Medication Abortions: Is a state’s limitation of drug induced abortions only to FDA-approved practices constitutional? Courts disagree.

Last week, three courts, the Oklahoma Supreme Court, the Western District of Texas and the Fifth Circuit Court of Appeals, issued rulings regarding the constitutionality of state abortion laws, specifically, whether a state’s limitation on medication abortions is constitutionally permissible.

On Tuesday October 29th, the Oklahoma Supreme Court reaffirmed its earlier ruling that the state’s 2011 preventive abortion law, H.B. 1970, is unconstitutional. The proposed law limited how medications could be administered to patients to induce abortions.  Oklahoma’s Attorney General Scott Pruitt appealed the Oklahoma Supreme Court’s initial holding in December 2012 that the law was unconstitutional to the United States Supreme Court.  The United States Supreme Court per curiam asked two questions regarding the Oklahoma’s Supreme Court’s holding: whether the law prohibited the use of “misprostol to induce abortions, including the use of misoprostol in conjunction with mifepristone according to a protocol approved by the Food and Drug Administration;” and whether it prohibited “the use of methotrexate to treat ectopic pregnancies.”  The Oklahoma Supreme Court answered both questions in the affirmative.  The U.S. Supreme Court reserved the possibility of further proceedings pending receipt of a response from the Oklahoma Supreme Court.

The first question addressed a medication abortion procedure in which mifepristone, often called RU-486, is taken orally, and two days later misoprostal is taken orally. Then two weeks later, the patient returns to the office to determine whether the procedure was successful.  The FDA approved of the use of mifepristone through forty-nine days of pregnancy in 2000, but does not approve of the use misoprostal for abortions. Since 2000, the medical profession has developed newer, more efficient, and in many physicians’ opinions, safer procedures, including the misoprostal process.  The FDA, however, has not approved these processes.  Pro-choice advocates argue that the new, refined procedures permit significantly lower dosages than the FDA-approved protocol, are more convenient for patients, and allow the clinics to extend the use of chemical abortions from 49 days to 63 days after a woman has detected physical evidence of her pregnancy. As noted by the Oklahoma Supreme Court, “[b]oth the American College of Obstetricians and Gynecologists and the World Health Organization have endorsed these off-label alternate regimens as safer and more effective than the now-outdated regimen provided for in [the 2000] FDA-approved label.”

The U.S. Supreme Court’s second question addressed the use of methotrexate, a drug frequently used by physicians to terminate early ectopic pregnancies without surgery, in ectopic pregnancies.  The Oklahoma law would ban the use of methotrexate to treat ectopic pregnancies, leaving surgery as the only other treatment for this condition.  Ectopic pregnancies (when an embryo develops outside of the womb) pose serious health risks to women, and surgery has the potential to lead to grave complications, including future infertility, organ damage and death. According to Nancy Stanwood, the Chairwoman of Physicians for Reproductive Health and Chief of Family Planning at the Yale School of Medicine, surgery is not a safe option for every patient. “Some women may not be candidates for surgery because they have underlying medical conditions or a high-risk of complications from anesthesia,” she explains. “Taking methotrexate off the table would be devastating.”

Since the FDA approved neither the combined use of misoprostol administered with mifepristone, nor the use of methotrexate in treating ectopic pregnancies, both protocols are “off-label uses” prohibited by H.B. 1970, effectively banning all medication abortions.  Therefore, H.B. 1970 “restricts the long-respected medical discretion of physicians” to provide off-label FDA abortion treatments to patients. Consequently, the Oklahoma Supreme Court answered the U.S. Supreme Court’s inquiries in the affirmative.

In the second judicial opinion decided last week, Western District of Texas District Court Judge Lee Yeakel held in Planned Parenthood of Greater Texas Surgical Health Services v. Abbott, No. 1:13-cv-862, 2013 WL 5781583 (W.D. Tex. Oct. 28, 2013), that certain provisions of the recently passed Texas anti-abortion legislation are unconstitutional. The provisions the district court held unconstitutional gained notoriety earlier this summer when Texas State Senator Wendy Davis filibustered against their inclusion in the law.

Judge Yeakel held that the admitting privileges provision lacked rational basis and violated physicians’ due process rights. The statute mandates that a physician performing an abortion must have active admitting privileges at a hospital within 30 miles of the clinic where he provides abortion services.  Furthermore, notwithstanding the due process violation, the admitting privileges provision imposed “undue burden on women seeking abortion procedures.”  The court noted that 24 counties would be left with no abortion provider and many would have to travel great lengths to find a physician. The American Congress of Obstetricians and Gynecologists issued a Texas fact which provides a map that shows how far women have to drive to hospitals with medical centers. No abortion clinics would be operating east of Waco or west of Interstate 35, a substantial portion of the state.  The court found these restrictions do not have a sufficient rational basis, and are overly burdensome on women.

Lastly, the court also held that the restriction of medication abortions, similar to those prohibited in the Oklahoma statute, H.B. 1970, placed a substantial obstacle on women seeking an abortion for whom surgical abortion is not a medically sound or safe option.  The district court upheld the Texas law’s provisions that limited medication abortions to only those that have been FDA-approved.  The court, however, noted that this provision was more burdensome, but not burdensome enough to rise to the level of undue burden for the average woman.  Also interestingly, Planned Parenthood did not challenge the ban on abortions after 20 weeks—the point where modern medical science has largely rendered fetuses viable outside the womb. The District Court imposed a preliminary injunction on Texas from allowing the provisions held unconstitutional from taking effect on November 1st, 2013. Texas Attorney General Greg Abbott filed an emergency appeal to the Fifth Circuit urging it to reverse the injunction.

