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The Rare Roberts Court Abortion Case… NOT

Oklahoma and RU-486

While most Supreme Court watchers had their eye on the Establishment Clause case this week, overlooked was an order released on Monday. That order has dismissed a case involving Oklahoma’s abortion law, a case they had previously granted but dismissed as “improvidently granted.”

One thing noticeable about the Roberts Court in recent years is the absence of cases involving abortion. This term, they got a chance to address the issue somewhat tangentially. The case was Cline vs. Oklahoma Coalition for Reproductive Justice. The name of the respondent should say it all- “Reproductive Justice.” However, before the pro-life movement starts marching outside the Supreme Court, it is important that the facts of this case be explained. Given those facts, it become clear that there is ample wiggle room to actually avoid the abortion issue altogether. The Court put this case on the docket amid the tumultuous debate in Texas over their proposed abortion legislation which later passed.

There are two types of abortions- medical and surgical. The horrible pictures of aborted fetuses are of the surgical kind. With medical abortions, however, the patient is given a series of prescription drugs which are approved by the FDA and their use specified. At issue is a 2011 Oklahoma law that regulates these prescription drugs in a manner approved by the FDA. So far, all sounds good for the state.

The general practice is to prescribe a drug, RU-486, and then two days later the woman takes a second prescription drug. Within two weeks, she should spontaneously abort the developing fetus. RU-486, according to the FDA guidelines, can be administered up to 49 days (or seven weeks) after the woman’s last menstrual cycle. The FDA mandates that RU-486 be taken at a licensed facility and that they must return to that facility two weeks after taking the second drug to make sure the medical abortion was successful.

However, medical doctors have “discovered” another protocol which they describe as “safer, less costly, and more efficient.” The “efficiency” aspect is somewhat ghoulish while the “cost” aspect is circumspect. As concerns the state, the issue of “safety” is paramount. One “positive” side effect of this protocol is that it allows RU-486 to be administered up to 63 days (9 weeks) after the last menstrual cycle. Hence, it pushes the boundary of the medical abortion option further into the gestational period.

The Oklahoma law notes correctly that this alternate protocol is “off label.” This means that the drugs are administered in a manner not specified on the label of those drugs. The law aims to keep the administration of the drugs “on label.” It is important to note that the Oklahoma law is in no way banning the use of RU-486 provided it is used as the FDA proscribes its use. Opponents of the law claim that it also prohibits the use of another drug, methoprexate. This drug is used to induce abortions in the case of ectopic pregnancies- those where the fetus fails to implant in the uterine lining and often in the fallopian tubes. Surgical abortions in the case of an ectopic pregnancy are admittedly dangerous and risky and sometimes fatal.

As for regular pregnancies, the law simply requires abortion providers to use the drugs as the FDA proscribes on the label. Pro-choice groups argue that since most abortion providers in Oklahoma and the United States use the off-label protocol (that is, it is now accepted medical practice), by banning the off-label use the Oklahoma legislature is denying access to all medical abortions. It needs to be noted that many doctors in other areas use drugs or combination of drugs that are “off label.” The practice is not specific to medical abortion techniques.

In fact, the lower court decided just that: the off label protocol was now accepted medical practice. The state, however, argued that the law did not seek to nor did it, in practical terms, prohibit medical abortions. Because the lower court agreed with this “accepted medical practice” theory, they struck down the law. The state then appealed to the Oklahoma Supreme Court. In a strange, one and a half page opinion, they did not even discuss the practical effect of the law and simply ruled the law was unconstitutional in that it restricted a woman’s right to abortion. Because they did not address the issues that were at the center of the appeal, the US Supreme Court gave them an opportunity to do so.

There are a couple of troubling facts for both sides in this case. The first is that there is evidence that the drugs used cause serious side effects. But then, all drugs have potential side effects. During FDA review of the off-label use of RU-486, for example, practically every subject experienced at least one of the 27 listed side effects. In 23% of the cases, the side effect was serious enough to require further medical attention. Regardless, in the on-label protocol use of RU-486, the efficiency of inducing a medical abortion is rather high.

The smoking gun for the state’s argument is that the off-label use of these drugs brings about a success rate lower than the on-label use of the drugs. During the FDA trials on the new protocol, 14.6% of pregnancies failed to end. Of these, about a quarter of the women decided to carry the pregnancy to term while half of the unsuccessful cases had incomplete abortions- that is, the entire fetus was not “expelled.” Some of these women opted for a surgical abortion, now later in the gestational period while many had to have a surgical abortion because of the off label protocol complications. The rate of complications and failed abortion is considerably lower with the on-label protocol. Thus, although the off-label protocol may be cheaper and may give a woman an extra two weeks of this option, it is certainly less efficient and less safe. Leaving aside the efficiency issue, the state’s interest is in the safe use of these drugs and the law would, given the legislative record, indicate this was the primary motive in passing the law.

