Amicus Curiae Brief — Glenhaven Healthcare LLC, et al., Petitioners v. Jackie Saldana, et al.
Supreme Court briefSep 30, 2022
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NO. 22-192
In the
Supreme Court of the United States
________________
GLENHAVEN HEALTHCARE LLC,
a California corporation, et al.,
Petitioners,
v.
JACKIE SALDANA, et al.,
Respondents.
________________
On Petition for Writ of Certiorari to the United
States Court of Appeals for the Ninth Circuit
________________
BRIEF OF THE CHAMBER OF COMMERCE
OF THE UNITED STATES OF AMERICA,
THE AMERICAN HOSPITAL ASSOCIATION,
THE AMERICAN HEALTH CARE
ASSOCIATION, AND THE AMERICAN TORT
REFORM ASSOCIATION AS AMICI CURIAE
IN SUPPORT OF THE PETITION
________________
Jennifer B. Dickey
U.S. CHAMBER
LITIGATION CENTER
1615 H Street NW
Washington, DC 20062
Counsel for the
Chamber of Commerce
of the United States
of America
Jeffrey S. Bucholtz
Counsel of Record
Alexander Kazam
KING & SPALDING LLP
1700 Pennsylvania Ave. NW
Washington, DC 20006
(202) 737-0500
jbucholtz@kslaw.com
Counsel for the Chamber of
Commerce of the United States
of America and American
Hospital Association
(Additional counsel listed on inside cover)
September 30, 2022
Chad Golder
AMERICAN HOSPITAL
ASSOCIATION
800 10th Street NW
Two CityCenter
Suite 400
Washington, DC 20001
Counsel for American
Hospital Association
Geoffrey M. Drake
KING & SPALDING LLP
1180 Peachtree Street NE
Atlanta, GA 30309
Counsel for the Chamber of
Commerce of the United States
of America and American
Hospital Association
Mark E. Reagan
HOOPER, LUNDY &
BOOKMAN, PC
101 Montgomery Street
11th Floor
San Francisco, CA 94104
H. Sherman Joyce
Lauren Sheets Jarrell
AMERICAN TORT
REFORM ASSOCIATION
1101 Connecticut Ave. NW
Suite 400
Washington, DC 20036
Counsel for American
Health Care Association
Counsel of American
Tort Reform Association
TABLE OF CONTENTS
TABLE OF AUTHORITIES ....................................... ii
INTEREST OF AMICI CURIAE................................ 1
INTRODUCTION AND SUMMARY OF
ARGUMENT ............................................................ 3
ARGUMENT ............................................................... 7
I.
The Question Presented Is of Exceptional
Importance ........................................................... 7
A. COVID-19 Has Posed Unprecedented
Challenges for American Businesses,
Especially Healthcare Providers ................. 7
B. The Decision Below Undermines the
PREP Act’s Critical Safeguards for
Front-Line Responders............................... 11
II. The Decision Below Creates a Circuit Split
and Conflicts With This Court’s Precedent ...... 17
CONCLUSION ......................................................... 22
ii
TABLE OF AUTHORITIES
Cases
Aetna Health Inc. v. Davila,
542 U.S. 200 (2004) ............................................ 6, 19
Anderson v. H&R Block, Inc.,
132 F. Supp. 2d 948 (M.D. Ala. 2000) ................... 21
Avco Corp.
v. Aero Lodge No. 1735, Int’l Ass’n
of Machinists & Aerospace Workers,
390 U.S. 557 (1968) ............................................ 5, 20
Beneficial Nat’l Bank v. Anderson,
539 U.S. 1 (2003) .......................................... 5, 17, 18
Caterpillar Inc. v. Williams,
482 U.S. 386 (1987) .......................................... 18, 20
Fayard v. Ne. Vehicle Servs., LLC,
533 F.3d 42 (1st Cir. 2008) .................................... 18
Filarsky v. Delia,
566 U.S. 377 (2012) ................................................ 12
Harlow v. Fitzgerald,
457 U.S. 800 (1982) ................................................ 12
Maglioli v. All. HC Holdings LLC,
16 F.4th 393 (3d Cir. 2021)................................ 6, 17
Metro. Life Ins. Co. v. Taylor,
481 U.S. 58 (1987) .................................................... 5
Pilot Life Ins. Co. v. Dedeaux,
481 U.S. 41 (1987) .................................................. 19
iii
Retail Prop. Tr.
v. United Bhd. of
Carpenters & Joiners of Am.,
768 F.3d 938 (9th Cir. 2014).................................. 20
Richardson v. McKnight,
521 U.S. 399 (1997) ................................................ 12
Salazar v. Ramah Navajo Chapter,
567 U.S. 182 (2012) ................................................ 16
Scheuer v. Rhodes,
416 U.S. 232 (1974) ................................................ 12
United States v. Winstar Corp.,
518 U.S. 839 (1996) ................................................ 16
Statutes & Regulations
28 U.S.C. § 1367 ....................................................... 20
42 U.S.C. § 247d-6d .......................................... passim
42 U.S.C. § 247d-6e .................................... 3, 5, 13, 19
Fifth Amendment to
Declaration Under the PREP Act,
86 Fed. Reg. 7872 (Feb. 2, 2021) ........................... 15
Other Authorities
Advisory Op. No. 21-01
on the PREP Act (HHS OIG Jan. 8, 2021)............ 14
Am. Tort Reform Ass’n,
COVID-19 Legal Services
Television Advertising (2021)................................ 14
Arora, Neha et al.