On Thursday October 31st, Judge Patricia Owen of the Fifth Circuit Court of Appeals reversed the preliminary injunction in a temporary ruling while an appeal proceeds on an expedited schedule. The Fifth Circuit held that Texas successfully argued that there is a substantial likelihood that it would prevail on the merits of the case in proving that the provisions would not unduly burden women seeking abortions.  The Court reversed the district court’s ruling that the admitting privilege provision unconstitutionally burdened women, holding that driving 150 miles to get an abortion was not a sufficient burden on some women.  The Court also reversed the district court’s “overly broad” judicially created “health exception” for medication abortions, but noted that Texas’s arguments were not strong enough to show a likelihood of success, and thus ruled a stay on whether the injunction was necessary. Lastly, the Court affirmed the district court’s holding that Texas’s FDA-approved medication abortion limitation was constitutional and did not place an undue burden on women. Judge Owen noted that the primary difference between the FDA-approved and “off label” medication abortion practices is that the FDA-approved abortion procedure is only allowed through the first seven weeks of the woman’s pregnancy while the “off label” practice is allowed through nine weeks.  She concluded that this FDA-approved procedure, which is more costly and involves more trips to the doctor, is not as widely used across the country and is only allowed through the first seven weeks of pregnancy, and, therefore that it does not create an undue burden for women.  Immediately, 13 of 36 abortion clinics throughout the state of Texas will close their doors pending a complete ruling by the Fifth Circuit in January.

The Fifth Circuit and Oklahoma Supreme Court decisions create a jurisdictional split over the constitutionality of the FDA-approved limitation in state abortion laws. This split elevates an already intense national debate over the best medication procedure for abortions.  Since 2000, studies by the World Health Organization (WHO) and independent scientists have found that the mifepristone “off-label” procedure is equally effective at a third of the original dose, and can be used nine weeks into pregnancy, rather than the seven its FDA label states, as noted by Judge Owen in the Fifth Circuit. Both the WHO and the American Congress of Obstetricians and Gynecologists now recommend a lower dose and fewer doctors’ visits than outlined by the FDA.  As Judge Yeakel stated,

[T]he FDA protocol is assuredly more imposing and unpleasant for the woman, requiring at least one additional visit to a clinic and allowing less control over the timing and convenience of the medically induced miscarriage. It also requires more of the physician’s time, as the physician   must administer the second dose. The FDA protocol is also marginally more expensive, due to the increased dosage, notwithstanding any additional cost of travel, time off of work, and childcare. Most importantly, the FDA protocol removes medication abortion as an option for any woman who discovers she is pregnant or decides to terminate a pregnancy after.

Both state laws at issue address a principle articulated in Roe v. Wade and reaffirmed in Planned Parenthood of Southeastern Pennsylvania v. Casey: “the right of the woman to choose to have an abortion before viability and to obtain it without undue interference from the state.” The U.S. Supreme Court held that before viability of the fetus, “the State’s interests are not strong enough to support a prohibition of abortion of the imposition of a substantial obstacle to the woman’s effective right to elect the procedure.”  This principle analyzes the viability of a state law regulating abortions through the undue burden test which states that “only where state regulation imposes an undue burden on a woman’s ability to make th[e] decision [whether or not to have an abortion] does the power of the State reach into the heart of the liberty protected by the Due Process Clause.” The U.S. Supreme Court held that although the states have a valid interest in potential life, these restrictions on a “woman’s choice cannot be considered a permissible means of serving [a] legitimate end[].”

Today, one in five early abortions in the United States are performed with medication. Nancy Northup, president and CEO of the Center for Reproductive Rights, applauded the Oklahoma Supreme Court decision, saying, “Physicians know better than politicians what’s right for their patients, and medical decisions should be made according to their advice and expertise, not any politician’s ideological agenda to ban abortion.” While Ms. Northup does have a strong argument that the physicians should be free to make medical decisions, the states have an interest in drawing a line somewhere to ensure that the medical practices used are safe and effective without placing an undue burden on women. The question is where that line will be and should be drawn.

In Casey, the U.S. Supreme Court drew the line on several restrictions holding that 24-hour waiting periods, parental consent provisions and reporting and recordkeeping requirements of the Pennsylvania statute did not impose undue burdens, but the spousal notification provision did impose an undue burden. This issue will face tremendous media and public interest attention and is at the heart of the debate over the limits of constitutional abortion regulation. With the Oklahoma law already on cert application to the U.S. Supreme Court and with a controversial contrasting decision in the Fifth Circuit on the same issue, the U.S. Supreme Court is faced with a jurisdictional split over whether a state law limiting medication abortions to those protocols approved by the FDA imposes an undue burden on women in violation of due process and the principles established in Roe v. Wade.

The FDA approval of a medical practice seems like a clear safe line for states to draw in an effort to protect the safety of women.  If the FDA hasn’t approved a practice that the medical profession argues is safer and more efficient, which has been the “most widely adopted” drug induced abortion practice, then the medical profession should argue that the FDA should approve the practice rather than argue for a more vague and potentially more dangerous practice of non-FDA-approved drug use. Consequently, the Supreme Court will likely rule that the FDA-approved limitation is constitutional under Roe v. Wade because “the incidental effect of making it more difficult or more expensive to procure an abortion cannot be enough to invalidate it”; and encourage the FDA to approve this new process if it really is better, as advertised by the medical profession.

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