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 Faculty Advisor EMILY HOROWITZ Special Advisor to the Law Reviews GLORIA GARCIA Administrative Assistant 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 Patricia D. White, B.A., M.A., J.D., Dean & Professor of Law Patrick O. Gudridge, A.B., J.D., Vice Dean & Professor of Law Ileana Porras, B.A., M.Phil., J.D., Associate Dean of Academic Affairs Raquel M. Matas, B.A., J.D., Associate Dean for Administration and Counsel to the Dean Douglas K. Bischoff, A.B., J.D., LL.M., Associate Dean for the Adjunct Faculty & Director of the Graduate Program in Real Property Development Georgina Angones, B.A., Assistant Dean for Law Development and Alumni Relations Marcelyn Cox, B.A., J.D., Assistant Dean, Career Development Office Michael L. Goodnight, B.A., M.S., Associate Dean of Admissions and Enrollment Management Janet E. Stearns, B.A., J.D., Dean of Students Marni B. Lennon, B.A., Ms.Ed., J.D., Assistant Dean for Public Interest and Pro Bono, Director, HOPE Public Interest Resource Center William P. VanderWyden, III, B.A., M.Ed., J.D., Assistant Dean for Professional Development Greg Levy, B.A., J.D., Assistant Dean of Academic Affairs and Student Services Stephanie D. Cox, B.A., Assistant Dean for External Affairs FACULTY David Abraham, B.A., M.A., Ph.D., J.D., Professor of Law & University of Miami Law Review Faculty Advisor Anthony V. Alfieri, A.B., J.D., Dean’s Distinguished Scholar, Professor of Law & Director of the Center for Ethics & Public Service Paula Arias, J.D., Director of International Moot Court Program & Lecturer in Law Jill Barton, B.J., B.A., M.S., J.D., Professor of Legal Writing & Lecturer in Law Ricardo Bascuas, B.A., J.D., Professor of Law Ellen Belfer, B.A., J.D., Professor of Legal Writing & Lecturer in Law Caroline Bettinger-Lopez, B.A., J.D., Associate Professor of Clinical Legal Education & Director, Human Rights Clinic William Blatt, A.B., J.D., Professor of Law Caroline M. Bradley, B.A. (Hons), LL.M., Professor of Law Patricia A. Brown, B.S.F.S., J.D., Director, Graduate Program in Taxation Sergio Campos, A.B., J.D., Associate Professor of Law Donna K. Coker, B.S.W., M.S.W., J.D., Professor of Law Charlton Copeland, B.A., M.A.R., J.D., Professor of Law Caroline Mala Corbin, B.A., J.D., Professor of Law Andrew Dawson, B.A., J.D., Associate Professor of Law Michele DeStefano, B.A., J.D., Professor of Law Stephen M. Diamond, B.A., A.M., Ph.D., J.D., Professor of Law 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 Stephen K. Halpert, A.B., J.D., Professor of Law 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 Jan L. Jacobowitz, B.S., J.D., Director of the Professional Responsibility and Ethics Program & Lecturer in Law Osamudia James, B.A., J.D., LL.M., Professor of Law D. Marvin Jones, B.S., J.D., Professor of Law Stanley I. Langbein, A.B., J.D., Professor of Law Tamara Rice Lave, B.A., M.A., Ph.D., J.D., Associate Professor of Law Lili Levi, A.B., J.D., Professor of Law Dennis O. Lynch, B.A., J.D., J.S.D., LL.M., Dean Emeritus & Professor of Law 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 Felix Mormann, J.D., LL.M., Associate Professor of Law Jessica Carvalho Morris, J.D., Director of International Graduate Law Programs Sarah A. Mourer, B.S., J.D., Director of the Capital Defense Project and Miami Innocence Project & Associate Professor of Clinical Legal Education George Mundstock, B.A., J.D., Professor of Law Peter Nemerovski, B.A., J.D., Professor of Legal Writing & Lecturer in Law JoNel Newman, B.A., J.D., Director of the Health and Elder Law Clinic & Professor of Clinical Legal Education James W. Nickel, B.A., Ph.D., Professor of Philosophy & Professor of Law Leigh Osofsky, A.B., J.D., Associate Professor of Law Bernard H. Oxman, A.B., J.D., Richard A. Hausler Endowed Chair& Professor of Law Kunal Parker, A.B., M.A., J.D., Ph.D., Dean’s Distinguished Scholar & Professor of Law Jan Paulsson, A.B., J.D., Michael Klein Distinguished Scholar Chair & Professor of Law Bernard P. Perlmutter, B.A., J.D., Co-Director of the Children & Youth Law Clinic & Professor of Clinical Legal Education Shara Pelz, B.A., J.D., Professor of Legal Writing & Lecturer in Law Alejandro Portes, B.A., M.A., Ph.D., Professor of Sociology & Professor of Law Tina Portuondo, B.A., J.D., LL.M., Director of the Heckerling Institute on Estate Planning Thomas A. Robinson, B.S., J.D., B.Litt., Professor of Law Scott Rogers, B.S., M.S., J.D., Director, Mindfulness and the Law Program & Lecturer in Law Laurence M. Rose, B.A., J.D., Director of the Litigation Skills Program & Professor of Law Emeritus Robert E. Rosen, A.B., M.A., J.D., Ph.D., Professor of Law Keith S. Rosenn, B.A., LL.B., Professor of Law & Chair of Foreign Graduate Law Program Edgardo Rotman, J.D., LL.M., Ph.D., LL.B., Lecturer in International & Comparative Law Andres Sawicki, S.B., J.D., Associate Professor of Law Stephen J. Schnably, A.B., J.D., Professor of Law Rebecca Sharpless, B.A., M.Phil., J.D., Professor of Clinical Legal Education Rachel Smith, B.A., J.D., Professor of Legal Writing & Lecturer in Law Rachel Stabler, B.A., J.D., Professor of Legal Writing & Lecturer in Law Kele Stewart, B.S., J.D., Co-Director of the Children & Youth Law Clinic & Professor of Clinical Legal Education Irwin P. Stotzky, B.A., J.D., Professor of Law Scott Sundby, B.A., J.D., Dean’s Distinguished Scholar & Professor of Law Jessi Tamayo, B.A., J.D., Director of Public Programming & Lecturer in Law Annette Torres, B.A., M.B.A., J.D., Professor of Legal Writing & Lecturer in Law Stephen K. Urice, B.A., Ph.D., J.D., Professor of Law Francisco Valdes, B.A., J.D., J.S.M., J.S.D., Dean’s Distinguished Scholar & Professor of Law Teresa Verges, B.A. J.D., Director, Investor Rights Clinic & Lecturer in Law Markus Wagner, J.S.M., M.J.I., J.D., Associate Professor of Law William H. Widen, A.B., J.D., Professor of Law Richard L. Williamson, Jr., A.B., M.A., J.D., Professor of Law Sally H. Wise, B.A., J.D., M.LL., Director of the Law Library & Professor of Law Jennifer H. Zawid, B.A., J.D., Director of the Externship Program & Lecturer in Law Cheryl Zuckerman, B.A., J.D., Professor of Legal Writing & Lecturer in Law Emeriti Terence J. Anderson, B.A., J.D., Professor Emeritus of Law Kenneth M. Casebeer, A.B., J.D., Professor Emeritus of Law Mary I. Coombs, B.A., M.A., J.D., Professor Emerita of Law M. Minnette Massey, B.B.A., LL.B., M.A., LL.M., Professor Emerita of Law Kathryn D. Sowle, B.A., J.D., Professor Emerita of Law STATEMENT OF EDITORIAL POLICY The University of Miami Business Law Review, formerly the University of Miami Business Law Journal (ISSN: 1047-2819), is an academic journal that publishes submitted articles and student notes and comments on legal issues arising in any field related to business. These areas include, but are not limited to, corporation, tax, antitrust, banking, securities regulation, bankruptcy, environmental, sports, entertainment, health, insurance, and labor law. The University of Miami Business Law Review is currently available on LEXIS and Westlaw, as well as on our organizational website at law.miami.edu/umblr. SUBSCRIPTIONS: The University of Miami Business Law Review strives to produce three issues per year, including a symposium issue. 