Before surgery, would a patient want to know what to expect and what the risks of the procedure are? Of course. Would a patient want a medication that was approved by the Food and Drug Administration (FDA) and prescribed within its guidelines? Of course. Women considering a medical abortion such as RU-486 should be entitled to accurate and truthful information concerning this procedure.
Medical abortions are on the rise and abortion providers such as Planned Parenthood state they will make greater use of it. However, abortion providers are not following FDA guidelines and are prescribing an off-label use of RU-486. Off-label use means the FDA guidelines are not followed which require: (1) use of RU-486 for only up to seven weeks of pregnancy; (2) physicians must personally administer each of the two doses at the facility; and, (3) physicians must provide backup medical care for complications. In addition, abortion providers are minimizing what a woman will experience after taking the drug.
After examining the scientific evidence, the Oklahoma legislature enacted House Bill 1970 and banned the off-label use of RU-486 to protect women. The Oklahoma Coalition for Reproductive Justice filed suit to stop the implementation of the law. The district court held the law was unconstitutional and issued a permanent injunction. The Oklahoma Supreme Court summarily stated that the law was unconstitutional based on Planned Parenthood v. Casey; however, it did not provide any explanation or analysis.
A petition for certiorari was filed at the US Supreme Court, and several amicus briefs were also filed including one representing women and families hurt by RU-486. In June, the petition for certiorari was granted and two questions were certified to Oklahoma Supreme Court. The questions were whether the bill prohibits: (1) the use of misoprostol to induce abortions, including the its use as approved by the Food and Drug Administration and (2) the use of methotrexate to treat ectopic pregnancies. The Oklahoma Supreme Court answered both questions in the affirmative using the plain language of the statute and rejecting the restrictions on medical discretion of physicians.
On October 29th, the US Supreme Court dismissed the writ of certiorari as improvidently granted. But, this may not be the end of the story as the Oklahoma Legislature will probably take up the issue in February 2014 and any subsequent legislation will likely be challenged.
The term "medical" abortion sounds safe and harmless, but can have serious negative physical and psychological consequences. This commentary will discuss two issues. First, the state has the right to provide reasonable regulations for the health and safety of women. Second, medical abortions expose women to increased risks of physical and psychological harm.
The US Supreme Court recognized in Casey that because the state has a substantial interest in the life of the unborn child, the state may promulgate regulations that do not create an undue burden on the woman's right to decide, particularly regulations that are "designed to foster the health of a woman seeking an abortion." The court noted that this was true as with any medical procedure.
Furthermore, the Supreme Court upheld abortion regulations that "are not efforts to sway or direct a woman's choice, but rather are efforts to enhance the deliberative quality of that decision or are neutral regulations on the health aspects of her decision In Planned Parenthood v. DeWine, the Court of Appeals for the Sixth Circuit concluded that there was no evidence that an Ohio statute that paralleled Oklahoma's law would impose an undue burden on a woman's ability to decide, and therefore, was constitutional. Unlike the Sixth Circuit's detailed analysis, the Oklahoma Supreme Court summarily concluded that the Oklahoma provision was unconstitutional without analysis or explanation.
As long as there is a "commonly used and generally accepted method" of abortion, there is not a "substantial obstacle to the abortion right." The US Supreme Court stated in Gonzales v. Carhart: that "mere convenience" is not sufficient to overcome the regulation and the State can ban some procedures that have different risks than other procedures.
The RU-486 regimen poses a substantial risk to the physical health of women, including the risk of death. Both the FDA (PDF) and Danco, the drug manufacturer, have acknowledged that RU-486 poses health risks for women. The Congressional Staff Report on RU-486 cited FDA findings concerning the physical risks to women taking the RU-486 regimen. The FDA's Medical Officer's review indicated that, "[m]ore than one adverse event was reported for most patients ... Approximately [twenty-three percent] of the adverse events in each gestational age group were judged to be severe." The report calls these "startling adverse effects," which the FDA knew during the RU-486 NDA review process.
Also of concern was "the incredibly high failure rate of the drug." The report concluded: "By any objective standard, a failure rate approaching eight percent and requiring subsequent surgical intervention as the 'best' outcome is a dismal result."
In 2011, the FDA issued a report (PDF) on the post-marketing events of RU-486. The FDA reported that there were 2,207 adverse complications in the United States related to the use of RU-486, including hemorrhaging, blood loss requiring transfusions, serious infections, and death. Among the 2,207 adverse events were fourteen deaths, 612 hospitalizations, 339 blood transfusions, and 256 infections (including 48 "severe infections").
