Volume 23, Issue 3 - Business Law Review

Business
Law Review
Volume 23, Issue 3
Summer 2015
2014 – 2015
Special Issue: Health Law
Articles
Legal, Operational, and Practical Considerations
in Responding to Communicable Diseases:
Domestic Lessons Learned from the
2014 Ebola Outbreak.................................................................................Jane Jordan, Greg Measer,
Asha Agrawal and James G. Hodge, Jr.
Ebola, Quarantine, and Flawed CDC Policy........................................................................ Robert Gatter
Pharmaceuticals and Boipiracy:
How the AIA May Inadvertently Reduce
the Misappropriation of Traditional Medicine................................ Ryan D. Levy and Spencer Green
Terminating the Hospital-Physician
Employment Relationship: Navigating Conflicts
Arising from the Physician’s Dual Roles
as Employee and Medical Staff Member................................................................... Gayland Hethcoat
Note
Wollschlaeger, a Patient’s Right to Privacy,
and a Renewed Focus on Mental Health Treatment............................................Chad A. Pasternack
UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
Volume 23
Summer 2015
2014 – 2015
EXECUTIVE BOARD
JOSHUA A. BERMAN
Editor in Chief
CARA R. BAROS
Executive Editor
MICHAEL BINKO
Senior Articles Editor
CHAD A. PASTERNACK
Executive Editor
JOSEPH PICONE
Senior Notes & Comments
Editor
JOSHUA WIRTH
Senior Notes & Comments
Editor
KRISTEN SUSIK
Senior Notes & Comments
Editor
ANDREW WILLARD
Symposium & Events
Editor
JACOB A. EPSTEIN
Managing Editor
MELANIE ADELSON
Alumni Editor
BRYAN E. MARTINEZ
Articles & Comments
Editor
JACOB SHONKWILER
Articles & Comments
Editor
JORDAN P. SARASON
Articles & Comments
Editor
STEVEN A. VITALE
Articles & Comments
Editor
RAY NICHOLAS
Articles & Comments
Editor
EDITORIAL BOARD
RANON ALTMAN
CLAIRE ARRITOLA
BENJAMIN BURNS
JARED BOROCZ-COHEN
GABRIELLA E. BRAGA
PETER CAPACCHIONE
ALEXANDER COOK
YANI CRESPO
JAMES DIAMOND
JOCELYN EZRATTY
SAMUEL FALK
JOSEPH M. FELDMAN
KRISTEN FERRER
BROOKE FLANDERS
DANIELLE FURNEAUX
ABRAHAM GEAN
TODD B. GREEN
DEMI HALMOUKOS
TIFFANY HENDRICKS
ALEXIS KANAREK
KEN KANZAWA
PROFESSOR FRED MCCHESNEY
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EMILY HOROWITZ
Special Advisor to the Law Reviews
GLORIA GARCIA
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MAXWELL J. LEVINE
RAQUEL LORET DE MOLA
JORDAN M. MACEJKA
DAVID NEWFIELD
KELSEY PAINE
KATIA RAMUNDO
JESSALYNN RUBIO
MACKENZIE RUROEDE
SOLOMON SCHOONOVER
SAMUEL L. WINIKOFF
MERIDYTH WASSERMAN
UNIVERSITY OF MIAMI SCHOOL OF LAW
ADMINISTRATION
Donna E. Shalala, B.A., Ph.D., President of the University
Thomas J. LeBlanc, B.S., M.S., Ph.D., Provost & Executive Vice President
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Sergio Campos, A.B., J.D., Associate Professor of Law
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Michele DeStefano, B.A., J.D., Professor of Law
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Mary Teresa Doud, B.A., M.A., J.D., Professor of Legal Writing & Lecturer in
Law
Mary Doyle, B.A., LL.B., Dean Emerita & Professor of Law
Alyssa Dragnich, B.A., J.D., Professor of Legal Writing & Lecturer in Law
Marc Fajer, A.B., J.D., Professor of Law
Zanita E. Fenton, A.B., J.D., Professor of Law
Mary Anne Franks, B.A., M.Phil., Ph.D., J.D., Associate Professor of Law
Christina M. Frohock, B.A., M.A., J.D, Professor of Legal Writing & Lecturer
in Law
A. Michael Froomkin, B.A., M.Phil., J.D., Laurie Silvers and Mitchell
Rubenstein Distinguished Professor of Law
Michael H. Graham, B.S.E., J.D., Dean’s Distinguished Scholar for the
Profession, Professor of Law
Susan Haack, B.A., M.A., B.Phil., Ph.D., Distinguished Professor in the
Humanities, Cooper Senior Scholar in Arts and Sciences, Professor of
Philosophy & Professor of Law
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Frances R. Hill, B.A., M.A., Ph.D., J.D., LL.M., Dean’s Distinguished Scholar
for the Profession, Professor of Law
Jennifer Hill, B.A., M.A., J.D., Professor of Legal Writing & Lecturer in Law
Elizabeth M. Iglesias, B.A., J.D., Professor of Law
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Lili Levi, A.B., J.D., Professor of Law
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Martha R. Mahoney, B.A., M.A., J.D., Dean’s Distinguished Scholar &
Professor of Law
Elliott Manning, A.B., J.D., Dean’s Distinguished Scholar for the Profession,
Professor of Law
Fred McChesney, A.B., J.D., Ph.D., Carlos de la Cruz-Soia Mentschikoff Chair
in Law and Economics
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Sarah A. Mourer, B.S., J.D., Director of the Capital Defense Project and Miami
Innocence Project & Associate Professor of Clinical Legal Education
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Professor of Clinical Legal Education
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of Law
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Estate Planning
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& Lecturer in Law
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Professor of Law Emeritus
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Law Program
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Comparative Law
Andres Sawicki, S.B., J.D., Associate Professor of Law
Stephen J. Schnably, A.B., J.D., Professor of Law
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Rachel Smith, B.A., J.D., Professor of Legal Writing & Lecturer in Law
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Kele Stewart, B.S., J.D., Co-Director of the Children & Youth Law Clinic &
Professor of Clinical Legal Education
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& Professor of Law
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Emeriti
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Cite as: U. MIAMI BUS. L. REV.
BUSINESS
LAW REVIEW
Volume 23, Issue 3
Summer 2015
2014 – 2015
ARTICLES
Legal, Operational, and Practical Considerations
in Responding to Communicable Diseases:
Domestic Lessons Learned from the
2014 Ebola Outbreak
Jane Jordan, Greg Measer,
Asha Agrawal and James G. Hodge, Jr.
341
Ebola, Quarantine, and Flawed CDC Policy
Robert Gatter
375
Ryan D. Levy and Spencer Green
401
Gayland Hethcoat
425
Chad A. Pasternack
451
Pharmaceuticals and Biopiracy:
How the AIA May Inadvertently Reduce
the Misappropriation of Traditional Medicine
Terminating the Hospital-Physician
Employment Relationship: Navigating Conflicts
Arising from the Physician’s Dual Roles
as Employee and Medical Staff Member
NOTE
Wollschlaeger, A Patient’s Right to Privacy,
and a Renewed Focus on Mental Health Treatment
Legal, Operational, and Practical
Considerations for Hospitals and Health
Care Providers in Responding to
Communicable Diseases Following the 2014
Ebola Outbreak
Jane E. Jordan, J.D., * Gregory Measer, ** Asha M. Agrawal, *** and
James G. Hodge, Jr., J.D., LL.M. ****
This article analyzes some of the potential issues that may arise
during epidemics or other public health emergencies. It
specifically focuses on legal and operational preparedness
experiences at Emory University during the 2014 Ebola crisis.
Emory University Hospital was the first health care facility in
the U.S. to treat patients diagnosed with Ebola Viral Disease
(EVD). Although EVD has particularly frightening symptoms
and a high mortality rate, its containment and treatment
implicate similar legal, practical, and operational issues as
other highly infectious and communicable diseases. These issues
include laws related to: isolation and quarantine; travel
restrictions; duties to treat highly infectious patients;
implications of the federal Emergency Medical Treatment and
Active Labor Act (EMTALA); health care workers’ rights to a
safe working environment, workers’ compensation, medical
leave; confidentiality protections afforded by the HIPAA Privacy
Rule; disability protections for patients under the Americans
with Disabilities Act (ADA); and crisis standards of care and
*
Deputy General Counsel/Chief Counsel for Health Affairs, Office of the General
Counsel, Emory University.
**
Senior Legal Researcher, Public Health Law and Policy Program, J.D. Candidate
(2015), Sandra Day O’Connor College of Law, ASU.
***
Senior Legal Researcher, Public Health Law and Policy Program, J.D. Candidate
(2016), Sandra Day O’Connor College of Law, ASU.
****
Associate Dean and Professor; Director, Public Health Law and Policy Program,
Director, Network for Public Health Law – Western Region Office, Sandra Day
O’Connor College of Law, ASU.
341
342
UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
[Vol. 23:341
negligence claims. Practical and operational issues are also
explored for hospitals and other health providers to consider
when facing a public health emergency or other publicized event
involving patients with infectious conditions. Hospitals, health
care workers, and public health officials can take guidance from
these experiences to develop their own response plans in the
future.
I. INTRODUCTION .............................................................................. 342
II. LEGAL ISSUES ARISING FROM EBOLA AND OTHER PUBLIC
HEALTH EMERGENCIES ................................................................. 345
A. Emergency Public Health Legal Authorities in Response to
Ebola ........................................................................................ 345
B. Isolation and Quarantine ......................................................... 347
C. Travel Restrictions ................................................................... 350
D. Duty to Treat ............................................................................ 352
E. Emergency Medical Treatment and Active Labor Act ............. 354
F. Right to a Safe Working Environment, Workers’
Compensation, and the Family Medical Leave Act ................. 356
G. HIPAA Privacy Rule and Other Issues of Confidentiality ....... 358
H. Americans with Disabilities Act ............................................... 360
I. Crisis Standards of Care.......................................................... 363
J. General Principles of Potential Negligence Claims ................ 365
III. OPERATIONAL, CLINICAL, AND PRACTICAL ISSUES: EMORY’S
EBOLA EXPERIENCE....................................................................... 367
A. Hazardous Waste, Environmental Safety, and Transport
and Disposal of Waste ............................................................. 367
B. Supply Chain and Vendor Agreements .................................... 369
C. Clinical Protocols .................................................................... 369
D. Emory’s Care Transformation Model and Patient Centered
Care ......................................................................................... 370
E. Team Preparedness and Drills ................................................ 372
F. Public Relations, Communications, and Education ................ 373
IV. CONCLUSION.................................................................................. 374
I.
INTRODUCTION
It was July 30, 2014, a typical hot and humid summer afternoon at
Emory University Hospital (Hospital) in Atlanta, Georgia. Emory’s
campus was relatively quiet with students on their summer break.
2015]
COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
343
Emory’s Special Containment Disease Unit (SCDU) 1 was empty.
Created in 2002 as a two-bed special isolation facility at the request of
the Centers for Disease Control and Prevention (CDC), the SCDU was
designed to treat CDC employees (either from its main headquarters in
Atlanta or the field) exposed to or infected with dangerous pathogens.
Since its creation, the SCDU had been used only twice.
The day began like any other for many at Emory Hospital, including
Dr. Bryce Gartland, a hospitalist and Vice President of Operations, Bob
Bachman, the Hospital’s CEO, and Nancye Feistritzer, Chief Nursing
Officer. They were unaware that officials from the U.S. Department of
State visited the SCDU two days earlier. On the morning of July 30, the
State Department called infectious disease specialist and SDCU director
Dr. Bruce Ribner to ask if Emory would accept and treat Dr. Kent
Brantly, an American who contracted Ebola Viral Disease (EVD) while
on a medical mission in Liberia. 2 Dr. Ribner quickly announced that
Emory was to receive and treat Dr. Brantly, leading to two frenzied days
of preparation prior to his arrival on August 2.3
EVD is an emerging zoonotic viral disease that originally arose in
rural areas of Central Africa. It was first identified in humans in 1976 in
a remote hamlet of Zaïre (now the Democratic Republic of the Congo)
near the Ebola River.4 Humans contract EVD through direct physical
contact with bodily fluids from an infected, clinically ill individual. 5 It
terrifies affected populations due to its hemorrhagic nature, causing
massive bleeding, elimination of waste, and, in many instances, death.
No vaccine or other type of therapeutic intervention is currently available
1
Four hospitals in the United States (Emory; Nebraska Medical Center in Omaha; the
National Institutes of Health in Bethesda, MD; and St. Patrick Hospital in Missoula, MT)
have similar high containment units (HCUs) with select beds for isolating patients with
highly infectious and dangerous diseases.
2
Shortly thereafter, Emory was requested to treat a second American on the same
medical mission, Nancy Writebol, who arrived at the Hospital on August 5, 2014.
3
See Maria M. Lameiras, Ebola: From Microscope to Spotlight, EMORY MAG.,
Autumn 2014, at 18, 21, available at http://www.emory.edu/EMORY_MAGAZINE/
issues/2014/autumn/print.pdf.
4
K.A. Alexander et al, What Factors Might Have Led to the Emergence of Ebola in
West Africa?, PLOS (Nov. 11, 2014), http://blogs.plos.org/speakingofmedicine/2014/11/
11/factors-might-led-emergence-ebola-west-africa/ (citing Team RoaWIS (1978) Ebola
haemorrhagic fever in Sudan, 1976. Bulletin of the World Health Organization 56: 247).
5
Carol Clark, Disrupting the Balance, EMORY MED., Fall 2014, at 20, 21, available at
http://emorymedicinemagazine.emory.edu/issues/2014/fall/print.pdf. Three fruit bat
species are believed to be EVD’s “reservoir,” or the organism that carries the pathogen to
other wildlife and humans without dying or becoming ill from it. Id.
344
UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
[Vol. 23:341
for EVD beyond supportive care. 6 Subsequent outbreaks have occurred
sporadically since 1976, but most have dissipated quickly. 7
The 2014 outbreak in dense, poor urban areas of several West
African nations is the exception. 8 Lacking professional medical
treatment, widespread transmission has been associated with home care
and traditional burial practices that involve a great degree of touch and
interaction with the deceased.9 Hospitals failing to follow infection
control procedures, use standard barrier precautions, and employ
sufficient, informed, or qualified staff contribute further to EVD’s
spread. 10 Although the rate of new EVD cases reported to the World
Health Organization (WHO) appears to be waning, 22,092 confirmed,
probable, and suspected cases of Ebola have been reported as of January
25, 2015, and 8,810 deaths globally. 11
As noted by CDC Director Dr. Thomas Frieden, “[w]e live in a
world where we are all connected by the air we breathe, the water we
drink, the food we eat, and by airplanes that can bring disease from
anywhere to anywhere in a day.” 12 Although EVD has particularly
frightening symptoms and a high mortality rate, its containment and
treatment implicate similar legal, practical and operational issues as other
communicable diseases. This article analyzes actual and potential legal
6
Ebola Virus Disease (EVD) Information for Clinicians in U.S. Healthcare Settings,
CDC, http://www.cdc.gov/vhf/ebola/healthcare-us/preparing/clinicians.html (last updated
Mar. 16, 2015).
7
Clark, supra note 5, at 21 (“Subsequent outbreaks have also been associated with
forested backwaters and have quickly burned themselves out. That is, until the current
outbreak in West Africa”).
8
Id.
9
Scott F. Dowell et al., Transmission of Ebola Hemorrhagic Fever: A Study of Risk
Factors in Family Members, Kikwit, Democratic Republic of the Congo, 1995, 179 J.
INFECTIOUS DISEASES, Supp. 1, 1999, at S87, S90.
10
Alexander et al, supra note 4; Barbara Kerstiëns & Francine Matthys, Interventions
to Control Virus Transmission During an Outbreak of Ebola Hemorrhagic Fever:
Experience from Kikwit, Democratic Republic of the Congo, 1995, 179 J. INFECTIOUS
DISEASES, Supp. 1, 1999, at S263, S264-65; J.J. Muyembe-Tamfum et al., Ebola
Outbreak in Kikwit, Democratic Republic of Congo: Discovery and Control Measures,
179 J. INFECTIOUS DISEASES, Supp. 1, 1999, at S259, S260.
11
Update: Ebola Virus Disease Epidemic—West Africa, January 2015¸ 64 CDC
MORBIDITY & MORTALITY WKLY. REP. 109, 109 (2015). Sierra Leone, Liberia, and
Guinea had the most cases, with 7,968, 3,138, and 2,569 EVD patients, respectively. Id.
For the week ending January 24, 2015, an average of eleven daily confirmed cases were
reported from Sierra Leone, less than one from Liberia, and three from Guinea. Id.
12
CDC Director Thomas Frieden, Press Conference on the First Ebola Case Diagnosed
in the United States (Sept. 30, 2014) (transcript and audio available at http://www.cdc.
gov/media/releases/2014/t0930-ebola-confirmed-case.html); see also Press Release,
CDC, CDC Announces First Case of Middle East Respiratory Syndrome Coronavirus
Infection (MERS) in the United States (May 2, 2014), available at http://www.cdc.gov/
media/releases/2014/p0502-US-MERS.html.
2015]
COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
345
issues arising during epidemics or other public health emergencies,
specifically focusing on Emory’s legal and operational preparedness
experiences during the 2014 Ebola crisis. Hospitals, physicians, nurses,
and public health officials can learn from that experience in developing
their own response plans for a future similar crisis.
II.
LEGAL ISSUES ARISING FROM EBOLA AND OTHER PUBLIC
HEALTH EMERGENCIES
A.
Emergency Public Health Legal Authorities in Response to
Ebola
Law is a cornerstone of public health emergency preparedness,
funding, and response to emerging threats like Ebola. In December 2014,
Congress approved $5.4 billion to address the Ebola outbreak globally,
including specific earmarks to the National Institutes of Health, the CDC,
and others. 13 Routine public health powers authorized by law may be
used successfully to address emerging infectious disease threats.
However, threats like EVD raise the possibility of invoking emergency
powers to respond more rapidly in coordinated ways. Formal emergency
declarations can affect public health and medical responses by instantly
altering the legal environment, depending, in part, on the type of
emergency declared. 14 In the U.S., federal and many state (as well as
select local) governments may declare states of “emergency,”
13
Consolidated and Further Continuing Appropriations Act, 2015, H.R. 83, 113th
Cong. (2014); Press Release, Dep’t of Health & Human Servs., 35 U.S. Hospitals
Designated as Ebola Treatment Centers (Dec. 2, 2014) (available at http://www.hhs.gov/
news/press/2014pres/12/20141202b.html ) (“Hospitals with Ebola treatment centers have
been designated by state health officials to serve as treatment facilities for patients based
on a collaborative decision with local health authorities and the hospital administration.
Ebola treatment centers are staffed, equipped, and have been assessed to have current
capabilities, training, and resources to provide complex treatments for Ebola patients
while minimizing risk to [HCWs].”). In particular, the Defense Advanced Research
Projects Agency (“DARPA”), the Pentagon’s elite research arm, awarded Emory
University up to $10.8M over three years to direct a project using the blood from
survivors of EVD to test a novel way of treating infectious diseases, including not only
EVD but potentially seasonal flu and malaria. Julie Steenhuysen, Blood from Ebola
Survivors Could Help Spur New Disease Treatments, REUTERS (Feb. 4, 2015, 2:45 PM),
http://in.reuters.com/article/2015/02/04/health-ebola-antibodiesidINKBN0L80PP20150204.
14
James G. Hodge, Jr. & Evan D. Anderson, Principles and Practice of Legal Triage
During Public Health Emergencies, 64 N.Y.U. ANN. SURV. AM. L. 249, 250 (2009).
346
UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
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“disaster,” 15 or “public health emergency,” 16 among other classifications.
These declarations may empower public and private entities to address
public health crises like EVD by:
•
Offering public and private sectors greater
flexibility to act to protect the public’s health through
testing, screening, treatment, and vaccination programs;
•
Authorizing use of social distancing measures to
control the spread of infectious conditions;
•
Allowing temporary suspensions of regulations
that may impede emergency responses;
•
Enabling efforts among volunteer health
providers through limits of, or protections from, claims
of liability; 17
•
Facilitating transitions to what the U.S. Institute
of Medicine defines as “crisis standards of care”
(discussed below); 18 and
•
Altering medical licensing standards and scopes
of practice to facilitate emergency responses. 19
Although states of emergency can further public health preparedness,
their invocation is unpredictable and precarious. In response to the threat
of EVD in 2014, neither the President nor the federal Department of
Health and Human Services (DHHS) declared any major states of
15
Evan D. Anderson & James G. Hodge, Emergency Legal Preparedness Among
Select U.S. Local Governments, 3 DISASTER MED. & PUB. HEALTH PREPAREDNESS. S176,
S176 (Supp. 2 2009).
16
DEP’T OF HEALTH & HUMAN SERVS., EMERGENCY SYSTEM FOR ADVANCE
REGISTRATION OF VOLUNTEER HEALTH PROFESSIONALS (ESAR-VHP)—LEGAL AND
REGULATORY ISSUES 10–11 (2006).
17
Sharona Hoffman et al., Law, Liability, and Public Health Emergencies, 3 DISASTER
MED. & PUB. HEALTH PREPAREDNESS 117, 123 (2009); Sara Rosenbaum et al., State Laws
Extending Comprehensive Legal Liability Protections for Professional Health-Care
Volunteers During Public Health Emergencies, 123 PUB. HEALTH REPS. 238, 238–41
(2008).
18
HEALTH SYS. RESEARCH, INC., ALTERED STANDARDS OF CARE IN MASS CASUALTY
EVENTS: BIOTERRORISM AND OTHER PUBLIC HEALTH EMERGENCIES, AGENCY FOR
HEALTHCARE RESEARCH & QUALITY PUBL’N NO. 05-0043 (2005).
19
James G. Hodge Jr. et al., Emergency Legal Preparedness for Hospitals and Health
Care Personnel, 3 DISASTER MED. & PUB. HEALTH PREPAREDNESS S37, S39 (Supp. 1
2009).
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COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
347
emergency. 20 DHHS’ Secretary Sylvia Burwell did issue a limited
declaration on December 9, 201421 to support EVD vaccine development
under the Public Readiness and Emergency Preparedness (PREP) Act. 22
Among states, only Connecticut’s Governor issued a state of public
health emergency, which was declared on October 6, 2014. 23
Governments’ reticence to declare formal states of emergency in
response to EVD may seem incredulous given the national attention in
the fall of 2014 and Americans’ perception of the risks. However, the
lack of emergency declarations is understandable for several reasons.
First, public health emergency declarations are typically issued in
response to known or imminent threats of substantial harms to the
population. A handful of domestic cases of a non-airborne, slowlyspreading condition like EVD may frighten the general public, but it does
not constitute an imminent threat to the public’s health. Second, neither
DHHS nor most states had to issue any declaration to apply existing
public health powers (e.g., education, testing, screening, treatment,
quarantine, isolation, closures) to address EVD. Finally, while
emergency laws can help mobilize efforts, they do not provide precise
legal guidance. Framed in broad statutory or regulatory language, these
laws offer more so a menu of legal powers and options rather than a
definitive guide for action. Implementation of emergency powers may be
one route to effective response efforts, but are not by definition a
panacea. In reality, national, state, and local actors like Emory University
Hospital must prioritize legal issues and generate practical solutions in
real time to facilitate legitimate public health efforts designed to limit the
spread of EVD in balance with communal and individual interests.
B.
Isolation and Quarantine
Public health powers to issue quarantine or isolation orders for
infectious diseases like EVD are politically controversial and often
20
Press Secretary Josh Earnest, Press Briefing in the James S. Brady Press Briefing
Room (Oct. 16, 2014) (transcript available at https://www.whitehouse.gov/the-pressoffice/2014/10/16/press-briefing-press-secretary-josh-earnest-10162014)
(stating
President Obama is not “actively considering [a national health emergency] right now”).
21
Press Release, Sylvia M. Burwell, Sec’y, Dep’t of Health & Hum. Servs., Sec’y
Burwell Issues Declaration Under PREP Act to Support Dev. of Ebola Vaccines (Dec. 9,
2014), available at http://www.hhs.gov/news/press/2014pres/12/20141209a.html.
22
Public Readiness and Emergency Preparedness (PREP) Act, Pub. L. No. 109-148
(codified in Public Health Service Act, 42 U.S.C. §§ 247d-6d, 247d-6e).
23
Letter from Daniel P. Malloy, Governor, State of Conn., to the Honorable Denise
Merill, Sec’y of the State, and Clerks of the General Assembly (Oct. 7. 2014),
http://www.governor.ct.gov/malloy/lib/malloy/2014.10.07_Declaration_of_Public_
Health_Emergency.pdf.
348
UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
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misunderstood. 24 Quarantine is designed to separate and restrict the
movement of persons suspected or known to be exposed to an infectious
disease. 25 Isolation, on the other hand, separates persons who are
suspected or known to be infected with an infectious disease. 26 The
powers to issue and enforce quarantine and isolation orders are primarily
vested in state and local public health agencies. 27 At the federal level, the
Public Health Service Act affords the Secretary of DHHS the power to
restrict movement of persons with specific infectious diseases, including
EVD, into and throughout the United States.28 Authority to carry out
these functions at the federal level is delegated to CDC. 29 CDC can
quarantine or isolate persons travelling to the U.S. or across state lines.
However, it does not typically exercise these powers. 30 Variations among
federal and state law in how and when to implement emergency powers
can lead to confusion, especially during exigencies.31
Implementation of isolation and quarantine orders entails significant
due process protections, including adequate evidentiary proof (often
grounded in clear and convincing evidence),32 sufficient notice, right to a
hearing and counsel, and assurances that medical and other needs of
affected persons are met. 33 Social distancing measures, including
quarantine and isolation, were necessitated by the lack of
pharmaceuticals in West Africa, although their effectiveness in
24
JAMES G. HODGE, JR., PUBLIC HEALTH LAW IN A NUTSHELL 93–94 (2013).
Legal Authorities for Isolation and Quarantine, CDC, http://www.cdc.gov/
quarantine/aboutLawsRegulationsQuarantineIsolation.html (last updated Oct. 8, 2014)
(emphasis added).
26
HODGE, JR., supra note 24, at 94 (2013) (emphasis added).
27
Id. at 93-94; see also State Quarantine and Isolation Statutes, NAT’L CONF. OF
STATE LEGISLATURES (Oct. 29, 2014), http://www.ncsl.org/research/health/statequarantine-and-isolation-statutes.aspx.
28
42 U.S.C. § 264 (2012).
29
Legal Authorities for Isolation and Quarantine, CDC, http://www.cdc.gov/
quarantine/aboutLawsRegulationsQuarantineIsolation.html (last updated Oct. 8, 2014).
30
Id.
31
Jim Kuhnhenn, Where’s Czar? Ebola Raises Management Questions, ASSOCIATED
PRESS
(Oct.
28,
2014,
5:48
PM), http://bigstory.ap.org/article/
c736c4d56e30479d877e79e7cf87e3e7/wheres-czar-ebola-raises-management-questions.
32
Christine M. Grant & Patricia I. Elliott, 21st-Century Scientific Evidence Issues in
Public Health Quarantines and Takings, in SCIENTIFIC EVIDENCE REVIEW: CURRENT
ISSUES AT THE CROSSROADS OF SCIENCE, TECHNOLOGY AND THE LAW, MONOGRAPH NO. 7
127, 133 (Christine M. Grant & Helen E. Witt eds. 2006) (“State courts traditionally have
given great deference to public health authorities requesting orders of quarantine.
However, the claim of authority is not absolute—it can be refuted with facts . . . .Civil
confinement usually requires clear and convincing evidence of the need for quarantine,
coupled with supervised detention.”).
33
Lawrence O. Gostin, James G. Hodge, Jr. & Scott Burris, Is the United States
Prepared for Ebola?, 312 JAMA 2497, 2498 (2014).
25
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COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
349
combatting EVD varied. 34 Because symptoms may not appear for up to
twenty-one days after first exposure, 35 quarantine measures in response
to EVD have a finite end point. However, EVD social distancing
measures must be stringently enforced to prove effective because of the
high morbidity and mortality rates associated with the disease.
Use of social distancing powers is controversial due to the direct
infringement on individual liberty and autonomy, among other interests.
Quarantine orders, based on potential exposure to infectious conditions
like EVD, are especially contentious. Mandatory enforcement can
negatively impact quarantined individuals (as was the case with those
potentially exposed to Thomas Eric Duncan) 36 and contribute to
compliance failures.
In October 2014, Maine nurse Kaci Hickox garnered significant
media attention when she resisted a quarantine order upon returning to
the U.S. from treating EVD patients in Sierra Leone. 37 Hickox only
exhibited a minor fever when arriving at Newark Liberty International
Airport. 38 However, Governors Andrew Cuomo (New York) and Chris
Christie (New Jersey) implemented an automatic quarantine for any
health care worker (“HCW”) returning from West Africa who had come
in contact with EVD patients (exceeding CDC recommended guidance).
Governor Christie worked with state public health agents to place Hickox
in a mandatory quarantine setting outside a Newark hospital. 39 After
three days, New Jersey reversed the mandatory quarantine and Hickox
returned to her home in Maine, where she faced another court ordered
quarantine. 40 Still presenting no outward symptoms, Hickox resisted the
order, 41 arguing that the automatic quarantines unconstitutionally
34
Abhishek Pandey et al., Strategies for Containing Ebola in West Africa, 346 SCI.
991, 992 (2014).
35
Ebola Virus Disease, Signs and Symptoms, CDC, http://www.cdc.gov/vhf/Ebola/
symptoms/index.html (last updated Nov. 2, 2014).
36
After Thomas Eric Duncan’s death in Dallas, Texas, his contacts were subject to a
mandatory quarantine. While none of the contacts actually became infected, many were
stigmatized or unable to return to work or school. Kevin Sack et al., Life in Quarantine:
21 Days of Fear and Loathing, N.Y. TIMES, Oct. 19, 2014, at A1.
37
Jess Bidgood & Dave Philipps, Judge in Maine Eases Restrictions on Nurse, N.Y.
TIMES, Nov. 1, 2014, at A18.
38
Id.
39
Id.
40
Temporary Order, Mayhew v. Hickox, No. CV-2014-36 (Me. Dist. Ct. Oct. 30,
2014).
41
In view of the media and trailed by a police car, Hickox went for a bike ride with her
boyfriend to publicly defy the quarantine order. Sydney Lupkin & Aaron Katersky, Talks
with Ebola Nurse Kaci Hickox Fail, Governor to Use ‘Full Authority’, ABC NEWS (Oct.
30, 2014, 10:13 AM), http://abcnews.go.com/Health/talks-ebola-nurse-kaci-hickox-failgovernor-full/story?id=26569596.
350
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infringed on her liberty interests and discouraged HCWs from providing
aid in EVD affected countries. 42 State officials in Maine defended the
quarantine as a public health necessity43 authorized by its quarantine
law. 44 When challenged, the Maine District Court relaxed the court
order, allowing Hickox to move about freely, submit to self-monitoring,
and report any upcoming travel. 45 Ultimately, Hickox never contracted
EVD. Her case illustrates the potential pitfalls and inconsistencies related
to quarantine and isolation powers or other social distancing measures.
C.
Travel Restrictions
Like social distancing measures, government restrictions on
individual travel and movement implicate fundamental liberties. Yet
these powers are vital to maintaining the public’s health and often
explicitly authorized by law. 46 Travel restrictions and screening are
exercised at the federal and state levels. Federal regulations may limit
persons with EVD from traveling between states. 47 States may also have
their own authority to restrict one’s travel within and outside its borders
for public health purposes. 48 Furthermore, federal oversight of passport
approval, 49 immigration law, 50 transportation regulations, 51 and “Do Not
Board” requirements 52 may restrict the entry or exit of persons into and
out of the U.S.
Federal powers to restrict travel are broad, but federal officials have
been reluctant to completely prohibit travel to and from the affected
EVD regions. WHO has consistently recommended against closing
borders in response to EVD, in part because border closures make it
“difficult to transport supplies, personnel, and other resources.”53 Some
42
Bidgood & Philipps, supra note 37, at A18.
Id.
44
ME. REV. STAT. ANN. tit. 22 § 810 (2004).
45
Order Pending Hearing, Mayhew v. Hickox, No. CV-2014-36 (Me. Dist. Ct. Oct.
31, 2014).
46
HODGE, JR., supra note 24, at 48.
47
42 C.F.R. § 70.3 (2014).
48
See, e.g., MICH. COMP. LAWS ANN. § 30.410 (2012).
49
22 U.S.C. § 211a (2012).
50
8 U.S.C. § 1182(a)(1)(A) (2012).
51
14 C.F.R. § 382.21 (2014).
52
Federal Air Travel Restrictions for Public Health Purposes—United States, June
2007-May 2008, 57 CDC MORBIDITY & MORTALITY WKLY. REP. 1009, 1009–12 (2008).
53
WHO Urges Countries to Avoid Actions that Compromise Ebola Response Efforts,
WORLD HEALTH ORG. (Aug. 28, 2014), http://www.afro.who.int/en/media-centre/
pressreleases/item/6929-who-urges-countries-to-avoid-actions-that-compromise-ebolaresponse-efforts.html.
43
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COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
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members of Congress 54 called for President Obama to close the U.S.
border to West African nations, but he repeatedly refused.55 CDC
Director Dr. Thomas Frieden warned that border closures have the
potential to drive Ebola cases underground, causing the outbreak to
spread undetected and continue indefinitely. 56 CDC has warned
Americans to avoid nonessential travel to Liberia, Guinea, and Sierra
Leone, 57 but does not limit the provision of resources to those countries.
Rather than instituting mandatory travel restrictions in response to
EVD (as some countries have required), U.S. authorities have opted for
tighter screening protocols intended to prevent disease spread and allow
aid to continue to reach the affected countries. On October 8, 2014, CDC
announced enhanced screening measures at five U.S. airports to detect,
assess, and respond to potential Ebola cases. 58 Additionally, CDC issued
recommended guidance regarding the screening and monitoring of
persons with potential Ebola exposure. 59 However, states are not required
to follow CDC’s guidance. Accordingly, many opted to enforce their
own more or less restrictive protocols. 60 Other institutions may also opt
(as Emory did) to implement their own guidelines accounting for specific
54
See Steven Nelson, Congressman: Close Border to Ebola Countries, US NEWS (July
30, 2014, 11:52 AM), http://www.usnews.com/news/articles/2014/07/30/congressmanclose-border-to-ebola-countries; Sarah Ferris, Dems Call for Ebola Flight Ban, THE HILL
(Oct. 9, 2014, 4:03 PM), http://thehill.com/policy/healthcare/220317-dems-call-forobama-to-ban-flights-from-ebola-countries; Arlette Saenz & John Parkinson, 4 Things
Some DC Lawmakers Want Obama to Do About Ebola, ABC NEWS (Oct. 17, 2014, 12:02
PM), http://abcnews.go.com/blogs/politics/2014/10/4-things-some-dc-lawmakers-wantobama-to-do-about-ebola/.
55
President Barack Obama, Remarks by the President After Meeting on Ebola (Oct. 6,
2014) (transcript available at https://www.whitehouse.gov/the-press-office/2014/10/06/
remarks-president-after-meeting-ebola) (“Because of the measures that we’ve put in
place, as well as our world-class health system and the nature of the Ebola virus itself -which is difficult to transmit—the chance of an Ebola outbreak in the United States is
extremely low.”).
56
Tom Frieden, CDC Chief: Why I Don’t Support a Travel Ban to Combat Ebola
Outbreak, FOX NEWS (Oct. 9, 2014), http://www.foxnews.com/opinion/2014/10/09/cdcchief-why-dont-support-travel-ban-to-combat-ebola-outbreak/.
57
Travel Health Notices, CDC, http://wwwnc.cdc.gov/travel/notices (last updated Mar.
6, 2015).
58
Press Release, CDC, Enhanced Ebola Screening to Start at Five U.S. Airports and
New Tracking Program for all People Entering U.S. From Ebola-affected Countries (Oct.
8, 2014) (available at http://www.cdc.gov/media/releases/2014/p1008-ebola-screening.
html) (describing enhanced screening at airports in New York, NY, Washington, DC,
Newark, NJ, Chicago, IL, and Atlanta, GA).
59
Interim U.S. Guidance for Monitoring and Movement of Persons with Potential
Ebola Virus Exposure, CDC, http://www.cdc.gov/vhf/ebola/exposure/monitoring-andmovement-of-persons-with-exposure.html (last updated Dec. 24, 2014).
60
State Ebola Protocols, CDC, http://www.cdc.gov/phlp/publications/topic/ebola.html
(last updated Mar. 9, 2015).
352
UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
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workplace-related factors (e.g., students, faculty, researchers and other
non-HCW employees). 61
D.
Duty to Treat
Do physicians and other medical professionals have a duty to treat
patients with highly infectious and dangerous diseases? What rights of
employees to safety or other concerns must be considered in deciding to
accept and treat a patient with a dangerous disease? Does a safety
concern of a HCW ever outweigh any obligation to treat a patient?
Emory’s team of physicians, nurses, lab technologists, chaplains, and
others enthusiastically expressed willingness to accept and treat U.S.bound patients with EVD as reflected in the comments provided by Dr.
Kent Brantly during a press conference on the day of his discharge with
the entire Emory care team present on stage. 62 Although Emory Hospital
never faced the issue of having a physician or employee refuse to treat a
highly infectious patient, HCWs’ resistance to treat highly infectious
patients could be a critical factor in other cases, especially in facilities
lacking personnel who are prepared to handle patients with diseases like
EVD. 63
In Bragdon v. Abbot, 64 the U.S. Supreme Court clarified that a
medical professional may not categorically refuse to treat disabled
patients (as defined in the Americans with Disabilities Act of 1990
(ADA)) for discriminatory reasons. Notwithstanding ethical principles,65
medical professionals can refuse to treat patients in a number of
circumstances as a general rule under common law. 66 In Childs v. Weis, 67
61
Guidelines for Travel to Countries Affected by Ebola Virus Disease, EMORY UNIV.
(Nov. 7, 2014), http://global.emory.edu/support/travel/ebola_travel_policy.html.
62
Dr. Kent Brantly, Press Conference Announcing Discharge of Dr. Kent Brantly &
Nancy Writebol (Aug. 21, 2014) (video available at http://www.wsbtv.com/news/news/
ebola-patients-released-emory-university-hospital/ng6jR/) [hereinafter Emory August 21
Press Conference].
63
See Manny Fernandez, Dallas Nurse Contracts Ebola Virus, Elevating Response
and Anxiety¸ N.Y. TIMES, Oct. 13, 2014, at A1.
64
Bragdon v. Abbott, 524 U.S. 624 (1998).
65
While the law may impose no, or a limited, duty on physicians to treat patients with
AIDS and other infectious diseases, physicians’ moral and ethical obligations are more
well-established. Ann Bitton Gazvy & James V. Hertzel, To Treat or Not to Treat:
Healthcare Providers’ Duties, 126 N.J. Law., Feb. 1989, at 52.
66
See, e.g., Anderson v. Houser, 523 S.E.2d 342 (Ga. Ct. App. 2000); see also Polly J.
Price, Ebola and the Law in the United States: A Short Guide to Public Health Authority
and Practical Limits 17 (Emory Legal Studies Research Paper No. 14-299), available at
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2538187; Christopher C. White,
Health Care Professionals and Treatment of HIV-Positive Patients: Is There an
Affirmative Duty to Treat Under Common Law, the Rehabilitation Act, or the Americans
with Disabilities Act?, 20 J. LEGAL MED. 67, 77 (1999).
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COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
353
a lower court expressed this “no duty” rule.68 Since the physician/patient
relationship is essentially contractual in nature and no obligation to treat
arises until its creation,69 medical professionals can terminate an existing
physician/patient relationship with proper notice and transition to an
alternative provider. 70 However, refusal to treat can result in professional
sanctions by the governing licensing boards in a particular state. 71
Even if EVD patients are likely considered disabled under the ADA,
a physician can defend a decision to deny treatment if the patient
presents a significant risk to the physician’s health. 72 The ADA does not
require that a person benefit from services where such individual poses a
“direct threat” to the health or safety of others, meaning a significant risk
to the health or safety of others that cannot be eliminated by a
modification of policies, practices, or procedures or by the provision of
auxiliary aids or services.” 73 There is no standard definition of
“significant risk”, as each situation must be determined on a case-by-case
basis balancing objective and prevailing medical standards and science
with a physician’s judgment.
In Bragdon, the Supreme Court noted “the importance of prohibiting
discrimination against persons with a recognized disability while
protecting others from significant health and safety risks, resulting, for
instance, from a contagious disease.” 74 A physician’s belief, even in
good faith, that a significant risk existed to his or her health would not
necessarily provide relief from liability under the ADA. However, in the
event of a new, unknown pathogen that lacks medical objectives or
scientific information regarding transmission risks, a physician or other
67
Childs v. Weis, 440 S.W.2d 104 (Tex. App. 1969).