India, Pfizer Seek to Bridge Dispute Over
Vaccine Indemnity, Reuters (May 21, 2021) ......... 13
iv
Binzer, Peggy
The PREP Act: Liability Protection for
Medical Countermeasure Development,
Distribution, and Administration,
6 Biosecurity & Bioterrorism 293 (2008) .............. 12
CDC,
Nursing Home Care (Sept. 6, 2022),
https://www.cdc.gov/nchs/fastats/nursinghome-care.htm ....................................................... 10
CDC,
Residential Care Communities
(Sept. 28, 2022),
https://www.cdc.gov/nchs/fastats/residential
-care-communities.htm .......................................... 10
CDC,
Weekly Updates by Select Demographic and
Geographic Characteristics (Sept. 21, 2022),
https://www.cdc.gov/nchs/nvss/vsrr/covid_w
eekly/index.htm#SexAndAg ................................ 4, 9
Chidambaram, Priya
Kaiser Family Found.,
Over 200,000 Residents and Staff in
Long-Term Care Facilities Have Died
From COVID-19 (Feb. 3, 2022) ............................... 9
Cohen, Patricia
Omicron Could Knock a Fragile
Economic Recovery Off Track,
N.Y. Times (Dec. 2, 2021) ........................................ 8
v
DOJ Statement of Interest,
Bolton v. Gallatin Ctr. for Rehab.
& Healing, LLC, No. 20-cv-00683
(M.D. Tenn. Jan. 19, 2021), ECF No. 35-1............ 15
Francis, Theo et al.
The Delta Variant Is Already
Leaving Its Mark on Business, Wall St. J.
(Aug. 15, 2021) ......................................................... 8
Gostin, Lawrence O. & James G. Hodge, Jr.,
O’Neill Inst. for Nat’l & Global Health Law
Monkeypox: National Emergency
Declaration & Powers (Aug. 7, 2022) .................... 16
Hunton Andrews Kurth,
COVID-19 Complaint Tracker (2022),
https://www.huntonak.com/en/covid-19tracker.html ........................................................... 14
Jacobs, Andrew
Health Care Workers Still Face Daunting
Shortages of Masks and Other P.P.E.,
N.Y. Times (Dec. 20, 2020) ...................................... 8
Karikari-Martin, Pauline
Centers for Medicare & Medicaid
Services Staffing Study to Inform Minimum
Staffing Requirements for Nursing Homes,
CMS.gov (Aug. 22, 2022) ......................................... 4
Mackintosh, Eliza
The ‘Worst Variant’ Is Here,
CNN (July 14, 2022) ................................................ 8
Mandavilli, Apoorva
The Coronavirus Can Be Airborne Indoors,
W.H.O. Says, N.Y. Times (July 9, 2020) ................. 7
vi
Nat’l Ctr. for Health Statistics,
Long-Term Care Providers and
Services Users in the United States,
2015–2016 (2019) ................................................... 11
O’Connor, Amy
COVID 19 Hits Already-Troubled
Nursing Home Insurance Market,
Ins. J. (May 10, 2020) ............................................ 14
OECD,
Enhancing Public Trust in COVID-19
Vaccination: The Role of Governments
(May 10, 2021) ....................................................... 13
Pearson, Caroline et al.
NORC: Univ. of Chi., The Impact of
COVID-19 on Seniors Housing (2021) .................... 9
Press Release,
Am. Health Care Ass’n/Nat’l Ctr. for
Assisted Living, AHCA Releases Report
Highlighting Unprecedented Economic
Crisis in Nursing Homes (Mar. 2, 2022) ............... 10
Press Release,
Am. Health Care Ass’n/Nat’l Ctr. for
Assisted Living, COVID-19 Exacerbates
Financial Challenges of Long-Term Care
Facilities (Feb. 17, 2021) ....................................... 10
Press Release,
Am. Health Care Ass’n/Nat’l Ctr. for
Assisted Living, Survey: Nursing Homes
Still Facing Staffing & Economic Crisis
(June 6, 2022)........................................................... 4
vii
Press Release,
HHS, Biden-Harris Administration
Bolsters Monkeypox Response;
HHS Secretary Becerra Declares Public
Health Emergency (Aug. 4, 2022) .......................... 15
Simon, Ruth
COVID-19 Shuttered More
Than 1 Million Small Businesses,
N.Y. Times (Aug. 1, 2020)........................................ 8
Szabo, Liz
Many U.S. Health Experts Underestimated
the Coronavirus . . . Until It Was Too Late,
Kaiser Health News (Dec. 21, 2020) ....................... 7
Tufekci, Zaynep
Why Telling People They Don’t Need Masks
Backfired, N.Y. Times (Mar. 17, 2020) ................... 7
Whoriskey, Peter et al.
Hundreds of Nursing Homes Ran Short
on Staff, Protective Gear as More Than
30,000 Residents Died During Pandemic,
Wash. Post (June 4, 2020) ....................................... 9
INTEREST OF AMICI CURIAE 1
The Chamber of Commerce of the United States
of America is the world’s largest business federation.
It represents approximately 300,000 direct members
and indirectly represents the interests of more than
three
million
companies
and
professional
organizations of every size, in every industry sector,
and from every region of the country. An important
function of the Chamber is to represent the interests
of its members in matters before Congress, the
Executive Branch, and the courts. To that end, the
Chamber regularly files amicus curiae briefs in cases,
like this one, that raise issues of concern to the
nation’s business community.
