Sixth Circuit Upholds RU-486 Law
By Mailee Smith
Tuesday, October 2nd, 2012

The Sixth Circuit Court of Appeals has rejected Planned Parenthood’s challenge to a 2004 Ohio law regulating the abortion drug RU-486.  In Planned Parenthood Southwest Ohio v. DeWine, the court ruled that the Ohio law is not vague and does not impose an “undue burden” on women seeking abortions.  Rather than “using as directed,” the abortion industry has been handing out life-ending drugs against the restrictions established by the U.S. Food and Drug Administration (FDA), and some women died.  And yet, the abortion industry went to court to continue with its potentially deadly practices.

The FDA approved the abortion drug regimen RU-486 (under the brand name Mifeprex) for use only through 49 days of pregnancy. The regimen actually involves two different drugs: oral administration of mifepristone on day one, followed by an oral administration of misoprostol on day 3 (together known as the Mifeprex regimen).   The FDA approved the drug regimen under a special code section that allows the FDA to restrict the use of the drugs.

Not only did the FDA approve the drug just through 49 days gestation, but the FDA specifically outlined that women are to take each dose in a clinic or physician’s office, with the second dose in the regimen to be taken orally.  However, abortion providers—including Planned Parenthood—purposely flout these restrictions, providing the drugs past 49 days and instructing women to take the second dose at home vaginally or buccally (not orally).

But providing the Mifeprex regimen outside the restrictions approved by the FDA is dangerous. 

In 2011, the FDA reported that 14 women had died after using the Mifeprex regimen, and eight of these women had died from a bacterial infection.  In all eight deaths, the Mifeprex regimen had been administered in a manner unapproved by the FDA.  Significantly, no woman has died from bacterial infection following use of the Mifeprex regimen as approved by the FDA.

As reported by the U.S. Government Accountability Office (GAO), the number of women dying from bacterial infection following use of the Mifeprex regimen is not within the range expected.  In other words, more women have died from bacterial infection following use of the Mifeprex regimen than the FDA expected—and in all eight cases, the drugs were used in an unapproved manner.

Notably, the labeling for the Mifeprex regimen states that nearly all women will suffer adverse effects following use of the drug regimen.

And hence the need for the Ohio law.  In 2004, the legislature passed the measure which requires that physicians provide the Mifeprex regimen only in the way approved by the FDA.  In response, Planned Parenthood immediately filed suit.

Among Planned Parenthood’s claims were that the Ohio law is “vague” (i.e., Planned Parenthood allegedly didn’t understand what it was supposed to do, in being instructed to follow the FDA’s clear instructions for the administration of the drug regimen) and that the Ohio law creates an “undue burden.”  The Circuit rejected both of these claims.

The court also pointed out that “Planned Parenthood did not sustain its burden” in showing that the law imposes any burden on a woman seeking an abortion with the Mifeprex regimen.  “Review of the evidence shows that the district court correctly concluded that the record simply does not give rise to a reasonable inference that the [law] imposes a substantial obstacle for Ohio women deciding whether to abort a pregnancy.” 

Simply put, Planned Parenthood had been unable to produce any evidence that the regulation of the Mifeprex regimen creates any obstacle to women.  As is Planned Parenthood’s typical game plan, the abortion giant placed politically and financially motivated rhetoric before the court without any substance to back up its claims.  Both the lower court and the Sixth Circuit saw through this ruse.

The Circuit also noted that “the Supreme Court has not articulated any rule that would suggest that the right to choose abortion encompasses the right to choose a particular abortion method.” 

In sum, medically supported regulation of the Mifeprex regimen that is aimed at protecting women is not an “undue burden.”  It does not ban abortion.  Other alternatives—such as surgical abortion, which Planned Parenthood deems “very safe”—exist.  Requiring that abortion providers abide by the only regimen considered safe by the FDA is not an obstacle for women—it is a protection. 

AUL has been involved in this case since 2007, filing three amicus briefs on behalf of Members of Congress in support of the State of Ohio.  The most recent was filed on behalf of Speaker of the U.S. House of Representatives John Boehner (OH), U.S. Senator Tom Coburn, M.D. (OK), and U.S. Representatives Steve Austria (OH), Dan Benishek, M.D. (MI), Diane Black, R.N. (TN), Charles Boustany, M.D. (LA), Paul Broun, M.D. (GA), Bill Cassidy, M.D. (LA), Steve Chabot (OH), John Fleming, M.D. (LA), Bob Gibbs (OH), Andy Harris, M.D. (MD), Bill Johnson (OH), Jim Jordan (OH), Robert Latta (OH), Jean Schmidt (OH), Steve Stivers (OH), and Pat Tiberi (OH), demonstrating to the Sixth Circuit that medically appropriate regulation of the Mifeprex regimen is not an “undue burden.”  One issue still remains unresolved before the trial court, and therefore the case will continue.

Posted in categories: Abortion, Abortion Pill, Amicus Briefs, Blog, RU-486.
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