Id. at 107 (“Since it is unquestionably the law that the relationship of physician and
patient is dependent on contract, either express or implied, a physician is not . . . liable for
arbitrarily refusing to respond to a call of a person even urgently in need of medical or
surgical assistance provided that the relation of physician and patient does not
exist . . . .”).
69
White, supra note 66, at 78.
70
Termination of the physician/patient relationship must be carefully and
appropriately accomplished with adequate notice to avoid claims of patient abandonment.
AMERICAN MEDICAL ASSOCIATION, CODE OF MEDICAL ETHICS 261, OP. 8.115—
TERMINATION OF THE PHYSICIAN-PATIENT RELATIONSHIP (2008); Can My Physician
Terminate My Care or Discontinue Seeing Me?, GA. COMPOSITE MED. BD.,
http://medicalboard.georgia.gov/can-my-physician-terminate-my-care-or-discontinueseeing-me (last visited Mar. 22, 2015).
71
Price, supra note 66, at 17-18; White, supra note 66, at 93 n.173.
72
Ariel R. Schwartz, Note, Doubtful Duty: Physicians’ Legal Obligation to Treat
During an Epidemic, 60 STAN. L. REV. 657, 671 (2007).
73
42 U.S.C. § 12182(b)(3) (2012); Schwartz, supra note 72, at 671.
74
See Schwartz, supra note 72, at 671 (citing Bragdon, 524 U.S. at 649; Sch. Bd. of
Nassau Cty. v Arline, 480 U.S. 273, 287 (1987)).
68
354
UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
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health provider might legitimately posit that there is a “significant risk”
outweighing any obligation to treat under the ADA or other ethical and
moral principles.
E.
Emergency Medical Treatment and Active Labor Act
One exception to the general “no duty to treat” principle discussed
above is a provider’s obligation to treat and stabilize patients in
emergency settings. If a patient presents in a hospital emergency room
(ER), this assessment, treatment, and stabilization requirement is wellestablished under the federal Emergency Medical Treatment and Active
Labor Act (EMTALA). 75 EMTALA requires hospitals that receive
federal funds (through Medicare and Medicaid) to provide stabilizing
treatment to patients presenting with emergency conditions in the ER
without regard for the patient’s ability to pay. Once the patient is stable,
they may be appropriately admitted or transferred for further care.
EMTALA focuses solely on the hospital’s obligations to assess
whether an “emergency” exists (e.g., childbirth is considered an
emergency) and, if so, provide stabilizing care and treatment.76 As a
result, hospitals must treat patients with highly infectious and
communicable diseases if the conditions are deemed to be an emergency
(such as EVD). Absent an EMTALA waiver pursuant to a federallydeclared emergency, EMTALA requires stabilizing treatment even in the
face of potential threats to the health and safety of HCWs. Separate
federal standards under the Occupational Safety and Health Act (OSHA),
discussed below, may also apply.
EMTALA obligations extend to physicians by way of (1)
employment of physicians by the hospital or health system, (2) a contract
between a physician and a hospital under which the physician agrees to
provide ER services, or (3) in the context of many community hospitals,
by the physician’s staff privileges. For example, as noted by Ariel
Schwartz, “if an on-call physician negligently acts inconsistent with the
hospitals’ EMTALA obligations,” 77 or violates hospital medical staff
bylaws, the physician and the hospital may face liability under EMTALA
and up to a $50,000 penalty. Additionally, the physician may be liable
via contract, which may include possible expulsion from the medical
staff pursuant to medical staff bylaws. 78
Hospitals have limited flexibility in how they satisfy their EMTALA
obligations during emergencies. DHHS’ policies may allow hospitals to
75
76
77
78
42. U.S.C. §§ 1395dd(a)–(b) (2012).
Id.
Schwartz, supra note 72, at 679.
§ 1395dd(d)(1); Schwartz, supra note 72, at 679.
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COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
355
avoid EMTALA sanctions for direction, relocation, or transfer of patients
prior to screening or stabilization in limited circumstances pursuant to a
Section 1135 waiver. 79 Hospitals can also transfer patients in nonemergency situations. The federal Centers for Medicare and Medicaid
Services (CMS) issued the following guidelines in 2002:
CMS does not require that a hospital’s medical staff
provide on-call coverage 24 hours/day, 365 days/year. If
there comes a particular time that a hospital does not
have on-call coverage for a particular specialty, that
hospital lacks capacity to treat a patient needing that
specialty service and it is therefore appropriate to
transfer the patient because the medical benefits of the
transfer outweighs the risks . . . Medicare does not set
requirements on how frequently a hospital’s medical
staff of on-call physicians is expected to provide on-call
coverage . . . .We are also aware that there are some
hospitals that have limited financial means to maintain
on call coverage all of the time . . . CMS allows
hospitals flexibility to comply with EMTALA
obligations by maintaining a level of on-call overage that
is within their capability. 80
In many cases, patients may present in a non-emergent state or in
settings other than a hospital ER, such as an outpatient physician clinic.
Even though EMTALA is not implicated, providers should have clear
protocols in place, including: (1) questions used to screen patients
concerning potential exposure; (2) isolation of patients if answers to the
screening questions are positive; (3) procedures for testing for EVD (or
other communicable diseases); (4) transfer protocols, agreements to
transfer to the hospital ER, or procedures for admission to the hospital;
and (5) if there is no specialized service in the facility, a transfer to a
facility that can treat the patient.
79
Public Health Emergency Declaration Q&As, DEP’T OF HEALTH & HUMAN SERVS.,
http://www.phe.gov/Preparedness/legal/Pages/phe-qa.aspx (last updated Apr. 24, 2013).
80
Schwartz, supra note 72, at 680 (citing Memorandum from Dir., Survey &
Certification Group., Dep’t of Health & Human Servs., to Associate Reg’l Adm’rs 2
(June 13, 2002), available at http://www.cms.hhs.gov/SurveyCertificationGenInfo/
downloads/SCLetter02-34.pdf).
356
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F.
Right to a Safe Working Environment, Workers’
Compensation, and the Family Medical Leave Act
Related to, and balanced with, the duty to treat is the right of
employees in the workplace to a safe working environment mandated by
OSHA. 81 After the initial decision was made to accept the first two
patients, Emory’s next and equally important question was how to
provide that care safely—both for the patients and for the HCWs on the
care team. As part of Emory’s SCDU, the Environmental Health and
Safety Officer was constantly present and led the OSHA response
requirements and personal protective equipment (PPE) training with the
HCWs. As discussed below, Emory’s adherence to clinical protocols and
safety measures were critical both to successful treatment and to assuring
employees of their own personal safety.
Generally, employers have to provide a workplace free from
“recognized hazards that are causing or are likely to cause death or
serious physical harm” to employees. 82 When dealing with a highly
infectious disease like EVD, OSHA expects employers to develop a
program based upon a “hazard assessment” of potential exposure at the
worksite, including: (1) conducting employee awareness and other
trainings regarding the potential hazard, (2) creating protocols and
procedures requiring the issuance of PPE if necessary to prevent
infection and transmission, (3) providing a means of reporting infection
and medical surveillance for infected employees, (4) maintaining
appropriate documentation of all of the foregoing, (5) preserving and
maintaining patient medical records, and (6) appropriately recording with
OSHA any occupationally-related infections.83
Similarly, employees must comply with safety and health standards
and regulations. 84 Employees can refuse to work when there is a
81
29 U.S.C. § 654 (2012); see also John B. Flood, Revisiting the Right to Refuse
Hazardous Work Amidst the Anthrax Crisis of 2001, 5 U. PA. J. LAB. & EMP. L. 545, 567
(2003); Refusing to Work Because Conditions are Dangerous, OCCUPATIONAL SAFETY &
HEALTH ADMIN., https://www.osha.gov/as/opa/worker/refuse.html (last visited Mar. 22,
2015) (public guidance issued by OSHA discussing an employee’s right to refuse work).
82
29 U.S.C. § 654 (2012).
83
OCCUPATIONAL SAFETY & HEALTH ADMIN., OSHA 3122-06R, PRINCIPAL
EMERGENCY RESPONSE AND PREPAREDNESS REQUIREMENTS AND GUIDELINES (2004).
84
29 U.S.C. § 143 (2012) (“Nothing in this chapter shall be construed to require an
individual employee to render labor or service without his consent, nor shall anything in
this chapter be construed to make the quitting of his labor by an individual employee an
illegal act; nor shall any court issue any process to compel the performance by an
individual employee of such labor or service, without his consent; nor shall the quitting
of labor by an employee or employees in good faith because of abnormally dangerous
conditions for work at the place of employment of such employee or employees be
deemed a strike under this chapter.”).
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reasonable apprehension of death or serious physical harm and no less
drastic alternative is available.85 Related to significant health hazards that
may result from treating EVD patients, employees could also refuse to
work because they believe that their health is in imminent danger due to
the actual presence or reasonable probability of the disease. Such
employees are engaged in “protected activity” under the Act 86 and thus
not subject to adverse action by the employer for refusal to work unless
the employer can establish through “objective” evidence that (1) there is
no hazard or (2) its response plan will protect employees from exposure.
Like any employer, hospitals must also address issues relating to the
potential for workers’ compensation benefits and the applicability of the
Family and Medical Leave Act (FMLA).87 With respect to workers’
compensation benefits, in the event that an employee contracts EVD as a
result of occupational exposure (in other words, the illness arises out of
and in the course of employment as proven by the employee through
competent medical evidence), the employee may be entitled to receive
temporary total disability benefits in lieu of wages, reasonable and
necessary medical treatment, and an award for any resulting permanent
disability (e.g., reduced respiratory capacity). An employer should
evaluate whether it has adequate worker’s compensation insurance
coverage and coverage limits that include occupational diseases.
If an employee contracts the disease and it is not occupationally
related, the employee may be entitled to disability benefits if the
employer provides such benefits. Again, the employer should carefully
evaluate the extent of benefits and any exclusions. The employer must
consider whether EVD is going to involve significant medical issues by
determining (1) whether the employee is infectious; (2) what type of
treatment is necessary; (3) whether the employee presents a health risk to
others; and (4) when the employee can safely return to work. 88
Employers should also identify competent medical professionals with
expertise in infection control that can advise on all medically related
85
Whirlpool Corp. v. Marshall, 445 U.S. 1 (1980); see also Stepp v. Review Bd. of the
Indiana Emp’t Sec. Div., 521 N.E. 2d 350 (Ind. Ct. App. 1988) (employee who refused to
perform tests on fluids with AIDS warning label was properly suspended and
discharged); Marshall v. N.L. Indus., Inc., 618 F. 2d 1220, 1224 (7th Cir. 1980)
(discharge of an employee in response to the employee’s good faith refusal to expose
himself to conditions he reasonably believes are dangerous is discriminatory).
86
29 U.S.C. § 660(c) (2012); see also U.S. DEP’T OF LABOR, AUDIT REPORT NO. 05-97107-10-105, NATIONWIDE AUDIT OF OSHA’S SECTION 11(C) DISCRIMINATION
INVESTIGATIONS (1997).
87
29 U.S. C. § 2601 (2012); 29 C.F.R. pt. 825 (2014).
88
Mark A. Lies II et al., Ebola and Employer Liability Issues, SEYFARTH SHAW LLP
(Oct. 10, 2014), http://www.environmentalsafetyupdate.com/osha-compliance/ebola-andemployer-liability-issues/.
358
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issues, including worker’s compensation. 89 Under the FMLA, eligible
employees may be entitled to up to twelve weeks of unpaid leave if the
employee or a spouse, child, or parent has a “serious health condition,”
like EVD. This is especially important considering that both Emory and
CDC issued guidelines mandating a twenty-one-day period of isolation
for persons with EVD. 90
Emory carefully considered all of these laws in preparing for the
arrival of its EVD patients. Providing a safe working environment was
critical. Emory also determined that FMLA would be fully utilized if
applicable and requested (which it was not). With respect to workers’
compensation benefits, Emory determined that any worker who
contracted EVD would be entitled to workers’ compensation related to
their medical expenses, time away from work, and post-traumatic
syndrome disease at a rate of one-hundred percent (higher than the sixtysix percent rate required in Georgia for disability91). Fortunately, this
benefit was not utilized at Emory. With respect to a potential claim for
“fear of contracting EVD,” such claims were to be adjudged ineligible
for workers’ compensation unless the employee actually contracted the
disease. This also was never an issue at Emory, but could be in a
different setting and circumstances.
G.
HIPAA Privacy Rule and Other Issues of Confidentiality
When treating patients with a highly infectious, lethal disease that is
the subject of massive media attention, a paramount obligation is to
maintain the confidentiality of patient information under federal and state
law, including the Health Insurance Portability and Accountability Act
(“HIPAA”) 92 and the accompanying Privacy Rule. 93 Despite the fact that
the identities and images of the patients treated at Emory (and indeed
elsewhere nationally) were universally published, Emory patients were
classified as “no information” patients, meaning that specifics of their
condition, or even their identities, were carefully protected and managed
in all public communications. In communications with the news media,
89
Id.
Interim U.S. Guidance for Monitoring and Movement of Persons with Potential
Ebola Virus Exposure, CDC, http://www.cdc.gov/vhf/ebola/exposure/monitoring-andmovement-of-persons-with-exposure.html (last updated Dec. 24, 2014) [hereinafter CDC
Guidelines]; John Fox, Bill Bornstein & Susan Grant, Emory Healthcare Ebola
Preparedness Protocols, EMORY HEALTHCARE, http://www.emoryhealthcare.org/ebolaprotocol/ehc-message.hmtl (last visited Mar. 22, 2015) [hereinafter Emory Protocols].
91
Georgia Workers’ Compensation Act, O.C.G.A. § 34-9-261 (2014)
92
Health Insurance Portability and Accountability Act of 1996, Pub. L. 104-191, 110
Stat. 1938.
93
45 C.F.R. §§ 160, 164.102-164.106, 164.500-164.534 (2014).
90
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COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
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the Emory care team never used the patients’ names until Dr. Brantly’s
news conference prior to his discharge from the Hospital. These actions
appeared mysterious to the media, but Emory’s respect for confidential
information was maintained throughout. In public communications,
Emory’s team educated the media and the public on the disease itself,
attempting to dispel fears, misunderstandings, and inaccuracies.
Heightened risks to patient privacy and the need to control
communications were recognized immediately at Emory. Its Chief
Privacy Officer was one of the first administrative employees brought
onto the team with other clinical care and operations personnel. 94 Efforts
to ensure HIPAA Privacy Rule compliance included several email
“blasts” to all Emory healthcare employees reminding them of the
obligations to ensure patient privacy, and warning about sharing any
information even if no identifiable patient information was used.
Employees were reminded not to talk about or discuss patient
information in public areas (cafeterias, lobbies, etc.) and not to post
anything about patients on any social media websites. Emory also
activated an additional control on its electronic medical records system
so workers who tried to access the EVD patients’ records were stopped
by an electronic message asking the employees to affirmatively check a
box attesting that they were authorized to view the information before
the system permitted them to continue. Audit trials were conducted to see
if anyone accessed the records without permission. Similar audits at the
University of Nebraska’s Medical Center led to the discovery and
termination of two workers who violated privacy requirements by
reviewing information about one of the EVD patients treated there. 95
In November 2014, DHHS issued a special Bulletin specifically
related to HIPAA Privacy in Emergency Situations in light of the EVD
outbreak. 96 DHHS sought to clarify that that while the protections of the
Privacy Rule are not set aside in an emergency, there are “ways to ensure
that appropriate uses and disclosures of the information still may be
made when necessary to treat a patient, to protect the nation’s public
health, and for other critical purposes.” 97
DHHS clarified that protected health information may be disclosed
(1) to a public health authority; (2) at the direction of a public health
94
Hospitals with Ebola Patients are Under Great Pressure to Ensure Their Privacy,
14 REP. ON PATIENT PRIVACY, Nov. 2014, at 1, available at http://aishealth.com/sites/all/
files/marketplace_pdf_samples/samplerpp.pdf.
95
Id. at 4.
96
Memorandum from the Dep’t of Health & Human Servs., Bulletin: HIPAA Privacy
in Emergency Situations (Nov. 2014) (available at http://www.hhs.gov/ocr/privacy/
hipaa/understanding/special/emergency/emergencysituations.pdf).
97
Id.
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authority or to a foreign government acting in collaboration with a public
health authority; (3) to “persons at risk” of contracting or spreading the
disease; (4) to family, friends and others “involved in an individual’s
care and for notification;” (5) to anyone “as necessary to prevent or
lessen a serious and imminent threat to the health and safety of a person
or the public” consistent with applicable law; and (6) to the media or
others not involved if the patient has not objected to or restricted the
release of this information, or the patient is incapacitated and the
disclosure is believed to be in the best interests of the patient and
consistent with any prior expressed preferences of the patient.98 With
respect to the permitted disclosure to the media, patient consent is key.
Also, anyone disclosing patient information may only share the
“minimum necessary” information to accomplish the purpose of
disclosure. 99
H.
Americans with Disabilities Act
As hospitals decide whether to accept and treat patients with EVD or
similar communicable diseases in the future, 100 patient disability status
will be an important consideration. Generally, persons with
communicable or otherwise infectious diseases may satisfy the
requirements of Section 504 of the Rehabilitation Act of 1973 (Rehab
Act), 101 the ADA (involving health care and human service providers and
institutions), 102 and the ADA Amendments Act of 2008 (ADAAA), 103
and may therefore be protected against discriminatory acts, including the
decision by a provider not to accept or treat a covered individual. These
statutes all prohibit covered entities (such as hospitals) from
discriminating against (i.e., refusing to treat) persons with disabilities in
98
Id.
Id. (“In general, . . . affirmative reporting to the media or the public at large about an
identifiable patient, or the disclosure to the public or media of specific information about
treatment of an identifiable patient, such as specific tests, test results or details of a
patient’s illness, may not be done without the patient’s written authorization (or the
written authorization of a personal representative who is a person legally authorized to
make health care decisions for the patient). See 45 CFR 164.508 for the requirements for
a HIPAA authorization.”).
100
The decision to accept and treat these Ebola patients at Emory was clinically based,
and therefore did not focus on legal analysis. Nevertheless, under different circumstances
or with another disease, the issue may play a larger role in the decision process.
101
Rehabilitation Act of 1973, Pub. L. No. 93-112, 87 Stat. 355, 394 (1973) (codified
as amended at 29 U.S.C. § 794).
102
Americans with Disabilities Act of 1990, Pub. L. No. 101-336, 104 Stat. 327 (1990)
(codified as amended at 42 U.S.C. §§ 12101-12213 (2012)).
103
ADA Amendments Act of 2008, Pub. L. No. 110-325, § 2, 122. Stat. 3553, 3553-54
(2008).
99
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COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
361
providing benefits and services, or conducting programs and activities on
the basis of their disability. This leads to the ultimate question of whether
an infectious disease such as EVD is, in fact, a “disability.” 104
The Rehab Act (later incorporated into the ADA) protects
individuals defined as potentially benefitting from rehabilitation
services. 105 Amendments in 1974 expanded the definition of
“handicapped individuals” to include any person who (1) has a physical
or mental impairment which substantially limits one or more of such
person’s major life activities; (2) has a record of such an impairment; or
(3) is regarded as having such as impairment. 106 These definitional terms,
including what constituted a “physical or mental impairment” are not
defined by the Rehab Act 107 and were subsequently refined by DHHS, 108
although DHHS unequivocally stated that the list was “not
comprehensive” and that certain terms in the statute (i.e. whether the
condition “substantially limits” a person’s major life activities) were not
“capable of definition.” 109
What constitutes a handicap or a disability has been the subject of
considerable litigation following the passage of the Rehab Act and its
amendments, and particularly following the precedent-setting case of
School Board of Nassau County v. Arline. 110 In Arline, the Supreme
Court held that an individual with a contagious disease (in this case,
tuberculosis) is considered handicapped and thus entitled to protection
under the Rehab Act. The Court’s ruling in Arline has played a pivotal
role in the development of federal disability law, especially as applied to
persons diagnosed and living with HIV and AIDS because of the
communicable nature of HIV. 111
104
Office for Civil Rights, Your Rights Under Section 504 and the Americans with
Disabilities Act, DEP’T OF HEALTH & HUMAN SERVS., http://archive.hhs.gov/ocr/504ada.
html (last visited Mar. 24, 2015).
105
Rehabilitation Act of 1973, Pub. L. No. 93-112, 87 Stat. 355, 394 (1973).
106
Rehabilitation Act Amendments of 1974, Pub. L. No. 93-651, 89 Stat. 2–5 (1974)
(codified at 29 U.S.C. §§ 706, 780, 790 (1974)).
107
Nor were definitional terms subsequently defined in the ADA in 1990. Further
regulations provide guidance as to what constitutes a “physical or mental impairment” to
include a “physiological disorder or condition” that affects “one or more of the following
body systems: neurological, musculoskeletal, special sense organs, respiratory (including
speech organs,) cardiovascular, reproductive, digestive, genitourinary, hemic and
lymphatic, skin and endocrine.” 29 C.F.R. § 1630.2(h)(1) (2014).
108
45 C.F.R. pt. 84 (2014).
109
45 C.F.R. pt. 84 app. A.
110
Sch. Bd. of Nassau Cnty. v. Arline, 482 U.S. 273 (1973).
111
Donald H.J. Hermann, The Development of AIDS Federal Civil Rights Law: AntiDiscrimination Law Protection of Persons Infected With Human Immunodeficiency
Virus, 33 IND. L. REV. 783 (a comprehensive analysis and retrospective of the application
of the public health laws and federal and state decisions relating to persons with HIV
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Whether an individual infected with EVD or another highly
infectious disease has a disability and therefore qualifies for protection
under the ADA has not been settled or even addressed. 112 It would
appear that such an individual would satisfy the first two requirements of
a “disability,” (1) having “a physical or mental impairment that
substantially limits one or more major life activities”, and (2) having a
“record of such impairment,” 113 but whether the third prong of that test
(“regarded and treated as though they have an impairment”), is uncertain.
Although the mortality rates of EVD have been enormously high in West
Africa during the 2014 outbreak, all but one patient treated for EVD in
the United States have survived and been declared free of the disease and
not a threat to the public. 114
The ADA specifies that it does not apply to impairments that are
“transitory and minor,” defining “transitory” as “an impairment with an
actual or expected duration of 6 months or less.” 115 While the life cycle
of EVD appears to be less than six months (either ending in death or
being declared disease-free), the long-term health effects on persons who
are declared disease free are unknown and still undergoing scrutiny. 116
infection and AIDS); see Bragdon, 524 U.S. at 642 (a person with asymptomatic HIV is
entitled to claim protection under the ADA since it constituted an “impairment” that
substantially limits the “major life activity” of reproduction and therefore cannot be
denied medical treatment. However, HIV is not always a per se disability under the
ADA); see also Sussle v. Sirina Protection Sys. Corp., 267 F. Supp. 2d 285 (E.D.N. Y.
2003) (although Hepatitis C is a “physical impairment” and thus a disability, plaintiff
failed to demonstrate that the impairment substantially limited a major life activity).
112
Schwartz, supra note 72, at 669.
113
42. U.S.C. § 12102(1)(A)-(B) (2012); see also The ADA: Questions and Answers,
EQUAL EMP’T OPPORTUNITY COMM’N, http://www.eeoc.gov/eeoc/publications/adaqa1.
cfm (last visited Mar. 24, 2015) (“The first part of the definition makes clear that
the ADA applies to persons who have substantial, as distinct from minor, impairments,
and that these must be impairments that limit major life activities such as seeing, hearing,
speaking, walking, breathing, performing manual tasks, learning, caring for oneself, and
working. An individual with epilepsy, paralysis, a substantial hearing or visual
impairment, mental retardation, or a learning disability would be covered, but an
individual with a minor, non-chronic condition of short duration, such as a sprain,
infection, or broken limb, generally would not be covered. The second part of the
definition would include, for example, a person with a history of cancer that is currently
in remission or a person with a history of mental illness. The third part of the definition
protects individuals who are regarded and treated as though they have a substantially
limiting disability, even though they may not have such an impairment.”).
114
Bruce Ribner, Statement at News Conference (Aug. 21, 2014) (transcript available
at
http://news.emory.edu/stories/2014/08/ebola_press_conference_ribner_statement/
campus.html).
115
42. U.S.C. § 12102(3)(B).
116
Kelsey Ryan, Ebola Survivors Face Long Term Health Effects, THE WICHITA
EAGLE, http://www.kansas.com/news/local/article3952318.html (last updated Nov. 15,
2014, 11:21 AM).
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For example, one long-term effect currently being researched is the
medical condition of uveitis, an inflammation of the inner workings of
the eye. Researchers previously found that survivors of a 1995 EVD
outbreak in the Democratic Republic of the Congo developed eye pain
and vision problems after having the virus. 117 Additionally, chronic
arthralgia—pain in the joints—was also common in people living in
Gabon with EVD antibodies present in their blood.118 Due to its potential
long-term effects, EVD could potentially be defined as a medical
condition that is not “transitory.”
Assuming that the issue of transience is resolved, another issue is
whether a person with EVD would be regarded as having an impairment
or a substantially limiting disability, even though they may not actually
have, or currently be suffering from, such an impairment. In its
interpretation of this prong of the definitional test of a “disability,” the
Equal Employment Opportunity Commission states that “this provision
would protect a severely disfigured qualified individual from being
denied employment because an employer feared the ‘negative reactions’
of others.” 119 The fearful and negative public reaction to the EVD
outbreak in the United States may have devastating effects even to third
parties who themselves were not infected with EVD but who simply had
contact with infected (though asymptomatic) patients. 120 While important
to consider, it is too early at this stage to predict the legal outcome if a
patient who has been previously infected with EVD, survives, and then
faces some sort of discriminatory action.121
I.
Crisis Standards of Care
Crisis standards of care (CSC) substantially alter how health care
facilities operate and deliver care as necessitated by widespread or
catastrophic disaster.122 Operating under such standards shifts the focus
117
Kapay Kibadi et al., Late Opthalmologic Manifestations in Survivors of the 1995
Ebola Virus Epidemic in Kikwit, Democratic Republic of the Congo, 179 J. INFECTIOUS
DISEASES, Supp. 1, 1999, at S13, S13.
118
Ryan, supra note 116.
119
The ADA, supra note 113.
120
See Erik Ortiz, Ohio Bridal Shop Visited by Ebola Nurse Amber Vinson Is Closing
Down, (Jan. 9, 2015, 9:29 AM), http://www.nbcnews.com/storyline/ebola-virusoutbreak/ohio-bridal-shop-visited-ebola-nurse-amber-vinson-closing-down-n282861.
121
See Schwartz, supra note 72, for a comprehensive analysis of a physician’s duty to
treat in an epidemic, focusing in particularly on SARS, HIV-AIDS, avian influenza, and
Ebola.
122
INST. OF MED. OF THE NAT’L ACADS., GUIDANCE FOR ESTABLISHING CRISIS
STANDARDS OF CARE FOR USE IN DISASTER SITUATIONS: A LETTER REP. 18 (Bruce M.
Altevogt et al. eds., 2009), available at http://www.nap.edu/openbook.php?record_id=
12749&page=R1.
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of care from the individual patient to the population.123 Normally,
providing care at such a level potentiates legal claims against health care
providers, but a formal declaration at the state level offers legal powers
and protections for those providers. 124 Caring for the few domestic EVD
patients to date required efforts from hundreds of HCWs acting of their
own volition and access to specialized isolation facilities and supplies. 125
Without an approved treatment for EVD, administration of readily
available, routine medical treatments satisfies existing standards of
care, 126 even though some patients recovered after receiving
experimental treatments such as ZMapp and Brincidofovir. 127 In 2012,
the Institute of Medicine described how scarcity of personnel, space, and
medications when treating infectious diseases, like EVD, can necessitate
shifts from conventional standards of care to CSC. 128 Presently, the
United States has the capacity to concurrently treat only a small number
of EVD patients in specialized isolation facilities.129 A domestic EVD
outbreak would likely spread resources thin, temporarily transforming
123
COMMITTEE ON GUIDANCE FOR ESTABLISHING STANDARDS OF CARE FOR USE IN
DISASTER SITUATIONS, INST. OF MED. OF THE NAT’L ACADS., CRISIS STANDARDS OF CARE:
A SYSTEMS FRAMEWORK FOR CATASTROPHIC DISASTER RESPONSE 42 (2012), available at
http://www.phe.gov/coi/Documents/Committee%20on%20Guidance%20for%20Est%20
SC%20for%20Use%20in%20Disaster%20Situations%20Atlanta%20Conf.pdf
[hereinafter JOINT PREPAREDNESS CONFERENCE 2012]; INST. OF MED., CRISIS STANDARDS
OF CARE: A SYSTEMS FRAMEWORK FOR CATASTROPHIC DISASTER RESPONSE 33 (Dan
Hanfling et al. eds., 2012), available at http://www.nap.edu/openbook.php?record_id=
13351 [hereinafter Hanfling et al.] (While the focus under CSC becomes the needs of the
population, the purpose of establishing these standards is to ensure that “the best possible
care is given to individuals and the population as a whole”).
124
JOINT PREPAREDNESS CONFERENCE 2012, supra note 123 (situational circumstances
and a declaration from a state government indicating that CSC “will be in effect for a
sustained period” offers health care providers additional legal protections in determining
how to best allocate scarce resources.).
125
James G. Hodge, Jr. et. al, Law and the Public’s Health: Law, Medicine, and Public
Health Preparedness: The Case of Ebola, 130 PUB. HEALTH REP. 167, 167-68 (2015).
126
Makikio Kitamura, U.S. Ebola Patient Brantly to Be Released From Hospital,
BLOOMBERG BUS. (Aug. 31, 2014, 3:39 AM), http://www.bloomberg.com/news/articles/
2014-08-21/u-s-ebola-patient-brantly-to-be-released-from-hospital (Supportive care at
specialized isolation facilities remains the standard treatment for EVD. This includes
keeping the patient hydrated, replacing lost blood, and fighting opportunistic infections
with antibiotics.).
127
JAMES G. HODGE, JR., NETWORK PUB. HEALTH. L., EMERGENCY LEGAL
PREPAREDNESS CONCERNING EBOLA: A PRIMER, (Dec. 1, 2014), available at
https://www.networkforphl.org/_asset/dzf8u4/Ebola-Outbreak-2014---NetworkOverview.pdf.
128
Hanfling et al., supra note 123.
129
See US Has Capacity for 11 Ebola Patients at Specialized Hospitals, ABC NEWS
(Oct. 16, 2014, 4:47 PM), http://abcnews.go.com/Health/us-capacity-11-ebola-patientsspecialized-hospitals/story?id=26251721.
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COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
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basic clinical standards of care.130 With changes to medical CSC comes a
corresponding shift in legal standards of care and the potential for
decreased risks of liability related to triaging public health and medical
services. 131
J.
General Principles of Potential Negligence Claims
Liability risks pose ongoing concerns for HCWs and health care
entities on the frontline of the EVD emergency responses as they attempt
to navigate patient care.132 Liability may arise from a health care
provider’s actions or even a failure to act. Medical malpractice and
wrongful death claims may be brought if a physician fails to diagnose, or
misdiagnoses, delays treatment, or uses unapproved treatments without
first obtaining adequate consent. 133 For instance, the initial handling of
the EVD case of Thomas Eric Duncan 134 in Dallas, Texas led to threats
of litigation and a settlement after physicians failed to diagnose his EVD
during his initial visit to the hospital emergency room. 135 Health care
entities may also be at an increased liability risk for failing to have
proper emergency procedures in place for, or adequately training
employees to handle, infectious diseases like EVD.136
130
Hodge, Jr., et al, supra note 127, at 168.
James G. Hodge, Jr., The Evolution of Law in Biopreparedness, 10 BIOSECURITY &
BIOTERRORISM 38, 38–48 (2012); Hanfling et al., supra note 123 (legal standards of care
are not required to change in conjunction with medical standards of care, but emergency
planners should “consider whether additional liability protections are warranted in their
jurisdictions”).
132
Sharona Hoffman, Responders’ Responsibility: Liability and Immunity in Public
Health Emergencies, 96 GEO. L. J. 1913, 1918 (2008).
133
Hodge Jr., et al, supra note 127, at 169.
134
Greg Botelho, U.S. Ebola Patient: The Travels and Health Travails of Thomas Eric
Duncan, CNN (Oct. 2, 2014, 9:29 PM), http://www.cnn.com/2014/10/01/health/us-ebolapatient/ (Mr. Duncan was the first domestically diagnosed Ebola case. Texas Health
Presbyterian Hospital Dallas, the hospital where he was eventually diagnosed and treated
is not one of the four United States hospitals with specialized HCUs to isolate and treat
patients with highly infectious and dangerous diseases).
135
Justin Moyer, Dallas Hospital Settles With Family of Ebola Patient Thomas Eric
Duncan, Disputes Media Accounts of His Treatment, WASH. POST (Nov. 13, 2014),
http://www.washingtonpost.com/news/morning-mix/wp/2014/11/13/dallas-hospitalsettles-with-family-of-ebola-patient-thomas-eric-duncan-disputes-media-accounts-of-histreatment/ (After an initial visit to the Dallas hospital, Duncan, who presented with a
fever that spiked to 103 degrees Fahrenheit, was sent home with antibiotics despite CDC
guidance to look for “for patients who had traveled to areas with “active” Ebola
transmission and had temperatures above 101.5 degrees.”).
136
Jeffery P. Clark et al., Ebola Preparedness: Mission Critical for Hospitals and
Health Systems, REINHART (Oct. 21, 2014), available at http://www.reinhartlaw.com/
Documents/LE_20141021Revised-FINAL.pdf.
131
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Implementing CSC in a hospital setting requires difficult decisions
centered on testing, screening, and treatment. 137 Using new or
experimental drugs to treat patients further implicates liability risks. To
obviate the potential for negligence claims, health care entities should
ensure proper development, implementation, and testing of clinical
protocols for diagnosing and treating infectious disease. 138 Providing
hospital employees with proper access to PPE and adequate training
ensures all protocols are followed safely. 139 As for patient treatment,
health care providers should comply with appropriate standards of care,
obtain proper patient consent, and seek FDA approval prior to
administering any new or experimental treatment. 140 As discussed
throughout, Emory’s team was dedicated to careful and coordinated
preparation, education of both its HCWs and other employees during the
entire experience, constant refinement of clinical protocols,141 and
promotion of a culture that is characterized as “patient and family
centered.” 142
Health care providers do not have a comprehensive liability
protection. However, state and federal governments offer a bevy of
specific immunities, high burdens of proof for civil malpractice
claims, 143 and other protections 144 from acts of negligence by HCWs and
137
James G. Hodge, Jr., Gregory Measer & Asha M. Agrawal, “Top 10” Issues in
Public Health Legal Preparedness and Ebola, ABA HEALTH ESOURCE, Nov. 2014,
available at http://www.americanbar.org/publications/aba_health_esource/2014-2015/
november/top10.html.
138
Clark et al., supra note 136.
139
Id.; Guidance on Personal Protective Equipment To Be Used by Healthcare
Workers During Management of Patients with Ebola Virus Disease in U.S. Hospitals,
Including Procedures for Putting On (Donning) and Removing (Doffing), CDC,
http://www.cdc.gov/vhf/ebola/healthcare-us/ppe/guidance.html (last updated Feb. 12,
2015).
140
Hodge, Jr. et al, supra note 127, at 169; Elaine Schattner, Ebola, Experimental
Drugs and Informed Consent: Should Those At Risk Simply Take What The
(Aug.
31,
2014,
8:03
PM),
Doctor Orders?,
FORBES
http://www.forbes.com/sites/elaineschattner/2014/08/31/ebola-experimental-drugs-andinformed-consent-should-those-at-risk-simply-take-what-the-doctor-orders/.
141
Lameiras, supra note 3, at 21, 23.
142
EMORY HEALTHCARE, CARE OF THE PATIENT WITH EBOLA VIRUS DISEASE (2014),
available at http://www.emoryhealthcare.org/ebola-protocol/pdf/overview-of-ebola.pdf.
143
Jessica Dye, Ebola Lawsuits Would Face High Hurdles in Texas, REUTERS (Oct. 7,
2014, 7:02 AM), http://www.reuters.com/article/2014/10/07/us-health-ebola-usa-liabilityidUSKCN0HW0W920141007. In Texas, a malpractice claim due to emergency room
error requires plaintiffs show hospital staff were “willfully and wantonly negligent.” Id.
In Duncan’s case, this would involve showing that “the staff had to have consciously put
[the patient] or others at extreme risk by releasing him” instead of just showing a mistake
was made. Id.
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COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
367
volunteers that supplement the hospital’s planning and preparations for
insulating itself against liability. 145 Other protections may shield against
some negligence claims directed at hospitals or other select entities. For
example, the Emergency Management Assistance Compact, agreed to by
all states, insulates public agents at the state or local level against
liability claims. 146 These protections apply typically only for a limited
time, however, and may require emergency declarations to trigger their
benefits. 147 Moreover, they do not apply to liability claims based on
gross negligence, willful or criminal acts, or potential failures to plan. 148
Concerning pharmaceutical companies, liability can arise in the
manufacturing, testing, development, distribution, or administration of
new drugs or vaccines, especially in real-time emergencies. However,
these entities may be immunized from liability via the PREP Act. 149
DHHS Secretary Sylvia Burwell issued a PREP Act declaration on
December 9, 2014, in support of the development of three different EVD
vaccines to combat the EVD outbreak internationally and prevent a
future domestic outbreak. 150
III.
OPERATIONAL, CLINICAL, AND PRACTICAL ISSUES: EMORY’S
EBOLA EXPERIENCE
A.
Hazardous Waste, Environmental Safety, and Transport
and Disposal of Waste
In preparing to receive Emory’s first two EVD patients, Dr. Gartland
did not anticipate the significance of the Hospital’s proximity to CDC
headquarters. 151 CDC assumed responsibility for the ultimate disposal of
the enormous amounts of hazardous waste generated in caring for the
144
TRUST FOR AMERICA’S HEALTH (TFAH), TFAH LIABILITY PROTECTIONS RELEVANT
STATUTES (2008), available at http://healthyamericans.org/reports/bioterror08/pdf/legalpreparedness-law-review-of-state-statutes-and-codes.pdf.
145
Rosenbaum et al., supra note 17, at 238-41.
146
Emergency Management Assistance Compact, Pub. L. No. 104-321, 110 Stat. 3877
(1996).
147
HODGE, JR., supra note 24, at 244.
148
See James G. Hodge, Jr. & Erin Fuse Brown, Assessing Liability for Health Care
Entities That Insufficiently Prepare for Catastrophic Emergencies, 306 JAMA 308, 309
(2011).
149
Public Readiness and Emergency Preparedness (PREP) Act, Pub. L. No. 109-148,
119 Stat. 2818 (2005) (codified in Public Health Service Act at 42 U.S.C. §§ 247d-6d,
247d-6e).
150
Burwell, supra note 21.
151
Emory University Hospital is on the same side of Clifton Road in Atlanta as CDC
headquarters, separated only by a few academic buildings owned by Emory University.
368
UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
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EVD patients. Emory Hospital’s close proximity “along” the street to
CDC greatly facilitated compliance with U.S. Department of
Transportation (DOT) Hazardous Materials Regulations 152 for
transporting hazardous waste. 153 Because wastes from EVD patients are
considered “hazardous material” under the DOT, they are subject to
stringent procedures and regulations set forth by local, state, and federal
agencies. 154 Such wastes must be appropriately incinerated, autoclaved,
or otherwise inactivated to prevent further potential for infection. Strict
compliance with regulations is mandatory, even for “off-site”
commercial transport (including final transport for disposal).155
Due to EVD’s clinical pathway, Emory’s team prioritized waste
disposal, but no one foresaw the need to properly dispose of nearly 40
bags of waste per day for the two patients. 156 Contracts were prepared
with outside vendors and additional equipment was ordered and installed
prior to the patients’ arrivals since existing equipment at the Hospital
was insufficient to address the initial disposal needs of the SCDU and
other units. As well, the Hospital arranged with CDC for the ultimate
disposal of the waste.
In the future, responding hospitals must be prepared to quickly
address similar challenges to best ensure the safety of the patients,
HCWs, and other staff. While another epidemic or public health
emergency caused by a different pathogen may not present the same
waste disposal challenges as EVD, health providers should have access
to an expert in these issues or on staff. Advance contracts with medical
152
49 C.F.R. pts. 171-180 (2014).
40 C.F.R. § 260.10 (2014) (definition of “off-site” location for purposes of the
hazardous waste regulations from the Department of Transportation); 40 C.F.R.