The American Hospital Association (“AHA”) is a
national organization that represents nearly 5,000
hospitals, healthcare systems, networks, and other
providers of care. AHA members are committed to
improving the health of the communities that they
serve and to helping ensure that care is available to
and affordable for all Americans. The AHA provides
extensive education for healthcare leaders and is a
source of valuable information and data on healthcare
issues and trends.
It ensures that members’
perspectives and needs are heard and addressed in
national health-policy development, legislative and
1 The parties received timely notice of this brief under Rule
37.2(a). Petitioners and respondents have consented to the filing
of this brief. Pursuant to Rule 37.6, amici curiae state that no
counsel for any party authored this brief in whole or in part and
that no entity or person, aside from amici curiae, their members,
or their counsel, made any monetary contribution intended to
fund the preparation or submission of this brief.
2
regulatory debates, and judicial matters. One way in
which the AHA promotes the interests of its members
is by participating as amicus curiae in cases, like this
one, with important and far-ranging consequences for
its members.
The American Health Care Association and the
National Center for Assisted Living (“AHCA/NCAL”)
is the largest association in the United States
representing long term and post-acute care providers,
with more than 14,000 member facilities.
AHCA/NCAL’s diverse membership includes nonprofit and proprietary skilled nursing centers, assisted
living communities, sub-acute centers and homes for
individuals with intellectual and development
disabilities. By delivering solutions for quality care,
AHCA/NCAL aims to improve the lives of the millions
of frail elderly and individuals with disabilities who
receive long term or post-acute care in our member
facilities each day. AHCA/NCAL files amicus curiae
briefs in cases, like this one, that have important
implications for long term and post-acute care.
The American Tort Reform Association (“ATRA”)
is a broad-based coalition of businesses, corporations,
municipalities, associations, and professional firms
that have pooled their resources to promote reform of
the civil justice system with the goal of ensuring
fairness, balance, and predictability in civil litigation.
ATRA files amicus curiae briefs in cases, like this one,
involving important liability issues.
During the COVID-19 pandemic, America’s
businesses and healthcare providers have faced
extraordinary challenges. The just and efficient
resolution of tort litigation arising from the COVID-19
3
pandemic, and the adjudication of such disputes in a
proper forum, are of great concern to amici and their
members.
Accordingly, amici have a strong interest in the
proper interpretation of the Public Readiness and
Emergency Preparedness (“PREP”) Act, 42 U.S.C.
§§ 247d-6d, 247d-6e, which affords healthcare
providers, manufacturers, distributors, and other
entities involved in the response to the pandemic
important protections, including immunity from most
tort liability and access to a federal forum in cases
implicating the Act.
INTRODUCTION AND
SUMMARY OF ARGUMENT
This case presents an issue of exceptional
importance that has divided the courts of appeals: the
proper interpretation of a federal statute regulating
the nation’s emergency response during a once-in-acentury pandemic and other global health
emergencies.
In early 2020, a highly contagious and deadly new
virus began sweeping around the world and across the
country. Little at the time was known about COVID19, how it spread, how it harmed those infected, how
it could be contained, or how it could be prevented.
Healthcare providers were forced to adapt to rapidly
changing circumstances and information.
The impact of the COVID-19 pandemic on
American business has been felt far and wide. And
healthcare providers—including the senior care and
other long-term-care providers that serve America’s
most vulnerable populations—have faced especially
4
severe challenges. In an urgent struggle against an
invisible foe, they not only lacked consistent, welldefined guidance from public health officials, but were
often hamstrung by worldwide shortages of personal
protective equipment, testing kits, and other
pandemic countermeasures. Despite the heroic efforts
of America’s healthcare workers, more than a million
Americans have died—the vast majority of them over
age 65. 2 Meanwhile, hundreds of senior care facilities
have closed and the sector is in a financial and
CMS is also considering
workforce crisis. 3
establishing new minimum staffing requirements for
nursing homes, which would place further financial
pressure on them. 4
These serious challenges for healthcare providers
are compounded by the threat of thousands of lawsuits
alleging that the negligent or improper administration
of infection control policies caused residents to
contract COVID-19. A major issue in many of these
cases, which have been filed in state courts across the
2 CDC, Weekly Updates by Select Demographic and Geographic
Characteristics (Sept. 21, 2022), https://www.cdc.gov/nchs/nvss/
vsrr/covid_weekly/index.htm#SexAndAg.
3 Press Release, Am. Health Care Ass’n/Nat’l Ctr. for Assisted
Living, Survey: Nursing Homes Still Facing Staffing & Economic
Crisis (June 6, 2022), https://www.ahcancal.org/News-andCommunications/Press-Releases/Pages/Survey-Nursing-HomesStill-Facing-Staffing-&-Economic-Crisis.aspx.
4 Pauline Karikari-Martin, Centers for Medicare & Medicaid
Services Staffing Study to Inform Minimum Staffing
Requirements for Nursing Homes, CMS.gov (Aug. 22, 2022),
https://www.cms.gov/blog/centers-medicare-medicaid-servicesstaffing-study-inform-minimum-staffing-requirements-nursinghomes.
5
country, is the availability of federal removal
jurisdiction. While some cases arising from the
COVID-19
pandemic
may
be
appropriately
adjudicated in state court, in other cases, including
this one, defendants are entitled to a federal forum.
Over a decade ago, Congress recognized the
possibility of a nationwide public health emergency
like COVID-19, and expressly provided certain
protections for those on the front line of responding to
it, in the PREP Act, 42 U.S.C. §§ 247d-6d, 247d-6e.
