People march through downtown Amarillo to protest a lawsuit in federal court to ban the abortion drug mifepristone Saturday, Feb. 11, 2023, in Amarillo, Texas. (AP Photo/Justin Rex)
A conservative federal appeals court sided in part with the Justice Department Wednesday and opted to keep a widely-used abortion pill available nationwide, but kept intact a key portion of a conservative lower court judge's ruling that could have profound and wide-ranging consequences for the pharmaceutical industry.
On Tuesday, a three-judge panel on the conservative Fifth U.S. Circuit Court of Appeals blocked the portion of U.S. District Judge Matthew J. Kacsmaryk's ruling, which would have effectively banned the sale and use of the abortion drug mifepristone nationwide. But the panel kept in place Kacsmaryk's decision to roll back the U.S. Food and Drug Administration's (FDA) 2016 decision to make the drug more easily available, including by mail, finding that anti-abortion doctors who had treated patients suffering from side effects had been sufficiently injured to justify their lawsuit.
In an unprecedented decision issued Friday, Kacsmaryk had ordered the FDA to revoke its approval of the abortion pill mifepristone, which was granted in the year 2000. Mifepristone is one part of a two-drug combination used in the U.S. for medication abortions; the second drug, misoprostol, can be used on its own, but studies show it is less effective than using both drugs to end an early pregnancy.
The appeals court decision was a partial victory for the Biden administration, and the drug will remain available as the case proceeds through further litigation. But the judges were clearly hostile to any suggestion that expanding access to mifepristone is a good thing.
Specifically, U.S. Circuit Judges Catharina Hayes, a George W. Bush appointee, and Kurt Engelhardt and Andrew Oldham, both Donald Trump appointees, found Wednesday that the drug could harm physicians — not because they took the pill, but because they treated patients who had. The court reasoned that the plaintiffs, a group of anti-abortion doctors, therefore had standing to sue to pull mifepristone from the market, a ruling that might well open the floodgates for similar litigation involving other drugs.
In an unsigned, 43-page ruling, the judges railed against the FDA for what they described as malfeasance on the part of the regulatory agency. The panel pointed to the "Patient Agreement Form" that mifepristone's manufacturer, Danco, requires users to sign, and concluded that the FDA "cannot deny that serious complications from mifepristone are certainly impending" because of the warnings on the form. It even included a copy of the form in its ruling and highlighted the portion that said "in about 2 to 7 out of 100 women," the medication abortion would be unsuccessful, and said it essentially amounted to an admission by the FDA that 100,000-350,000 women must have had "unsuccessful chemical abortions" since the time the drug's approval.
The panel reasoned that because those women would then need to seek the services of an emergency room physician, those physicians have suffered "a concrete, particularized injury" redressable by litigation.
The judges devoted several pages to exploring the harm that doctors claim to have suffered as a result of the FDA's approval of mifepristone. The judges cited physicians who said caring for patients who had taken the drug was "emotionally taxing" to the point of affecting doctors' "quality of life," and that when some women suffered "torrential bleeding" after taking mifepristone, emergency physicians were forced to perform surgical abortions, which went against their personal beliefs.
According to the judges, these claims of harm suffered by physicians have become more frequent after the FDA increased access to mifepristone.
The panel directly addressed the potential for its take on doctors' standing to challenge mifepristone approval to awaken more lawsuits on other drugs, and appeared to try to minimize concerns about potential judicial overreach.
"We do not hold that doctors have constitutional standing whenever they're called upon to do their jobs," the panel assured in its ruling. "And we do not hold that doctors have standing to challenge FDA's actions whenever the doctor sees a patient experiencing complications from an FDA-approved drug." The panel characterized the distribution of mifepristone as "an exceedingly unusual regime," that "cut out doctors from the prescription and administration" of the drug that will cause injury to the doctors themselves.
Irrespective of the Fifth Circuit's insistence on the narrowness of its holding, its underlying logic could handily be applied in other cases. If doctors' stress from treating patients constitutes the kind of injury sufficient to confer them standing to successfully challenge FDA regulations, similar fallout by medical professionals might catalyze challenges to more medications, devices, and procedures.
The court was unwilling, however, to extend the loose view it took on physicians' legal standing to the FDA, which had requested to step in and advocate in on behalf of pregnant women.
"[The] FDA's assertion that the district court's injunction will harm pregnant women or other members of the public does not speak to the irreparable injury factor (although it may speak to other factors), because those persons are not stay applicants in this case," the ruling said.
The panel also summarily dismissed the FDA's warning as to the consequences of its ruling.
"The theory appears to be that we cannot recognize plaintiffs' standing here without opening a Pandora's box in which doctors have standing to litigate everything at all times, including the banalities of over-the-counter Advil," summarized the panel. "We disagree because FDA's own documents show that mifepristone bears no resemblance to ibuprofen," said the ruling as it pointed to the "Black Box" warning included on mifepristone's (but not ibuprofen's) packaging.
The panel sided with the Biden Administration on its request to stay the portion of Kacsmaryk's ruling that ordered the FDA to revoke approval of mifepristone altogether. The court's decision on this aspect of the case was based not on practical considerations of mifepristone, but on procedural standards relating to administrative agency rulemaking.
In fact, the panel offered a particularly critical take on the FDA's process in 2016 when the agency approved expanded access to the drug. The court said that the FDA's studies were inherently flawed, and because the FDA eliminated certain safeguards during the study process, the judges found its approval to be suspect.
The Fifth Circuit ruling will remain in place at as the case proceeds. The order also directed that the appeal be placed on "the next available Oral Argument Calendar." The parties will next argue before the Fifth Circuit, and in the likely event of an appeal thereafter, the case would reach the U.S. Supreme Court for potential consideration.
An appeal to the current Supreme Court — one that is not only exceedingly hostile to abortion, but that is also committed to curtailing the authority of federal administrative agencies — is unlikely to yield positive results for the Biden administration.
Judge Haynes indicated in the opinion that she concurs only with the panel's decision to expedite the appeal and the denial of the motion to dismiss. Haynes said she would have granted only a brief administrative stay and turned the case over for oral arguments.
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