§ 262.20(f) (An EPA hazardous waste manifest is not required when transporting
hazardous waste across the street or along a street, provided your organization owns
property along the road on which you are transporting it. However, if the waste is a DOT
hazardous material, a DOT bill of lading is required whenever you are transporting
hazardous materials in commerce. In the event of a discharge, the hazardous waste
generator is required to comply with the requirements for transporters at 40 C.F.R.
§ 263.30 (immediate action) and § 263.31 (discharge clean up)); see also On-Site and
Off-Site Transportation of Hazardous Waste [40 CFR 260.10], ENVT’L RES. CTR. (May
16, 2007), http://www.ercweb.com/resources/viewreg.aspx?id=6976.
154
29 C.F.R. § 1910.1030 (2014) (bloodborne pathogens standard); see, e.g., GA. COMP.
R. & REGS. 391-3-4 (2005); GA. CODE ANN. §§12-8-20 (2004); Fact Sheet: Safe
Handling, Treatment, Transport and Disposal of Ebola-Contaminated Waste,
OCCUPATIONAL SAFETY & HEALTH ADMIN., https://www.osha.gov/Publications/OSHA_
FS-3766.pdf. [hereinafter OSHA Ebola Fact Sheet].
155
OSHA Ebola Fact Sheet, supra note 154.
156
U.S. ARMY INST. OF PUBLIC HEALTH, STANDARD OPERATING PROCEDURE EBOLA
VIRUS DISEASE WASTE MANAGEMENT IN THE MEDICAL TREATMENT FACILITY 13,18
(2014),
available
at
http://phc.amedd.army.mil/PHC%20Resource%20Library/
EVDWasteManagementonMTFSOP.docx.
153
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COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
369
waste vendors should be regularly reviewed to assure vendors are
qualified to address pathogen-related waste disposal issues. Finally,
developing relationships with local and state officials regarding waste
disposal helps obviate misunderstandings and assures compliance with
complex waste management regulations.
B.
Supply Chain and Vendor Agreements
For Emory and other hospitals facing an infectious disease
emergency, supply chain issues and availability of equipment and
supplies are critical. For EVD patients, having a sufficient supply of
personal protective equipment (PPE) is essential to effective treatment.
Emory’s clinical protocols, noted below, required HCWs to don a new
set of PPE every time they entered a patient’s room, 157 resulting in large
quantities of PPE being used daily. Hospitals must carefully review their
vendor contracts and their capacity to ramp up deliveries for critical
supplies without sudden price increases, substitutions, or special delivery
fees. Resource alternatives should be prearranged in case the normal
supply chain is interrupted or a vendor cannot meet demand. Inventoried
supplies critical to EVD treatment (or any infectious disease during an
emergency or epidemic) must be secured. In the event of a supply
shortage, conservation and prioritization distribution plans should be
developed.
C.
Clinical Protocols
Guidelines for the care and treatment of patients with EVD continue
to evolve as the science surrounding the disease progresses. Hospitals
and health systems must remain up to date on real-time developments.
Relevant CDC guidelines,158 for example, are comprehensive, accessible,
and continually updated. Emory determined that “all of American health
care needs some level of preparedness for Ebola and other types of
communicable diseases . . . .” 159 To this end, Emory developed its own
clinical protocols, utilizing lessons learned from its own experience
while incorporating guidelines issued by CDC and others “with the hope
that [they] can help other health systems develop their own Ebola
readiness plans.” 160
157
158
159
160
Emory Protocols, supra note 90.
CDC Guidelines, supra note 90.
Emory Protocols, supra note 90.
Id.
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UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
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D.
Emory’s Care Transformation Model and Patient Centered
Care
To limit the number of individuals exposed to EVD at Emory, every
HCW in direct contact with EVD patients was knowledgeable in how to
handle patients’ every need—from drawing blood and taking vital signs
to administering medications and cleaning up bodily fluids. Safety
precautions involved in donning and doffing of PPE entailed almost 70
total separate steps 161 and considerable time. As a result, Emory’s care
team determined that once a HCW entered a patient’s room, the worker
would be physically present for the entire shift without exiting the room.
This model of care demands a unique culture, one Emory began
cultivating in 2007 when the current state of performance was assessed
for safety, evidence-based decision-making, anticipation of needs, and
teamwork among caregivers. Emory Hospital surveyed patient and
family perceptions of their involvement in care decisions. As leaders and
staff assessed the organizational culture and perception of care through
directed focus groups, it became apparent that employees, patients, and
families doubted the Hospital’s ability to meet the quality promise to
patients of “impeccable clinical outcomes, delivered safely with
outstanding service.” 162 This assessment necessitated a “culture
transformation” 163 for Emory to meet its promise of quality care to
patients centered on five essential attributes: (1) patient- and familycentered care, (2) shared decision making, (3) cultural competency and
diversity, (4) fair and just culture, and (5) transparency (see Figure 1.
Care Transformation Model below).
161
Emory Protocols, supra note 90 at Support Document 10: Standard Operating
Procedures: SCDU.
162
About Us, EMORY HEALTHCARE, http://www.emoryhealthcare.org/employment/
about-us.html (last visited Mar. 26, 2015).
163
Interview by Jane E. Jordan with Susan M. Grant, Chief Nurse Exec. & Chief
Patient Servs. Officer, Emory Healthcare (Feb. 1, 2015).
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COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
371
Figure 1. Care Transformation Model 164
The new culture, focused on the interests of the patient and his or her
family, supported the EVD care team in its goal to put aside any egos
and work together. For example, none of Emory’s physicians refused to
take blood or clean up bodily waste. As two nurses stated,
We had to be a family, we relied on each other to be
safe . . . .There were no egos—there couldn’t be . . . .We
all really worked and functioned as a team. It was truly
collaborative, not just among the nurses, but the staff,
the physicians, the lab . . . .We all had a lot on our
minds, more than just what was happening in the
isolation unit, so we had to take care of each other.165
The Hospital also addressed emotional support for the care team.
Chaplains were available at all times for team members. Daily “huddles”
allowed members to share any mistakes witnessed and lessons learned
during the day. While “soft” issues such as culture and emotional support
164
Id. Patients and the “promise” of quality are seated on a platform of Patient- and
Family-Centered Care, illustrating that patients are at the source of control. The attributes
that staff and leadership identified that would transform the culture and care was placed
on the platform: transparency, fair and just culture, cultural competence, shared decisionmaking and patient- and family-centered care. Teamwork ribbons link the attributes.
165
Lamerias, supra note 3, at 25 (quoting Sharon Vanairsdale, Clinical Nurse
Specialist, and Carolyn Hill, Nursing Unit Director for the SCDU).
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UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
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are often downplayed in preparing for an epidemic or public emergency,
Emory’s success was tied to its appreciation of these issues.
E.
Team Preparedness and Drills
Emory’s treatment of four EVD patients to date has been grounded
in excellent clinical care, adherence to the highest levels of safety,
appreciation of relevant legal principles, and its dedicated care team. The
Hospital’s response was also positively impacted by twelve years of
planning and practice, including biannual “preparedness” drills. In
establishing its SDCU in 2002, Emory determined that it would also be
prudent to establish an enterprise-wide program, known as the Office of
Critical Event Preparedness and Response (CEPAR). 166 CEPAR is
dedicated to assuring coordinated emergency responses to diseases,
natural disasters, or other emerging threats. Still, any facility treating
patients with a communicable disease must “expect the unexpected.” 167
Preparedness requires comprehensive team readiness to address the nonclinical issues that invariably arise. While the specific composition of
this larger team depends on the circumstances, essential non-clinical
competencies would likely include:
166
•
Public Relations/Communications/Crisis Management
•
Hospital Operations
•
Risk Management
•
Security/Facilities Management/Transportation
•
Environmental Safety
•
Compliance/Privacy
•
Legal
•
Customer Service/Patient Relations/Pastoral Care
•
Human Resources
CEPAR: Office of Critical Event Preparedness and Response, EMORY UNIV., www.
emergency.emory.edu (last visited Mar. 26, 2015). “CEPAR serves as the center for
Emory enterprise-wide planning for and coordinated response to catastrophic events
affecting Emory and the broader community.” Id.
167
Alexander Isakov et al., Safe Management of Patients with Serious Communicable
Diseases: Recent Experience With Ebola Virus, 161 ANNALS INTERNAL MEDICINE 829,
829–30; see also Emory Protocols, supra note 91, for a compilation of Emory’s protocols
and external resources used in the treatment of EVD patients.
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COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS
373
These preparedness teams must be assembled before an emergency
occurs to avoid wasting invaluable time. In Emory’s case, clinical, legal,
and administrative preparedness prior to the patients’ arrivals was critical
to its successful clinical outcome, as well as uniting these disparate
operational units around a common goal.
F.
Public Relations, Communications, and Education
Once the non-clinical team is in place and a situation presents,
practical issues involving public relations and communications must be
addressed both internally and for the external public. Messaging of
events, especially those implicating “fear factors,” is critical. Institutions
must educate the public to try to dispel these fears and circumvent
associated tendencies to panic or engage in irrational decisions. As
Emory did, other institutions should consider:
•
Agreeing in advance on consistent external
messaging;
•
Identifying a spokesperson with substantive
knowledge who engenders trust of employees, patients,
and the public;
•
Educating the media on the facts surrounding
patient treatment while protecting patient confidentiality;
•
Demonstrating effective
external community partners;
coordination
with
•
Developing
a
communications
strategy
addressing issues on timing and notice to internal
management and other leaders (e.g., governing board of
trustees); and
•
Disseminating information to employees on and
off the care team effectively.
Although Emory’s senior management was involved and supportive,
the Hospital’s most visible spokespersons were clinicians and care
providers who made public appearances to educate the media about
medical and scientific facts of EVD, including how it is (and is not)
transmitted. The clear and simple message, “We can fear, or we can
care,” was intended to allay the public’s anxiety. 168 Emory’s governing
168
Susan M. Grant, Op-Ed., I’m the Head Nurse at Emory. This is Why We Wanted to
Bring the Ebola Patients to the U.S., WASH. POST (Aug. 6, 2014), http://www.
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boards, employees, and staff knew about events before media
publication, where possible, through town hall-style meetings, emails,
and information sessions. Emory’s website 169 was consistently updated
after the arrival of the first two EVD patients, including public posting of
its clinical protocols (utilizing protocols from CDC and others).170
IV.
CONCLUSION
Domestic concerns over EVD have waned as most U.S. patients,
largely HCWs infected while working in West African countries, have
been successfully treated. Though limited in its duration, the EVD crisis
in 2014 exposed the sad truth that many American hospitals and other
health care providers may not be clinically, operationally, or practically
prepared to handle the impact of a highly lethal, contagious disease
despite years of preparedness funding and efforts to assure readiness.
Lessons learned can be universally implemented to circumvent negative
health impacts of future infectious disease threats. Every health provider
must commit to developing an implementable preparedness plan,
engaging in routine preparedness exercises and training, and remaining
on guard for the next inevitable communicable to menace the health of
patients and the public.
washingtonpost.com/posteverything/wp/2014/08/06/im-the-head-nurse-at-emory-this-iswhy-we-wanted-to-bring-the-ebola-patients-to-the-u-s/.
169
Ebola, EMORY NEWS CTR., http://news.emory.edu/tags/topic/ebola/index.html (last
updated Mar. 9, 2015).
170
Emory Protocols, supra note 91.
Ebola, Quarantine, and Flawed CDC Policy
Robert Gatter *
The CDC’s Interim Guidance for Monitoring and Movements of
Persons with Potential Ebola Virus Exposure is deeply flawed
because it disregards the science of Ebola transmission. It
recommends that officials quarantine individuals exposed to the
virus but who do not have any symptoms of illness, ignoring the
fact that only those with Ebola symptoms can communicate the
virus to others. Consequently, any quarantine order based on the
Guidance is surely unconstitutional and illegal under most
states’ public health statutes—as exemplified by the State of
Maine’s failed petition to quarantine Nurse Kaci Hickox in
October 2014. This article examines the Guidance and events
surrounding its creation to explore why the CDC issued
quarantine recommendations that lack scientific foundation. It
also catalogues the costs of doing so, concluding that the
Guidance undermines rather than serves population health.
INTRODUCTION ..................................................................................... 376
A. THE CDC’S GUIDANCE ..................................................................... 379
B. THE SCIENCE OF EBOLA TRANSMISSION .......................................... 382
C. THE LAW .......................................................................................... 385
D. THE GUIDANCE IN CONTEXT ............................................................ 389
1. Thomas Eric Duncan ................................................................. 390
2. Nurses Pham and Vinson........................................................... 391
3. Dr. Craig Spencer and Nurse Kaci Hickox ............................... 393
4. Theoretical Risks of Transmission ............................................. 395
E. THE MANY COSTS OF ACCOMMODATING FEAR IN PUBLIC
HEALTH POLICY ............................................................................ 396
*
Professor of Law and Co-Director, Center for Health Law Studies, Saint Louis
University School of Law and Professor of Health Management and Policy, Saint Louis
University College for Public Health and Social Justice. Special thanks to Srishti Miglani,
faculty fellow extraordinaire, for her assistance.
375
376
UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
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My approach is to figure out what works, get it done and
base it all on data.
Tom Frieden, MD, M.P.H.
Director, CDC
INTRODUCTION
Remember Kaci Hickox? She is the nurse who volunteered to treat
Ebola patients in a disease-stricken West African nation, and then
dominated the news when she fought against efforts by two states to
quarantine 1 her after she returned home symptom-free.
You might remember how she stood up to New Jersey Governor
Chris Christie, who had mandated the quarantine of everyone who
treated Ebola patients, even those who could not transmit Ebola to others
because they did not have any symptoms of the disease. 2 Christie applied
this mandate to Hickox when she returned to the U.S. through Newark
Liberty International Airport.3 When New Jersey’s policy was criticized
on the grounds that it ignored the science of Ebola transmission, Christie
claimed he was acting “out of an abundance of caution.” 4 Hickox,
sounding more like a seasoned politico than a nurse, quipped that the
governor seemed to be acting “out of an abundance of politics.”5
Almost certainly, you would recognize two famous photos of her.
One is a quarantine-selfie taken from a tent erected in a parking lot of the
Newark hospital where she was being held against her will.6 In the
1
Throughout this article, I use the word “quarantine” to include both the complete
separation of one exposed to Ebola from those who have not been exposed (e.g., the kind
of quarantine imposed by New Jersey on Kaci Hickox) and the near-complete separation
of one exposed to Ebola from those who have not been exposed, which allows the person
exposed to be with others so long as she is not within three feet of any non-exposed
person (e.g., the kind of quarantine that Maine sought to impose on Kaci Hickox).
2
Leslie Savan, Nurse Kaci Hickox Takes on Bully Governors Christie, Cuomo and
LePage, THE NATION (Oct. 29, 2014, 4:58 PM), http://www.thenation.com/blog/186681/
nurse-kaci-hickox-takes-bully-governors-christie-cuomo-and-lepage#.
3
Anemona Hartocollis & Emma G. Fitzsimmons, Tested Negative, Nurse Criticizes
Her Quarantine, N.Y. TIMES, Oct. 26, 2014, at A1.
4
Susan Cornwall, Maine Nurse Sees Ebola Quarantines as ‘Abundance of Politics’,
REUTERS (Nov. 2, 2014, 2:14 PM), http://www.reuters.com/article/2014/11/02/us-healthebola-usa-idUSKBN0IM0PR20141102.
5
Id.
6
See Frank Rosario & Joe Tacopino, Ebola Nurse’s Quarantine Hell, N.Y. POST (Oct.
27, 2014, 1:27 AM), available at http://nypost.com/2014/10/27/ebola-nurse-gets-prisontreatment-in-quarantine-hell/.
2015]
EBOLA, QUARANTINE, AND FLAWED CDC POLICY
377
photo, Hickox is wearing a patient’s gown, and we see that the Spartan
shelter behind her is a makeshift hospital room. 7 The second photo was
taken a week or so later after Nurse Hickox had returned to her home in
Fort Kent, Maine. In it, she is riding a bike in front of her house,
indicating that she would not quarantine herself voluntarily despite a
request by Maine health officials that she do so for another two weeks
until the incubation period for the Ebola virus expired.8
You might even remember that, following this defiant bike ride, the
State of Maine petitioned a court for a quarantine order against Hickox.9
The Court rejected the petition as unnecessary to safeguard the public’s
health because Hickox was symptom-free, and only those with Ebola
symptoms pose a risk of transmission. 10
Unnoticed or forgotten during this time was the Interim U.S.
Guidance for Monitoring and Movement of Persons with Potential Ebola
Virus Exposure (the “Guidance”). 11 It is authored by the Centers for
Disease Control and Prevention (“CDC”), the most authoritative public
health agency in the country, if not the world. The CDC released the
Guidance publically on October 29, 2014, 12 the day before the State of
Maine filed its petition for a quarantine order.13
The Guidance recommends that state and local health agencies
monitor and effectively quarantine even asymptomatic individuals, who,
like Hickox, were exposed directly to the Ebola virus while in countries
where the disease is widespread and while wearing appropriate
protective equipment. 14
Maine’s health officials and lawyers attached the Guidance to the
State’s petition. 15 The petition correctly assessed that the Guidance
placed Nurse Hickox in the category of having “some risk” of becoming
7
See id.
Nurse Defies Ebola Quarantine in Maine, Rides Bike, CBS NEWS (Oct. 30, 2014,
1:52 PM), http://www.cbsnews.com/news/ebola-nurse-kaci-hickox-defies-quarantine-inmaine-goes-on-bike-ride/.
9
See Verified Petition for Public Health Order, Mayhew v. Hickox, No. 2014-36 (Me.
Dist. Ct. Oct. 30, 2014) [hereinafter Petition], http://courts.maine.gov/news_reference/
high_profile/hickox.shtml.
10
Order Pending Hearing at 3, Mayhew v. Hickox, No. 2014-36 (Me. Dist. Ct. Oct.
31, 2014) [hereinafter Order Pending Hearing], http://courts.maine.gov/news_reference/
high_profile/hickox.shtml.
11
See CDC, INTERIM U.S. GUIDANCE FOR MONITORING AND MOVEMENT OF PERSONS
WITH POTENTIAL EBOLA VIRUS EXPOSURE (Dec. 24, 2014) [hereinafter GUIDANCE]. The
Guidance has been updated and amended by CDC since its initial publication.
12
See id.
13
See Petition, supra note 9.
14
See GUIDANCE, supra note 11, at 9 (referencing table addressing “some risk”
category and “asymptomatic” clinical criteria).
15
See Petition, supra note 9, Exhibit A.
8
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UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
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ill with Ebola herself,16 and it sought an order that was based nearly
word-for-word on the relevant recommendations of the Guidance. 17
So how could a court reject Maine’s petition? After all, it was based
not only on the recommendation of the State’s chief health officer, but
also on the express recommendations of the nation’s leading public
health agency. How can a state judge, without any public health
expertise, rule that a quarantine order grounded squarely on the
recommendations of the CDC was not necessary to protect the public
against the spread of Ebola?
The answer is as shocking as it is simple. The recommendations in
the CDC’s Guidance lack a basis in the science of Ebola transmission.
Nobody can transmit Ebola to another person unless and until symptoms
of the disease appear. 18 The CDC, itself, says so. According to the
agency’s educational materials for the public, an individual “can only get
Ebola from [t]ouching the blood or body fluids of a person who is sick
with or has died from Ebola.” 19 So, even if we knew that an individual
was infected with Ebola, that person would not pose any risk of
transmission to anyone until after the virus had incubated fully and after
the person began experiencing symptoms of the illness. Given this fact,
quarantining someone who, like Hickox, does not display any symptoms
of illness does not serve a public health purpose; instead, it unnecessarily
separates from others a person who poses no health risk to the
community, no matter how likely it is that such a person develops
symptoms in the future.
Accordingly, the Guidance’s recommendation to severely restrict an
asymptomatic person’s contact with others is irrational because it
contradicts the science. The CDC’s recommended restrictions, as applied
to Nurse Hickox, so clearly lacked a foundation in the scientific facts
about Ebola transmission that the Maine court had no choice but to
disregard the CDC’s Guidance, and thus reject that portion of the State’s
petition.
The real question is why the CDC included these recommendations
in the Guidance in the first place. It is unfathomable that the CDC’s
experts were not aware that the agency’s recommended public health
actions lacked a basis in the science of Ebola transmission. There must
16
Id. ¶¶ 25-27.
Compare id. ¶ 35 with GUIDANCE, supra note 11, at 9 (showing recommended
“public health action” for “asymptomatic” individuals in the “some risk” category).
18
See Facts about Ebola in the U.S., CDC, http://www.cdc.gov/vhf/ebola/pdf/
infographic.pdf (last visited Mar. 15, 2015); see also Review of Human-to-Human
Transmission of Ebola Virus, CDC, http://www.cdc.gov/vhf/ebola/transmission/humantransmission.html (last visited Mar. 16, 2015).
19
See CDC, Facts about Ebola in the U.S., supra note 18.
17
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EBOLA, QUARANTINE, AND FLAWED CDC POLICY
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be some other explanation, such as political pressure to stop the rising
tide of fear, or perhaps the CDC silently suspected that this strain of the
virus was more easily transmissible than earlier strains with which
experts had experience.
This article argues that, regardless of its reasons, the CDC may have
fundamentally damaged its credibility, and that of health officials
everywhere, by issuing recommendations in its Guidance that are
unsupported by science. The price of doing so is the erosion of public
health authority, which, ultimately, erodes population health.
A. THE CDC’S GUIDANCE
The real protagonists of this story are not Nurse Hickox or Governor
Christie. Rather, they are the CDC and its Ebola Guidance. The
Guidance creates a matrix of recommendations20 for public health
officials about whether to monitor or restrict the movements of
individuals exposed to the Ebola virus and, if so, to what degree.21 The
matrix first divides individuals into four categories based on the
likelihood that they will become sick with Ebola—high risk, some risk,
low risk, and no identifiable risk. 22 Again, these categories refer to the
risk that the individual will become sick with Ebola, not the far more
relevant risk that an individual will infect someone else. In other words,
the matrix is flawed from the outset because it is based on the risk of
illness, and not on the risk of transmission.
The Guidance further sub-divides each of these risk categories based
on whether an individual has symptoms of illness or is asymptomatic. 23
Thus, the Guidance creates eight categories and eight corresponding sets
of recommendations with respect to monitoring or restricting the
movements of individuals. For example, there are recommendations for
those who are deemed to be at “high risk” for becoming sick with Ebola
and who also have certain clinical symptoms; another set for those who
are deemed to be at “high risk” for becoming sick with Ebola but who
are asymptomatic; another set for those who are deemed to be at “some
20
The Guidance is exactly that—guidance. It is a recommendation or a statement of
policy that is issued by the CDC, as a federal agency. As such, it is exempt from even
informal, notice-and-comment rule-making procedures. See 5 U.S.C. § 553(b) (2014).
Consequently, the Guidance does not have the force of law. See e.g., Prof’ls and Patients
for Customized Care v. Shalala, 56 F.3d 592 (5th Cir. 1995).
21
See GUIDANCE, supra note 11.
22
Id. at 9-12.
23
Id.
380
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risk” and have certain clinical symptoms; and still another for those who
are deemed to be at “some risk,” but who are symptom-free, and so on. 24
The monitoring recommendations that correspond with each
category range from no monitoring to active monitoring (where public
health authorities regularly inquire about the individual’s temperature
and other clinical symptoms) to direct active monitoring (where public
health officials directly observe the individual and determine what, if
any, clinical symptoms exist).25 The Guidance recommends direct active
monitoring for all asymptomatic individuals in the “high risk” and “some
risk” categories. 26 “High risk” individuals include those who have had
direct contact with the blood or bodily fluids of someone sick with
Ebola, those who have lived with a person sick with Ebola, and those
who have handled the body of someone who died from Ebola. 27 Those
with “some risk” of contracting Ebola include individuals who, while in
countries where Ebola is widespread, have had direct contact with
someone sick with Ebola while wearing personal protective equipment,
as well as those who have had prolonged contact with a person sick with
Ebola in the patient’s home, in a health care facility, or in a community
setting. 28 The Guidance recommends only active monitoring for
asymptomatic individuals in the “low risk” category, which includes
those who have been in a country with widespread Ebola within the past
twenty-one days, but who had no known exposures; those who have had
brief direct contact (e.g., shaking hands) with a person with Ebola, while
the person was in the early stage of the disease; those who have had brief
proximity (e.g., briefly being in the same room) with a person with
Ebola, while the person was symptomatic; those who come into direct
contact with a person sick with Ebola, while wearing personal protective
equipment while in countries without widespread Ebola; and those who
have traveled on an aircraft with a person with Ebola, while the person
was symptomatic. 29 Finally, no monitoring at all is recommended for
those who have had no known exposure and are experiencing no
symptoms of any illness. 30
24
Id.
See id. at 2 (distinguishing active and direct active monitoring).
26
Id. at 9.
27
Id.
28
Id. at 10.
29
Id. at 11 (recommending, as an exception, direct active monitoring for individuals
who have traveled on an aircraft and sat within three feet of someone who was
symptomatic with Ebola).
30
Id. at 12. Of course, monitoring recommendations only apply to those who are
asymptomatic because the purpose of monitoring is to determine if and when a person
without symptoms of Ebola becomes symptomatic for the disease. Once a person has
Ebola symptoms, monitoring gives way to isolation and treatment.
25
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EBOLA, QUARANTINE, AND FLAWED CDC POLICY
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Central to this story, however, are recommendations in the Guidance
for restricting the movements of asymptomatic individuals in the “high
risk” and “some risk” categories, which are so substantial that they
closely resemble a complete quarantine. 31 They include:
•
[E]xclusion from long-distance commercial
conveyances (aircraft, ship, train, bus) or local public
conveyances (e.g., bus, subway);
•
Exclusion from public places (e.g., shopping
centers, movie theaters), and congregate gatherings;
•
Exclusion from workplaces for the duration of a
public health order, unless approved by the state or local
health department (telework is permitted);
•
Non-congregate
public
activities
while
maintaining a 3-foot distance from others may be
permitted (e.g., jogging in a park); . . .
•
Any travel will be coordinated with public
health authorities to ensure uninterrupted direct active
monitoring;
•
Federal public health travel restrictions (Do Not
Board) may be implemented based on an assessment of
the particular circumstance . . . . 32
No movement restrictions are recommended under the Guidance for
either the “low risk” or “no risk” categories.33
In short, the Guidance recommends that individuals in the “high
risk” and “some risk” categories be restricted from traveling, working,
going to public places, or otherwise coming within three feet of another
person. The only thing separating such a person from someone who is
“quarantined” appears to be that the “patient” may go for a walk or jog in
a location so isolated as to not risk coming within three feet of someone
else and may drive to that isolated jogging spot alone if public health
officials are notified of the plan. In essence, this is house-arrest with
limited solo-driving and solo-jogging privileges.
31
The Guidance distinguishes between controlling movement and quarantining
individuals by giving these actions separate definitions. See GUIDANCE, supra note 11, at
3. Oddly, the Guidance defines “quarantine” and then never uses that term outside of the
definition section of the document.
32
GUIDANCE, supra note 11, at 9-10.
33
Id. at 11-12.
382
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These are the restrictions that the State of Maine sought to impose on
Kaci Hickox based upon a straight-forward application of the
Guidance. 34 At the time, she fell into the “some risk” category because
she had come into direct contact with several people sick with Ebola
while she was in Sierra Leone (a country where Ebola was widespread),
and while she was wearing personal protective equipment. 35 Moreover,
at the time of Maine’s petition, Nurse Hickox did not have any
symptoms of Ebola, but she was still within the twenty-one day
incubation period of the virus.36 Within the structure of the Guidance’s
matrix, she fell into the category for asymptomatic individuals who have
“some risk” of becoming sick with Ebola themselves. Correspondingly,
the Guidance recommended that she be subject to direct active
monitoring and that her movements be restricted such that she would not
come within three feet of another person for the remainder of the
incubation period.
As described next, the restrictions on movements for asymptomatic
individuals recommended by the Guidance do not have a basis in the
science of Ebola transmission. Accordingly, they violate a fundamental
principle of public health practice and public health law that actions
taken to protect population health be based in scientific fact.
B. THE SCIENCE OF EBOLA TRANSMISSION
Ebola is a hemorrhagic fever virus, which means that it infects and
overwhelms vascular cells, causing them to burst and bleed.37 By
severely damaging the vascular system, the illness undermines the
body’s ability to regulate itself or mount an effective immune response,
resulting in multi-organ system failure and death.38 Ebola is a
particularly lethal hemorrhagic fever, causing death in fifty to ninety
percent of those it infects.39
34
See Petition, supra note 9, ¶ 35.
Id. ¶¶ 26-29.
36
Id. ¶ 26.
37
See Viral Hemorrhagic Fevers: Fact Sheet, CDC, http://www.cdc.gov/ncidod/dvrd/
spb/mnpages/dispages/Fact_Sheets/Viral_Hemorrhagic_Fevers_Fact_Sheet.pdf;
Nat’l
Inst. of Health, Hemorrhagic Fevers, MEDLINEPLUS, http://www.nlm.nih.gov/
medlineplus/hemorrhagicfevers.html (last visited Mar. 12, 2015); Ruth Tam, This is How
You Get Ebola, As Explained by Science, PBS NEWSHOUR (Sept. 30, 2014, 8:24 PM),
http://www.pbs.org/newshour/updates/know-enemy/; Meghana H. Raykar et al., Ebola
Virus Disease, 3 PHARMTECHMEDICA 493, 493 (July-Aug. 2014).
38
Raykar, supra note 37, at 493.
39
See id.
35
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EBOLA, QUARANTINE, AND FLAWED CDC POLICY
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The virus is not easily transmitted from one human to another.
Unlike an influenza or cold virus, it is not airborne, 40 meaning that it
does not “hang in the air” for long periods of time, and so it cannot be
breathed in by another person. 41 Instead, it is only spread as a result of
contact with the bodily fluids of one who is in the throes of the illness.
The CDC says that Ebola is transmitted:
through direct contact (through broken skin or mucous
membranes in, for example, the eyes, nose, or mouth)
with:
• blood or body fluids (including but not limited
to urine, saliva, sweat, feces, vomit, breast milk, and
semen) of a person who is sick with Ebola
• objects (like needles and syringes) that have
been contaminated with the virus
• infected fruit bats or primates (apes and
monkeys)
Ebola is not spread through the air, by water, or in
general, by food.42
These limited routes of communication explain why those infected with
Ebola are health care workers who have cared for sick and dying Ebola
patients in hospitals, or family members and others who have cared for
sick and dying Ebola patients in their homes, or those who have prepared
for burial the bodies of deceased Ebola victims. 43
Meanwhile, individuals exposed to the Ebola virus, but who do not
yet have symptoms of the illness, have never transmitted the virus to
others. Since 1976, when Ebola was first discovered in humans, there
have been twenty-five reported outbreaks, including the 2014 epidemic,
40
See Ebola Transmission, CDC, http://www.cdc.gov/vhf/ebola/transmission/ (last
visited Mar. 12, 2015).
41
See What We Know about Transmission of the Ebola Virus Among Humans, WHO
(Oct. 6, 2014), http://www.who.int/mediacentre/news/ebola/06-october-2014/en/; Tom
Howell Jr., CDC Throws Cold Water on Talk of ‘Airborne’ Ebola Transmission, WASH.
TIMES (Dec. 1, 2014), available at http://www.washingtontimes.com/news/2014/dec/1/
cdc-dismisses-talk-airborne-ebola-transmission/. While there has been speculation about
the possibility that the current strain of Ebola circulating in West Africa could mutate so
as to become airborne, see e.g., Michael T. Osterholm, What We’re Afraid to Say About
Ebola, N.Y. TIMES, Sept. 12, 2014, at A31, there is no evidence that the current strain is
airborne.
42
Ebola Transmission, supra note 40.
43
See id.; Tam, supra note 37, at 4.
384
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which is the largest. 44 From those outbreaks there have been 16,242
confirmed cases of human Ebola infection, 45 and that number could be
closer to 25,000 once additional suspected and probable cases are
confirmed. 46 Not one of these cases has resulted from contact with a
person who did not have symptoms of the illness. Not one.
No wonder the CDC, in its public education materials, identifies
“[t]ouching the blood or body fluids of a person who is sick with or has
died from Ebola” as the “only” way to become infected with the virus. 47
An editorial in the New England Journal of Medicine, criticizing the
policy of quarantining health care workers who treat Ebola patients in
West Africa, put a finer point on the power of our experience with the
virus to explain how it is transmitted.
Health care professionals treating patients with this
illness have learned that transmission arises from contact
with bodily fluids of a person who is symptomatic—that
is, has a fever, vomiting, diarrhea, and malaise. We have
very strong reason to believe that transmission occurs
when the viral load in bodily fluids is high, on the order
of millions of virions per microliter. This recognition
has led to the dictum that an asymptomatic person is not
contagious; field experience in West Africa has shown
that conclusion to be valid.48
Ebola can incubate inside the body of a person it infects for as long
as twenty-one days without the person experiencing even a fever, 49 let
alone the bleeding, vomiting, and diarrhea that poses a risk to others.50
44
See A. Elisha & B. Adegboro, Ebola Virus Diseases, 15(3) AFR. J. CLN. & EXPER.
MICROBIO. 117, 117-118 (2014).
45
2,387 cases resulted from the first twenty-four outbreaks, which is just the sum of
the confirmed cases reported by WHO for those previous cases. See id. Another 13,855
confirmed cases have resulted from the current outbreak in three West African nations.
2014 Ebola Outbreak in West African—Case Counts, CDC (Mar. 12, 2015),
http://www.cdc.gov/vhf/ebola/outbreaks/2014-west-africa/case-counts.html [hereinafter
Case Counts]. The sum of the confirmed case counts from the 2014 outbreak and those
from the prior twenty-four outbreaks is 16,242.
46
See Case Counts, supra note 45 (reporting 22,525 suspected, probable and
confirmed cases).
47
See CDC, Facts about Ebola in the U.S., supra note 18.
48
Jeffrey M. Drazen et al., Ebola and Quarantine, 371 N. ENG. J. MED. 2029, 2029
(2014) (emphasis added).
49
Raykar et al., supra note 37, at 494 (Ebola incubation period is two to twenty-one
days).
50
Drazen et al, supra note 48, at 2029 (“[W]e now know that fever precedes the
contagious stage, allowing workers who are unknowingly infected to identify themselves
before they become a threat to their community. This understanding is based on more
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That is why a person infected with—but asymptomatic for—Ebola is not
infectious to others. In short, somewhere between 16,242 and 25,000
Ebola cases over nearly forty years reveal, without exception, that one
who is infected with the virus is not contagious until signs of sickness
appear.
Given these facts about Ebola transmission, the Guidance’s
recommendation that health officials prohibit a person who does not have
symptoms of the illness from coming within three feet of another person
for the twenty-one day incubation period of the virus is plainly irrational.
It guards against a form of transmission, the risk of which is so
infinitesimally small as to be unprecedented in the decades-long human
history of this virus. Moreover, in doing so, the Guidance ignores
conclusions that can be drawn reliably from thousands—even tens of
thousands—of cases.
It should come as no surprise then that the state court judge in Maine
summarily denied the petition seeking an order to quarantine Nurse
Hickox, which was based on the scientifically unfounded
recommendation in the CDC’s Guidance to separate from others
individuals who are not contagious. As the next section explains, any
public health official ordering the quarantine of an asymptomatic person
exposed to Ebola is almost surely violating state quarantine law and is
certainly violating the federal Constitution.
C. THE LAW
Every state, as a vestige of its original sovereignty, retains its police
power, 51 which authorizes states to protect the health, safety, and welfare
of its citizenry by, among other things, enacting quarantine laws. 52 In
fact, every state has enacted some form of quarantine law. 53 As a
condition of quarantining an individual, states’ laws typically require
than clinical observation: the sensitive blood polymerase-chain-reaction (PCR) test for
Ebola is often negative on the day when fever or other symptoms begin and only
becomes reliably positive 2 to 3 days after symptom onset.”).
51
See Jacobson v. Massachusetts, 197 U.S. 11, 25 (1905) (“the police power [is] a
power which the State did not surrender when becoming a member of the Union under
the Constitution”).
52
See id. (explaining that the police power includes the authority of a state to regulate
for the purpose of protecting the public health and safety, and it includes the power to
enact quarantine laws).
53
See TRUST FOR AM. HEALTH, STATE QUARANTINE AND ISOLATION LAWS (2004),
http://healthyamericans.org/reports/bioterror04/Quarantine.pdf; see also MODEL STATE
EMERGENCY HEALTH POWERS ACT (2001), http://www.publichealthlaw.net/MSEHPA/
MSEHPA.pdf.
386
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public health officials to obtain a court order authorizing such action.54
Moreover, states’ laws commonly prohibit a court from issuing a
quarantine order unless the state puts forth evidence that the person who
would be subject to the order poses a health risk to the population and
that it is necessary to quarantine that person in order to protect the public
from this risk. 55
By recommending that state and local health officials quarantine
individuals exposed to Ebola but who show no signs of illness, the
Guidance is setting up health officials for failure under many states’
laws. As established above, a person exposed to Ebola who has no
symptoms of the disease cannot infect others with the virus, not even if
we somehow knew that the person was incubating the virus.
Consequently, asymptomatic individuals do not “pose a risk” of
spreading Ebola to others, and, therefore, it is not “necessary” to
quarantine those individuals in order to protect the public’s health.
Because the burden falls on the state to establish the existence of a “risk”
of contagion as well as the “necessity” of quarantine, health officials
simply cannot prevail when pursuing an order to quarantine an
asymptomatic person exposed to Ebola.
This is exactly why a judge in Maine denied the State’s petition to
quarantine Kaci Hickox. Under Maine law, a court may not issue a
quarantine order unless, “based upon clear and convincing evidence, the
court finds that a public health threat exists . . . ,” and, even then, the
court may order only “the least restrictive measures necessary to
effectively protect the public health.”56 In Hickox’s case, health officials
admitted in the petition that “[i]ndividuals infected with Ebola Virus
Disease who are not showing symptoms are not yet infectious,” 57 and
that Nurse Hickox showed no symptoms. 58 Given Maine law and these
facts, the Court had no choice but to reject the portion of the petition
seeking to prohibit Nurse Hickox from coming within three feet of
anyone else for the remainder of the twenty-one day incubation period.
The judge wrote: “According to the information presented to the court,
Respondent [Hickox] currently does not show any symptoms of Ebola
54
See id.; see TRUST FOR AM. HEALTH, supra note 53, at 14. In some states, health
officials must obtain an initial temporary quarantine order from a court, which can be
obtained on an ex parte basis, e.g., ME. REV. STAT. tit. 22, § 250-2 (2014), while in other
states, health officials may act initially on their own authority to quarantine an individual
temporarily so long as officials pursue a court order in support of the quarantine within a
short period of time, e.g., MODEL STATE EMERGENCY HEALTH POWERS ACT § 605.
55
MODEL STATE EMERGENCY HEALTH POWERS ACT § 605; TRUST FOR AM. HEALTH,
supra note 53.
56
ME. REV. STAT. tit. 22, § 812-1 (2014).
57
Petition, supra note 9, ¶ 14.
58
See id. ¶ 27.
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EBOLA, QUARANTINE, AND FLAWED CDC POLICY
387
and is therefore not infectious.” 59 Consequently, the court held that “[t]he
State has not met its burden at this time to prove by clear and convincing
evidence that limiting Respondent’s movements to the degree requested
is ‘necessary to protect other individuals from the dangers of
infection’ . . . .” 60
Even if health officials or a court were to issue an order under a
state’s law prohibiting an asymptomatic individual from coming within
three feet of another person, it would almost certainly be set aside as
violating the Due Process Clause of the Fourteenth Amendment to the
federal Constitution. The clause provides that “[n]o State shall . . .
deprive any person of . . . liberty . . . without due process of law . . . .” 61
The Supreme Court of the United States has interpreted this language to
protect individuals from deprivations of liberty by a state where such
state action lacks sufficient substantive justification; the purpose is to
prevent governments from acting arbitrarily. 62 In particular, when state
action deprives someone of a “fundamental liberty interest,” the state
carries a burden to prove that its action is “narrowly tailored to serve a
compelling state interest.” 63 Fundamental liberty interests are those that
are “‘deeply rooted in this Nation’s history and tradition,’ . . . and
‘implicit in the concept of ordered liberty,’ such that ‘neither liberty nor
justice would exist if they were sacrificed,’” 64 and they include freedom
from physical restraint or confinement 65 for the purpose of protecting the
public’s health. 66
As applied here, there is no doubt that prohibiting an asymptomatic
individual from traveling, working, being in public places, or otherwise
coming within three feet of another person imposes a substantial physical
restraint on that individual to the point of constituting confinement. In
other words, such a prohibition deprives the individual of a fundamental
liberty interest. Thus, the state would be required to prove that such a
59
Order Pending Hearing, supra note 10, at 3.