Enacted two years after the outbreak of the SARS
epidemic, the PREP Act affords broad immunity from
tort liability to individuals and entities involved in the
administration, manufacture, distribution, use, or
allocation of pandemic countermeasures.
Crucially, rather than leave the adjudication of
disputes arising from a national emergency response
to disparate state courts across the country, Congress
established an exclusive federal remedial scheme and
expressly preempted state law that might interfere
with that scheme.
This structure, combining
preemption with exclusive federal remedies, is the
defining feature of a “complete preemption” statute,
which creates federal removal jurisdiction even when
claims are pleaded under state law.
See, e.g.,
Beneficial Nat’l Bank v. Anderson, 539 U.S. 1 (2003)
(National Bank Act); Metro. Life Ins. Co. v. Taylor, 481
U.S. 58 (1987) (ERISA); Avco Corp. v. Aero Lodge
No. 1735, Int’l Ass’n of Machinists & Aerospace
Workers, 390 U.S. 557 (1968) (Labor Management
Relations Act).
The decision below upends Congress’s carefully
calibrated scheme. Instead of recognizing the PREP
6
Act as a “complete preemption” statute and allowing
removal of a broad class of tort claims arising from the
administration of pandemic countermeasures—as the
text, structure, and purpose of the Act require—the
Ninth Circuit reasoned that the Act provides an
exclusive cause of action only for “willful misconduct,”
not negligence, and therefore “is not a complete
preemption statute.” App. 15a–17a. This holding
contradicts the Third Circuit’s conclusion that the
PREP Act is a complete preemption statute—at least
with respect to willful misconduct claims.
See
Maglioli v. All. HC Holdings LLC, 16 F.4th 393, 409
(3d Cir. 2021). And as to respondents’ negligence
claims, the Ninth Circuit’s requirement of a one-to-one
correspondence between the state-law claim and a
replacement federal cause of action is inconsistent
with this Court’s precedent, which makes clear that
the elements of a state claim need not “precisely
duplicate” the federal claim for complete preemption
to apply. Aetna Health Inc. v. Davila, 542 U.S. 200,
215–16 (2004). The Ninth Circuit’s holding in the
alternative—that even if respondents’ willful
misconduct claim is completely preempted, there is no
federal jurisdiction because their other claims are not
completely preempted, see App. 16a–17a—sets up a
bizarre all-or-nothing test that likewise finds no
support in this Court’s precedent.
The Chamber accordingly urges this Court to
grant the petition for certiorari. The acknowledged
split between the Ninth Circuit and the Third Circuit
supports the Court’s review, and the proper
interpretation and application of the PREP Act is too
important to await further percolation.
7
ARGUMENT
I.
The Question Presented Is of Exceptional
Importance
A. COVID-19 Has Posed Unprecedented
Challenges for American Businesses,
Especially Healthcare Providers
The COVID-19 pandemic has tested the resilience
of American business like nothing before. At the
outset of the pandemic, business owners confronted a
novel, fast-moving threat that no one, not even the
nation’s top public health experts, fully understood or
anticipated. 5
In responding to this emergency,
businesses and healthcare providers have had to
adapt to rapidly changing circumstances and evolving
guidance from public health officials on key issues
ranging from the utility of face masks, 6 to the mode of
viral transmission, 7 to unprecedented restrictions on
their operations. Even today, information about
COVID-19 continues to evolve.
As a result of the pandemic and the ensuing
lockdowns, more than a million American businesses
5 See Liz Szabo, Many U.S. Health Experts Underestimated the
Coronavirus . . . Until It Was Too Late, Kaiser Health News (Dec.
21, 2020), https://khn.org/news/article/many-us-health-expertsunderestimated-the-coronavirus-until-it-was-too-late/.
6 Zaynep Tufekci, Why Telling People They Don’t Need Masks
Backfired, N.Y. Times (Mar. 17, 2020), https://www.nytimes.com/
2020/03/17/opinion/coronavirus-face-masks.html.
Apoorva Mandavilli, The Coronavirus Can Be Airborne
Indoors, W.H.O. Says, N.Y. Times (July 9, 2020), https://
www.nytimes.com/2020/07/09/health/virus-aerosols-who.html?.
7
8
closed their doors—many of them permanently. 8 The
rise of successive new variants of the virus has dealt
repeated setbacks to the fragile economic recovery. 9
Amid the turmoil, healthcare and senior care
providers have been especially hard hit. A delayed
rollout of COVID-19 test kits, followed by months of
shortages, hampered detecting the virus where it
might do most harm, including at senior care and
other
long-term-care
facilities
that
serve
predominantly the elderly and infirm. Meanwhile, a
severe nationwide shortage of respirator masks and
other personal protective equipment, which persisted
well into the course of the pandemic, required difficult
decisions about how to allocate scarce resources and
hindered providers’ ability to protect front-line
workers and patients. 10
8 Ruth Simon, COVID-19 Shuttered More Than 1 Million Small
Businesses, N.Y. Times (Aug. 1, 2020), https://www.wsj.com/
articles/covid-19-shuttered-more-than-1-million-smallbusinesses-here-is-how-five-survived-11596254424?mod=
article_relatedinline.
9 Eliza Mackintosh, The ‘Worst Variant’ Is Here, CNN (July 14,
2022), https://www.cnn.com/2022/07/13/world/coronavirus-news
letter-intl-07-13-22/index.html; Patricia Cohen, Omicron Could
Knock a Fragile Economic Recovery Off Track, N.Y. Times (Dec.
