The Volokh Conspiracy
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Fourth Circuit Rejects Claim that West Virginia Abortion Law Is Preempted
A mifepristone manufacturer is unsuccessful in evading West Virginia's prohibition on abortion, even when performed by medication.
After the Supreme Court's Dobbs decision, West Virginia adopted a law, the Unborn Child Protection Act, that prohibits abortion in most circumstances. As enacted, the prohibition extends to medication abortions, such as those which may be performed with mifepristone.
GenBioPro, a manufacturer of generic mifepristone, challenged the West Virginia law, arguing that the prohibition is preempted by federal law, and the FDA's regulations governing the prescription and administration of mifepristone in particular, insofar as it prevents doctors from prescribing mifepristone for the purposes of terminating a pregnancy.
A federal district court rejected GenBioPro's claim. Today, in GenBioPro v. Raynes, a divided panel of the U.S. Court of Appeals for the Fourth Circuit affirmed. Judge Wilkinson wrote for the court, joined by Judge Alston (sitting by designation). Judge Benjamin dissented.
Judge Wilkinson's opinion for the court begins:
After the Supreme Court "return[ed] the issue of abortion to the people's elected representatives" in Dobbs v. Jackson Women's Health Organization, 597 U.S. 215, 232 (2022), West Virginia enacted a law prohibiting abortion in most circumstances. The question before us is whether certain federal standards regulating the distribution of the abortion drug mifepristone preempt the West Virginia law as it applies to medication abortions. The district court determined there was no preemption, and we now do the same.
For us to once again federalize the issue of abortion without a clear directive from Congress, right on the heels of Dobbs, would leave us one small step short of defiance. Appellant GenBioPro finds this clear directive in a maze of provisions in the Food and Drug Administration Amendments Act of 2007. It argues that these provisions vested the FDA with the exclusive authority to regulate access to mifepristone. We disagree. In our view, the Act leaves the states free to adopt or diverge from West Virginia's path. Because the Act falls well short of expressing a clear intention to displace the states' historic and sovereign right to protect the health and safety of their citizens, we affirm.
The body of the opinion briiefly addresses standing (an easy question here), and then applies the existing law of preemption (such as it is) in a rather straight-forward manner (albeit in a typical Wilkinsonian way), implicitly acknowledging that the current Supreme Court does not appear particularly sympathetic to preemption claims. (One of several ways in which the current Court is less "pro-business" than is commonly assumed.)
Given the general presumption against finding preemption of traditional state authority, absent a clear congressional directive, the argument that federal pharmaceutical regulations preempt state abortion laws is hard to make. As in many contexts, the federal regulations provide a "floor" of regulation that states may exceed, as West Virginia has here, placing far greater limitations on the use of mifepristone (a de facto prohibition for its use in abortion) than does the federal government.
Judge Wilkinson's opinion concludes:
Just after the Supreme Court restored the states' traditional authority to regulate abortion, GenBioPro would have us wrest it right back from them. Appellant attempts to assemble a preemption theory out of statutory scraps and fragments that do nothing to hide the fact that the theory is but a fig leaf for an assault on the Dobbs decision. We are asked to infer sweeping field preemption over a broad swath of high-risk drugs in the face of a saving clause indicating that Congress chose nothing of the sort. We are further asked to prevent the states from protecting the health and safety of their citizens whenever their laws touch upon high-risk drugs in any way. Not only that, but we are asked to do all this under what are at best the fuzziest set of federal instructions when the Supreme Court has insisted upon congressional clarity. If Congress wishes to preempt laws like West Virginia's, why hasn't it come right out and said so? For us to sally forth and strike down this statute in the face of all these obstacles invites certain reversal. "Into the valley of Death Rode the six hundred." Alfred Lord Tennyson, The Charge of the Light Brigade (1854).
Our decision, by contrast, is a narrow one. We take no position on the wisdom or folly of West Virginia's abortion law. As Dobbs makes clear, that judgment belongs with the people and their elected representatives. One can of course agree or disagree with the Dobbs decision. But that is not the point. At a time when the rule of law is under blunt assault, disregarding the Supreme Court is not an option. We do not suggest that the FDAAA lacks any preemptive effect. States are certainly not free to dilute federal safety standards where they have been clearly established. Nor do we deny that Congress may preempt state abortion laws if it chooses to do so and acts pursuant to its enumerated powers. We simply hold that it must express that intention with the clarity befitting such a significant alteration to our system of dual sovereignty. Because the FDAAA does not do so, we decline to overturn the West Virginia law.
Judge Benjamin dissented. Her dissent begins:
In a troubling opinion, the majority finds that a West Virginia law, which is a near outright ban on access to mifepristone, is not preempted by federal regulations. Put plainly, this law erects barriers to life-saving healthcare for countless West Virginians in ways not envisioned by Congress. Despite the law's overbreadth and potentially fatal consequences—to say nothing of its dangerous spillover effects on healthcare systems serving vulnerable communities in neighboring states—the majority would allow West Virginia's Unborn Child Protection Act ("UCPA") to stand.
But the twin sensitivities of abortion access and states' rights cannot influence our willingness to recognize the Food and Drug Administration's (FDA) clear authority in this area. And they cannot justify inaction as West Virginia enacts legislation which upsets "the constitutional balance between the National Government and the States." See Maj. Op. at 14 (quoting Bond v. United States, 572 U.S. 844, 857 (2014)). So, while I concur in the majority's finding that GenBioPro has standing to sue, because the UCPA is preempted by federal law, I must respectfully dissent.
In the majority's view, neither field preemption nor conflict preemption thwarts West Virginia's passage of the UCPA. I address and reject each point in turn.
According to Judge Benjamin, insofar as the Food and Drug Amendments Act creates a "comprehensive framework" for a regulatory regime that mitigates risk while ensuring access, it should be understood to preempt state laws governing relevant drugs. I understand the appeal of this point, but it is hard to argue that Congress, in giving the FDA a way to approve and make available potentially dangerous drugs subject to regulations designed to protect patients, Congress gave the agency authority to preempt laws seeking to prohibit abortion -- laws that, in effect, are focused on a different set of risks or concerns than those with the FDa's purview.
I suspect GenBioPro will seek en banc review before seeking certiorari, in no small part because the makeup of the Fourth Circuit is far more favorable to its position (and concerns about the availability of abortion) than the Supreme Court is likely to be. But even should GenBioPro succeed with en banc review, I cannot imagine the current Supreme Court disagreeing with Judge Wilkinson's bottom line.
