Over the past few months, Bexis, with the substantial help of several Reed Smith associates, has prepared a law review article – “Federal Preemption and the Post- Dobbs Reproductive Freedom Frontier” – which will soon be published in the Food & Drug Law Journal. A draft of this article is now available on SSRN.
The core premise of Bexis’ article is very simple: Once the FDA has said “yes” and approved a particular drug for a particular indication (“intended use”) for sale in the United States, federal preemption precludes any state from saying “no” and trying to ban that same FDA-approved drug. It doesn’t matter whether that drug is morphine, methadone, minoxidil – or mifepristone.
In GenBioPro, Inc. v. Sorsaia, 2023 WL 3211847 (S.D.W. Va. May 2, 2023) (“Sorsaia”), the plaintiff “is the only United States manufacturer of generic mifepristone,” and the defendants are West Virginia state and local prosecutors. Id. at *1. The plaintiff manufacturer aims to put into practice the preemption theories in Bexis’ article and to have West Virginia’s ban on medication abortions (W. Va. Code §16-2R-2) declared preempted by the FDCA and the FDA’s approval of mifepristone for precisely that purpose.
The word “preemption” does not appear in Sorsaia, but in this preliminary skirmish, the mifepristone manufacturer won every issue of importance – ensuring that it would have the opportunity to present its preemption arguments.
Unlike the attenuated standing arguments credited in certain Texas litigation, the plaintiff in Sorsaia had a rock solid basis for standing – the state was threatening to ban its only product, id. at *1, by threatening to revoke the license, and jail for at least three years, any West Virginia physician so bold as to prescribe the plaintiff’s FDA-approved drug for its FDA-approved use. Id. Even before that post-Dobbs statute, however, West Virginia “prohibit[ed] providers from prescribing medication abortion drugs via telemedicine.” Id. at *2 (citation omitted).
The FDA’s response, however, has been the diametric opposite of West Virginia’s – “continually eas[ing] restrictions on access to mifepristone,” which explains the current attempts to overturn more than twenty years of FDA mifepristone regulation under administrations of both parties:
- In 2000 (during the Clinton administration), the FDA approved mifepristone under so-called “Section H, as a drug “that provide meaningful therapeutic benefit to patients over existing treatments.”
- In 2007 (during the Bush Administration), Congress amended the FDCA to provide for Risk Evaluation and Mitigation Strategy (“REMS”), “to assure safe use,” which the FDA applied to mifepristone.
- In 2011 (during the Obama Administration), the FDA completed the REMS for mifepristone, mandating that it “only be prescribed by certified physicians, dispensed in certain healthcare facilities, and taken in the provider’s clinic.”
- In 2016 (during the Obama Administration), the FDA amended this REMS, “expanding those who could be certified to prescribe . . . from ‘physicians’ to ‘healthcare providers,’ and reducing the number of required patient visits to their healthcare providers.”
- In 2019 (during the Trump Administration), the FDA approved generic mifepristone, subject to the same REMs.
- In 2023 (during the Biden Administration), “the FDA promulgated a new REMS for mifepristone which no longer limits dispensation of the drug to healthcare settings, thereby allowing patients to receive the medication either by mail or from certified pharmacies.”
Sorsaia, 2023 WL 3211847, at *2. The contrast between the FDA’s and West Virginia’s approach to the same drug – combined with the Supremacy Clause (federal law “shall be the supreme law of the land; and the judges in every state shall be bound thereby, anything in the Constitution or laws of any State to the contrary notwithstanding,” U.S. Const. Art. 6, cl. 2) – are the basis for the manufacturer’s suit in Sorsaia.
But first the plaintiff manufacturer had to defeat the state’s standing and TwIqbal arguments – and it did.
First, the state argued that, because the manufacturer had not previously sold mifepristone in West Virginia, it had not suffered any “particularized” or “concrete” injury from that state’s ban. Sorsaia, 2023 WL 3211847, at *4. Didn’t work. “Financial harm,” such as loss of a potential market “is a classic and paradigmatic form of injury in fact.” Id. Thus, “lost business opportunities are a form of economic injury.” Id. at *5. The manufacturer thoroughly defeated this standing challenge:
[Plaintiff] is a well-established manufacturer of a nationally distributed and federally approved product. . . . [Its] FDA approval allows it to sell mifepristone nationwide. . . . [T]he growing market for mifepristone . . . now accounts for more than half of abortions in the United States. Plaintiff asserts that several nationwide pharmacy chains − some of which have locations in [the state] − have evinced a desire to sell mifepristone but are prevented from doing so by West Virginia’s statutes and Defendants’ threatened legal action.
Id. Thus, “there is nothing ‘conjectural or hypothetical’ about [plaintiff’s] affirmations that it would be selling its product to a wider market in West Virginia were it not for” that state’s” restrictions on sale and use of its FDA-approved product. Id.