2, 2021), https://www.nytimes.com/2021/12/02/business/economy
/omicron-economy.html; Theo Francis et al., The Delta Variant
Is Already Leaving Its Mark on Business, Wall St. J. (Aug. 15,
2021), https://www.wsj.com/articles/-delta-variant--businesseconomy-11629049694.
10 See Andrew Jacobs, Health Care Workers Still Face Daunting
Shortages of Masks and Other P.P.E., N.Y. Times (Dec. 20, 2020),
https://www.nytimes.com/2020/12/20/health/covid-ppe-shortages
.html; Peter Whoriskey et al., Hundreds of Nursing Homes Ran
9
Not surprisingly, all of those factors took a major
toll on long-term care and senior care facilities, with
their vulnerable populations and communal living
arrangements. In many ways, these facilities have
performed admirably under the most difficult of
circumstances; according to one study, about twothirds of assisted living facilities had no deaths from
COVID-19 in all of 2020. 11 But COVID-19 proved
especially dangerous for the elderly.
Of the
approximately one million Americans who have died
from COVID-19, about 75 percent were over the age of
65. 12 More than 200,000 of those deaths have been
residents or staff members of senior care facilities. 13
Despite the efforts of the nation’s healthcare workers,
who
delivered
care
under
extraordinary
circumstances to protect the vulnerable, the sheer
scale of the tragedy makes the potential for litigation
enormous.
Short on Staff, Protective Gear as More Than 30,000 Residents
Died During Pandemic, Wash. Post (June 4, 2020),
https://www.washingtonpost.com/business/2020/06/04/nursinghomes-coronavirus-deaths/.
11 Caroline Pearson et al., NORC: Univ. of Chi., The Impact of
COVID-19 on Seniors Housing, at 2–3 (2021), https://info.nic.org/
hubfs/Outreach/2021_NORC/20210601%20NIC%20Final%20Re
port%20and%20Executive%20Summary%20FINAL.pdf.
12 CDC, Weekly Updates, supra note 2.
13 Priya Chidambaram, Kaiser Family Found., Over 200,000
Residents and Staff in Long-Term Care Facilities Have Died
From COVID-19 (Feb. 3, 2022), https://www.kff.org/policywatch/over-200000-residents-and-staff-in-long-term-carefacilities-have-died-from-covid-19/#:~:text=More%20than%2020
0%2C000%20long%2Dterm,deaths%20over%20this%20bleak%2
0milestone.
10
The pandemic wreaked havoc that has left the
long-term care sector in dire straits. There are nearly
30,000 assisted living facilities and more than 15,000
skilled nursing facilities nationwide, about a third of
which operate on a non-profit basis. 14 In the first year
of the pandemic (during which the events at issue in
this case took place), long-term care facilities spent an
estimated $30 billion on PPE and additional staffing
alone. 15 The long-term care industry lost an estimated
$94 billion from 2020 to 2021, 16 and as of March 2022,
32 to 40 percent of residents lived in facilities at risk
of closing due to financial strain, leaving vulnerable
seniors in search of new homes, caretakers, and
communities. 17 Meanwhile, more and more seniors
will likely need long-term care services, as the number
of Americans over age 80 is expected to triple over the
CDC,
Nursing
Home
Care
(Sept.
6,
2022),
https://www.cdc.gov/nchs/fastats/nursing-home-care.htm; CDC,
Residential Care Communities (Sept. 28, 2022), https://www.cdc.
gov/nchs/fastats/residential-care-communities.htm.
14
15 Press Release, Am. Health Care Ass’n/Nat’l Ctr. for Assisted
Living, COVID-19 Exacerbates Financial Challenges of LongTerm Care Facilities (Feb. 17, 2021), https://www.ahcancal.org/
News-and-Communications/Press-Releases/Pages/COVID-19Exacerbates-Financial-Challenges-Of-Long-Term-CareFacilities.aspx#.
16 Id.
17 Press Release, Am. Health Care Ass’n/Nat’l Ctr. for Assisted
Living, AHCA Releases Report Highlighting Unprecedented
Economic Crisis in Nursing Homes (Mar. 2, 2022),
https://www.ahcancal.org/News-and-Communications/PressReleases/Pages/AHCA-Releases-Report-Highlighting-Un
precedented-Economic-Crisis-in-Nursing-Homes.aspx.
11
next three decades. 18 By weakening the PREP Act’s
protections for healthcare providers, the Ninth
Circuit’s decision exacerbates this mounting national
crisis.
B. The Decision Below Undermines the
PREP Act’s Critical Safeguards for
Front-Line Responders
Congress foresaw that a pandemic could create
circumstances like those seen with COVID-19, with
businesses reeling and healthcare providers
struggling to protect people from novel threats under
a shadow of crippling liability. In enacting the PREP
Act, Congress did not preempt all tort claims arising
from a pandemic. But it did seek to shield those on
the front line of defending the American population
against
a
pandemic—those
involved
in
manufacturing,
distributing,
or
allocating
countermeasures such as vaccines, tests, and surgical
masks—from liability that might prevent them from
continuing to operate and perform their critical
functions. 19 When those front-line responders are
18 Nat’l Ctr. for Health Statistics, Long-Term Care Providers
and Services Users in the United States, 2015–2016, at 3 (2019),
https://www.cdc.gov/nchs/data/series/sr_03/sr03_43-508.pdf.
“Covered person[s]” under the PREP Act include
manufacturers, distributors, and “program planner[s]” of
countermeasures, as well as “qualified person[s] who prescribed,
administered, or dispensed . . . countermeasure[s].” 42 U.S.C.
