Calling the measure unjustified and likely illegal, a federal appeals court on Tuesday blocked the state from telling doctors how they can and cannot use certain drugs for abortions.
In a unanimous decision, a three-judge panel of the 9th U.S. Circuit Court of Appeals said the limits lawmakers put on RU-486 and another drug “substantially burdened” the legal right of women to terminate a pregnancy. Potentially more significant, the judges said attorneys for the state never provided any evidence that the restrictions were necessary to protect the health of women.
In fact, Judge William Fletcher, writing for the court, said the evidence they have suggests just the opposite: Women were more likely to suffer complications if doctors had to follow the law.
Tuesday's ruling is at least an interim victory for Planned Parenthood and the Tucson Women's Center.
The law has been on temporary hold since it was set to take effect in April. Tuesday's ruling enjoins it from being enforced while its legality is litigated, a process that could take months, or longer.
In issuing Tuesday's order for a preliminary injunction, however, the judges concluded the law likely will be found illegal after a full-blown trial.
But Josh Kredit, attorney for the anti-abortion Center for Arizona Policy, which helped craft the law, said he believes this ruling ultimately will be overturned. He said federal appellate courts in two other jurisdictions reached contrary conclusions.
If nothing else, Kredit said these disparate rulings likely will force the U.S. Supreme Court to wade into the fight.
At the heart of the case is the fact that both organizations have used RU-486 which is an abortion drug technically known as mifepristone, as well as misoprostol, a drug taken at home 24 to 48 hours later to ensure that the fetus is expelled.
Attorneys for both organizations said their doctors have determined that combination in certain dosages is effective in terminating a pregnancy through the ninth week.
But a 2012 state law says any medication used to induce abortion must be administered “in compliance with the protocol authorized by the U.S. Food and Drug Administration.” The FDA has approved RU-486 only for the first seven weeks, and only when given in two doses on separate days, each one administered by a physician.
Fletcher said there was no basis for the restriction.
He pointed out the FDA not only encourages “off-label” use of drugs by doctors — sometimes known as “evidence-based” use — “but encourages it as a part of the effective practice of medicine.”
Federal courts have allowed some restrictions on abortions, but they generally have been based on some finding that the limits are necessary to protect the health of women.
Kredit said the legislators who voted for the measure made their own medical findings that the FDA-approved use, both in terms of dosage and limited to seven weeks, was the safest way to go for women.
Attorney General Tom Horne, whose office defended the law, said the courts should have honored that.
“I think (adopting) the FDA protocol should be a 'safe harbor' for a state,” he said.
Kredit also pointed out the FDA approved RU-486 under special rules for dangerous drugs that limited its marketing and distribution.
But Fletcher said those rules do not limit the use of the drug. More to the point, the judge said the state's argument that the FDA protocol actually is safer for women does not hold up under closer examination.
“The on-label regiment requires three times more mifepristone than the evidence-based regimen,” the judge said. And he said there was nothing presented to the court showing that any doctor was using the drug in a dangerous manner.
“Therefore, on the current record, the Arizona law appears wholly unnecessary as a matter of women's health,” Fletcher wrote.
And the medical evidence, he continued, goes beyond that.
He said the on-label regimen fails to terminate a pregnancy in about 1 percent of cases, and as many as 8 percent of women who were given that FDA-approved dosage required surgical abortion procedures to stop heavy bleeding caused by the medications. By contrast, the off-label use failed only in about 0.5 percent of cases, and fewer than 2 percent of women needed surgical follow up.
Kredit did not dispute those numbers but brushed them aside, saying lawmakers had their own evidence.
“And when there's a split in medical evidence, you defer to the Legislature,” he said. “It is the Legislature's job to protect the public health.”
But Kredit conceded that “medical evidence” the Legislature was not some specific study but based solely on the FDA's conclusion the drug was dangerous and should be used according to specific labeling.
That point was not missed by Nancy Northup, president of the Center for Reproductive Rights whose attorney argued the case.
“Politicians need to stop playing doctor, leave the practice of medicine to trained health care professionals, and stop meddling in women's personal decisions about their health and families,” she said in a prepared statement.
Fletcher said there are other factors, including cost, which convinced the court the restriction burdened the right of women to terminate a pregnancy.
A higher dosage required for on-label use makes a $160 difference. On top of that, the fact the second dose needs to be given by a doctor clinic means another visit to the clinic, and another bill.
“Finally, the evidence-based regiment allows women to take misoprostol in their homes, eliminating the risk that they will pass their pregnancies, a process involving heavy bleeding and cramping, during their trip home from the second clinic visit,” Fletcher wrote.
There's another complicating factor: Misoprostol, that second drug, was approved by the FDA only to treat ulcers. Following the 2012 law would have made that drug unavailable to abortion providers.
The appellate judges said the law would have affected more than just women beyond the seventh week of pregnancy, removing the option of a medication abortion and leaving a surgical abortion as the only alternative.
The cited testimony from Planned Parenthood that it said could not afford to have a doctor at the Flagstaff clinic for the two days a week that following the FDA-approved protocol would have required. That would have meant women wanting a medication abortion, even before seven weeks, would have to go to the nearest clinic — in Glendale.