Id.
61
U.S. CONST. amend. XIV.
62
See Wolff v. McDonnell, 418 U.S. 539, 558 (1974) (“The touchstone of due process
is protection of the individual against arbitrary action of government.”).
63
Reno v. Flores, 507 U.S. 292, 301-02 (1993).
64
Washington v. Glucksberg, 521 U.S. 702, 703 (1997) (quoting Palko v. Connecticut,
302 U.S. 319, 325 (1937)).
65
See id. at 719; see also Foucha v. Louisiana, 504 U.S. 71, 80 (1992) (addressing
claims of an insanity aquitee to be discharged from confinement, the Court said
“[f]reedom from bodily restraint has always been at the core of the liberty protected by
the Due Process Clause from arbitrary governmental action.”).
66
See e.g., Best v. St. Vincent Hosp., No. 03-0365, 2003 WL 21518829 (S.D.N.Y.
2003) (applying strict scrutiny to New York City’s action to isolate a tuberculosis patient
until he completed treatment), aff’d in part, vacated in part, remanded in part sub nom
Best v. Bellvue Hosp., 115 Fed. Appx. 459 (2d. Cir. 2004).
60
388
UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
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physical restraint is narrowly tailored to serve the state’s compelling
interest in protecting the public from the spread of Ebola. A quarantine
order is not “narrowly tailored” to the state’s interest if there exists a less
restrictive alternative that will also serve the state’s interest in preventing
the spread of an infectious disease. 67 Where the government’s interest is
in protecting the public from becoming infected with Ebola by a person
who has been exposed to the virus but who does not have any symptoms
of illness, there are far less restrictive alternatives to a near-absolute
quarantine. An asymptomatic person is not infectious to others, so the
state’s interest is served by regularly monitoring to determine whether
and, if so, when the person develops symptoms of illness, which would
indicate that the individual had become infectious and must be isolated
from others. 68 Because the public’s health can be protected from the
spread of Ebola in the case of an asymptomatic person by court-ordered
monitoring, which is much less restrictive than a near-absolute
quarantine, a federal court would surely rule that quarantining an
asymptomatic person is not narrowly tailored to serve the state’s interest
in preventing the spread of this virus. Consequently, the order would be
set aside as unconstitutional.
In the end, both the science and the law quite clearly indicate just
how poorly conceived the movement restrictions recommended in the
Guidance really are. They cannot be justified by the science of Ebola
transmission, and so they cannot be enforced by law. The CDC has
highly skilled scientists who specialize in infectious diseases, and it has
many highly skilled lawyers. It is extraordinarily unlikely, then, that the
agency was not aware of the substantial shortcomings of the Guidance
67
See id. at *7-8 (quoting Shelton v. Tucker, 364 U.S. 479, 488 (1960)) (“Even [when]
the governmental purpose [is] legitimate and substantial, that purpose cannot be pursued
by means that broadly stifle fundamental personal liberties when the end can be more
narrowly achieved. The breadth of legislative abridgment must be viewed in the light of
less drastic means for achieving the same basic purpose.”).
68
In making the determination that quarantine is not narrowly tailored to the state’s
interest in preventing the spread of Ebola, a federal court is likely to defer to the
judgments of health officials only if they are based on current medical knowledge
about (a) the nature of the risk (how the disease is transmitted), (b)
the duration of the risk (how long is the carrier infectious), (c) the
severity of the risk (what is the potential harm to third parties) and (d)
the probabilities the disease will be transmitted and will cause
varying degrees of harm.
Sch. Bd. of Nassau Cnty., Fla. v. Arline, 480 U.S. 273, 274 (1987). Although Arline
concerned a claim of disability discrimination under the Rehabilitation Act, the Court’s
logic about the standard of review it would apply to medical findings concerning the
transmission of contagious diseases is applicable in the realm of substantive due process.
See Scott Burris, Rationality Review and the Politics of Public Health, 34 VILL. L. REV.
933, 937-42 (1989).
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EBOLA, QUARANTINE, AND FLAWED CDC POLICY
389
when applied to asymptomatic individuals who have been exposed to
Ebola. What then explains the CDC’s decision to include in its Guidance
that those individuals be subject to such extreme restrictions on their
movements? That question is addressed in the next section.
D. THE GUIDANCE IN CONTEXT
The short and recent history of Ebola in America is one of mounting
fear and finger-pointing at the CDC. It began in September 2014, when
Thomas Eric Duncan, a Liberian visiting family in Dallas, Texas, was
diagnosed with Ebola. 69 It peaked a month later when a physician, Craig
Spencer, who had treated Ebola patients in West Africa was admitted to
a New York City hospital with the disease after having spent the
previous week out among New Yorkers eating in restaurants, bowling,
and riding the subway. 70 In between, two nurses contracted Ebola as a
result of caring for Duncan in a Dallas hospital, despite efforts to follow
CDC protocol. 71 Moreover, one of the nurses traveled on a commercial
flight while she had a low-grade fever indicating the onset of Ebola
symptoms, and the CDC did not prohibit her from doing so even after the
nurse notified the CDC of her fever. 72 Each of these events belied
statements from CDC Director Tom Frieden that the U.S. was prepared
to “stop Ebola in its tracks” when it entered the country. 73 Consequently,
the CDC and its director came under fire for its missteps and perceived
failure to protect Americans adequately. 74
The CDC issued its Guidance in the heat of these events and
criticism. Accordingly, we cannot fully appreciate the rationale for the
seemingly unscientific recommendations the Guidance makes without
analyzing them in this context. Doing so allows for an educated guess
that the CDC recommended the quarantine of non-infectious individuals
both because it could not rule out the theoretical possibility that an
asymptomatic person incubating Ebola could infect another person and,
more importantly, because the agency could not take the political
69
Sydney Lupkin, Ebola in America: Timeline of the Deadly Virus, ABC NEWS (Nov.
17, 2014, 11:01 AM), http://abcnews.go.com/Health/ebola-america-timeline/story?id=
26159719 [hereinafter Lupkin, Timeline].
70
Id.
71
Id.
72
Id.
73
Tom Frieden, Why U.S. Can Stop Ebola in its Tracks, CNN (Oct. 2, 2014, 5:43 PM),
http://www.cnn.com/2014/10/02/opinion/frieden-ebola-first-patient/.
74
See, e.g., Jennifer Haberkorn & Lauren French, CDC Director in Hot Zone at Ebola
Hill Hearing, POLITICO (Oct. 16, 2014, 8:20 PM), http://www.politico.com/story/2014/
10/hearing-will-have-public-health-officials-grilled-on-ebola-111943.html.
390
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embarrassment of yet another mistake. All of this is described in greater
detail in this section, which proceeds chronologically through the key
events.
1. Thomas Eric Duncan
Thomas Eric Duncan arrived in the U.S. on September 20, 2014, to
reunite with and marry the mother of his 16-year-old son. 75 Shortly
before leaving Liberia, he had helped transport a sick, pregnant woman
to and from a local hospital. 76 At one point, he carried her from his car to
her house. 77 She died from Ebola the next morning, but it is unclear
whether Duncan understood what she had died from when he left for the
U.S. four days later. 78 He was screened by officials before boarding his
international flight. 79 At the time, his temperature was normal. 80 He also
reported, errantly, that he had not had any recent contact with an Ebola
victim. 81
On September 25, Duncan went to Texas Presbyterian Hospital in
Dallas, where he told a nurse that he had a fever and that he had recently
traveled to the U.S. from Liberia.82 Based on this information alone, his
treating physician should have recognized the possibility of an Ebola
infection and isolated him. Instead, the physician at the hospital sent him
home with some antibiotics. 83 Duncan’s symptoms progressed, and he
returned to the hospital much sicker several days later. 84 He was then
admitted and isolated, and the diagnosis of Ebola was first made on
September 28. 85 On October 8, Duncan died. 86
When the news reported that Ebola had entered the U.S. and that the
country’s first Ebola patient was being treated in a Dallas hospital, Dr.
Tom Frieden held a press conference where he famously said, “We will
75
Anna Almendrala, What We Know About Thomas Eric Duncan, The First Ebola
Patient Diagnosed in the U.S., HUFFINGTON POST (Oct. 14, 2014, 2:51 PM), http://www.
huffingtonpost.com/2014/10/06/thomas-eric-duncan-dallas-ebola-patientus_n_5942150.html.
76
Id.
77
Id.
78
Id.
79
Id.
80
Id.
81
Id.
82
Id.
83
Id.
84
Alana Horowitz et al., Thomas Eric Duncan Dead; Dallas Ebola Patient Had Been
Critically Ill, HUFFINGTON POST (Oct. 8, 2014, 11:20 AM), http://www.huffingtonpost.
com/2014/10/08/thomas-eric-duncan-dead-ebola-dallas_n_5952502.html.
85
Almendrala, supra note 75.
86
Horowitz, supra note 84.
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EBOLA, QUARANTINE, AND FLAWED CDC POLICY
391
stop it in its tracks, because we’ve got infection control in hospitals and
public health that tracks and isolates people if they get symptoms.” 87 As
events unfolded, however, it became apparent that infection control in
the hospital treating Duncan was not working as it should.
2. Nurses Pham and Vinson
Nina Pham and Amber Vinson are nurses at the hospital that treated
Thomas Eric Duncan.88 Both cared for him while he was in the throes of
the illness, changing his sheets, washing him, and mopping his floors.89
They each wore protective gear including gloves, suits, and masks, and
they used a buddy system both to put on and take off their equipment
each shift. 90 Neither can identify a time when they breached CDC
protocol for the use of personal protective equipment by health care
workers treating Ebola patients.91 At most, they noted that the hospital
did not initially have the head gear and positive-pressure suits used by
caretakers at Emory University. 92
Despite their best efforts to follow then-current CDC protocol, both
Nurse Pham and Nurse Vinson became infected with Ebola. Nurse Pham
was the first to develop a fever on October 11, and she went straight to
the hospital after notifying public health officials. 93 Nurse Vinson
entered the hospital three days later, also with a fever. 94 Each was later
transferred to other facilities more experienced in the care of Ebola
patients. Pham went to the National Institutes of Health in Maryland, and
Vinson went to Emory University Hospital. 95 Both were nursed through
their illnesses, survived, and were discharged.96
The CDC was criticized intensely as soon as the nurses were
diagnosed with Ebola. 97 Dr. Frieden had assured America that hospitals
were prepared to prevent the spread of Ebola, and yet two nurses were
87
Mikayla Bouchard, CDC Head Frieden on Ebola in America: ‘We Will Stop It In Its
Tracks’, ABC NEWS (Oct. 5, 2014, 2:18 PM), http://abcnews.go.com/Health/cdc-headfrieden-ebola-america-stop-tracks/story?id=25975221.
88
How Did Dallas Nurses Catch Ebola?, BOS. GLOBE (Oct. 15, 2014), available at
http://www.bostonglobe.com/news/nation/2014/10/15/how-did-dallas-nurses-catchebola/x8olat9b0m4dRKSyxkVtUM/story.html.
89
Id.; see also The Ebola Warriors, DALL. MORNING NEWS (Dec. 28, 2014), available
at http://res.dallasnews.com/interactives/texan-of-the-year-2014/.
90
DALL. MORNING NEWS, supra note 89.
91
BOS. GLOBE, supra note 88.
92
DALL. MORNING NEWS, supra note 89.
93
Id.
94
Id.
95
Id.
96
See id.
97
Haberkorn & French, supra note 74.
392
UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
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infected. Moreover, in what could be viewed as an admission that the
agency’s Ebola infection-control policies and procedures were
insufficient, the CDC issued a new protocol instructing health care
workers how to best protect themselves from infection when caring for
Ebola patients, which called for enhanced forms of personal protective
equipment. 98
To make matters worse, the CDC did not stop Nurse Vinson from
boarding a commercial flight even after she informed the agency that she
had a low-grade fever a day after Nurse Pham had been hospitalized with
then-suspected Ebola. 99 Later, CDC officials admitted that the agency
should have instructed Vinson not to board the plane when she reported a
slight fever. 100 As result of this blunder, the CDC contacted each of the
more than 130 passengers on that flight to determine which of them, if
any, required active monitoring. 101 All of this happened at a time when
health officials were already monitoring more than 100 other Americans
who had treated, lived with, or otherwise come into contact with Thomas
Eric Duncan or any other U.S. victim of Ebola.102
At this point, Congress, if not the public, lost confidence in the
CDC’s ability to protect Americans. Some Republican legislators called
for Dr. Frieden’s resignation as Director of the CDC. 103 The Speaker of
the House urged the Obama Administration to restrict air travel to the
U.S. from the West African nations where Ebola was widespread. 104 One
Republican Senator announced that he would bypass the Administration
and introduce a bill to ban the issuance of visas to foreign nationals from
any of those West African nations. 105 Even Democrats were highly
98
Lisa Schnirring, CDC Unveils New PPE Guidance for Ebola, UNV. OF MINN. CRT.
INFECTIOUS
DISEASE
RESEARCH
&
POLICY
(Oct.
20,
2014),
http://www.cidrap.umn.edu/news-perspective/2014/10/cdc-unveils-new-ppe-guidanceebola; CDC Tightened Guidance for U.S. Healthcare Workers on Personal Protective
Equipment for Ebola, CDC (Oct. 20, 2014), http://www.cdc.gov/media/releases/2014/
fs1020-ebola-personal-protective-equipment.html.
99
Haberkorn & French, supra note 74; see also Lupkin, Timeline, supra note 69.
100
Will Dunham, U.S. Lawmakers Blast Government’s Ebola Response, Urge Travel
Ban, REUTERS (Oct. 16, 2014, 7:33 PM), http://www.reuters.com/article/2014/10/16/ushealth-ebola-usa-idUSKCN0I517E20141016.
101
See Timothy Williams, Ebola-Infected Health Worker in Dallas Took a Flight on
Monday, N.Y. TIMES (Oct. 15, 2014), available at http://www.nytimes.com/2014/10/16/
us/ebola-infected-dallas-health-worker-was-on-flight.html.
102
See id.
103
See Dunham, supra note 100.
104
Id.
105
Press Release, Office of U.S. Sen. Marco Rubio, Rubio Announces Legislation to
Impose Temporary Visa Ban on Ebola Affected Countries (Oct. 20, 2014), http://www.
rubio.senate.gov/public/index.cfm/2014/10/rubio-announces-legislation-to-imposetemporary-visa-ban-on-ebola-affected-countries.
FOR
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EBOLA, QUARANTINE, AND FLAWED CDC POLICY
393
critical. The ranking Democrat on a House subcommittee before which
Dr. Frieden testified said, “It would be an understatement to say that the
response to the first U.S.-based patient with Ebola has been mismanaged,
causing risk to scores of additional people.” 106
3. Dr. Craig Spencer and Nurse Kaci Hickox
Things went from bad to worse on October 23, 2014, when it was
reported that a physician, Craig Spencer, who had treated Ebola patients
in West Africa, was admitted to Bellevue Hospital in New York City
after reporting to health officials that he had developed a fever and
gastrointestinal symptoms. 107 Dr. Spencer had returned to his home in
New York from Guinea six days earlier. 108 During those six days, he had
not been monitored by health officials 109; rather, he had been taking his
own temperature twice a day and watching for any sign of a fever, which
was consistent with the instructions he had been given by Doctors
Without Borders—the medical relief organization through which he had
volunteered to treat Ebola patients in Guinea.110
Alarming to many, however, was that Dr. Spencer, while infected
with Ebola, had been out in public in New York City during those six
days before he experienced symptoms of the illness. 111
[H]e traveled to Manhattan’s Highline Park and a
popular restaurant called The Meatball Shop on
Tuesday. The next day, he took a 3-mile run along
Riverside Park and traveled on the subway to Brooklyn,
106
Dunham, supra note 100.
Lupkin, Timeline, supra note 69.
108
See id.
109
Dr. Spencer entered the country through JFK International Airport on Oct. 17, 2014,
Sydney Lupkin, New Jersey, New York, Illinois, Toughen Ebola Quarantine Rules After
Doctor Case, ABC NEWS (Oct. 24, 2014), http://abcnews.go.com/Health/york-doctorebola-quarantine/story?id=26431431 [hereinafter Lupkin, States Toughen], which was
five days before CDC instituted a new policy of requiring that all travelers entering the
U.S from any West African nation where Ebola was widespread be monitored by public
health officials. See CDC Press Release, CDC Announces Active Post-Arrival
Monitoring for Travelers from Impacted Countries (Oct. 22, 2014), http://www.cdc.gov/
media/releases/2014/p1022-post-arrival-monitoring.html. Thus, Dr. Spencer was not
subject to this new policy having entered the country before it had been announced. This
change in policy occurred the day before Dr. Spencer experienced his first symptoms and
was admitted to the hospital with Ebola.
110
Lupkin, States Toughen, supra note 109.
111
Id.
107
394
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where he went bowling. He was fatigued, but had no
fever, officials said. 112
On October 24, the day after Craig Spencer entered the hospital with
Ebola and in direct response to the public fear his story triggered, several
states took matters into their own hands. Rather than follow the CDC’s
lead of permitting travelers returning home from West Africa to go out in
public even if they had had contact with someone sick with Ebola, New
Jersey, New York, and Illinois instituted policies to quarantine all such
travelers—regardless of symptoms—until the twenty-one day incubation
period for Ebola had elapsed for each of them. 113 Governors Christie and
Cuomo defended their tough new policies, saying “[w]e are no longer
relying on C.D.C. standards” because a “voluntary Ebola quarantine is
not enough.” 114
Nurse Hickox landed at Newark Liberty International Airport the
very day after New Jersey instituted its new policy of mandatory
quarantine. 115 She became the first person subjected to mandatory
quarantine of travelers from an Ebola-ridden country. 116 It triggered a
stand-off between the Obama Administration, which rebuked states that
instituted mandatory quarantine for overreacting and potentially
undermining Ebola relief efforts, and the governors of those states, who
raised concerns that the federal government’s response to Ebola was
insufficient to protect the public’s health.117 As described in the
introduction to this article, New Jersey officials released Hickox from
her quarantine two days later on October 27, after she agreed to travel by
private means directly to her home state of Maine, where, as we know,
she then fought the efforts of that state to quarantine her.
112
Id.
Id.
114
Marc Santora, First Patient Quarantined Under Strict New Policy Test Negative for
Ebola, N.Y. TIMES (Oct. 24, 2014), available at http://www.nytimes.com/2014/10/25/
nyregion/new-york-ebola-case-craig-spencer.html?&hp&action=click&pgtype=
Homepage&version=LedeSum&module=a-lede-package-region&region=top-news&WT.
nav=top-news.
115
Sam Frizell, First Ebola Worker Quarantined Under New Policy Tests Negative,
TIME (Oct. 25, 2014), available at http://time.com/3538834/ebola-quarantine-new-york/.
116
Id.
117
See David Martosko, Chris Christie Insists He DIDN’T Do U-turn Under Pressure
From Obama After Ebola Nurse is Allowed to Leave New Jersey Hospital Quarantine
Test to Return to Maine, DAILY MAIL (Oct. 25, 2014), available at http://www.dailymail.
co.uk/news/article-2808178/Obama-forces-Chris-Christie-U-turn-allow-Ebola-nurseleave-quarantine-tent.html (“‘Illinois has since adopted this policy, so has now the state
of Maryland.’ [Gov. Christie] said. ‘So I’m telling you guys this is going to become a
national policy eventually. Eventually the CDC will come around.’”).
113
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EBOLA, QUARANTINE, AND FLAWED CDC POLICY
395
4. Theoretical Risks of Transmission
During this same timeline, news outlets reported that scientists had
not ruled out the possibility that Ebola is transmissible through coughing
and sneezing. 118 Nor could they rule out the possibility that
asymptomatic individuals might shed some virus cells before developing
significant symptoms. 119 These reports were based on statements from
scientists that laboratory data had not eliminated the theoretical risk of
Ebola transmission through a cough or sneeze droplet or the theoretical
risk that an asymptomatic person with a non-zero viral load could
transmit Ebola to another person. Moreover, there is at least one
coincidence suggesting that the CDC felt compelled to account for these
statements about theoretical risks from scientists. The agency, at about
the same time that it issued its Guidance, also updated its web-based
FAQs concerning Ebola transmission via coughing or sneezing. 120 The
new version clarified that “[t]here is no evidence indicating that Ebola
virus is spread by coughing or sneezing,” 121 which is different from
saying definitively that the virus cannot be spread that way.
All of this together describes the context in which the CDC made its
recommendation in the Guidance to severely restrict the movements of
asymptomatic individuals like Nurse Hickox. The agency acted in the
midst of fear that, without mandatory quarantine, health care workers
incubating Ebola, like Craig Spencer, would be out in public and
somehow spread the virus. It acted in the midst of fear that Kaci Hickox
might be another Craig Spencer. Furthermore, it issued the Guidance at a
time when public attention was focusing on theoretical rather than actual
risks, and when confidence in the CDC was at a low point given the
mistakes and policy shifts it had made during the crisis.
Viewed from this perspective, it seems plausible that the CDC would
issue a policy to account for theoretical risks that science had yet to ruleout, and not simply the known risks that science and field experience
confirmed as true. With its credibility substantially damaged by its
earlier blunders and mistaken predictions, the agency might have
118
David Willman, Some Ebola Experts Worry Virus May Spread More Easily Than
Assumed, L.A. TIMES (Oct. 7, 2014), available at http://www.latimes.com/nation/la-naebola-questions-20141007-story.html#page=1; Jon Greenberg, George Will Says a
Sneeze or Cough Could Spread Ebola, POLITIFACT (Oct. 19, 2014),
http://www.politifact.com/punditfact/statements/2014/oct/19/george-will/george-willclaims-sneeze-cough-spread-ebola/.
119
Willman, supra note 118.
120
Arthur Delaney, CDC Removed Info On Coughing and Sneezing from Ebola Q&A
(UPDATE), HUFFINGTON POST (Oct. 30, 2014), http://www.huffingtonpost.com/2014/10/
30/cdc-ebola_n_6078072.html.
121
Id.
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rationalized that it was necessary to accommodate public fear by
recommending severe “movement restrictions” for asymptomatic
individuals with at least “some risk” of developing Ebola. The CDC may
have convinced itself that this would prevent another embarrassment and
thereby preserve its ability to set policy throughout the crisis.
Of course, this is merely an educated guess based on information that
is publically available. Perhaps hardball politics was going on behind
closed doors, which has yet to come to light. In any case, the story of the
CDC’s Guidance, and of the events that preceded it, is a cautionary tale
of how even the most authoritative public health agency can go wrong
when it makes policy divorced from science. It demonstrates how expert
administrators with impeccable credentials and the best of intentions can
make public health policy that accommodates public fear at the expense
of science. The next and final section of this article examines the price
we pay when that happens.
E. THE MANY COSTS OF ACCOMMODATING FEAR IN PUBLIC
HEALTH POLICY
A fundamental principle of public health practice is that policy must
be grounded in science. It is embedded in Dr. Frieden’s practice,
described in the epigraph of this article, to “base it all on data.” 122
Regardless of the underlying reason (or rationalization), the CDC’s
recommendation in its Guidance that asymptomatic individuals exposed
to Ebola patients while in West Africa be prohibited from coming within
three feet of another person for the twenty-one day incubation period of
the virus breached this core principle. As demonstrated by almost forty
years of experience, encompassing twenty-five Ebola outbreaks, and
somewhere between 16,000 and 25,000 human cases, asymptomatic
individuals incubating Ebola do not pose a risk of transmission to
others. 123 Consequently, subjecting them to a near-absolute quarantine
does not serve a public health purpose. Instead, it accommodates and
exacerbates public fear, deprives some individuals of their right to move
about freely, and sets a dangerous example for ignoring science. Each of
these comes at a high cost, and some of those costs are apparent from our
recent experience with Ebola.
As others have noted, one cost of unnecessary restrictions on the
liberty of those who travel to West Africa to care for Ebola patients is
122
Jon Schuppe, CDC Chief Tom Frieden Confronts Ebola Crisis Cool and Collected,
NBC NEWS (Aug. 10, 2014), http://www.nbcnews.com/storyline/ebola-virus-outbreak/
cdc-chief-tom-frieden-confronts-ebola-crisis-cool-collected-n175351.
123
See supra text accompanying notes 44–46.
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EBOLA, QUARANTINE, AND FLAWED CDC POLICY
397
that such a policy discourages health care workers from volunteering to
provide such treatment. 124 The medical relief organization, Doctors
Without Borders, for which both Craig Spencer and Kaci Hickox
volunteered, reported in late October 2014 that it had already seen the
“chilling effect” that a threat of quarantine and similar restrictions were
having on its volunteers. 125 Anxiety and confusion among workers over
quarantine laws caused the organization to consider shortening stays in
West Africa so as to accommodate the twenty-one days a worker might
need to remain away from family and co-workers after returning
home. 126
Imposing additional burdens on individuals who would otherwise
fight the spread of Ebola at its source is not only unfair to health care
workers volunteering their services at great personal risk, but it also
increases the risk that the disease spreads. Like a wildfire, an infectious
disease will spread if not contained.127 Thus, the best way to protect the
population of the U.S. against Ebola is to contain it and stop it in West
Africa. That, of course, requires willing volunteer health care workers to
travel abroad to take up the fight.
Additionally, when the CDC accommodates public fear by
recommending a near-absolute quarantine of health care workers
returning from West Africa, it creates cover for others to do the same.
The Secretary of Defense, at the request of the Joint Chiefs of Staff,
announced a policy in late October to quarantine all military personnel
for twenty-one days when they return from service in any of the three
West African nations where Ebola was widespread. 128 This tremendous
waste of financial and military resources was designed to comfort
military personnel and their families against the fear that somehow an
asymptomatic soldier might infect a loved one with Ebola back home. 129
Once the precedent is set for accommodating irrational public fear
over the transmission of Ebola from asymptomatic individuals, it is
124
Drazen, supra note 48, at 2029.
Jonathan Allen, U.S. Quarantines ‘Chilling’ Ebola Fight in West Africa: MSF,
REUTERS (Oct. 30, 2014), http://www.reuters.com/article/2014/10/31/us-health-ebolausa-msf-idUSKBN0IJ2PR20141031.
126
Id.
127
Dan Roberts, CDC Director Warns Ebola like ‘Forest Fire’ as Congress Readies for
Hearing, GUARDIAN (Oct. 16, 2014), available at http://www.theguardian.com/world/
2014/oct/16/ebola-congress-hearing-cdc-director.
128
Barbara Starr, Hagel Announces Mandatory Ebola Quarantine, CNN (Oct. 29,
2014), http://www.cnn.com/2014/10/29/politics/military-ebola-quarantine/.
129
See Dan Lamothe, Military Begins First Quarantine-Like Monitoring in U.S. for
Ebola Mission Troops, WASH. POST (Nov. 13, 2014), available at http://www.
washingtonpost.com/news/checkpoint/wp/2014/11/13/military-begins-first-quarantinelike-monitoring-in-u-s-for-ebola-mission-troops/.
125
398
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difficult to contain. It imposes a social, if not a legal, obligation on health
care workers to quarantine themselves rather than risk being perceived as
irresponsible. 130 Likewise, it puts political pressure on state politicians to
out-do each other in the name of soothing public fear and comforting
their constituents. As one newspaper headline put it, “Is Your State
Quarantining Ebola Doctors?” 131 The accompanying article stated that
“[s]everal governors in tough reelection fights are rejecting CDC’s Ebola
Guidelines in favor of more draconian rules.” 132
Discrimination against those associated with Ebola is an even uglier
cost to accommodating irrational public fear about transmission of the
disease. Here are just a few examples of Ebola discrimination in the U.S.
Officials in several states excluded teachers and students from
classrooms merely because they or someone they live with traveled to
West Africa. 133 Health care workers who had treated Ebola patients in
Atlanta, New York, and Dallas lost moonlighting jobs, were denied
service in local businesses, and had their children turned away from day
care for fear that they posed a danger.134 School-aged brothers from
Senegal, living in the U.S., were beaten by classmates yelling “Ebola.” 135
Certainly, there would be cases of discrimination regardless of whether
the CDC accommodated public fear through its Guidance, but we must
130
See Rebecca Martinez & Eric Hodge, North Carolina Doctor in Voluntary
Quarantine After Returning from Liberia Aid Mission, WUNC (Jan 7, 2015), http://wunc.
org/post/north-carolina-doctor-voluntary-quarantine-after-returning-liberian-aid-mission?
utm_source=Facebook&utm_medium=Social&utm_campaign=FBWUNC4651.
131
Sam Baker & Sophie Novack, Is Your State Quarantining Ebola Doctors?, NAT.
JOURNAL (Oct. 30, 2014), http://www.nationaljournal.com/health-care/is-your-statequarantining-ebola-doctors-20141030.
132
Id.
133
See, e.g., Connecticut School Lifts Ban on Girl Barred Over Ebola Fears, REUTERS
(Oct. 30, 2014), http://www.reuters.com/article/2014/10/31/us-health-ebola-usa-schoolidUSKBN0IK01P20141031); see Aimee Jones, Newton High School Teacher Removed
From School Until She is Medically Cleared for Ebola, NEWTON CITIZEN (Oct. 29, 2014),
available
at
http://www.newtoncitizen.com/news/2014/oct/29/newton-high-schoolteacher-removed-from-school/); see also Amanda Terkel, Oklahoma Teacher Will Have
To Quarantine Herself After Trip to Ebola-Free Rwanda, HUFFINGTON POST (Oct. 28,
2014), http://www.huffingtonpost.com/2014/10/28/ebola-rwanda-oklahoma-teacher_n_
6062726.html); see also Allison Ross, Teacher Leaves Catholic School Amid Ebola
Fears, COURIER-JOURNAL (Nov. 4, 2014), available at http://www.courier-journal.com/
story/news/education/2014/11/03/louisville-catholic-teacher-resigns-amidst-ebola-fears/
18417299/.
134
Anemona Hartocollis & Nate Schweber, Bellevue Employees Face Ebola at Work,
and Stigma of It Everywhere, N.Y. TIMES (Oct. 29, 2014), available at http://www.
nytimes.com/2014/10/30/nyregion/bellevue-workers-worn-out-from-treating-ebolapatient-face-stigma-outside-hospital.html?_r=4.
135
Elizabeth Barber, 2 Kids from Senegal Were Beaten Up in NYC by Classmates
Yelling ‘Ebola’, TIME (Oct. 28, 2014), available at http://time.com/3542955/senegalkids-brothers-assaulted-ebola-bronx-tremont-school-new-york-city-pabe-amadou-drame/.
2015]
EBOLA, QUARANTINE, AND FLAWED CDC POLICY
399
assume that cases of discrimination increase significantly when the
nation’s leading public health authority suggests that there is reason to
fear that we might catch Ebola even from those who do not appear to be
sick.
Finally, when the CDC, through the Guidance, ignores the facts
about Ebola transmission, it erodes confidence in science, which makes
the work of protecting the public’s health all the more difficult. Consider
the latest measles outbreak in the U.S. From January 1 through April 3,
2015, there were 159 cases of measles spanning eighteen states and the
District of Columbia.136 The recent resurgence of measles in the U.S. is
often blamed on parents who ignore the scientific facts about the risks
and benefits of the measles vaccine.137 How can the CDC or any public
health agency blatantly ignore the science of Ebola transmission, and
then urge American parents to set aside their unfounded fear and trust the
science behind the measles vaccine?
In the face of both widespread fear over Ebola in the U.S. and the
CDC’s damaged credibility following several early mistakes, it might
have been a near impossible task for the agency to fend-off its critics and
hold public health policy accountable strictly to the science of Ebola
transmission. But that is the fight the CDC should have taken up. Instead,
by issuing its deeply flawed Guidance, the agency ignored its bedrock
responsibility and, as a result, undermined the public’s health.
136
Measles Cases and Outbreaks, CDC (Mar. 30, 2015), http://www.cdc.gov/measles/
cases-outbreaks.html.
137
See, e.g., Jennifer Shih, Why Worry About the Measles Outbreak?, CNN (Aug. 7,
2014), http://www.cnn.com/2014/08/07/opinion/shih-measles-vaccine/.
Pharmaceuticals and Biopiracy: How the
America Invents Act May Reduce the
Misappropriation of Traditional Medicine
Ryan Levy* and Spencer Green **
For decades, Eastern traditional medicine has been
misappropriated by others who claim it as their own and attempt
to obtain patent protection for it. As long this practice has
existed, the international community has pushed back against it.
Several countries and international bodies have created
databases of traditional knowledge, hoping to preclude the
issuance of patents on that knowledge. Other countries, like
Thailand, have extended intellectual property protection to the
traditional knowledge stakeholders themselves. However, a
recent change to U.S. patent law may have the unintended
consequence of helping resolve the issue of biopiracy.
Prior to the passage of the America Invents Act, a foreign
invention could only serve as prior art to U.S. patents if the
foreign invention itself was patented or if it was described in a
printed publication. Because much traditional knowledge was
never recorded, U.S. law did not consider it to be prior art. This
allowed corporations to obtain patent protection for traditional
medicine, even though indigenous peoples had been using it for
centuries.
The America Invents Act, however, eliminated the requirement
that a public use occur “in this country” to constitute prior art.
As a result, public use of traditional knowledge anywhere in the
world renders it prior art to all subsequent U.S. patent
applications. This article analyzes how this dramatic shift in the
*
Ryan Levy is a shareholder at Patterson Intellectual Property Law, P.C., located in
Nashville, Tennessee.
**
Spencer Green is currently a law clerk at Patterson Intellectual Property Law, P.C.,
located in Nashville, Tennessee. He expects to earn his Juris Doctor from Belmont
University College of Law in May 2015.
401
402
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scope of available prior art affects the patent strategies of
companies and provides different remedies to traditional
knowledge stakeholders.
I. INTRODUCTION .................................................................................. 402
II. A BRIEF HISTORY OF GEOGRAPHIC LIMITATIONS ON PRIOR
ART ................................................................................................ 405
III. THE PROBLEM OF BIOPIRACY ........................................................ 406
A. Biopiracy in the Pharmaceutical Industry ............................... 406
i. Kwao krua .......................................................................... 407
ii. Hoodia ................................................................................ 407
iii. Madagascar rosy periwinkle .............................................. 408
B. Negative Consequences of Biopiracy....................................... 409
C. Royalties Paid to Indigenous Knowledge Stakeholders........... 411
IV. PUSHBACK FROM THE INTERNATIONAL COMMUNITY ................... 413
A. Traditional knowledge databases ............................................ 413
B. Sui Generis: Granting property rights in traditional
knowledge ................................................................................ 415
C. WIPO Progress Report on the Status of Traditional
Knowledge as Prior Art ........................................................... 416
V. CHANGES IN THE SCOPE OF “PRIOR ART”....................................... 417
A. Substantive changes to U.S. patent law under the America
Invents Act ............................................................................... 418
B. Limitations of the administrative process ................................ 420
C. Federal Court Practice ............................................................. 421
VI. CONCLUSION.................................................................................. 422
I. INTRODUCTION
In 1995, two Indian immigrants at the University of Mississippi
Medical Center obtained a U.S. patent entitled “Use of turmeric in
wound healing” (the “Tumeric Patent”).1 The patent acknowledged that
turmeric had been used “in India as a traditional medicine for the
treatment of various sprains and inflammatory conditions.” 2 However,
this patent purported to put turmeric to a new use based on “experimental
1
U.S. Patent No. 5,401,504 col. 1 l. 37-39 (filed Dec. 28, 1993); see also Prithwiraj
Choudhury & Tarun Khanna, Bio-Piracy or Prospering Together? Fuzzy Set and
Qualitative Analysis of Herbal Patenting by Firms 24 (Harvard Bus. Sch., Working Paper
14-081, 2014) [hereinafter Choudhury & Khanna, Bio-Piracy], available at http://www.
hbs.edu/faculty/Publication%20Files/14-081_6cfa4f81-d5cb-44f6-9a0c-1fe7c91f61ef.
pdf.
2
‘504 Patent., supra note 1 col. 1 l. 37-39 (filed Dec. 28, 1993).
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PHARMACEUTICALS AND BIOPIRACY
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evidence.” 3 The inventors claimed a “method of promoting healing of a
wound in a patient, which consists essentially of administering a woundhealing agent consisting of an effective amount of turmeric powder to
said patient.” 4 The problem is that turmeric had, in fact, been used in
wound healing for millennia. 5
Because of the widespread use of turmeric for wound healing,
particularly in India, this patent had the potential to have significant
effects. Indians living in America could infringe the patent by using this
home remedy and Indian companies would be subject to liability if they
exported goods to the United States that used the remedy. 6 In response,
the Indian Council of Scientific and Industrial Research (CSIR) sought
reexamination of the patent. 7 It demonstrated, through ancient Sanskrit
texts and academic publications, that the patented method lacked
novelty. 8 The United States Patent and Trademark Office (USPTO)
issued a Reexamination Certificate in 1998 cancelling every claim of the
patent. 9 Thus, with respect to the Turmeric Patent, the patent system
corrected itself. A bad patent was issued on traditional medicine, adverse
parties utilized the available administrative procedures, and the USPTO
cancelled the claims.
However, due to geographic limitations on prior art, patents based on
or claiming traditional knowledge are not always invalidated. Many
traditional knowledge stakeholders do not have the benefit of printed
publications embodying their knowledge. Under pre-America Invents
Act (AIA) law, patents on that knowledge remain valid. 10 Moreover, the
mere grant of a patent on a method for using turmeric in wound healing
brought about significant social harm, despite its later invalidation. A
remedy that the Indian people had utilized for thousands of years was
now owned by the University of Mississippi Medical Center.11 The
Indian people were outraged that a patent had been granted on
3
Id.
Id. col. 3 l. 4-7.
5
Choudhury & Khanna, Bio-Piracy, supra note 1, at 23.
6
See 35 U.S.C. § 271(a) (2012) (providing that “whoever without authority makes,
uses, offers to sell, or sells any patented invention, within the United States or imports
into the United States any patented invention during the term of the patent therefor,
infringes the patent.”).
7
TOBIAS KIENE, THE LEGAL PROTECTION OF TRADITIONAL KNOWLEDGE IN THE
PHARMACEUTICAL FIELD 17 (2011).
8
Id; ‘504 Patent., supra note 1 Reexamination Certificate (issued Apr. 21, 1998).
9
Id.
10
Patents issued before March 18, 2013 are governed by the Patent Act, rather than by
the America Invents Act. Medisim Ltd. v. BestMed, LLC, 758 F.3d 1352, 1354 n.1 (Fed.
Cir. 2014). Under the Patent Act, foreign inventions were not regarded as prior art unless
they were “patented or described in a printed publication.” 35 U.S.C. § 102(a) (2006).
11
Choudhury & Khanna, Bio-Piracy, supra note 1, at 23.
4
404
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“something that has been the collective wisdom of a people for
centuries.” 12
The USPTO has received tens of thousands of patent applications
relating to traditional uses of Indian and Chinese herbal remedies.13
However, a recent change in U.S. patent law will affect whether such
patents continue to be granted, whether they are enforced, and how the
patent claims are drafted. Prior to the passage of the America Invents Act
(AIA), 14 foreign public use, sale, or knowledge of these traditional
remedies was not regarded as “prior art” to U.S. patents.15 As a result,
even if traditional remedies had been used for thousands of years outside
the United States, they could not be used to invalidate a U.S. patent
unless they were published. 16 The AIA changed that by eliminating the
“in this country” limitation to those types of prior art.17
This article addresses how the America Invents Act will affect the
patent strategies of pharmaceutical companies seeking U.S. patents based
on traditional medicine. It also discusses whether the AIA has created a
new avenue through which traditional knowledge stakeholders may
invalidate patents based on traditional medicine. Part I provides
background on the history of geographic limitations to prior art under
U.S. patent law. Part II discusses biopiracy, how it affects traditional
knowledge stakeholders, and how Western firms have responded to
charges that they expropriated traditional knowledge. Part III discusses
the various measures that governmental entities and international bodies
have taken in order to combat biopiracy. Part IV identifies and discusses
the particular changes to the U.S. patent system under the AIA that may
affect pharmaceutical companies’ ability to obtain protection for
inventions based on traditional knowledge.
12
Id. at 26.
Prithwiraj Choudhury & Tarun Khanna, Codifying Prior Art and Patenting: Natural
Experiment of Herbal Patent Prior Art Adoption at the EPO and USPTO 15 (Harvard
Bus. Sch., Working Paper No, 14-079, 2014) [hereinafter Choudhury & Khanna, Prior
Art], available at http://www.hbs.edu/faculty/Publication%20Files/14-079_9f881e56002c-4603-a778-5a698184c827.pdf.
14
Leahy-Smith America Invents Act, Pub. L. No. 112-29, 125 Stat. 284 (2011)
(codified at 35 U.S.C. §§ 1–390 (2011)) [hereinafter America Invents Act or AIA].
