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Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 1 of 34
`
`UNITED STATES DISTRICT COURT
`DISTRICT OF MARYLAND
`
`AMERICAN COLLEGE OF
`OBSTETRICIANS AND
`GYNECOLOGISTS, on behalfofits members
`and members 'patients,
`COUNCIL OF UNIVERSITY CHAIRS OF
`OBSTETRICS AND GYNECOLOGY, on
`behalfof its members and members 'patients,
`NEW YORK STATE ACADEMY OF
`FAMILY PHYSICIANS, on behalfofits
`members and members' patients,
`SISTERSONG WOMEN OF COLOR
`REPRODUCTIVE JUSTICE COLLECTIVE,
`on behalfofits members and members'
`patients, and
`HONOR MACNAUGHTON, M.D.,
`
`Plaintiffs,
`
`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.
`
`Civil Action No. TDC-20-1320
`
`MEMORANDUM OPINION
`
`On July 13, 2020, this Court granted a Motion for a Preliminary Injunction filed by
`
`Plaintiffs and thus enjoined Defendants, including the United States Food and Drug Administration
`
`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 2 of 34
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`("FDA"), the United States Department of Health and Human Services ("HHS"), and Secretary of
`
`Health and Human Services Alex Azar ("the Secretary"), from enforcing during the COVID-19
`
`pandemic FDA requirements that mifepristone, an oral medication used as part of a regimen to
`
`induce an abortion, must be dispensed in person after the patient has signed a Patient Agreement
`
`Form. Prelim. Inj. at 2-3, ECF No. 92. Pending before the Court is Defendants' Renewed Motion
`
`to Stay the Preliminary Injunction and for an Indicative Ruling Dissolving the Preliminary
`
`Injimction, which is now fully briefed. Upon inquiry by the Court on October 15,2020, the parties
`
`stated that they do not request a hearing on the Motion, and, in the absence of identified factual
`
`disputes, the Court finds that no hearing is necessary. See D. Md. Local R. 105.6. For the reasons
`
`set forth below, the Motion will be DENIED.
`
`BACKGROUND
`
`The claims in this case, and the findings of fact and conclusions of law on which the Court
`
`based the issuance of the July 13, 2020 preliminary injunction ("the Preliminary Injimction") are
`
`fully described in the Court's memorandum opinion of that date, which is incorporated herein by
`
`reference. See Am. Coll. of Obstetricians & Gynecologists v. U.S. Food & Drug Admin, y
`
`^F.
`
`Supp. 3d
`
`, No. TDC-20-CV-1320, 2020 WL 3960625, at *1-7 (D. Md. July 13, 2020)
`
`("^COG"). Additional background information and facts specific to the Motion are provided
`
`below.
`
`I,
`
`Procedural History
`
`On July 13, 2020, the Court issued the Preliminary Injunction enjoining Defendants from
`
`enforcing the FDA's in-person dispensing and signature requirements for mifepristone ("the In-
`
`Person Requirements") until 30 days after the end of the public health emergency ("PHE"), as
`
`declared by the Secretary pursuant to 42 U.S.C. § 247d(a), relating to the COVID-19 pandemic.
`
`On July 22, 2020, Defendants appealed the Preliminary Injunction to the United States Court of
`
`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 3 of 34
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`Appeals for the Fourth Circuit. On July 24, 2020, Defendants filed with this Court a Motion to
`
`Stay the Preliminary Injunction pending the appeal, which was denied on July 30, 2020.
`
`Defendants then filed a Motion to Stay with the Fourth Circuit, which denied it on August 13,
`
`2020.
`
`On August 26, 2020, Defendants filed with the United States Supreme Court an
`
`Application for a Stay of the Preliminary Injunction pending appeal. Mot. Stay Prelim. Inj., U.S.
`
`Food & Drug Admin, v. Am. Coll. of Obstetricians & Gynecologists, No. 20A34 (U.S. Aug. 26,
`
`2020). On October 8, 2020, the Supreme Court issued an order holding Defendants' application
`
`"in abeyance to permit the District Court to promptly consider a motion by the Government to
`
`dissolve, modify, or stay the injunction, including on the ground that relevant circumstances have
`
`changed." Order, U.S. Food & Drug Admin, v. Am. Coll. of Obstetricians & Gynecologists, No.