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MEMBERSHIP: The University of Miami Business Law Review selects members on the basis of academic performance and a student writing competition. The Editorial Board does not discriminate on the basis of age, color, handicap, national origin, race, religion, sex, or sexual orientation. COPYRIGHT: Copyright (c) 2015 by the University of Miami Business Law Review. The author of each article published in the University of Miami Business Law Review grants permission for copies of that article to be made and used for classroom use, provided that the user identifies the author and the journal, affixes proper notice of copyright to each copy, and sends notice and a description of the use to the University of Miami Business Law Review. In addition, the author of each article grants the University of Miami Business Law Review the right to authorize the publication, reproduction, and distribution of the article in electronic, computerized-retrieval systems, and similar forms, and to transfer such rights. For reprint permission for purposes other than classroom use, please contact the University of Miami Business Law Review at the address below, fax (305-284-6506), or email ([email protected]). Please allow at least one business week for processing. Address all inquiries to: Editor in Chief University of Miami Business Law Review University of Miami School of Law 1311 Miller Drive, Law Library D334 Coral Gables, Florida 33146 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 [Vol. 23:341 “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). 2015] 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 [Vol. 23:341 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 2015] 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:341 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 2015] COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS 351 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 [Vol. 23:341 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). 2015] 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 [Vol. 23:341 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. 2015] 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:341 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.”). 2015] COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS 357 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:341 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 2015] COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS 359 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. 360 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:341 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 2015] 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 362 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:341 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). 2015] COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS 363 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. 364 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:341 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. 2015] COMMUNICABLE DISEASE RESPONSE CONSIDERATIONS 365 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. 131 366 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:341 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. 2015] 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 [Vol. 23:341 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 2015] 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. 370 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:341 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). 2015] 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). 372 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:341 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. 2015] 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. 374 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:341 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 [Vol. 23:375 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. 8 378 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:375 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 2015] EBOLA, QUARANTINE, AND FLAWED CDC POLICY 379 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:375 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 2015] EBOLA, QUARANTINE, AND FLAWED CDC POLICY 381 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:375 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 2015] EBOLA, QUARANTINE, AND FLAWED CDC POLICY 383 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:375 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 2015] EBOLA, QUARANTINE, AND FLAWED CDC POLICY 385 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:375 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. 2015] 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 [Vol. 23:375 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). 2015] 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:375 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. 2015] 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 [Vol. 23:375 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 2015] 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:375 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®ion=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 2015] 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. 396 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:375 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. 2015] 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:375 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:401 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). 2015] PHARMACEUTICALS AND BIOPIRACY 403 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:401 “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 2015] 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:401 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 2015] PHARMACEUTICALS AND BIOPIRACY 407 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:401 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. 