Case 8:20-cv-01320-TDC Document 90 Filed 07/13/20 Page 1 of 80
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`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.,
`
`
`
`
`
`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,
`
`
`
`
`Plaintiffs,
`
`v.
`
`Civil Action No. TDC-20-1320
`
`Defendants.
`
`
`
`
`MEMORANDUM OPINION
`
`Plaintiffs American College of Obstetricians and Gynecologists (“ACOG”), Council of
`
`University Chairs of Obstetrics and Gynecology (“CUCOG”), New York State Academy of
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`

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`Case 8:20-cv-01320-TDC Document 90 Filed 07/13/20 Page 2 of 80
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`Family Physicians (“NYSAFP”), SisterSong Women of Color Reproductive Justice Collective
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`(“SisterSong”), and Honor MacNaughton, M.D. have filed a civil action against the United States
`
`Food and Drug Administration (“FDA”), FDA Commissioner Stephen M. Hahn, the United States
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`Department of Health and Human Services (“HHS”), and Secretary of Health and Human Services
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`Alex Azar (“the Secretary”), challenging the enforcement during the COVID-19 pandemic of
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`certain FDA requirements relating to in-person dispensing and signature requirements for an oral
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`medication used to induce an abortion or to manage a miscarriage. Plaintiffs have filed a Motion
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`for a Preliminary Injunction seeking an order barring the enforcement of these requirements during
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`the pandemic. The Motion is fully briefed, and the Court held a hearing on the Motion on June 19,
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`2020. For the reasons set forth below, Plaintiffs’ Motion for a Preliminary Injunction is
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`GRANTED IN PART and DENIED IN PART.
`
`BACKGROUND
`
`I.
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`Medication Abortion
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`On September 28, 2000, FDA approved Mifeprex, the brand name for the drug
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`mifepristone (collectively, “mifepristone”), as the first non-surgical abortion drug that, when taken
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`in conjunction with another drug, misoprostol, can cause the early termination of an intrauterine
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`pregnancy. In 2019, FDA approved a generic version of mifepristone. The use of mifepristone
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`and misoprostol to cause an abortion, referred to as a medication abortion, is a two-part regimen
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`(“the Mifepristone-Misoprostol Regimen”). First, the patient takes mifepristone, a single 200 mg
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`tablet taken orally. Mifepristone blocks the body’s receptors for the hormone necessary to sustain
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`pregnancy, which then causes the pregnancy tissue and lining of the uterus to break down and
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`separate from the uterine wall. Then, 24 to 48 hours after taking mifepristone, the patient takes
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`misoprostol, another oral medication. Misoprostol causes uterine contractions that expel the
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`contents of the uterus. As a result, between 2 and 24 hours after taking misoprostol, the patient
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`will experience cramping and bleeding that signals the pregnancy is being expelled.
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`The use of mifepristone in conjunction with misoprostol is also a widely accepted medical
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`regimen to manage a miscarriage. While misoprostol alone has been prescribed after a miscarriage
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`to completely expel the pregnancy, taking mifepristone first decreases the need for a follow-up,
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`in-office procedure to fully evacuate the uterus.
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`II.
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`FDA Regulation
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`When FDA first approved mifepristone in 2000, it recognized that the drug carried serious
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`risks, such as an incomplete abortion or serious bleeding. In an effort to mitigate potential
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`complications, FDA put in place several restrictions on dispensing and distributing the drug,
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`including that the drug be prescribed only by a qualified physician and that it be administered in a
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`hospital, clinic, or medical office only by or under the supervision of such a physician. In 2007,
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`FDA deemed the imposed restrictions to be an approved Risk Evaluation and Mitigation Strategy
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`(“REMS”), a statutorily authorized designation which allows for additional FDA restrictions
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`beyond those set forth on the drug’s labeling. Under the Federal Food, Drug, and Cosmetic Act
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`(“FDCA”), 21 U.S.C. §§ 301-399i (2018), the federal government can enforce REMS against
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`healthcare providers and the manufacturer of the drug, known as the “drug sponsor.” See, e.g., 21
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`U.S.C. § 355(p)(1)(B) (prohibiting a person from introducing or delivering a new drug into
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`interstate commerce if the person fails to maintain compliance with the REMS); 21 U.S.C. §
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`333(f)(4)(A) (subjecting a drug manufacturer as a “responsible person” to civil penalties for
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`violations of the REMS scheme).