Conversely, the pro-choice crowd correctly notes that in several other areas, Oklahoma allows, even endorses, the use of off-label prescription drug usage. They cite, for example, a state law that mandates insurance companies cannot discriminate in payments for off-label use of drugs that treat cancer. Another correct assertion is that the concept of labeling is primarily a marketing device. If the FDA intended no off-label uses of any drug, it would inhibit medical innovation. The popular drug Viagra, originally prescribed for high blood pressure, is now technically used “off label” to treat something else, and is accepted medical practice. Third, they are arguing for deference to the medical community which advocates the off label use of RU-486. The abortion clinic in this case performs 67% of their abortions medically and all of them are off label. In this respect, they argue, the Oklahoma law would effectively ban all medical abortions.

They are correct only insofar as it would ban medical abortions that currently use the off label regimen. The law would not ban medical abortions, just how the drugs are to used. Yes, it has the “side effect” of narrowing the time frame for this option, but what did abortion clinics in Oklahoma and elsewhere do before this off label regimen was “discovered?”

It would be one thing if the state of Oklahoma banned the use of RU-486 within their borders. Since 67% of abortions rely on its use, it would effectively eliminate the bulk of abortions in the state, despite the FDA’s approval of the drug. However, that in no way approximates the issues here. The state is simply mandating, based on the evidence which is illustrated in the legislative record, that the drug should be used as the FDA proscribes and places on the label. Of course, the FDA can always change the label and allow this new protocol, but they haven’t for the statistical evidence listed earlier. It should be noted that during the legislative debate, there were no grandstanding pro-life speeches and the bill was rationally debated without any Wendy Davis filibustering the law. In essence, the democratic process worked.

It would be difficult to divine a Court decision other than there are likely three firm votes in favor of the law- Alito, Scalia, and Thomas- who would not view the law as an undue burden on a woman’s “right” to abortion. One could also count four likely votes against the law- Breyer, Ginsburg, Sotomayor, and Kagan. As usual in these tight cases, it would come down to Kennedy and Roberts. Kennedy has a record in the area of abortion jurisprudence largely following the Sandra Day O’Connor line of thinking which parses the individual statute narrowly, looks at its practical effect, and then decides if the practical effect is an undue burden.

Roberts was in the majority in the Carhart vs. Gonzalez decision which upheld a Nebraska law which banned late term abortions. However, a more careful reading of that decision indicates that although he disagreed with the methods used, he did not necessarily disagree with the practice itself. Furthermore, during his confirmation hearings, he said that Roe v. Wade was settled law and that he would respect precedent. But, this case will not rely on Roe, but more likely on Casey vs. Planned Parenthood which established the undue burden standard. Since Roberts likes to take the narrow view, the question is, as with Kennedy, does the law place an undue burden on women in the practical sense?

Since the Supreme Court gave the Oklahoma courts a mandate to explain their reasoning for striking down the law, that response was received by the Court. Apparently the reasoning passed constitutional muster since they have now dismissed the case. The practical result is that off-label medical abortions are now readily available in Oklahoma. No reasons by the Supreme Court were involved in the simply single-page dismissal of the case. Either the reasoning was sound or Roberts and Kennedy lacked the will to pursue this case in the area of abortion rights. We may never know the reasoning.

However, this very week Planned Parenthood challenged the recently passed Texas abortion law. The lower District Court ruled that the law was likely unconstitutional and struck down most of its provisions. Furthermore, they issued an injunction pending appeal by the Fifth Circuit Court of Appeals which banned the state from enforcing the law. The 5th Circuit subsequently lifted the injunction and reversed the District Court in several key provisions. Planned Parenthood then appealed directly to the United States Supreme Court. Justice Scalia receives such appeals from the 5th Circuit. He can handle the appeal himself or refer it to the entire Court. He has given Texas two weeks to respond to Planned Parenthood’s appeal.

It will be interesting to see if the Court will take this case, if Scalia will handle it himself, and whether it is too late in the current term to schedule it for oral argument. It may very well be that he could delay it past the Christmas holiday thus making it more difficult to get on this term’s docket. Because of one provision- that doctors who perform abortions have patient admitting privileges at hospitals- several clinics have closed in Texas. Pro-choice groups argue that abortion laws will turn back the clocks to women seeking unsafe back-alley abortions. They argue for safe, readily available abortion. Part of making them “safe” is making sure that doctors have the means to admit patients to hospitals in cases where complications resulting from abortions occur. If Scalia rejects the appeal, it would be even more interesting to see if the full Court takes up the case.

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