`
`20A34 (U.S. Oct. 8, 2020). The Supreme Court further stated that "[t]he District Court should
`
`rule within 40 days of receiving the Government's submission." Id. On October 30, 2020,
`
`Defendants filed their Renewed Motion to Stay the Preliminary Injunction and for an Indicative
`
`Ruling Dissolving the Preliminary Injunction ("the Motion"), arguing that changed circumstances
`
`render Plaintiffs unlikely to succeed on the merits of their underlying claim, such that a stay or
`
`dissolution of the Preliminary Injunction is now warranted.
`
`II.
`
`Additional Facts
`
`With the Motion, Defendants have supplemented the record with declarations from state
`
`government officials of seven different states describing changes to public health restrictions and
`
`guidance in their states during the CO VID-19 pandemic. Defendants also cite to publicly available
`
`media reports, scientific articles, and government websites and ask the Court to take judicial notice
`
`of additional facts "from sources whose accuracy cannot reasonably be questioned," including
`
`government websites. Renewed Mot. Stay ("Mot.") at 6, ECF No. 141-1 (quoting Fed. R. Evid.
`
`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 4 of 34
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`201(b)(2)). Accordingly, and pursuant to the approach agreed to by the parties at the hearing on
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`the original Motion for a Preliminary Injunction, the Court will take judicial notice of updated
`
`facts and circumstances from federal and state government websites relating to the state of the
`
`COVID-19 pandemic up to the date of the issuance of this opinion. See Fed. R. Evid. 201(b)(2);
`
`United States v. Garcia, 855 F.3d 615, 621 (4th Cir. 2017) ("This court and numerous others
`
`routinely take judicial notice of information contained on state and federal government websites.").
`
`In opposing the Motion, Plaintiffs also cite various media, scientific, and government sources and
`
`have submitted the declarations of five expert witnesses consisting of two epidemiologists, a
`
`physician and public health expert, a reproductive health physician, and an economist. The parties
`
`generally do not contest the facts and opinions offered by the other side.
`
`A.
`
`The COVID-19 Pandemic
`
`According to the Centers for Disease Control and Prevention ("CDC"), a component of
`
`HHS, as of July 2020, the United States had had over three million cases of COVID-19 resulting
`
`in over 130,000 deaths, with the number of new cases per day surpassing 44,000 each day in July
`
`leading up to the Court's issuance of the Preliminary Injunction on July 13, 2020. See ACOG,
`
`2020 WL 3960625, at *4. As of December 5,2020, the United States has had approximately 14.5
`
`million total cases of COVID-19 and has sustained more than 280,000 deaths from the coronavirus.
`
`Trends in Number ofCOVID-19 Cases and Deaths in the US Reported to CDC, by State/Territory,
`
`U.S. Ctrs. for Disease Control & Prevention, https://covid.cdc.gov/covid-data-
`
`tracker/#trends_dailytrendscases (last visited Dec. 8,2020) [hereinafter "CDC, COVID-19 Data'']
`
`(United States "Cases" and "Deaths" by "Total"). On that date, the nation had 206,992 new cases
`
`and had surpassed 100,000 cases for 28 straight days, with cases surpassing 150,000 20 times
`
`during that time period. Id. (United States "Cases" by "Daily Trends"). In the seven days leading
`
`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 5 of 34
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`up to December 5, over 1.3 million new cases were reported, for a seven-day moving average of
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`188,504 new cases per day. Id.
`
`As of November 12, 2020, the daily number of new cases was increasing in 46 states.
`
`Reingold Decl. I 8, Opp'n Mot. Ex. 1, ECF No. 142-1. In 49 states and the District of Columbia,
`
`the seven-day moving average number of new COVID-19 cases is higher now than when the
`
`Preliminary Injunction was issued in July 2020. See CDC, C0VID~}9 Data ("Cases" by "Daily
`
`Trends" for each state).
`
`The current data thus shows that infection rates are increasing dramatically as compared to
`
`July 2020. According to Dr. Arthur Reingold, Division Head of Epidemiology at the University
`
`of California at Berkeley School of Public Health, because the rates of hospitalizations and positive
`
`tests are also increasing, the higher cases numbers reflect a true rise in the incidence of COVID-
`
`19 nationwide. Reingold Decl.