§ 247d-6d(i)(2). “Program planner[s]” are those who “supervised
or administered a program with respect to the administration,
dispensing, distribution, provision, or use” of certain
countermeasures. Id. § 247d-6d(i)(6). A “qualified person” is a
“licensed health professional or other individual who is
19
12
faced with tort lawsuits, the Act also ensures access to
a federal forum, even when plaintiffs try to plead their
claims in terms of state law.
In public health emergencies, the government
works hand-in-hand with private sector partners,
including healthcare providers, who generally lack the
protection from liability enjoyed by public officials.
See Peggy Binzer, The PREP Act: Liability Protection
for
Medical
Countermeasure
Development,
Distribution, and Administration, 6 Biosecurity &
Bioterrorism 293 (2008). Just as a lack of immunity
for public officials exercising discretionary functions
may result in “the diversion of official energy from
pressing public issues, and the deterrence of able
citizens from acceptance of public office,” Harlow v.
Fitzgerald, 457 U.S. 800, 814 (1982), insufficient
protection for private parties that assist the
government in times of need may result in
“unwarranted timidity” and a failure to act “with the
decisiveness and the judgment required by the public
good,” Filarsky v. Delia, 566 U.S. 377, 389–90 (2012)
(quoting Richardson v. McKnight, 521 U.S. 399, 409
(1997) & Scheuer v. Rhodes, 416 U.S. 232, 240 (1974)).
Enacted shortly after a different coronavirus
outbreak, the SARS epidemic of 2003, the PREP Act
addresses this concern by providing “targeted liability
protection” for a range of pandemic response activities
called for by the HHS Secretary, including the
development, distribution, and dispensing of medical
countermeasures, as well as the design and
authorized to prescribe, administer,
countermeasures. Id. § 247d-6d(i)(8).
or
dispense”
such
13
administration of countermeasure policies. See 42
U.S.C. § 247d-6d. That immunity has proved crucial
to America’s integrated national response to COVID19. For example, the lack of equivalent protections in
other countries hindered the rollout of vaccines that
could have saved untold numbers of lives. 20 As the
Organization for Economic Cooperation and
Development has observed, instituting “reliable and
transparent legal provisions for the indemnification of
vaccine manufacturers” is crucial for preventing a
“wave of litigation” from “creating a disincentive for
manufacturers to enter the vaccine market.” 21
At the same time, to ensure the uniform and
efficient resolution of disputes relating to
countermeasures, the PREP Act establishes an
exclusive federal remedial scheme. See id. §§ 247d-6d,
247d-6e (specifically noting interest in “timely” and
“uniform” adjudication). Forcing litigation over the
PREP Act, including the scope of its applicability and
the immunity it affords, to play out across 50 state
court systems would defeat Congress’s purpose of
ensuring uniformity and efficiency.
The stakes are high. Trial lawyers have spent
tens of millions of dollars on advertisements related to
See, e.g., Neha Arora et al., India, Pfizer Seek to Bridge
Dispute Over Vaccine Indemnity, Reuters (May 21, 2021), https://
www.reuters.com/business/healthcare-pharmaceuticals/indiapfizer-impasse-over-vaccine-indemnity-demand-sources-202105-21/.
20
21 OECD, Enhancing Public Trust in COVID-19 Vaccination:
The Role of Governments (May 10, 2021), https://www.oecd.org/
coronavirus/policy-responses/enhancing-public-trust-in-covid19-vaccination-the-role-of-governments-eae0ec5a/.
14
COVID-19, and more than 10,000 lawsuits have
already been filed—in every state across the land. 22
Making matters worse, liability insurers often refuse
to cover claims like the one in this case. Rather,
insurers have enacted broad COVID-19 exclusions,
placed moratoria on new medical professional liability
business, and have been “extremely selective” about
what types of facilities they will do business with and
what they will insure. 23 This has left long-term care
facilities in a very vulnerable position.
Congress designed the PREP Act as the ultimate
backstop. Yet the Ninth Circuit’s decision allows
plaintiffs to plead around the PREP Act’s complete
preemption regime by couching their claims in state
tort law. By diverging from the Third Circuit’s
reasoning in Maglioli, the decision also opened a
rupture in how that important federal statute applies
in different regions of the country and contradicted the
federal government’s own considered position on the
PREP Act. Both the U.S. Department of Health and
Human Services and the U.S. Department of Justice
have identified the PREP Act as a “complete
preemption” statute. See Advisory Op. No. 21-01 on
the PREP Act, at 1 (HHS OIG Jan. 8, 2021); Fifth
22 Am. Tort Reform Ass’n, COVID-19 Legal Services Television
Advertising (2021), https://www.atra.org/white_paper/covid-19legal-services-television-advertising/; Hunton Andrews Kurth,
COVID-19 Complaint Tracker (2022), https://www.huntonak.com
/en/covid-19-tracker.html.
23 Amy O’Connor, COVID 19 Hits Already-Troubled Nursing
Home Insurance Market, Ins. J. (May 10, 2020),
https://www.insurancejournal.com/news/national/2020/05/10/56
7421.htm.
15
Amendment to Declaration Under the PREP Act, 86
Fed. Reg. 7872, 7874 (Feb. 2, 2021) (“The plain
language of the PREP Act makes clear that there is
complete preemption of state law as described above”);
DOJ Statement of Interest, Bolton v. Gallatin Ctr. for
Rehab. & Healing, LLC, No. 20-cv-00683 (M.D. Tenn.