15
35 U.S.C. § 102(a) (2006).
16
Id.
17
See 35 U.S.C. § 102(a) (2012).
13
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II.
PHARMACEUTICALS AND BIOPIRACY
405
A BRIEF HISTORY OF GEOGRAPHIC LIMITATIONS ON PRIOR
ART
Geographic limitations on prior art have been a long-standing feature
of U.S. patent law following passage of the Patent Act of 1836. 18 Before
the advent of airplanes and the Internet, which carry products and
information rapidly across the world, geographic limitations on prior art
enabled American “inventors”—who sought to commercially exploit
foreign inventions in this country—to receive patents on that technology,
despite not having invented it. 19 Nonetheless, these patents were
arguably consistent with the Constitution’s Intellectual Property Clause,
which grants Congress the power “to promote the progress of science
and the useful arts.” 20 These entrepreneurs introduced to the United
States new technology that would otherwise be unavailable, thereby
promoting the progress of science in this country. 21 In the modern world,
however, geographic limitations on prior art are no longer required to
ensure that new technology is made available across seas. Advances in
how people trade information globally also reduce the burden of
examining patent applications in light of all prior art, wherever it may be
found.
The U.S. patent system seeks to do more than simply encourage the
introduction of new products into American markets. There are costs
associated with granting monopolies to patent holders and removing
information from the public domain. To properly balance those costs
against the social and economic benefits of the introduction of new
technology, the Framers understood the Intellectual Property Clause to
embody certain limitations. Patents may not be granted to non-inventors,
and inventions in the public domain may not be removed from the public
domain. 22 Modern patent law reflects those understandings by granting
patent protection only to inventors who have “invent[ed] or
discover[ed]” technologies 23 that are useful, 24 novel, 25 non-obvious, 26
18
Patent Act of 1836, ch. 357, 5 Stat. 117, Sec. 7 (1836). (providing that a patent shall
only issue if the invention “had [not] been invented or discovered by any other person in
this country prior to the alleged invention or discovery thereof by the applicant . . . or
described in any printed publication in this or any foreign country.”).
19
If, however, each of the claim limitations was embodied in a printed publication, a
U.S. patent would be denied. See id.
20
U.S. CONST. art I, § 8, cl. 8.
21
See Margo A. Bagley, Patently Unconstitutional, 87 MINN. L. REV. 679, 684 (2003)
(arguing that geographic limitations on prior art are unconstitutional because they permit
the patenting of inventions in the public domain).
22
Id.
23
35 U.S.C. § 101 (2012).
24
Id.
25
35 U.S.C. § 102 (2012).
406
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and enabled. 27 By eliminating geographic restrictions on prior art, the
America Invents Act has broadened the scope of prior art in a way that
may prevent future patents on traditional knowledge. In doing so, it will
help ensure that the U.S. patent system does not prejudice the public or
harm traditional knowledge stakeholders.
III.
THE PROBLEM OF BIOPIRACY
“Biopiracy” describes circumstances in which “developed countries
use biotechnology patents to expropriate the biological [or] genetic
heritage of less developed countries.” 28 Accusations of biopiracy
typically involve the theft of traditional knowledge that is otherwise held
by indigenous people. 29 The textbook example involves valuable uses of
local plants or animals within a particular indigenous community.
Corporations may become aware of these uses, then seek to patent and
commercialize that knowledge for their own gain.30 Companies often
attempt to patent rights in indigenous knowledge or the products and
methods derived from that knowledge. 31 As such, the patentee may
receive significant financial compensation for their patent rights, while
leaving the indigenous community with no gain.
A.
Biopiracy in the Pharmaceutical Industry
Due to the medicinal nature of much traditional knowledge,
pharmaceutical companies are among the most common perpetrators of
biopiracy. Consumers often have allergies to drugs or simply desire to
avoid the side effects associated with such medicines. 32 As a result, the
market for pharmaceutical products based on traditional knowledge is
growing, and pharmaceutical companies seek to take advantage. 33 These
companies frequently become aware of traditional remedies for common
medical problems, then commercialize and patent some variation of
26
35 U.S.C. § 103 (2012).
35 U.S.C. § 112 (2012).
28
Baruch A. Brody, Traditional Knowledge and Intellectual Property, 20 KENNEDY
INST. OF ETHICS J. 231 (2010).
29
Id.
30
Id. at 232.
31
Peter Drahos, Indigenous Knowledge, Intellectual Property and Biopiracy, 22 EUR.
INTELL. PROP. REV. 245 (2000).
32
J. Maheswari, Patenting Indian Medicinal Plants and Products, 4 INDIAN J. SCIENCE
& TECH. 298, 300 (2011).
33
See Chika A. Ezeanya, Contending Issues of Intellectual Property Rights Protection
and Indigenous Knowledge of Pharmacology in Africa South of the Sahara, 6 J. PAN AFR.
STUD. 24, 29 (2013).
27
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PHARMACEUTICALS AND BIOPIRACY
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those remedies for their own benefit. The USPTO receives literally
thousands of patent applications that relate in some way to traditional
knowledge. 34
Below are a few of the most well-known instances of pharmaceutical
biopiracy. These examples reflect the complexity of the issues, the
varying cultural perceptions on the commercialization of traditional
medicine, and the limits of the patent system’s ability to resolve these
conflicts.
i. Kwao krua
The Thai herb kwao krua had been used for over 100 years and its
medicinal uses had been documented in Thai writings as early as 1931. 35
More recently, however, certain plant-produced hormones have been
discovered in the plant.36 These hormones have been used in modern
medicine to enhance male sexual performance, enlarge and firm breasts,
and firm the skin. 37 A company based in South Korea holds a U.S. patent
on an extract from kwao krua for some of these purposes. 38
The concern for the Thai people is that the steps for extraction
disclosed in the patent do not differ from the methods that practitioners
of traditional medicine have used for nearly a century. 39 Unfortunately,
publications discussing this practice were not considered as prior art to
the U.S. patent. 40 Threats of legal action have disrupted local producers
of kwao krua and the plant has been harvested quickly for commercial
purposes, which does not allow time for the plant’s regrowth.41 Due to
the grant of intellectual property protection in this traditionally used plant
and its extract, indigenous peoples’ customs relating to the plant’s
ordinary production and use have been disturbed.42
ii. Hoodia
The San people of the Kalahari Desert in South Africa have been
using Hoodia, a local plant, as an appetite-suppressant since ancient
34
Choudhury & Khanna, Prior Art, supra note 1, at 15.
DANIEL F. ROBINSON, CONFRONTING BIOPIRACY: CHALLENGES, CASES
INTERNATIONAL DEBATES 55 (2010).
36
Id.
37
Id.
38
U.S. Patent No. 6,673,377 (filed Aug. 28, 2000).
39
ROBINSON, supra note 35, at 55.
40
See id.
41
Id. at 59.
42
See id.
35
AND
408
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times. 43 Suppressing their appetite by consuming Hoodia allowed them
to engage in longer hunting expeditions and carry fewer supplies,
increasing the productivity of the hunts.44 Pursuant to an international
treaty, the Convention on Biodiversity (CBD), the San people have
received royalty payments for the sales of drugs containing Hoodia by
multinational pharmaceutical companies.45 However, serious questions
remain about the fairness and propriety of such profit-sharing
agreements. 46 Moreover, the United States is not a party to the CBD, so
profits gained through the exploitation of the U.S. patents on Hoodia
result in no benefit to the San people.47 Thus, numerous patents that
incorporate the San people’s indigenous knowledge of Hoodia have been
granted in both the United States and Europe, with little or no benefit
from the sales of products protected by those patents to the San people.
iii. Madagascar rosy periwinkle
The commercialization of the healing properties of the Madagascar
rosy periwinkle is another example of a pharmaceutical company reaping
the rewards of Eastern medicinal plants. The plant had been long used in
traditional medicine by the indigenous communities of Madagascar,
among others. 48 Inspired by the use of this plant in traditional medicine,
Eli Lilly & Company 49 isolated two extracts that give the plant its
healing properties: vinblastine and vincristine. 50 Those extracts are now
used in drugs the company markets for the treatment of cancer.51 Eli Lily
receives around $100 million each year from these drugs, but the
indigenous peoples of Madagascar do not share in the profits. 52
43
Fritz Dolder, Traditional Knowledge and Patenting: The Experience of the
Neemfungicide and the Hoodia Cases, 26 BIOTECHNOLOGY L. REP. 583, 587 (2007).
44
Id.
45
Saskia Vermeylen, Contextualizing ‘Fair’ and ‘Equitable’: The San’s Reflections on
the Hoodia Benefit-Sharing Agreement, 12 LOC. ENV’T 423, 428 (2007).
46
See generally id. (discussing the San people’s perceptions of the fairness of the
Hoodia Benefit Sharing Agreement); see infra Part I.C.
47
List
of
Parties,
CONVENTION
ON
BIOLOGICAL
DIVERSITY,
http://www.cbd.int/information/parties.shtml (last visited Mar. 29, 2015) (listing the
parties to the CBD).
48
Michael Hassemer, Genetic Resources, in INDIGENOUS HERITAGE AND
INTELLECTUAL PROPERTY, 151, 168 (ed. Silke von Lewinski 2004).
49
Eli Lilly & Company has approximately 39,000 employees worldwide, markets
products in 125 countries, and had net sales of over $23 billion in 2013. Key Facts, ELI
LILLY & CO., http://www.lilly.com/about/key-facts/Pages/key-facts.aspx (last visited
Mar. 29, 2015).
50
Hassemer, supra note 48 at 168.
51
Id.
52
Id.
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PHARMACEUTICALS AND BIOPIRACY
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Despite the perceived misappropriation of Malagasy culture,
Malagasy healers never used the rosy periwinkle for the uses to which
Eli Lilly is putting it. They used it primarily in treating diabetes.53
Because Eli Lilly used the plant to produce new compounds, for new
medicinal uses, they may be able to obtain patent protection even under
the America Invents Act. 54 However, the expanded scope of prior art
under the new Section 102 will not be without impact on Eli Lilly’s
ability to patent these sorts of inventions. Consideration of the Malagasy
use may force companies like Eli Lilly to narrow their patent claims,
directing them only at the new innovation. Accordingly, even where
prior art may not entirely bar new patents, its consideration may affect
the reach of new patent claims.
B.
Negative Consequences of Biopiracy
The greatest criticism of the expropriation of indigenous medical
knowledge by for-profit companies is that it is simply unfair. 55 These
critics argue that pharmaceutical companies are permitted to realize
millions of dollars in sales from some traditional remedies with little or
no payment to the actual indigenous knowledge holders.56 Critics of the
Turmeric Patent leaned heavily on the perceived unfairness of patenting
a remedy that had been used to heal wounds in India for hundreds of
years. 57 It was also an issue in Eli Lilly’s use of the Madagascar rosy
periwinkle, which generates $100 million in sales for the company
annually. 58 Ironically, the patenting of traditional knowledge may cause
the sale of products embodying traditional knowledge to the traditional
knowledge holders at monopoly prices. 59 Such sales, however, would
53
Id.
The AIA would consider medicinal uses of the plant that were known to the public
to be prior art. 35 U.S.C. § 102 (2012).
55
See e.g., Lester I. Yano, Protection of the Ethnobiological Knowledge of Indigenous
Peoples, 41 UCLA L. REV. 443, 445 (arguing that permitting drug developers to profit off
indigenous knowledge without compensating indigenous practitioners “is unfair and
hypocritical.”); David Conforto, J. ENVTL. L. & LITIG. 357, 365 (acknowledging the
perceived unfairness of geographic restrictions on prior art). But see generally Jim Chen,
37 MCGEORGE L. REV. 1 (arguing that biopiracy is only a perceived problem, not an
actual problem, and that the “biopiracy narrative” is false).
56
See e.g., Yano, supra note 55.
57
See Choudhury & Khanna, Bio-Piracy, supra note 1, at 25-26.
58
Hassemer, supra note 48, at 168.
59
Martin Khor, IPRs, Biodiversity, and the Theft of Indigenous Knowledge, 28
INTERDISC. SCI. REVIEWS 7, 8 (2003).
54
410
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have to occur within the United States to obtain the benefit of the
monopoly a U.S. patent would provide. 60
The most egregious examples of the exploitation of traditional
knowledge can occur when individuals and companies are prevented
from utilizing knowledge that they had been using for centuries. An
American patent does not preclude exportation of the patented invention
to foreign countries, but it does prevent importation of products
embodying the claimed invention to the U.S. 61 Due to the threat of legal
action, many such entities in countries that serve as the source of
traditional knowledge have been precluded from using that knowledge. 62
For instance, despite a history of the use of kwao krua by the indigenous
people of Thailand, threats of legal action have disrupted local
production of the herb. 63
In India, individuals and companies had been using extract from
neem trees for centuries to repel insects and bacterial diseases. 64 Once a
patent on a variation of this extract was granted to W.R. Grace & Co., the
company sought to force Indian companies producing neem-based
products to license its technology. 65 Local companies feared that this
patent would preclude them from exporting goods to the U.S. market and
would drive up the price of neem seeds.66 By depriving Indian companies
of their ability to export certain neem-based products to the world’s
largest economy, the neem patent deprived Indian people of their ability
to exploit their indigenous knowledge within the world economy. 67 This
led to a worldwide campaign to cancel the patent.68 By allowing for
patent protection on inventions derived from traditional knowledge, the
60
See 35 U.S.C. § 271(a) (2012) (limiting patent infringement to infringements
“within the United States” or importation “into the United States.”)
61
Id.
62
This use preclusion extends to personal uses only to the extent that patented methods
are being used inside the United States. The primary impact is with respect to
commercialization of traditional knowledge because products embodying the patents
would be shipped to the U.S.
63
ROBINSON, supra note 35, at 59.
64
Itsuki Shimbo et al., Patent Protection and Access to Genetic Resources, 26 NATURE
BIOTECHNOLOGY 645, 645 (2008).
65
Id.
66
Shayana Kadidal, Subject-Matter Imperialism? Biodiversity, Foreign Prior Art and
the Neem Patent Controversy, 37 IDEA 371, 376-77 (1997). But see Emily Marden, The
Neem Tree Patent: International Conflict Over the Commodification of Life, 22 B.C.
INT’L & COMP. L. REV. 279, 285 (articulating that effects of the neem patent on Indian
farmers are unclear and that the patent may help Indian farmers because W.R. Grace
processes its seeds in India).
67
Jonathan B. Warner, Using Global Themes to Reframe the Bioprospecting Debate,
13 IND. J. GLOBAL LEGAL STUD. 645, 651–652 (2006).
68
Shimbo, supra note 64.
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PHARMACEUTICALS AND BIOPIRACY
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use of the traditional knowledge itself amongst indigenous people may
be eroded. 69
Not only is the patenting of these traditional remedies unfair to the
indigenous knowledge holders, it is also unfair to the public, who grants
the “inventors” of these remedies the right to exclude others.70 The grant
of patent protection to inventors is based on a quid pro quo with society.
Inventors agree to disclose their discoveries to the public through the
patent’s specification and, in return, the public grants them an exclusive
right to exploit those discoveries for a limited time. In this way, both the
inventor and the public benefit from the protections that patent law
provides. This paradigm breaks down, however, when the discovery to
be disclosed is already known to the public. If the invention has been
used publicly for thousands of years, there is no benefit to the public in
granting the patentee the exclusive right to exploit it. When well-known
traditional knowledge is patented, there can be no quid pro quo, and the
public does not get the benefit of its bargain.
C.
Royalties Paid to Indigenous Knowledge Stakeholders
In response to the backlash that companies face due to their
misappropriation of traditional knowledge and pursuant to the Nagoya
Protocol under the Convention on Biological Diversity (CBD), which
requires benefit-sharing agreements with indigenous people, companies
will occasionally pay royalties to indigenous knowledge stakeholders.
While this scenario is fairer than it would be if no royalties were paid, it
is accompanied by its own unique set of problems. Conceptions of
fairness are culturally defined and indigenous peoples are often
concerned with social, environmental, and spiritual concerns that are not
accounted for by most profit-sharing agreements. 71 Therefore, while the
payment of royalties may be perceived as “fair” by the pharmaceutical
companies that are exploiting traditional knowledge, such arrangements
may not be perceived as fair by the indigenous people themselves. 72
The CBD sought to resolve a fundamental dispute regarding the
ownership of genetic resources by declaring that states’ sovereign rights
over natural resources extend to genetic resources.73 This model requires
a “government-to-government approach,” even though private actors
69
Khor, supra note 59, at 8.
See supra Part I.
71
Vermeylen, supra note 45, at 425-26.
72
See id.
73
Matthias Buck & Claire Hamilton, The Nagoya Protocol on Access to Genetic
Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization
to the Convention on Biological Diversity, 20 REV. EUR. COMMUNITY & INT’L L. 47, 47
(2011).
70
412
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ordinarily conduct transactions in genetic resources and traditional
knowledge. 74 The CBD has raised the level of protection for sovereign
rights to genetic resources, but has not augmented the level of protection
for the traditional knowledge holders themselves.75 Moreover, because
each member government has interpreted the provisions of the CBD
differently, standards governing the obligations of the parties and the
fairness of benefit-sharing agreements vary dramatically. 76
A prime example of how these benefit-sharing agreements under the
CBD fail to compensate most traditional knowledge holders is in the
treatment of the San people of Southern Africa. 77 The San’s traditional
knowledge relating to consuming Hoodia as an appetite suppressant is
the subject of a benefit-sharing agreement through South Africa’s
Council for Scientific and Industrial Research (CSIR). 78 Through the
benefit sharing agreement, the CSIR has permitted companies such as
Pfizer and Unilever to commercially exploit Hoodia. 79 The San never
granted prior informed consent for the commercialization of their
traditional knowledge. 80 Thus, the San began in a disadvantaged
bargaining position and did not obtain an equitable benefit-sharing
agreement. In fact, the vast majority of San people had never even heard
of the benefit-sharing agreement. 81 Under the benefit-sharing agreement,
the CSIR was to pay the San peoples eight percent of the “milestone
payments” made by licensees during the drug’s clinical development. 82
After the drug’s development was completed, the San would receive a
six percent royalty on the marketing of the drug. 83
To make matters worse, the very existence of a benefit-sharing
agreement disturbed long-standing San values regarding egalitarianism. 84
To facilitate the negotiation of a benefit-sharing agreement, the San were
pressured to elect leaders, thus changing the nature of group-decision
making that had previously prevailed in San culture.85 Most of the San
74
Id. at 48.
Id. at 56.
76
Id. at 55-56.
77
See supra Part II.A.iii.
78
Vermeylen, supra note 45, at 427.
79
World Health Organization, Protecting Traditional Knowledge: the San and Hoodia,
84 BULL. OF THE WHO 345 (2006). See also Ezeanya, supra note 33, at 30 (discussing the
sublicensing of Hoodia to Pfizer).
80
Vermeylen, supra note 45, at 427.
81
Id. at 429.
82
Leon Marshall, Africa’s Bushmen May Get Rich from Diet-Drug Secret, Nat’l
Geographic News (Apr. 16, 2003), available at http://news.nationalgeographic.com/
news/2003/04/0416_030416_san1.html.
83
Id.
84
Vermeylen, supra note 45, at 431.
85
Id.
75
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PHARMACEUTICALS AND BIOPIRACY
413
people were not consulted regarding the benefit-sharing agreement and
cared less about monetary compensation than they did about nonmonetary benefits, such as access to education and land.86 They also
expressed concerns that the money would be wasted and misused by
public officials.87 These people’s interests were not represented. Not only
did the majority of the San people not gain any tangible benefit from the
benefit-sharing agreement, the benefits that were gained came at the
expense of their traditional mode of decision-making.
IV.
PUSHBACK FROM THE INTERNATIONAL COMMUNITY
Unsurprisingly, the perceived unfairness of allowing companies to
expropriate traditional knowledge for their own commercial gain has
been met with strong international resistance. Countries with vast
traditional knowledge have sought to protect that knowledge either by
publishing it in English or by granting property rights in that knowledge
to the indigenous people. Additionally, international treaties, such as the
CBD, have sought to address the problem by providing some protections
for indigenous knowledge stakeholders. This Part explores the two major
ways that countries rich in traditional knowledge seek to prevent the
misappropriation of that traditional knowledge, as well as suggestions
that have been made by the World Intellectual Property Organization
(WIPO).
A.
Traditional knowledge databases
The most obvious and effective means of preventing the grant of
patents based on traditional knowledge is to ensure that the traditional
knowledge will be considered as prior art. At the most basic level, if
those opposing the issuance of a patent can demonstrate that the
“invention” is already known to the public, the invention is ineligible for
patent protection either because it is not novel or because the invention’s
improvement over the prior art would have been obvious to person of
ordinary skill in the art.88 One of the reasons that patents based on
traditional knowledge have been granted under U.S. law—despite their
obviousness or lack of novelty—is that foreign “public use” did not
qualify as prior art. 89 Foreign prior art must have been published in
English to be considered by the USPTO and federal courts. 90 In response,
86
87
88
89
90
Id. at 430.
Id.
See 35 U.S.C. §§ 102–103 (2012).
35 U.S.C. § 102 (2006).
37 C.F.R. § 3.26 (2014).
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various governments and international organizations have created
traditional knowledge databases that serve as a published written record
of the traditional knowledge.
The most inclusive of these databases is WIPO’s “Centralized
Access to Search and Examination” (CASE) database. While not
specifically directed at traditional knowledge, CASE facilitates
communication amongst patent offices worldwide.91 This allows patent
examiners to view patent applications in other participating jurisdictions
and share their own examination results.92 For instance, if a patent
application based on medical uses of indigenous Australian plants is filed
in the United Kingdom’s Intellectual Property Office, the UK patent
examiner can access the database to determine whether any similar
applications had been filed with IP Australia. 93 In this way, the scope of
available prior art and the accessibility of that prior art are both
improved.
WIPO’s PATENTSCOPE Search System provides patent attorneys,
inventors, and researchers a free and accessible way to search patent
documents from over thirty participating countries and organizations. 94
In addition to WIPO’s databases, China, India, the Republic of Korea,
Bioversity International, Peru, the Philippines, the Inuit of Nunavik, and
the Dene in Canada have all established databases directed specifically
towards traditional knowledge. 95 These databases consist of English
language documents that have recorded traditional knowledge.
These traditional knowledge databases have had a measurable impact
on the subject matter of patents that have been granted. For instance,
following the EPO’s adoption of India’s traditional knowledge database,
new patents based on herbal formulations were ninety-six percent more
likely to be a mix of herbal and synthetic formulations. 96 This trend is
likely the result of patent applicants seeking to avoid the prior art.
Synthetic formulations are more likely to be novel than herbal ones.
Therefore, if a patent applicant can improve upon traditional herbal
91
WIPO CASE—Centralized Access to Search and Examination, WIPO, http://www.
wipo.int/case/en/ (last visited Mar. 29, 2015).
92
Id.
93
IP Australia is Australia’s administrative body that “administers intellectual property
rights and legislation relating to patents, trademarks, designs and plant breeder’s rights.”
IP AUSTRALIA, About Us, http://www.ipaustralia.gov.au/about-us/ (last updated Mar. 20,
2015).
94
WIPO, PUB. NO. L43/8E, PATENTSCOPE SEARCH: THE USER’S GUIDE 1-2 (2013),
available at http://www.wipo.int/edocs/pubdocs/en/patents/434/wipo_pub_l434_08.pdf.
95
WIPO, PROGRESS REPORT ON THE STATUS OF TRADITIONAL KNOWLEDGE AS PRIOR
ART 33 (2001) [hereinafter WIPO, PROGRESS REPORT], available at http://www.wipo.int/
edocs/mdocs/tk/en/wipo_grtkf_ic_2/wipo_grtkf_ic_2_6.pdf.
96
Choudhury & Khanna, Prior Art, supra note 1, at 30.
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remedies by introducing some synthetic component, that applicant is
more likely to avoid the novelty and non-obviousness issues that are
associated with deriving an invention from traditional knowledge. By
forcing patent applicants to consider a broader range of prior art,
traditional knowledge databases have spurred innovation. Not only do
databases preclude patents based on existing traditional knowledge, they
force inventors to improve upon traditional remedies through additional
innovation.
B.
Sui Generis: Granting property rights in traditional
knowledge
While establishing traditional knowledge databases is focused on
preventing third parties from obtaining intellectual property protection
for traditional knowledge, some countries have affirmatively provided
for intellectual property protection to traditional knowledge stakeholders.
This sort of system, which creates new categories of intellectual property
rights for traditional knowledge, has been characterized as a sui generis
regime. 97 Thailand, for example, has extended intellectual property
protection to traditional Thai medicine through the Act on Protection and
Promotion of Traditional Thai Medicinal Intelligence.98 Under this
statute, the rights holder has the sole right to produce, distribute, or
improve upon the medicine. 99 Anyone seeking to use Thai traditional
medicine for commercial benefits is required to apply to “obtain
benefits” and must pay fees for their use of the traditional medicine.100
While this law will likely deter or prevent some of the types of
misappropriation described in this article, it opens the door to domestic
misappropriation of traditional medicine and alienates the indigenous
people themselves. Indigenous Thai peoples, such as the Karen, hold
views regarding traditional medicines, and the herbs that create them,
that are fundamentally incompatible with intellectual property
protection. 101 The Karen people reject the viewpoint that natural
97
See J. Janewa OseiTutu, A Sui Generis Regime for Traditional Knowledge: The
Cultural Divide in Intellectual Property Law, 15 MARQ. INTELL. PROP. L. REV. 147, 150–
51 (noting that legislatures in countries that possess vast traditional knowledge may seek
to create sui generis rights to protect that traditional knowledge).
98
Act on Promotion and Protection of Traditional Thai Medicinal Intelligence, B.E.
2542 (1999) (Thai.), translation available at http://www.wipo.int/wipolex/en/text.jsp?
file_id=179713.
99
Id. § 34.
100
Id. § 19.
101
This article takes no position on whether such views are preferable to well
established patent regimes, such as that in the United States. For more information on the
cultural differences relating to intellectual property protection, see generally OseiTutu
supra note 97.
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resources, such as herbs, should be considered resources at all.102 They
believe that plants and animals have spirits and should be respected like
humans are. 103 Thus, medicines should not be hoarded and should not be
traded for a profit. 104 If medicinal herbs are abused through commercial
exploitation, practitioners of traditional Karen medicine would perceive
this as an abuse of the herbs’ spirit and internalize that harm. 105
Ironically, by refusing to grant patents on such knowledge, the U.S.
patent system may be more consistent with traditional Karen values than
the Thai system. The Act on Protection and Promotion of Traditional
Thai Medicinal Intelligence may enable local practitioners of traditional
medicine to claim a monopoly on the use of certain remedies. The law’s
requirement that users of traditional medicine pay royalties is
inconsistent with the Karen people’s beliefs relating to the use of these
herbs. From the Karen’s perspective, commercialization and the grant of
exclusive rights over the medicinal use of certain herbs would be an
abuse of the herb’s spirit and would cause a spiritual injury to indigenous
medical practitioners themselves. 106 Rather than protecting traditional
knowledge stakeholders, as they purport to do, these types of laws can be
adverse to the interests of indigenous peoples if they do not carefully
consider local religion and customs. By contrast, the AIA would not
allow a patent on this traditional knowledge and consequently would
preserve the spiritual integrity of Karen medicine.
C.
WIPO Progress Report on the Status of Traditional
Knowledge as Prior Art
Although WIPO has not undertaken to attempt to solve the issue of
biopiracy, it has made suggestions to member states that seek to resolve
whether traditional knowledge should qualify as prior art.107 WIPO’s
Progress Report on the Status of Traditional Knowledge as Prior Art
identifies two particular problems in establishing traditional knowledge
as prior art. 108 First, the definition of prior art in many jurisdictions
excludes most traditional knowledge. 109 For example, U.S. patent law
effectively excluded most traditional knowledge as prior art before the
102
Daniel F. Robinson, Legal Geographies of Intellectual Property, ‘Traditional’
Knowledge and Biodiversity: Experiencing Conventions, Laws, Customary Law, and
Karma in Thailand, 51 GEOGRAPHICAL RES. 375, 379 (2013).
103
Id.
104
Id. at 378 & 380.
105
See id. at 379.
106
Id.
107
WIPO, PROGRESS REPORT, supra note 95, at 21–23.
108
Id. at 14.
109
Id.
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enactment of the America Invents Act. 110 Second, on a practical level,
traditional knowledge may be difficult for patent examiners to
discover. 111 Traditional knowledge, even when it is recorded in databases
or other writings, is often not arranged in an orderly manner. 112 It is
difficult to search, which diminishes its value to patent examiners
looking for prior art.
To address these issues, WIPO suggests that IP offices and
traditional knowledge documentation initiatives “build bridges” to enable
more effective communication.113 To facilitate this bridge-building,
WIPO suggests that member nations begin by establishing more efficient
classification systems. 114 While the International Patent Classification
(IPC) system is extremely effective and is used on ninety-five percent of
all patent documents, a more detailed system is needed for traditional
medicine. 115 One such example is India’s Traditional Knowledge
Resource Classification (TKRC) system. 116 A more detailed and
organized system for arranging traditional knowledge would allow
people to find the relevant prior art that they are looking for.
V.
CHANGES IN THE SCOPE OF “PRIOR ART”
Some of the most widely debated reforms under the America Invents
Act are contained in the new Section 102. One of the primary goals of
the America Invents Act was to bring the U.S. patent system in line with
the rest of the world.117 Section 102 served as one of the primary vehicles
for accomplishing that goal, in part, by eliminating geographic
restrictions on public use, sale, or knowledge as prior art.118 This
dramatic shift in the scope of prior art to the U.S. patent system is likely
to have unforeseen consequences in the context of biopiracy and the
protection of traditional knowledge. Public knowledge, sale, or use of
traditional knowledge outside the United States may now serve as prior
110
See supra Part II.
WIPO, PROGRESS REPORT, supra note 95, at 14.
112
Id. at 4.
113
Id. at 21.
114
Id. at 22.
115
Id. at 22-23.
116
Id. at 23.
117
Mark Schafer, Note, How the Leahy-Smith America Invents Act Sought to
Harmonize United States Patent Priority with the World, A Comparison with the
European Patent Convention, 12 WASH. U. GLOBAL STUD. L. REV. 807, 807 (2013).
118
The new Section 102 made other major changes to the U.S. patent system to bring it
in line with the rest of the world, including, significantly, transitioning to a first-to-file
system for determining priority. This article does not address those other changes because
they are less significant to the issue of biopiracy than the changing scope of prior art.
111
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art to U.S. patents. Thus, applicants seeking U.S. patent protection based
in part upon traditional knowledge may have more difficulty prosecuting
and maintaining patents due to the changes to Section 102, which
effectively renders most traditional knowledge ineligible for patent
protection in the United States.
A.
Substantive changes to U.S. patent law under the America
Invents Act
Under the 1952 Patent Act, a person could not obtain a patent if “the
invention was known or used by others in this country, or patented or
described in a printed publication in this or a foreign country, before the
invention thereof by the applicant for a patent.” 119 By the plain language
of the statute, the only foreign art that could serve as a bar to a U.S.
patent were patents and printed publications. U.S. courts applied this
requirement strictly, rejecting challenges to the novelty or nonobviousness of U.S. patents based on a foreign public use of the
invention. 120 In the context of biopiracy, this rule presented a significant
challenge to those attempting to protect the interests of traditional
knowledge stakeholders. Traditional knowledge is rarely published, so it
rarely served as prior art to U.S. patents.
The disputes surrounding the patentability of compounds derived
from the neem tree embodied this very problem. In the early 1990s,
American researchers found a way to improve upon a traditional Indian
pesticide derived from the neem tree by making it suitable for long-term
storage. 121 Although this improvement, arguably, would have been
obvious to Indian farmers, under Section 102 foreign knowledge could
only serve as a bar to a U.S. patent if it was published prior to the
“invention” by the U.S. applicant. 122 In 1995, a coalition of 225 groups
and over 100,000 individual farmers filed a petition with the USPTO
seeking to invalidate the patent.123 Although a similar patent 124 was
invalidated by the European Patent Office (EPO),125 the U.S. patent
119
35 U.S.C. § 102(a) (2006).
See, e.g., E. I. du Pont de Nemours & Co. v. Berkley & Co., 620 F.2d 1247, 1265
(8th Cir. 1980) (holding that evidence of an invention’s use in France was inadmissible to
show the obviousness of an American patent).
121
See U.S. Patent No. 5,124,349 (filed Oct. 31, 1990).
122
Emily Marden, The Neem Tree Patent: International Conflict over the
Commodification of Life, 22 B.C. INT’L & COMP. L. REV. 279, 284 (1999).
123
Id. at 286.
124
Eur. Patent No. 0436257 (filed Dec. 20, 1990) (issued Sept. 14, 1994) (revoked Mar.
8, 2005), available at https://register.epo.org/application?number=EP90250319&lng=
en&tab=legal.
125
Id.
120
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remains valid because pre-AIA law continues to apply to patents granted
before the AIA took effect.126 These differing results are likely explained
by the difference between the EPO, which is permitted to consider
foreign knowledge, and the old Section 102, which excluded such
knowledge if it was not published.
Since the passage of the America Invents Act, however, the scope of
prior art under the U.S. patent system has been brought in line with the
European system. The new Section 102 removed the “in this country”
limitation that used to apply to the “public use” and “on sale” bars. It
also added the phrase “available to the public” to “clarify the broad scope
of relevant prior art.” 127 U.S. law no longer requires publication for
foreign prior art to block a U.S. patent. Prior art for patents issued under
the American Invents Act “will no longer have any geographic
limitations.” 128
The changes to Section 102 also included the addition of “or
otherwise available to the public” as a broad category of prior art. While
Congress indicated that the purpose of the phrase “available to the
public” was “to clarify the broad scope of relevant prior art, as well as to
emphasize the fact that it must be publically available,” there was no
guidance as to what type of prior art was covered by this phrase and not
the remainder of Section 102(a)(1).129 One interesting postulation as to
the different prior art covered by “or otherwise available to the public” is
that the clause could include orally transmitted information that had yet
to be physically recorded. 130 Though appearing inadvertent, this change
to Section 102 by the AIA may further assist in the use of traditional
knowledge as prior art.
In hypothetically considering the neem-related patents as being
subject to the post-AIA patent rules, testimony regarding the hundreds of
years of public use of the neem tree as a pesticide, orally transmitted
information regarding its effectiveness, and foreign public use of the
neem tree would all be admissible to show that the American “invention”
lacks novelty or is obvious. 131
126
Philip Schuler, Biopiracy and Commercialization of Ethnobotanical Knowledge, in
POOR PEOPLE’S KNOWLEDGE 159, 162 (J. Michael Finger & Philip Schuler eds. 2004).
127
H.R. REP. NO. 112-98, at 42-43 (2011), reprinted in 2011 U.S.C.C.A.N. 67, 72-73.
128
Id. at 42.
129
S. REP. NO. 111-18, at 6 (2009).
130
Joshua D. Sarnoff, Derivation and Prior Art Problems with the New Patent Act,
2011 PATENTLY-O PAT. L.J. 12, 27 (2011).
131
The availability of this type of evidence may be determined by the particular
proceeding in which the validity of the patent is being determined. See supra Part III.B.
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Limitations of the administrative process
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Through the increasingly adversarial model of the USPTO’s
administrative system, the patent system as a whole has a tendency to
correct itself. As in the case of the Turmeric Patent, third parties may
participate in the administrative process and obtain cancellation of
invalid patents. 132 However, geographic limitations on prior art present a
substantial obstacle to the USPTO’s ability to perform that function.
Moreover, although the new Section 102 drastically expands the scope of
available prior art, the practical limitations of the USPTO and the
restrictions placed on the administrative system limit the impact these
changes will have on the issuance of new patents.
Federal regulations place limits on the availability of particular types
of documentation and when those documents may be presented by third
parties. Pre-issuance third party submissions are limited to patents,
published patent applications, or other printed publications. 133 Thus,
before the USPTO has issued a patent, third parties may only submit
evidence of public use if that use is contained in a printed publication.134
In a post-grant review, 135 third parties may offer evidence of prior public
use or sale. 136 However, a post-grant review may be sought only within
nine months of the issuance of the patent.137 Following that nine-month
period, a third party may initiate an inter partes review, 138 but only
patents and printed publications may be considered as prior art. 139 This
leaves a narrow nine-month window after the issuance of the patent in
which third parties may submit evidence of public use of the invention to
the USPTO.
132
See supra Part I.
35 U.S.C. § 122(e) (2012).
134
See id.
135
Post-grant review is an administrative proceeding to determine the validity of a
recently granted patent.
136
See 35 U.S.C. § 321(b) (2012) (permitting third parties to “request to cancel as
unpatentable one or more claims of a patent on any ground that could be raised under
paragraph (2) or (3) or subsection 282(b) (relating to invalidity of the patent or any
claim)”) (emphasis added).
137
§ 321(c).
138
Inter partes review is an administrative proceeding through which a third party can
challenge the validity of one or more patent claims. It is available after the time period
for a post grant review has lapsed.
139
35 U.S.C. § 311(b) (2012) (“A petitioner in an inter partes review may request to
cancel as unpatentable 1 or more claims of a patent only on a ground that could be raised
under Section 102 or 103 and only on the basis of prior art consisting of patents or
printed publications”).
133
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C. Federal Court Practice
Due to the short period in which a patent may be challenged at the
administrative level based on public use or sale, the courts are likely to
be the forum in which the AIA’s changes to Section 102 will invalidate
new patents. Courts will consider both oral and documentary evidence in
determining whether there has been a public use or sale of products
embodying the patent. For instance, in Trans-World Mfg. Corp v. Al
Nyman & Sons, Inc., the Federal Circuit upheld the sufficiency of
evidence supporting a jury verdict of obviousness based on both oral and
documentary evidence.140 The jury relied both on photographs of the
prior art and the testimony of one of the inventors himself. 141
While documentary evidence may be difficult to come by in cases
involving traditional medicine, oral evidence is still available. At trial,
cross-examination of inventors may reveal the obviousness or lack of
novelty of the claimed invention, as it did in Trans-World Mfg. Corp.
Additionally, those with personal knowledge of how the traditional
medicine was used may testify as to those facts. The fact that this type of
evidence is available at trial, but is largely unavailable at the
administrative level, means that the new Section 102 will have a greater
impact in patent litigation than in the issuance of new patents.
However, the trend toward accelerated litigation schedules for patent
cases may make the timely acquisition of such evidence difficult. In one
of the more aggressive district courts, the Western District of Tennessee,
invalidity and unenforceability contentions are due within ninety days
after an answer is filed. 142 In the Eastern District of Texas, a popular
forum for patent disputes, invalidity and unenforceability contentions are
due within thirty-five days of the initial case management conference.143
As of the drafting of this article, there has yet to be a patent
invalidated by prior art that only became applicable by the removal of the
geographic limitation from Section 102. Because the post-AIA version of
Section 102 applies to patents issued from applications having, at any
time, at least one claim with an effective filing date on or after March 16,
2013, there should soon be an increase in attention to the broader
availability of prior art.
Despite the challenges of putting evidence of foreign public use
before the USPTO and the difficulties faced in litigation, it is axiomatic
that a patent is essentially useless if it will be invalidated upon litigation.
140
Trans-World Mfg. Corp. v. Al Nyman & Sons, Inc., 750 F.2d 1552, 1559 (Fed. Cir.
1984).
141
Id. at 1560.
142
W.D. Tenn. LPR 3.5 (2014).
143
E.D. Tex. P.R. 3-3 (2014).
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Therefore, pharmaceutical companies seeking patents relating to
traditional knowledge are likely to consider the scope of foreign public
knowledge, use, and sale in drafting their patent claims, even if that
information will never be presented to the USPTO.
VI.
CONCLUSION
After the passage of the America Invents Act, U.S. patent law
theoretically should refuse protection to a larger number of “inventions”
based on traditional knowledge. However, practical considerations
significantly limit the effect that the AIA will have on the patentability of
traditional knowledge. The American regulatory system is likely to
narrow the practical—as opposed to the statutory—scope of prior art.
Even if oral traditions in South Africa may qualify as prior art under the
statute, they will not have that effect at the administrative level unless the
patent examiner knows of those traditions. Additionally, as demonstrated
by pharmaceutical companies’ responses to traditional knowledge
databases, these companies are likely to move towards combining
remedies derived from traditional knowledge with more synthetic
elements, thus avoiding novelty and non-obviousness issues.
When the invention is known to the public before the issuance of a
patent, there is no need to encourage innovation or disclosure, so there is
no justification for the grant of patent protection. The America Invents
Act provides the beginnings of a solution both for this foundational
problem of U.S. patent law and for the injustice that can result from the
misappropriation of traditional knowledge. It cannot, however, solve this
problem entirely.