`
`9-10. Dr. Reingold has concluded that the severity of the
`
`pandemic will likely intensify in the coming months, both because the risk of infection will only
`
`increase as Americans travel for the holidays and gather indoors during the winter, and because of
`
`recent studies that have shown that the coronavirus can become aerosolized and therefore spread
`
`more easily. Id.
`
`15, 28. Consistent with this opinion, on November 2,2020, Dr. Deborah Birx,
`
`Coordinator of the White House Coronavirus Task Force, issued a report stating that the nation is
`
`"entering the most concerning and most deadly phase of this pandemic." Id. 18.
`
`According to Dr. Mary Travis Bassett, Director of the Fran9ois-Xavier Bagnoud Center for
`
`Health and Human Rights at Harvard University, this ongoing resurgence of COVID-19 presents
`
`a particularly significant risk to abortion patients because more than half of all abortion patients
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`identify as Black or Hispanic, and at least 75 percent are low-income, while the death rate from
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`COVID-19 is approximately three times higher among Black and Hispanic individuals as
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`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 6 of 34
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`compared to non-Hispanic white individuals, and younger Blacks and Hispanics ages 25 to 44 are
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`700 percent to 900 percent more likely to die from the coronavirus than whites of the same age.
`
`Bassett Decl.
`
`15-16, 19, 21, Opp'n Mot. Ex. 2, ECF No. 142-2. According to a recent study,
`
`pregnant women of these demographic groups represent a disproportionately higher percentage of
`
`pregnant women who die from COVID-19. Id. II22.
`
`Even with the current progress on vaccines and medical treatments, even a vaccine
`
`approved imminently will likely not be widely administered until spring 2021, and even then, 40
`
`to 50 percent of the population may decline to get vaccinated. Reingold Decl.
`
`19-21,23. As
`
`Dr. Reingold has noted, recently considered or approved medical treatments such as remdesivir
`
`are not yet widely available, do not cure COVID-19 or make transmission of the virus harder, and
`
`instead are primarily used to treat high-risk or already severely ill patients. Id.
`
`35-36.
`
`B, HHS and FDA Actions
`
`At the time of the issuance of the Preliminary Injunction, the Secretary had previously
`
`declared the nationwide PRE relating to the COVID-19 pandemic, and HHS and FDA had taken
`
`actions to temporarily allow the prescription of certain opioids without an in-person evaluation,
`
`and to temporarily decline to enforce requirements for administering certain drugs at a medical
`
`facility and for conducting in-person laboratory testing and imaging studies before prescribing
`
`certain other drugs. ACOG, 2020 WL 3960625, at *19. On October 2, 2020, based on the
`
`"continued consequences" of the COVID-19 pandemic, the Secretary renewed the PRE, for a third
`
`time, on a nationwide basis. Renewal of Determination that a Public Health Emergency Exists,
`
`Health & Human Servs. (Oct. 2, 2020), https://www.phe.gov/emergency/news/
`
`healthactions/phe/Pages/covidl9-20ct2020.aspx [hereinafter "HHS, Third PHE Declaration'"^
`
`All of the HHS and FDA actions relating to in-person evaluations and procedures remain in effect.
`
`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 7 of 34
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`on a nationwide basis. Sarpatwari Decl. % 12, Opp'n Mot. Ex. 4, ECF No. 142-4. Another such
`
`action, FDA guidance issued in March 2020 to allow drug sponsors to temporarily forgo certain
`
`in-person actions during clinical trials, was renewed in September 2020 without changes to the
`
`relevant provisions. Id. 22. According to Dr. Ameet Sarpatwari, an epidemiologist and an
`
`Assistant Professor at both Harvard Medical School and the Harvard T.H. Chan School of Public
`
`Health, because the ongoing and updated guidance from HHS and FDA to effectively suspend in-
`
`person requirements relates to matters with more significant health risks than those caused by the
`
`dispensing of mifepristone without fulfilling the In-Person Requirements, the fact that such
`
`guidance remains in effect is inconsistent with the position that COVID-19 health risks are now
`
`so minimal that the Preliminary Injunction should be lifted. Id. 9,24.
