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.

 

Comments

[Joe_dallas]

DEANDREA GIST BENJAMIN, Circuit Judge, concurring in part and dissenting in part:
"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."

Curious if the dissenting judge is familiar with Dobbs?

[Riva]

And not so much life saving to the lives extinguished in the chemical abortions.

[Frank Drackman]

Don’t you know? Killing with poison is different than other methods.

[Brett Bellmore]

Mifepristone isn't a poison, as such. It just induces delivery, which is fatal if done too early in pregnancy.

[Riva]

Six to one, half dozen to another for the extinguished life.

[Darwinnie]

What would Dobbs have to do with the outcome here?

[Joe_dallas]

It’s a chemical abortion

[wvattorney13]

A contrary ruling would effectively overrule Dobbs. States would have to permit medication abortions---a practice that Dobbs said they could wholly prohibit.

[David Nieporent]

Dobbs said that there was no constitutional right to abortion. It said nothing one way or the other about whether there was a statutory right to use mifepristone.

[Brett Bellmore]

But how is the federal government supposed to presume to create a statutory right that overcomes the states' general police power? What enumerated power would you base that on?

Given that abortion isn't itself a constitutional right, the 14th amendment is no help here. And, as the state isn't prohibiting commerce in mifepristone, (It still has legal medical uses.) just its use to induce abortions, so neither is the commerce clause.

The federal government has no general power to create statutory rights against state governments, it needs a constitutional hook to do so. There is none in this case.

[Sarcastr0]

Regulate commerce does not only mean prohibit.

[Brett Bellmore]

I realize you're not a big fan of federalism, enumerated powers, the 10th amendment, or really any constitutional limit on federal power, but that's not even a bad joke of an argument, and you'd never follow that 'reasoning' where the federal governmentbwas mandating the legality of something you disapproved of.

[Sarcastr0]

You asked.
That's the law.

You are wrong about the law, no matter how confident and unable to countenance other perspectives you may be.

[David Nieporent]

I suspect that no federal law creates any right to mifepristone, so I'm answering only in the abstract here: the answer is in fact that commerce clause. Now, I know you reject every application of that constitutional provision post-1930 or so, but as the courts currently interpret the commerce clause, that would be the answer.

[Brett Bellmore]

Could the federal government, by this reasoning, create a statutory right to street racing, simply by not banning interstate commerce in cars, without even mentioning racing?

After all, there is no statutory right to use mifepristone for abortions. At most there is such a right to engage in commerce in it, which might imply a statutory right to use it for SOME, presumably lawful, purpose.

And mifepristone does have lawful medical uses in West Virginia. Abortion just isn't one of them.

So, just as a right to engage in commerce in automobiles doesn't imply a right to use them for street racing, a right to commerce in mifepristone doesn't imply a right to use it for abortions.

I'm afraid you're still reasoning, even after Dobbs, as though abortion had some special constitutional status. It doesn't, it's just another act like any other, as subject to the police power as any other,

[Sarcastr0]

You're making no sense.

Step 1: do you know what a statutory right is?

[Brett Bellmore]

It's a right established by a statute, and statutes can only create rights where the government has some authority to begin with,

[Riva]

You're just confusing Sarcastr0. Dumb it down some more.

[Josh R]

The federal government has the authority (N&P Clause carrying into execution a Commerce Clause power) to create a statutory right to use mifepristone for abortion. The question this ruling dealt with was whether Congress did that, not whether they were authorized to do so.

[Brett Bellmore]

Yeah, right. Clear as mud.

Prior to Dobbs Congress had the authority, they could have called it 14th amendment enabling legislation. After Dobbs?

"To make all Laws which shall be necessary and proper for carrying into Execution the foregoing Powers, and all other Powers vested by this Constitution in the Government of the United States, or in any Department or Officer thereof."

So if no such power is vested, the law can't be necessary and proper.

[wvattorney13]

I could see the argument that the commerce clause would apply to that hypothetical law. Congress could declare that it wants a robust market in mifepristone and state regulations against using it for abortion harms that commerce.

However, this general principle runs against the strong rationale of Dobbs that abortion regulation has been a point of contention in this country for 50 years. Putting aside the fact that Congress has made no such statement about mifepristone, its ability to do so would be called into question under the pages of cautionary language about the regulation of abortion.