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`In 2011, FDA approved the existing mifepristone REMS with additional Elements to
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`Assure Safe Use (“ETASU”), a special category of REMS. An ETASU can be imposed on a drug
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`that has been “shown to be effective” but is “associated with a serious adverse drug experience”
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`such that it can be approved only on the condition that the designated elements are satisfied. 21
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`U.S.C. § 355-1(f)(3). The ETASU requirements imposed in 2011 consisted of provisions
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`mandating that the drug be prescribed only by specially certified physicians, that it be dispensed
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`only in hospitals, clinics, or medical offices, and that it be dispensed only with documentation that
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`certain safe-use conditions were met, such as securing the signature of the patient on a Patient
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`Agreement Form and providing that form and a Medication Guide to the patient.
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`In 2013, FDA reviewed the existing REMS and reaffirmed the elements already in place.
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`Three years later, in 2016, in response to a supplemental application by the drug sponsor requesting
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`modifications to the REMS, 21 U.S.C. § 355-1(g)(4), FDA conducted another review of the
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`existing mifepristone REMS. In that review, FDA determined that “no new safety concerns have
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`arisen in recent years and that the known serious risks occur rarely,” and that “[g]iven that the
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`numbers of . . . adverse events appear to be stable or decreased over time, it is likely that . . . serious
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`adverse events will remain acceptably low.” 2016 Clinical Review at 39, 47, 49, Opp’n Mot. PI
`
`Ex. 19, ECF No. 62-11. As a result of the review, FDA made several changes to the REMS. Going
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`forward, FDA permitted certain nonphysicians to prescribe the drug as long as they meet certain
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`certification requirements, in part because the review “clearly demonstrate[d] that efficacy is the
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`same with non-physician providers compared to physicians.” Id. at 43. FDA also eliminated the
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`requirement that the drug be administered in a hospital, clinic, or medical office and instead
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`permitted it to be self-administered by the patient at a different location, based on the finding that
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`there is “no significant difference in either efficacy or safety” for women who take both
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`mifepristone and misoprostol at home as compared to women who take mifepristone at a medical
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`office and misoprostol at home. Id. at 39. FDA also extended the gestational period during which
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`the medication is approved for use from seven weeks to ten weeks into a pregnancy. Of the
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`requests made during this REMS review, the drug sponsor did not ask for changes to, or
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`elimination of, the requirement that the drug be dispensed only in person at a healthcare facility.
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`Mifepristone is thus presently subject to three ETASU requirements. The first ETASU
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`requirement, adopted pursuant to the “ETASU A” category which requires that “health care
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`providers who prescribe the drug have particular training or experience or are specially certified,”
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`21 U.S.C. § 355-1(f)(3)(A), provides that prescribing healthcare providers must certify in a written
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`form submitted to the drug sponsor that they have certain required qualifications, such as the ability
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`to assess the duration of the pregnancy and to diagnose an ectopic pregnancy, and will comply
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`with specific use guidelines, including providing counseling about the risks of the Mifepristone-
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`Misoprostol Regimen, providing and reviewing the Patient Agreement Form, as discussed below,
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`and recording the serial number of each package of mifepristone in the patient’s medical records.
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`The second ETASU requirement, imposed under the “ETASU C” category which “requires
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`that the drug be dispensed to patients only in certain health care settings,” 21 U.S.C. § 355-
`
`1(f)(3)(c), provides that mifepristone may be dispensed only in a hospital, clinic, or medical office,
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`by or under the supervision of a certified healthcare provider (“the In-Person Dispensing
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`Requirement”). Under this requirement, patients are not permitted to obtain mifepristone through
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`a mail-order or retail pharmacy or to receive the medication by mail from their healthcare provider
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`even if otherwise permitted by state law. Of the approximately 17 drugs subject to ETASU C,
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`mifepristone is the only one for which the patient may take the medication alone, without clinical
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`supervision.