`
`C.
`
`State Experiences
`
`Defendants have presented declarations from state government officials of seven states:
`
`Alabama, Idaho, Indiana, Kentucky, Mississippi, Nebraska, and Oklahoma. In general, the
`
`declarations primarily describe the imposition in each state in March or April 2020 of closures or
`
`public health restrictions relating to some combination of businesses, restaurants and bars, public
`
`facilities, social gatherings, medical procedures, schools, and childcare facilities; the subsequent
`
`relaxation of some or all of those restrictions over time; and, in some instances, the imposition of
`
`mandates to wear face masks. In Alabama, for example, the state began to re-open in stages
`
`starting in April and continuing into May, and many schools opened in the fall. Harris Decl.
`
`13-17, 22, Mot. Ex. 1, ECF No. 141-4. Although many of the state's childcare facilities closed in
`
`March 2020 for economic reasons, through a grant program, Alabama facilitated the opening of
`
`76 percent of childcare centers by early September 2020. Buckner Decl. 3-4, 7, Mot. Ex. 8,
`
`ECFNo. 141-11. After a mask requirement was imposed in July 2020, the 14-day moving average
`
`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 8 of 34
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`of new COVID-19 cases dropped Ifom 1,753 per day to 704 by October 20, 2020, and the number
`
`of COVID-19 hospitalizations dropped from 1,335 to 859 by October 19, 2020. Harris Decl.
`
`18, 20-21.
`
`In Mississippi, after the adoption of a shelter-in-place order on April 1, 2020 and a ban on
`
`non-essential elective surgeries for the month of April, restrictions were gradually eased beginning
`
`in mid-April, public schools opened in the fall, and by September 30,2020, the remaining COVID-
`
`related restrictions had been eased or lifted, though there remain limitations on the operational
`
`capacity of certain businesses. Dobbs Decl. ^[116-13, Mot. Ex. 5, EOF No. 141-8. At that time, a
`
`mandatory mask mandate was eased to require masks only imder limited circumstances. Id. 112.
`
`Oklahoma lifted initial restrictions on businesses and elective medical procedures beginning in
`
`late April 2020, and by June 1 it had entered the last phase of reopening without restriction. Budd
`
`Decl. 7-9, Mot. Ex. 6, EOF No. 141-9. Schools, which closed in March, "largely re-opened" in
`
`the fall with in-person learning in most but not all districts. Id. 111. Childcare centers were never
`
`ordered closed and have received emergency ftmding. Id. 114.
`
`Kentucky lifted closures of businesses, childcare centers, and other facilities in May and
`
`early June 2020, subject to continuing capacity and social distancing guidance. Fawns Decl.
`
`13-22, Mot. Ex. 2, ECF No. 141-5. The state imposed a mask mandate in July 2020 and was able
`
`to reopen most schools in the fall. Id. UK 25-26. In Indiana, initial restrictions were lifted through
`
`a phased reopening beginning on May 4,2020, and as of September 26,2020, capacity restrictions
`
`were removed for social gatherings, restaurants and bars, and other venues. Foster Decl. IK 9-14,
`
`Mot. Ex. 4, ECF No. 141-7. Indiana continues to require individuals to wear masks. Id. f 14.
`
`In Nebraska, by July 6,2020, earlier restrictions on restaurants and bars, public gatherings,
`
`and childcare centers had been eased, and restrictions on elective medical procedures had been
`
`8
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`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 9 of 34
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`eliminated. Anthone Decl.
`
`5-12, Mot. Ex. 3, ECF No. 141-6. By September 21, 2020, the
`
`remaining restrictions were largely ended. Id. HI 7-12. The state permitted schools to reopen for
`
`in-person classes in the fall, and many school districts, but not all, have done so. Id. || 10, 12.
`
`As for Idaho, on June 13, 2020, the state entered the fourth stage of reopening, which generally
`
`allowed businesses to operate and gatherings to occur, subject to social distancing and sanitation
`
`requirements. Kane Decl. | 7, Mot. Ex. 7, ECF No. 141-10 (citing Stage 4 Stay Healthy
`
`Guidelines, Idaho
`
`Rebounds: Our Path
`
`to
`
`Prosperity (June
`
`13, 2020),
`
`https://rebound.idaho.gov/stage-4-stay-healthy-guidelines/).