Jan. 19, 2021), ECF No. 35-1.
Given the proliferation of state court litigation,
and given how long cases take to wend their way
through the state court system, many health-care
providers and long-term care facilities simply cannot
afford to wait longer for this Court to take up the
question presented in this case. The only way to
ensure that the PREP Act is applied as Congress
intended, and that it provides the protective effect it
was designed to provide in a time of crisis, is to grant
review now.
Furthermore, COVID-19 will not be the last
public health emergency the nation faces. Already,
the Biden Administration has declared the ongoing
spread of monkeypox virus in the United States a
public health emergency. 24 In the wake of that
announcement, commentators observed that a federal
declaration under the PREP Act could “enhance
access” to drugs used to treat monkeypox by
“provid[ing] significant liability protections for
24 Press Release, HHS, Biden-Harris Administration Bolsters
Monkeypox Response; HHS Secretary Becerra Declares Public
Health Emergency (Aug. 4, 2022), https://www.hhs.gov/about
/news/2022/08/04/biden-harris-administration-bolsters-monkey
pox-response-hhs-secretary-becerra-declares-public-healthemergency.html.
16
persons involved in the chain of medical
countermeasure distribution and administration.” 25
Ultimately, if courts continue to disregard the
statute’s guarantees of broad immunity and exclusive
federal jurisdiction, despite the plain text and the
HHS Secretary’s consistent interpretation of it,
companies and individuals who relied on those
promises of forum exclusivity and liability protection
will be less likely to put their trust in such guarantees
the next time around. The PREP Act incentivizes the
private sector to work with the government and take
the necessary risks to address public health crises.
Failure to enforce the PREP Act according to its terms
therefore has serious implications not only for the
COVID-19 crisis, but for future emergencies, in which
private-sector coordination may “become more
cumbersome and expensive for the Government, and
willing partners more scarce.” Salazar v. Ramah
Navajo Chapter, 567 U.S. 182, 191–92 (2012) (citing
United States v. Winstar Corp., 518 U.S. 839, 883
(1996) (plurality opinion)). The result will be a less
effective national emergency response and needless
loss of lives and livelihoods.
In sum, the PREP Act reflects Congress’s
recognition that a national emergency like COVID-19
requires a whole-of-nation response.
The Act
therefore
provides
the
Secretary
with
a
comprehensive national regulatory tool to encourage
25 Lawrence O. Gostin & James G. Hodge, Jr., O’Neill Inst. for
Nat’l & Global Health Law Monkeypox: National Emergency
Declaration & Powers (Aug. 7, 2022), https://oneill.law.
georgetown.edu/monkeypox-national-emergency-declarationpowers/.
17
the development of designated countermeasures,
while limiting liability for loss related to the
administration of such countermeasures and ensuring
adjudication of such liability in a federal forum. In
holding that the PREP Act is not a complete
preemption statute, the Ninth Circuit thwarted that
congressional design and made removal of tort claims
turn not on their substance but on how plaintiffs
choose to label those claims. That decision was
inconsistent with precedents of this Court and other
courts of appeals.
II. The Decision Below Creates a Circuit Split
and Conflicts With This Court’s Precedent
As petitioners note, the Ninth Circuit’s holding
that the PREP Act is “not a complete preemption
statute”—full stop—creates a clear split with the
Third Circuit’s decision in Maglioli, 16 F.4th 393. In
Maglioli, the Third Circuit recognized that “[t]he
PREP Act’s language easily satisfies the standard for
complete preemption” of claims alleging willful
misconduct because “[i]t provides an ‘exclusive cause
of action . . . and also set[s] forth procedures and
remedies governing that cause of action.’” Id. at 409
(quoting Beneficial Nat’l Bank, 539 U.S. at 8). The
court found that the complete preemption regime did
not apply in that case only because it read the
complaint as “alleg[ing] negligence, not willful
misconduct.” Id. at 410. Here, in contrast, the Ninth
Circuit acknowledged that the complaint asserts
claims for both negligence and willful misconduct,
App. 5a—and yet the court rejected complete
preemption categorically, even for the willful
misconduct claim, App. 15a–17a. That direct conflict
18
by itself, concerning the interpretation of a federal
emergency-response statute, calls out for this Court’s
review.
The Ninth Circuit’s decision also contravenes
important precedents of this Court.
The wellestablished test for complete preemption is whether
Congress intended to “supersede” state laws and in
their place “create a federal remedy . . . that is
exclusive[.]” Beneficial Nat’l Bank, 539 U.S. at 11.
Nothing in that test suggests that the federal
substitute must be coextensive with the underlying
state-law claim; indeed, such a rule would not make
sense because Congress might well intend to replace
certain state-law claims with more tailored federal
remedies. As Judge Boudin once observed, “[f]or
complete preemption to operate, the federal claim
need not be co-extensive with the ousted state claim.”
Fayard v. Ne. Vehicle Servs., LLC, 533 F.3d 42, 46 (1st
Cir. 2008). On the contrary, “the superseding federal
scheme may be more limited or different in its scope
and still completely preempt.” Id. (citing Caterpillar
Inc. v. Williams, 482 U.S. 386, 391 n.4 (1987)).
And that is precisely how the PREP Act works.
First, the Act displaces state-law tort claims within a
defined area, regardless of scienter. Section 247d6d(a) provides “immun[ity] from suit and liability
under Federal and State law with respect to all claims
for loss caused by, arising out of, relating to, or
resulting from the administration to or the use by an
individual of a covered countermeasure.” 42 U.S.C.