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`The third ETASU requirement, adopted under the “ETASU D” category which provides
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`that the drug “be dispensed to patients with evidence or other documentation of safe-use
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`conditions,” 21 U.S.C. § 355-1(f)(3)(D), requires that the certified healthcare provider give a copy
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`of a Patient Agreement Form disclosing certain information about mifepristone and its risks to the
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`patient, that the healthcare provider review it with the patient and counsel her about the risk of
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`serious complications, and that the patient sign the form acknowledging that she had read and
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`received the form and received the counseling. The language in the Patient Agreement Form can
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`be read as requiring that the prescriber and patient be in the same location when this paperwork is
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`completed, as the form states above the provider’s signature line: “The patient signed the
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`PATIENT AGREEMENT in my presence after I counseled her and answered all her questions.”
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`Mifepristone REMS, Patient Agreement Form, Compl. Ex. 2, ECF No. 1-4. In this action,
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`Plaintiffs challenge the present enforcement of both this “In-Person Signature Requirement” and
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`the In-Person Dispensing Requirement (collectively, “the In-Person Requirements”).
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`III. Current Mifepristone-Misoprostol Regimen
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`Under the current FDA requirements, certified healthcare providers typically prescribe and
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`dispense the drugs for a medication abortion using the following regimen. First, the healthcare
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`provider must assess a patient’s eligibility for a medication abortion. This assessment includes
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`determining that the patient has been pregnant for less than the maximum ten weeks to be eligible
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`for a medication abortion and that the patient does not have an ectopic pregnancy, one in which
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`the fertilized egg is growing outside the uterus, a condition which would disqualify the patient for
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`the Mifepristone-Misoprostol Regimen. FDA does not restrict where and how this initial
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`assessment is conducted. Based on the healthcare provider’s best medical judgment, it may take
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`place in person and may require an ultrasound or blood work to establish the existence of a
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`pregnancy. In recent times, the assessment has also occurred entirely through remote technologies
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`such as a video connection over the internet, referred to as telemedicine, through which the
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`healthcare provider makes the necessary determinations based on the patient’s reported medical
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`history, last menstrual period, results of over-the-counter pregnancy tests, and symptoms. Once a
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`patient has been deemed eligible for a medication abortion, the patient is counseled on the risks
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`and alternatives, and the healthcare provider reviews with the patient other required information.
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`After the healthcare provider has obtained the patient’s informed consent, the prescriptions for
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`mifepristone and misoprostol are issued. At this stage, the healthcare provider gives the patient
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`specific instructions for the use of the drugs and follow-up care, including information about
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`potentially serious complications and how to address them if they arise.
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`If not already at the healthcare provider’s hospital, clinic, or medical office, the patient then
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`visits that facility to pick up the prescribed mifepristone. While onsite, the patient must sign the
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`Patient Agreement Form containing information about mifepristone and its risks previously
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`discussed during the consultation. She then receives a copy of the Patient Agreement Form and
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`the mifepristone Medication Guide, which contains substantially similar information. Once the
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`patient has the drug, she can take it orally at any location of her choosing, including at home.
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`Then, 24 to 48 hours later, the patient orally takes misoprostol, which can be obtained through a
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`retail or mail-order pharmacy, or at the same healthcare facility. That drug can also be taken at a
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`location of the patient’s choosing, and the physical response to the drugs does not begin until 2 to
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`24 hours after misoprostol is taken. Under current FDA labeling for mifepristone, the healthcare
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`provider will have discussed with the patient the necessity of arranging to be in a comfortable
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`location shortly after taking misoprostol when cramping and bleeding associated with the regimen
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`begin. Finally, patients are advised to follow up with their healthcare provider 7 to 14 days after
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`the completion of the Mifepristone-Misoprostol Regimen to ensure that the abortion was
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`successful. This consultation need not take place in person.
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`IV. COVID-19
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`COVID-19 is a highly contagious and life-threatening respiratory disease caused by the
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`SARS-CoV-2 novel coronavirus that is transmitted through respiratory transmission, including
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`droplet and possibly aerosolized transmission, and the touching of contaminated surfaces.