One solution would be to eliminate some of the evidentiary
restrictions in administrative procedures, thereby permitting witness
testimony regarding foreign public uses. That could be accomplished by
eliminating those restrictions in inter partes review or by extending the
time period for post-grant review, which contains fewer evidentiary
restrictions. However, this change would add to the USPTO’s already
considerable workload. It would also change the nature of the
proceedings such that they may become full adversarial trials bearing
closer resemblance to litigation in the federal courts than administrative
proceedings. Individual district courts could also decide to amend
litigation schedules through local patent rules in a way that would
provide defendants with more time to locate invalidating foreign prior
art. Both of these potential solutions would prolong an already lengthy
and expensive patent litigation process, which would not serve the
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parties, the courts, or the USPTO well. As is often the case, the law
cannot provide a perfect solution to this problem.
Due to practical and procedural constraints on the availability of
foreign prior art, the impact that the America Invents Act’s expansion of
the scope of prior art will have remains somewhat unclear. What is clear
is that the statute now permits traditional knowledge stakeholders to
introduce evidence of foreign public use in their efforts to invalidate
controversial patents. This possibility alone may be enough to deter
companies from drafting patent claims that cover traditional knowledge,
while allowing them to seek protection for their own innovations.
Terminating the Hospital-Physician
Employment Relationship: Navigating
Conflicts Arising from the Physician’s Dual
Roles as Employee and Medical Staff
Member
Gayland O. Hethcoat II *
In an effort to meet the challenges of the post-health reform
marketplace, hospitals have accelerated the practice of
employing physicians. Despite this trend, many hospitals require
their employed physicians to also maintain membership and
privileges on the medical staff—the self-governing entity
comprised of fellow physicians that oversees the practice of
medicine within the hospital setting. Recent case law identifies at
least two salient issues that will likely arise from physicians’
dual roles as hospital employee and medical staff member and
be a point of negotiation and litigation: (1) the applicability of
“due process” rights, which are typically afforded in medical
staff peer review actions, to employment termination actions,
and (2) the obligation to report employment termination actions
to the federal government’s National Practitioner Data Bank, a
central database for information about medical staff peer review
actions and other incidents that may reflect on physicians’
competence and quality of care. This article examines how and
why these issues may become points of contention and proposes
various practical solutions to avoiding or mitigating such
conflicts.
*
LL.M., Loyola University Chicago; J.D., University of Miami; B.S., Virginia
Commonwealth University. The author is Corporate Counsel for Dignity Health, based in
its corporate office in Pasadena, California. The author thanks Carolyn Metnick of
Akerman LLP and Serj Mooradian of Barnes & Thornburg LLP for their comments on a
draft of this article. The author welcomes submission of comments on this article to
[email protected] The views expressed in this article are strictly the
author’s own.
425
426
UNIVERSITY OF MIAMI BUSINESS LAW REVIEW
[Vol. 23:425
I.
THE EVOLVING PHENOMENON OF HOSPITAL EMPLOYMENT OF
PHYSICIANS ................................................................................... 427
II. NAVIGATING TERMINATION-RELATED CONFLICTS ARISING
FROM THE PHYSICIAN’S DUAL ROLES AS EMPLOYEE AND
MEDICAL STAFF MEMBER ............................................................. 430
A. The Applicability of Medical Staff “Due Process” Rights to
Employment Termination Actions ............................................ 431
B. Reporting Employment Termination Actions to the National
Practitioner Data Bank............................................................ 438
III. PRACTICE POINTERS ...................................................................... 444
IV. CONCLUSION ................................................................................... 449
Five years after passage of the federal Affordable Care Act (ACA), 1
hospital employment of physicians remains one of the most frequently
cited strategies for hospitals and physicians to meet the challenges of the
post-health reform marketplace. Many health industry analysts opine that
the employment relationship offers a template for hospitals and
physicians to align their operations and financial interests and thus
position themselves to meet greater demand for high-quality, costefficient care, as reflected in various initiatives in the ACA, such as its
Medicare reform measure involving “accountable care organizations”
(ACOs). 2 Although the full impact of hospital employment of physicians
is unseen, one observation is readily apparent: The increase in hospital
employment of physicians further hastens the demise of the voluntary
medical staff model—the traditional paradigm of hospital-physician
relations. 3
Under the voluntary medical staff model, private-practice physicians,
aggregated together as the medical staff, operate on a mostly independent
basis within a hospital’s confines, subject to the rules in the medical
staff’s bylaws and administrative oversight by the hospital’s governing
body. By definition, the employment model confers hospitals with a
degree of control over physicians—control they would not otherwise
have under the voluntary medical staff model. Nevertheless, many
hospitals preserve the traditional medical staff structure and require their
employed physicians to also maintain membership and privileges on the
medical staff. This overlap naturally invites questions about the
1
Patient Protection and Affordable Care Act, Pub. L. No. 111-148, 124 Stat. 119
(2010).
2
See EZEKIEL J. EMANUEL, REINVENTING AMERICAN HEALTH CARE 224–30 (2014)
(discussing Medicare-participating ACOs).
3
See Lawrence P. Casalino et al., Hospital-Physician Relations: Two Tracks and the
Decline of the Voluntary Medical Staff Model, 27 HEALTH AFF. 1305, 1311–12 (2008).
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HOSPITAL-PHYSICIAN EMPLOYMENT TERMINATION
427
interrelationship between the physician’s roles as hospital employee and
as member of the hospital’s medical staff. 4
For all its potential, the continued growth of hospital employment of
physicians will inevitably bring with it a greater share of relationships
that do not work out and end in termination. Recent case law identifies at
least two salient issues that will likely be a point of negotiation and
litigation regarding physician employment arrangements: (1) the
applicability of “due process” rights, which are typically afforded in
medical staff peer review actions, to employment termination actions,
and (2) the obligation to report employment termination actions to the
federal government’s National Practitioner Data Bank (NPDB), a central
database for information about medical staff peer review actions and
other incidents that may reflect on physicians’ competence and quality of
care. 5 These issues have long been major points of contention within
medical staff peer review law, but the overlay of the employment
relationship on the medical staff affiliation requires looking at them
anew.
This article examines how and why termination of a physician’s
employment with a hospital may trigger conflicts regarding due process
and NPDB reporting and proposes various practical solutions to avoiding
or mitigating these conflicts. To put this discussion in context, this article
begins with an overview of the market forces that are driving more
physicians to become hospital employees and more hospitals to become
physician employers. An analysis of the legal disputes over due process
and NPDB reporting that may emerge from physicians’ concurrent roles
as hospital employee and medical staff member follows. Finally, this
article suggests how hospitals and physicians alike can minimize these
disputes by ensuring clarity and precision in negotiating and drafting
physician employment agreements and in carrying out termination
decisions.
I.
THE EVOLVING PHENOMENON OF HOSPITAL EMPLOYMENT
OF PHYSICIANS
Physicians have historically enjoyed a level of respect and prestige
that few others in society command. Such reverence, however, does not
come free, premised as it is on the notion that, as licensed professionals
who have undergone years of rigorous training, physicians will always
act independently in the best interests of their patients, regardless of their
self-interests or the interests of others who stand to benefit from the
4
5
See infra Part I.
See infra Part II.
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patient-physician relationship. Numerous sources of law codify and
make explicit this implicit promise, as, for example, the doctrine in many
jurisdictions that prohibits the “corporate practice of medicine” (subject
to the common exception that hospitals may employ physicians without
violating this prohibition, as discussed below).6 Likewise, protection of
physician independence undergirds many laws regulating hospital
operations, such as state hospital licensing laws and the Medicare
conditions of participation requiring hospitals to maintain a selfgoverning medical staff, which adheres to a set of bylaws. 7
Traditionally, under the voluntary medical staff model recognized by
law, the local community hospital was the “physician’s workshop.”8 That
is, the hospital was a place where physicians could access equipment and
staff to perform procedures and provide services not otherwise available
in their private offices.9 In exchange, physicians would serve in
leadership roles on the medical staff and take emergency department call
coverage, usually without pay. 10 For some physicians, contributing their
time and energy to their affiliated hospital was more than just a work
requirement; it was a civic duty. 11
As with so many aspects of healthcare delivery and finance,
however, the nature of hospital-physician relations has not been static. In
the 1990s, many hospitals acquired large numbers of primary care
physicians’ (PCPs) practices and employed the physicians, thinking a
managed care model of capitation payments, based on PCPs acting as
“gatekeepers” for the rest of the healthcare system, would become the
national standard. 12 For physicians, the uncertainty and lower payment
rates offered by managed care organizations, combined with the
generous terms proposed by hospitals, made hospital employment
enticing. 13 But when the capitated model failed to take off as anticipated,
many hospitals divested their employed primary care practices because
they were losing money. 14
Although hospitals’ experiences in the 1990s provided a cautionary
tale, they ultimately did not curb the practice of employing physicians.
6
See infra Part II.A.
See, e.g., 42 C.F.R. § 482.22 (2014) (requiring hospitals, as a condition to
participation in Medicare, to “have an organized medical staff that operates under bylaws
approved by the governing body and is responsible for the quality of medical care
provided to patients by the hospital”).
8
Casalino et al., supra note 3, at 1306.
9
Id.
10
Id.
11
Id.
12
Id.
13
Id.
14
Id.
7
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Indeed, hospital employment of physicians continued into the 2000s,
during which many hospitals began to employ specialists in addition to
PCPs. 15 Now, more than half of practicing physicians in the United
States are employed by hospitals or integrated healthcare delivery
systems. 16 With its incentives for hospitals, physicians, and other
healthcare providers to further integrate themselves in an effort to cut
costs while improving the quality of their care, 17 the ACA has been a
major contributing factor to the increase in hospital employment of
physicians in more recent years. One such initiative under the ACA
involves recruiting ACOs into the Medicare program with the prospect of
sharing in the cost savings that are anticipated to result from tighter
coordination among providers and an accompanying reduction in
duplicative and unnecessary interventions.18 By design, the ACO concept
is intended to be a flexible one, and, as such, hospital employment of
physicians is one model that may be conducive to achieving its goals,
through such measures as “incentive-driven compensation linked to
productivity and clinical behavior” and reductions in “excess costs
associated with unnecessary practice variation and unnecessarily
expensive supplies selected by physicians.” 19 Although the ACO
program and the risk-based payment approaches codified in the ACA
technically apply only to Medicare and other public payers, they are
poised to be adopted by private payers as well.20
While the ACA has no doubt fostered an environment favorable to
hospital employment of physicians, other, more local factors have played
an important role, too. For hospitals, employing physicians is, at bottom,
a competitive measure, allowing them to reinforce their place within an
existing hospital market or enter into a new one, or preempt competition
from specialist-owned ambulatory surgery centers (ASCs), specialty
hospitals, and imaging facilities.21 Relatedly, employing physicians may
15
See id. at 1307–08.
Robert Kocher & Nikhil R. Sahni, Hospitals’ Race to Employ Physicians—The
Logic Behind a Money-Losing Proposition, 369 NEW ENG. J. MED. 1790, 1790 (2011).
17
See generally EMANUEL, supra note 2, at 224–30 (discussing various cost-control
measures in the ACA).
18
See id. at 224–28.
19
Kocher & Sahni, supra note 16, at 1792.
20
See, e.g., Press Release, U.S. Dep’t of Health & Human Servs., Better, Smarter,
Healthier: In Historic Announcement, HHS Sets Clear Goals and Timeline for Shifting
Medicare Reimbursements from Volume to Value (Jan. 26, 2015), available at http://
www.hhs.gov/news/press/2015pres/01/20150126a.html (noting the creation of the Health
Care Payment Learning and Action Network, through which the U.S. Department of
Health and Human Services “will work with private payers, employers, consumers,
providers, states and state Medicaid programs, and other partners to expand alternative
payment models into their programs”).
21
See Casalino et al., supra note 3, at 1308.
16
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allow hospitals to improve their operations by filling a shortage in a
particular specialty or a gap in emergency department call coverage or
availability for consultation that would otherwise exist. 22 For physicians,
relinquishing the responsibilities of a private practice and becoming a
hospital employee promise “more regular work hours and less frequent
call responsibility, and . . . shelter from an increasingly complex and
unstable market.” 23 In short, hospital employment of physicians can be
both individually and collectively beneficial.
To be sure, not all physicians are opting for hospital employment.
Many physicians have taken the opposite course and become competitors
with hospitals, increasing their ownership in ASCs, specialty hospitals,
and imaging facilities.24 For physicians—mostly specialists, often in
markets that lack a consolidated hospital presence—ownership in these
facilities enables them to increase their efficiency and profitability by
providing a narrow range of procedures and reaping the “facility fee”
payment that hospitals would otherwise receive. 25 Accordingly, these
physicians “may rarely set foot in the hospital.”26 Even private-practice
PCPs and other physicians whose practice is not procedure-based are
becoming more detached from their community hospitals, using
hospitalists (who may be hospital employees) to admit and treat large
numbers of patients rather than assuming call coverage responsibilities. 27
Thus, as one study concluded, a dichotomy is emerging such that
“physicians will increasingly choose the path of hospital employment or
of separation from hospitals, with the two paths coexisting in some
communities, while one path or the other predominates in others.” 28 The
ramifications of this divergence are not yet fully realized, but it at least
appears “[t]he voluntary medical staff model, traditionally the foundation
of physician-hospital relations, [is] entering a period of decline.” 29
II.
NAVIGATING TERMINATION-RELATED CONFLICTS ARISING
FROM THE PHYSICIAN’S DUAL ROLES AS EMPLOYEE AND MEDICAL
STAFF MEMBER
For most hospital-employed physicians, the employment agreement
and medical staff bylaws are the primary authorities that govern their
22
23
24
25
26
27
28
29
See id.
Id. at 1309.
See id. at 1310.
Id.
Id.
Casalino et al., supra note 3, at 1310–11.
Id. at 1313.
Id. at 1305.
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practice within the hospital. In many ways, the hospital employment
agreement may resemble previous employment agreements to which the
physician was a party, addressing such matters as compensation,
benefits, insurance, and scope of responsibilities. Typically, the
agreement will also require the physician to be a member of the
hospital’s medical staff and maintain appropriate privileges for his or her
practice, and to abide by the medical staff bylaws, rules, and regulations.
Depending on the particular arrangement, the agreement may provide
that termination of employment will result in automatic termination of
the physician’s medical staff membership or privileges, or vice versa.
By contrast, the medical staff bylaws act as a charter that sets forth
the medical staff’s system of governance and the rights and duties of all
medical staff members vis-à-vis the hospital governing body. 30 The
requirement to have medical staff bylaws and to ensure certain content
therein stems from various regulatory sources, including state hospital
licensing laws, federal conditions of hospital participation in Medicare,
and rules from accrediting organizations, such as The Joint
Commission. 31 Although courts have held medical staff bylaws to be
enforceable contracts in some cases, 32 they generally have not held them
to be enforceable employment contracts. 33 Nevertheless, reference to and
incorporation of medical staff bylaws in employment agreements raise
questions as to how the agreement, bylaws, and the laws underlying them
interrelate and which controls in the event of a conflict. Having an
answer to these questions is especially important when the hospitalphysician relationship breaks down and is terminated, and will clarify
both hospitals’ and physicians’ rights and responsibilities.
A.
The Applicability of Medical Staff “Due Process” Rights to
Employment Termination Actions
To appreciate why contentions regarding due process may arise from
a hospital’s termination of a physician’s employment, it is helpful first to
understand why the procedures for terminating, suspending, or taking
other adverse actions against a physician’s medical staff membership or
privileges are themselves the focus of so many legal disputes. As noted,
multiple sources of law and regulation govern the organization and
operation of medical staffs and their bylaws, including the procedures for
30
See KAREN S. RIEGER ET AL., HEALTHCARE ENTITY BYLAWS AND RELATED
DOCUMENTS: NAVIGATING THE MEDICAL STAFF/HEALTHCARE ENTITY RELATIONSHIP
§ 1.1, at 2 (3d ed. 2011).
31
See id. §§ 2.1–2.3, at 5–9.
32
See id. § 3.3, at 26 nn.17–18 (collecting cases).
33
See, e.g., Engelstad v. Va. Mun. Hosp., 718 F.2d 262, 267 (8th Cir. 1983) (noting
that “[s]taff privileges do not establish an employment contract with the hospital”).
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peer review actions. One such source is the federal Health Care Quality
Improvement Act of 1986 (HCQIA). 34 To “balance the chilling effect of
litigation on peer review with concerns for protecting physicians
improperly subjected to disciplinary action,” 35 HCQIA immunizes
hospitals and their medical staffs from liability for damages resulting
from a determination that adversely affects a physician’s standing on a
medical staff, but only if minimum safeguards are in place (usually as set
forth in the medical staff bylaws) to ensure fairness to the physician. 36
Thus, in lawsuits in which physicians seek damages arising from peer
review actions (often on contractual, tortious, and statutory theories, such
as theories of defamation and violation of antitrust laws), the steps taken
by the medical staff in implementing the action are a significant point of
analysis because they are the key to HCQIA immunity.
As a relatively new form of hospital-physician alignment, hospital
employment of physicians is not subject to the same degree of regulation
as hospital-physician affiliation through the medical staff.37 To the extent
the law specifically addresses hospital employment of physicians, it
usually does so within state law doctrines pertaining to the “corporate
practice of medicine.” In Berlin v. Sarah Bush Lincoln Health Center, 38
the Illinois Supreme Court aptly summarized the corporate practice of
medicine and its restrictions on employment of physicians:
The corporate practice of medicine doctrine prohibits
corporations from providing professional medical
services. Although a few states have codified the
doctrine, the prohibition is primarily inferred from state
medical licensure acts, which regulate the profession of
medicine and forbid its practice by unlicensed
individuals. The rationale behind the doctrine is that a
corporation cannot be licensed to practice medicine
because only a human being can sustain the education,
34
Health Care Quality Improvement Act of 1986, Pub. L. No. 99-660 (codified at 42
U.S.C. §§ 11101–11152 (2013)).
35
Freilich v. Upper Chesapeake Health, 313 F.3d 205, 211–12 (4th Cir. 2002) (quoting
Bryan v. James E. Holmes Reg’l Med. Ctr., 33 F.3d 1318, 1322 (11th Cir. 1994)); see
also 42 U.S.C. § 11101 (2013) (describing the congressional findings relating to
HCQIA).
36
See 42 U.S.C. §§ 11111–11112 (2013) (limiting damages for “professional review
actions” where requirements for notice, hearing, and governing standards are met).
37
Not to be overlooked, employment laws of general applicability, such as antidiscrimination laws, do impose legal requirements onto the hospital-physician
employment relationship. These laws, however, are not unique to this type of
employment relationship.
38
Berlin v. Sarah Bush Lincoln Health Ctr., 688 N.E.2d 106 (Ill. 1997).
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training, and character-screening which are prerequisites
to receiving a professional license. Since a corporation
cannot receive a medical license, it follows that a
corporation cannot legally practice the profession.
The rationale of the doctrine concludes that the
employment of physicians by corporations is illegal
because the acts of the physicians are attributable to the
corporate employer, which cannot obtain a medical
license. The prohibition on the corporate employment of
physicians is invariably supported by several public
policy arguments which espouse the dangers of lay
control over professional judgment, the division of the
physician’s loyalty between his patient and his
profitmaking employer, and the commercialization of the
profession. 39
Critics contend that the complexities of delivering and paying for health
care in the modern era have rendered the legal doctrine an outdated relic
from “when health care was ‘a cottage industry, made up of independent
professionals operating as solo practitioners.’” 40 As the Office of
Inspector General (OIG) of the U.S. Department of Health and Human
Services (HHS) concluded in a report on state laws prohibiting hospital
employment of physicians:
[T]he debate over the corporate practice of medicine
doctrine is an argument over who will control the
delivery of medical care. This contention focuses on
whether physicians should make decisions free of
external constraints or whether outside parties (a hospital
administrator, for example) should be able to exert
control over physician behavior. 41
Notably, many states’ corporate practice of medicine doctrine
includes an exception for hospitals to employ physicians. The rationale
for this exception differs from jurisdiction to jurisdiction; where courts
have taken up the issue, some have reasoned that the public policy
arguments against the corporate practice of medicine—for example, the
commercialization of medicine—do not apply to hospitals organized as
39
Id. at 110 (citations omitted).
OFFICE OF INSPECTOR GEN., U.S. DEP’T OF HEALTH & HUMAN SERVS., STATE
PROHIBITIONS ON HOSPITAL EMPLOYMENT OF PHYSICIANS, OEI-01-91-00770, at 2 (1991),
available at https://oig.hhs.gov/oei/reports/oei-01-91-00770.pdf.
41
Id.
40
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charitable institutions, while others have opined that hospital licensing
acts and other laws expressly allow hospitals to offer medical care to
patients. 42 Likewise, the source of these exceptions varies—be it
statutes, 43 court opinions, 44 or state attorney general opinions. 45
Even in these states, however, there may be constraints on the
manner or circumstances in which hospitals may terminate their
employed physicians. This is particularly so in states that regulate
hospital employment of physicians legislatively. For example, in
Colorado, a hospital statutorily may not “limit or otherwise exercise
control over the physician’s independent professional judgment
concerning the practice of medicine or diagnosis or treatment or . . .
require physicians to refer exclusively to the health care facility or to the
health care facility’s employed physicians.”46 Violation of this
prohibition may subject the hospital to regulatory penalties or any
resulting liability to patients or the physician.47 Moreover, a physician
who believes he or she has been the subject of such a violation “has a
right to complain and request review of the matter” pursuant to the
42
Berlin, 688 N.E.2d at 111–112 (discussing cases). A small minority of states still
prohibits hospital employment of physicians on corporate practice of medicine grounds.
California is one such state. To achieve the benefits associated with employment of
physicians, such as greater clinical integration and joint contracting with insurers,
California hospitals have pursued various approaches tailored to California’s regulatory
environment. One such approach, for example, involves the operation of clinics by
medical foundations—often hospital affiliate or subsidiary entities which engage
physicians on an independent contractor basis to provide professional services and which
manage the administrative aspects of those physicians’ practices. See DEBRA A. DRAPER
ET AL., CAL. HEALTHCARE FOUND., A TIGHTER BOND: CALIFORNIA HOSPITALS SEEK
STRONGER TIES WITH PHYSICIANS 3–4 (2009), available at http://www.chcf.org/~/media/
MEDIA%20LIBRARY%20Files/PDF/T/PDF%
20TighterBondCAHospitalsSeekTiesWithDocs.pdf. Another, somewhat similar approach
entails the structuring of clinics as outpatient hospital departments, where independent
contractor physicians render their professional services, and the hospital furnishes the
“necessary infrastructure and support for operating the clinics, including the physical
space, management, support staff, equipment, supplies, medical records, patient
registration, and facility billing.” Id. at 4. One analysis of these strategies suggested that
while they may offer hospitals a proxy for directly employing physicians, they “may
ultimately add costs to the health care system because of the additional infrastructure
required to operate them.” Id. at 7.
43
See infra note 46.
44
See, e.g., Berlin, 688 N.E.2d at 106.
45
See, e.g., 1992 Op. Att’y Gen. Va. 147.
46
COLO. REV. STAT. § 25-3-103.7(3) (2014). Other states impose similar statutory
conditions on hospital employment of physicians. See, e.g., 210 ILL. COMP. STAT.
85/10.8(a)(3); N.D. CENT. CODE § 43-17-42; S.D. CODIFIED LAWS § 36-4-8.1(1); TENN.
CODE ANN. § 63-6-204(f)(1)(A); WIS. STAT. § 448.08(5)(a)(1).
47
COLO. REV. STAT. § 25-3-103.7(3); see also, e.g., 210 ILL. COMP. STAT. 85/10.8(c)–
(d) (containing similar provisions).
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hospital’s medical staff bylaws or policies, which “shall ensure that the
due process rights of the parties are protected.” 48 From these provisions,
one can infer that a hospital may not lawfully terminate a physician for
exercising his or her “independent professional judgment” and that if a
termination action appeared to be a smokescreen for restricting such
exercise, the physician would be entitled to minimum procedural
safeguards to validate the basis for the termination.49 The statute does
not, however, presume that no one can stand in judgment of an employed
physician; it implies that any void created by restrictions on hospital
action will be filled by the medical staff, which, as an independent body
comprised of other physicians, can review the propriety of a fellow
physician’s “independent professional judgment.”
Absent these types of statutory protections, the scope of a hospitalemployed physician’s termination rights will depend on the content of
the employment agreement and its relationship to the medical staff
bylaws, as illustrated by the recent Hawaii case of Woodruff v. Hawaii
Pacific Health. 50 In that case, a hospital system terminated a pediatric
hematologist/oncologist in connection with an investigation of the
physician’s billing practices. 51 Because of violations for false billing
claims, the hospital system was a party to a corporate integrity agreement
with the OIG and accordingly had to report to the agency and other
interested parties overpayments and “material deficiencies” in billing
practices. 52 To comply with Medicare regulations, the system’s billing
office instituted a policy prohibiting physicians from billing for certain
invasive procedures performed by a nurse practitioner in the outpatient
48
COLO. REV. STAT. § 25-3-103.7(7); see also, e.g., 210 ILL. COMP. STAT. 85/10.8(a)
(containing similar provisions).
49
This inference is supported by reference to Illinois’ statute authorizing hospital
employment of physicians. It contains review procedures that are similar to those under
the Colorado statute but goes further than that statute by prohibiting “retaliat[ion] against
any employed physician for requesting a hearing or review” under the statute. 210 ILL.
COMP. STAT. 85/10.8(e). By contrast, although state peer review protection statutes
generally do not directly regulate hospital-physician employment arrangements, at least
one court has held that a state statute recognizing the confidentiality of peer review
proceedings impliedly prohibits a hospital from terminating an employee physician
because of the physician’s conduct as a peer reviewer of another physician’s care. See
Yedidag v. Roswell Clinic Corp., No. 34,286, 2015 N.M. LEXIS 51, at *39–41 (N.M.
Feb. 19, 2015) (holding that New Mexico’s peer review confidentiality statute, N.M.
STAT. ANN. § 41-9-5, which impliedly “prohibits an employer from retaliating against a
physician who participates in a peer review because the unlawful acquisition and
utilization of peer review information is a factual prerequisite to such retaliation,” is a
“mandatory rule of law incorporated into physician-reviewer employment contracts”).
50
Woodruff v. Haw. Pac. Health, No. 29447, 2014 Haw. App. LEXIS 26 (Haw. App.
Jan. 14, 2014).
51
See id. at *1–2.
52
See id. at *5.
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hospital setting. 53 The plaintiff physician expressed resistance and
disagreement over the application and interpretation of the policy and, as
an audit and investigation found, had submitted numerous billing claims
that did not meet the standards in the policy. 54 After disclosing these
findings to the OIG and offering to accept the physician’s resignation
(which the physician did not tender), the hospital system terminated the
physician’s employment. 55 The physician’s medical staff privileges were
unaffected by the termination, but shortly thereafter the chief executive
officer of the hospital where she practiced suspended them. 56 On review,
however, the hospital’s medical executive committee ruled that the
suspension was unwarranted and therefore lifted the suspension.57
Among the various causes of action the physician alleged in
litigation following her termination, she argued the hospital bylaws
“were incorporated into [her] employment agreement . . . and therefore
she was entitled to a hearing before her employment was terminated.”58
For support, the physician cited her employment agreement, which
required her to maintain in good standing medical staff membership and
appropriate privileges, and to comply with the medical staff bylaws and
all other rules, regulations, policies, and procedures.59 The agreement
53
See id. at *10.
See id. at *11–14.
55
See id. at *14–17.
56
See id. at *17. The opinion does not specify the grounds for suspension of the
physician’s privileges, but the short gap between termination of the physician’s
employment and suspension of her privileges suggests the underlying reasons for both
actions may have been the same.
57
See id. at *17–18.
58
Id. at *46–47. Where an employer hospital is a public hospital, an employee
physician facing termination may argue that he or she is owed a pre-termination hearing
and other procedural rights as a matter of constitutional due process. For instance, in the
recent case of Winger v. Meade District Hospital, No. 13-1428-JTM, 2015 U.S. Dist.
LEXIS 28234 (D. Kan. Mar. 9, 2015), the employee physician asserted that the employer
public hospital violated his right to constitutional due process when it revoked his
temporary medical staff privileges because of a finding of substandard care and then
subsequently terminated his employment. The court rejected this argument on the ground
that the medical staff bylaws and employment agreement did not create “a
constitutionally protected liberty or property interest such that the due process protections
were applicable . . . .” Id. at *13 (quoting Couture v. Bd. of Educ. of Albuquerque Pub.
Sch., 535 F.3d 1243, 1256 (10th Cir. 2008)). As the court noted, the employment
agreement explicitly incorporated the bylaws, which “provide[d] that temporary
privileges, such as those held by [the physician], could be revoked at any time, without
any procedural rights.” Id. at *16. Thus, even for physicians employed by public
hospitals, the scope of termination-related procedural rights available to them will
generally turn on the provisions of the medical staff bylaws and the employment
agreement, as it does for their private-sector counterparts.
59
See Woodruff, 2014 Haw. App. LEXIS 26, at *49–50.
54
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also provided that loss of medical staff membership was “grounds for
automatic and immediate termination of employment . . . .” 60
On appeal, the court held that the employment agreement did not
confer to the physician rights associated with peer review actions under
the medical staff bylaws. 61 To the extent the agreement incorporated
provisions of the bylaws, it did so one-sidedly, in favor of the hospital
system; it conditioned the physician’s employment on compliance with
the bylaws but did not require the hospital system to comply with the
bylaws. 62 Nevertheless, the court went on to note that the hearing
procedures under the bylaws did “not apply to employment terminations,
but only to adverse actions relating to staff membership and clinical
privileges.” 63 Although the employment termination “may have ended
the increased access to hospital facilities [the physician] had as an
employee,” the court concluded “it did not affect the access to and
privileges at [the hospital] she enjoyed as a medical staff member.” 64
Suspension of the physician’s privileges did follow her employment
termination, but she was afforded—and was vindicated by—the medical
staff review process in that action and did not otherwise challenge it in
the litigation.65
As Woodruff shows, while a hearing and other related procedural
rights may be standard course in medical staff peer review actions, such
rights are much more likely to be the exception, and not the norm, in
physician employment termination actions. In those jurisdictions that
prohibit the corporate practice of medicine, or authorize such practice by
hospitals, but subject to certain restrictions, hospitals run the risk of
violating the prohibition—and incurring all the liabilities that come with
doing so—if they terminate or take other adverse action against a
physician’s employment as a means to retaliate against or impinge on the
physician’s independent professional judgment. Otherwise, any
parameters to a hospital’s ability to terminate a physician’s employment
must appear in the employment agreement. Woodruff demonstrates that a
mere citation in an employment agreement to the hospital’s medical staff
60
Id. at *50.
See id. at *51–52.
62
See id. at *50–51.
63
Id. at *51–53; see also Bryant v. Glen Oaks Med. Ctr., 650 N.E.2d 622, 630 (Ill.
App. 1995) (making similar observations where a pathologist argued the hearing and
appellate review provisions in the medical staff bylaws applied to the termination of his
medical directorship).
64
Woodruff, 2014 Haw. App. LEXIS 26, at *53; see also Bryant, 650 N.E.2d at 630
(noting the plaintiff physician’s “fail[ure] to appreciate the distinction between his
medical staff privileges and his ability to provide pathology services with the free and
unfettered right to use the pathology laboratory”).
65
Woodruff, 2014 Haw. App. LEXIS 26, at *53.
61
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bylaws is not sufficient to extend the rights therein to employment
termination actions. If a physician is to receive notice, a hearing, or any
other rights with respect to termination of employment, the employment
agreement must enumerate them with specificity.
B.
Reporting Employment Termination Actions to the National
Practitioner Data Bank
The availability of a process to challenge medical staff peer review
actions is important to physicians because it provides a mechanism to
preserve the status quo and stave off losing, in whole or in part, their
medical staff membership or privileges. Insofar as a physician is able to
avail him or herself during such review process, he or she may be able to
avoid an outcome that, in the longer term, may be even worse than losing
his or her medical staff membership or privileges at a particular facility:
a report to the NPDB. As a corollary, one would expect physicians to
advocate fiercely for a hearing and other rights in employment
termination actions if the outcome of the action were reportable to the
NPDB. The question, then, is whether physician employment termination
actions are, in fact, reportable to the NPDB.
The NPDB is a creation of HCQIA. Complementing the immunity
provisions under HCQIA, the NPDB is intended to bolster the integrity
of the peer review process by “accumulating and disseminating data
pertaining to adverse peer review actions which have an impact on the
clinical privileges of physicians and other medical staff members.”66 In
relevant part, HCQIA requires hospitals and other “health care entities”
to report to the NPBD “professional review actions” that “adversely
affect[ ] the clinical privileges of a physician for a period longer than 30
days.” 67 HCQIA’s definition of “professional review action” is
particularly dense, “but the essence of the definition . . . is that it is a
recommendation or an action based on an assessment of ‘the competence
or professional conduct of a physician’ that will have an adverse effect
on such physician’s clinical privileges or membership/appointment in a
professional society.” 68
In the context of analyzing reporting obligations regarding physician
employment termination actions, identifying the potentially reportable
66
RIEGER ET AL., supra note 30, § 2.4, at 16.
42 U.S.C. § 11133(a)(1)(A) (2013); see also 45 C.F.R. § 60.11(a)(i) (2014). HCQIA
also requires reporting of a physician’s surrender of his or her clinical privileges “while
the physician is under an investigation by the entity relating to possible incompetence or
improper professional conduct, or in return for not conducting such an investigation or
proceeding.” 42 U.S.C. § 11133(a)(1)(B) (2013); see also 45 C.F.R. § 60.11(a)(ii)
(2014)).
68
RIEGER ET AL., supra note 30, § 2.4, at 10 (quoting 42 U.S.C. § 11151(9) (2013)).
67
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“professional review action” is an important threshold task. Is the
employment termination decision itself the potentially reportable action?
Or, where termination of a physician’s medical staff membership or
privileges occurs in tandem with termination of the physician’s
employment, is the termination of the physician’s medical staff
membership or privileges the reportable action (or both)? The first
question generally has been overlooked, which is curious considering
that HCQIA defines “clinical privileges” as not only medical staff
membership and privileges in the ordinary sense, but also “the other
circumstances pertaining to the furnishing of medical care under which a
physician or other licensed health care practitioner is permitted to furnish
such care by a health care entity.” 69 Arguably, this definition is broad
enough to encompass a physician’s status as a hospital employee as an
“other circumstance” to render care in the hospital setting, especially in
light of the fact that so many physicians are opting for employment over
affiliation as an independent practitioner on the medical staff as the
“credential” for practicing medicine within the hospital environment. 70
Perhaps it is assumed that because termination of a physician’s
employment tends to be initiated by hospital administration or human
resources personnel, the employment termination action is not an action
performed by what HCQIA describes as a “professional review body”
engaged in “professional review activity.” 71 If these terms referred only
to medical staff review bodies engaged in medical staff review activity,
then such an assumption would have support. But HCQIA is not so
limited; it specifically includes hospitals and their governing body and
other committees in the definition of “professional review bod[ies]” that
may conduct “professional review activity.” 72 Thus, when one construes
these terms more robustly, and interprets HCQIA’s definition of “clinical
privileges” to capture a physician’s employment status in relation to a
hospital, one could reasonably conclude that HCQIA casts a wide
enough net to require reporting of physician employment termination
actions where the action is “based on the competence or professional
conduct of an individual physician (which conduct affects or could affect
adversely the health or welfare of a patient or patients) . . . .” 73 Because
termination of a physician’s employment without cause could meet this
69
42 U.S.C. § 11151(3) (2013); see also 45 C.F.R. § 60.3 (2014).
See supra Part I.
71
See 42 U.S.C. § 11151(10)–(11) (2013) (defining quoted terms); see also 45 C.F.R.
§ 60.3 (2014).
72
See 42 U.S.C. §§ 11151(10)–(11) (2013) (defining quoted terms); see also 45 C.F.R.
§ 60.3 (2014).
73
42 U.S.C. § 11151(9) (2013).
70
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basis, 74 even without-cause employment termination actions could be
reportable under this interpretation.
Despite its theoretically broad scope, in practice, HCQIA’s NPDB
provisions have been analyzed more narrowly to discern whether
termination of a physician’s medical staff membership or privileges is
reportable, to the extent it is connected with termination of the
physician’s employment by a hospital. On this issue, conventional
wisdom holds that termination of the physician’s medical staff
membership or privileges is not reportable, at least where the termination
happens automatically following the employment termination action.
Proponents of this view have traditionally pointed to a passage in the
2001 version of the National Practitioner Data Bank Guidebook—a
compilation of guidelines on reporting to and querying from the NPDB
published by the Health Resources and Services Administration (HRSA)
within HHS—that describes the example of a hospital that has a “system
of professional review established under its bylaws” and an
“employment termination procedure,” the latter of which the hospital
uses “to end a practitioner’s employment without use of the professional
review process,” resulting in revocation of the practitioner’s clinical
privileges. 75 According to this version of the Guidebook, a report on the
revocation of the practitioner’s privileges would be voided “since the
professional review process had not been followed in terminating the
practitioner’s privileges” and “[t]he termination was not a professional
review action.” 76
In April of 2015, HRSA released a much-anticipated updated version
of the Guidebook, in which the agency essentially reiterated its position
from the 2001 iteration. The new Guidebook maintains the distinction
between a “system of professional review established under [a hospital’s]
bylaws” and an “employment termination procedure,” concluding like
the 2001 version that as long as revocation of a practitioner’s privileges
is “not a result of a professional review action,” the revocation is not
reportable. 77 But the Guidebook now clarifies that “if the hospital had
74
See Langenberg v. Warren Gen. Hosp., No. 1:12-cv-175-NBF, 2013 U.S. Dist.
LEXIS 166183, at *31-32 (W.D. Pa. Nov. 22, 2013) (describing the purpose of a withoutcause provision in a physician’s employment agreement as “not to guarantee that no
cause exists for termination of the contract but, rather, to ensure that each party has the
ability to unilaterally terminate the contract without the need to state a cause. Such
circumstances do not foreclose the possibility that the terminating party might have
reasons for its decision to invoke [the without-cause provision]”).
75
HEALTH RES. & SERVS. ADMIN., U.S. DEP’T OF HEALTH & HUMAN SERVS., NPDB
GUIDEBOOK, at F-9 (2001).
76
Id.
77
HEALTH RES. & SERVS. ADMIN., U.S. DEP’T OF HEALTH & HUMAN SERVS., NPDB
GUIDEBOOK, at E-40 (2015) [hereinafter 2015 GUIDEBOOK].
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performed a professional review of the practitioner’s privileges as a
result of the review, the professional review action would have been
reportable, even if the action started as an employment termination.” 78
This added commentary suggests that a direct connection between an
adverse privileging action and a finding regarding a practitioner’s
competence or professional conduct is necessary to give rise to a
reporting duty; if the privileging action is merely a formality that follows
from an employment termination action, the privileging action is not
reportable, even if the employment termination action itself was related
to the practitioner’s competence or professional conduct.
In an era of increased employment of physicians, where physicians’
employment status and medical staff membership and privileges often
overlap such that termination of employment will cause automatic
termination of medical staff membership and privileges, HRSA’s
continuation of its policy in the 2001 version of the Guidebook should
come as a welcome development for hospitals and physicians alike.
Indeed, prior to issuance of the revised Guidebook in 2015, one
reasonably could have surmised that HRSA might change its
enforcement posture, as the agency has indicated that underreporting of
professional review actions by hospitals is the “next compliance
effort” 79; to the extent more physicians are trading traditional medical
staff affiliation for employment, and such underreporting is attributable
to hospitals not reporting employment-related actions, physician
employment termination actions conceivably could have become an area
of renewed interest for HRSA.
The risks of litigation that a hospital may assume in not following
HRSA’s now years-long guidance on reporting employment terminationrelated actions are on full display in the recent Pennsylvania federal
district court case of Langenberg v. Warren General Hospital. 80
78
Id. (emphasis added).
See HEALTH RES. & SERVS. ADMIN., U.S. DEP’T OF HEALTH & HUMAN SERVS.,
NATIONAL PRACTITIONER DATA BANK 2012 ANNUAL REPORT 38 (2014), http://www.
npdb.hrsa.gov/resources/reports/2012NPDBAnnualReport.pdf (noting “a robust plan to
conduct educational outreach activities targeted at specific audiences associated with
hospital compliance involving querying and reporting to the Data Bank”); see also
Hospital Reporting—The Next Compliance Effort, THE DATA BANK (Aug. 2012),
http://www.npdb.hrsa.gov/enews/Aug2012enews.jsp (noting “the next phase of our
compliance initiative–the Hospital Compliance Effort”). According to HRSA data, at the
start of 2011, forty-seven percent of hospitals had never reported revoking or restricting a
physician’s clinical privileges to the NPDB. See Peter Eisler & Barbara Hansen,
Thousands of Doctors Practicing Despite Errors, Misconduct, USA TODAY, Aug. 20,
2013, http://www.usatoday.com/story/news/nation/2013/08/20/doctors-licenses-medicalboards/2655513/.