But we win this case simply because the FDA has only approved mifepristone by saying that it is safe for use. West Virginia is preempted only in that it cannot second guess the FDA's judgment on that point. It can use its police powers to outlaw its use for abortion purposes qua abortion purposes.

[Josh R]

Brett, we all know you hate the Court's Commerce Clause jurisprudence (and how the N&P clause applies to it). But wvattorney explains why that jurisprudence supports a federal statute guaranteeing access to mifepristone.

And no wvattorney , it does not conflict with anything in Dobbs which said abortion regulation should be left to our elected representatives, which includes Congress. Dobbs was not in any way a federalism decision.

[Brett Bellmore]

Right, it's possible that the Court would uphold such a law under current execrable commerce clause jurisprudence. It's also possible that they wouldn't be that keen on Dobbs being so easily circumvented.

But, YET AGAIN, West Virginia isn't interfering in interstate commerce in this drug. They're regulating what it can be used for in West Virginia, no different from having traffic laws despite cars being articles in interstate commerce.

If we were to take seriously the reasoning that's proposed here, all state level police power exercises exist purely on the sufferance of Congress. And that's not a position the Supreme court has ever adopted, in fact, it's one they've expressly refused to adopt.

[David Nieporent]

Right, it's possible that the Court would uphold such a law under current execrable commerce clause jurisprudence. It's also possible that they wouldn't be that keen on Dobbs being so easily circumvented.

That would not in any way "circumvent" Dobbs.

But, YET AGAIN, West Virginia isn't interfering in interstate commerce in this drug.

Banning the sale of a drug for its major use obviously affects the market for that drug.

If we were to take seriously the reasoning that's proposed here, all state level police power exercises exist purely on the sufferance of Congress. And that's not a position the Supreme court has ever adopted, in fact, it's one they've expressly refused to adopt.

They have not. See, e.g., U.S. v. Lopez, where the Court said that the law banning guns near schools exceeded congressional power only because the law didn't have an interstate hook written into it. All Congress had to do was add a few words to the law, and no problem. Wickard, of course, said that Congress could ban the growing of a product for private intrastate use because that affected the interstate market for that product. That notion was reaffirmed in Raich.

[Brett Bellmore]

You've read Lopez, I'm sure. Yes, they expressly refused to go there.

"To uphold the Government's contentions here, we would have to pile inference upon inference in a manner that would bid fair to convert congressional authority under the Commerce Clause to a general police power of the sort retained by the States. Admittedly, some of our prior cases have taken long steps down that road, giving great deference to congressional action. See supra, at 556-558. The broad language in these opinions has suggested the possibility of additional expansion, but we decline here to proceed any further. To do so would require us to conclude that the Constitution's enumeration of powers does not presuppose something not enumerated, cf. Gibbons v. Ogden, supra, at 195, and that there never will be a distinction between what is truly national and what is truly local, cf. Jones & Laughlin Steel, supra, at 30. This we are unwilling to do."

[Josh R]

The Raich Court established the principle that Congress can reach economic activity which gun possession in school zones is not.

[David Nieporent]

Could the federal government, by this reasoning, create a statutory right to street racing, simply by not banning interstate commerce in cars, without even mentioning racing?

I have no idea what "this reasoning" is supposed to refer to. I didn't say anything about "by not banning… without even mentioning."

Under current jurisprudence, Congress can "occupy the field" on a particular topic, such that a state can't legislate in that area at all.

I'm afraid you're still reasoning, even after Dobbs, as though abortion had some special constitutional status.

I am not. I'm afraid you're still reasoning as if "regulate commerce among the several states" only meant the shipping of goods across state lines, and did not give Congress the power to regulate the use of those goods after they have moved across state lines. (Again, I know you think that the constitution should be interpreted that way, but it isn't.)

[ReaderY]

If Congress passed a statute tomorrow clearly and explicitly prohibiting states from interfering with interstate commerce in abortifacients, I don’t see any reason it would be unconstitutional. GenBioPro would win, easily, if such a statute existed.

Dobbs only returned the question to legislatures. It didn’t say anything about WHICH legislature. Interstate commerce is in Congress’ ballpark, not the states’.