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`Reingold Decl. ¶¶ 13-14, Mot. PI Ex. 2, ECF No. 11-4. Because many individuals infected with
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`the coronavirus lack symptoms and the disease currently lacks an effective vaccine, it is
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`exceedingly difficult to control its spread. Id. ¶ 17. Since the first confirmed case of COVID-19
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`was reported in the United States in late January 2020, the Centers for Disease Control and
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`Prevention (“CDC”), a component of HHS, has reported that there have been over three million
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`cases of COVID-19, and over 130,000 deaths, across the nation. See Cases in the U.S., U.S. Ctrs.
`
`For Disease Control & Prevention, https://www.cdc.gov/coronavirus/2019-ncov/cases-
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`updates/cases-in-us.html (last updated July 10, 2020) (“CDC, COVID-19 Cases”).1 At the initial
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`peak of the pandemic in March 2020, the CDC reported more than 43,000 new COVID-19 cases
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`per day nationwide. See New Cases by Day, U.S. Ctrs. For Disease Control & Prevention,
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`https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/cases-in-us.html (last updated July 9,
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`2020) (“CDC, New Cases by Day”). Now, during July 2020, new cases per day have surpassed
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`44,000 each day so far this month. Id. Worldwide, there have been more than 11 million cases
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`and over 545,000 deaths. Coronavirus Disease (COVID-19) Situation Report – 171, World Health
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`Organization
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`(July
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`9,
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`2020),
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`
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`https://www.who.int/docs/default-source/corona
`
`
`1 At the hearing on the Motion, the parties agreed that the Court may take judicial notice of
`updated facts relating to the state of the COVID-19 pandemic as of the date of the issuance of this
`opinion. See United States v. Garcia, 855 F.3d 615, 621 (4th Cir. 2017) (“Under Federal Rule of
`Evidence 201(b), the district court may judicially notice a fact that is not subject to reasonable
`dispute . . . This court and numerous others routinely take judicial notice of information contained
`on state and federal government websites.”).
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`viruse/situation-reports/20200709-covid-19-sitrep-171.pdf?sfvrsn=9aba7ec7_2 (“WHO, COVID-
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`19 Situation Report”).
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`On March 13, 2020, the President of the United States issued a proclamation to declare that
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`the “COVID-19 outbreak in the United States constitutes a national emergency” and to authorize
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`the Secretary of HHS to temporarily waive or modify certain Medicare, Medicaid, and health
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`insurance requirements for the duration of the public health emergency. See Proclamation on
`
`Declaring a National Emergency Concerning the Novel Coronavirus Disease (COVID-19)
`
`Outbreak, White House
`
`(Mar. 13, 2020), https://www.whitehouse.gov/presidential-
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`actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid
`
`-19-outbreak/. The Governors of all 50 states have declared a state of emergency or public health
`
`emergency and have issued some combination of stay-at-home orders, restrictions on the operation
`
`of businesses and restaurants, and limitations on social gatherings in response to the pandemic.
`
`See Executive Orders, Council of State Govt’s, https://web.csg.org/covid19/executive-orders/ (last
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`visited July 7, 2020). Several states have also banned elective surgeries, including abortions,
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`because of the pandemic. See, e.g., In re Rutledge, 956 F.3d 1018, 1023 (8th Cir. 2020); Adams
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`& Boyle, P.C. v. Slatery, 956 F.3d 913, 924 (6th Cir. 2020).
`
`A.
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`Federal Agency Action
`
`In response to this unprecedented public health crisis, federal agencies have issued
`
`guidance or instituted waivers in recognition of the health risks associated with patient travel to
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`medical facilities during the pandemic. On January 31, 2020, the Secretary declared a public health
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`emergency (“PHE”) pursuant to the Public Health Service Act, 42 U.S.C. § 247d (2018). See
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`Determination that a Public Health Emergency Exists, Health & Human Servs. (Jan. 31, 2020),
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`https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.
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` Under
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`this
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`provision, the Secretary may declare that “a disease or disorder presents a public health
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`emergency” or that “a public health emergency, including significant outbreaks of infectious
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`diseases or bioterrorist attacks, otherwise exists.” 42 U.S.C. § 247d(a) . Upon such a declaration,
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`the Secretary “may take such action as may be appropriate to respond to the public health
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`emergency.” Id.
