Since before the Dobbs decision reversed decades of precedent on reproductive rights, we have been looking at the implications for drug and device manufacturers. See here and here. Our posts have, of course, followed the ins and outs of the notorious AHM (or Hippo) litigation as it makes its way up to the Supreme Court for an inevitable merits decision. See here , here, and here. We have also been following a challenge in the Southern District of West Virginia to state law effectively banning and criminalizing the use of medications that the FDA has approved specifically for abortion. In that case, GenBioPro, Inc. v. Sorsaia, the only US manufacturer of (generic) mifepristone contends that a series of West Virginia laws violate both the Supremacy Clause and Commerce Clause. When the court rejected the defendants’ challenge to the plaintiff’s standing, we were encouraged about the plaintiff’s chances on preemption, noting both the court’s rigor and its rejection of the Northern District of Texas court’s result-driven analysis in AHM. A week later, in discussing the Supreme Court’s National Pork decision on the dormant commerce clause, we offered:
We find it unlikely, but not impossible, that some state law about medication abortion might still violate Healy and Walsh. For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use.
We are sorry to say that our optimism on preemption was misplaced and our prediction on the dormant commerce clause was correct.
Last week, the district court in GenBioPro, Inc. v. Sorsaia, No. 3:23-0058, 2023 U.S. Dist. LEXIS 149195 (S.D.W. Va. Aug. 24, 2023), considered the rest (i.e., not standing) of the defendants’ motions to dismiss. The first part of the decision provided false hope for the plaintiff. After recapping the state laws and the regulatory history of mifepristone, the court stated:
The result of [FDA’s] heightened scrutiny and extensive review is a REMS which unambiguously assures the safety of the drug without any additional safeguards from the States. Defendants have not disputed the safety of mifepristone, nor could they.
Id. at *8. This came with a declaration that the court did not find the Fifth Circuit’s AHM decision’s “primary determinations to be persuasive.” Id. at *7 n.8. The Sorsaia court then rejected the defendants’ argument that the enunciation of the new “major questions doctrine” in West Virginia v. EPA, 142 S. Ct. 2587 (2022), essentially wiped out the possibility of preemption. We will not dwell on that part, because the argument was weak. Defendants contended that anything about abortion was a “major question” that had to be decided by Congress rather than FDA and abortion was not mentioned in the FDCA, FDAAA, or other acts governing FDA. The FDCA “does [not] mention any other specific procedure, device, cosmetic, or medication it instructs the FDA to regulate.” Id. at *14. Instead, FDA’s regulation of mifepristone is authorized by numerous provisions, including “FDAAA’s express command that FDA promulgate a REMS for Subpart H-approved drugs (including mifepristone), subject to certain delineated principles, including accessibility.” Id. at *13. That was the end of the part we like.
The preemption analysis started off on the wrong foot in the same way many courts have before—misapprehending that there is a broad presumption against preemption. Citing Levine, the Sorsaia court stated “there is a presumption against preemption, especially in a field traditionally occupied by the States.” Id. at *17. Not for implied preemption. There is such a presumption in field preemption, which was not at issue in either Levine or Sorsaia. Since the Supreme Court’s decision in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), eight years after Levine, there is no such presumption in express preemption either. Albrecht, which reworked Levine on implied preemption, did not mention any such presumption. With this non-existent presumption in play and the focus wrongly on Congress’s intent as to mifepristone in particular, Sorsaia rejected both obstacle and conflict preemption. This rejection also hinged in large part on the characterization that the West Virginia laws merely “restricted” the use of mifepristone, rather than functionally banning and criminalizing the use of an FDA-approved prescription medication for its FDA-approved intended use.
On obstacle preemption, the court analyzed the REMS provisions in FDAAA as “directing the FDA to consider burden and access when promulgating REMS with elements to assure safe use to ensure that the elements themselves would not be unduly burdensome upon patient access.” Id. at *22 (emphasis in original). Combined with the fact that Roe was still in effect when FDAAA passed, the Sorsaia court concluded Congress did not intend “for the FDAAA access language to preempt state abortion restrictions which would have been unconstitutional at the time the FDAAA was passed.” Id. at *23. This perverse reasoning dictated that “the [state] UCPA and abortion restrictions do not pose an ‘unacceptable obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” Id. (citing Levine). “Any additional or incidental burden West Virginia has placed upon patients wishing to obtain mifepristone”—presumably, leaving the state to receive medical care without the threat of felony prosecution—“does not provide an unconstitutional ‘obstacle’ to the FDAAA’s unambiguous directive to FDA.” Id. at *24. One state criminalizing the prescription of a medication that FDA has approved for use by prescription throughout the United States does seem like an obvious obstacle to the charge in the FDCA that FDA has sole authority to approve prescription medications.
