American College of Obstetricians & Gynecologists v. United States Food and Drug Administration

CourtDistrict Court, D. Maryland
DecidedJune 15, 2020
Docket8:20-cv-01320
StatusUnknown

This text of American College of Obstetricians & Gynecologists v. United States Food and Drug Administration (American College of Obstetricians & Gynecologists v. United States Food and Drug Administration) is published on Counsel Stack Legal Research, covering District Court, D. Maryland primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
American College of Obstetricians & Gynecologists v. United States Food and Drug Administration, (D. Md. 2020).

Opinion

UNITED STATES DISTRICT COURT DISTRICT OF MARYLAND

AMERICAN COLLEGE OF OBSTETRICIANS AND GYNECOLOGISTS, on behalf of its members and members’ patients, COUNCIL OF UNIVERSITY CHAIRS OF OBSTETRICS AND GYNECOLOGY, on behalf of its members and members’ patients, NEW YORK STATE ACADEMY OF FAMILY PHYSICIANS, on behalf of its members and members’ patients, SISTERSONG WOMEN OF COLOR REPRODUCTIVE JUSTICE COLLECTIVE, on behalf of its members and members’ patients, and HONOR MACNAUGHTON, M.D.,

Plaintiffs, Civil Action No. TDC-20-1320 v.

UNITED STATES FOOD AND DRUG ADMINISTRATION, STEPHEN M. HAHN, M.D., in his official capacity as Commissioner of Food And Drugs, and his employees, agents and successors in office, UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES and ALEX AZAR, J.D., in his official capacity as Secretary, United States Department of Health and Human Services, and his employees, agents and successors in office,

Defendants.

MEMORANDUM OPINION Plaintiffs American College of Obstetricians and Gynecologists (“ACOG”) and four other entities and individuals have filed the present action against the United States Food and Drug Administration (“FDA”), the United States Department of Health and Human Services (“HHS”), FDA Commissioner Stephen M. Hahn, and Secretary of Health and Human Services Alex Azar in which they challenge the FDA’s failure to suspend for the duration of the COVID-19 pandemic certain requirements relating to medication abortion as a violation of the Fifth Amendment of the

United States Constitution. The States of Indiana, Louisiana, Alabama, Arkansas, Idaho, Kentucky, Mississippi, Missouri, Nebraska, and Oklahoma (“the States”) have filed a Motion to Intervene seeking intervention as of right or, in the alternative, permissive intervention. Having reviewed the submitted materials, the Court finds that no hearing is necessary. See D. Md. Local R. 105.6. For the reasons set forth below, the States’ Motion to Intervene will be denied. BACKGROUND Medication abortion, the process of ending an early pregnancy by taking certain medication, typically involves two FDA-approved prescription medications: mifepristone, which blocks the body’s receptors to hormones necessary to sustain pregnancy, and misoprostol, which causes uterine contractions to expel the contents of the uterus. This regimen first requires a

clinician to assess a patient’s eligibility for a medication abortion, a step which the FDA presently allows to take place either through an in-person assessment or entirely through an online consultation, known as telemedicine. Once a patient has been deemed eligible for a medication abortion, a clinician can issue prescriptions for the two pills and will give the patient instructions for their use and about follow-up care, including information about how to address any potentially serious complications. Under FDA requirements, the patient must pick up the prescribed mifepristone, consisting of a single tablet, at the clinician’s hospital, clinic, or medical office. While onsite, the patient is required to sign a form containing information about the regimen and potential risks with the medication. The patient then may take the mifepristone orally at a location of her choice, including at home. A day or two later, the patient takes misoprostol, which can be obtained through the same healthcare facility or through a mail-order or retail pharmacy. That pill also may be taken at a location chosen by the patient. Several hours later, the patient will experience cramping and bleeding that expels the pregnancy.

The focus of the present lawsuit is on the FDA’s requirements relating to the first pill, mifepristone. Since mifepristone was approved for marketing by the FDA in 2000, the FDA has required the medication be dispensed in person. Since 2011, this in-person requirement, and other requirements, have been imposed under the FDA’s Risk Evaluation and Mitigation Strategy (“REMS”) authority, which allows the FDA to place restrictions beyond those contained on the drug’s labeling to ensure that the drug’s benefits outweigh its risks. Within that authority, the FDA may also impose additional Elements to Assure Safe Use (“ETASU”). Mifepristone in particular has three ETASU: (1) “In-Person Dispensing,” which requires mifepristone to be dispensed only in a hospital, clinic, or medical office, by or under the supervision of a certified prescriber; (2) “Prescriber Certification,” which requires prescribing clinicians to fax a form to the drug

distributor attesting and agreeing to various details, and (3) “Patient Form,” which requires that the patient sign a special form containing information regarding the mifepristone regimen and its risks, that the prescriber provide a copy of the form to the patient, and that a copy of the form be placed in the patient’s medical file. Compl. ¶¶ 60-62, ECF No. 1. Starting in early 2020, COVID-19, the disease caused by novel coronavirus SARS-CoV- 2, has swept across the United States as part of a worldwide pandemic. During this public health emergency, the Centers for Disease Control and Prevention (“CDC”), a component of HHS, has issued guidance to health care professionals encouraging them to leverage telemedicine in order to protect individuals from COVID-19. In turn, HHS and FDA have taken steps to afford clinicians greater flexibility and discretion in prescribing otherwise highly regulated drugs without preliminary in-person visits. Plaintiffs’ claim in this action is that in the context of the dangerous conditions prevalent during the ongoing COVID-19 pandemic, Defendants’ continuing requirement of in-person dispensation of mifepristone, despite the availability of telemedicine and

mail-order services for obtaining the drug, creates an undue burden on women seeking medication abortions, in violation of their constitutional rights. DISCUSSION In their Motion, the States seek intervention as of right in this case pursuant to Federal Rule of Civil Procedure 24(a) or, in the alternative, permissive intervention under Rule 24(b). Defendants do not oppose the States’ Motion. Plaintiffs contend that the Motion should be denied because the States do not meet the requirements for either mandatory intervention or permissive intervention under Rule 24. I. Intervention as of Right A party may intervene as of right when it “claims an interest relating to the property or

transaction that is the subject of the action, and is so situated that disposing of the action may as a practical matter impair or impede the movant’s ability to protect its interest, unless existing parties adequately represent that interest.” Fed. R. Civ. P. 24(a)(2). The United States Court of Appeals for the Fourth Circuit has interpreted this language to require a party seeking to intervene as of right to meet four requirements: the intervenor must (1) submit a timely motion to intervene; (2) demonstrate a “direct and substantial interest” in the property or transaction at issue; (3) prove that the interest would be impaired if intervention was not allowed; and (4) establish that the interest is inadequately represented by existing parties. Richman v. First Woman’s Bank, 104 F.3d 654, 659 (4th Cir. 1997). The parties do not dispute the timeliness of the States’ Motion. Therefore, the Court will focus on the remaining three factors. A. Direct and Substantial Interest A direct or substantial interest exists when a party “stand[s] to gain or lose by the direct

legal operation of the district court’s judgment” in the underlying action. Teague v.

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