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`In March and April 2020, FDA informed drug sponsors for two specific drugs, Spravato
`
`and Tysabri, that during the pandemic it would not enforce the associated ETASU C requirement
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`that a drug be administered or dispensed only at a hospital, clinic, or medical office—the same
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`limitation imposed on mifepristone—even though both still must be administered in-person by a
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`physician. In March 2020, FDA also announced that during the PHE, it would not enforce certain
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`REMS ETASU requirements that mandate that a patient undergo certain in-person procedures,
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`such as laboratory tests or imaging studies such as magnetic resonance imaging (“MRI”), before
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`prescribing certain drugs, when a health care professional exercising medical judgment determines
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`that the patient can safely forgo the procedure. U.S. Food & Drug Admin., Policy for Certain
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`REMS Requirements During the COVID-19 Public Health Emergency: Guidance for Industry and
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`Health Care Professionals 7, (Mar. 2020), https://www.fda.gov/media/136317/download (“FDA,
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`COVID-19 REMS Guidance”) (cited in Reingold Decl. ¶ 46).
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`Based on his PHE declaration, the Secretary, with the concurrence of the Acting
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`Administrator of the Drug Enforcement Administration (“DEA”), invoked the use of the
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`“telemedicine exception” in the Controlled Substances Act (“CSA”), 21 U.S.C. § 802(54)(D),
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`which permits practitioners to forgo otherwise mandatory requirements that they conduct an in-
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`person evaluation of a patient before prescribing certain controlled substances, including opioids,
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`and to permit them instead to rely on telemedicine to assess a patient before issuing a prescription.
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`More broadly, HHS has acted to advance the use of telemedicine during the pandemic. On
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`March 17, 2020, the Secretary announced that HHS was taking measures to facilitate telemedicine
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`so that patients can “access healthcare they need from their home, without worrying about putting
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`themselves or others at risk during the COVID-19 outbreak.” Secretary Azar Announces Historic
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`Expansion of Telehealth Access to Combat COVID-19, Health & Human Servs. (Mar. 17, 2020),
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`https://www.hhs.gov/about/news/2020/03/17/secretary-azar-announces-historic-expansion-of-
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`telehealth-access-to-combat-covid-19.html (“Azar, Telehealth Announcement”). That day, HHS
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`also announced that it would waive penalties for good-faith violations of privacy requirements by
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`health care providers using standard online communications platforms such as FaceTime and
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`Zoom to see patients. OCR Announces Notification of Enforcement Discretion for Telehealth
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`Remote Communications During the COVID-19 Nationwide Public Health Emergency, Health &
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`Human Servs. (Mar. 17, 2020), https://www.hhs.gov/about/news/2020/03/17/ocr-announces-
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`notification-of-enforcement-discretion-for-telehealth-remote-communications-during-the-covid-
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`19.html. Another HHS component agency, the Centers for Medicare and Medicaid Services
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`(“CMS”), temporarily expanded Medicare coverage to include a broader range of telemedicine
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`services during the pandemic to “limit risk of exposure and spread of the virus.” President Trump
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`Expands Telehealth Benefits for Medicare Beneficiaries During COVID-19 Outbreak, Ctrs. For
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`Medicare & Medicaid Servs.
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`(Mar. 17, 2020), https://www.cms.gov/newsroom/press-
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`releases/president-trump-expands-telehealth-benefits-medicare-beneficiaries-during-covid-19-
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`outbreak (“CMS, Telehealth Announcement”) (quoted in Reingold Decl. ¶ 45).
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`CDC has also issued advisory guidance to health care professionals to use telemedicine
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`“whenever possible” as “the best way to protect patients and staff from COVID-19.” Prepare
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`Your Practice
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`for COVID-19, U.S. Ctrs. For Disease Control & Prevention,
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`https://www.cdc.gov/coronavirus/2019-ncov/hcp/preparedness-resources.html (last updated June
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`12, 2020) (“CDC, Prepare Your Practice”) (quoted in Reingold Decl. ¶ 40). CDC has separately
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`advised patients to “[u]se telemedicine or communicate with your doctor or nurse by phone or
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`email,” to reschedule procedures not urgently needed, and to limit in-person visits to the pharmacy
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`by using mail-order or delivery services where possible. Coronavirus Disease 2019 (COVID 19):
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`Doctor Visits and Getting Medicines, U.S. Ctrs. For Disease Control & Prevention,
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`https://www.cdc.gov/coronavirus/2019-ncov/daily-life-coping/doctor-visits-medicine.html
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`(last
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`updated June 8, 2020) (“CDC, Doctors and Medicines”) (quoted and cited in Reingold Decl. ¶ 42).