The issue here was purely statutory. The matter was within Congress’ power to decide. If GenBioPro had had a winning statutory argument, then the courts should have ruled in its favor. The ruling they did make was correct, but only because GenBioPro’s statutory argument was lousy. Nothing to do with Dobbs either way.

[Josh R]

Under Murphy v. NCAA, Congress cannot pass a law which forbids West Virginia from enacting its statute. But, Congress can pass a law stating that individuals cannot be prevented from using mifepristone for abortions. In that case, the WV law is preempted.

[ReaderY]

I agree that how state legislatures choose to decorate their statute books is not a matter for Congress to legislate on. It is also not a justiciable question for courts, as decoration activities of this sort don’t affect anyone. By “preventing states from interfering” I was not intending to address a legislature’s decisions about decorating its statute books with its preferred choice of words, but only actions that have some concrete affect on others in a way that would give them standing to sue.

[Josh R]

West Virginia's statute has a concrete affect that gave GenBioPro standing to sue.

If Congress passed a law which stated "no state can outlaw the use of mifepristone for use as an abortifacient," that statute would be unconstitutional under Murphy (West Virginia would sue).

But, if Congress passed a law which stated "anyone who impedes the use mifepristone as an abortifacient has committed a Class E felony" is constitutional and preempts West Virginia's statute. (GenBioPro would sue).

[Brett Bellmore]

Neither law would be constitutional.

[ReaderY]

You’re quibbling here. Move on.

[JonFrum]

"life-saving healthcare."

Murdering babies.

[Longtobefree]

Not babies, a "future person" with full rights, according to a district court, the ultimate arbiter of truth.

[Riva]

Well, I suppose the newly conceived life cannot yet vote or pass a driver's test, but that doesn't mean we're not discussing a life.

[Frank Drackman]

Follow the Science! An unborn Human is as much a “Life” as the Sea Turtle Eggs you go to Federal Prison for touching.
And I’m not for killing unborn Sea Turtles either
Better to let them grow and…,,
I’m kidding! I dont even know what you do with Grown Sea Turtles

Frank

[wvattorney13]

Holy crickeys! An anti-abortion law survives the Fourth Circuit? The Solicitor General should buy a lottery ticket. I might as well.

[JoeFromtheBronx]

The federal courts here interpreted the reach of federal law.

The question was not merely "returned to the states." It remains the responsibility of the federal courts. The federal government still regulates drugs and medicine in ways that will touch upon abortion.

It is a safe bet the conservative Supreme Court will support the majority here. The wrong-minded Dobbs opinion is largely why we are even here.

[JoeFromtheBronx]

Or the "people's elected representatives."

The courts are going to have a role to play.

[ReaderY]

I think any interpretion of the reach of the federal law was completely unnecessary and irrelevant. They should have limited their opinion to interpreting the content of federal law. The FD&C Act, by its own terms, does not pre-empt state law on the matter. The 4th Court should have followed the District Court’s approach and said only this and nothing further.

[Brett Bellmore]

I do agree with that. They lost as a matter of pure statutory interpretation, so there was no need for the court to address any constitutional issues.

[Drewski]

Not a fan of courts ruling by predicting SCOTUS, especially when it's based on vibes. The Dobbs holding doesn't mandate this outcome. The opinion is full of political rhetoric that isn't legal analysis. It's so disrespectful to the plaintiff that I wonder if it actually violates the judicial code of conduct.

That said, they're right that preemption here requires a showing of clear Congressional intent. I think that's the correct outcome.

[Darwinnie]

That’s where I am. I don’t see what Dobbs has to do with this preemption question.

[neurodoc]

Could we see by a show of hands how many here would be willing to let the legal permissibility of pre-viability abortions be decided by a majority of the electorate? Those who aren't have no qualms imposing their moral vision on others?

[Brett Bellmore]

Waves hand.

It's generally admitted that states can legitimately prohibit acts that fall well short of murder. Even non-fatal abuse of non-human animals, where no rights bearing entities' interests are at stake at all!

So, why would viability, the point at which abortion straightforwardly becomes just another form of murder, be the earliest point at which it could be prohibited? Wouldn't this imply vastly more stringent limits on all sorts of laws, not just abortion?