`
`As of October 22, 2020,
`
`approximately 75 percent of schools were fully open with in-person learning, with most of the rest
`
`having some in-person and some online learning. Id. ^11.
`
`Both Indiana and Nebraska report that although their state laws require in-person
`
`examinations before any abortion, including a medication abortion, the number of abortions in
`
`these states in 2020 have exceeded the number that occurred in 2019. Foster Decl. || 17-18;
`
`Anthone Decl. 114.
`
`Notably, as of December 5, 2020, the most recent date for which the CDC has reported
`
`seven-day moving averages for all of these states,' all seven states have now experienced
`
`significant growth in average daily new cases as compared to when the Preliminary Injunction was
`
`issued on July 13, 2020, and all but one have seen such growth in the average daily deaths from
`
`COVID-19, with particularly significant increases in most of those numbers since the filing of the
`
`' Although gaps in reported daily data have prevented the CDC from providing seven-day moving
`averages for Oklahoma for later dates, Oklahoma's COVID-19 case dashboard reports a seven-
`day moving average for December 6,2020 of2,270 daily new cases. See COVID-19 Cases - Main
`Page, Oklahoma State Dep't of Health, https://oklahoma.gov/covidl9.html (last visited Dec. 8,
`2020) (Oklahoma "Case Status by Date of Onset" displayed by "Trend Line").
`
`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 10 of 34
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`Motion on October 30,2020 and the completion of the briefing on November 20,2020, as set forth
`
`below:
`
`n
`
` Seveii'ajayMovmS Average o'New Daily GC>VID-19 Gases
`
`7/13/20
`
`10/30/20
`
`11/20/20
`
`12/5/20
`
`% Change
`(7/13 to 12/5)
`
`United States
`
`Alabama
`Idaho
`Indiana
`Kentucky
`Mississippi
`Nebraska
`
`Oklahoma
`
`60,491
`1,525
`478
`
`529
`
`357
`
`897
`193
`
`619
`
`79,603
`1,368
`876
`2,597
`1,642
`724
`1,019
`907
`
`164,850
`2,108
`1,423
`6,535
`2,766
`1,294
`2,391
`2,436
`
`188,504
`3,228
`1,435
`6,573
`3,411
`1,878
`1,892
`2,837
`
`212%
`
`112%
`
`200%
`1,143%
`855%
`
`109%
`
`880%
`
`358%
`
`See CDC, COVID-19 Data ("Cases" by "Daily Trends" for each listed state) [hereinafter "Average
`Cases Table"]; see also Reingold Decl. ^ 41.
`
`Seven^Day Moy ng Average of New Daily GOVlD-19 Deat IS
`
`7/13/20
`
`10/30/20
`
`11/20/20
`
`12/6/20
`
`United States
`
`Alabama
`
`Idaho
`
`Indiana
`Kentucky
`Mississippi
`Nebraska
`
`Oklahoma
`
`726
`
`16
`
`1
`
`9
`
`5
`
`22
`
`1
`
`3
`
`816
`
`1,434
`
`2,138
`
`10
`
`9
`
`27
`
`11
`
`11
`
`7
`
`10
`
`31
`
`13
`
`49
`
`16
`
`16
`
`17
`
`11
`
`43
`
`17
`
`77
`
`25
`
`22
`
`29
`
`14
`
`% Change
`(7/13 to 12/6)
`
`194%
`
`169%
`1,600%
`756%
`
`400%
`
`0%
`2,800%
`367%
`
`See CDC, COVID'19 Data ("Deaths" by "Daily Trends" for each listed state) [hereinafter
`"Average Deaths Table"].
`
`According to Dr. Bassett, the significant increase in COVID-19 cases across the nation is partially
`
`driven by the reopening practices of these and other states. Bassett Decl. ^ 16.