In accordance with the US Supreme Court's decisions in Casey and Gonzales, providing for the safety of drugs and medical procedures are within the legitimate function of the state. Women deserve to know the risks of a medical abortion.
Increased Risks of Physical and Psychological Harm
In Casey, the Supreme Court emphasized the need for a woman to have full, accurate, and truthful information so that she could make an informed decision. Off-label use of RU-486 regimen misleads women into thinking that it is safe and approved by the FDA.
In 2006, the Oklahoma State Board of Medical Licensure and Supervision produced the Woman's Right to Know Booklet (PDF) to provide women accurate and truthful information. The booklet discusses the RU-486 procedure and side effects. More scientific information is available on the risks and side effects of the RU-486 regimen and that those risks are greater than with surgical abortion.
Researchers have concluded (PDF) that there are increased risks of physical problems with the RU-486 regimen including: more pain, more nausea or vomiting, higher failure rate, greater risks of acute bleeding requiring surgery, post-procedure bleeding continues for a longer period of time, more women require surgery for persistent bleeding, more total blood loss, and greater risk of massive, life-threatening hemorrhage. They also report that "mifepristone abortion has 10 times more risk of death from infection than surgical abortion and 50 times more risk of death from infection compared to childbirth."
The risks of RU-486 may also be trans-generational. Dr. Bernard Nathanson, co-founder of the National Association for the Repeal of Abortion Laws (NARAL) and who presided over 60,000 abortions, Dr. Nathanson warned there may be the possibility that disorders could be passed down to surviving offspring of women who have taken the drug. "RU-486 is the drug which acts on the female reproductive system, and anything that does that we have to be keenly aware of what are called trans-generational effects." In addition, he warned that if a woman starts taking the regimen but then changes her mind and wants to carry the baby to term, the newborn may have serious deformities.
The RU-486 regimen also has increased risks for psychological problems. In scientific studies (PDF), women rated medical abortions as more stressful and experienced more disruptions in their lives. They also experienced a significant decline in self-esteem and higher PTSD intrusion scores.
There are at least five major reasons why women are at greater risk of more severe psychological trauma with the RU-486 regimen than with a surgical abortion. First, the woman has a participatory role with a medical abortion which may cause greater psychological trauma; because the woman is directly responsible for the abortion which may exacerbate guilt and other negative feelings. She cannot close her eyes to the process and tell herself that someone else is doing this to her. Simply looking in the mirror can become a triggering event. Second, medical abortion requires the woman to be more alert and involved during the process. Therefore, it is impossible for her to distance herself psychologically from the abortion. Third, there is a greater potential for the woman to see her expelled unborn child. There is no doubt in her mind that she has taken the life of her unborn child. Fourth, although women usually say that they choose a medical abortion because it is in the privacy of their home, that privacy that can lead to greater trauma. This is because the woman is more likely at home alone. Thus, it is likely that she is without emotional support at the time of the abortion. Fifth, the woman's home becomes a trigger point for negative emotions instead of being a place of refuge. This is because she is at home and more specifically in the bathroom. Therefore, her home and the bathroom are associated with the abortion that she participated in a major and very visual way. The home becomes a daily trigger of the abortion experience.
The RU-486 medical abortion regimen creates greater risks of both physical and psychological harm to women than surgical abortion. The Oklahoma Legislature was correct in providing for the protection of women considering the RU-486 regimen and requiring the FDA guidelines be followed instead of the off-label use that abortionists are prescribing. The Supreme Court has allowed these reasonable medical regulations. Scientific studies demonstrate the increased physical and psychological risks to women, and therefore, the Oklahoma Legislature was acting within its legitimate interests and authority. So, we will wait and see what the Legislature does in 2014.
Linda L. Schlueter is President of Trinity Legal Center, a nonprofit, public interest litigation and legislation support center assisting post-abortive women. Mrs. Schlueter was the chief brief writer in the effort to overturn Roe v. Wade and Doe v. Bolton in 2003-2004. She authored an amicus curiae brief representing Sandra Cano, the "Doe" of Doe v. Bolton and 180 post-abortive women in the partial birth abortion case, Gonzales v. Carhart. It was the only amicus brief cited by the United States Supreme Court in that case. She has testified before the legislatures in both the United States and foreign countries concerning the abortion issue.
Suggested citation: Linda L. Schlueter, Cline v. Oklahoma Coalition for Reproductive Justice: Increased Risk of Physical and Psychological Harm, JURIST - Hotline, Dec. 26, 2013, http://jurist.org/hotline/2013/12/linda-schlueter-cline-ru486.php.
This article was prepared for publication by Alexandra Cabonor, an associate editor with JURIST's professional commentary service. Please direct any questions or comments to her at firstname.lastname@example.org