I'll freely admit that the ratio between the state's interest in the preservation of innocent human life, and the liberty interest of citizens, maxes out once viability is reached, since the liberty interest in ceasing to be pregnant no longer depends on killing the baby. But why treat it as abruptly dropping to zero before that point?

Even if you assume the previable baby is less than human, maybe on a sliding scale depending on the degree of development, again the state makes a crime of even less than fatal harm to sub human species.

This looks like exactly the sort of judgement call about balancing different interests that is exactly the province of democratic decision making.

[ReaderY]

We let the legality of racial discrimination be decided by majority vote, either directly or through representative government. And those who agree with the Rev. Dr. King’s theological position that the practice is a sin have no qualms about imposing this equally religiously-rooted moral vision on others.

[wvattorney13]

Waiving over here. In addition to what Brett said, every law imposes a moral judgment on people, and many impose only moral judgments on people. Abortion, the killing of a human life, is a strange place to roll out the libertarian flag.

[Frank Drackman]

The “Electorate” has already been born

[Michael D]

This isn’t about any particular judicial decision, but rather the politics surrounding the issue. What I find striking is that in the U.S., abortion laws often gravitate toward the extremes: on one end, the option to terminate a pregnancy up to the moment of birth; on the other, near-total bans with only the narrowest exceptions.

In contrast, much of the rest of the world has reached a broader political consensus that neither extreme reflects the views of most people. As a result, many countries adopt laws that acknowledge the moral complexity of the issue—allowing abortion in the earlier stages of pregnancy, while imposing increasing restrictions as the pregnancy progresses. These policies reflect the recognition that there is no perfect answer, and that certain gestational milestones warrant greater legal protection for unborn life.

I suspect this polarization is, at least in part, a product of the two-party system. Binary political structures tend to produce binary policy outcomes—it's either “on or off,” with little room for nuance. In contrast, multiparty systems introduce more voices into the legislative process, making compromise a necessity rather than a liability. The result is often legislation that better reflects the broad middle ground of public opinion, while extreme positions are diluted or marginalized through coalition-building.

Two-party systems, especially under first-past-the-post voting like in the U.S., tend to polarize debate into all-or-nothing positions. Parties have incentives to maximize contrast, not compromise, particularly on cultural or moral issues like abortion.

In multi-party systems, proportional representation allows for a broader ideological spectrum to be present in legislatures. Governing coalitions must often negotiate policy positions that accommodate center-left, center-right, and even religious or liberal minority parties—leading to more moderate and stable legal frameworks.

That’s why many European countries, for example, have time-based abortion laws, reflecting compromise among multiple perspectives. These frameworks tend to remain in place longer and generate less social or legal whiplash than the U.S. model.

[Brett Bellmore]

It's actually a product of Roe, and you should expect it to gradually go away after Dobbs.

Because of Roe there was no moderating political impulse at either end: The pro'choice' side didn't need moderation, the judiciary had handed them a complete victory that didn't require persuading the public to see it their way.

And moderation got the pro life side nothing, because winning the public over didn't matter as long as the courts had the other side's back.

But now moderation has benefits, and extremism costs, and you should expect moderation... in another generation, perhaps. The distortions wrought by Roe can't vanish overnight.

[ReaderY]

That’s not entirely true. A number of states implemented a European-style compromise of exactly the sort you favor, keeping abortion legal but reducing the gestation limit from the 20 weeks allowed by the Roe/Casey framework to something less.

[Michael D]

That is good news. One supposes that we hear very little about those states and are instead given news reports that highlight these extremes.

[wvattorney13]

I would posit that this is where the average voter is on the issue, the "man on the street." He would want some choice for a woman to terminate her pregnancy in the very early stages but not up to 24 weeks.

I think an 8 or 12 week limit would gather large majorities of support once the politicization of the issue dies down.

The problem is that he is never given that choice: All ballot initiatives are either "abortions are evil" or "kill the baby in the birth canal."

[Brett Bellmore]

There's actually been a lot of polling on this topic.

Pro-'choice' advocates are forever citing crude polls that just ask if you want abortion to be 'legal', without getting into the weeds. But the weeds are where it gets interesting.