80
Langenberg v. Warren Gen. Hosp., No. 1:12-cv-175-NBF, 2013 U.S. Dist. LEXIS
166183 (W.D. Pa. Nov. 22, 2013).
79
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Following complaints the physician had raised about patient safety and
quality of care, the hospital in that case terminated the employment of a
vascular surgeon only months into the employment, citing the withoutcause provision in the employment agreement. 81 Pursuant to the
hospital’s medical staff bylaws, the physician’s medical staff
membership and privileges terminated automatically and immediately
upon termination of his employment. 82 A month later, the hospital filed a
report with the NPDB “stating that [the physician] had been terminated
because, inter alia, he ‘often lacked civility and was demeaning to
Hospital staff,’ which had a ‘disruptive and detrimental effect on the
Hospital’s working environment.’” 83 The NPDB report further stated that
the bases for the report were the physician’s “‘failure to comply with
corrective action plan,’ ‘abusive conduct toward staff,’ and ‘disruptive
conduct.’” 84 During the course of the physician’s employment, however,
the hospital never disciplined him for any misconduct or provided him
with any corrective action plan.85 After submission of the NPDB report,
the physician struggled to obtain other employment. 86
In the federal lawsuit that ensued, the physician asserted a litany of
causes of action, all of which were premised on the hospital’s allegedly
improper filing of the NPDB report. 87 Among them, the physician
asserted three breach-of-contract claims that were rooted in the hospital’s
failure to afford the physician any procedural rights before reporting to
the NPDB. 88 The governing “contract” for these claims was the
employment agreement and the bylaws. As to the bylaws claims, the
physician first argued that the hospital breached by submitting the NPDB
report despite language in the bylaws stating that automatic termination
of a physician’s medical staff membership and privileges resulting from
the expiration or termination of a “contractual relationship” with the
hospital was not an “adverse action,” which would implicate the fair
81
See id. at *2–7.
See id. at *3.
83
Id. at *3 (citation omitted). The opinion is not entirely clear as to whether the
hospital reported the employment termination action or the consequent termination of the
physician’s medical staff membership and privileges to the NPDB. But the court’s
characterization of the physician’s legal assertions suggests the hospital reported the
latter. See id. at *20 (noting the physician “maintains that the Hospital breached the
Bylaws by treating his automatic termination of staff membership and clinical privileges
as an ‘adverse action’ for NPDB reporting purposes”).
84
Id. at *3.
85
Id.
86
See id.
87
See id. at *6.
88
See id.
82
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hearing plan in the bylaws. 89 Relatedly, the physician contended that the
hospital breached the bylaws by “failing to afford him due process
procedures ‘pursuant to a professional review action,’ including notice of
the charges against him, a hearing at which he could contest the charges,
and an opportunity to appeal any unfavorable ruling.’” 90 With respect to
the employment agreement, the physician argued that the hospital
breached the covenant of good faith and fair dealing implied therein by
submitting the NPDB report “in the absence of due process measures and
after having informed [the physician] that his termination was on a ‘noncause basis.’” 91
On a motion to dismiss, the court rejected all the physician’s breachof-contract claims. The defect in his first count was that there was “no
ambiguity in the Bylaws concerning the fact that the automatic and
immediate loss of clinical privileges and staff membership which results
from a termination of the physician’s employment contract (as was the
case here) [wa]s not an ‘adverse action’ giving rise to due process
hearing procedures.” 92 The physician apparently attempted to equate the
bylaws term “adverse action” with the HCQIA term “professional review
action”—so as to implicate the HCQIA procedures associated with the
latter term—but by doing so he necessarily had to look outside the
“operative contractual document” and therefore could not state a viable
claim for breach of contract. 93 For the same reason, the alternative
bylaws breach claim “fare[d] no better.” 94 As the bylaws were clear that
termination of a physician’s employment would prompt the loss of his or
her medical staff membership and privileges, the physician was
“unwarranted” in his “attempt to infuse meaning into the Bylaws’ use of
the term ‘adverse actions’ by referencing the HCQIA’s
definitions . . . .” 95 In a similar vein, the court held that the hospital could
not have violated an implied duty under the employment agreement when
it exercised its express right to terminate the agreement without cause.96
Any contention of the physician with the NPDB report that followed
from the termination was, according to the court, an effort to “(once
again) conflat[e] [the hospital’s] statutory responsibilities and reporting
requirements under the HCQIA with its contractual obligations under the
89
90
91
92
93
94
95
96
See id. at *13–15.
Id. at *7.
Id. at *8.
Id. at *7.
Id.
Id. at *8.
Id.
See id. at *10–11.
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Employment Agreement and thereby graft[ ] additional obligations onto
the Employment Agreement that do not appear in that document.”97
Although Langenberg does not speak to whether employment
termination actions against physicians are reportable to the NPDB, it at
least shows that the practice of hospitals reporting such actions is not
unprecedented, even where the hospital did not extend HCQIA’s
procedural safeguards to the physician who is the subject of the report.
Like Woodruff, the case further reinforces the primacy of the
employment agreement and medical staff bylaws in governing disputes
arising from a hospital terminating a physician’s employment.
Ultimately, if a physician is to be afforded any procedural rights to
challenge an action that may generate an NPDB report, the employment
agreement or medical staff bylaws must ensure that those rights are
available.
III.
PRACTICE POINTERS
The success of hospital employment of physicians as a form of
hospital-physician alignment will turn, in no small part, on the
contingencies hospitals and physicians have in place to resolve potential
conflicts. It may seem somewhat counterintuitive and adversarial to
make issues regarding termination a particular point of focus, but by
reaching common ground on these issues at an early stage, hospitals and
physicians can better avoid confusion about their rights and obligations,
and mitigate the likelihood of disputes escalating like those in Woodruff
and Langenberg.
At the outset, hospitals and physicians considering the employment
model should identify and articulate their negotiating positions on due
process rights related to termination and where on the continuum they
can compromise. One might expect physicians to advocate for as many
procedural rights as they can get, while hospitals, wanting maximum
flexibility, would push for the opposite. But the negotiation need not be
so partisan and polarized. One potential middle-ground approach is to
demarcate rights associated with “with-cause” termination from those
rights associated with “without-cause” termination.
As to the former, the parties may consider enumerating the grounds
for with-cause termination by the hospital to include issues involving
quality of care or patient safety. If the hospital desires to terminate on
one of these grounds, it could provide the physician a notice of its intent
to terminate and an opportunity for the physician to respond in some type
of review forum. The review forum could be conducted through the
97
Id. at *10.
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medical staff, as the American Medical Association (AMA) proposes in
opining on with-cause termination of physician employment agreements,
with the physician receiving “full due process under the medical staff
bylaws” and a stay on the termination until after the “governing body has
acted on the recommendation of the medical staff.” 98 Alternatively, the
review process could be a scaled-down version of a peer review
proceeding, perhaps entailing a combination of medical staff and hospital
human resources functions. As one commentator suggests: “[E]ven if a
full-blown, formal peer review process never occurs, hospitals can at
least attempt to approximate one by offering a review by the medical
staff, and some opportunity for physicians to present their sides of the
story.” 99
Contrary to what they might expect, hospitals could reap a number of
legal benefits by affording their employed physicians an opportunity to
challenge a termination action for quality-of-care or patient safety
concerns. For one, if the process and resulting decision are structured to
fit within HCQIA’s statutory terms—that is, the outcome is a
“professional review action” that meets the statute’s notice, hearing, and
governing standard requirements, taken by a “professional review body”
during the course of “professional review activity” 100—then the hospital
and review process participants could arguably receive immunity from
damages. Thus, the hospital could mitigate its liability stemming from
allegations that a termination action was wrongful or gave rise to other
contractual or tortious causes of action. Plus, the hospital could much
more definitively conclude that the termination action was a reportable
“professional review action.” 101 In similar fashion, by conducting review
98
See AM. MED. ASS’N, AMA PRINCIPLES FOR PHYSICIAN EMPLOYMENT § 3(e) (2014).
Susan O. Scheutzow & Sean P. Malone, No-Cause Terminations and Data Bank
Reports: Does a No-Cause Termination Mean No Lawsuit?, MEDSTAFF NEWS (Am.
Health Lawyers Ass’n. Wash., D.C.), Nov. 2014, at 7.
100
See 42 U.S.C. §§ 11151(9)–(11) (defining quoted terms) (2013); see also 42 C.F.R.
§ 60.3 (2014). As with reporting of physician employment termination actions to the
NPDB, immunity from damages for such actions would turn on a finding that the
physician’s employment status constitutes “clinical privileges” under HCQIA. See supra
Part II.B.
101
See supra Part II.B; see also supra note 100. To be sure, compliance with HCQIA’s
due process provisions is not a prerequisite to reporting a professional review action. See
Leal v. Sec’y, U.S. Dep’t of HHS, 620 F.3d 1280, 1287 (11th Cir. 2010) (explaining that
42 U.S.C. § 11112, “which sets out standards that professional review actions must
comply with in order for those who participate in them to be immune from liability for
money damages in suits brought by disciplined physicians, . . . does not govern when a
summary suspension, which is a type of professional review action, is reportable”);
Robert R. Harrison, Reporting the Summary Suspension of Medical Staff Privileges:
Requirements, Sanctions, and Interpretive Challenges, MEDSTAFF NEWS (Am. Health
Lawyers Ass’n. Wash., D.C.), Mar. 2015, at 4 (“For NPDB reporting purposes, hospitals
99
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activity through bodies that act as peer review committees, the hospital
could, depending on the applicable state law, privilege from discovery or
admissibility in litigation the communications and documents that are
generated during the review process.102 Finally, a review process that
removes the hospital from directly passing judgment on a physician’s
provision of medical care could shield the hospital from charges of
engaging in the corporate practice of medicine. 103
By contrast, negotiating physician rights relating to without-cause
termination may be more challenging because without-cause termination
is inherently supposed to be hassle-free. The AMA looks upon withoutcause termination with some skepticism, advising physicians to
“carefully consider the potential benefits and harms of entering into
employment agreements containing without cause termination
provisions” and to ensure that these provisions are not a vehicle for the
employer hospital to terminate for reasons relating to “quality, patient
safety, or any other matter that could trigger the initiation of disciplinary
action by the medical staff.” 104 For hospitals, however, the ability to
terminate a physician’s employment without cause is often critical,
providing a mechanism “to part ways with allegedly trouble-making
physicians with no questions asked, without a costly peer review process,
have relied on an underlying HCQIA function—the granting of immunity for
professional review actions—to support the interpretation that no report is required in the
absence of a professional review action, but the guidance has not been explicit on that
point.”). In Langenberg, the physician argued to the contrary—that, by deeming
automatic revocation of a physician’s privileges following termination of an employment
agreement with the hospital as outside the ambit of an “adverse action” subject to a
hearing, the hospital’s medical staff bylaws expressed the position that such revocations
lack the indicia of a “professional review action” that satisfies the procedural standards
for immunity under HCQIA and therefore were not reportable to the NPDB. See
Langenberg, U.S. Dist. LEXIS 166183, at *15–22. The court did not rule on the merits of
whether the hospital properly reported to the NPDB, instead limiting its conclusion only
to the determination that the hospital did not breach the terms of the medical staff bylaws
by making the report. See id. at *20–22. The ruling leaves open the possibility that the
physician could initiate HCQIA’s administrative procedures for challenging the
substance of the hospital’s NPDB report. See 45 C.F.R. § 60.16 (2014) (enumerating
procedures for disputing the accuracy of NPDB information). Indeed, it appears the
physician did take this course, as the court later stayed the proceeding while the physician
moved forward with an administrative proceeding and subsequent district court action
against HHS involving the NPDB report. See Langenberg v. Papalia, Civil Action No.
12-175 Erie, 2014 U.S. Dist. LEXIS 133941 (W.D. Pa. Sept. 14, 2014).
102
See RIEGER ET AL., supra note 30, § 2.4, at 9 n.12 (collecting state statutes). Federal
law, however, would provide no analogous peer review privilege. See, e.g., Agster v.
Maricopa County, 422 F.3d 836, 839 (9th Cir. 2005) (noting that HCQIA “granted
immunity to participants in medical peer reviews, but did not privilege the report
resulting from the process”).
103
See supra Part II.A.
104
AM. MED. ASS’N, AMA PRINCIPLES FOR PHYSICIAN EMPLOYMENT § 3(f) (2014).
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and without having to make a [NPDB] report that can generate lawsuits
for defamation, interference with business relationships, or bad-faith peer
review.” 105
Short of scrapping without-cause termination rights altogether, there
are a number of aspects of the without-cause termination provision that
hospitals and physicians could negotiate. The period of any notice prior
to such termination would be an obvious target. Linkage of the
physician’s employment status with his or her medical staff membership
and privileges—such that termination of the employment triggers
termination of the physician’s medical staff membership and
privileges—may be another point of deliberation. As a practical matter, a
physician’s medical staff membership and privileges may be meaningless
after termination of employment, but by decoupling them from the
physician’s employment status, the hospital could effectively put the
physician on notice that his or her employment status and medical staff
affiliation are distinct and that termination of employment will implicate
only those rights under the employment agreement.
Severing the connection between the physician’s employment status
and medical staff affiliation could also ward off the quandary of the
hospital having to determine whether to report to the NPDB termination
of the physician’s medical staff membership and privileges automatically
occurring because of termination of the physician’s employment. 106 Even
in those arrangements where the physician’s medical staff membership
and privileges and employment status remain synchronized, the parties
could bargain for a representation that the hospital will not report to the
NPDB an automatic termination of the physician’s medical staff
membership or privileges. While it is generally correct, as the hospital
argued in Langenberg, that a hospital’s “reporting requirements under
the HCQIA are not a matter that could be altered, waived, or otherwise
bargained away through a contractual arrangement between [a h]ospital
and a physician,” 107 HRSA’s guidance in the Guidebook suggests that
such a representation would be acceptable because the automatic
termination of the physician’s medical staff membership or privileges
would not be a “professional review action” that would implicate the
statute. 108
Ultimately, whatever terms the parties agree to, they should make
sure to draft them with precision in the employment agreement. This may
seem like an obvious point, but it warrants emphasis given the
105
Scheutzow & Malone, supra note 99, at 5.
See supra Part II.B.
107
Langenberg v. Warren Gen. Hosp., No. 1:12-cv-175-NBF, 2013 U.S. Dist. LEXIS
166183, at *21-22 (W.D. Pa. Nov. 22, 2013).
108
See 2015 GUIDEBOOK, supra note 77, at E-40; supra Part II.B.
106
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“[m]ultiple layers of contractual relationship between the parties . . . .” 109
References to the medical staff bylaws and related rules, regulations,
policies, and procedures will be particularly important and should prompt
review of the specific documents or provisions being referenced and
determination of whether they track the terminology from relevant laws,
such as HCQIA (as was not the case in Langenberg, to the physician’s
detriment). Uses of “[l]anguage such as making the employment
agreement ‘subject to,’ ‘except as otherwise stated,’ or ‘except as
otherwise permitted’ by the bylaws” may create the situation,
intentionally or unintentionally “where the terms of the employment
agreement are superseded.” 110 Yet, as Woodruff cautions physicians,
even broadly worded requirements in the employment agreement for the
physician to comply with the medical staff bylaws are generally
insufficient, on their own, to render the procedures for medical staff peer
review actions applicable to employment-based actions. 111
Finally, the impetus is on hospitals to think through the propriety and
consequences of terminating a physician’s employment before doing so.
Termination is a drastic measure, and as such, it may not be the
appropriate response to remediate a problem with a physician.
Particularly where a hospital has clinical concerns, the hospital may find
that the medical staff framework—with all the corrective action powers
at the medical staff’s disposal, such as the authority to convene
investigative committees and subject a physician with deficiencies to
peer supervision—may be more conductive to resolving the problem. As
noted, moreover, going the medical staff route may have the added
benefits of ensuring certain legal protections are in place and accruing
physician buy-in toward the employment model. On the other hand, a
quick, clean severance may sometimes be appropriate, such as where the
physician is creating a disruption for other staff. Termination of the
physician’s employment, potentially along with the physician’s medical
staff membership and privileges, may be proper then.
In addition to the operational factors that will shape employment
termination decisions, larger market forces will also critically affect the
contentiousness of these decisions. For physicians in the post-health
reform system, “it will be harder to revert to private practice if
relationships sour, since new payment structures and care models will
make it increasingly difficult for traditional private practices to remain
109
Patrick D. Souter, Hospital-Physician Employment Agreements and Medical Staff
Bylaws: Potential Issues Resulting from Overlapping Contractual Obligations,
MEDSTAFF NEWS (Am. Health Lawyers Ass’n. Wash., D.C.), May 2014, at 1.
110
Id. at 2.
111
See Woodruff v. Haw. Pac. Health, No. 29447, 2014 Haw. App. LEXIS 26, at *50–
51 (Haw. App. Jan. 14, 2014).
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profitable.” 112 Indeed, “[e]mployment choices that physicians make
today may not be able to be undone.” 113 Acknowledging this reality,
hospitals should likely anticipate more challenges to their employment
termination decisions, leading to the types of assertions in Woodruff and
Langenberg that various procedures must be exhausted before the
termination decision can take effect. As a spillover effect for hospitals,
messy employment termination actions could undermine among already
employed physician staff the very sense of collaboration and
coordination that the employment relationship is meant to engender, and
deter employment of other physicians. Clearly, termination of the
hospital-physician employment relationship is not a matter to be taken
lightly.
IV. CONCLUSION
Hospital employment of physicians continues to take further root in
the healthcare landscape, yet the voluntary medical staff structure
remains intact. Hospitals and physicians accordingly will have to
confront questions about the physician’s dual roles as hospital employee
and medical staff member, and the rights and responsibilities that attach
to one role and carry over to the other. The pre-employment negotiation
will be the best opportunity for the parties to sort through and reach
consensus on these issues, including the applicability of traditional peer
review protections in the medical staff context to employment
termination actions and the duty to report such actions to the NPDB.
Although the employment model is intended to give hospitals greater
flexibility and control of physicians’ practice, hospitals are well advised
to consider some type of pre-termination review process for their
employed physicians, particularly in circumstances that involve clinical
practice issues. Doing so could have a number of longer-term legal
advantages and shore up goodwill among physicians. Once they have
agreed to a set of terms, the parties should draft them carefully in writing
in the employment agreement, avoiding vague, overly broad references
to extra-contractual documents, such as the medical staff bylaws, which
could muddle the parties’ understanding about which document
supersedes the others. If and when the time comes to terminate a
physician’s employment, hospitals should make sure a thorough
decision-making process is in place, requiring due consideration of the
reasons for the termination; any available alternatives, including
disciplinary action initiated through the medical staff; and the risks of
112
113
Kocher & Sahni, supra note 16, at 1790.
Id. at 1792.
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liability. Taken together, these steps could go a long way toward
facilitating the spirit of partnership the hospital-physician employment
model is supposed to promote.
Wollschlaeger, a Patient’s Right to Privacy,
and a Renewed Focus on Mental Health
Treatment
Chad A. Pasternack *
In response to doctors pushing gun control agendas on patients,
Florida enacted the Firearm Owners Privacy Act. The law,
upheld by the Eleventh Circuit in Wollschlaeger v. Governor of
Florida, protects patients from intrusive lines of inquiry
unrelated to their treatment and from discrimination due to
firearm ownership. While patients in Florida benefit greatly
from the Firearm Owners Privacy Act, this note argues for more
specific language in the law, which would parallel language in
the Florida Mental Health Act (“Baker Act”). The proposed
changes would limit inquiries into firearm ownership to
instances where there is a substantial likelihood of serious
bodily harm to the patient or others.
I. INTRODUCTION .................................................................................. 452
II. PRIOR REGULATION OF HEALTHCARE.............................................. 454
A. A Brief History of Federal Healthcare Regulation ................... 454
1. Surgeon General’s Report on Smoking and Health ............. 454
2. Creation of Medicare and Medicaid .................................... 456
B. Changing Definition of Healthcare ........................................... 459
1. Preventive Medicine ............................................................ 460
2. Mental Health ...................................................................... 460
C. Regulation in Florida................................................................ 462
1. The Baker Act ...................................................................... 462
2. Patient Records .................................................................... 465
III. FIREARM OWNERS PRIVACY ACT ................................................... 466
A. Language of the Act .................................................................. 466
*
Executive Editor, University of Miami Business Law Review; J.D. Candidate 2015,
University of Miami School of Law; B.S. 2012, The College of New Jersey. Thank you
to the University of Miami Business Law Review members and executive board. It has
been a pleasure working with all of you.
451
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B. Legislative History .................................................................... 470
C. Wollschlaeger v. Governor of Florida ...................................... 473
IV. LESS DISCRETION, MORE EFFECTIVE ............................................. 476
V. CONCLUSION .................................................................................... 479
I. INTRODUCTION
A young mother is concerned about a rash on her son, so she brings
him to a pediatrician. Once inside the examination room, the doctor asks
the mother a series of questions about her home, including whether she
owns any firearms. Bewildered about and uncomfortable with this
question, the mother refuses to answer and pleads with the doctor to
focus on her son instead. The doctor frowns, and then he advises the
mother that she will have thirty days to find a new pediatrician.
To a physician, the aforementioned scenario may be a reasonable
practice of preventive medicine. In fact, counseling patients on firearm
safety is a practice encouraged by the American Medical Association.1
But, the patient on the receiving end of the inquiry may feel vulnerable,
threatened, and violated. Particularly when a patient goes to a doctor for
a specific purpose, as opposed to for an ordinary wellness visit, it is
presumable that the patient neither expects nor desires such intrusive
inquiries in the name of preventive care. The physicians’ gun control
movement is a result of excessive media coverage of mass shootings and
inadequate treatment of the mentally ill.2 Instead of treating the root
causes of gun violence, such as mental illness and breakdown of the
family unit, “the public health establishment’s histrionic reflex is . . . to
control and confiscate.” 3
In response to this movement among healthcare providers, Florida
enacted a law that curtails doctors’ ability to question patients on
ownership or possession of firearms and ammunition, which is known as
1
Press Release, President Robert M. Wah, M.D., American Medical Association,
AMA Response to Court Ruling on Florida’s Gun Gag Law (July 28, 2014).
2
Vik Khanna, Why Public Health Needs a New Gun Doctrine, AMERICA’S 1ST
FREEDOM, Dec. 2014, at 64. While Khanna, a public health professional educated at the
Johns Hopkins University Bloomberg School of Hygiene and Public Health, admittedly
believes the Second Amendment secures the rights of individuals to own firearms and
enjoys firearm ownership, he brings a level of fairness to the conversation by discussing
data that typically goes unreported. For instance, he noted a 2013 report produced by the
Institute of Medicine was ignored by the media. The report, ordered by the Centers for
Disease Control, concluded that defensive uses of firearms occur more than previously
recognized, firearm ownership is a crime deterrent, and unauthorized possession of a
firearm is a crucial driver of gun related violence. Id.
3
Id.
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the Firearm Owners Privacy Act. 4 Essentially, the law dictates limits on
preventive medicine in regards to firearms. This note will show that the
Firearm Owners Privacy Act is indeed a valid regulation of healthcare.
To clarify, this note will not discuss the Second Amendment, gun
control, or gun rights. 5
First, this note will explore the evolution of healthcare regulation.
Part II will begin with a brief discussion of a few major developments in
regulation at the federal level. In particular, regulations pertaining to
tobacco usage and Medicare will be used to show how healthcare
regulations came about and gained acceptance, and the faculty the
federal government has to impose such regulations. Along with the
development of regulations, the advancement and changing nature of
healthcare itself will be discussed. This note will focus on how mental
health treatment, using preventive medicine as a backdrop, has advanced
since the mid-1900s. After discussing healthcare at the macro-level, this
note will narrow its focus to regulations in Florida, namely the Baker
Act 6 and regulations of patient medical records.
Second, there will be a thorough analysis of the Firearm Owners
Privacy Act. Part III will include both an analysis of the plain text of the
law and its legislative history. Then, this note will examine the
implications of the Eleventh Circuit’s interpretation of the Act in
Wollschlaeger v. Governor of Florida.
Third, this note will propose changes to the Firearm Owners Privacy
Act based on its legislative history and the Baker Act. As enacted, the
Firearm Owners Privacy Act fails to effectuate its intended purpose,
which is to protect the rights of patients by prohibiting agenda-driven
inquiries into firearm ownership. 7 In particular, Section 790.338 should
be amended so that the exception to the general prohibition of inquiry
4
See infra Part III.B; 2011 Fla. Laws 112 (codified at FLA. STATS. §§ 790.338,
381.026, 456.072 (2014)).
5
For more information on these issues, see McDonald v. City of Chicago, 561 U.S.
742 (2010) (holding the Second Amendment right to keep and bear arms is incorporated
by the Fourteenth Amendment and applicable to the states); District of Columbia v.
Heller, 554 U.S. 570 (2008) (holding the Second Amendment confers an individual right
to keep and bear arms); Peruta v. County of San Diego, 742 F.3d 1144 (9th Cir. 2014)
(holding “the right to keep and bear arms includes the right to carry an operable firearm
outside the home for the lawful purpose of self-defense”); Palmer v. District of
Columbia, ___ F. Supp. 2d ___, Case No. 1:09-CV-1482, 2014 WL 3702854 (D.D.C.
July 24, 2014) (holding Washington D.C.’s complete ban on the carrying of firearms
outside the home is unconstitutional); Julie Morgan, Back to the Basics: Restoration of
Our Right to Keep and Bear Arms Through a National Reciprocity Act, 21 U. MIAMI BUS.
L. REV. 223 (2013) (discussing the constitutionality and need for a national concealedcarry reciprocity law).
6
Florida Mental Health Act, FLA. STAT. §§ 394.451-394.47891 (2014).
7
See infra Part III.B.
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into firearm ownership requires a good faith belief that there is a
substantial likelihood of harm, instead of only relevance to the patient’s
medical care or safety.
II. PRIOR REGULATION OF HEALTHCARE
Like any regulatory scheme, the American healthcare system has
developed slowly. If the regulations in effect today were unilaterally
imposed overnight, rather than after years of piecemeal evolution, such
regulations would have been rejected. But, “[s]light encroachments
create new boundaries from which legions of power can seek new
territory to capture.” 8 Concurrent with the evolution of healthcare
regulation, the very definition of “healthcare” has undergone change. A
brief history of these developments will provide the necessary context for
an analysis of our present state of healthcare regulation.
A. A Brief History of Federal Healthcare Regulation
In the mid-twentieth century, the federal government directed an
unprecedented amount of its attention towards the nation’s healthcare.
Two initiatives in particular were monumental in crafting our present
healthcare system: the Surgeon General’s 1964 report on smoking and
health, and the creation of Medicare and Medicaid. The former, a
landmark step in policymaking, and the latter, landmark steps in social
insurance, are prototypical of federal healthcare regulation.
1. Surgeon General’s Report on Smoking and Health
The government’s first major push in its effort to expand healthcare
regulation began in 1964 with the Surgeon General’s report, Smoking
and Health. 9 The report opened with a simple question that held farreaching effects: “[I]s the use of tobacco bad or good for health, or
devoid of effects on health?” 10 Unlike today, the carcinogenic effects of
smoking were not common knowledge in the 1960s, nor were they
proven scientifically by reliable research methods.
In the early pages of the report, the Surgeon General discussed the
problem that plagues most scientific research—causality. Whereas
finding a correlation is merely finding a relation between phenomena, 11
8
Reid v. Covert, 354 U.S. 1, 39 (1957).
U.S. DEP’T OF HEALTH, EDUC. & WELFARE, SMOKING & HEALTH: REPORT OF THE
ADVISORY COMMITTEE TO THE SURGEON GENERAL OF THE PUBLIC HEALTH SERVICE (1964)
[hereinafter SURGEON GENERAL REPORT].
10
Id. at 5.
11
MERRIAM-WEBSTER’S COLLEGIATE DICTIONARY 280 (11th ed. 2003).
9
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causation is “an act or agency which produces an effect.” 12 The report
noted, “thoughts about causality in the realm of this inquiry were
constantly and inevitably aroused in the minds of the members because
they were preoccupied with the subject of their investigation—‘Smoking
and Health.’” 13 Causality was determined by analyzing the effect or noneffect of tobacco on the user’s tissues, organs, and other qualities that
may affect the user’s health, for better or worse. 14
Scientific methods aside, the importance of the report flows from its
findings. It found that the habitual use of tobacco is primarily related to
the addictive nature of nicotine.15 Average smokers had nine to tenfold
increases in risk of developing lung cancer, and heavy smokers had
upwards of a twenty-fold risk increase. 16 The report stated its conclusion
succinctly: “[o]n the basis of prolonged study and evaluation of many
lines of converging evidence, the Committee makes the following
judgment: Cigarette smoking is a health hazard of significant importance
in the United States to warrant appropriate remedial action.”17
Once presented with this conclusion, it was only a matter of time
before Congress acted. That action came in 1965 in the form of the
Federal Cigarette Labeling and Advertising Act. 18 The Act made it
unlawful “for any person to manufacturer, import, or package for sale or
distribution within the United States any cigarettes the package of which
fails to bear the following statement: ‘Caution: Cigarette Smoking May
Be Hazardous to Your Health.’” 19 While this warning brought public
attention to the effects of cigarette smoking, the language was weak and
limited only to the package itself. Accordingly, Congress enacted the
Public Health Cigarette Smoking Act of 1969, 20 which required stronger
language to be put on packaging. It prohibited advertising cigarettes on
any medium of electronic communication that is regulated by the Federal
Communications Commission. 21 Additionally, it required annual
reporting to Congress by the Secretary of Health, Education and Welfare
regarding information and recommendations related to smoking, 22 as
12
Id. at 196.
SURGEON GENERAL REPORT, supra note 9, at 20.
14
Id. at 21.
15
Id. at 32.
16
Id. at 31.
17
Id. at 33.
18
Federal Cigarette Labeling and Advertising Act, Pub. L. No. 89-92, 79 Stat. 282
(1965) (codified as amended at 15 U.S.C. §§ 1331-1341 (2012)).
19
Id. § 4.
20
Public Health Cigarette Smoking Act of 1969, Pub. L. No. 91-222, 84 Stat. 87
(1970) (codified as amended at 15 U.S.C. §§ 1331-1341 (2012)).
21
Id. § 6.
22
Id. § 8(a).
13
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well as annual reporting by the Federal Trade Commission of the
effectiveness of cigarette labeling and current practices of advertising. 23
The aforementioned series of events set precedent for healthcare
regulation. The Surgeon General conducted research and declared that
the evidence revealed cigarette smoking to be a health hazard and matter
of public concern. 24 Within only a few years, the tobacco industry was
being regulated by the Federal Trade Commission, the Federal
Communications Commission, and the Secretary of Health, Education
and Welfare. 25
2. Creation of Medicare and Medicaid
The 1960s was a busy decade in the healthcare arena. In addition to
combating the perils of smoking, Congress expanded access to healthcare
by establishing Medicare and Medicaid through the Social Security
Amendments of 1965. 26 As originally enacted, Medicare provided health
insurance for individuals who attained the age of 65 and were entitled to
Social Security benefits or were qualified railroad retirement
beneficiaries.27 Medicare coverage includes both hospital insurance and
supplementary medical insurance. As for Medicaid, it was created to
enable the States to provide medical assistance to “families with
dependent children and of aged, blind, or permanently and totally
disabled individuals, whose income and resources are insufficient to
meet the costs of necessary medical services,” as well as rehabilitation
and other services to help beneficiaries attain independence.28
The Social Security Amendments of 1965 explicitly prohibit federal
interference:
Nothing in this title shall be construed to authorize any
Federal officer or employee to exercise any supervision
or control over the practice of medicine or the manner in
which medical services are provided, or over the
23
Id. § 8(b).
My discussion of the Surgeon General’s report and its effects on policy should not
be interpreted as being critical of either the findings of the report nor of the legislative
response. Neither of these matters is of concern to this note. Rather, the cigarette smoking
legislation is a paradigm of how matters once not thought to be health concerns can
quickly morph into leading health concerns, and how the legislative response can be
broader in scope than the traditional components of healthcare, i.e., the doctor-patient
relationship.
25
Known today as the Secretary of Health and Human Services.
26
Social Security Amendments of 1965, Pub. L. No. 89-97, 79 Stat. 286 (1965)
(codified as amended at 42 U.S.C. §§ 1395-1396v (2012)).
27
Id. § 101.
28
Id. § 121.
24
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selection, tenure, or compensation of any officer or
employee of any institution, agency, or person providing
health services; or to exercise any supervision or control
over the administration or operation of any such
institution, agency, or person. 29
That said, this prohibition is more appropriately described as a
prohibition of direct control over the practice of medicine. In other
words, the ability to indirectly control is retained through the power to
regulate: “The Secretary shall prescribe such regulations as may be
necessary to carry out the administration of the insurance programs under
this title.” 30
Before proceeding into any further discussion of how healthcare is
regulated through Medicare and Medicaid, this note must clarify that
healthcare providers choose to accept Medicare and Medicaid, thereby
agreeing to regulations promulgated by the Department of Health and
Human Services. 31 Even though hospitals and doctors are typically
referred to as some variation of the phrase “healthcare provider,” they are
businesses and businessmen, respectively. By not accepting Medicare
and Medicaid, these healthcare providers would turn away a significant
source of revenue. Therefore, it is persuasive for healthcare providers to
accept Medicare and Medicaid and to submit to federal regulation.
Because this discussion is meant to be a superficial exploration into
Medicare and Medicaid, the only regulations that will be discussed are
the Emergency Medical Treatment and Active Labor Act
(“EMTALA”) 32 and the use of diagnosis-related groups (“DRG”).
EMTALA applies to “participating hospitals” that have “entered into a
provider agreement under Section 1395cc,” 33 which is the agreement to
participate in and receive payments from Medicare. Therefore, in order
to access the segment of the market that consists of Medicare patients,
hospitals agree, pursuant to EMTALA, to provide a screening
examination and stabilizing treatment to any individual who comes to the
hospital’s emergency department, regardless of whether the individual is
29
Id. § 102.
Id.
31
See Ass’n of Am. Physicians & Surgeons v. Weinberger, 395 F. Supp. 125, 134
(N.D. Ill. 1975) aff’d Ass’n of Am. Physicians & Surgeons v. Mathews, 423 U.S. 975
(1975) (“each individual physician and practitioner has the ability to choose whether or
not to participate in the [Medicare] program. It is true that there will exist economic
incentive or inducement to participate in the program. However, such inducement is not
tantamount to coercion or duress”).
32
Emergency Medical Treatment and Active Labor Act, 42 U.S.C. § 1395dd (2012).
33
§ 1395dd(e)(2).
30
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eligible for Medicare benefits.34 In order to enforce the requirements of
the statute, it authorizes a civil money penalty of up to $50,000 and may
exclude doctors from participation in Medicare and Medicaid programs
for flagrant or repeated offenses. 35
A second type of regulation imposed on healthcare providers through
Medicare is the use of a prospective payer system that reimburses
hospitals based on diagnoses, not actual cost. 36 By reimbursing hospitals
through DRGs, which are classifications of different diagnoses and
procedures, the government forces hospitals to match their costs to the
expected reimbursement.
Under cost-based reimbursement, each hospital was
treated as a singular entity entitled to receive its unique
costs of treating Medicare patients. In contrast, under
DRG-based reimbursement, each hospital is treated as a
member of a group and it is entitled to reimbursement
only by virtue of its status as part of that group. Each
hospital receives reimbursement for the average of a
type of case in an average class of hospitals in an
average location. 37
As a result, hospitals are incentivized to cut costs, which may occur at
the expense of patients’ treatment. For example, reducing lengths of
patient stays reduces costs, but also inhibits physicians’ abilities to
monitor patient recoveries. 38 Yet the incentives resultant from fixed
reimbursement go beyond increasing efficiency. A hospital that cannot
match its costs to the reimbursement would suffer a loss; and conversely,
a hospital that can treat a patient for less than the prospective payment
will turn a profit. 39 Regardless of the wisdom of this tradeoff, the federal
34
§ 1395dd(a)-(b). This note is not critical of EMTALA. EMTALA saves lives. Yet,
EMTALA is a prime example of how regulations can be imposed on healthcare providers
by the federal government through healthcare providers’ acceptance of Medicare and
Medicaid.
35
§ 1395dd(d).
36
See David M. Frankford, The Complexity of Medicare’s Hospital Reimbursement
System: Paradoxes of Averaging, 78 IOWA L. REV. 517, 570-71 (1993).
37
Id. at 577.
38
For a more thorough analysis of the effects of a prospective payment system on
hospital behavior, see Martin F. Grace & Jean M. Mitchell, Regulation of Health Care
Costs: The Implications of the Prospective Payment Reimbursement System, 2 U. FLA. J.
L. & PUB. POL’Y 125 (1989).
39
Pamela H. Bucy, Health Care Reform and Fraud by Health Care Providers, 38
VILL. L. REV. 1003, 1015 (1993) (arguing that DRGs have encouraged fraud, including
cost shifting to non-Medicare patients, false reporting of costs, and false diagnoses of
patients).
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government, by being the insurer of such a large segment of the
population, is able to place controls on hospital behavior so as to reduce
its own costs. While the government cannot directly control the practice
of medicine, its role as insurer gives it considerable influence over
healthcare practitioners. By controlling the money, the government is
able to regulate the process.
B. Changing Definition of Healthcare
Healthcare n: the field concerned with the maintenance
or restoration of the health of the body or mind.40
Webster’s published this definition in 1998. In 2004, Webster’s
published the following definition:
Healthcare n: the provision of medical and related
services aimed at maintaining good health, especially
through the prevention and treatment of disease.41
As medical science continually improves, what we consider
“healthcare” will continually change. For example, look to the use of
antihistamines to treat allergies. Prior to the 1900s, little was known
about allergic reactions.42 Over the course of a few decades, scientists
learned how allergens affect the body. By the early 1940s, antihistamines
were invented and administered. Side effects of these early drugs
included sedation and dry mouth. 43 While one can function with dry
mouth, sedation is more inhibiting. Fortunately, by the 1980s,
pharmaceutical companies were able to produce non-sedative
antihistamines.44 In under a century, people went from experiencing
unexplained physiological reactions to understanding that their reactions
are caused by “allergies,” which can be treated with over-the-counter
medication.
In order to maintain the relevancy of how different areas of
healthcare have developed, this note will only discuss the shift to
preventive medicine and changes in mental health treatment.
40
WEBSTER’S UNABRIDGED DICTIONARY 882 (2d ed. 1998).
WEBSTER’S DICTIONARY OF THE ENGLISH LANGUAGE 867 (2d ed. 2004).
42
M.B. Emanuel, Histamine and the Antiallergic Antihistamines: A History of Their
Discoveries, 29 CLINICAL AND EXPERIMENTAL ALLERGY, 1 (Supp. 3 1999).
43
Id. at 9.
44
Id.
41
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1. Preventive Medicine
Stated simply, preventive medicine is a mixture of science and
philosophy that encourages patients to be proactive in maintaining their
health. Instead of merely treating conditions as they occur, practitioners
of preventive medicine are more forward looking in their approach to
patient treatment. By treating conditions sooner or by controlling risk
factors, health outcomes improve and costs decrease.
Preventive medicine can be broken down into three levels: primary
prevention, secondary prevention, and tertiary prevention.45 At the
primary prevention level, the goal is to keep new problems from
developing. This can be accomplished through the use of vaccines and
immunization programs, or by making lifestyle changes, such as
exercising, quitting smoking, and reducing alcohol consumption.
Preventive medicine is always forward looking—lose weight and stop
smoking now to reduce the risk of developing heart disease later.
Despite a patient’s best efforts, some conditions are not preventable.
But, with secondary prevention, conditions can be detected early and
treated promptly. 46 Wellness visits to physicians are encouraged because
many conditions are asymptomatic.47 Examples of conditions that are
commonly detected and treated at this stage of care are breast cancer,
hypertension, high cholesterol, and skin cancer. 48 Unlike the primary
prevention stage, the goal here is to prevent the condition from
advancing to a point where it causes health to deteriorate.
Along the same lines, the objective of tertiary prevention is to
prevent existing conditions from worsening, often through treatment,
rehabilitation, or surgery. 49 Although there is much debate over whether
this is in fact preventive medicine and not purely reactive medicine, the
conditions dealt with are typically progressive, so the focus remains on
the future. 50
2. Mental Health
Over the past half-century, the mental health system in the United
States has undergone a dramatic transformation. Prior to the 1960s,
mental health treatment consisted, in large part, of detention in state
45
William Rakowski, The Definition and Measurement of Prevention, Preventive
Healthcare, and Health Promotion, 18 GENERATIONS 18 (Spring 1994).
