods, all the state courts except those in North Carolina and Missouri (no idea why) will accept certified questions from federal courts, including the U.S. Supreme Court.

To have the jurisdiction to ask the questions, the Supreme Court has to grant review of the case (grant “certiorari” or “cert” in its lingo).  So, in this case the Court wanted the Oklahoma Supreme Court to answer some questions, so it granted cert and asked its questions, but it made it clear that it was not committing itself to hear the case until it had heard the Oklahoma Court’s answers, which is why it reserved further proceedings (like briefing) until those answers arrived.

Background to the Case

That’s the process, but what is this case and what do the questions mean in its context?

In 2010 Oklahoma passed a statute that for the first time put special requirements on medical (drug-induced) abortions, different from those applying generally to all abortions.  These requirements were largely requirements for disclosures to women about the procedure.

In 2011 Oklahoma enacted amendments to the previous act that move from disclosure to prohibition, providing, in relevant part

No physician who provides RU-486 (mifepristone) or any abortion-inducing drug shall knowingly or recklessly fail to provide or prescribe the RU-486 (mifepristone) or any abortion-inducing drug according to the protocol tested and authorized by the U.S. Food and Drug Administration and as authorized in the drug label for the RU-486 (mifepristone) or any abortion-inducing drug.

As far as I can tell, the act is to be enforced by civil actions for damages, actual and punitive, that, under the statute, can be brought by the pregnant woman, her husband at the time of the abortion, or the fetus’s maternal grandparents.  Successful plaintiffs are entitled to attorneys fees.[1]

RU-486, or mifepristone, is the so-called abortion pill.  Developed in France, the FDA finally approved it in the U.S. in 2000, as a non-invasive alternative to a surgical abortion.  The drug was approved, as is always the case with the FDA, with an approved label, which set out the indications and methods of use for which the FDA had found the drug “safe and effective.”  The labeled indication was a pregnancy up to not more than 49 days (seven weeks) after the last menstrual period.  The woman was to take 600 milligrams of the drug at a health care facility, then return two days later to take a dose of misoprostol, which helps in the expulsion of the fetal remains.  Two weeks later, the label requires the woman to return to the facility, to check to ensure that the procedure succeeded.

In the following 13 years, doctors have developed other ways to use RU-486 for abortion, methods that have been approved by the American College of Obstetricians and Gynecologists and the World Health Organization. These reduce the dose of RU-486 from 600 mg to 200 mg, allow the woman to take the misoprostol at home instead of in the clinic, and expand the appropriate period for use of RU-486 from seven weeks after the last menstrual period to nine weeks.  In some cases, other variations from the labeled instructions have been used.

Such “off-label” use is a common aspect of the FDA’s regulation of drugs and medical devices, and one that is strongly defended by the American Medical Association as limiting the FDA’s “regulation of the practice of medicine.” In many cases, off-label use of FDA approved drugs is the standard of care, violation of which can lead to malpractice verdicts or professional discipline.

The Oklahoma statute did not ban any off-label use except for that of RU-486 and any other “abortion-inducing drug.”  (It defined “abortion-inducing drugs” to include specifically both misoprostol and another drug, methotrexate, when they are used for the purpose of inducing abortions.)

The plaintiffs sued to enjoin the statute, contending (almost certainly correctly) that this was passed for the purpose, and with the effect, of substantially curtailing women’s access to medical abortions, by cutting two weeks off their useful period and by requiring additional expensive and difficult trips to clinics. The trial court granted summary judgment in favor of the plaintiffs.

The Oklahoma Supreme Court affirmed, after a fashion. Its three-paragraph, unanimous per curiam decision says the case is controlled by the U.S. Supreme Court’s decision in Planned Parenthood v. Casey.  Most of the opinion is taken up with recitations, from federal and Oklahoma law, of the supremacy of federal law.  (The court even included, as an indented block quotation, the entire Supremacy Clause of the federal constitution.)    The “analysis” is limited to the following: “The challenged measure is facially unconstitutional pursuant to Casey, 505 U.S. 833. The mandate of Casey remains binding on this Court until and unless the United States Supreme Court holds to the contrary.”  That is, “don’t blame us!”

The state applied for cert, contending that its Supreme Court had misread Casey and had ignored the Court’s subsequent Carhart opinion.  It also contended that the decision raised a conflict of authority with a Sixth Circuit decision, upholding a similar but somewhat more limited Ohio Statute, Planned Parenthood Southeast Ohio Region v. DeWine, 696 F.3d 490 (2012).  The original plaintiffs opposed cert and the Court ended up certifying its two questions to the Oklahoma Supreme Court.

The Interesting Issues

I work in Law and the Biosciences.  I keep an eye on the abortion cases and occasionally teach them a bit, but I do not usually write about them.  I do follow closely, and teach, FDA law.  And I’ve had to learn more about the First Amendment and commercial, or professional speech.  This is an interesting case for several reasons.

First, from an FDA perspective, I cannot remember a state ever banning an off label use of a prescription drug before.  States generally trust doctors with prescribing authority – and the AMA and state medical associations work to ensure that.  Off-label prescription is a deeply entrenched part of American medicine. Frankly, I am not keen on it, but a combination of practical and political reasons makes me think it won’t change. It was therefore a shock to me to see a statute banning such use.  I asked around and no one else could think of an example.

The only vaguely similar example I could come up with is sports performance-enhancing drugs.  Congress (not a state) banned off-label uses of anabolic steroids and then, a few years later in 1990, moved those drugs to Schedule III of the controlled substances act (and thus effectively banned off label uses). It slid human growth hormone into the gap, basically replacing the words “anabolic steroids” with “human growth hormone” and criminalizing off label use of that drug.  But those are the only examples of limits on off-label use (apart from the federal Controlled Substances Act) that I can think of – and they are Congressional actions.