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`B.
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`Impact on Medication Abortion Care
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`Plaintiffs have presented the expert opinion of Dr. Arthur Reingold, Division Head of
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`Epidemiology at the University of California at Berkeley School of Public Health, as well as expert
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`opinions from six physicians who provide or oversee abortion services in locations across the
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`United States, including in New York, Massachusetts, Maryland, Washington, D.C., New Mexico,
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`and California. The physicians include: Dr. Allison Bryant Mantha (“Dr. Bryant”), a board-
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`certified obstetrician/gynecologist (“OB/GYN”) practicing at Massachusetts General Hospital in
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`Boston, Massachusetts and an Associate Professor at Harvard Medical School; Dr. Heather
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`Paladine, a physician practicing at a community health center in New York City who is also the
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`Assistant Attending Physician at New York Presbyterian Hospital and an Assistant Professor of
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`Medicine at Columbia University Medical Center; Dr. Angela Chen, a board-certified OB/GYN
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`practicing at the University of California at Los Angeles (“UCLA”) Medical Center and an
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`Associate Clinical Professor in the Department of Obstetrics and Gynecology at the David Geffen
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`School of Medicine at UCLA; Dr. Serina Floyd, a board-certified OB/GYN who is the Medical
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`Director of Planned Parenthood of Metropolitan Washington, D.C. (“PPMW”) overseeing care at
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`PPMW clinics in Maryland and Washington, D.C. and an Assistant Professor of Medical
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`Education at the University of Virginia; Dr. Eve Espey, a licensed OB/GYN practicing at the
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`University of New Mexico Hospital in Albuquerque, New Mexico and the Chair of the Department
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`of Obstetrics and Gynecology at the University of New Mexico School of Medicine; and Dr. Honor
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`MacNaughton, a board-certified physician practicing in family planning clinics in Massachusetts
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`and an Associate Professor at Tufts University School of Medicine.
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`These experts have testified to the challenges that COVID-19 presents to patients fulfilling
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`the In-Person Requirements in order to obtain a medication abortion and to the ability of healthcare
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`providers to meet all medically necessary requirements through telemedicine. First, they have
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`asserted that COVID-19 has adversely impacted the availability of in-person abortion care in the
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`United States. According to Dr. Paladine, at various times, medical offices and clinics have either
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`closed entirely or reduced the number of in-person appointments so that visits to obtain
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`mifepristone have been stopped or delayed. Paladine Decl. ¶ 13, Mot. PI Ex. 3, ECF No. 11-5.
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`For example, her own clinic closed entirely to in-person visits, then reopened operating at only 10
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`percent of capacity. Id. ¶¶ 13-14. She estimates that it will operate at 25 percent capacity through
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`Spring 2021. Id. ¶ 14. According to Dr. MacNaughton, the COVID-19 pandemic caused the
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`hospital system in which she works to close all but three primary care clinics to in-person visits,
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`so that abortion or miscarriage patients had to be referred to family planning clinics, which are
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`only open one half-day per week and are often located outside the patient’s local community, in
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`order to obtain mifepristone. MacNaughton Decl. ¶¶ 7-8, Mot. PI Ex. 7, ECF No. 11-9. Because
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`most of the primary care clinics were closed to in-person care, many of Dr. MacNaughton’s
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`colleagues were not able to provide mifepristone to these patients because of the In-Person
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`Requirements. Id. ¶ 7.
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`Case 8:20-cv-01320-TDC Document 90 Filed 07/13/20 Page 14 of 80
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`Even if healthcare facilities are open, abortion patients face particular challenges in
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`traveling to them for in-person appointments during the pandemic, many of which arise because
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`60 percent of women obtaining abortion care are people of color and 75 percent are poor or low-
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`income. Bryant Decl. ¶¶ 18-19, Mot. PI Ex. 1, ECF No. 11-3. As noted by Dr. Reingold, the health
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`risks from exposure are particularly amplified in communities of color, where individuals are
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`suffering higher rates of serious illness and death from COVID-19. Reingold Decl. ¶ 52. One
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`study has shown that African Americans have three and a half times the risk of death as whites.