46
Id.
47
Id.
48
Id.
49
Id.
50
See id.
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mental hospitals, 51 otherwise known as asylums. During the
deinstitutionalization movement that took place between 1955 and 1980,
over 400,000 people were released from mental hospitals.52 Afterwards,
attention turned to community support programs, which had goals of
continuous community treatment and support services, as well as
assertive crisis and outreach services. 53 Instead of focusing on
containment and restraint, the newer system emphasized rehabilitation.
Patients were taught social skills and skills that support independent
living and employment. 54
By the 1990s, the mental health system transformed again, this time
to focus on recovery. “Central to recovery principles is the idea that
people can live meaningful and personally satisfying lives without the
complete elimination of psychiatric symptoms.” 55 Because the current
focus is on helping patients recover, healthcare providers and related
organizations spend large amounts on outreach initiatives so that more
people seek and receive treatment.56 A study of data from the Veterans
Health Administration from 1997 to 2005 shows a significant increase in
usage of mental health services. During that period, there was a 7%
annual growth in usage, 57 and the number of veterans who received at
least one mental health contact increased 117.6%. 58
The current mental health landscape involves three main changes: (1)
focusing on health rather than illness,59 (2) reducing negative stigmas
associated with mental health treatment,60 and (3) increasing
collaboration between primary care and mental health.61 Together, these
changes are designed to make mental health treatment both more
accessible to more people and to make more people willing to seek and
51
Catherine H. Stein et al, Mental Health System Historians: Adults with
Schizophrenia Describe Changes in Community Mental Health Care Over Time, 85
PSYCHIATRIC QUARTERLY 3 (Oct. 2, 2014).
52
Id.
53
Id.
54
Id.
55
Id.
56
Eric D. A. Hermes et al, Recent Trends in the Treatment of Posttraumatic Stress
Disorder and Other Mental Disorders in the VHA, PSYCHIATRIC SERVICES 471, 472 (May
2012).
57
Id. at 471.
58
Id. at 472.
59
A. Kathryn Power, Focus on Transformation: A Public Health Model of Mental
Health for the 21st Century, 60 PSYCHIATRIC SERVICES 580 (May 2009).
60
Eric R. Pedersen & Andrew P. Paves, Comparing Perceived Public Stigma and
Personal Stigma of Mental Health Treatment Seeking in a Young Adult Sample, 219
PSYCHIATRY RES. 143 (2014).
61
Stephen Petterson et al, Mental Health Treatment in the Primary Care Setting:
Patterns and Pathways, 32 FAMILIES, SYSTEMS, & HEALTH 157 (June 2014).
462
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receive treatment. The focus on health, rather than illness, and the goal of
reducing negative stigmas are part of an attitudinal change in medicine,
which corresponds closely to the rise in preventive medicine. The
modern healthcare attitude, which is gaining acceptance, is that going to
a doctor should be a routine part of life and that doing so allows us to
live better and longer.
C. Regulation in Florida
Our discussion thus far has been on healthcare at the national level.
Most healthcare regulation, however, is imposed at the state level. 62 In
Florida, most laws regulating healthcare can be found in Title XXIX,
Public Health, and Title XXXII, Regulation of Professionals and
Occupations, of the Florida Statutes. This note will limit its discussion to
those statutes pertaining to mental health treatment and medical records.
1. The Baker Act
The Florida Mental Health Act, more commonly known as the Baker
Act, establishes the state’s goals and policies for mental health
treatment.63 In passing the Baker Act, it was “the intent of the
Legislature . . . to evaluate, research, plan and recommend . . . programs
designed to reduce the occurrence, severity, duration, and disabling
aspects of mental, emotional, and behavioral disorders.” 64 There is a
clear policy favoring medical treatment, rather than predeinstitutionalization-style containment.
Treatment programs “shall include, but [are] not limited to,
comprehensive health, social, educational, and rehabilitative services to
persons requiring intensive short-term and continued treatment in order
to encourage them to assume responsibility for their treatment and
recovery.” 65 The goal is to help patients recover and lead meaningful
lives. But, that can be a difficult goal to attain considering that many
suffering from mental health conditions either go undiagnosed or will not
consent to treatment. In such circumstances, it is the intent of the
Legislature
that any involuntary treatment or examination be
accomplished in a setting which is clinically appropriate
and most likely to facilitate the person’s return to the
community as soon as possible; and that individual
62
63
64
65
See U.S. CONST. amend. X.
Florida Mental Health Act, FLA. STAT. §§ 394.451-394.47891 (2014).
FLA. STAT. § 394.453 (2014).
Id.
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dignity and human rights be guaranteed to all persons
who are admitted to mental health facilities or who are
being held [for involuntary examination]. 66
Yet, even when treating or examining an involuntary patient, restraint
and seclusion is justified only in response to imminent danger to the
patient or others. 67
Along the same vein of legislation geared towards the treatment of
communicable diseases, the Baker Act recognizes the competing
interests of the patient and the public in mental health treatment: (1) the
patient recovering and functioning in society, and (2) protecting the
public from people who are dangerous due to their mental illnesses.
Mental health is defined as a person’s “state of mind characterized by
emotional well-being, good behavioral adjustment, relative freedom from
anxiety and disabling symptoms, and a capacity to establish constructive
relationships and cope with the ordinary demands and stresses of life.” 68
Treatment, on the other hand, is “the administration of appropriate
measures (e.g., drugs, surgery, therapy) that are designed to relieve a
pathological condition.” 69 Therefore, the missing component of the
equation is mental illness. The Baker Act defines mental illness as “an
impairment of the mental or emotional processes that exercise conscious
control of one’s actions or of the ability to perceive or understand reality,
which impairment substantially interferes with the person’s ability to
meet the ordinary demands of living.” 70 However, developmental
disabilities, intoxication, and conditions manifested only by antisocial
behavior 71 or substance abuse are not included as mental illnesses.
As previously discussed, EMTALA requires hospitals that have
entered into Medicare provider agreements to provide stabilizing
treatment to all individuals who enter the hospital’s emergency
department, regardless of their ability to pay. 72 The value society places
on human life is greater than the value it places on emergency stabilizing
66
Id.
Id.
68
AMERICAN PSYCHOLOGICAL ASSOCIATION DICTIONARY OF PSYCHOLOGY 568 (1st ed.
2007) [hereinafter APA DICTIONARY].
69
Id. at 956.
70
FLA. STAT. § 394.455(18) (2014).
71
Antisocial behavior is defined as “aggressive, impulsive, and sometimes violent
actions that violate the established rules, conventions, and codes of a society, such as the
laws upholding personal and property rights.” APA DICTIONARY, supra note 68, at 62.
72
See supra Part II.A.2.
67
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treatment. 73 Like EMTALA, the Baker Act grants patients the right to
treatment. “A person shall not be denied treatment for mental illness and
services shall not be delayed at a receiving or treatment facility because
of inability to pay.” 74 But, after mental health services are provided,
hospitals are entitled to make every reasonable effort to collect
appropriate reimbursement—they simply cannot condition treatment on
payment. 75 Particularly because people with mental illnesses may be a
danger to themselves or others, public policy dictates that they receive
prompt treatment.
Dangerous mentally ill patients, however, do not always seek
treatment when they should. Accordingly, the Baker Act provides for
involuntary examination and placement. A person can be compelled to
undergo examination if,
[w]ithout care or treatment, the person is likely to suffer
from neglect or refuse to care for himself or herself; such
neglect or refusal poses a real and present threat of
substantial harm to his or her well-being; and it is not
apparent that such harm may be avoided through the
help of willing family members or friends or the
provision of other services; or . . . [t]here is a substantial
likelihood that without care or treatment the person will
cause serious bodily harm to himself or herself or others
in the near future, as evidenced by recent behavior.76
An involuntary examination is a drastic measure, but it is a necessary
step to save lives, i.e., it is the preliminary step to involuntary placement.
A person may be placed in involuntary inpatient placement if “[t]here is
substantial likelihood that in the near future he or she will inflict serious
bodily harm on himself or herself or another person, as evidenced by
recent behavior causing, attempting, or threatening such harm.” 77 People
73
Therefore, providing a patient emergency treatment for mental illness is the
functional equivalent of providing life-saving treatment to a patient in an emergency
department. In effect, they are both lifesaving measures.
74
FLA. STAT. § 394.459 (2014).
75
§ 394.459(2)(a).
76
FLA. STAT. § 394.463(1)(b) (2014). The statute also requires that either the person
refused examination after conscientious disclosure of the purpose of examination, or the
person is unable to determine for himself or herself whether the examination is necessary.
§ 394.463(1)(a).
77
FLA. STAT. § 394.467(1)(a) (2014). In addition, criteria for involuntary inpatient
placement requires the person be mentally ill, and refuse or be unable to determine
whether voluntary placement is necessary. Instead of a substantial likelihood of inflicting
harm, a person may be placed in involuntary placement if he or she is manifestly
incapable of surviving alone or with the help of family and friends. In all circumstances,
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who continually exhibit behavior that qualifies them for involuntary
inpatient placement may be placed into involuntary outpatient
placement. 78 While the Baker Act does have the “teeth” necessary to
protect mentally ill patients from inflicting harm on themselves or others,
its ultimate goal remains helping patients recover.79
2. Patient Records
Under Florida law, a patient’s medical records are confidential.80 The
information contained in medical records is personal, and by prohibiting
disclosure, the patient’s privacy, along with the sanctity of the doctorpatient relationship, is protected. Without privacy protections, patients
may be reluctant to seek treatment or be forthright with their doctors, for
fear that third parties may stumble upon that information. Accordingly,
in Florida, medical “records may not be furnished to, and the medical
condition of a patient may not be discussed with, any person other than
the patient, the patient’s legal representative, or other health care
practitioners and providers involved in the patient’s care or treatment,
except upon written authorization from the patient.”81
In spite of the need to protect the privacy of patients, there are
exceptions to the rule. For instance, medical records may be disclosed
without written authorization to “any person, firm, or corporation that
has procured or furnished such care or treatment with the patient’s
consent” 82; when compulsory physical examination is made during the
course and scope of litigation 83; “[i]n any civil or criminal action, unless
otherwise prohibited by law, upon the issuance of a subpoena from a
court of competent jurisdiction and proper notice to the patient or the
patient’s legal representative by the party seeking such records”84; or to a
healthcare provider’s attorney in a medical negligence action.85
Whether the purposes of the exceptions to the rule are for economic
and judicial efficiency or because they present equitable solutions, the
effect is that patient records may be disclosed without authorization and
over the objection of the patient. Even though patients have relatively
strong federal privacy protections regarding their medical records, under
all available less restrictive alternatives must have been judged to be inappropriate. See
§ 394.467(1).
78
FLA. STAT. § 394.4655 (2014).
79
See FLA. STAT. § 394.4573 (2014).
80
See FLA. STAT. § 456.057 (2014).
81
§ 456.057(7).
82
§ 456.057(7)(a)(1).
83
§ 456.057(7)(a)(2).
84
§ 456.057(7)(a)(3).
85
§ 456.057(7)(a)(d).
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Florida law, they face the risk, in certain circumstances, of having their
medical records disclosed to third-parties.
III. FIREARM OWNERS PRIVACY ACT
On June 2, 2011, Florida Governor Rick Scott signed the Firearm
Owners Privacy Act into law. 86 The law, often referred to as the “Docs
vs. Glocks” law, protects patients’ privacy by restricting inquiry into
firearm ownership and prohibiting discrimination by physicians against
patients due to firearm ownership. 87 Four days after being signed into
law, several physicians’ groups initiated litigation seeking an injunction
to enjoin enforcement and a declaration that the law is unconstitutional.88
Thereafter, the district court issued its opinion in Wollschlaeger v.
Farmer (the “District Court Opinion”), enjoining the State from
enforcing the majority of the law.89
In the District Court Opinion, the court noted “as part of the practice
of preventive medicine, practitioners routinely ask and counsel patients
about a number of potential health and safety risks, including household
chemicals, swimming pools, drugs, alcohol, tobacco, and firearms.” 90 For
this reason, both the American College of Physicians and its Florida
chapter argued that a physician has an obligation to provide preventive
injury counseling on firearm safety. 91
Ultimately, the court granted the plaintiffs’ injunction based on its
finding that the Firearm Owners Privacy Act is unconstitutional due to
vagueness. 92 The constitutionality of the Firearm Owners Privacy Act,
however, was upheld on appeal, and the District Court Opinion was
reversed. 93 Consequently, the focus of this note will be on the
effectiveness of the law—not its constitutionality.
A. Language of the Act
By enacting the Firearm Owners Privacy Act, the Florida Legislature
created or amended three statutes: Section 790.338, Medical privacy
concerning firearms, prohibitions, penalties, exceptions; Section
86
2011 Fla. Laws 112.
See infra Parts III.A, C.
88
Complaint for Declaratory and Injunctive Relief, Wollschlaeger v. Farmer, 880 F.
Supp. 2d 1251 (S.D. Fla. 2012).
89
Wollschlaeger v. Farmer, 880 F. Supp. 2d 1251, 1270 (S.D. Fla. 2012).
90
Id. at 1257.
91
Id.
92
Id. at 1267-69.
93
See infra Part III.C.
87
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381.026, Florida Patient’s Bill of Rights and Responsibilities; and
Section 456.072, Grounds for discipline, penalties, enforcement.94
First, Section 790.338, although grounded in the actions of
healthcare practitioners, is located in Chapter 790 of the Florida Statutes,
which is entitled “Weapons and Firearms.” 95 If a significant portion of
the Act is located in the chapter on Weapons and Firearms, then is the
law a regulation of healthcare or a regulation of firearms? Despite the
location of the restrictions on physician conduct in the Florida Statutes,
the statute is a regulation of healthcare. This note contends that the
deliberate placement of this part of the Firearm Owners Privacy Act was
a strategic decision to emphasize the rights of firearm owners as
patients—the majority of the Act is patient-centric—and not merely to
dictate what healthcare providers can or cannot do.
Section 790.338 begins by prohibiting healthcare providers and
facilities from “intentionally [entering] any disclosed information
concerning firearm ownership into the patient’s medical record if the
practitioner knows that such information is not relevant to the patient’s
medical care of safety, or the safety of others.” 96 The central theme of the
statute is relevance. If the information is not relevant, then it need not be
entered into a patient’s medical records. Considering that patient medical
records may, under certain circumstances, be disclosed without the
patient’s authorization, Section 790.338(1) protects the patient’s privacy
in personal information unrelated to his or her treatment.
Next, Section 790.338 instructs healthcare providers on making
inquiries into firearm ownership and possession:
(2)
A health care practitioner licensed under chapter
456 or a health care facility licensed under chapter 395
shall respect a patient’s right to privacy and should
refrain from making a written inquiry or asking
questions concerning the ownership of a firearm or
ammunition by the patient or by a family member of the
patient, or the presence of a firearm in a private home or
other domicile of the patient or a family member of the
patient. Notwithstanding this provision, a health care
practitioner or health care facility that in good faith
believes that this information is relevant to the patient’s
medical care or safety, or the safety of others, may make
such a verbal or written inquiry.
94
95
96
2011 Fla. Laws 112.
FLA. STAT. Chapter 790 (2014).
FLA. STAT. § 790.338(1) (2014).
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(3)
Any emergency medical technician or paramedic
acting under the supervision of an emergency medical
services medical director under chapter 401 may make
an inquiry concerning the possession or presence of a
firearm if he or she, in good faith, believes that
information regarding the possession of a firearm by the
patient or the presence of a firearm in the home or
domicile of a patient or a patient’s family member is
necessary to treat a patient during the course and scope
of a medical emergency or that the presence or
possession of a firearm would pose an imminent danger
or threat to the patient or others.97
Upon reading subsection (2), one is left to ponder, what does it mean to
have a good faith belief that information regarding firearm ownership or
possession is relevant to a patient’s medical care or safety, or the safety
of others? The juxtaposition of these two subsections enables application
of the interpretive maxim noscitur a sociis—“a word may be known by
the company it keeps.” 98 Subsection (3) uses the phrase “a firearm would
pose an imminent danger or threat to the patient or others.” 99 By
choosing to use this phrase in subsection (3) but not in subsection (2), the
Legislature must have decided that an “imminent danger or threat to the
patient or others” is not a necessary prerequisite for a healthcare provider
to have a good faith belief that an inquiry is relevant to a patient’s
medical care or safety. So, what is necessary? If a physician maintains a
generalized belief that firearms are dangerous and are a threat to the
patient’s and others’ safety, may the physician make the inquiry? What if
the physician does not maintain such a generalized belief, but instead,
treats a clumsy patient? May the physician, concerned that the clumsy
patient will unintentionally discharge a firearm, make the inquiry then?
The remainder of Section 790.338 is less troublesome in interpreting:
(4)
A patient may decline to answer or provide any
information regarding ownership of a firearm by the
patient or a family member of the patient, or the
presence of a firearm in the domicile of the patient or a
family member of the patient. A patient’s decision not to
answer a question relating to the presence or ownership
of a firearm does not alter existing law regarding a
physician’s authorization to choose his or her patients.
97
98
99
§§ 790.338(2)-(3).
Russell Motor Car Co. v. United States, 261 U.S. 514, 519 (1923).
§ 790.338(3).
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(5)
A health care practitioner licensed under chapter
456 or a health care facility licensed under chapter 395
may not discriminate against a patient based solely upon
the patient’s exercise of the constitutional right to own
and possess firearms or ammunition.
(6)
A health care practitioner licensed under chapter
456 or a health care facility licensed under chapter 395
shall respect a patient’s legal right to own or possess a
firearm and should refrain from unnecessarily harassing
a patient about firearm ownership during an
examination.
(7)
An insurer issuing any type of insurance policy
pursuant to chapter 627 may not deny coverage, increase
any premium, or otherwise discriminate against any
insured or applicant for insurance on the basis of or upon
reliance upon the lawful ownership or possession of a
firearm or ammunition or the lawful use or storage of a
firearm or ammunition. Nothing herein shall prevent an
insurer from considering the fair market value of
firearms or ammunition in the setting of premiums for
scheduled personal property coverage. 100
In effect, the preceding subsections create a “protected class” of firearm
owners in terms of how healthcare providers may treat them. Like an
employment relationship, a physician may terminate the doctor-patient
relationship at will. In spite of the at-will nature of the relationship,
doctors are no longer free to use firearm ownership as a cause for
termination of the relationship.101 Further, because of the discrimination
provision, doctors may not charge firearm owners more, make firearm
owners wait longer, limit the days in which firearm owners may schedule
appointments, or carry out any other discriminatory practices against
firearm owners.
Subsection (6) leaves some room for the imagination. It deals with
unnecessary harassment, so unlike the subsections before it, it does not
100
§§ 790.338(4)-(7).
Admittedly, this is a somewhat inaccurate statement of the law. See Wollschlaeger
v. Farmer, 880 F. Supp. 2d 1251, 1264-65 (S.D. Fla. 2012) (“the State itself
acknowledges that the law does not prevent a physician from terminating the doctorpatient relationship”). It does not alter existing law pertaining to termination of the
doctor-patient relationship, but by terminating the relationship because of firearm
ownership, the doctor is subject to discipline. By being subject to discipline, the doctor
can terminate the relationship, but is not free to do so.
101
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necessarily pertain to inquiry. By its language, it is not clear if the
subsection prohibits anything, or is merely a recommendation. In the
former clause, 102 the term “shall” is used, which means “[h]as a duty to;
more broadly, is required to.” 103 On the other hand, the latter clause 104
uses the term “should,” which does not possess significant legal meaning
and is not defined in Black’s Law Dictionary. 105 Was this merely an
oversight on the part of the drafters, or was it their intention that the
latter clause be a recommendation?
As for subsection (7), the Legislature foreclosed on any argument
that firearm ownership makes a firearm owner an inherently riskier
candidate for insurance. The Legislature then concluded Section 790.338
with subsection (8), which designates violations of subsections (1)-(4) as
grounds for discipline. 106
Second, Section 381.026, the Florida Patient’s Bill of Rights and
Responsibilities, 107 was amended to add several provisions
complementary to those already discussed. If the amendment of Chapter
790 left any doubt that the Firearm Owners Privacy Act is a regulation of
healthcare, the amendment of Section 381.026 should eliminate that
uncertainty. Subsections (2), (4), (5), and (6) of Section 790.338 have
counterparts in Section 381.026, wherein they are subsections (8), (9),
(10), and (11), respectively. 108
Third, Section 456.072 was amended to give teeth to the Firearm
Owners Privacy Act. Now, violations of any of the provisions of Section
790.338 constitute grounds for discipline.109
B. Legislative History
Recall the earlier hypothetical in which a young mother who refused
to answer a pediatrician’s question about firearm ownership was told to
find a new doctor. 110 A similar scenario unfolded in Ocala, Florida. 111
102
§ 790.338(6) (“A health care practitioner licensed under chapter 456 or a health care
facility licensed under chapter 395 shall respect a patient’s legal right to own or possess a
firearm”) (emphasis added).
103
BLACK’S LAW DICTIONARY 1585 (10th ed. 2014).
104
§ 790.338(6) (“A health care practitioner licensed under chapter 456 or a health care
facility licensed under chapter 395 . . . should refrain from unnecessarily harassing a
patient about firearm ownership during an examination.”) (emphasis added).
105
See BLACK’S LAW DICTIONARY (10th ed. 2014).
106
§ 790.338(8).
107
Florida Patient’s Bill of Rights and Responsibilities, FLA. STAT. § 381.026 (2014).
108
§§ 381.026(8)-(11) (2014).
109
FLA. STAT. § 456.072(1)(mm) (2014).
110
Supra Part I.
111
See Health & Human Servs. Comm., Fla. H.R. Staff Analysis, H.R. 0155C, at 2
(Apr. 7, 2011).
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There, a pediatrician asked a patient’s mother whether there were
firearms in her home. When she refused to answer, the doctor advised
her that she had thirty days to find a new pediatrician, and that he asks all
of his patients about their firearm ownership in order to provide safety
advice. After receiving much media attention, the incident in Ocala “led
many to question whether it should be an accepted practice for a doctor
to inquire about a patient’s firearm ownership.” 112 As noted in the
District Court Opinion, many physicians groups encourage inquiry into
patients’ firearm ownership. 113 According to legislative findings, the
American Medical Association recommends its members inquire as to
the presence of firearms in the home and educate patients on the dangers
of firearms to children. 114 Further, the Legislature found the American
Academy of Pediatrics recommends physicians include questions about
firearms in their patient history taking. 115
During the legislative drafting process of the Firearm Owners
Privacy Act, the bill went through a series of revisions. The first
Committee Substitute of the original bill in the Florida House of
Representatives contained language pertaining to both the mental health
of the patient and whether the possession of firearms would pose an
imminent danger to the patient or others. The bill read:
(6)
Notwithstanding any other provision of this
section, it is not a violation for:
(a) Any psychiatrist as defined in s. 394.455,
psychologist as defined in s. 490.003, school
psychologist as defined in s. 490.003, clinical social
worker as defined in s. 491.003, or public or private
physician, nurse, or other medical personnel to make
an inquiry prohibited by paragraph (1)(a) if the
person making the inquiry in good faith believes that
the possession or control of a firearm or ammunition
by the patient or another member of the patient’s
household would pose an imminent danger or threat
to the patient or others.
(b) Any public or private physician, nurse, or other
medical personnel to make an inquiry prohibited by
paragraph (1)(a) if such inquiry is necessary to treat
112
113
114
115
Id.
See supra notes 90-91 and accompanying text.
Crim. Justice Comm., Fla. H.R. Staff Analysis, H.R. 0155, at 2 (Mar. 4, 2011).
Id.
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a patient during the course and scope of a medical
emergency which specifically includes, but is not
limited to, a mental health or psychotic episode
where the patient’s conduct or symptoms reasonably
indicate that the patient has the capacity of causing
harm to himself, herself, or others.
(c) Any public or private physician, nurse, or other
medical personnel to enter any of the information
disclosed pursuant to paragraphs (a) and (b) into any
record, whether written or electronic.116
Notably, subsection (6)(a) requires a good faith belief that possession of
a firearm would pose an imminent danger, and not just a vague good
faith belief that possession of a firearm would be relevant to a patient’s
medical care or safety. 117
Further, although subsection (b) specifies that it is not limited to
mental health or psychotic episodes, their specific mention is telling of
the drafters’ intent. It was wise, though, to not limit the exception only to
mental health or psychotic episodes. The House of Representatives’ Staff
Analysis points out that “[i]n certain instances, questions about gun
ownership may be necessary to the treatment of a patient (e.g.,
psychiatrists treating suicidal patients, emergency room physicians
treating gun shot victims who need to know the type, caliber, etc. of
firearm and ammunition used, etc.).” 118 Stated differently, the legislative
history indicates that, to be relevant to a patient’s treatment, the dangers
associated with gun ownership must be concrete, not abstract or
hypothetical.
In fact, the first Committee Substitute of the bill explained abstract
conceptions of danger do not satisfy the requirements for the exception.
Following subsection (6) above, a hanging paragraphing stated:
However, a patient’s response to any inquiry permissible
under this subsection shall be private and may not be
disclosed to any third party not participating in the
treatment of the patient other than a law enforcement
officer conducting an active investigation involving the
patient or the events giving rise to a medical emergency.
The exceptions provided by this subsection do not
116
Firearm Owners Privacy Act, H.R. 0155-01 (Fla. 2011).
Compare Firearm Owners Privacy Act, H.R. 0155-01 (Fla. 2011) with FLA. STAT.
§ 790.338(2) (2014).
118
Crim. Justice Comm., supra note 114, at 5.
117
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apply to inquiries made due to a person’s general
belief that firearms or ammunition are harmful to
health or safety. 119
The former sentence of the hanging paragraph protects patients from
disclosures such as those authorized under Section 456.057. 120 The latter
sentence clarifies what is meant by phrases such as “good faith
[belief] . . . would pose an imminent danger” and “necessary to treat a
patient during the course and scope of a medical emergency.”
Despite the clarity provided by these provisions, they were not
written into the final bill. Instead, the Legislature opted to use more
general language. The specific language may very well have been too
specific—information regarding firearm ownership or possession may be
relevant even though the threat or danger is not imminent. Nonetheless,
the unrefined language of the prior version of the bill provides valuable
insight into the true intent of the Legislature in passing the Firearm
Owners Privacy Act.
C. Wollschlaeger v. Governor of Florida
After the district court enjoined the State of Florida from enforcing
several core provisions of the Firearm Owners Privacy Act, the Eleventh
Circuit reversed, holding that the district court erred in finding the law
facially violates the First Amendment and that the law is not
unconstitutionally vague. 121 Finding the law to be a legitimate regulation
of professional conduct, the Eleventh Circuit stated “[i]t is
uncontroversial that a state may police the boundaries of good medical
practice by routinely subjecting physicians to malpractice liability or
administrative discipline for all manner of activity that the state deems
bad medicine, much of which necessarily involves physicians speaking
to patients.” 122
Before addressing the law itself, the court discussed the need for the
law. It noted there is an imbalance of power in the doctor-patient
relationship. “When a patient enters a physician’s office, the patient
depends on the physician’s knowledge and submits to the physician’s
authority . . . . So when physicians inquire about the presence of firearms
119
Firearm Owners Privacy Act, H.R. 0155-01 (Fla. 2011) (emphasis added).
See supra Part II.C.2. The House of Representatives’ Staff Analysis acknowledges
HIPAA authorizes disclosure of protected health information to certain entities without a
waiver or authorization; therefore, if information relating to firearm ownership qualifies
as protected health information, the law would conflict with HIPAA. Crim. Justice
Comm., supra note 114, at 5.
121
Wollschlaeger v. Governor of Florida, 760 F.3d 1195 (11th Cir. 2014).
122
Id. at 1203.
120
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in patients’ homes, some patients may feel that their physicians demand
an answer.” 123 Inside the examination room a patient may feel powerless
to deny the doctor an answer.
While the lion’s share of the decision discusses First Amendment
issues, this note will only address its discussion of vagueness. The
plaintiffs argued Sections 790.338(1)–(2) are vague because a
requirement that information be “relevant” to a patient’s medical care or
safety does not specify whether a physician must make a specific finding
of relevance for each patient, or whether the firearm information must be
relevant at the time of treatment or if future relevance is satisfactory. 124
Looking to the plain meaning of the word, the court defined “relevant” as
“[r]elated to the matter at hand; to the point; pertinent.” 125 Determination
of relevancy, according to the court, must be done on a case-by-case
basis. 126 To make that determination, the doctor must analyze
particularized information about the patient.127
The court points out that essential to the issue of relevancy is the
requirement that the doctor believe in good faith that firearm ownership
or possession is relevant to the patient’s medical care or safety. 128 But,
the justification the court provides in support of this proposition
seemingly detracts from the purpose of the law. The court reasoned,
Thus, a physician may make firearms inquiries of any or
all patients, so long as he or she does so with the good
faith belief—based on the specifics of the patient’s
case—that the inquiry is relevant to the patient’s medical
care or safety, or the safety of others.129
Taking this statement to the extreme, a physician could ask all patients of
a given demographic about their firearm ownership if he or she believes
that firearms ownership poses an inherent danger to members of that
demographic. Such interpretation of the law is untenable. The court
further explained that “[i]f . . . the physician seeks firearm information to
suit an agenda unrelated to medical care or safety, he or she would not be
making a ‘good faith’ inquiry.” 130 Although the court is correct in that
inquiring into firearm ownership for the purpose of promoting an agenda
123
Id. at 1214.
Id. at 1227.
125
Id. (quoting American Heritage Dictionary of the English Language 1098 (William
Morris, ed., 1969)) (alterations in original).
126
Id.
127
Id. at 1228.
128
Id.
129
Id..
130
Id.
124
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would be contrary to the law, it is unlikely that there will be such a clear
demarcation between promoting an agenda and acting on the belief that
is the core of the agenda. A doctor who would promote an agenda would
likely hold strong beliefs about the dangers of firearms. In making the
inquiry by virtue of the underlying belief, based on the Eleventh Circuit’s
opinion, the physician would be in accord with the law.
As for the phrase “unnecessarily harassing,” the court again looked
to the plain meaning of the words. It explained harass means “[t]o disturb
or irritate persistently.” 131 Similar to other parts of the law, this provision
is designed to prevent doctors from pursuing an agenda inside their
offices. The “unnecessarily harassing” provision “communicates that
health care providers should not disparage firearm-owning patients, and
should not continue over a patient’s objection or attempt to speak to the
patient about firearm ownership when not relevant to medical care or
safety.” 132 Additionally, the court explained the modifier “unnecessary”
“allows physicians the freedom to challenge—i.e., ‘harass’—patients
regarding firearms when doing so is necessary for health or safety
reasons if the patient might find the physicians’ advice unwelcome.” 133
This freedom is necessary for instances such as when a doctor is treating
a mentally unstable patient, and the patient objects to the doctor’s
inquiries. Not only do physicians have the defense that the harassment
was necessary, the Eleventh Circuit pointed out that even if a patient
feels harassed, the patient cannot by himself or herself subject the doctor
to discipline. A patient can either file a complaint, which will then trigger
an investigation, or a civil malpractice action. Regardless, the doctor
need not fear an adverse judgment or professional discipline so long as
he or she was operating in good faith and the information was relevant
and necessary. 134
To be brief, the court held the record keeping, inquiry, and
harassment provisions not void for vagueness. It found “persons of
‘common intelligence’” would experience no difficulty in interpreting
and applying the law. 135
131
Id. at 1229 (alteration in original) (quoting American Heritage Dictionary of the
English Language 600).
132
Id.
133
Id.
134
Id.
135
See id. at 1230.
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IV. LESS DISCRETION, MORE EFFECTIVE
From examining the legislative history of the Firearm Owners
Privacy Act, it is clear that the Legislature intended the exceptions in
Section 790.338 be construed narrowly. An expansive reading of these
exceptions, as done by the court in Wollschlaeger, would render the law
fruitless. In prior versions of the bill, the exceptions were formulated in
terms such as “imminent danger” and “mental health or psychotic
episode.” 136 By the law’s final passage, all references to the patient’s
mental health were removed and replaced with more general language
referring to the patient’s medical care or safety.
Even though the Legislature opted to remove the language pertaining
to mental health, a patient’s mental state should be a prominent factor in
determining the relevancy of information regarding firearm ownership or
possession. As previously mentioned, according to the Baker Act, mental
illness means “an impairment of the mental or emotional processes that
exercise conscious control of one’s actions or of the ability to perceive or
understand reality.” 137 This note posits that any person unable to exhibit
control over his or her actions or to properly perceive and understand
reality is a dangerous person. An innocuous gesture may be perceived as
a threat, and a threat, no matter how slight, may receive a
disproportionate response. Not only should healthcare providers have the
ability to question someone suffering from mental illness about
ownership or possession of firearms, it would be irresponsible and a
dereliction of duty to refrain from such inquiry. 138
In a like manner, the phrase “imminent danger” also places the
patient’s mental state under scrutiny, which could be inferred from
behavior. 139 However, a patient would not need to be mentally ill in order
to be in a mental state in which he or she poses an imminent danger to
himself or herself or others. For example, a patient in a state of rage,
although in control of his or her actions and able to perceive reality
normally, may pose an imminent threat to others.
136
See supra Part III.B.
FLA. STAT. § 394.455(18) (2014).
138
This note speaks only of those currently suffering from mental illness, and not of
people who were once deemed mentally ill but are now healthy. But see Tyler v.
Hillsdale Cnty. Sheriff’s Dep’t, 775 F.3d 308 (6th Cir. 2014) (“The government’s interest
in keeping firearms out of the hands of the mentally ill is not sufficiently related to
depriving the mentally healthy, who had a distant episode of commitment, of their
constitutional rights”).
139
Assuming, arguendo, that the danger will be caused by the patient. Of course, the
patient may also be the victim of violence. Under those circumstances the existence of an
imminent danger would be evidenced by external factors.
137
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Being that both phrases from the prior version of the bill dealt with
the patient’s mental state, why then did the Legislature ultimately enact
Section 790.338(2) without any indicator that relevancy requires the
patient possess a particular mental state? As a reminder, the
Wollschlaeger court stated that a doctor may direct firearms inquiries
towards all patients, so long as the information is relevant, based on the
specifics of the case, to the patient’s medical care of safety. Despite not
being too vague for constitutional purposes, this interpretation of the law
leaves doctors with a healthy dose of discretion to apply their personal
beliefs regarding firearms to their relevancy determinations. Would
changing the language from “relevant to the patient’s medical care or
safety” strengthen Section 790.338(2) so that it better effectuates its
originally intended purpose?
With regards to the language of the law, there are several phrases
that the Legislature has previously considered that better tie in a mental
state component. Limiting inquiries only to times when there is
“imminent danger” creates risk because some dangers are foreseeable,
even probable, but not imminent. Likewise, a requirement that the patient
is mentally ill or experiencing a psychotic episode is too narrow. There
will be dangerous patients who are fully conscious of their actions and of
the world around them. In contrast to the Firearm Owners Privacy Act
and its legislative history, the Baker Act uses a combination of these
phrases as the criteria for involuntary examination. A patient may be
taken for involuntary examination if he or she is mentally ill and either
likely to suffer from neglect and such neglect poses a real and present
threat of substantial harm to his or her well-being, or there is substantial
likelihood that the patient will cause serious bodily harm to himself or
herself or others, as evidenced by recent behavior.140
Consider if, instead of its present form, Section 790.338(2) read in
part:
Notwithstanding this provision, a health care practitioner
or health care facility that in good faith believes that
there is a substantial likelihood that the ownership or
possession of a firearm or ammunition by the patient or
by a family member of the patient, or the presence of a
firearm in a private home or domicile of the patient or a
family member of the patient, will cause serious bodily
harm to the patient or others in the near future.
140
FLA. STAT. § 394.463(1)(b) (2014).
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By borrowing the language of the Baker Act, the Firearm Owners
Privacy Act would more clearly define what is necessary for the inquiry
to be relevant. Additionally, the language of the Baker Act is time-tested.
The aforementioned language has withstood judicial scrutiny for over
twenty-five years. 141
In light of the various terms so far discussed, the substantial
likelihood of harm exception used in the Baker Act is relatively strong. It
does not require a weighing of probabilities, nor is it activated by a mere
possibility of harm. However, it has its limitations. As written, this
exception is forward-looking only. If a patient presents with a gunshot
wound, information on the caliber and type of ammunition would likely
aid the treating physician. Section 790.338(3) creates an exception to the
general rule for such medical emergencies, but the exception only applies
to emergency medical technicians and paramedics. Therefore, in order
for the language derived from the Baker Act to be workable, Section
790.338(3) would also need to be amended to expand its scope from
emergency services workers to all healthcare providers.
While these changes would make the Firearm Owners Privacy Act
more effective, less invasive changes may be sufficient. To reiterate, the
problem with the law as currently enacted is that the relevancy inquiry
leaves physicians too much leeway. If the amount of discretion
physicians have in making the relevancy determination could be limited,
the law would be more effective. The law could be improved by
amending the previously mentioned subsections. But, there is an
alternative path that offers less resistance. In lieu of revising substantial
portions of the law, the Legislature should reinstate that portion of the
hanging paragraph that excludes from the exception those inquiries made
due to a general belief that firearms or ammunition are dangerous.
When the law was originally drafted in the Legislature, it had a
purpose. Now it is better written, but to do that, the exceptions were
broadened. The phrase “relevant to the patient’s medical care or safety”
creates a sensible exception, yet gives doctors the ability to exploit a
loophole. With this loophole, physicians with an understanding of the
law can act in large part as if Section 790.338(2) does not exist.
Wollschlaeger states that relevancy must be determined on a case-bycase basis upon particularized information. Other than that, there is no
explicit limitation of what type of information will suffice for that
determination. If the Legislature added language to indicate that “the
exceptions provided by Section 790.338(2) do not apply to inquiries
made due to a person’s general belief that firearms or ammunition are
harmful to health or safety,” the excessive amount of discretion held by
141
See Paddock v. Chacko, 522 So. 2d 410, n.5 (Fla. Dist. Ct. App. 1988).
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physicians would be reduced. Thus, it would not fall within the exception
for a physician to inquire as to firearm ownership for patients given his
or her belief that the patient is part of an at-risk demographic.
In short, the Firearm Owners Privacy Act would be most improved
by amending Section 790.338 so that the exception to the general
prohibition against inquiries concerning firearm ownership would require
a good faith belief that there is a substantial likelihood of serious bodily
harm to the patient or others in the near future. By making substantial
likelihood of serious bodily harm a sine qua non to the exception, clever
physicians will be less able to pursue an agenda under the pretext of
preventive medicine. If, on the other hand, the Legislature were to find
that such a change would be too radical, the law could still be improved
by merely adding an explanation that to be relevant, more is necessary
than a general belief that firearms are dangerous.
V. CONCLUSION
Certainly, patients benefit when they can enter a physician’s
examination room without fear of being harassed or being subject to a
political agenda. Likewise, physicians have responsibilities that will, at
times, require them to broach sensitive subjects. The Florida Firearm
Owners Privacy Act recognizes this dichotomy by both explicitly
granting patients a right to privacy in regards to their firearm ownership
and possession, and by carving out exceptions for when that information
is pertinent to treatment.
That said, the exceptions are broader than are necessary for
physicians to provide adequate treatment. Amending the law to phrase
the exceptions in more specific language will serve to better effectuate
the law’s purpose by raising the threshold for which the information is
deemed relevant. What the law should advise the healthcare consuming
public and physicians alike is that firearm ownership is not intrinsically a
cause for medical concern. Only when there is an antecedent medical
diagnosis or indication that a patient may be harmed or harm others, or
during the course of a medical emergency, should a physician ever
inquire into firearm ownership or possession.
Earlier, this note mentioned that the federal government regulates
healthcare in some ways through Medicare.142 Currently, the federal
government has no regulations in place that either prohibit or compel
inquiry into firearm ownership. Nonetheless, the Centers for Medicare &
Medicaid Services contends, “nothing in [the Affordable Care Act]
prohibits or otherwise limits communication between health care
142
Supra Part II.A.2.
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professionals and their patients, including communications about
firearms. Health care providers can play an important role in promoting
gun safety.” 143 This is the sentiment that precipitated the need for the
Firearm Owners Privacy Act. Florida took the initiative to protect the
privacy rights of patients, which in turn improves access to and usage of
healthcare. Let Florida’s system serve as a roadmap for other states that
wish to put patient care above politics.
143
Centers for Medicare & Medicaid Services, Affordable Care Act Implementation
FAQs – Set 11, http://www.cms.gov/CCIIO/Resources/Fact-Sheets-and-FAQs/aca_
implementation_faqs11.html (last visited Jan. 7, 2015).
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