Thomas Owen Rice

“ Courts have determined that the APA alone does not demonstrate congressional intent to authorize a state to sue the federal government as parens patriae. See Bernhardt, 923 F.3d at 181; Am. Fed’n of Tchrs. v. Cardona, No. 5:20-CV-00455-EJD, 2021 WL 4461187, at *5 (N.D. Cal. Sept. 29, 2021) . However, states are not necessarily precluded from bringing a parens patriae suit against the federal government, including where the underlying statute forming the basis for the APA action authorizes a parens patriae suit. ”

“ A court may imply a lack of irreparable harm where there is no “speedy action” and a plaintiff sleeps on its rights. Lydo Enters. v. City of Las Vegas, 745 F.2d 1211, 1213 (9th Cir. 1984) .
Plaintiffs assert that the Mifepristone REMS Program imposes costs that are not compensable where the restriction of access to mifepristone causes patients to miss the window for medication abortion, leaving patients with procedural abortion or carrying a pregnancy to term, options that impose higher costs on Plaintiffs’ state-run health care programs. ”

“ Plaintiffs assert the following direct harm: (1) unrecoverable costs on the States’ Medicaid and other state-funded health care programs from increased surgical abortions and pregnancy care, (2) practice restrictions on providers and pharmacists, including state employees, and (3) unrecoverable costs in implementing systems to comply with the 2023 REMS’ patient agreement and licensure requirements. ”

“ First, “nationwide injunctive relief may be inappropriate where a regulatory challenge involves important or difficult questions of law, which might benefit from development in different factual contexts and in multiple decisions by the various courts of appeals.” ”

“ The purpose of administrative exhaustion is to prevent “premature interference with agency processes, so that the agency may function efficiently and so that it may have an opportunity to correct its own errors, to afford the parties and the courts the benefit of its experience and expertise, and to compile a record which is adequate for judicial review.” ”

“ Mandatory injunctions are disfavored and require a higher showing that the “facts and law clearly favor the moving party.” Garcia v. Google, 786 F.3d 733, 740 (9th Cir. 2015) .
Plaintiffs contend they are seeking a prohibitory injunction to maintain the “status quo.” ECF Nos. 3, 78. Plaintiffs seek an “order enjoining Defendants from doing two things: (1) enforcing the 2023 REMS, and (2) changing the status quo to make mifepristone less available in the Plaintiff States.” ”

“ Thus, the Court finds that administrative exhaustion through a citizen petition on the January 2023 REMS would be futile.
3. APA Claim Plaintiffs assert they are likely to succeed on the merits of the claim that the 2023 REMS is contrary to law and arbitrary and capricious under the APA. ECF No. 3 at 19–29.
To obtain injunctive relief, Plaintiff must show that there are “serious questions going to the merits” of its claims or that it is “likely to succeed on the merits.” ”

“ B. Irreparable Harm Plaintiffs assert they will suffer irreparable harm from the 2023 REMS in at least three ways: (1) financial costs on Plaintiffs that cannot be compensated, (2) burdens on Plaintiffs’ institutions and providers who provide abortion care, and (3) harm to the health and well-being of patients and providers “by aggravating the ongoing crisis of reduced access to abortion care.” ”

“ Abortion restrictions vary state-by-state and Plaintiffs allege harm not shared nationwide. For example, Plaintiffs allege harm from the 2023 REMS in light of the influx of patients from states who do not have similar services available. ”

“ All drugs previously approved under Subpart H, including Mifeprex, were deemed to have a REMS in place. Pub. L. No. 110-85, tit. IX, § 909 (b) . Under the Federal Food, Drug and Cosmetic Act (“FDCA”) , a new drug cannot be marketed and prescribed until it undergoes a rigorous approval process to determine that it is safe and effective. 21 U.S.C. § 355.
In 2011, FDA issued a new REMS for Mifeprex incorporating the same restrictions under which the drug was approved eleven years earlier. Id., ¶ 90; ECF No. 51-2. In 2013, FDA reviewed the existing REMS and reaffirmed the restrictions in place. ”

“ Plaintiffs’ Motion for Preliminary Injunction (ECF No. 3) is GRANTED in part. Pursuant to Federal Rule of Civil Procedure 65 (a) , Defendants and their officers, agents, servants, employees, attorneys, and any person in active concert or participation, are PRELIMINARILY ENJOINED from: “altering the status quo and rights as it relates to the availability of Mifepristone under the current operative January 2023 Risk Evaluation and Mitigation Strategy under 21 U.S.C. § 355-1 in Plaintiff States.” No bond shall be required. ”

“ In 2019, FDA approved a different manufacturer’s abbreviated NDA for a generic version of mifepristone and established the Mifepristone REMS Program, which covered both Mifeprex and the generic drug. Id. at 32, ¶ 103; ECF No. 51-3. In May 2020, American College of Obstetricians and Gynecologists (“ACOG”) sued FDA, challenging the Mifepristone REMS Program’s in-person dispensing requirement in light of the COVID-19 pandemic. ”

“ Alternatively, the Ninth Circuit also permits a “sliding scale” approach under which an injunction may be issued if there are “serious questions going to the merits” and “the balance of hardships tips sharply in the plaintiff’s favor,” assuming the plaintiff also satisfies the two other Winter factors. All. for the Wild Rockies v. Cottrell, 632 F.3d 1127, 1131 (9th Cir. 2011) (“ [A] stronger showing of one element may offset a weaker showing of another.”) ”

“ Plaintiffs also contend the ongoing implementation of the 2023 REMS modifications impose costs on Plaintiffs. Id. at 33. Economic costs that may not be recovered through the ordinary course of litigation satisfy the irreparable harm standard. ”