When it comes to elective abortion, the public's support absolutely implodes after the first trimester. Support for the legality of abortion after that point really just means support for medically necessary abortions, and to some extent abortion for victims of rape and incest. NOT elective abortion.

Here's some recent polling from Gallup.

Per Gallup, you've got 35% support for "legal under any circumstances", 16% support for "legal in most circumstances", 33% for "legal in only a few circumstances", 12% for "illegal in all circumstances". Sounds pretty good for the pro-choicers, doesn't it?

But then you ask about trimesters, and find out that the people in the first part of the poll were apparently thinking only about early abortions, because by the 2nd trimester, support for elective abortion drops to 37%.

A bit more detailed polling.

38% support for abortion under all circumstances in the 1st trimester, 15% in the 2nd trimester, and 8% in the third trimester.

That 8% are your hard core pro-choicers, just like the 16% who want it illegal "in all cases" (But other polling says that it isn't really in all cases, even hard core pro-lifers are OK with abortion to save the mother's life.) in the 1st trimester are the hard core pro-lifers.

The problem historically has been that "medical necessity" ends up being defined so vaguely that it amounts to elective abortion, because you have clinics willing to say that it's medically necessary to spare the mother any upset about giving live birth, a mental health issue.

The problem in that regard wasn't Roe, it was Doe v Bolton, decided the same day, which prohibited second guessing a doctor's determination of medical necessity. And so you ended up with a group of doctors who professionally would declare medical necessity any time a woman wanted an abortion.

Doe v Bolton made a hash of Roe's trimester scheme, rendering the promise of regulation after the 1st trimester hollow. I actually think Roe might have survived if not for Doe.

[Brett Bellmore]

"All ballot initiatives are either "abortions are evil" or "kill the baby in the birth canal.""

That's not fair, a few state laws have gone so far as to avert the state's gaze from infanticide, if committed soon after birth.

[ReaderY]

I agree with the outcome. But I much prefer the District Court’s reasoning to the 4th Circuit’s.

The District Court eschewed pontificating about the general structure of American government and the proper constitutional relationship between the federal government and the states. Instead, it focused on a specific statutory feature of the FD&C Act. The Act has a specific anti-preemption or “savings” clause which says that for drugs, state law is not preempted unless Congress says so clearly and specifically. And it is this specific statutory provision, not the judiciary’s own self-inflating airy-fairy pontificating about the supposed general nature of government, that ought to be the appropriate legal basis of the presumption that state law is not preempted unless the statute says so in clear and specific terms.

The 4th Circuit majority got this backwards, starting with an entire section, Section 3, that as I see it consisted entirely of unnecessary airy-fairy self-important pontification. I would have gotten rid of the entire section. Moreover, while the majority did eventually get to the anti-preemption provision, it got there at the end of its reasoning, treating it essentially as an afterthought, l after forcing the reader to sit through a seemingly endless yap about the wonders of federalism.

I would have ditched the lot and kept things simple. In controversial cases like these, it’s important for courts to show deference to primary sources of law. State laws are presumed non-preempted because Congress specifically said so. And that’s that. Move on. No need to inquire further.

I completely agree that, once the presumption of non-preemption is in place, GenBioPro’s argument totally falls to the ground. i agree the FDAAA clearly intended to instruct the FDA that, in establishing its own safety rules, it needed to ensure that its rules did not prevent patient access, but the provision about patient access applies only to the FDA and not to anyone else’s rules. I also agree that, if GenBioPro’s position were accepted, the FD&C act would have to be interpreted to invalidate not just state abortion laws but numerous other state laws restricting narcotics, criminalizing assisted suicide, etc., laws whose validity has been accepted for many years and which Congress in no way intended to invalidate.

So while I agree with the outcome, I think the District Court reached it in a much more appropriate and correct way. I don’t necessarily disagree with the sentiments expressed in the 4th Circuit’s purple ponticatory prose passages. I just think these passages were not merely completely unnecessary, they tended to detract from the opinion’s legal persuasiveness rather than adding to it. The 4th Circuit should have followed the KISS principle like the District Court did.