`
`As a result of the resurgence of COVID-19, since late October and into November 2020,
`
`all of these states have started to reinstitute more stringent public health restrictions. For example,
`
`in Nebraska, as of October 21, 2020, more stringent limitations were issued for restaurants and
`
`10
`
`

`

`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 11 of 34
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`social gatherings, and elective surgeries were restricted at medical facilities that cannot maintain
`
`a certain level of resources for COVID-19 care. Anthone Decl. ^ 5-9. In Kentucky, on November
`
`18, 2020, restrictions were reimposed on restaurants, bars, offices, indoor recreation facilities,
`
`theaters and event spaces, social gatherings, and schools, including suspending in-person school
`
`instruction for all public and private schools, with the closure for middle and high schools
`
`extending until January 2021. Gov. Beshear Implements New Restrictions to Save Lives, Office
`
`of
`
`the
`
`Governor
`
`(Nov.
`
`18,
`
`2020),
`
`https://kentucky.gov/Pages/Activity-
`
`stream.aspx?n=GovemorBeshear&prld=475 [hereinafter "Office of the Governor, Kentucky Nov.
`
`18 Restrictions''^]. In Alabama, beginning on November 8, 2020, the state imposed stricter social
`
`distancing requirements on retailers, close-contact service providers, athletic facilities,
`
`entertainment venues, and restaurants. Order of the State Health Officer Suspending Certain
`
`Public Gatherings Due to Risk ofInfection by COVID-19, Alabama State Health Officer 5-7, 11
`
`(amended Nov. 5, 2020) https://www.alabamapublichealth.gov/legal/assets/order-adph-cov-
`
`gatherings-110520.pdf.
`
`D.
`
`The Economic Impact
`
`Although unemployment rates have declined since peaking in April 2020, according to
`
`Trevon Logan, Professor of Economics and Interim Dean of Social and Behavioral Sciences at the
`
`Ohio State University, the current state of the economy remains "quite poor." Logan Decl. m 9,
`
`12, Opp'n Mot. Ex. 5, ECF No. 142-5. Unemployment rates remain double what they were in
`
`February 2020, and even as of October 31, 2020, the number of individuals filing new
`
`unemployment claims remained higher than at any point in history before the COVlD-19
`
`pandemic. Id.
`
`12-13. In October 2020, the numbers of long-term unemployed individuals and
`
`discouraged workers who have given up looking for employment both grew by over 1.2 million
`
`11
`
`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 12 of 34
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`and 1.7 million, respectively. Id.
`
`14, 16. Recent U.S. Census Bureau surveys establish that as
`
`of October 2020, approximately 25 percent of adults in the United States expect a loss of income
`
`in their household in the next month, more than 30 percent have difficulty paying ordinary
`
`household expenses, and almost 10 percent do not have enough to eat. Id. 1[1|19,21. Atthesame
`
`time, the economic and relief programs from the CARES Act have expired and have not been
`
`renewed. Id.
`
`18, 22. These economic difficulties disproportionately affect low-income women
`
`of color who comprise the majority of abortion patients, as the unemployment rate among Blacks
`
`remains over 10 percent, and 80 percent of all exits from the labor force in September 2020 were
`
`by women. Id.
`
`26-27. According to Professor Logan, the economic challenges faced by low-
`
`income communities, communities of color, and women with children will persist for the
`
`foreseeable future. Id. 129.
`
`£.
`
`The Patient Experience
`
`Beyond the ongoing and anticipated impact of COVID-19, Plaintiffs have provided a
`
`declaration from Plaintiff Dr. Honor MacNaughton, a board-certified physician practicing in
`
`primary care clinics in Massachusetts and an Associate Professor at Tuffs University School of
`
`Medicine, who describes ongoing barriers to patients' ability to meet the In-Person Requirements.
