Ohio Supreme Court Prohibits Off-Label Use of RU-486 and Denies Release of Clinic Records


With thanks to our colleague Jill Zimon for passing along info on two important decisions by the Ohio Supreme Court.

First, as reported on the website of the Ohio Supreme Court and Justice System, today, July 1, 2009, the Court ruled against off-label use of RU-486:

The Supreme Court of Ohio ruled today that a state law enacted in 2004 mandates that Ohio physicians providing the drug mifepristone (RU 486) to patients for the purpose of inducing an abortion must do so in accordance with the approval letter and final printed labeling for the drug issued by the U.S. Food and Drug Administration (FDA), which includes compliance with the 49-day gestational limit and with the treatment protocols and dosage indications expressly approved by the FDA.

The Court’s 4-3 majority decision was authored by Justice Terrence O’Donnell.

The FDA approved mifepristone, commonly referred to as RU-486, for manufacture and use in the United States in September 2000. The FDA’s approval of RU-486 was based on clinical trials involving patients no more than 49 days pregnancy, and who received an oral dose of 600 mg of RU-486, followed two days later by an oral dose of 0.4 mg of misoprostol.  Clinics in Ohio, however, were using the drug for terminations of pregnancies of longer duration based on additional clinical evidence, but not approved by FDA.

Off-label use of drugs is common.  As noted in the original report:

After a drug has been approved by the FDA, in the absence of additional state-level regulation, doctors are permitted to prescribe that drug in different medical situations and to employ different dosages and delivery protocols for the drug than those initially approved by the FDA. This practice, known as “off-label” use, is not barred by federal law or FDA regulations.  As a result of research conducted following FDA approval of RU-486, an off-label protocol was developed in which doctors administer a 200 mg oral dose of RU-486 followed three days later by 0.8 mg of misoprostol to patients whose pregnancies have progressed as long as 63 days. This off-label regime was adopted by the Planned Parenthood clinics in Cleveland, Columbus and Cincinnati and by other providers of abortion services in Ohio.

A law passed by the Ohio General Assembly enacted in 2004 barred Ohio physicians from administering or prescribing RU-486 to induce an abortion unless the drug was provided to a patient “in accordance with all provisions of federal law that govern the use of RU-486.”

That law defined “federal law” as:

“any law, rule or regulation of the United States or any drug approval letter of the (FDA) … that governs or regulates the use of RU-486 for the purpose of inducing abortions.” Under R.C. 2919.123, the prescription or administration of RU-486 by a doctor to a patient in a manner not consistent with “federal law” is a criminal offense punishable as a felony.”

Before this law took effect, Planned Parenthood of Southwest Ohio and other plaintiffs filed suit in federal district court asserting four different legal bases on which the statute was unconstitutional and therefore unenforceable.  They recieved an injunction preventing state officials or local prosecutors from enforcing the original statute.   Then, in 2006, while the temporary injunction remained in place:

the U.S. District Court for the Southern District of Ohio granted summary judgment in favor of Planned Parenthood, holding that R.C. 2929.123 was unconstitutionally vague and permanently enjoining enforcement of the entire statute.

The state of Ohio then appealed that ruling to the U.S. Sixth Circuit Court of Appeals.  Prior to ruling on the state’s appeal, the Sixth Circuit asked the Supreme Court of Ohio to review and interpret the law and to answer two certified questions:

“1) Does O.R.C. § 2919.123 mandate that physicians in Ohio who perform abortions using mifepristone do so in compliance with the forty-nine-day gestational limit described in the FDA approval letter?”

“2) Does O.R.C. § 2919.123 mandate that physicians in Ohio who perform abortions using mifepristone do so in compliance with the treatment protocols and dosage indications described in the drug’s final printed labeling?”

Writing for the majority in today’s Supreme Court decision, Justice O’Donnell answered yes to both questions, stating that the:

“provisions of R.C. 2919.123 are not ambiguous.  It allows physicians to provide or prescribe mifepristone to a patient to induce an abortion only if ‘the physician provides the RU-486 (mifepristone) … in accordance with all provisions of federal law that govern the use of RU-486 (mifepristone) for inducing abortions.’”

In a second decision, the Ohio Supreme Court on Wednesday ruled that Cincinnati Planned Parenthood would not have to release records to an attorney who contended that the Planned Parenthood affiliate “engaged in a pattern of abuse by failing to report to state officials cases of statutory rape.”

According to the Columbus Dispatch:

The court denied a request from the parents of a 14-year-old Cincinnati girl for records of other girls who obtained abortions from the Planned Parenthood of Southwest Ohio clinic.

The parents sued after the girl received an abortion in 2004 under false pretenses. She had been
sexually abused and impregnated by her 21-year-old soccer coach, a police investigation revealed.
The coach impersonated the girl’s father in order to give her permission for the abortion.

The parents accused Planned Parenthood of negligence and of a pattern of ignoring evidence of
abuse. They sought records from the abortion provider to establish their claim.

