Chelius v. Wright

CourtDistrict Court, D. Hawaii
DecidedAugust 8, 2023
Docket1:17-cv-00493
StatusUnknown

This text of Chelius v. Wright (Chelius v. Wright) is published on Counsel Stack Legal Research, covering District Court, D. Hawaii primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Chelius v. Wright, (D. Haw. 2023).

Opinion

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF HAWAII

GRAHAM T. CHELIUS, M.D., et al., CIV. NO. 17-00493 JAO-RT

Plaintiffs, ORDER DENYING DEFENDANTS’ MOTION TO STAY PROCEEDINGS vs.

XAVIER BECERRA, J.D., in his official capacity as SECRETARY, U.S. D.H.H.S., et al.,

Defendants.

ORDER DENYING DEFENDANTS’ MOTION TO STAY PROCEEDINGS Defendants Xavier Becerra, J.D., in his official capacity as Secretary of the United States Department of Health and Human Services (“HHS”), and Robert M. Califf, in his official capacity as Commissioner of Food and Drugs, United States Food and Drug Administration (“FDA”) (collectively, “Defendants”), move to stay the proceedings in this drug regulation case pending the outcomes of two parallel litigations. ECF No. 171 (Motion to Stay Proceedings); ECF No. 184 (Letter Brief supplementing Motion to Stay). Plaintiff Graham T. Chelius, M.D., on behalf of himself and his patients, as well as Plaintiffs Society of Family Planning and California Academy of Family Physicians, on behalf of their respective members and patients (collectively, “Plaintiffs”), oppose the requested stays. ECF Nos. 173, 186. The Court DENIES Defendants’ Motion because a stay pending either parallel litigation is not warranted under the circumstances of this case.

I. BACKGROUND Plaintiffs principally challenge the FDA’s Risk Evaluation and Mitigation Strategy (“REMS”) for mifepristone, a drug used in its generic and brand name forms as a regimen for early-term medication abortions. A “REMS” is a special

set of safety regulations that goes above and beyond standard safety measures when “necessary to ensure that the benefits of a drug outweigh [its] risks.” ECF No. 1 at 3 (quoting and altering 21 U.S.C. § 355-1(a)(1)). Plaintiffs filed their

original complaint on October 3, 2017, claiming among other things that the FDA’s 2016 version of the REMS was overburdensome relative to mifepristone’s minimal health risks and, therefore, that the 2016 REMS exceeded the FDA’s

statutory authority under the Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 355-1(a)(1), amounting to a violation of the Administrative Procedure Act (“APA”), 5 U.S.C. § 706(2). ECF No. 1 at 60–61. From early 2018 to spring 2021, the parties litigated various motions

concerning the original complaint. Defendants moved to dismiss the complaint in February 2018, ECF No. 30, and subsequently withdrew that motion given Plaintiffs’ clarifying responses on issues of organizational standing, see ECF No.

40. The parties filed cross-motions for summary judgment in December 2019, ECF Nos. 86 and 89, but the Court had no occasion to decide those motions prior to entering a stay awaiting the Supreme Court’s impending decision in a pertinent

abortion-access case, June Med. Servs. L. L. C. v. Russo, 18-1323 (petition for cert. filed Apr. 17, 2019). ECF No. 107 (January 2020 Entering Order staying this case pending June, over Plaintiffs’ objections). June was argued in March 2020 and

decided in June 2020. See 140 S. Ct. 2103. Before this Court could lift the stay and resume summary judgment briefing, the parties jointly requested continuing upcoming deadlines until after the Supreme Court’s impending decision in a case on its emergency docket, FDA v. Am. Coll. of

Obstetricians & Gynecologists, No. 20A34 (appl. for stay filed Aug. 26, 2020) (“ACOG”). ECF No. 115 (September 2020 Joint Request for Continuance of Status Conference). Following the Supreme Court’s January 2021 grant of the

application for stay in ACOG, 141 S. Ct. 578, this Court lifted the stay in this case and ordered the parties to revise and resubmit their cross-motions for summary judgment. See ECF No. 128. Plaintiffs did so in April 2021. ECF No. 141. Defendants were required to resubmit by mid-May 2021. ECF No. 130.

Prior to that deadline, however, the FDA took two intervening actions prompting a second stay of the proceedings. First, on April 12, 2021, the FDA announced that it would exercise discretion to enforce one component of the

mifepristone REMS being challenged by Plaintiffs, for the duration of the COVID- 19 public health emergency. See ECF No. 148 at 2–3; ECF No. 169-1 at 6. And second, in early May 2021, the FDA notified Plaintiffs that it was undertaking a

fresh review of the mifepristone REMS and would consider any relevant data and evidence submitted by Plaintiffs during that review. See ECF No. 148 at 2. The parties jointly agreed to stay this action pending the FDA’s 2021 review, id., and

the Court ordered so, ECF No. 149. The 2021 review resulted in the FDA issuing an updated mifepristone REMS in January 2023, see ECF No. 157 at 5, after which the Court lifted the second stay of this case, ECF No. 158. Plaintiffs filed their Amended and

Supplemental Complaint on April 10, 2023, challenging the 2023 REMS by claiming among other things that the updated REMS are still overburdensome relative to mifepristone’s health risks and thus still exceed the FDA’s authority

under the FDCA. ECF No. 169 at 92. Plaintiffs request declaratory relief— declarations that the REMS violates the Constitution and the APA—as well as injunctive relief—enjoining Defendants from requiring a REMS and/or remanding to the FDA with instructions to remove the REMS. Id. at 94–95.

Just when the parties were set to litigate the Amended and Supplemental Complaint, they once again took a pause to contemplate another stay of the proceedings: on May 4, 2023, Defendants moved for a stay pending the parallel

mifepristone litigation in Alliance for Hippocratic Medicine v. FDA, No. 2:22-CV- 223-Z (N.D. Tex. filed Nov. 18, 2022). ECF No. 171. Plaintiffs submitted an Opposition to that Motion, ECF No. 173, Defendants submitted a Reply, ECF No.

175, and Plaintiffs submitted a Sur-Reply, ECF No. 180. The Court heard arguments on June 15, 2023. ECF No. 182. Following those arguments, the Court directed Defendants to indicate in a letter whether they support staying this action

pending another parallel mifepristone litigation, Washington v. FDA, No. 1:23-cv- 3026-TOR (E.D. Wash. filed Feb. 23, 2023). Defendants support such a stay, ECF No. 184, while Plaintiffs do not, ECF No. 186. See also ECF No. 189 (Defendants’ Reply Letter further advocating for a stay based on Washington).

The Alliance and Washington litigations are summarized below. A. The Alliance Litigation The plaintiffs in the Alliance litigation are physicians providing pregnancy-

related health care, including emergency care after unsuccessful medication abortions, and national associations of such physicians. See No. 2:22-CV-223-Z, ECF No. 1 at 8–12. They assert APA challenges to the FDA’s original approval of mifepristone as a medication abortion regimen and the FDA’s post-approval

abatement of the REMS from March 2016 to December 2021. See id. at 94–111. Their allegations of a lax mifepristone regime include, for example, that the FDA’s 2021 enforcement-discretion decision lacked legal authority, see id. at 107–08, and

that all of the FDA’s actions concerning mifepristone are contrary to the Comstock Act, 18 U.S.C. §§ 1461, 1462, which allegedly “prohibit[s] the distribution of chemical abortion drugs by postal mail, express company, or common carrier,” id.

at 6–7.

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