`
`Dr. MacNaughton's clinics continue to operate at only 20 percent capacity, with the reproductive
`
`health clinics open only for half days, twice a week, and bringing children to the clinics is strongly
`
`discouraged. MacNaughton Decl. 6, 11, Opp'n Mot. Ex. 3, ECF No. 142-3. With COVID-19
`
`cases on the rise. Dr. MacNaughton's patients continue to struggle with childcare challenges or
`
`other logistical difficulties of getting to a doctor's office. Id. tH 7, 9,11. For example, one patient
`
`had several high-risk factors for COVID-19, had quit her job to avoid viral exposure, and had
`
`difficulty making an appointment due to the clinic's reduced hours. Id. 15. Another patient shares
`
`12
`
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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 13 of 34
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`a home with two elderly relatives and a young child, does not have a car, and thus would have to
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`take public transportation or a ride share to go to the clinic. Id. | 9. Another has three children
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`attending school remotely and lacks childcare. Id. ^ 8. Dr. MacNaughton further reported that
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`because of the Preliminary Injunction, these patients were evaluated through telemedicine,
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`received mifepristone through delivery, and took the dose, without logistical or medical
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`complications. Id. 10.
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`DISCUSSION
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`In the Motion, Defendants argue that the Preliminary Injunction should be stayed or
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`dissolved because of "changed circumstances" since the issuance of the Preliminary Injunction on
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`July 13, 2020. Mot. at 1. Defendants also argue that, at a minimum, the Preliminary Injunction
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`should be stayed in part or modified because the scope of the injunction is too broad in light of
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`variations in the conditions in different states and across time.
`
`I.
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`Legal Standards
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`Under Federal Rule of Civil Procedure 62(d), while an interlocutory order granting a
`
`preliminary injunction is on appeal, a court may "suspend" the injunction. Fed. R. Civ. P. 62(d).
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`In considering a motion to stay under this provision, the Court must consider (1) whether the stay
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`applicant has made a "strong showing" of a likelihood of success on the merits; (2) "whether the
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`applicant will be irreparably injured absent a stay"; (3) "whether issuance of the stay will
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`substantially injure the other parties interested in the proceeding"; and (4) "where the public
`
`interest lies." Hiltonv. Braunskill,^%\ U.S. 11^,116
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`see Long v. Robinson, A'MV2d911,
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`979 (4th Cir. 1970).
`
`Ordinarily, dissolution or modification of an existing preliminary injunction is "proper only
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`when there has been a change of circumstances between the entry of the injunction and the filing
`
`13
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`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 14 of 34
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`of the motion that would render the continuance of the injunction in its original form inequitable."
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`Favia v. Ind. Univ. ofPenn., 1 F.3d 332, 337 (3d Cir. 1993); see Gooch v. Life Investors Ins. Co.
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`ofAm.y 672 F.3d 402, 414 (6th Cir. 2012); see also Multi-Channel TV Cable Co. v. Charlottesville
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`Quality Cable Operating Co., 60 F.3d 823,1995 WL 406612, at *3 (4th Cir. 1995) (unpublished
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`table decision). To obtain such a dissolution or modification, the moving party must demonstrate
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`"significant changes in fact, law, or circumstance since the previous ruling." Gooch, 672 F.3d at
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`402 (quoting Gill v. Monroe Cty. Dep't ofSoc. Servs., 873 F.2d 647, 648-49 (2d Cir. 1989)); see
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`Favia, 1 F.3d at 344 (referring to the moving party's "burden of demonstrating a 'significant'
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`change in facts"); Stone v. Trump, 400 F. Supp. 3d 317, 332 (D. Md. 2019) (holding that a party
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`moving to dissolve or modify a preliminaiy injunction must establish "a significant change either
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`in factual conditions or in law" that makes "enforcement of the [preliminary injunction] . . .
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`detrimental to the public interest"). "Minor changes in the facts or law usually are insufficient."
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`Multi-Channel TV Cable, 1995 WL 406612, at *3.
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`While a preliminary injunction is on appeal, a district court ordinarily may not dissolve or
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`modify it. See, e.g., Doe v. Pub. Citizen, 749 F.3d 246, 258 (4th Cir. 2014). Upon a motion
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`seeking such action, however, a court may issue an indicative ruling stating "either that it would
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`grant the motion if the court of appeals remands for that purpose or that the motion raises a
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`substantial issue." Fed. R. Civ. P. 62.1(a). The moving party would then convey that ruling to the
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`United States Court of Appeals to determine whether remand for such a decision is warranted. See
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`Fed. R. Civ. P. 62.1(b), (c); Fed. R. App. P. 12.1.
`
`14
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`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 15 of 34
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`n. stay or Dissolution
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`A.