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`Id. ¶ 51. These same communities are also more likely to be working in essential jobs that require
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`interaction with the public and to live in crowded or multigenerational housing in which the risk
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`of viral spread, and the risk to more vulnerable elderly relatives, is increased. Id. ¶¶ 51-54.
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`Securing transportation to a medical office is more difficult for abortion patients from these
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`communities. According to Monica Simpson, the Executive Director of SisterSong, a national,
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`multi-ethnic membership organization dedicated to improving policies and systems relating to the
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`reproductive lives of marginalized communities, because “people of color are less likely to own a
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`car than white people,” they “rely more heavily on public transportation, borrowing a car, getting
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`a ride from a friend, or paying for a car service, all of which expose them to risks of infection.”
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`Simpson Decl. ¶ 9, Mot. PI Ex. 8, ECF No. 11-10 (citing Car Access United States, Nat’l Equality
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`Atlas, https://nationalequityatlas.org/indicators/Car_access (last visited May 22, 2020)).
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`According to Dr. Reingold, both public transportation and sharing an enclosed car with others
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`increases the risk of exposure to COVID-19. Reingold Decl. ¶ 36. As noted by Dr. Espey, for
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`abortion patients in rural states such as New Mexico face trips that can last several hours each way
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`and thus must accept additional risks associated with stops at gas stations and restrooms. Espey
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`Decl. ¶¶ 10-11, Mot. PI Ex. 6, ECF No. 11-8.
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`Case 8:20-cv-01320-TDC Document 90 Filed 07/13/20 Page 15 of 80
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`Moreover, where 60 percent of abortion patients already have children, they face the
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`additional barrier of arranging for childcare during medical visits. According to Dr. Bryant and
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`Dr. Chen, this challenge is more acute during the pandemic because many schools and daycare
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`centers have closed, medical offices may not permit patients to bring children to the office, regular
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`childcare networks have been disrupted, and having elderly relatives care for children presents
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`significant health risks. Bryant Decl. ¶ 95; Chen Decl. ¶¶ 10, 18, Mot. PI Ex. 4, ECF No. 11-6.
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`The transportation and childcare difficulties are magnified by the economic downturn resulting
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`from the pandemic which disproportionately impacts the same communities. According to an
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`April 2020 study, 61 percent of Hispanic Americans and 44 percent of African Americans reported
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`that they or someone in their household had experienced a job or wage loss due to the coronavirus
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`outbreak, as compared with 38 percent of white adults. Simpson Decl. ¶ 7. Thus, during the
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`economic crisis resulting from the pandemic, “even paying for transportation to the clinic presents
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`a hardship” for many patients. MacNaughton Decl.¶ 13.
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` At the same time, the demand for abortion services is likely increasing. According to Dr.
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`Bryant, these same challenges of closed physician offices and transportation and childcare
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`difficulties have made it more difficult for women to obtain prescriptions for oral, injection, or
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`intra-uterine contraception or to travel to pharmacies to obtain contraceptive devices. Bryant Decl.
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`¶ 20. She asserts that the economic downturn resulting from the pandemic has also caused some
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`to be unable to pay the cost of prescription contraceptives. Id. As to women who then become
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`pregnant, “many people are suddenly and unforeseeably unemployed, and struggling to manage
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`their existing obligations, including caring for their existing children . . . some people for whom a
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`pregnancy would otherwise have been welcome now feel unable to have a baby at this time.” Id.
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`Case 8:20-cv-01320-TDC Document 90 Filed 07/13/20 Page 16 of 80
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`The six physicians have attested that they have used telemedicine across their practice
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`during the pandemic in order to reduce the burden and risk to patient, themselves, their families
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`and their communities while at the same time meeting patients’ health needs. See id. ¶ 97; Paladine
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`Decl. ¶¶ 12-27; Chen Decl. ¶¶ 6, 8; Floyd Decl. ¶¶ 6, 11-12, 14, Mot. PI Ex. 5, ECF No. 11-7;
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`Espey Decl. ¶¶ 1, 3; MacNaughton