[Brett Bellmore]

" I also agree that, if GenBioPro’s position were accepted, the FD&C act would have to be interpreted to invalidate not just state abortion laws but numerous other state laws restricting narcotics, criminalizing assisted suicide, etc., laws whose validity has been accepted for many years and which Congress in no way intended to invalidate."

That's what I meant above by, "Wouldn't this imply vastly more stringent limits on all sorts of laws, not just abortion?" As I said above, by this sort of reasoning, since federal law allows interstate commerce in automobiles, states had by implication been stripped of their right to prohibit street racing.

Their argument proved insanely too much, if accepted. I think they were just hoping to find a court that wanted to overturn Dobbs on the sly.

[ReaderY]

Dobbs merely decided that abortion is a legislative matter. WHICH legislature decides is outside its scope. It gets decided by the normal rules.

The Interstate Commerce power has been interpreted expansively enough that if a future Congress passed a law explicitly preempting state laws restricting interstate commerce in abortifacients, it would be clearly constitutional and would not implicate Dobbs in any way.

To the extent the 4th Circuit majority is suggesting otherwise, I disagree with it.

[Brett Bellmore]

Yes, the Court has in the past interpreted the Interstate Commerce clause as though it read, "To regulate;" Whether they're interested in expanding that mistake any further is the question; They're not obligated to, and maybe they're not inclined to, either. From the Lopez decision:

“To uphold the Government’s contentions here, we would have to pile inference upon inference in a manner that would bid fair to convert congressional authority under the Commerce Clause to a general police power of the sort retained by the States.”

[ReaderY]

GenBioPro manufactures its mifepristone outside West Virginia, and has to transport it across state lines to sell it there. So this is interstate commerce by a very, very direct and traditional definition.

The “negative commerce clause,” which GenBioPro also relied on in its arguments in the District Court but did not appeal, directly prohibits state laws that result in obstructing the flow of interstate commerce. The Supreme Court recently, in National Pork Producers v. Ross (2023) held that this clause does not apply to state laws whose primary purpose is to regulate morality rather than protect or advantage in-state businesses. The District Court quite correctly applied this case in rejecting GenBioPro’s commerce clause argument, holding that West Virginia’s abortion law is a morals law very much like California’s law against pork from pigs raised in conditions the California legislature considered inhumane.

But the positive Commerce Clause has no such limitation. Congress has the power, if it chooses, to pre-empt state morals laws to the extent they obstruct interstate commerce. That means that it could choose to pre-empt West Virginia’s abortion law to the extent it obstructs interstate commerce in abortifacients as straightforwardly as it could choose to preempt California’s restrictions on pork to the extent they obstruct interstate commerce in that commodity.

The whole point of Dobbs is that there is nothing special about abortion. It and commercial articles related to it get treated the same way as anything else. That means abortifacients get treated just like pork, and just like uranium (involved in another case the District Court relied on in rejecting GenBioPro’s claims), so far as the Commerce Clause and federal pre-emption under it are concerned.

[Brett Bellmore]

The state is not prohibiting the flow of interstate commerce, they are simply prohibiting one particular USE of an article in interstate commerce. Mifepristone still has legal uses in West Virginia.

Thus my analogy, that while a state might not be able to prohibit importation of cars, it can still prohibit street racing in residential areas, not withstanding that street racing uses cars.

[David Nieporent]

The state is not prohibiting the flow of interstate commerce,

ReaderY didn't say "prohibiting." He said "obstruct."

Again, you are doing Brettlaw here, substituting your view of what the commerce clause should be for the courts' view of what the commerce clause is.

[ReaderY]

Let’s discuss an actual situation where Congress is actually seeking to protect a commodity that states are seeking to restrict, the Protection of Lawful Commerce in Arms Act, which expressly preempts certain state laws that Congress determined unduly interfere with commerce in firearms.

Do you agree that this act is constitutional under the Commerce Clause (separate from 2nd Amendment considerations) and Congress could still have passed it and decided to protect commerce in arms from state laws enacted by gun control folks even if Heller and its progeny had gone the other way?

If so, why can’t Congress pass a Protection of Lawful Commerce in Abortifacients Act to protect commerce in abortifacients from states that seek to restrict it? Under Dobbs, normal Commerce Clause rules apply, so the two situations ought to evaluated similarly.