The analysis of conflict preemption was similarly flawed, as we see it. Citing Bartlett and Mensing, the Sorsaia court described the issue as “[t]heoretically—regardless of the intent of the FDAAA—the mifepristone REMS could directly conflict with West Virginia’s restrictions, thereby creating a system in which individuals regulated by both federal and state law could not comply with both mandates.” Id. at *25. This is a bit backwards, because FDA’s authority and its approval of defendant’s generic mifepristone predated the West Virginia ban and the Supremacy Clause puts the focus on whether state law conflicts with federal law. As we have stated several times before, once the FDA says “yes,” a state cannot say “no.” See here, here, and here. That is about as direct a conflict as we can imagine. In any event, Sorsaia sidestepped a true conflict analysis by concluding that the manufacturer was “not regulated by the UCPA at all.” Id. (emphasis in original). The reasoning was that certain UCPA provisions were directed at “licensed medical professionals,” which did not include a drug manufacturer. This analysis ignored that another provision of the UCPA discussed earlier in the opinion made it a felon for “any other person [to] induce . . . or attempt to . . . induce an abortion.” Id. at *2. Unless manufacturing, selling, and distributing the only approved abortifacient will never be considered an attempt to induce an abortion, this sidestep should not have worked. The obvious issue, especially because plaintiff sells a generic drug, is that a ban of an FDA-approved drug conflicts with the FDA’s approval by all conventional reasoning. The Sorsaia court dropped a confusing footnote on this issue, citing Bartlett and saying it rejected “Defendants’ argument that GenBioPro may simply choose to stop selling mifepristone in West Virginia, and thus avoid any conflict between state and federal law.” Id. at *26 n.10. However, the Supreme Court’s treatment of the “stop selling” argument means that a state ban creates a conflict with the federal action of approval and must yield.
There was more. In rejecting the defendants’ challenge to standing, the court had concluded that the plaintiff could assert the interest of licensed medical professionals in West Virginia who purchased and otherwise planned to distribute its mifepristone. The court still found no conflict because “the UCPA is a restriction on the incidence of abortion, rather than a state directive in a direct conflict with the logistical REMS regulations.” Id. at *28. That bit of contortion was purportedly supported by the Supreme Court’s rejection of preemption in cases about uranium mining (a field preemption analysis where the petitioner did not raise an impossibility argument) and horsemeat (express preemption analysis only). Id. at *29. These have little to do with the conflict/impossibility preemption analysis for a drug specifically approved by a federal agency with specific requirements imposed by a REMS.
The Sorsaia court also rejected field preemption and dormant commerce clause challenges to the state law. We think these were fairly foregone conclusions, so we will not spend time on them. The interesting part for dormant commerce clause devotees is that the court did a Pike balancing test, the viability of which has been debated since National Pork. One significant aspect of plaintiff’s case was kept alive, though. West Virginia law prohibits prescribing mifepristone via telemedicine and the current REMS on mifepristone expressly authorizes it. This is a conflict that the Sorsaia court recognizes:
This conflict between the REMS and the state statute creates the kind of impossibility preemption discussed above—a licensed medical professional prescribing mifepristone could not comply with both the access determination made by FDA and the access determination made by West Virginia as to telehealth.
Id. at *37. It is incongruous to find a conflict here but not as to the more restrictive West Virginia laws, but it does mean the case is still alive. Eventually, the case seems likely to get up to the Fourth Circuit, as which time the rejection of broader preemption in this opinion will be examined. In terms of tea leaves, the Fourth Circuit did reverse a plaintiff’s verdict in Knight v. Boehringer Ingelheim Pharmaceuticals, Inc., 984 F.3d 329 (4th Cir. 2021), because the district court applied Levine to reject implied preemption and then Albrecht came down. Whether Sorsaia’s reliance on Levine after Albrecht will lead to the same fate remains to be seen. Of course, what the Supreme court does with AHM in the interim may be determinative.