In a split decision, the Supreme Court said Planned Parenthood could not be compelled to turn
over confidential medical records, but the parents still can pursue their legal claims against the
clinic.

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  • invalid-0

    Thanks to the Ohio Supreme Court women’s reproductive health will be protected. The abortion drug has been responsible for the deaths of at least a dozen women worldwide and it has injured more than 1,200 women in the United States according to FDA figures from 2007. The law was necessary because Planned Parenthood was telling women they should use the drug vaginally and that contributed to the deaths of six women. They modified their practice after the deaths and the Ohio law said the drug should not be used vaginally.

    • invalid-0

      As of March 31, 2006 the FDA reports:
      http://www.fda.gov/NewsEvents/Testimony/ucm112562.htm
      Deaths Reported After Use of Mifepristone

      FDA is aware of 12 deaths possibly involving the use of mifepristone in women. Nine of these deaths were in the U.S. Of these, five were determined to be related to infections, one involved an undiagnosed ectopic pregnancy, one appears unlikely to be related to the use of mifepristone, one was determined to be unrelated to either the medical abortion or the use of mifepristone and misoprostol, and one that is currently under investigation appears not to have involved the administration of misoprostol and appears to be unrelated to the use of mifepristone. In addition, there were three deaths in other countries related to mifepristone and misoprostol induced abortion. These 12 deaths are described below:

      * Five deaths in U.S. women associated with mifepristone and misoprostol induced medical abortion, with what appears to be a rapidly fatal toxin-mediated shock syndrome
      o Four of these five, all in California, were confirmed to involve a rare anaerobic bacterium, Clostridium sordellii (C. sordellii). All involved the use of mifepristone 200 mg orally, followed by 800 mcg of misoprostol inserted intravaginally, a regimen that is not part of the FDA-approved labeling.
      o One U.S. woman from the west, whose death was confirmed to involve a different bacterium, Clostridium perfringens (C. perfringens). This case involved the use of mifepristone 200 mg orally, followed by 800 mcg of misoprostol inserted intravaginally, a regimen that is not part of the approved labeling.
      * One death in a U.S. woman who had an undiagnosed ectopic pregnancy. Ectopic pregnancy is a contraindication for the use of mifepristone.
      * One death involving a woman who initially had an unsuccessful attempted surgical abortion, followed by an unsuccessful medical abortion involving mifepristone, and then followed by a second and successful surgical abortion. The woman was hospitalized approximately one month after taking mifepristone, and she died approximately 24 hours after admission during a hysterectomy. There was no autopsy, but pathology findings included a degenerated, pus-filled uterine fibroid. Cultures were negative for any Clostridial bacteria. Based on the available evidence at this time, FDA and the Centers for Disease Control and Prevention (CDC) do not believe this death was related to the use of mifepristone.
      * One death in the northeastern U.S. was determined to be unrelated to either the medical abortion or the use of mifepristone and misoprostol.
      * One death in the southwestern U.S. is still under investigation, but appears not to have involved the administration of misoprostol, and appears to be unrelated to the medical abortion or the use of mifepristone.
      * One death in Canada of a woman who died during participation in a clinical trial. This death was due to sepsis involving C. sordellii.
      * One death in Sweden of woman as a result of severe hemorrhage related to a medical abortion.
      * One death of a British woman was attributed to gastric (stomach) bleeding from an ulcer.

      The four California deaths, plus the Canadian case, were reported in the New England Journal of Medicine in December 2005, by CDC scientists. Since that time, CDC has been actively seeking additional cases across the country. FDA is aware that CDC has identified two additional cases which appear to be unrelated to the use of mifepristone:

      * A death from the midwest in a woman who had a second trimester medical abortion employing misoprostol and laminaria (a moisture absorbing medical device inserted into the vagina to stimulate cervical dilation), but not mifepristone. This woman had C. perfringens.
      * A toxin-mediated infectious death due to C. sordellii in a woman who initially was reported to have had a medical abortion. However, the woman had appendicitis and pneumonia, not a uterine infection, and CDC has been unable (despite extensive investigation) to find evidence that she had an abortion or had ever been pregnant.

      The cases of women with C. sordellii infection are of great concern to FDA and CDC. C. sordellii is a rare infection and has been reported in the literature since the 1930s. The largest case series, published in 1989 by McGregor, Soper, and colleagues in the obstetrical literature, describes cases after vaginal delivery and Cesarean section, as well as a case of spontaneous endometritis. All developed a fatal shock syndrome. Other literature describes infectious illnesses in intravenous drug users and in organ transplant recipients.

  • crowepps

    This law is entirely for the purpose of restricting abortions. It doesn’t have anything to do with ‘women’s reproductive health’. I find it really strange that this drug is widely used on in Europe with few problems and that the complications are claimed to increase dramatically as soon as it is used in an area with anti-legal abortion activists. A drug that’s been in use for 20 years and has only killed a dozen women worldwide is a very safe drug.