Since my last post, the case has taken a turn. A panel of the Fifth Circuit Court of Appeals has issued a temporary ruling allowing the abortion pill mifepristone to stay on the market, subject to certain safety protocols. Both standing and timeliness were essential issues in that decision.
So it’s worth examining the question of timeliness, so we can understand what has happened and what may happen.
The history of the case is complicated and can be very confusing, so a timeline and some shorthand terminology may help:
2000 — The FDA approves the use of mifepristone for pregnancies less than 7 weeks, with a variety of safety protocols, such as requiring three in-person office visits and limiting dispensing to doctors (the “2000 Original Approval” and the “2000 Protocols”).
2002 — A petition is filed by one of the plaintiff organizations, challenging the approval of mifepristone. (the “First Petition”.)
March 2016 — The FDA rejects the 2002 Petition (the “2016 First Petition Rejection”)
March 2016 – The FDA also expanded the use of mifepristone to pregnancies less than 10 weeks and altered some of the safety protocols by reducing the number of office visits and allowing non-doctors to prescribe (“2016 Protocols”.)
March 2019 — A new petition is filed by two of the plaintiff organizations, challenging the 2016 Protocols but not the 2000 Original Approval (the “Second Petition”).
April 2019 — The FDA approves a generic form of mifepristone.
April 2021 — The FDA announces that due to the COVID pandemic it would permit dispensing mifepristone through the mail as an exercise of “enforcement discretion”.
December 2021 — The FDA rejected virtually all the challenges raised by the 2019 Petition (“the 2021 Second Petition Rejection”).
December 2021 – The FDA also announced that it would permanently permit dispensing mifepristone by mail and removed the requirement of an in-person office visit (the “2021 Protocols”).
November 2022 — The current lawsuit was filed.
The Statute of Limitations
Challenges to actions by federal agencies must be filed within six years from when the decision is final. This is the “statute of limitations”.
On the face of it, the lawsuit filed in November 2022 is clearly too late to contest the 2000 Original Approval (by 22 years) or the 2016 First Petition Rejection (by 8 months).
Other agency actions, however, are certainly within the six-year limit: the approval of the generic drug in 2019, the 2021 Second Petition Rejection and thus the 2016 Protocols that were being challenged, and the 2021 Protocols. But none of these actions explicitly dealt with the approval of the drug itself, just with how it can be used.
The challenge for the plaintiffs, then, is to find a way around the six-year statute of limitations to attack the 2000 Original Approval of the drug – so they could argue that the FDA should never have approved it to begin with.
What has Happened in Court So Far?
The plaintiffs’ main timeliness argument is that the FDA re-opened the Original Approval of the drug when it issued the 2016 and 2021 Protocols. This would mean that the clock was re-started in 2021. The district court agreed with this argument and thus held that their challenge to the Original Approval was within the statute of limitations.
This argument seems very vulnerable to being overturned. When the FDA loosened the safety and dispensing protocols in 2016 and 2021, they took for granted that the drug was already approved. They didn’t even ask for comments or input from the public. Even when the FDA approved the generic form of the drug in 2019, that didn’t involve a reconsideration of the name brand version. It’s hard to see how any of these decisions reopened the 2000 Original Approval.
The district court also came up with an argument on its own that was not explicitly argued by the plaintiffs. The court raised a theory called “equitable tolling”, which basically holds that the statute of limitations doesn’t preclude a lawsuit if the defendant ran the clock out.
The law requires the FDA to respond to petitions within 180 days, but they sat on the petitions for almost fourteen years in one case and over two years in the other. So the court ruled that “equitable tolling” stopped the statute of limitations clock during those delays and the plaintiffs could thus challenge the 2000 Original Approval.
This argument seems intuitively compelling. After all, you would think that the plaintiffs shouldn’t be punished for the FDA’s inaction. But it is actually pretty weak.
To win, a plaintiff has to show that they acted diligently to vindicate their rights and that some extraordinary circumstance stopped them from filing. There was no extraordinary circumstance — or any apparent reason at all — that prevented a challenge to the 2016 Petition Denial. Instead, they waited six years and eight months to file their lawsuit. It’s hard to see how that delay could be attributed to unreasonable behavior by the FDA.
What Happened Next?
The district court’s ruling was very sharply criticized and was immediately appealed to the Fifth Circuit Court of Appeals. After receiving numerous briefs and acting on a very tight schedule, a three-judge panel of the circuit court granted a temporary stay (like pressing the “pause” button) of part of the district court’s order but allowed other parts to go into effect.
The circuit panel managed to give both sides half a loaf. They agreed with the plaintiffs that the doctors and organizations probably had standing to file the case. They then agreed with the government that the FDA never re-opened the 2000 Original Approval and rejected the equitable tolling argument. But they also held that the statute of limitations clock on the 2016 Protocols didn’t start to run until the 2021 Second Petition Rejection.
Thus they found that the challenge to the 2000 Original Approval was barred by the statute of limitations. But the plaintiffs’ case against the extremely lax and dangerous 2016 Protocols is still alive and within the statute of limitations, although there remains a major question whether the plaintiffs can prove they still have standing to challenge them.
As a result, until a full appeal is heard and a ruling issued, the drug can still be used, but under the original 2000 Protocols. That reinstates the requirement that the drug only be used in the first 7 weeks of pregnancy, that the mother make three visits to the doctor, and that only doctors could prescribe.
It’s important to note that this ruling is not “precedential”. It is not binding on the panel that will eventually hear the appeal on its merits and certainly not on the Supreme Court. So we must take this decision for what it is – a ruling with a limited lifespan.
Nevertheless, it’s a very important victory, however temporary it may turn out to be. It significantly restricts the availability of the drug and prevents the abortion industry from conducting its deadly business by mail. It also gives mothers substantially more safety protection. And it will save lives of unborn children.
Where Do We Go From Here?
The Justice Department has already said it will file an emergency appeal to the Supreme Court. However the Court handles the case, it will ultimately have to come back down to the Fifth Circuit or the district court for further proceedings. So this litigation will not end anytime soon.
The merits of the case are being hotly contested at every level – whether the FDA abused its authority when they approved either the drug itself or the protocols for its use. But courts take procedural issues like standing and timeliness very seriously and often prefer to decide cases on those grounds if it will allow them to avoid ruling on the merits.
The circuit panel’s ruling on the temporary stay may turn out in the end to be the best the plaintiffs can get. Even if mifepristone remains available, it may still be possible to overturn the FDA’s extremely lax 2021 Protocols. That would be a disappointing result, but we have to take whatever victories we can get.
[Disclosure: the plaintiffs in this lawsuit are represented by Alliance Defending Freedom. I am a member of ADF’s Allied Attorney Network, but had no involvement in this litigation.]