[Brett Bellmore]

I'm not willing to analyze this apart from the 2nd amendment. The PLCAA is, expressly, enacted in defense of a constitutional right, as 14th amendment enabling legislation. Section 5 enabling legislation does not have to have a commerce clause basis.

Congress might have been able to enact a limited version of the PLCAA, that bound federal, but not state, courts, under its authority over the judiciary. It absolutely needed the 14th amendment hook to bind the state courts.

Congress can't just invent new 14th amendment rights, and Dobbs thus precludes section 5 enabling legislation in the context of abortion.

[ReaderY]

One of the stated purposes - it’s Section 2(b)(4) is “to prevent the use of such lawsuits to impose unreasonable burdens on interstate and foreign commerce.” The purposes are entirely separable.

[Brett Bellmore]

Missed the very next clause?

"(3)To guarantee a citizen’s rights, privileges, and immunities, as applied to the States, under the Fourteenth Amendment to the United States Constitution, pursuant to section 5 of that Amendment."

It's section 5 enabling legislation, and I'm not going to discuss it as though it weren't.

[Josh R]

In City of Boerne v. Flores the Court held that Congress cannot use its Section 5 power to decide the substance of what is protected by the 14th. Only the courts can.

As such, for Section 5 of the 14th to be the authority for the statute, it would have to be the case that state laws which permit suing gun manufacturers violate the 2nd Amendment. I am not aware of any rulings holding they do.

[ReaderY]

Also, the Comstock Act by its terms restricts interstate commerce in abortifacients. If your view is Congress lacks the power to protect or encourage commerce in abortifacients because abortion is a state matter, is it also your view that Congress lacks the power to ban it?

If so, why would that it be? Normally, if something falls within the Interstate Commerce Clause, it’s totally up to Congress to decide whether it wants to restrict it or protect and remove obstructions to it.

Fairness in constitutional analysis means what’s sauce for the goose is sauce for the gander, and the same rules apply to all. Even in highly emotional issues like abortion in which one is deeply personally invested.

[Brett Bellmore]

And, again, the West Virginia law doesn't prohibit interstate commerce in any way, it simply criminalizes one particular use of a particular drug, regardless of whether or not it has moved in interstate commerce.

If we were to take this sort of reasoning seriously, basically the entire state police power would become subject to federal control.

[wvattorney13]

The issue is that a state's entire police power for all practical purposes IS subject to a federal override using the commerce power.

I disagree with it as much as you. But as long as we are talking about what the current jurisprudence is versus what we wish it were, the feds have basically plenary power by tying a regulation to an effect on commerce.

[Brett Bellmore]

That may be where you'd end up if you took that reasoning seriously, but the Court is never going to take it that seriously.

[David Nieporent]

starting with an entire section, Section 3,

Surely it started with Section 1.

[ReaderY]

Also, I completely agree with the portion of the opinion savaging West Virginia’s attempt to challenge GenBioPro’s standing. Standing was obvious here. It’s a total no brainer that a company will lose sales if a law bans its product. West Virginia’s efforts to claim otherwise were a complete waste of briefing pages and the court’s time.

[wvattorney13]

It's colorable. The law doesn't ban the company's product, only a particular non-accepted use for it. It would be as if paint thinner companies were challenging laws that prohibited huffing it in your garage. On that front, the paint thinner company's argument would be no different than that of a general citizen wishing to challenge a police power regulation of the state.

The standing doctrine can have harsh results sometimes. It never hurts to challenge it.

[ReaderY]

Totally disagree. If no “huffing it” means you can’t use paint thinners in your garage, the paint thinner company would unquestionably have standing to challenge such a law, as it restricts the permissible uses and hence reduces the sales of paint thinners. It’s in a totally different position from the average citizen. Average citizens are not in the business of selling the restricted product, and the existence of the law does not cause them to lose money.

[Brett Bellmore]

Sure, they'd have standing, which is not to say they'd have the merits on their side. There are a lot of chemicals that have legitimate industrial uses, but which you can't obtain and use in your garage. For instance, even prior to the recent Biden regulations to phase out PERC, you couldn't have bought it at Ace Hardware to clean things in your garage.