Federal appellate judges this morning questioned the legal justification of Arizona lawmakers in restricting — if not banning outright — the ability of women to terminate a pregnancy using medication instead of surgery.
Robert Ellman, the state's solicitor general, told the 9th U.S. Circuit Court of Appeals lawmakers were entitled to conclude that abortion drugs should be used only as labeled by the U.S. Food and Drug Administration. At the very least that means medication abortions for only the first seven weeks of pregnancy; the “evidence based” practices used by doctors in Arizona allows use through nine weeks.
Ellman did not dispute that following FDA protocols also are more expensive and require a second trip to a clinic. But he told the judges that lawmakers were entitled to conclude that following the FDA protocol protects the health of women, something the U.S. Supreme Court has said states may do even if it does impose additional hurdles on access to abortions.
Judge William Fletcher said there's a flaw in Ellman's argument.
“The evidence now in the record seems to me to show that the ‘evidence based’ protocol is both safer, less expensive, more convenient than the on-label protocol,” he told Ellman. And that, Fletcher suggested, means the state erected an “undue burden” in the path of women who want to terminate a pregnancy without proper justification.
Ellman, however, said the Supreme Court has said only that women have a constitutional right to terminate a pregnancy prior to viability of a fetus.
“It is not the right to choose the method by which you do so,” he told the judges. In this case, he said, state lawmakers have done nothing to limit surgical abortions.
But Alice Clapman, representing the Planned Parenthood Federation of America, said that's hardly a comparison. She noted there was evidence in the record that some women are so afraid of a surgical procedure that they will give up their right to an abortion and carry an unwanted baby to term.
The immediate decision for the judges to reach is whether state will be able to start enforcing the 2012 law.
It had been set to take effect in April. A trial judge refused a request to block it while the issue is working its way through the courts, but the 9th Circuit issued a temporary stay.
Today's hearing was to decide whether to keep that injunction in place.
The larger question, though, is whether Arizona legislators had any legal basis for imposing a restriction that put a halt to the commonly used practices of both Planned Parenthood and the Tucson Women's Clinic.
At issue is the use by the two medical organizations of mifepristone, an abortion-inducing drug known as RU-486, and misoprostol, a drug taken at home 24 to 48 hours later to ensure the fetus is expelled.
Clapman said the FDA protocols allow the use of mifepristone to induce abortions through only seven weeks, versus the current nine-week practice.
Potentially more significant, she said, is that misoprostol has no FDA labeling for abortion use, and without the second drug, the first one is useless.
Even assuming the court does not read the law that way, Clapman said there are new burdens on the women who still could get medication abortions.
“These women would have to pay an additional $200 to ingest completely unnecessary medication, mifepristone, three times the necessary dosage, and that would come with additional side effects as well,” Clapman told the judges.
“They would have to come into the clinic an extra time to take the misoprostol,” she continued, versus the current practice of taking it at home days later. Aside from the additional travel requirement, Clapman said that means the woman will feel the effects of the drug in starting to expel the fetus while they are traveling home.
Ellman told the court that lawmakers had a “legitimate purpose” in mandating the drugs be used only as prescribed by the FDA protocols. He said that agency is in charge of evaluating the safety of new drugs.
But Judge Susan Graber pointed out that the U.S. Supreme Court has recognized both the importance and acceptability of off-label uses of drugs.
“Is the Legislature, notwithstanding that, entitled to say, well, we don't care what the Supreme Court says?” she asked.
Ellman said lawmakers concluded there were studies showing that RU-486 was “dangerous.” But Graber shot back there was no link between any deaths linked to RU-486 and any suggestion that was because of off-label use.
Not willing to concede anything, Ellman said there are other considerations, including that women, sent home with the second pill, will forget how to take it or not take it properly. “That danger does not exist under the FDA-based protocols,” he said.
Graber responded that the challengers had presented evidence there were no deaths with more than 700,000 uses.
“I don't dispute that,” Ellman conceded. But he insisted lawmakers had a “rational basis” for the restrictions.
Fletcher took the argument a step farther, saying the evidence the court has actually shows that the off-label protocols actually are safer. He said only 2 percent of women who were treated that way later needed a surgical abortion, versus 8 percent who underwent a medical abortion following the FDA-approved protocols.
The court gave no indication when it will rule on whether the injunction remains in place.