2015] PHARMACEUTICALS AND BIOPIRACY 409 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:401 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. 2015] PHARMACEUTICALS AND BIOPIRACY 411 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:401 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 2015] 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). 414 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:401 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. 2015] PHARMACEUTICALS AND BIOPIRACY 415 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. 416 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:401 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. 2015] PHARMACEUTICALS AND BIOPIRACY 417 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. 111 418 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:401 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 2015] PHARMACEUTICALS AND BIOPIRACY 419 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. 420 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW B. Limitations of the administrative process [Vol. 23:401 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 2015] PHARMACEUTICALS AND BIOPIRACY 421 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). 422 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:401 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 2015] PHARMACEUTICALS AND BIOPIRACY 423 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). 2015] 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. 428 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:425 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 2015] HOSPITAL-PHYSICIAN EMPLOYMENT TERMINATION 429 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. 16 430 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:425 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. 2015] HOSPITAL-PHYSICIAN EMPLOYMENT TERMINATION 431 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”). 432 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:425 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). 2015] HOSPITAL-PHYSICIAN EMPLOYMENT TERMINATION 433 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. 40 434 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:425 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). 2015] HOSPITAL-PHYSICIAN EMPLOYMENT TERMINATION 435 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. 436 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:425 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 2015] HOSPITAL-PHYSICIAN EMPLOYMENT TERMINATION 437 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. 61 438 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:425 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 2015] HOSPITAL-PHYSICIAN EMPLOYMENT TERMINATION 439 “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). 70 440 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:425 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]. 2015] HOSPITAL-PHYSICIAN EMPLOYMENT TERMINATION 441 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). 79 442 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:425 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 2015] HOSPITAL-PHYSICIAN EMPLOYMENT TERMINATION 443 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. 444 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:425 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. 2015] HOSPITAL-PHYSICIAN EMPLOYMENT TERMINATION 445 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 99 446 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:425 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). 2015] HOSPITAL-PHYSICIAN EMPLOYMENT TERMINATION 447 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. 106 448 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:425 “[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). 2015] HOSPITAL-PHYSICIAN EMPLOYMENT TERMINATION 449 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. 450 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:425 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. 451 452 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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. 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 453 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. 454 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 455 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). 13 456 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 457 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). 30 458 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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). 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 459 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. 41 460 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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. 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 461 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 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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. 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 463 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. 67 464 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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, 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 465 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). 466 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 467 381.026, 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). 468 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 (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). 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 469 (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. 101 470 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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). 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 471 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. 472 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 473 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. 120 474 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 475 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. 476 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 477 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). 478 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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). 2015] WOLLSCHLAEGER & PATIENTS' RIGHT TO PRIVACY 479 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. 480 UNIVERSITY OF MIAMI BUSINESS LAW REVIEW [Vol. 23:451 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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