Having said that, I don’t really see a good federal preemption argument. Yes, the Federal Food Drug and Cosmetic Act allows off-label use.  And it authorizes on-label use to the extent that state laws restricting it may be preempted – see the Supreme Court cases  preempting state tort (or product liability) cases for devices or generic (but not brand name) drugs. But it seems to me hard to say that just because federal law permits doctors to prescribe a drug for uses that the federal government has never specifically approved, it therefore preempts states from forbidding those uses that the FDA has not specifically approved.

Second, as a matter of constitutional abortion laws, governments cannot impose “undue burdens” on the right to an abortion.  This seems to me a winner in this context. In light of the ACOG and WHO endorsement of the off-label regimens, it seems to me very hard to argue that demanding on-label use of RU-486 provides no significant benefits. It imposes more restrictive limits and more doctor visits on the women seeking abortions.  When the cost has no countervailing benefit it seems to me that imposes, by definition, an “undue” burden.

Two of three judges on the Sixth Circuit Planned Parenthood panel disagreed.  I think they erred by not measuring the “undue” or “due” nature of the burden in relation to the benefits of the regulation.  In any event, they did not decide the question whether the Act unduly burdens a woman’s right to health and life under the Fourteenth Amendment, which was held for trial at the district court.

Third, in an idea raised to me by a former CLB fellow, what about the First Amendment?  A doctor writes a prescription for the pills. Does what he says about how they should be taken – the dose, the location, the timing – fall within First Amendment protections for speech with patients?  I am leery about the application of commercial speech to medicine – it seems to me it could undue much valuable regulation.  But the courts do not necessarily share my views. Late last year, in a heralded case, U.S. v. Caronia, the Second Circuit reversed a criminal conviction for off-label promotion of a date rape drug on the ground that it punished the drug rep for speaking. The court analyzed the restriction under the Commercial Free Speech factors of Central Hudson and found it constitutionally lacking.  I’m not happy about that decision, but, if it ends up being “the law,” how would that affect this case?

I would note a different First Amendment case I like better from Florida.  The Florida legislation forbid doctors from asking their patients about their ownership of guns (something doctors with depressed patients had an understandable interest in).  A federal district court enjoined that statute in Wollschlaeger v. Scott in July 2012 as a violation of the doctors’ (and patients’) First Amendment rights.  The appeal is pending in the 11^th Circuit.

It does seem to me that “treating a patient” with a prescription drug is not just “speech,” but then, it seemed to me that banning pharmaceutical companies from getting access to physician prescription records that they wanted to use for marketing purposes wasn’t exactly speech, either. The Supreme Court disagreed, in Sorrell v. IMS Health Inc.  I don’t know much about the First Amendment’s application to professional speech; I don’t think I want to know much about it.  But it seems to me it might be applied here.

The Likely Resolution

In fact, though, I do not think the Oklahoma case is likely to be a vehicle to explore any of these issues.  As the plaintiffs argued, both in their complaint and in their opposition to the petition for certiorari – and as the Supreme Court’s questions recognize – the Oklahoma law was drafted poorly in a way that bans more than just off-label use of RU-486.

The Oklahoma statute requires on-label use only of all abortion-inducing drugs, including specifically misoprostol and methotrexate, when used for the purpose of inducing abortions.  This was, not to put too fine a point on it, dumb.

The FDA’s label for the use of RU-486 includes the use of misoprostol as part of the medical abortion.  But misoprostol’s label does not include its use as part of a surgical abortion. In fact, its only currently approved (and thus labeled) use is to prevent stomach ulcers in people taking non-steroidal anti-inflammatory drugs (like aspirin).  Its use with mifepristone is off-label (as is its quite common use in inducing labor).  The Oklahoma statute, by requiring only on-label use of RU-486, requires the use of misoprostol, but that same statute, by requiring only on-label use of misoprostol, forbids that use.  It thus bans all use of RU-486.  Similarly, methotrexate, originally approved as chemotherapy for an uncommon cancer, is the only drug available for medical use in ectopic pregnancy, a pregnancy where the fetus is attached to the fallopian tubes and not the uterus. That condition is fatal for the fetus and very dangerous for the woman. Medical treatment with methotrexate is safer than surgical removal – but that’s also off label and so forbidden in Oklahoma.

The Court noticed.  The questions it asks the Oklahoma court are whether the statute prohibits using misoprostol to induce abortions and prohibits use of methotrexate to treat ectopic pregnancies.  Assuming the Oklahoma court says that it does – which, from the statutory language, would seem inevitable – the act will clearly ban an FDA-approved method of medical abortion and ban a safer treatment for ectopic pregnancy, both of which would seem easily “undue burdens.”

Thus the Court seems highly likely, after getting such answers from the Oklahoma court, to dismiss the writ of certiorari and allowing the Oklahoma trial court’s injunction to stand . . . until Oklahoma next amends its statute.  There will be other chances – the Ohio case may eventually reach the Court and both North Dakota and Arizona have enacted laws similar to Ohio’s.  North Dakota’s statute is currently enjoined as litigation continues.

Conclusion

Cline v. Oklahoma Coalition for Reproductive Justice itself seems unlikely to make interesting or important law. But the anti-abortion strategy behind it, when embodied in more competently drafted statutes, may.  This is worth watching.

Hank Greely

[1] The plaintiffs’ complaint says it also subjects the physicians and any licensed facility where the procedures are performed to disciplinary sanctions; I don’t see that in the Act, except with respect to certain reporting requirements, but I suspect the plaintiffs’ lawyers are right.