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Wednesday, July 17, 2024 | Back issues
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Appeals court keeps abortion pill on shelves but limits use

Federal regulators will seek Supreme Court relief after the Fifth Circuit opted to uphold restrictions on the use of mifepristone.

WASHINGTON (CN) — The final word on mifepristone’s use nationwide will be in the hands of the Supreme Court after the Fifth Circuit issued a late-night ruling to keep the popular abortion pill on store shelves nationwide but under limited circumstances. 

“The Justice Department strongly disagrees with the Fifth Circuit’s decision in Alliance for Hippocratic Medicine v. FDA to deny in part our request for a stay pending appeal,” Attorney General Merrick Garland said in a statement Thursday. “We will be seeking emergency relief from the Supreme Court to defend the FDA’s scientific judgment and protect Americans’ access to safe and effective reproductive care.”

Abortion rights advocates say the Fifth Circuit’s ruling would restrict abortion access nationwide, even if the New Orleans-based federal appeals court did not go as far as U.S. District Judge Matthew Kacasmaryk, who last week granted an injunction by to halt the approval that the Food and Drug Administration bestowed on mifepristone over 20 years ago. 

“This decision is a wolf in sheep's clothing,” Nancy Northup, president and CEO of the Center for Reproductive Rights, said in a statement. “The appellate court order repeats serious errors in Judge Kascmaryk ruling. Again, it is wrong on the facts and the law, resulting in an unprecedented override of the FDA’s scientific judgment.”

The ruling from the Fifth Circuit was unsigned and unpublished, meaning it can't be relied on as precedent.

“As the stay applicants, defendants bear the burden of showing why ‘extraordinary circumstances’ demand that we exercise discretion in their favor,” the motions panel of three Republican appointees wrote Wednesday. “To the extent the defendants make any such showing, they do so only with respect to the 2000 Approval — not the plaintiffs’ alternative arguments.” 

U.S. Circuit Judge Catharina Haynes concurred with the ruling only in part. A footnote to the ruling says the George W. Bush appointee would have granted an administrative stay and deferred the question of a longer stay to a merits panel hearing oral arguments. Haynes was joined on the motions panel by U.S. Circuit Judges Kurt Engelhardt and Andy Oldham, both Trump appointees.

In its bid to stay the injunction, the Biden administration had to explain the harm it would face if Kacasmaryk’s ruling took effect. The FDA said people across the country would be harmed if they lost access to a medication used in reproductive care. The panel said those arguments focused too heavily on parties not before them. 

“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 panel wrote. “Since FDA does not articulate any irreparable harm that FDA will suffer absent a stay, it makes no showing on this ‘critical’ prong.” 

Because the FDA and Danco — the producer of mifepristone — failed to show they would be injured by the district court’s ruling, the panel said it would offer tailored relief. 

“The applicants’ arguments suggest, at best, that they require relief only from the district court’s treatment of the 2000 Approval,” the panel wrote. “They make no argument as to why the district court’s treatment of the 2016 Major REMS Changes and later FDA activity irreparably harms anyone.” 

The 2016 changes relate to mifepristone’s administration — making it available for up to 10 weeks instead of seven — and distribution — allowing doctors to prescribe the pill via telehealth and distribute it through the mail. 

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A medical advocacy group that opposes abortion, the Alliance for Hippocratic Medicine, claims its members could be harmed by mifepristone’s approval. It is not alleged that any member of the group has ever prescribed the drug, but rather that one of the members might have to one day treat a patient who has taken mifepristone and developed an adverse reaction. 

Mifepristone has been used by over 5 million people during the two-plus decades it has been on the market. For every million people who took mifepristone during that time, only five have died from it. This makes the drug's safety record better than other common medications approved by the FDA like penicillin or the erectile-dysfunction drug Viagra. 

The doctors claim that, on the rare chance a patient did have an adverse reaction and that person happened to seek help from them, then they could be harmed by the drug. This theory of standing has been admonished by the government and legal experts who say it could have broad implications for suits moving forward. 

In a footnote, the panel said it was aware the Supreme Court had rejected similar standing arguments. 

“We are cognizant of the fact that the Supreme Court has disavowed the theories of third-party standing that previously allowed doctors to raise patients’ claims in abortion,” the panel wrote. 

Even so the panel was not persuaded by the FDA's arguments against the doctors’ supposed injury. 

“At this preliminary, emergency stage, we are unpersuaded by applicants’ contentions that all of these theories fail to create a justiciable case or controversy,” the judges wrote. 

The panel justifies endorsing the standing argument based off the FDA’s prescription and distribution of mifepristone. The judges said the agency allows mifepristone to be prescribed without a doctor’s consultation and taken without a physical exam. 

“We hold that on the record before us applicants know that hundreds of thousands of women will — with applicants’ own statistical certainty — need emergency care on account of applicants’ actions,” the panel wrote (emphasis in original). “And because applicants chose to cut out doctors from the prescription and administration of mifepristone, plaintiff doctors and their associations will necessarily be injured by the consequences. This is an exceedingly unusual regime. In fact, as far as the record before us reveals, FDA has not structured the distribution of any comparable drug in this way.” 

While the FDA argued it would likely succeed in its appeal, the appeals panel disagreed. The panel said that if an agency does not follow its own regulations, then claims on its actions might not be barred by exhaustion. This argument hits on the doctors' claim that the FDA was delayed in responding to its petition against mifepristone. 

“FDA plainly and repeatedly refused to follow its own regulations here,” the panel wrote. “Even assuming any of plaintiffs’ challenges were unexhausted and that it wasn’t futile to raise them before FDA, FDA’s repeated failure to follow its own regulations indicates that the district court did not abuse its ‘discretion to waive exhaustion.’”

The Alliance for Defending Freedom, which represents the doctors, called the Fifth Circuit’s ruling a victory. The group claims the FDA illegally approved mifepristone and has been evading responsibility for the two decades it’s been on the market. 

“The FDA put politics ahead of the health of women and girls when it impermissibly failed to study how dangerous the chemical abortion drug regimen is and when it unlawfully removed every meaningful safeguard that it previously implemented,” the alliance's senior counsel Erin Hawley said in a statement. “The FDA should have to answer for the damage it has done to the rule of law and the harm it has caused to countless women and girls.”

Representatives for the FDA declined to comment on the ruling.

A similar case on mifepristone is already playing out in Washington state, which belongs to the Ninth Circuit. Splits between the circuit often attract Supreme Court intervention.

Follow @KelseyReichmann
Categories / Appeals, Consumers, Government, Health

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