§ 247d-6d(a). Then the Act creates, as the “sole
exception” to the immunity conferred by subsection
(a), “an exclusive Federal cause of action” for claims of
19
willful misconduct causing death or serious injury. Id.
§ 247d-6d(d)(1). For other tort claims, the Act does not
leave claimants without a remedy, but sets up a nofault administrative compensation fund. Id. § 247d6e(a).
The Ninth Circuit held that the Act does not
completely preempt state-law negligence claims
because the only judicial remedy it provides is for
“willful misconduct,” rather than negligence.
App. 16a. But this Court has firmly rejected that
mirror-image approach to complete preemption. As
this Court has made clear in the ERISA context,
complete preemption has never been “limited to the
situation in which a state cause of action precisely
duplicate[d] a cause of action under [the federal
statute].” Aetna Health, 542 U.S. at 215–16. This
Court explained that such an approach would not “be
consistent with our precedent,” because “Congress’s
intent to make the ERISA civil enforcement
mechanism exclusive would be undermined if state
causes of action that supplement the [ERISA]
remedies were permitted, even if the elements of the
state cause of action did not precisely duplicate the
elements of an ERISA claim.” Id.
The same goes for the PREP Act. Indeed, the
PREP Act’s preemption provision employs the same
key language—“relating to”—as ERISA. 42 U.S.C.
§ 247d-6d(a). This Court has repeatedly recognized
that “relat[ing] to” has a “broad common-sense
meaning.” Pilot Life Ins. Co. v. Dedeaux, 481 U.S. 41,
47 (1987) (internal quotation marks omitted). This
powerfully preemptive language confirms that statelaw negligence claims—which supplement the
20
remedies Congress chose to make available in the
PREP Act—are completely preempted. In reaching
the opposite result, the Ninth Circuit failed to apply a
basic principle of federal jurisdiction: “[t]he nature of
the relief available after jurisdiction attaches is, of
course, different from the question whether there is
jurisdiction
to
adjudicate
the
controversy.”
Caterpillar, 482 U.S. at 391 n.4 (quoting Avco Corp.,
390 U.S. at 561).
Moreover, puzzlingly, despite acknowledging that
“Congress intended a federal claim . . . for willful
misconduct claims,” the Ninth Circuit rejected
complete preemption altogether. App. 16a. The court
held flatly that the PREP Act “is not a complete
preemption statute,” even for willful misconduct
claims, because while respondents’ willful misconduct
claim “may be preempted,” the Act does not “‘entirely
supplant[] state law causes of action’” such as
respondents’ negligence-based claims. App. 16a–17a
(quoting Retail Prop. Tr. v. United Bhd. of Carpenters
& Joiners of Am., 768 F.3d 938, 947 (9th Cir. 2014)).
As petitioners rightly point out, this all-or-nothing
reasoning ignores basic principles of federal
jurisdiction, which do not require that every claim in
a federal case contain a federal question. See Pet. 17–
19. Indeed, the lack of such a requirement is the very
premise of supplemental jurisdiction over state-law
claims. See 28 U.S.C. § 1367. The Ninth Circuit’s
novel test, for which it cited no authority, also conflicts
with this Court’s approach in complete preemption
cases. For example, in Beneficial National Bank, this
Court upheld removal to federal court even though the
National Bank Act completely preempted only the
plaintiffs’ purported “state-law claim of usury,” 539
21
U.S. at 11, and not their remaining claims for
“intentional misrepresentation” and “breach of
fiduciary duty,” among other things, Anderson v. H&R
Block, Inc., 132 F. Supp. 2d 948, 949 (M.D. Ala. 2000).
The Ninth Circuit’s contrary approach turns that
common-sense practice on its head and essentially
nullifies the concept of supplemental jurisdiction in
complete preemption cases.
In addition to the
importance of the question presented in its own right
and the clear circuit split, these conflicts with
established precedent make the case for this Court’s
review all the more compelling.
22
CONCLUSION
The Court should grant the petition for certiorari.
Respectfully submitted,
Jennifer B. Dickey
U.S. CHAMBER
LITIGATION CENTER
1615 H Street NW
Washington, DC 20062
Counsel for the
Chamber of Commerce
of the United States
of America
Jeffrey S. Bucholtz
Counsel of Record
Alexander Kazam
KING & SPALDING LLP
1700 Pennsylvania Ave. NW
Washington, DC 20006
(202) 737-0500
jbucholtz@kslaw.com
Geoffrey M. Drake
KING & SPALDING LLP
Chad Golder
1180 Peachtree Street NE
AMERICAN HOSPITAL
Atlanta, GA 30309
ASSOCIATION
Counsel for the Chamber of
800 10th Street NW
Commerce of the United
Two CityCenter
Suite 400
States of America and
Washington, DC 20001 American Hospital
Association
Counsel for American
Hospital Association
23
Mark E. Reagan
H. Sherman Joyce
HOOPER, LUNDY &
Lauren Sheets Jarrell
BOOKMAN, PC
AMERICAN TORT
101 Montgomery Street REFORM ASSOCIATION
11th Floor
1101 Connecticut Ave. NW
San Francisco, CA 94104 Suite 400
Washington, DC 20036
Counsel for American
Health Care Association Counsel of American
Tort Reform Association
September 30, 2022
This is a copy of a public record, reproduced as it was published. It is not legal advice, and it may not be the version a court would rely on. Check the official source before you cite it.