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`Changed Circumstances
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`As to whether they can presently make a strong showing of a likelihood of success on the
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`merits, Defendants argue only that changed circumstances establish that the In-Person
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`Requirements no longer present an undue burden to women seeking a medication abortion during
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`the COVID-19 pandemic. Specifically, Defendants argue that the Court's prior findings regarding
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`the burdens facing abortion patients during the COVID-19 pandemic, such as the increased health
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`risks associated with travel to medical facilities, the closure of or limited access to medical
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`facilities, greater childcare and transportation challenges, and the economic impact of the
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`pandemic on economically disadvantaged women and people of color have "either been mitigated
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`or resolved." Mot. at 5. Based on the evidence presented, the Court finds no such changed
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`circumstances because (1) the COVID-19 pandemic continues to pose a significant health risk
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`necessitating the Preliminary Injunction; and (2) as a result of that ongoing risk, the specific
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`barriers underlying the undue burden determination have not been sufficiently "mitigated or
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`resolved" to alter the likelihood of success on the merits and to warrant a stay or dissolution. Id.
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`1.
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`Health Risk
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`In finding that the In-Person Requirements currently pose an undue burden on women
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`seeking a medication abortion, the Court focused primarily on the determination that "the COVID-
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`19 pandemic has created a significant burden upon patients and the public that renders travel to
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`medical facilities fraught with health risk to themselves, medical professionals, others they
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`encounter during such trips, and the members of their households to whom they return." ACOG,
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`2020 WL 3960625, at *20. The evidence establishes that since the Court granted the Preliminary
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`Injunction on July 13,2020, this health risk has only gotten worse. Since that date, the number of
`
`15
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`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 16 of 34
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`COVID-19 cases in the United States has increased four-fold, from over three million to more than
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`14.5 million, and the number of deaths from COVID-19 have more than doubled, from 130,000 to
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`more than 280,000. Id. at *19; CDC, COVID-19 Data. As of July 13,2020, the seven-day moving
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`average of new cases per day nationwide was approximately 44,000; as of December 5, 2020, it
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`was 188,504. See AGOG, 2020 WL 3960625, at *19; CDC, COVID-19 Data. According to Dr.
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`Reingold, because the percentage of positive tests is also increasing, the dramatic rise in the
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`number of COVID-19 cases relative to earlier time periods reveals a true rise in case numbers.
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`Reingold Decl. K 9. This increase is not limited to any one part of the nation. In 49 states and the
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`District of Columbia, the seven-day moving average of daily new cases is higher now than in July
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`2020. CDC, COVID-19 Data.
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`The severity of the pandemic is expected to intensify in the coming months. As noted by
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`Dr. Reingold and Dr. Bassett, with the colder weather keeping more people indoors in less
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`ventilated spaces, and with the likelihood of more travel and indoor social gatherings during the
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`holiday season, the rate of viral spread will likely increase, particularly in light of recent research
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`supporting the conclusion that COVID-19 may be spread not only through droplet transmission,
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`but also through airborne transmission of viral particles that can remain suspended in or travel in
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`the air. Reingold Decl.
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`14-15 (citing Coronavirus Disease 2019 (COVID-19), Scientific Brief:
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`SARS-CoV-2 and Potential Airborne Transmission, U.S. Ctrs. for Disease Control & Prevention,
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`(Oct. 5, 2020), https://www.cdc.gOv/coronavirus/2019-ncov/more/scientific-brief-sars-cov-
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`2.html); Bassett Decl. ^15. Notably, although the CDC, the National Institutes of Health ("NIH"),
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`and the FDA are all components of HHS, Defendants have offered no expert opinions, from a
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`scientist at one of these agencies or elsewhere in the federal government, to contradict the facts
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`and conclusions provided by Dr. Reingold and Dr. Bassett. Rather, the current alarming trends
`
`16
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`

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`Case 8:20-cv-01320-TDC Document 144 Filed 12/09/20 Page 17 of 34
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`have led Dr. Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases
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`at NIH, to state on October 30, 2020 that the United States is "in for a whole lot of hurt. It's not a
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`good situation. ... All the stars are aligned in the wrong place as you go into the fa

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