Late yesterday, a district court in Texas issued its much-anticipated ruling in Alliance for Hippocratic Medicine v. Food and Drug Administration, a challenge to the FDA’s approval of the abortion medication mifepristone, which has been on the market for over two decades. As some hoped and others feared, the court ruled against the FDA, concluding that mifepristone should not be an approved medication.
By an amazing coincidence, a second district court, this one in Washington State, issued its own ruling in a competing mifepristone lawsuit soon after the Texas decision, issuing an order barring the FDA from altering the status of mifepristone, at least in the plaintiff states. (Interestingly enough, this is not the only time we’ve seen dueling opinions on a high-profile health-law question issued on the same day. The same thing happened with Halbig v. Burwell and King v. Burwell in 2014, creating a circuit split in a matter or hours. Go figure.)
I previewed some of the arguments in each case in prior posts. Here and here I explained why the district court in Texas lacked jurisdiction to hear AHM’s claims against the FDA. Among other things, the plaintiffs lack standing, did not file within the relevant statute of limitations, and did not exhaust their administrative options. Nothing in the district court’s opinion changes my view of these arguments. If anything, it reinforces them. Among other things, the court makes clear that the conclusion that AHM satisfies Article III standing requirements rests on outlier decisions like Havens Realty (which the Supreme Court may consider overturning, or simply abandoning, next term), which progressive groups like CREW tried to use in their emoluments litigation.
Additionally, the opinion’s embrace of an expansive conception of equitable tolling and refusal to enforce the administrative exhaustion requirement rest on the most gossamer of threads—the analysis reads more like what one would expect in a time-limited law-school exam than a thoughtfully considered judicial opinion. And the invocation of Section 705 of the Administrative Procedure Act to justify the unusual remedy of issuing a stay of the FDA’s 2000 approval of mifepristone is too clever by five. No matter what one thinks of abortion or the availability of mifepristone, this opinion is hard to defend (and that’s without getting into the merits of the issue).
As it happens, the second decision is no better. For reasons I explained here, the plaintiff states in that case face equivalent jurisdictional hurdles in demonstrating standing and exhaustion, particularly insofar as they were suing to maintain the status quo (as opposed to challenging the FDA’s existing mifepristone rules as too restrictive). The Washington district court barely engages these arguments, waiving them away with conclusory statements unaccompanied by any meaningful analysis. It is enough to make a cynical observer think that the opinion was rushed for release, perhaps explaining the coincidental timing. Whatever the faults of the Texas ruling—and there are many—at least there is substantive analysis to critique. The Washington decision is more like a punt. Its one saving grace is that it does not attempt to justify nationwide relief and instead limits the effect of its injunction to the plaintiff states.
Where does this all leave us? The Texas decision stayed the effective date FDA’s 2000 approval of mifepristone—in effect suspending the approval (with a caveat that it would revoke the approval if the U.S. Court of Appeals for the Fifth Circuit disapproves of the court’s use of APA Section 705 in another case), but has also stayed the effective date of the decision by seven days to afford the government time to appeal. Meanwhile, the Washington decision has enjoined the FDA from “altering the status quo” concerning its regulation of mifepristone as of the FDA’s January 2023 rules governing prescription and distribution of the drug within the plaintiff states. Thus, at least within those states, we would appear to have dueling injunctions (as happened with the DACA litigation), virtually guaranteeing quick action from appellate courts, if not the Supreme Court itself.
I hope to have more to say about both of these decisions shortly, time permitting.