Second, defendants also contended that the plaintiff manufacturer’s injuries were not “redressable.” Id. at *6-8. Those arguments were likewise meritless. First, relief was not dependent on “third-party action” – that of prescribing physicians and intermediate distributors. That argument contravened the standing holdings of just about every other abortion case in history. “None of the cases in which doctors, contraceptive providers, or other vendors were found by the Supreme Court to have standing found that relief was impermissibly premised on third-party customer sales.” Id. at *6 (citations omitted). Defendants’ “argument that no medical practitioner or pharmacy in the state of West Virginia would ever prescribe or sell mifepristone [was] facially implausible.” Id. at *7. Making an argument that thin probably cost the defendants considerable credibility with the court.
Sorsaia had even less patience with defendants’ third argument − reliance on the 1873 Comstock Act (18 U.S.C. §§1461-62, also a linchpin of the original Texas anti-mifepristone decision, Alliance for Hippocratic Medicine v. FDA, ___ F. Supp.3d ___, 2023 WL 2825871, at *9, 14-19 (N.D. Tex. Apr. 7, 2023)). This judge was singularly unimpressed:
[T]he Comstock Act is currently understood to apply only to use of the mails in an illegal manner. . . . The Department of Justice’s current enforcement interpretation concurs. While [one defendant] has obliquely threatened legal action against pharmacies willing to distribute mifepristone in West Virginia, he does not have the authority to enforce federal law. . . . [T]he entity with that enforcement authority − the Department of Justice − has stated that it will not enforce the Comstock Act against legal vendors of mifepristone. Accordingly, this Court declines to find that a widely abrogated 19th century statute which the federal government will not enforce bars redressability here.
Sorsaia, 2023 WL 3211847, at *7 (citations omitted). See also GenBioPro, Inc. v. Sorsaia, 2023 WL 3451688, at *1 (S.D.W. Va. April 21, 2023) (“the opinion in Alliance for Hippocratic Medicine, has been met with broad criticism from legal commentators. Therefore, the Court accords that opinion little weight.”) (citation omitted).
Nor did redressability preclude plaintiff from challenging certain West Virginia statutes that were not currently in effect. While ostensibly “suspended,” they were subject to a spring-back “provision that should it [the more recent statute] be found unconstitutional the older provisions would once again become enforceable.” Id. at *8. The plaintiff manufacturer made precisely the sort of constitutional challenge that would trigger that provision. “But as Plaintiff has challenged the [current statute], it also may challenge the provisions which would spring back into enforceability if this Court were to find the [current statute] unconstitutional.” Id. Yet another too-cute argument went down in flames.
The defendants, however, were nothing if not thorough in their standing contentions. The first-named defendant, a local prosecutor, contended that “the injury Plaintiff complains of cannot be traced to his actions or inaction.” Sorsaia, 2023 WL 3211847, at *8. Even though this argument against standing at least passed the red face test, it still lost. Since “the source of [plaintiff’s] alleged injury” was the West Virginia statutory scheme, and this defendant was a county prosecuting attorney, he was “charged with enforcing” it. Id. at *9. Given plaintiff’s allegations that it intended “to distribute its product within the state and to specific pharmacies within the county,” the claimed injury was traceable to that defendant. Id.
In addition, Sorsaia considered third-party standing, holding that the manufacturer plaintiff could “assert the rights of third parties to whom it wishes to sell mifepristone within West Virginia.” Id. at *9. The first step was easy. Third-party standing has been routine in abortion-related cases brought by both sides. “One widely recognized ground for third-party standing is the vendor-vendee relationship, where the vendor independently has established its own standing.” Id. (citation omitted). “Courts have invariably found that a vendor has a sufficiently close relationship with its customers when a challenged statute prevents that entity from transacting business with them.” Id. (citation and quotation marks omitted).
The second step was equally easy. The potential customers were subject to a “credible threat” of prosecution. Id. at *10. The state and its prosecutors had certainly not “disavowed enforcement.” Id.
[I]t is more than arguable that at least some of the pharmacies and medical personnel who could distribute mifepristone under the [FDA] 2023 REMS also could be prosecuted for that distribution under West Virginia law. . . . Further, rather than “disavowing enforcement,” both Defendants have affirmatively expressed that they will enforce the relevant criminal provisions.
Sorsaia, 2023 WL 3211847, at *10.
Standing, of course, is only the opening salvo of what promises to be a preemption battle royale in which the FDCA meets the country’s ongoing culture wars. We view Dobbs as the twenty-first century equivalent of the Volstead Act. However, it is clear from the Sorsaia opinion – particularly its treatment of the Comstock Act − that this court has no affinity for result-oriented fringe theories. As Bexis’ article indicates, we like the chances of FDA regulation and the Supremacy Clause where there is a level playing field.